User Manual
Contents
1. Guerbet M U000138 05 2 M U000138 05 User Manual Important advice Warnings and precautions for use 6 1 PRESENTATION 1 1 Introduction 8 1 2 Description of the injector installation and environment 8 1 2 1 Injector head 9 1 2 2 Power unit 10 1 2 3 Monitor 11 1 2 4 Installation 11 1 3 Guarantee and maintenance contract 13 2 USING THE INJECTION SYSTEM 2 1 Particularities 13 2 2 Starting the injection system 15 2 2 1 Power on and startup 15 2 2 2 Selecting the usage mode 16 2 2 3 Calibration 17 2 3 Preparing bags 19 2 3 1 Filling empty bags 19 2 3 2 Preparing the ScanBag 21 2 3 3 Selecting the bag kit 23 2 3 4 Inserting the bag in the single bag mode 23 2 3 5 Inserting bags in the double bag mode 26 2 3 6 Purging air 28 2 4 Configuring the monitor 30 2 4 1 General description of the main injection screens 30 2 4 2 Saving and deleting a protocol 33 2 4 3 Synchronising X rays and timer 36 M U000138 05 4 Contents SBI 5000 CT SBI 5002 CT 2 5 Injection 37 2 5 1 Preparing the injection 37 2 5 2 Starting the injection 39 2 5 3 Monitoring the injection 40 2 5 4 Procedures for stopping the injection 42 2 5 5 Safety procedures during the injection 43 2 5 6 Reinstalling the bag s 44 2 5 7 Injection history 45 2 6 Information window 47 2 6 1 Monitor tab 47 2 6 2 Control panel tab 49 2 6 3 Bag kit tab 51 2 6 4 Maintenance tab 51 2 7 Stopping the injector 53 2 7 1 Stopping from the home page2. Warning The lid of the injector head must remain closed during the whole calibration procedure ta Confirm on the injector head 8 VALIDATE The message Please wait appears on the control panel of injector head The message calibration OK appears followed by a sound signal indicating that calibration is proceeding correctly The message opening appears Three rapid beeps also indicate to the user that calibration is complete The message insert the contrast agent and validate appears which means that calibration is over M U000138 05 17 Depending on the configuration of the injector a new calibration may be required after 3 hours The following message will be displayed on the console Calibration occurs only outside the phases of preparation and injection It improves the measure of the bags volumes and is recommended to accept it However cancellation is possible STOP INFORMATIONS Eg somos EU Warning message before Button to calibration cancel calibration Button to confirm calibration Before performing the new calibration read the instructions on the console and ensure that no bag is left in the injector and no patient is connected to the injector To continue the procedure refer to the chapter 2 2 3 Homing STOP FORMATIONS M U000138 05 18 2 3 Preparing bags 2 3 1 Filling empty bags For the contrast agent the operator has the choice of di
3. ER The orange light indicates the contrast agent to purge 2 Press the button rapid purge and or the button slow purge until contrast agent comes out of the tube Visually check that the whole line is filled with contr n E Confirm that the purge is complete by pressing validation The message Purge terminated appears and the indicator light blink rapidly They then remain lit Purge in double bag mode The blue light indicates the saline to purge The blue light indicates the contrast agent to purge The button contrast switches from one to the other as many times as necessary Ell Press rapid purge and or slow purge until saline or contrast agent comes out of the tube Press contrast Press rapid purge and or slow purge until saline or contrast agent comes out of the tube Visually check that the both lines are filled with liquid 4 Confirm that the purge is complete by pressing validation The message Purge terminated appears and the indicator light blink rapidly They then remain lit M U000138 05 28 For safety reasons the purge phase cannot be validated without purging each of the bags at least once The purge is only effective when air has been totally removed from the tubes meaning that there is no more air in the bag s Check that there is contrast agent or saline in the whole tube Purging is a manual operation to be performed only by qualified perso
4. both single and double bag kits The main difference of SBI 5002 CT is its possibility to combine contrast agent and normal saline injections according to sequences chosen by the user to correspond to the development of new injection protocols The injector head is equipped with a hydraulic pressure sensor that guarantees better safety and higher precision than with syringe systems El OPEN button opens the 3 CONTRAST button only used on depressurised actuator bag SBI 5002 CT for the double bag mode to remove the bag s It controls the movement of the tube clamp of solution for injection from the injector for inserting and removing bags It is used to select one of the two bags for purging RAPID PURGE rapid purge of air in the bag s MINUS button not used 8 SLOW PURGE slow purge of air PLUS button not used from the bag s Blue light indicates an ongoing operation E n VALIDATION button validation of an on the saline solution action LCD screen indicates system status and INJECTION button starts injection from the procedure to follow with a static or injector head scrolling text Orange light indicates an ongoing operation on the contrast agent 12 Orange light indicates that the head is ready for injection M U000138 05 9 Cj S H i Presentation 1 2 2 Power unit The power unit produces uniform hydraulic pressure on the bag s of solution for injection contrast agent normal
5. diagnosis aa The two liquid function is for injections from the single dose container Do not use the two liquid function for injections from the multi dose container or in more than one patient wa his device is not intended for administration of medicinal products or chemotherapy It must not be used for applications other than that for which it is intended he SBI injection system must be used correctly to avoid air embolisms Once the bag is filled with the desired volume YOU MUST REMOVE ALL THE AIR IN THE BAG AND LINES WITH THE INJECTOR IF THIS PRECAUTION IS NOT TAKEN SERIOUS OR MORTAL INJURIES CAN RESULT z4 n the event of malfunction shut the device off immediately and disconnect it rapidly from the patient Check that everything is functioning properly again before reconnecting Turn the system power on activate it and proceed with a test injection If the problem is resolved reconnect the patient If the failure message is still displayed and cannot be corrected or if the injector still does not function properly STOP USING the SBI injection system until the problem has been correctly diagnosed and resolved Get in touch with your local Guerbet distributor or another certified Medex distributor contact information on the last page Carefully select the flow rate on the workstation to avoid inadvertently causing an injection rate that is too high AN INJECTION RATE THAT IS TOO HIGH CAN INJURE THE PATIENT Check al
6. name 14 characters i e letters figures spaces pet EZELZE IND Ga J EEETFELLETI EN J Confirm with OK The entered name appears at the top left in the orange bar of the main window If you open the protocol selection window the new protocol is available along with the existing protocols M U000138 05 33 Using existing protocols fl Press PROTOCOL Select the PROTOCOL name STOP TM 3 INFORMATIONS HOME PAGE k Press OK to confirm the protocol selection Note You can switch from the AZERTY keyboard or QUERTY or QUERTZ to the QUERTY or QUERTZ keyboard or AZERTY M U000138 05 34 Deleting a protocol i Press PROTOCOL Select the PROTOCOL to delete IZ d Press suppress press protocol B Name of protocol to delete ta Confirm with Yes M U000138 05 35 S B Using the injection system _ _ 2 4 3 Synchronising X rays and timers Synchronising X rays and timers Delay button Press Delay button to set two parameters e Synchronise SBI gt X rays ticked The injector controls the start of the X ray device depending on the programmed delay A beep indicates the end of this delay e Synchronise X rays gt SBI not ticked The X ray device controls the injector start Select the injection start mode in the information window Scanner see 2 6 1 By default the injector uses
7. of an incident 1 3 Guarantee and maintenance contract The guarantee is valid for one year and covers maintenance and parts The following are not covered by the guarantee a Any damage caused by using the injector in a manner not recommended by Medex Deterioration caused by shocks liquids and prolonged exposure to sources of heat Deterioration of the actuator bag by sharp instruments tools scissors rings etc Servicing by unauthorised personnel Software errors or deterioration due to uncontrolled an external disturbance At the end of the guarantee a maintenance contract is required whose terms are available upon request M U000138 05 13 2 Using the injection system 2 1 Particularities CHARACTERISTICS SBI 5000 CT SBI 5002 CT Performance Bag capacity 500 ml 250 ml x an 250 ml Total programmable volume 200 ml Flow rate 0 5 to 8 ml s Slow purge Installation and startup Power consumption M U000138 05 14 2 2 Starting the injection system 2 2 1 Power on and startu To turn on the power press the On Off switch on the back of the power unit Ell On Off switch M U000138 05 15 Bienvenue Welcome Veuillez patienter Loading please wait Using the injection system After turning the power on the screen temporarily displays Welcome 2 2 2 Selecting the usage mode The home page is displayed You can return to the mai
8. the kit selected CALIBRATION In the calibration step the injector calculates its reference position The bags must be removed from the head and the lid must be closed This obligatory step occurs automatically each time the device is turned on CONTRAST AGENT lodinated solution for injection used to enhance contrast in organs examined for diagnostic purposes CONTROL PANEL Panel with an LCD screen located on the injector head The control panel informs the user on the injector status It controls all the functions involved in preparing the injection bag insertion pressurisation purging and activation FILL FAST FILLER Injector accessory provided as standard equipment with each injector The filler is used to transfer bottle contents to Medex soft bags HYDRAULIC CONNECTOR Sealed connection between the injector head and the power unit The system can rapidly isolate the various components of the injector The injector must never be turned on if any of the components are not connected LID Top part of the injector that closes the injector head and maintains pressure It is opened by pushing the green lock buttons laterally and tilting the whole lid backwards It should be closed without force and must remain closed during injector pressurisation M U000138 05 61 LOG Record of events that occur during injector use There are two logs the injection log which gives details about injections performed each month and the injecto
9. the manual synchronisation mode with the time at 0 Synchronisation requires special connections between the injector and the X ray device For more information contact Medex or the representative in your country M U000138 05 36 2 5 Injection LL T 2 5 1 Preparing the injection Configuring phases The injection procedure can be programmed by selecting the number of phases the volumes injected the injection flow rate o the delay between phases Note With two bags the injection solution can be selected for each phase Single bag version Select the number of phases in the protocol gt phases not selected disappear E Select the volume gt a number pad for entering the volume appears e Enter the volume e Confirm with OK gt the volume is displayed the selection window Select the flow rate a number pad for entering the flow rate appears e Enter the flow rate e Confirm with OK gt the flow rate is displayed in the selection window e the phase duration is calculated automatically and is displayed Select the delay gt a number pad for entering the delay appears e Enter the delay e Confirm with OK gt the delay is displayed in the selection window Note step D is required if a delay is authorised between two phases M U000138 05 3 Double bag version D E Select the type of phase by pressing Phase gt the phase blinks blue and white e Select the solution in eac
10. 21 Fa Remove the white cap at the end of the Remove the red 350 concentration or blue extension line with the green ring foolproof cap 300 concentration from the ScanBag device ER Connect the extension 5 Break the removable part of 3 The ScanBag is ready line to the ScanBag the safety system on the for insertion into the SBI ScanBag as described on the injector head actuator bag packaging of the ScanBag M U000138 05 22 2 3 3 Selecting the bag kit The bag kit must be selected This kit refers to the size of the bags used This information informs the injector of the container volume that must be deducted from its measurement To open the bag kit window 1 Press the Information button in the main window 2 Select the tab Bag kits Medex 250 Medex 250 x Medex 250 Medex 250 ScanBag_100 ScanBag_150 ScanBag _200 ScanBag_100 ScanBag_150 ScanBag 200 double bag version single bag version An oversight or error in the choice of the kit can result in false information on the volume s actually present 2 3 4 Inserting the bag in the single bag mode Open the lid Push the buttons outward Tilt the lid backwards Tilt the spout forwards M U000138 05 23 Press the end of the tube into the cupholder El Insert the contrast agent Close the spout bag into the injector Not represented Close Put the green ring the lid without forcing it The f
11. 5 40 Ongoing injection phase The ongoing injection phase also corresponds to a colour code the phase is highlighted in blue for saline and in yellow for contrast agent Single bag Double bag 1 Ongoing injection phase Information on volumes Single bag Double bag Explanation and legend on page 28 Pressure measurement Pressure is measured in the injector head and is immediately displayed on the screen Maximum pressure entered pJ Pressure measured during the injection M U000138 05 41 S B Using the injection system _ 2 5 4 Procedure for stopping the injection Pause during injection An injection can be stopped temporarily This can be done in two manners a Press once on the manual controller za Press once on INJECTION on the injector head The status bar blinks Injection interrupted appears on the orange bar at the top The message pause blinks on the injector head To resume the injection again press once on the manual controller or on INJECTION on the injector head Permanent emergency stop during the injection If necessary the injection can be permanently stopped by pressing STOP The following dialogue box is displayed CIWARNING si i Disarmed console The message EMERGENCY STOP blinks for several seconds on the injector head za Confirm the dialogue box with OK The injector head remains activated Another injection can be started by re activati
12. 99 2 7 2 Stopping from the main injection window 54 3 SAFETY REMINDERS 3 1 Safety reminder basic principles 55 3 2 Procedures for checking and detecting failures 56 3 2 1 Checking sound alarms 56 3 2 2 Checking functional safety 56 3 2 3 Repair guide failure detection 57 3 3 Cleaning the injector 57 3 4 Preventive maintenance of the injector 58 3 5 Symbols 58 3 6 Transport 58 3 7 Recycling 58 3 8 Placing the cap before and after transport 59 4 GLOSSARY M U000138 05 9 IMPORTANTS WARNINGS WARNINGS AND PRECAUTIONS FOR USE Before using the SBI injection system carefully read the paragraphs below and make sure that you understand them completely If you neglect to do so you run the risk of causing material damages or injuries If you have questions get in touch with Medex or Guerbet customer service the supplier The dangers mentioned here entail a risk of serious injuries to the patient or operator Read this section carefully Warnings SBI injection system is only used to inject contrast agent solutions intravenously into human patients before CT examinations followed by an injection of normal saline in the case of version SBI 5002 CT It is not for any other use Only use it for the specified application wa he contrast agent must be placed in the contrast agent bag and the saline in the saline bag Reversing the contents of the bags can be dangerous for the patient and lead to a false
13. ILL line for each patient line with a patented double check valve BAGS MUST BE FILLED ONLY ONCE At the end of use discard them in compliance with rules relating to biologically hazardous materials guarantee aseptic conditions while avoiding accidental spills or damage to the apparatus always check that the packaging of the line and bag as well as the bag itself are intact If it has been opened or shows visible damage do not use the set wa Accidental liquid spills can cause electrocution Avoid spilling the contrast agent saline or any other liquid onto the injections system It must never be soaked in a liquid even during cleaning This would create conduction between the metal parts of the system and the patient ua Only use the SBI system when it is connected to an adequate electrical source Connect the device and its monitor directly to an electrical outlet that is grounded according to hospital standards Never use an extension cord Do not try to connect the system to a two wire outlet without a ground wire even with an adapter Immediately replace any worn or frayed cables ea SBI injection system and any electrical apparatus connected to the patient or catheter must be electrically insulated or adequately grounded to avoid electrocution Opening a component of the SBI injection system also entails a risk of electrocution Do not try to repair or modify the system or any of its components These devices con
14. ad Check the status of the buttons on the injector head by pressing the button on the injector head On the monitor the box corresponding to the button being pressed turns green if the button is active Check the status of auxiliary inputs by closing the spout and or lid On the monitor the box corresponding to the auxiliary input turns green if the auxiliary input is active Blocking unblocking an auxiliary input If one of the auxiliary inputs is damaged the injector will no longer function In an emergency the damaged auxiliary input can be blocked to continue injections Blocking an auxiliary input may have serious consequences Medex refuses all responsibility in the event of an incident Contact Medex as rapidly as possible in the event of damage M U000138 05 49 Using the injection system ss Blocking an auxiliary input Select the damaged input button by pressing on the padlock l The padlock locks and the box turns green Before blocking El White light Reset button Padlock unlocked After blocking 4 Green light gt input active 2 Padlock locked input forced Note Only one input can be blocked at a time nblocking an auxiliarv in Press Reset to the right of the padlock The padlock unlocks and the input light turns white M U000138 05 50 2 6 3 Bag kit tab This tab is used to select the bag kit see 2 3 3 2 6 4 Maintenance
15. atically sealed Two D sub 9 connectors after inserting the connectors lock them with the two side screws 2 screws per connector Monitor The other connections behind the monitor are only used for servicing and other possible accessories except for the D sub 9 with the power unit Ell D sub 9 connector to the power unit Two USB ports for updating and accessories Manual controller connection Loudspeaker Fl Connection for mouse or keyboard 6 Ethernet connection for maintenance M U000138 05 12 PRECAUTIONS FOR INSTALLING THE POWER UNIT To ensure optimal device function the power unit has an air extraction grid on the top The location chosen for installing the power unit must comply with the following restrictions Do not close it in a cupboard cabinet or a confined space wa Give preference to areas with no risk of spraying do not place a mug or cup of coffee on the cover Do not cover the ventilation grid cartons sheets rags etc amp Do not block the air inlets at the rear of the power unit Ihe hydraulic hose must not be bent by a radius of less than 50 mm at the risk of irremediably deteriorating the device Connecting and or disconnecting cables and or hydraulic connectors when the injector is operating can have serious consequences Starting the injector without connecting all the components can also cause operating problems Medex refuses all responsibility in the event
16. aximum pressure and measured pressure blink red when the current pressure is approaching the maximum pressure A sound alarm 5 beeps is heard when the boxes begin blinking red The monitor beeps at the end of the injection 125 1 Starting the injection Before starting the injection the following operations must be carried out 4 Validate on the injector head see 2 3 5 purge 2 Programme the following parameters number of phases volumes flow rates phase durations Note automatically calculated if the volumes and flow rates are configured Validate on the monitor by pressing the validation button When the monitor is activated allthe recorded parameters are checked When the injector head is ready the orange bar displays HEAD READY to confirm that the monitor is programmed and gives the system status 1 Ell Name of protocol selected System status Name of bag kit M U000138 05 39 S B Using the injection system _ _ Start the injection This can be done in two manners za Press once on the manual controller amp 4 Press once on the injection button on the injector head 2 5 3 Monitoring the injection Certain characters turn grey and inactive after the monitor is activated Phase STOP button Visualisation of bags Injection status Name of protocol selected Graphic visualisation of the injection Ead E E M U000138 0
17. d the Fill Fast Fig 7 M U000138 05 20 Proceed in the same manner to fill the two bags contrast agent normal saline in the double bag mode It takes approximately 8 seconds at high speed to fill 100 ml of contrast agent Note The extension lines supplied with the Medex bag kits are all equipped with check valves that prevent the reentry of air into the bags after they are purged Medex recommends purging the residual air in the bags before connecting the extension line This operation has the following advantages lt facilitates the insertion of the bags into the injector head by reducing their size It optimises the purge time It further reduces the risk of accidental air injection When the bags are filled and connected to the patient line by a male Luer Lock they can be inserted into the injector head A scrolling message says to insert the contrast agent bag whatever the usage mode selected in the main menu 2 3 2 Preparing the ScanBag The advantage of using the prefilled contrast agent bag ScanBag with the SBI injector is that no product transfer is required which enhances the aseptic conditions and saves time The system remains closed which limits any risk of contamination Choose the bag volume according to the volume to be injected taking into account the volume discarded during the purge Comply with the following connection instructions El Remove the ScanBag from its packaging M U000138 05
18. disinfect use wipes soaked with a disinfectant Power unit During normal use special cleaning is unnecessary However it can be cleaned with a rag soaked with surgical alcohol DO NOT SPRAY A CLEANING PRODUCT DIRECTLY ONTO THE POWER UNIT it could penetrate the box and damage the injector To disinfect use cleaning cloths soaked with a disinfectant M U000138 05 57 Maintenance servicing __ i 3 4 Preventive maintenance of the injector WARNINGS To maintain the performance and safety of the SBI injector Medex by Guerbet recommends annual servicing This servicing is generally under the user s responsibility and may be obligatory depending on local regulations The servicing operation must be performed by Medex certified personnel and or the local distributor Modification or repair of the injection system by someone other than a Medex certified representative and or the local distributor will result in a cancellation of the guarantee 3 5 Symbols G3 Ground Class 1 N Refer to the manual IP20 protection against the penetration of tools 2 2 5 mm in diameter 0459 Quality system in compliance with European Directive 93 42 EEC related to medical devices 3 6 Transport e injector must be transported in its original packaging e Maximum relative humidity 80 e Temperature 5 to 40 C 3 7 Recyclin At the end of its lifespan the injector must be return
19. ed to Medex or delivered to a recycling company M U000138 05 58 3 8 Placing the cap before and after transport Before and after transport the orange cap must be removed and replaced using 2 5 and 6 mm Allen keys After transport e Unscrew the ten screws on the power unit five on each side with the 2 5 mm Allen key e Remove the cover Warning the fan on the cover is connected to the power unit Take care not to damage this connection M U000138 05 59 e Manually unscrew the orange cap on the reservoir and the metal cap with the 6 mm Allen key with the 6 mm Allen key manually 4 e Reverse and screw the orange cap manually on the reservoir and the metal cap with the 6 mm Allen key manually with the 6 mm Allen key Replace the cover and screw it on Before transport Carry out the same operation in reverse M U000138 05 60 SBI Glossary ACTIVATION Step preceding the injection consisting in checking the purge operation Check that the injection parameters have been programmed and are consistent activate the monitor The injector has to be activated before starting an injection ACTUATOR BAG Rubber bag within the injector head The actuator bag surrounds the product bags contrast agent saline BAG KIT Single use set used for each injection The kit used must be entered on the monitor The injector actuator bag measures the volume depending on
20. ent of an incident Always connect the Luer lock with the green ring to the contrast agent bag Connect the Luer lock on the blue tube to the bag of saline only for the double bag mode Fill the bag with a volume of contrast agent corresponding to the volume to be injected taking into account the volume discarded during the purge Never refill a bag after it is has been used M U000138 05 19 Bag filling is explained in detail in the user instructions such as below After removing the bag from its packaging insert it into the slot Fit the stainless steel Fill Fast ring into the spike hole pressing firmly Fig 1 Then remove the spike cap Fig 2 Immediately press the bottle onto the spike top towards the bottom and to the right Fig 3 Press the button constantly to fill the bag Fig 4 f more than one bottle is required remove the empty bottle and insert a full bottle Note With this filling system two bags can be filled consecutively normal saline and contrast agent When prepared in advance the bottle can remain on the spike until it is used for the next patient guaranteeing the sterility of the contrast agent closed system When the bag or bags have been filled from one or more bottles remove everything Fig 5 Separate the bag from the spike keeping the bag straight Fig 6 Connect the bag to the extension line supplied with the bag If necessary wedge the bag behin
21. er The scanner mode is displayed in the main window Scanner start mode L3 Select the injection history inactive l volume of solution injected by the injection system The message Control panel inactive Close the information menu is displayed on the injector head M U0001 38 05 47 Selecting the pressure unit Pressure unit kPa 7 1 1 Pressure unit List of units available wa Select psi or kPa by pressing the selection bar Changing the date or time The date and time can only be changed before inserting the bag s or after removal of the bag s The orange bar displays a Select the date or time in the monitor tab Thu Feb 22 2007 B IB Date 16 11 22 H El Time 4 Cancel changes FA Confirm changes Decrease the value selected 1 E l increase the value selected wa Select the data to change the button turns blue Set using or wa Confirm the changes with OK M U000138 05 48 2 6 2 Control panel tab The control panel tab is available before inserting the bag s or after removing the bag s Ell Button status light FJ Buttons on control panel Reset button Auxiliary input block El Green light input active Valida This tab is used to check whether the injector head is functioning and indicates the status of the control panel buttons It also provides information of the status of auxiliary inputs The message control panel testing appears on the injector he
22. er among the advantages of the new concept that we discuss in this manual are the following improvements ea Hygiene during handling Patient comfort thanks to a smooth injection reduced side effects due to the high flow rate of a bolus as the patient does not feel the high pressure thrust of conventional syringe injectors Injection from a multi dose container bag containing up to 500 ml and to more than one patient is possible in the single liquid mode if aseptic conditions are maintained and Medex SECUFILL patient lines with check valves are used see the instruction leaflet Do not use the two liquid function for injections from the multi dose container or in more than one patient Shorter preparation time with a rapid filling system outside the examination room and with increased hygiene ua Safety impossible to proceed with the injection without first purging the system avoiding the risk of accidental air injection In addition a sensor under the injector head ensures perfect control of the injection ua Cost reduction for medical devices 1 2 Description of the injector installation and environment The three main components are The injector head in which the soft bags are placed The power unit that produces pressure The monitor M U0001 38 05 8 1 2 1 Injector head The injector head of model SBI 5000 CT uses single bag kits and the injector head of model SBI 5002 CT uses
23. h phase by pressing the corresponding buttons gt the button turns from orange to blue to indicate the type of solution injected Example Two contrast agent phases are followed by two Alternating contrast agent and saline phases saline phases e terminate the selection of the type of phase again press the phase button gt the phase button no longer blinks and the configuration window reappears Select the number of phases in the protocol gt Phases that are not selected disappear e Select the volume gt a number pad for entering the volume appears e Enter the volume e Confirm with OK gt the volume is displayed in the selection window D Select the flow rate gt a number pad for entering the flow rate appears e Enter the flow rate e Confirm with OK gt the flow rate is displayed in the selection window The duration of the phase is calculated automatically and is displayed 3 Select the delay gt a number pad for entering the delay appears e Enter the delay e Confirm with OK gt the delay is displayed in the selection window Note step E is required if a delay is authorised between two phases M U000138 05 38 Configuring maximum pressure The maximum pressure is the pressure limit during the injection Select the button maximum pressure gt a number pad for entering the pressure appears wa Enter the pressure Confirm with OK gt the pressure is displayed The boxes for m
24. l the programme parameters and injection settings before activating the injector SBI injection system is not compatible with magnetic resonance imagers MRI and must not be used in MRI There is a risk of explosion when the SBI injection system is in the presence of inflammable anaesthetics Never use the device in the presence of inflammable gases This device must not be used in the presence of INFLAMMABLE ANAESTHETICS MIXED WITH AIR OXYGEN OR NITROUS OXIDE ea he efficacy of the SBI injection system has been demonstrated when used with Medex accessories To avoid incompatibility or a possible malfunction only use Medex consumables dedicated to the SBI M U000138 05 6 Once the bag is filled with contrast agent it must be used in the next few hours Bacterial proliferation is possible if the contrast agent is exposed to air Always comply with the manufacturer s instructions on the label for handling filling use storage and disposal To avoid transmission of any infections comply with aseptic conditions when you handle the contrast agent the saline or any other device or means of transport or administration of the contrast agent or saline particularly bags extension lines and patient connections Consumables dedicated to the SBI injection system have been specifically designed for use with one or more patients During multipatient use the consumables must be protected downstream by changing the SECUF
25. ling the bag s il New bags can be installed during handling in two manners press on the monitor HH press Confirm by again pressing The message OPEN blinks for several seconds on the injector head on the injector head M U000138 05 44 2 5 7 Injection histor The injections are recorded and classified by month decembre 2010 1 janvier 2011 Manuel zum Fri Jan 14 2011 Ell Month archived Select a month to consult the injection history In the single bag mode only single bag injections are displayed In the double bag mode only double bag injections are displayed M U000138 05 45 A new window opens displaying the injection history for the selected month 3 4 1 Date and time of injection Return to the information window Maximum pressure measured 3 Protocol recorded Volume of contrast agent injected Month and year 1 Type of injection phase Note The injection history also indicates the following emergency stop maximum pressure reached M U000138 05 46 2 6 Information window i 2 6 1 Monitor tab fH A 2008 2008 4 E 6 Thu Apr 28 2003 08 58 20 Software version see 2 6 6 for Number of injections since updating the first use of the injection system 2 Pressure unit selection kPa psi 6 Button for changing the date and time Injection start mode Return to the injection window Manual Scann
26. me and the flow rate the duration is calculated automatically Enter the volume and the duration the flow rate is calculated automatically Note The delay table offers two possibilities e Pause between two phases and resumption with the injection button manual delay e Time between two phases with automatic resumption after the time period automatic delay e Pause between two phases press the injection button to resume the injection e Delay between the end of the preceding phase and the beginning of the following phase Time seconds between 2 phases Pause between 2 phases press the injection button to start the injection di Press PHASE to change the order of product injection double bag version the PHASE blinks blue and white Select the phase by pressing on the corresponding number 1 2 in the left column the phase changes colour orange for a contrast agent injection and blue for a saline injection Press PHASE to validate M U000138 05 31 S B Using the injection system _ Information on volumes e Remaining volume of liquid remaining in the bag s e Injected volume of liquid injected e Total total volume to inject Single bag Double bag M Volume remaining in bag A Volume of contrast agent Al Volume injected into patient Volume of saline Total volume to inject Bag levels Visualises the injector head and bags Ell Position of lid and spout For a single bag injecti
27. n menu later on M U0001 38 05 a For SBI 5000 CT select the single bag mode Single bag button gt access to injection mode for contrast agent alone Double bag button gt access to injection mode for contrast agent and normal saline only active for SBI 5002 CT Log button gt System failure and error log Stop button to stop the application Language button press the flag corresponding to your language 4 For SBI 5002 CT select the single bag or double bag mode 16 2 2 3 Calibration This operation takes place every time the injector is started Before this calibration phase homing a dialogue box appears and indicates the procedure to follow EH Warning message before FA Button to confirm that there is calibration no bag in the injector head Read the instructions in the dialogue box and make sure that there are no bags in the injector If one or two bags are present in the injector head they must be removed before the calibration phase Open the lid Press once OPEN The injector opens the actuator bag When the bag s is are removed the movement for opening the actuator bag can be stopped by pressing any key on the keyboard The message Close the lid appears mu Close the lid and press the validation button z4 Confirm with OK The word OK turns grey on the monitor and the message remove bags and validate to start calibration is displayed on the control panel
28. ng the monitor M U000138 05 42 2 5 5 Safety procedures during the injection Maximum pr rer h If the pressure during the injection exceeds the maximum pressure programmed the injector stops the injection The following dialogue box is displayed CIWARNING 58 i Maxi pressure reached 1150kPa The message MAXIMUM PRESSURE blinks for several seconds on the injector head Confirm the dialogue box with OK The injector head is inactivated Check that there are no obstructions or folds Inactivating the head The injector head is inactivated by pressing any button on the injector head except for the start injection button The injection is stopped The following dialogue box is displayed CIWARNNG 58 Maxi pressure reached 1150kPa Head inactivated The message HEAD INACTIVATED blinks for several seconds on the injector head ra Confirm the dialogue box with OK The injector head remains activated Another injection can be started by re activating the monitor M U000138 05 43 Using the injection system Lid open during injection If the lid of the injector head is opened the injection is stopped The following dialogue box appears CUWARNING d Cover opened The message Please wait lid open appears on the injector head pm Confirm the dialogue box with OK The injector head is inactivated The actuator bag opens 2 5 6 Return to reinstal
29. nnel trained in the use of this injector After validating the purge you can still go back and complete the purge if necessary Press once on _ validation and the message PURGE blinks slowly The contrast agent or saline can be purged up to the Y in the line and the purge can be completed with saline or contrast agent until liquid comes out of the line M U000138 05 29 2 4 Confiquring the monitor 2 4 1 General description of the main injection screens S B Using the injection system _ Main window co E F3 Go Protocol name System status Information volumes Bag kit Phase configuration M U000138 05 STOP Configuration and information on pressure Maximum flow rate Graph Injector head status HOME PAGE TJ Injection synchronisation and delay Time from injection start 12 Total injection time Stop system Tl Open the information window Return to the main menu ICH Time Monitor validation button 30 Programming protocol phases main window fl Select the number of phases by pressing on the corresponding number 1 2 in the left column unused phases disappear Enter the volumes flow rates and durations by pressing on the empty box in the PROTOCOL table that you wish to change Confirm each value with OK Name of parameter modified Value entered Note Enter the volu
30. on Contrast agent bag status For a double bag injection Positions of saline bag and contrast agent bag Programming the pressure Pressure can be programmed in two units psi or kPa The unit can be selected by opening the information window see 2 6 2 if Max Enter the pressure limit during the injection using the number pad and confirm by pressing OK Measure Measures the instantaneous injection pressure Warning The time for detecting an occlusion depends on the maximum pressure chosen the closer the measured pressure is to the maximum pressure entered the shorter the time for detecting an occlusion Medex refuses all responsibility in the event of an incident M U000138 05 32 Main menu From here you can go back to the home page to change the mode single bag gt double bag or to display the error log Protocol Opens the protocol window to display select write save or delete a protocol see 2 4 2 Information Opens the information window see 2 6 e change a pressure unit e to correct the date and time e display the injection history e select a bag kit e to update the software Stop system Stops the injection system at the end of the workday see 2 7 2 2 4 2 Saving and deleting a protocol Saving a protocol Fill in the phase table and maximum pressure Press PROTOCOL in the main window Press SAVE and a window for naming the protocol is displayed Enter the protocol
31. onnection and the component involved Monitor Monitor status can be checked by making sure that the menus are displayed on the screen after the power is turned on and that the buttons on the control panel are functioning properly M U000138 05 56 3 2 3 Repair guide failure detection In the event of malfunction shut the device off immediately and disconnect it rapidly from the patient Check that everything is functioning properly again before reconnecting Turn the system power on activate it and proceed with a test injection If the problem is resolved reconnect the patient If the failure message is still displayed and cannot be corrected or if the injector still does not function properly STOP USING the SBI injection system until the problem has been correctly diagnosed and resolved Contact your local Guerbet distributor or a Medex certified distributor contact information on the last page 3 3 Cleaning the injector Monitor The touchscreen must be cleaned regularly preferably with a special cloth for screens If not use absorbent paper with surgical alcohol DO NOT SPRAY A CLEANING PRODUCT DIRECTLY ONTO THE SCREEN it could penetrate the control box and damage the monitor During normal use special decontamination is unnecessary Injector head If contrast agent has been spilled onto the injector head clean it with a sponge soaked in hot soapy water Do not use an abrasive product or a scouring pad To
32. oolproof device into the slot buttons should lock adjust and wedge the tube into automatically the groove in the spout 3 Press the validation button This message appears Measuring contrast agent volume Please wait Purge blinks Type of cup used standard plastic cup or any cup as long as it only rests on the upper ring Maximum filling recommended of the cup to reduce the risk of contrast agent escaping if the cup is knocked Push the tube into the cupholder groove make sure that end of the tube does not extend too far into the cup This is to avoid contact between the tube and contrast agent when the cup is full M U000138 05 24 SUMMARY Open the injector lid Insert the contrast agent bag Close the lid without forcing it Press the validation button once YOU MUST NOW PURGE ga see 2 3 6 M U000138 05 25 2 3 5 Inserting bags in the double bag mode Inserting a double bag kit Hepeat steps 1 to 7 in the single bag procedure Note during the measurement of contrast agent bag volume the bag of saline can be placed on its support next to the cupholder E Contrast agent measurement terminated Insert the two bags and validate is displayed after beeps Remove the bag ETD insert the contrast agent and saline bags into the actuator bag Place the saline bag in front and slightly below the contrast agent bag EE Close the spout EPA Put the green ring fool
33. proof device into the slot adjust and wedge the tube into the groove in the spout Close the lid the transparent tube into the tube clamp next to the contrast agent orange ring and place the blue tube into the tube clamp next to the saline blue ring To move the tube clamp press the button Finally press the button validation to apply pressure to the injector Message Measuring saline please wait Purge M U000138 05 26 NOTE To avoid an oversight injector pressurisation is not possible until the tube clamp is activated which shows that the tubes have been inserted into the tube clamps In this case the following message appears Place the tubes into the tube clamps and a sound signal is heard Open the injector lid Insert the contrast agent bag Close the lid without forcing it Press the validation button once and wait for the beep Open the injector lid Insert the two bags Close the lid without forcing it Position the tubes in the tube clamp Press the validation button once to validate YOU MUST NOW PURGE see 2 3 6 NOTE The single bag or double bag cycle can be interrupted at any time by pressing any button during movement of the actuator bag The message CYCLE IS BEING CANCELLED appears on the LCD screen M U000138 05 2 S B Using the injection system _ 12 3 6 Purging air Purge in single bag mode
34. r error log LUER LOCK Sealed connector MANUAL CONTROLLER External manual controller connected to the monitor used for remote activation of the injection MONITOR One of the three components of an SBI It is generally placed next to the CT scanner control screen The monitor has a colour touchscreen and a manual controller It is used to program and monitor the injection POWER UNIT Power box with hydraulic pressure generator It controls bag squeezing in compliance with the protocol instructions and opens and closes the tube clamps on a double bag injector SBI 5002 CT PROTOCOL Sequence of phases that can be saved for subsequent use SALINE Normal saline used in conjunction with the contrast agent double bag mode SINGLE BAG DOUBLE BAG Injector usage mode The mode must be selected in the general menu on the monitor The single bag mode is used for examinations that only require contrast agent The double bag mode is used for examinations that require contrast agent and saline SPOUT Green pastic part located on the injector head which tilts forward Its position is detected with a sensor It is used to guide and fix the tubes when the bags are inserted in the actuator bag TUBE CLAMP Component situated on the right of the SBI 5002 CT injector head It is used to select the liquid injected pulsed bolus use The tube clamp grips the tubes from each bag and must be activated manually during bag insertion removal or during pu
35. rectly using the prefilled ScanBag developed by Guerbet or filling the empty bag supplied by Medex bag with yellow writing For normal saline only the empty bag supplied by Medex is suitable for the SBI injection system bag with blue writing The soft bags developed by Medex are easily and safely filled from a bottle with the rapid filling system Fill Fast which improves hygienic conditions The injector can use bags containing up to 500 ml of contrast agent in the single bag mode Depending on the model there are one or two bags an infusion set and a patient line 150 cm straight or 200 cm Y form with check valve With the Fill Fast system the filling can be done outside the examination room and at the same time preparation which reduces the handling time This operation involves creating a slight positive pressure in the bottle to accelerate the transfer from bottle to bag The Fill Fast system is supplied as standard equipment with the injector Warning about the consequences of using inadequate bags Only bags listed in the Medex Catalogue medical devices can be used Using inadequate bags can have serious consequences such as Non compliance with programmed volumes and flow rates Deterioration of the actuator bag in the injector head An inappropriate bag design can result in insufficient air removal and potentially an accidental injection of air with the risk of air embolisms Medex refuses all responsibility in the ev
36. rges M U000138 05 62 M U000138 05 63 Medex cee eee 1 10 Link in imaging Manufacturer 240 all e Jacques Monod 69792 Salnt Priest Cedex France T l 33 0 4 72 79 20 50 Fax 3300 4 72 79 20 69
37. rom another operator e wait too long before preparing the injector for a new patient changing bags or patient connection purging etc M U000138 05 55 Maintenance servicing _ 3 2 Procedures for checking and detecting failures 3 2 1 Checking sound alarms If a beep is heard from the injector and then the monitor after turning on the power the sound alarms are functioning 3 2 2 Checking functional safety Injector head When you start the machine the control panel displays the following message This message shows that the integrated electronic system is being checked The following message then appears It indicates the software version as well as the progress of synchronisation with the monitor After 10 seconds synchronisation is terminated and the display disappears before the user starts the programme It is also possible to check on the spout on the monitor in the control panel tab see 2 6 2 the functional status of the lid sensors Power unit The power unit is synchronised with the monitor when the injection system is started The software interface constantly checks the status of the main components of the power unit i e the position of the motor which varies and an I O module that controls the hydraulic cylinders and gives the status of various sensors In the event of a problem a dialogue box automatically informs the operator of a defective c
38. saline The flow rate of 0 5 ml s to 8 ml s is precisely adapted to ensure its regularity according to the pressure which can vary depending on the patient the catheter size the viscosity of the contrast agent injected and the patient lines etc 2 3 5 6 na Removable cover Injector head connection ventilation grid J On Off light On off switch Hydraulic connection with the tube clamp l Monitor connection EJ Hydraulic connection with the actuator bag M U0001 38 05 10 1 2 3 Monitor A 10 4 colour touchscreen monitor with a resolution of 800 x 600 guides the user in real time for the injection parameters as well as for safety saving examinations system status maintenance and software updating with a USB key 1 2 4 Installation The three components injection head power unit monitor are connected as follows Ell injector head Monitor P Power unit The connections to the power unit differ to avoid any error M U000138 05 11 Power unit Ell Female hydraulic connector rapidly locked by pressing on the sides unlocked by pushing the ring toward the box After unlocking the two ends of the connector are automatically sealed flush face self sealing connector technology Only for the SBI 5002 CT Male hydraulic connector smaller for the tube clamp locked rapidly by pressing on the sides unlocked by pulling the ring towards you After unlocking the two ends of the tube are autom
39. tab This tab is used for maintenance and software updating The software is updated using a USB key supplied by Medex Press Update Note Maintenance is only used by Medex technicians or certified personnel M U000138 05 51 i Using the injection system Update diagram Update D X WARNING 0x gt Return Update ex Confirm no USB key WARNING aum WARNING lt i Update Dx Heload USB key M U000138 05 52 2 7 Stopping the injector 2 7 1 Stopping from the home page SINGLE BAG Ell Stop button TWO BAGS LOG FILE SYSTEM STOP 2 Press STOP SYSTEM gt The following dialogue box is displayed Stop application Confirm with Yes gt the following screen appears Vous pouvez maintenant teindre le systeme en toute s curit lts now safe to turn off the system Shut off power supply M U000138 05 53 S B Using the injection system _ 2 7 2 Stopping from the main window after the start phase za Remove the bag s zu Press Stop system After pressing STOP SYSTEM the following dialogue box appears System stop o Yes No Cancel Confirm with Yes The following screens are displayed gH System stopping the following screen appears Vous pouvez maintenant teindre le systeme en toute s curit lts now safe to turn off the system Mede
40. tain no parts that can be replaced by the user Internal components must only be serviced by a certified Medex or Guerbet technician ma Always ask the patient to inform the technicians immediately the event of pain or a new sensation during the injection or examination so that risks of extravasation for instance can be detected Precautions for use Use of a contrast agent injector in children under two years of age must be the subject of initial risk analysis by the radiologist wa f the injector is used in children under two years of age adapt the injection rate to the chosen administration route intracranial foot hand to take into account any vascular fragility the minimum flow rate of the SBI injection system is 0 5 ml s M U0001 38 05 1 Presentation 1 1 Introduction Contrast agent injection must be a process that is reliable and easy for both the radiologist and the patient The various automatic operations must not jeopardise safety A perfect repetition of actions allows a comparative study based on different parameters whether planned or actually performed The main criteria on which the design of this injector is based are precision comfort and safety Its innovative principle consists in producing a uniform hydraulic pressure on a soft bag filled with contrast agent up to 2100 kPa 300 psi The technical characteristics of the injection are the same as for conventional syringe injectors Howev
41. x sera __ 2 In Imaging Shut off power supply NOTE Check that the lid and spout are closed on the injector head M U000138 05 54 3 Safety reminders 3 1 Safety reminder basic principles Contrast agent injections require compliance with essential safety rules The most important problems are extravasation air injection and nosocomial diseases To avoid them it is advisable to comply with the following instructions e Every operator or radiologist who uses an injector must undergo training involving critical care practices and possible risks e Compliance with the following principle is absolutely essential the same person prepares the injector filling purging connects the patient and starts the injection according to a selected programme whose parameters have been confirmed e During the first seconds of the injection it is strongly recommended that an operator remain near the patient to detect possible extravasation visually or by palpation e The same person complying with the obligatory rules of hygiene replaces the consumables soft bag and connectors if it is a bag or patient line with a two level check valve It is advisable to install the new preparation systematically without waiting for the patient to be disconnected The injector is ready for the next patient the bag has been filled and purged and the line is protected Do not e take over preparation f
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