Infusomat® Space - B.Braun Medical OÜ
Contents
1. L OK Ketel iain D Start Infusion Si CC Clear mifh Typical display during infusion Mains Set pressure limit and connection current pressure Battery Ge Meaning At the top of the screen the last therapy is indicated Yes No question can be answered by pressing 4 for yes or e for no Parameters which can be changed e g rate in ml h are opened with 4 or ox When editing parameters switch digits levels using 4 gt White background indicates current digit level Use 4 or to change current setting Help text on the bottom top of the screen indicates options how to proceed e g confirm rate with oe K start infusion with or clear rate by pressing Therapy profile C VTBI or time preselection Set rate can be opened with 4 ad Unit of drug application Total volume infused Remaining time Remaining VTBI E3 Han Bol 1200 mith ttt Bolus ml QO Bolus Limit ml s Parameter can dified has been pressed while the pump is infusing Start manual bolus at 1200 ml h by pressing see top of display or proceed to set bolus limit with 4 see bottom of display This hint pops up if a user tries to edit or change a parameter by pressing 4 when that parameter is unable to be changed MENU STRUCTURE NAVIGATION Display Alarm YTE intused ok confirm Pumpe turns off in 2sec H x Meaning Set pressure level with lt or2. Open certain functions Press to link the pump to and press to confirm SpaceControl and to assign a Press to Start Stop values settings alarms barcode after scanning infusion Cover of Battery Compartment Before changing the battery always disconnect the pump from the patient and switch off the device To remove the battery cover push the button below the battery compartment with a pointed pen and pull the cover away from device Slide green locking mechanism on back of battery up and take out battery pack for exchange A crank in order to open the pump door in case of emergency is attached to the inside of the battery compartment cover for closer information see 1 4 Port for drop sensor Le Port P2 for power supply SpaceStation connection lead 12V combi lead and further accessory leads staff call service Port P3 for SpaceControl INFUSOMAT SPACE OVERVIEW Pressure _ Air sensor sensor Opening lever Signal lamp Line guide Upstream cover sensor Fixaton of PoleClamp Universal Clamp Line up bar of pump with bar of PoleClamp and slide PoleClamp forward until locking mechanism clicks To remove push handle down and pull PoleClamp backwards Transport A maximum of three pumps Infusomat Space or Perfusor Space plus
3. Approx 6 hours Weight Approx 1 4 kg Dimensions W x H x D 214 x 68 x 124mm Volume preselection 0 1 99 99 ml in increments of 0 01 ml 100 0 999 0 ml in increments 0 1 ml 1000 9999 ml in increments 1 ml Time preselection 00 01 99 59 h Accuracy of set delivery rate 5 according to IEC EN 60601 2 24 Alarm in the case of incorrect dose For incorrect dosages of 1 4 ml due to malfunctions of the device the pump will automatically shut off Technical inspection safety check Every 2 years Chapter 7 TECHNICAL DATA Rate increments 0 1 99 99 ml h in increments of 0 01 ml h 100 0 999 9 ml h in increments of 0 1 ml h 1000 0 1200 ml h in increments of 1 ml h Accuracy of bolus infusion typ 5 KVO rate Delivery rate gt 10 ml h KVO rate 3 ml h Delivery rate lt 10 ml h KVO rate 1 ml h Delivery rate lt 1 ml h KVO rate set rate Computer connection USB connection in combination with B Braun interface lead CAN SP 8713230 including electrical insulation Please pay attention to safety notices Air detector Technical sensitivity Detection of air bubbles gt 0 01 ml Alarm triggering At an air bubble size of typ 0 02 0 3 ml respectively 1 5 ml h cumulated value over 1 h from air bubbles size 0 01ml Occlusion alarm pressures 9 levels from 0 1 1 2 bar Occlusion pressu
4. Caution If a wrong line is selected errors may occur during VTBI delivery and the alarm limits are shifted m Press 4 if the prime function is enabled to prime the infusion line with the rate displayed Cancel priming with E Repeat the procedure until the line is completely primed Then press e to proceed Note During priming all air and drop alarms are switched off m Establish the patient connection m Answer the question whether the old therapy is to be used either with E or the question can be deactivated via the service manual If you select 4 the pump jumps to the Main Menu If you select Y with no drop sensor connected you must first enter a VIBI which is smaller than the container filling and confirm it with 0 Note Due to safety reasons it is recommended to use the drop sensor particularly in connection with delivery rates lt 10 ml h Adjusting the delivey rate m Inthe Main Menu open the rate with 4 and set it with m Press to start the infusion Running arrows on the display and the green LED indicate that the pump is infusing Note The running infusion can be cancelled at any time by pressing The pump can be switched off at any time by pressing for 3 sec 11 12 Chapter 1 OPERATION 1 2 Entry With Different Combinations of Rate VIR Volume To Be Infused and Time The Infusomat Space offers the possibility to enter a volume and time limit in addition to an infus
5. gt and confirm by pressing Cancel to edit pressure by using Pre alarms are indicated by a message on the display e g VTBI near end an audible tone and a flashing yellow LED To confirm a pre alarm press vr In case of an operating alarm e g VTBI infused the infusion stops an audible tone sounds and the red LED flashes Confirm alarm by using 0 Press and hold for 3 sec to turn pump off A white bar stretches from left to right and counts down the 3 sec 9 Chapter 7 10 OPERATION OPERATION 1 1 Start of Infusion m Ensure that the pump is properly installed Check the equipment for completeness and damages Do not attach the infusion bottle below the pump level m Put the spike vertically into the infusion bottle Fill the bottom part of the drop chamber by max 2 3 m Fill the infusion line from below to the top then close the roller clamp m If the device is connected to the mains the display indicates the battery status the mains connection symbol and the last therapy m Press to switch on the device Observe the automatic self test The message Self test active and the software version are displayed two audible tones sound and all three LEDs yellow green red and blue flash once Information about the power supply mains or battery operation and the set pressure level are indicated In addition the line type appears at first provided that the line is already inse
6. 4 Then press Y to proceed 13 Chapter 7 14 OPERATION m Establish the patient connection and check the parameters with B m Start the infusion by pressing Note A new therapy can be started at any time during a stopped infusion If the pump is in the Main Status or Options Menu press repeatedly and follow the instructions as described 1 5 End of Infusion m Press to stop the infusion The green LED goes out Close the roller clamp and interrupt the patient connection m Press Answer the question whether the pump door is to be opened with 4 m Press down the green opening lever completely until it locks in place Remove the line and close the pump door m Press for 3 sec to switch off the pump Note The settings will be permanently saved by the switched off device 1 6 Standby Mode In the case of extended interruption the user has the option to maintain the set values m Press to stop the infusion Then press for less than 3 sec m Confirm the pump is supposed to switch into standby by pressing 4 m The default time for standby is displayed Accept the default time with 0x or change it with 0 24 hours and then confirm it by pressing gt While the pump is in the standby mode it s display shows the remaining time for this mode Exit standby by pressing o Chapter 2 ADVANCED OPERATIONS ADVANCED OPERATIONS 2 1 Status Request of Pump when Infusion is Runni
7. 9 INSTRUCTIONS FOR USE ACCESSORY Drop Sensor SP 8713180 The drop sensor provides an additional safety function and is therefore particularly recommended in connection with low delivery rates The connection of the Drop Sensor SP on the pump is located at the rear of the device in the lower left corner At the time of delivery the port of the drop sensor is protected by a cover Use a screw driver to break off the cover for further disposal Use holder on PoleClamp in order to park the drop sensor Short Stand SP 8713135 Use the Short Stand SP to attach an infusion container to the pump Caution Do only position the pump on a level surface if the pump is used in combination with the short stand 1 Push the PoleClamp on the pump 2 Plug the short stand into the aperture on the PoleClamp make sure that it audibly locks in 3 To remove the short stand Press the white button at the lower end of the PoleClamp and remove the short stand Battery Pack SP 8713180 For further information on the Battery Pack SP NiMH see Battery Operation Interface Lead CAN SP 8713230 Interface Lead CAN SP is needed in order to set up a connection between the SpaceStation pump and the computer outlet for service requirements 1 Push plug into socket F3 on the SpaceStation or P2 on the pump and connect with the CAN USB converter 2 Connect CAN USB converter to computer outlet as described in the Instructions fo
8. activated a The display states Reminder alarm b The display states Config not finished Confirm alarm with o and continue to set therapy Start Up configuration 2 A value edition was started but not finished and confirmed This is also possible with a missing disposable An acoustic tone sounds the display states Value not accepted the yellow LED blinks and a staff call is activated Confirm alarm with o and continue to set therapy 5 3 Alarm Hints If inproper entries are made the display states corresponding hints e g Attention Rate is out of range The parameter can not be modified and an audible tone sounds These hints disappear after a few seconds and don t need to be confirmed Chapter 6 BATTERY OPERATION AND MAINTENANCE BATTERY OPERATION AND MAINTENANCE The Infusomat Space is equipped with the latest NiMH battery It has an operating lifetime of 4 hours at 100 ml h when new For optimal treatment of the battery the device is equipped with protection against overcharge and deep depletion The battery pack is charged by the pump during connection to mains When disconnected from mains or in case of power failure the pump automatically switches to battery power Note Before changing the battery always disconnect the pump from the patient and switch off the device The battery status indicator is a trend display low medium high For more detailed information on the current battery ca
9. as IV and filter patency Increase occlusion pressure if necessary KVO finished The KVO time has ended Continue therapy or set new therapy Battery cover removed The battery cover is not properly engaged on the battery compartment When pushing on the battery cover listen for click Standby time expired The set standby time has ended Set new time or continue with previously set therapy No battery inserted It is not possible do use the pump without a battery pack Turn off pump and insert battery pack according to describtion Overview Infusomat Space Drive blocked Stepper motor does not deliver due to excess pressure in the system Interrupt patient connection and reinsert the line Calibrate device Pump calibration data have changed e g after an update Recalibrate device via the service program Chapter 5 ALARM Drop sensor connection Contact to the drop sensor is interrupted while the pump is delivering Check whether the drop sensor is correctly placed on the drop chamber If necessary replace the drop sensor or preselect VTBI time and proceed with therapy Check upstream The upstream sensor triggers an alarm Check if roller clamp is closed or infusion line is kinked Air bubble Accumulated air Air inside the system Check the line for small air bubbles and disconnect from patient to repeat priming if nec
10. case Measurement interval At 0 5 min Observation interval p x At min Start Up Graphs Measurement interval At 0 5 min Measurement duration T 120min Flow Q ml h 25 26 Chapter 7 TECHNICAL DATA TECHNICAL DATA Type of unit Volumetric infusion pump Classification acc to IEC EN 60601 1 e defibrillator proof CF equipment Protective Class Il Protective Class in combination with SpaceStation Class acc to Directive 93 42 EEC IIb Moisture protection IP 22 drip protected for horizontal usage External power supply e Rated voltage e External low voltage Via B Braun SpaceStation or optional mains adaptor rated voltage 100 240 V ACs 50 60 Hz for stand alone operation 11 16 V DC via external power supply 12 V or via SpaceStation Staff call Max 24 V 0 5 A 24 VA VDE 0834 EMC IEC EN 60601 1 2 60601 2 24 Time of operation 100 continuous operation Operating conditions Relative humidity e Temperature e Atmospheric pressure 30 90 without condensation 10 40 C 500 1060 mbar Storage conditions Relative humidity e Temperature e Atmospheric pressure 30 90 without condensation 20 55 C 500 1060 mbar Type of battery pack rechargeable NiMH Operating time of rechargeable battery Approx 4 hours at 100 ml h Recharging time
11. Infusomat Space and Accessory Instructions for Use Valid for Software 686C B BRAUN SHARING EXPERTISE CONTENTS Ss The Infusomat Space is accor ding to IEC EN 60601 1 resp IEC EN 60601 2 24 a volumetric infusion pump for infusion of small and large volumes at highest accuracy and is suitable for intravenous applications for blood transfusion and for enteral nutrition The medical specialist has to decide on the suitability of the application The decision has to be made on the basis of the warranted properties and technical data For further details please refer to the Instructions for Use CONTENTS Contents eegent EE 2 Infusomat Space Uwermlew EEN 3 Patient Safety oes Menu Structure Overview Menu Structure Navigation Chapter 1 Operation 1 1 Start of Infusion 1 2 Entry With Different Combinations of Rate VTBI Volume To Be Infused NG Nu issscsccsssascncccessscacccesadaacccccassnccecescassassccacesnesctecianasecocseaanetccteumicteecsainitetisaanseccottaaamanaecetaneee 12 1 3 Bolus Application 1 4 Infusion Line Change and New Therapy Start 1 5 End of Infusion LE Standby Mode osonni a a a inertia Chapter 2 Advanced Operations 2 1 Status Request of Pump when Infusion is Running 2 2 Rate VIBI and Time Change Without Infusion Interruption and Reset OF Status Menu Data sissisotaa ainina 15 Chapter 3 Special Functions 3 1 Dose Rate Calculati
12. The air detector cannot detect air diffusing in the following components three way stopcocks infusion adapters and further lines placed between pump and patient Other components Use only pressure proof and compatible disposable items min 2 bar 1500 mm Hg to avoid that performance data are influenced which would result in impairing patient safety Where several infusion lines are connected on one single vascular access the possibility of the lines exerting a mutual influence over each other cannot be excluded Refer to respective manufacturer s information for possible incompatibilities of equipment with respect to drugs Use only compatible combinations of equipment accessories working parts and disposables with luer lock connectors Connected electrical equipment must comply with the relevant IEC EN specifications e g IEC EN 60950 for data processing equipment The user operator is responsible for the system configuration if additional equipment is connected The international standard IEC EN 60601 1 1 has to be taken into account Safety Standards Infusomat Space satisfies all safety standards for medical electrical devices in compliance with IEC EN 60601 1 and IEC EN 60601 2 24 The EMC limits electro magnetic compatibility according to IEC EN 60601 1 2 and IEC EN 60601 2 24 are maintained If the equipment is operated in the vicinity of other equipment which may cause high levels of interference e g HF surg
13. approx 500 times before its lifetime decreases m When the pump is not connected to mains power the battery discharges itself slowly This can occur even when the pump is not operating The original capacity will only be reached after several cycles of charging and discharging m The battery operating time only can be realized if the pump operates continuously with a fully charged battery at room temperature The display of the battery operating time on the pump is an approximate value based on the current delivery rate If the battery is aged it may differ from the actual achievable operating time 23 Chapter 6 24 BATTERY OPERATION AND MAINTENANCE Caution Batteries may explode or leak if they are opened or incinerated Consider disposal directions Battery maintenance If the pump has been connected to mains for 30 days a complete discharge of the battery is necessary in order to prolong the lifetime of the battery To initiate the discharge process the writing Battery maintenance and the key will be displayed after switching the pump off By pressing 09 and 4 the discharge process will start The process is interrupted by switching the pump on again If the battery maintenance shall be continued a new activation is necessary After completely discharging the battery it will be completely charged again The total duration of the battery maintenance process takes approx twelve hours Caution Please take into accoun
14. atically calculated and displayed on the bottom of the display m Check the parameters with H on plausibility before starting with Concentration weight und dose can belatedly be changed in the Main Menu in the same way as the rate VIBI and time compare 2 2 The effect of weight and dose modifications on other parameter are being shown on the bottom of the display Additionally the total and intermediate amount of the infused drug can be taken from the Status Menu These can be checked and resetted in the same way as the other total and intermediate values A deactivation of the dose rate calculation is only possible when the pump is stopped Press from Main Menu and then press Y Chapter 4 OPTIONS __ OPTIONS The options functions may be selected and changed while the pump is infusing or stopped To edit a menu item select Options in the Main Menu and press 4 Then select desired function with H and follow the Instructions for Use as described 4 1 Occlusion Pressure The higher the pressure level is set at the higher the pressure level must rise before triggering an occlusion pressure alarm m Enter pressure in Options Menu by pressing 4 m Choose between nine pressure levels 1 lowest level 9 highest level by pressing 4 or gt and confirm entry with 0 4 2 Bolus Rate m Open bolus rate in Options Menu with 4 m Change bolus rate with BZ and confirm setting with o Note Set bol
15. e relevant room complies with the appropriate requirements e g VDE 0100 0107 and or the IEC publications resp national requirements m the equipment is used in accordance with the Instructions for Use and m the Technical Safety Checks are carried out regularly Warranty B Braun provides 24 months warranty as from the date of delivery for every Infusomat Space 12 months for every Battery Pack SP This covers repair or replacement of parts damaged as a result of design manufacturing errors or material defects Modifications or repairs to the unit undertaken by the user operator or by third parties invalidate the warranty The warranty does not cover the following Elimination of faults attributable to incorrect unauthorized handling or to normal wear and tear Technical Safety Check Service The Technical Safety Check is recommended to be carried out every 2 years and should be documented Servicing work must be carried out exclusively by B Braun trained personnel Check regularly Check for cleanliness completeness and damage Use only according to Instructions for Use Check the following items each time the pump is switched on self check audible alarm process and alarm control indication Chapter 8 WARRANTY TSC SERVICE CLEANING DISPOSAL Cleaning Clean external surface of pump using mild soap suds Do not use spray disinfectants at the mains power connection Recommended disinfectant f
16. ection Lead for Staff Call SP ssssccsccazacsscsssssccssesessessercecosnsteossanestsacasctasce 871 3232 Infusomat Space Lines Type Standard length 2 500M anmiana 870 0036 SP Type Standard length 300 em ENEE 827 0350 SP Type Injection With injection port EEN 870 0087 SP Type Transfusion with 200 um blood filter EEN 827 0066 SP Type Opaque UN Drotectedl ENEE 870 0125 SP Type Siliconized with siliconized Spike EEN 870 0230 SP Type Neutrapur PVC free PVC free set for the administration OF CVLOLOXIC AGENS cies tae Gina eect 825 0731 SP Type Neutrapur PVC free PVC free set for the administration of cytotoxic agents incl 0 2 um Titel 870 0095 SP Type Ys PIO CES een 875 1668 SP only available in selected A P countries 34 B BRAUN SHARING EXPERTISE Manufactured by B Braun Melsungen AG B Braun Melsungen AG Sparte Hospital Care Postfach 1120 PO Box 1120 D 34209 Melsungen D 34209 Melsungen Tel 0 56 61 71 0 Tel 0 56 61 71 0 Material No 3891 1794 Drawing No M686 70 02 01 F04 Fax 0 56 61 71 20 44 05 05 e Printed on pulp bleached 100 chlorine free www bbraun com
17. es is displayed in the menu item Battery Cap and the current software version in menu item Version 15 Chapter 3 16 SPECIAL FUNCTIONS SPECIAL FUNCTIONS 3 1 Dose Rate Calculation Overview The dose rate calculation enables a calculation of the rate in ml h Setting parameters 1 Concentration as the amount of the active ingredient per volume Amount of the active ingredient in ug mg mmol IU or mEq Volume in ml 2 Where necessary Patient weight in kg 3 Dose prescription time related as the amount of the active ingredient per min h or 24h time and patient weight related as the amount of the active ingredient per kg per min h or 24h 4 Where necessary VTBI in ml 3 2 Dose Rate Calculation Operation m Select dose rate calculation with 4 m Select the unit of the active ingredient with and confirm it with 4 m Enter the concentration by entering the amount of the active ingredient and the volume In order to do so set the values with and confirm with 0 m If the patient weight shall not be entered press Y Press 4 for a time and weight related calculation set the patient weight with 24 and confirm it with 0 m Select the dose prescription with and confirm it with 4 m Set the dose with and confirm with o The rate will be automatically calculated and displayed on the bottom of the display m Enter VIBI if necessary with and confirm it with o The time will be autom
18. essary No drops The drop sensor does not detect any drops The infusion container is empty the roller clamp is closed the drop sensor is not put on check the line for obstructions condensation on drop chamber remove by shaking it Too few drops The number of fallen drops is lower than the preset rate A negative pressure in a glas infusion container can be eliminated by opening the vent flap on the drop chamber Check whether the infusion bottle is empty the roller clamp is completely opened and whether there are any kinks in the line Too many drops The number of fallen drops is higher than the preset rate Check the line for damage and make sure that the line is correctly inserted Flow Drop chamber is completely filled or leak in the system Examine the line for damage and check the drop chamber Data were reset Therapy and pump settings could not be restored Enter therapy and pump settings anew Therapy data were reset Therapy data could not be restored Enter therapy anew The red LED doesn t extinguish until the administration is started again respectively the pump is turned off 21 Chapter 5 22 ALARM 5 2 Reminder Alarms Reminder alarms only occur in two cases 1 Aline is inserted the pump does not deliver no value is edited and the device is not operated for two minutes An acoustic tone sounds the yellow LED blinks and a staff call is
19. g h then the bolus will be given in mg You can use the service program to enter a default and a maximum bolus rate After a new therapy start however the device always returns to the default rate even if the bolus rate was manually changed beforehand Note If the bolus limit is not entered after pressing the pump switches back into the run display automatically Caution Take care not to overdose Given a bolus rate of 1200 ml h 1 ml will be administered in just 3 sec To cancel bolus infusion at any time press 0 1 4 Infusion Line Change and New Therapy Start Note Always interrupt the patient connection before changing a line to avoid dosing errors Never let the pump run unattended when changing the line Check and clean the safety clamp regularly m Press to stop the delivery The green LED goes out Close the roller clamp and interrupt the patient connection m Press and open the pump door with 4 Press down the green opening lever completely until it locks in place remove the line and insert a new line Note If for an unknown reason the pump door cannot be opened anymore you need to take a crank from the inside of the battery compartment cover Use this crank to remove the emergency aperture cover of the pump Place the crank in the aperture and turn it clockwise until the pump door opens m Close the pump door confirm the inserted line with o and open the roller clamp m f required prime the pump with
20. ical equipment nuclear spin tomography units mobile telephones etc maintain the recommended protective distances from these devices MENU STRUCTURE OVERVIEW Sg MENU STRUCTURE OVERVIEW Cutline On Off button Door open button E Start Stop button Bolus button Clear button 0 OK button Keypad with arrow up down left right button Connection button Menu Structure Start Up Main Special Status Options Menu Menu Functions Menu Menu Line Concentration Dose Rate Total Pressure selection Kai gt Calculation Pm Total volume GE y y y y Prime Weight Total Bolus Total amount Rate y y y y Use last Dose Total KVO therapy Total time Mode y Y y y Use dose rate Rate Intermed Contrast calculation volume y Y y y VIBI VIBI Intermed Display amount Light y y y Time Intermed Keypad time Light y y y Status Line Alarm Volume y y y Special Batt cap Date Functions y y y Options Version Time y Macro Mode The pump can be customized by de activating the menu itmes of the Start Up except VTBI and Options Menu as well as the bolus function via the service program 7 8 MENU STRUCTURE NAVIGATION MENU STRUCTURE NAVIGATION Display Last Therapy 1 Use last Therapy
21. ion rate When two of these parameters are entered the third will be calculated by the pump If a volume and or time is preselected an arrow symbol is placed in front of one of these parameters in the Main Menu It is called the target During the infusion of the pump this target symbol is displayed next to the moving arrows in the run display This indicates that the pump has been programmed either with a volume or time limit The assignment of the target symbol apparent in the Main Menu shows the established parameter for the application VTBI or time When the rate is changed the so called target parameter is principally not adjusted to the new rate but to the parameter which does not have the target symbol in front After the infusion has started the remaining VTBI and time are displayed in the Main Menu and the run display values are counting down 1 Enter VTBI and time The infusion rate will be calculated and displayed on the bottom of the display Target Volume m Select VIBI with H and open with 4 m Enter VTBI with EJ and confirm with ov m Select time with B and open with 3 m Enter time with es and confirm with o Check calculated rate on plausibility Proceed in the same way to calculate 2 and 3 2 Infusion with volume limit Enter rate and VTBI The infusion time will be calculated and displayed on the bottom of the display Target VTBI 3 Infusion with time limit Enter rate and time The infusion volu
22. me will be calculated and displayed on the bottom of the display Target Time Changing already entered values of VTBI and time rate VIBI and time already exist at the point of change a Target symbol is placed in front of VTBI mw Change of VIBI gt Adjustment of time Old and new target VTBI m Change of time gt Adjustment of rate Old and new target VTBI b Target symbol is placed in front of time m Change of time gt Adjustment of VTBI Old and new target Time m Change of VIBI gt Adjustment of time New target VTBI Chapter 7 OPERATION _ 1 3 Bolus Application There are three ways to administer a bolus 1 Manual Bolus Press Then press and hold button Fluid is adminis tered as long as button is held down The infused bolus volume is displayed The max bolus volume is limited to 10 sec 2 Bolus with volume preselection Press Then press 4 and set bolus limit by using Eg Press to confirm and start bolus 3 Bolus with rate calculation Press Then press ER and set bolus limit by using Eg Press 0 to confirm bolus limit Set time with in which a bolus is to be delivered Calculated bolus rate is shown on top of the display Press to confirm and start bolus The unit of the bolus always depends on the selected dose If the dose is for example selected as mg kg h then the bolus will be given in mg kg If a dose is administered without a relation to the patient s weight m
23. ng Press to switch between run display and Main Menu while the device is infusing Navigate through the menu using BH to check parameters In order to check the menu parameters in the Status Options Menu select Status respectively Options in the Main Menu open menu with 4 and scroll through menu with B 2 2 Rate VIBI and Time Change Without Infusion Interruption and Reset Of Status Menu Data m Press when the pump is in the run display in order to switch to the Main Menu Select rate VTBI time with and press 4 in order to open the parameter m Enter new value with EJ and confirm with o Reset Status Menu Data The parameters intermediate volume and time can be resetted when the pump is infusing or when the pump is stopped m Select Status in Main Menu with Band press KR m Highlight intermediate volume in ml or intermediate time in h min with and open parameter with 4 m Reset values by pressing a Both parameter total volume and time are being displayed in the pump as Total with the according unit and can be reset by starting a new therapy A second way to reset the parameters when the pump is in the Main Menu Press answer question if the last therapy is to be used with and reset the values with 4 The type of the inserted line is displayed in menu item Une and cannot be changed once it has been confirmed at the beginning of the infusion The current battery capacity in hours and minut
24. o patient only after the line was correctly inserted and completely primed Interrupt connection during line change to prevent incorrect dose delivery m Select infusion line catheter suitable for use with the intended medical application m Position the infusion line free of kinks m Recommended change of disposable each 24 h or as per national hygiene regulations m Installation in medically used rooms must comply with the appropriate regulations e g VDE 0100 VDE 0107 or IEC publications Observe national specifications and deviations m Do not operate the pump in the presence of flammable anaesthetics to prevent explosion m Compare the displayed value with the entered value Start infusion only if the values are corresponding m If staff call is used we recommend checking the equipment once after connecting the pump m Protect the device and the power supply against moisture m If the pump falls down or is exposed to force it must be checked by the service department m The displayed data must always be checked by the user prior to making further medical decisions m During mobile use homecare patient transport inside and outside the hospital Make sure the device is securely fixed and positioned Positioning changes and severe shock can lead to minor changes in the delivery accuracy 5 6 PATIENT SAFETY A supplemental patient monitoring must be carried out if life saving medication is performed
25. on Overview 3 2 Dose Rate Calculation Operation Chapter 4 Options 4 1 Occlusion Pressure 4 2 Bolus Rate 4 3 KVO Mode 4 4 Contrast Display Light Keypad Light 4 5 Alarm Volume 4 6 Date Time 4 7 Macro Mode Chapter 5 5 1 Pre Alarms and Operating Alarms 19 5 2 Reminder Alarms 22 5 3 Alarm Hints Chapter 6 Battery Operation and Maintenance EEN 23 Chapter 7 Start Up Graphs and Trumpet Cumes EE 25 Chapter 8 Technical Data cisccsccoscsesaieisceecascaiecsiossuescinncianiaie antvesneaniieietss 26 Chapter9 Warranty TSC Service Cleaning Disposal ssscssssssssssssssssees 28 Chapter 10 Instructions for Use ACCESSOTY EE 30 lee ONE 34 2 INFUSOMAT SPACE OVERVIEW INFUSOMAT SPACE OVERVIEW Arrow up and down Scroll through menus change setting of numbers from Press to reset single values 0 9 answer Yes No questions to zero and switch back to Press to Arrow left and right the previous screen menu open the Select data from a scale and switch between digits when level pump door numbers are entered Open a function while pump is running or stopped with the left arrow key a 0 0 O Press to Yellow LED Pre alarm reminder alarm a Press to S Green Red LED Infusion occuring device alarm on E operating alarm Blue LED Currently connected to SpaceControl
26. one SpaceControl may be stacked together Avoid external mechanical influence Locking Devices Together Line up the bar of lower pump with bar of pump above and slide lower pump back wards until the lock clicks and the green buttons are above each other To disconnect push green locking buttons of top pump device and slide bottom pump forward Pole Fixation Push opening of PoleClamp against vertical pole and lock screw tight Unscrew to release For vertical fixation of PoleClamp push lever down and rotate either way until lever clicks into notch Push lever for rotation Caution Do not lean on pump when attached to pole PATIENT SAFETY A Read Instructions for Use prior to use The infusion device should only be used by specially trained staff PATIENT SAFETY Operation m The initial training of the Infusomat Space is to be performed by B Braun sales personnel or other authorized persons After each software update the user is requested to inform himself about the changes of the device and accessories in the Instructions for Use m Ensure the unit is properly positioned and secured The pump must be positioned on a level surface if used in combination with the short stand Do not position the pump above the patient m Prior to administration visibly inspect the pump for damage missing parts or contamination and check audible and visible alarms during selftest m Connect t
27. or wiping available from B Braun e g Meliseptol After cleaning allow the device to vent for at least 1 min prior to use Do not spray into openings in the device Be sure to observe the instructions provided concerning waste disposal and hygiene for batteries and disposables The line guide element can be loosened with the help of a pointed object e g ballpoint pen which is inserted in the lower right corner The cover can then be cleaned under running water Spray disinfectant on the peristalsis and wipe it with a soft cloth Caution Do not touch peristalsis with sharp object When reinserting the line guide element make sure that it is not damaged and that it audibly locks in Prime the next infusion line in order to ensure the proper position of each finger Disposal The pumps as well as battery packs can be returned to B Braun for further disposal When taking care of disposing of disposables as well as infusion solutions please consider the applicable hygiene and disposal regulations Inspection on Delivery Despite careful packaging the risk of damage during transport cannot be entirely prevented Upon delivery please check that all items are present Do not use a damaged device Contact the service department Included in Delivery Infusomat Space Battery Pack SP Instructions for Use Set 29 Chapter 9 30 INSTRUCTIONS FOR USE ACCESSORY INSTRUCTIONS FOR USE ACCESSORY SpaceStation 8713140 Sta
28. p is infusing until the font size changes Chapter 5 ALARM _ ALARM The Infusomat Space is equipped with a audible and optical alarm signal Alarm Audible Optical signal User confirmation type signal Yellow LED Text Device j yes Press and hold Alarm until the pump switches off after a few seconds Opera yes Press 0x to ting acknowledge the Alarm audible alarm alarm text and staff call The red LED remains on until the infusion is restarted Pre yes de activate Press o to mute Alarm i via service alarm and turn off staff program call Visible alarm remains until end Reminder Press 0 to mute Alarm alarm turn off staff call and delete the alarm text Alarm fyes Hint disappears Hint without confirmation 5 1 Pre Alarms and Operating Alarms Pre alarms Pre alarms occur a few minutes dependable on service settings prior to operating alarms During pre alarms an audible tone sounds the yellow LED blinks and a staff call is activated optional The display message varies depending on the alarm reason The signal tone and the staff call are turned off with c Display and LED stay in pre alarm until the operating alarm goes off Pre alarms don t lead to an interruption of the infusion Display message Pre alarm reason VTBI near end The preselected volume is nearly infused Time near end The preselected time is almo
29. pacity operating time in hours and minutes please refer to menu item Batt Cap in the Status Menu of the Infusomat Space Important information for battery self check If the battery symbol is blinking during mains operation the battery is either discharged or has a reduced capacity In this case the pump should not be disconnected from mains If it is necessary to disconnect the pump from mains power for urgent reasons the user should check to ensure if the battery capacity is sufficient for the proposed use When the battery symbol blinks permanently gt 1h the battery must be checked by a technician and replaced if necessary Directions for optimal battery use The actual battery life may vary due to p ambient temperature m varying load e g frequent boluses The life of a battery can be prolonged if the battery is regularly charged and discharged For this the pump must be used in the battery mode until the battery alarm sounds Subsequently the pump should be connected to mains for at least 6 h This process is recommended to be done once per month Furthermore m f possible only charge the battery if it has been completely discharged m fa battery which is not completely discharged is charged several times its capacity can be reduced Its original capacity can be reached again if the battery is completely discharged and then recharged m Under normal temperature conditions a battery can be charged and discharged
30. pter 9 INSTRUCTIONS FOR USE ACCESSORY VE i i Alarm d i l l Amn Operation a ee wm without Alarm Off Alarm Operation ee Te vn Alarm ff OTAR Operation Jin the mode static without Off Alarm the staff call can be surpressed with Caution The user should always closely observe the local pump alarms as well Note A maximum of three plugs can be stacked upon each other in socket P2 Technical Data Connecting Wire white and green white and brown Alarm disconnected connected Operation connected disconnected Polarity of connexion is arbitrary max 24 V 0 5 A 12 VA 33 ORDERING Art No B Braun Infusomat Space 100 240 V EE 871 3050 Recommended accessories for the B Braun Infusomat Space SIE E 871 3140 STI e EE EE 871 3147 Space Cover COMMO Mi cccgsssscccan ateasacrsedsecossseteiccessssscedntegesscpsisecouescraianeeteansuattiesse 871 3145 Pole CAMP SP eet 871 3130 Power Supply SP Euro Bug 871 3110 Power Supply SP UK Plug ceccsssssssssssssssssssssssssssseseeeeseesseseesseeeeseeseeseeseeseeseetees 871 3111 Power Supply SP US luese deeg 871 3112 Power Supply SP Australian Plug EE 871 3113 Power Supply SP Universal Bug 871 3114 Combi Lead SP 12 Massage ege 871 3133 Drop SEASONS E 871 3175 Klee ee 871 3135 Battery Pack SP NiMH een 871 3180 interface Lead CAN SP rrinin 871 3230 Connection Lead SP 12V na 871 3231 Conn
31. r Use manual Caution The Interface Lead CAN SP is only to be used by the service department never use while patient is connected Note A maximum of three plugs can be stacked upon each other in socket P2 31 Chapter 9 32 INSTRUCTIONS FOR USE ACCESSORY Connection Lead SP 12 V 8713231 Install the Connection Lead SP 12 V in the following way 1 Connect plug to socket P2 on back of pump or F3 on SpaceStation respectively 2 Put the connection lead into the car socket 3 If necessary remove red adaptor of motor vehicle connector by slightly turning and simultanously pulling The green LED of the electronic box shows the operating voltage The mains connector can easily be replaced by another plug if required Caution Do not connect the pump to a patient during external car battery charging Note A maximum of three plugs can be stacked upon each other in socket P2 Connection Lead for Staff Call SP 8713232 To connect the Infusomat Space to staff call use the Connection Lead for Staff Call SP The staff call needs to comply with the requirements of VDE 0834 consider country specific regulations Note Test staff call signalling before every use The Infusomat Space offers three different staff call operating modes They are displayed in the signalling scheme Consider the staff call of the hospital when choosing an operating mode Choose the operating mode via the service program Cha
32. re Time to occlusion alarm min at rate Max bolus bar 1 ml h 25 ml h 100 ml h ml Level 1 typ 0 3 09 07 00 33 00 07 0 0347 Level 5 typ 0 7 25 53 01 14 00 15 0 0987 Level 9 typ 1 2 46 50 02 06 00 24 0 1787 Mechanical occlusion pressure limit under fault conditions Occlusion alarm pressure max 2 1 bar 210 kPa Max bolus volume 2 ml History protocol 1000 last history entries 100 events for system diagnose Refer to separate documents of the History Viewer for closer information to be set via the service program in increments of 0 01ml to be set via the service program from 0 5 3 8 ml h in increments of 0 1ml Note The technical data stated in this Instructions for Use manual were determined with the Infusomat Space lines as of Type Standard 870 0036 SP 27 Chapter 8 The CE mark confirms that this medical product complies with the Council Directive on Medical Devices 93 42 EEC dated 14th June 1993 B Braun Melsungen AG 28 WARRANTY TSC SERVICE CLEANING DISPOSAL WARRANTY TSC SERVICE CLEANING DISPOSAL Responsibility of the Manufacturer The manufacturer assembler installer or importer is responsible for the effects on safety reliability and performance of the equipment only if m assembly operations extensions re adjustments modifications or repairs are carried out by authorized personnel m the electrical installation of th
33. rted Then the accumulated air volume and the max size of air bubbles is indicated which is triggering the air alarm of the device During the first ever start up of the device the user is requested to select the language with Band confirm with 4 Answer the following question with 4 in order to take over language m Press to start the direct entry of therapy parameters or press and 4 to open the pump door in order to continue with inserting the line Caution You may only insert the line while the device is switched on and the line guide element is inserted Otherwise there is the danger of freeflow Pay attention to keep the roller clamp closed before inserting the infusion line especially at a tempera ture scale of 10 15 C Never leave the pump unattended when inserting the tube Insert the infusion line from right to the left Make sure that the line is routed straight At first route the line through the upstream sensor Then insert the two hole clip Chapter 7 OPERATION E In the next step attach the white clip without twisting the line Insert the freeflow clamp see red arrow in the opened aperture in the direction indicated by the arrow until the opening lever locks in and the safety clamp squeezes the lines flashing signal lamp goes out m Close the pump door Then select the inserted line with B and confirm it with 3 Open the roller clamp
34. st over Battery nearly empty The battery is almost discharged KVO active VTBI time are reached and the pump continues the infusion at the KVO rate A stopwatch on the display counts down the remaining time depending on the service program between 3 30 min After that the pump changes to the operating alarm 19 Chapter 5 20 ALARM The pre alarms VTBI near end volume preselection and Time near end time preselection can be deactivated via the service program Operating alarms Operating alarms lead to an interruption of the infusion An audible tone sounds the red LED flashes and a staff call is activated The display states Alarm and the reason for the operating alarm The signal tone and the staff call are turned off with ox Corrections are to be made according to the alarm reason Display message Alarm reason VTBI infused The preselected volume was infused Continue therapy or select new therapy Time expired The preselected time has ended Continue therapy or select new therapy Battery empty The battery pack is discharged Connect device with mains and or exchange battery pack The battery alarm will be on for 3 min Then the pump will automatically turn off Pressure high An occlusion occured in the system The set pressure level was exceeded A bolus reduction is automatically initiated by the pump Check if tubing contains kinks or is damaged as well
35. t the possibly reduced battery operating time when the battery maintenace isn t completed yet Chapter 6 START UP GRAPHS AND TRUMPET CURVES START UP GRAPHS AND TRUMPET CURVES Start Up Graphs Trumpet Curves 2 ml h Infusomat Space Line Type Standard 100 Infusomat Space Line Type Standard flow Delivery rate 1 ml h deviation Delivery rate 1 ml h 5 50 Epmax 1 WV 1 0 kel Epmin 0 5 50 o 30 60 90 _pAt min 120 2 5 11 19 pAt min 31 50 ml h Infusomat Space Line Type Standard 10 Infusomat Space Line Type Standard flow Delivery rate 25 ml h deviation Delivery rate 25 ml h 37 5 5 Epmax 5 D Epmin 12 5 5 0 30 60 90 _pAt min 120 2 S 1 19 pAt min 31 200 ml h Infusomat Space Line Type Standard 10 Infusomat Space Line Type Standard flow Delivery rate 100 mi h deviation Delivery rate 100 ml h 150 5 Epmax e _ y 100 0 Epmin 50 5 0 30 60 90 pAt min 120 2 5 11 19 pAt min 31 The graphs show the accuracy uniformity of flow in relation to time They allow for the following The delivery behaviour or delivery precision is essentially influenced by the type of the disposable used If other lines disposables than those stated in the order data are used deviations from the technical data of the pump cannot be excluded Trumpet Curves Measured values for second hour in each
36. tion for up to four pumps For further information see Instructions for Use of SpaceStation SpaceCover Standard 871 3147 SpaceCover Comfort 871 3145 Cover to be placed on upper SpaceStation incl built in handle The SpaceCover Comfort additionaly includes a central alarm management and alarm LEDs PoleClamp SP 8713130 A maximum of three B Braun Space pumps and one SpaceControl can be stacked together when used with the PoleClamp SP For detailed instructions on secure fixation of the PoleClamp SP please refer to Overview Infusomat Space and Patient Safety Power Supply SP 8713110 8713114 The Power Supply SP is adequate to supply power for a single pump and one SpaceControl 1 Connect plug of Power Supply SP with socket P2 on back of pump ensure that plug clicks 2 Push power plug into wall outlet Note For disconnection from pump press lever on plug down A maximum of three plugs can be stacked upon each other in socket P2 Technical Data 100 240V ACs 50 60 Hz Combi Lead SP 12 V 8713133 The Combi Lead SP can connect up to three pumps All pumps can then be operated via the Connection Lead SP 12 V 1 Connect plug of the Combi Lead SP 12 V with the socket P2 on the back of the pump 2 Connect plug of Connection Lead SP with Combi Lead SP 3 Push plug of Connection Lead SP into 12 V connector Note A maximum of three plugs can be stacked upon each other in socket P2 Chapter
37. us rate according to therapy requirements Take care not to overdose Given a bolus rate of 1200 ml h e g 0 33 ml are reached within just one second 4 3 KVO Mode The pump can continue the infusion with a preset KVO rate after a preselected VIBI time has passed see Technical Data The duration of the KVO delivery is defined in the service program m Open the KVO mode in the Options Menu with 4 m Answer the Yes No question with a to enable the KVO mode 4 4 Contrast Display Light Keypad Light Contrast as well as display and keypad light can be adjusted individually according to the lighting conditions m Open contrast display light keypad light in Options Menu by pressing 4 m Choose between 9 contrast and display light levels with 4 or gt and confirm with 0x 17 Chapter 4 18 OPTIONS 4 5 Alarm Volume Chose between 9 different alarm volume levels m Open alarm volume in Options Menu with 4 m Set volume with 4 or gt and confirm entry with o 4 6 Date Time m Open date time in the Options Menu with 4 m Modify date and time with EJ and confirm the setting with 0 4 7 Macro Mode The infusion rate appears larger on the display when the macro mode is activated and the pump is infusing m Open macro mode in Options Menu with 4 m Answer Yes No question by pressing to activate the macro mode For quick activation of macro mode Press and hold gt while the pum
Download Pdf Manuals
Related Search