Infusomat® Space P
Contents
1. Intrafix Air matic P BCV 180 cm 406 3783 Intrafix SafeSet 180 cm 406 3000 Intrafix SafeSet BCV 180 cm 406 3001 Intrafix SafeSet P 230 cm 406 3003 Intrafix SafeSet P 1 S 180 Cri e cecsssssssessesssessssssssessessssssesseestesnessecssesseeseess 406 3005 46 ORDERING Other Lines Fresenius Perfudrop Air M P sssssssssssessssssesssseesessssessesnenesssneensessntensens 48403608 Codan LOG P rinier a E oa stamina ae 43 4304 Codan VSG Pinin a o ta dantaint ada arla Ea ea Tad aeai a a Oaa EN 43 4291 Hint B Braun does not have any influence on the quality of other lines Changes in quality of those lines may have an influence on the technical characteristics of the pump B Braun therefore is not liable for deviations caused by disposables from other vendors than B Braun In case of inadequate performance caused by these disposables please contact the correspondant manufacturer 47 B BRAUN Manufactured by B Braun Melsungen AG B Braun Melsungen AG Sparte Hospital Care eet eee Seea D 34209 Melsungen Tel 49 0 56 61 71 0 Tel 0 56 61 71 0 Germany Fax 0 56 61 71 20 44 www bbraun com www bbraun com Material No 38911848 Drawing No M687 70 02 01 F04 0308 Printed on pulp bleached 100 chlorine free2. 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 5 PATIENT SAFETY Compare the displayed value with the entered value Only start the infusion if the values showing are the same If staff call is used we recommend checking the equipment once after connecting the pump Protect the device and the power supply against moisture If the pump falls down or is exposed to force it must be checked by the service department The displayed data must always be checked by the user prior to making further medical decisions 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 A supplemental patient monitoring must be carried out if life saving medication is performed The air detector cannot detect air diffusing in the following components three way stopcocks infusion adapters and further lines placed between pump and patient In case high potent drugs are given be sure to have a second infusion pump for that drug at hand Independant of the soft limit
3. 3 should differ from the one for levels 1 and 2 in case the pump is only allowed to be used by pain management professionals When ending PCA and starting it again the therapy data are set to default values Using the demand button also the patient is a permitted user With the demand button only a PCA bolus can be requested This is limited to pre defined doses by drug list and pump settings MENU STRUCTURE OVERVIEW 8 MENU STRUCTURE OVERVIEW Cutline On Off button Door open button Start Stop button Bolus button Menu Structure o CX o Clear button OK button Keypad with arrow up down left right button Connection button Start Up Main Special Options Status Menu Menu Functions Menu Menu Line Change to Dose Rate Occlusion Total selection PGY 1 2 Calculation gt Pressure gt Total volume y y y y Y Prime Concentration Drug Library Data Lock Total Total amount y y y y Use last Weight Piggyback Bolus Total therapy Rate Total time y y y y Y Use dose rate Dose Change over KVO Intermed calculation from Mode volume continuous y vy mode to PCA y y Use drug Rate Contrast Intermed library amount y y y y ViBI ViBi Display Intermed Light time y y y Time Keypad L
4. 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 Approx 6 hours Weight Approx 1 4 kg Dimensions W x H x D 214 x 68 x 124 mm 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 TECHNICAL DATA Chapter 8 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 as of a bolus volume gt 1 ml 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 default setting 0 1 ml h 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 bu
5. A maximum of three pumps Infusomat Space P or Perfusor Space plus one SpaceControl may be stacked together Avoid external mechanical influence Locking Devices Together Line up the bar of the lower pump with the bar of the pump above and slide the lower pump backwards 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 the opening of the PoleClamp against the vertical pole and lock the screw tightly 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 AN Read Instructions for Use prior to use The infusion device should only be used by specially trained staff PATIENT SAFETY Intended use The Infusomat Space Volumetric Infusion Pump System includes an external transportable electronic volumetric infusion pump dedicated administration sets and pump accessories The system is intended for use on adults pediatrics and neonates for the intermittent or continuous delivery of parenteral and enteral fluids through clinically accepted routes of administration These routes include but are not limited to intravenous irrigation ablation and enteral The system is used for the delivery of medications i
6. proper position of each finger Do not use Hexaquart 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 Testing the proper funciton of the device should be performed before initial use This is even ruled by law in several countries A respective form can be obtained from B Braun Included in Delivery Infusomat Space P Battery Pack SP Instructions for Use Set INSTRUCTIONS FOR USE ACCESSORY Chapter 10 INSTRUCTIONS FOR USE ACCESSORY SpaceStation 8713140 Station 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
7. time Remaining VTBI All status information is available in the bottom line of the dislplay The desired information can be selected by using Y 4 and will be displayed permanently thereafter e g drug long name time until syringe empty etc E3 Man Bol 1200 mith tt has been pressed while the pump is 0 4 infusing Start manual bolus at 1200 ml h by pressing see top of ml display or proceed to set bolus limit with 4 see bottom of display 9 MENU STRUCTURE NAVIGATION 10 Display This parameter can not be modified 023450780 Bam mihi VWTBLintused E Confirm Pump turns aff in 2sec s E Meaning 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 Set pressure level with 4 or gt and confirm by pressing 0 7 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 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 Confirming does not activate an acoustic feedback Press and hold for 3 sec to turn pump off A white bar stretches from left to right and counts down the 3 sec As long there is an infusion line inserted the pump will not turn off but
8. turned off at any time by pressing for 3 sec Exception Data lock level 2 and as long a disposable is inserted 1 2 Entry With Different Combinations of Rate VTBI Volume To Be Infused and Time The Infusomat Space P offers the possibility to enter a volume and time limit in addition to an infusion rate When two of these parameters are entered the third is 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 VIBI with amp 3 and confirm with ov m Select time with and open with 4 m Enter time with and confir
9. with a 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 15 ADVANCED OPERATIONS Chapter 1 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 that the device is supposed to switch to stand by by pressing 4 m The default time for standby is displayed Accept the default time with 0k or change it with 0 24 hours and then confirm it by pressing 0 gt While the pump is in the standby mode it s display shows the drug and the remaining time for this mode Change of remaining time by pressing 0K Exit standby by pressing 16 ADVANCED OPERATIONS Chapter 2 ADVANCED OPERATIONS 2 1 Status Request of Pump when Infusion is Running Press to switch between run display and Main Menu while the device is infusing Navigate through the menu using 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 switc
10. 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 09 and open the roller clamp m f required prime the pump with 4 Then press Y to proceed 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
11. 5 ALARMS The Infusomat Space P is equipped with a audible and optical alarm signal Alarm Audible Optical signal Staff call User confirmation type signal Red LED Yellow LED Text Device flashes flashes device alarm yes Press and follow Alarm and alarm the instruction on the code display see service program Opera flashes off see alarm yes Press 0 to ting description acknowledge the Alarm audible alarm alarm text and staff call The red LED remains on until the infusion is restarted Pre off flashes see alarm de Jactivate Press 9 to mute Alarm description _ via service alarm and turn off staff program call Visible alarm remains until end Reminder fyes off flashes see alarm yes Press ok to mute Alarm description alarm turn off staff call and delete the alarm text Alarm yes off off see alarm no Hint disappears Hint description without confirmation 5 1 Device Alarms When a device alarm occurs the infusion is immediately stopped Press to switch off the device Then switch the device on again In case of a repeated device alarm you must close the rollerclamp disconnect from the patient open the front door of the pump and take out the disposable The device needs to be handed to the service department 5 2 Pre Alarms and Operating Alarms Pre alarms Pre alarms occur a few minutes dependable on service settings prior to operating alarms During pre alar
12. Directive on Medical Devices 93 42 EEC dated 14th June 1993 B Braun Melsungen AG WARRANTY TRAINING 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 the 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 P 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 Training B Braun offers a training for version F Please ask your local representative for further details Technical Safety Check Service The Technical Safety Check is recommen
13. Infusomat Space P and Accessories Instructions for Use It is recommended that all pumps at your ward are equipped with the ft sion peer ea Valid for Software 687F B BRAUN CONTENTS CONTENTS lnfusomat Space P OVenvieW naninira iaiia 3 PAREN SARC EE OAE E AEE A EE A AAT 5 Menu Structure Overview ssssssssssssssssesssssssessssssessssssesesssssesessssssssssussessssesenssssesesssseessssueeees 8 Menu Structure Navigation ssssssssscccccsssssssssssssssssssessesssssssssssssssesssssssssesssssssssnsnnsessseseee 9 Chapter 1 Operation 11 Chapter 2 Chapter 3 Chapter 4 Chapter 5 Chapter 6 Chapter 7 Chapter 8 Chapter 9 Chapter 10 Ordering 1 1 Start of Infusion 1 2 Entry With Different Combinations of Rate VIBI Volume To Be Infused and Time 1 3 Bolus Application 1 4 Infusion Line Change and New Therapy Start 1 5 End of Infusion Re SORI NOE n EEE uaeecaeeseatesereatantpreeestuanccecegatpeeemc vette 6 Advanced Operations 2 1 Status Request of Pump when Infusion is Running 2 2 Rate VTBI and Time Change Without Infusion Interruption and Reset of Status Menu Data sN Special Functions 3 1 Dose Rate Calculation Overview 3 2 Dose Rate Calculation Operation 3 3 Drug Library 3 4 Patient Controlled Analgesia PCA 3 5 Piggyback Function Options 4 1 Occlusion Pressure 4 2 Data Lock 4 3 Bolus Rate 4 4 KVO Mode 4 5 Contrast Displa
14. Options Menu the lock will be activated again If the wrong code is entered twice the pump will switch into the last menu If the wrong code is entered twice again the pump will go into an audible alarm a nurse call will go off and the yellow LED blinks If a target value was reached while data lock is active a new start of the pump is only possible after entering the code In order to deactivate the function select Off in the data lock press 0 enter the code and press k again 4 3 Bolus Rate m Open bolus rate in Options Menu with 4 m Change bolus rate with 3 and confirm setting with Note Set bolus 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 4 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 selected in the service program 25 OPTIONS 26 Chapter 4 m Open the KVO mode in the Options Menu with 4 m Answer the Yes No question with 4 to enable the KVO mode 4 5 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
15. P 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 for 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 INSTRUCTIONS FOR USE ACCESSORY Chapter 10 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 adapt
16. Space P and Patient Safety Power Supply SP 8713110A 8713114A 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 AC 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 41 INSTRUCTIONS FOR USE ACCESSORY 42 Chapter 10 Drop Sensor SP 8713175 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 S
17. able An acoustic tone sounds the display states Value not accepted the yellow LED blinks and a staff call is activated Confirm alarm with and continue to set therapy ALARMS Chapter 5 5 4 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 32 BATTERY OPERATION AND MAINTENANCE Chapter 6 BATTERY OPERATION AND MAINTENANCE The Infusomat Space P 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 Prior to a longer storage of the pump gt 0 5 months the battery pack must be completely charged and then removed from the pump 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 capacity operating time in hours and minutes please refer to menu item Batt Cap in the Status Menu of the Infus
18. 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 account that if the battery maintenance has not been completed there is a possibility of a reduced battery operating time START UP GRAPHS AND TRUMPET CURVES Chapter 7 START UP GRAPHS AND TRUMPET CURVES Start Up Graphs Trumpet Curves 2 ml h Intrafix Primeline Classic 100 Intrafix Primeline Classic flow Delivery Rate 1 ml h deviation Delivery Rate 1 ml h 1 5 50 Epmax Mn aT i Eom 0 5 50 i 30 60 90 At min 120 5 11 19 At min 31 50 ml h Intrafix Primeline Classic 10 Intrafix Primeline Classic flow Delivery Rate 25 ml h deviation Delivery Rate 25 ml h 37 5 5 Epmax E SS Se es ere as to 7 ios eee Se a Ai Epmin 12 5 5 o 30 60 90 _pAt min 120 2 5 11 19 pAt min 31 200 ml h Intrafix Primeline Classic 10 Intrafix Primeline Classic flow Delivery Rate 100 ml h deviation Delivery Rate 100 ml h 150 5 100 Ei 0 yR lt a S 50 5 Epmin 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 t
19. bbles 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 Sensitivity upstream sensor 9 levels from 0 12 bar to 0 21 bar pressure reduction Occlusion alarm pressures 9 levels from 0 3 1 2 bar Occlusion pressure 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 05 32 00 28 00 05 0 0059 Level 5 typ 0 7 21 55 01 03 00 13 0 0625 Level 9 typ 1 2 37 35 01 38 00 17 0 0723 Mechanical occlusion pressure limit under fault conditions Occlusion alarm pressure max 3 bar 300 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 37 TECHNICAL DATA Chapter 8 Note The technical data stated in this Instructions for Use manual were determined with the Infusomat Space lines as of Intrafix Primeline Classic 406 2957 These technical data can change when using set configurations 38 WARRANTY TRAINING TSC SERVICE CLEANING DISPOSAL Chapter 9 The CE mark confirms that this medical product complies with the Council
20. confirm with 0 4 6 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 0 4 7 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 8 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 pump is infusing until the font size changes 4 9 Language This function enables a change of the pump language m Open language in the Options Menu with 4 m Select language with F then press 4 m Confirm Yes No question with 4 OPTIONS Chapter 4 4 10 Upstream Occlusion Pressure The device is equipped with an upstream pressure sensor that detects an occlusion e g closed roller clamp kinked line between the container and the pump The higher the pressure level is set at the lower the pressure level must drop before triggering an upstream occlusion pressure alarm m Access upstream 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 27 ALARMS 28 Chapter
21. ded to be carried out every 2 years and should be documented Servicing work must be carried out exclusively by B Braun trained personnel 39 WARRANTY TRAINING TSC SERVICE CLEANING DISPOSAL 40 Chapter 9 Check regularly Check for cleanliness completeness and damage Use only according to Instructions for Use During an exchange interval of the disposable the pump has to perform an occlusion test Check the following items each time the pump is switched on self check audible alarm process and alarm control indication Cleaning Clean external surface of pump using mild soap suds Do not use spray disinfectants at the mains power connection Recommended disinfectant for 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 hand 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
22. e calculation enables a calculation of the rate in ml h from the entered dose parameters Dose Infusion rate ml h ___ ml h Concentration x Patient weight optional 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 or Ibs 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 H 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 s weight does not need to be entered press Y Press 4 for a time and weight related calculation set the patient weight with and confirm it with 0 m Select the dose prescription with and confirm it with 4 m Set the dose with and confirm with 0 The rate will be automatically calculated and displayed at the bottom of the display m Check the calculated rate and if necessary the adapted parameters with B on plausibility before starting the infusion with m Chec
23. e therapy symbol looks like this PCA In case there is no demand button connected the therapy symbol looks like this PCA The demand button is connected to the interface P2 at the rear side of the pump Hint It is possible to start a therapy in continuous mode and switch over to PCA later on in case the drug is dedicated for use with continuous and PCA application SPECIAL FUNCTIONS 22 3 5 Piggyback Function The piggyback mode offers the possibility to interrupt the current primary infusion temporarily in order to administer a piggyback secondary infusion Above the pump the piggyback infusion line is connected with a Y connector to the administration set The secondary infusion is supposed to be located approx 20 cm higher than the primary infusion All infusion lines need to be completely primed A back check valve has to be placed according to the drawing see next page A precondition to start the piggyback function is that the pump is stopped Note Please mind to set a VIBI of the primary and secondary infusion that corresponds to the size of the container m Enter the rate manually or load into the pump via the dose rate calculation or the drug library It is not possible to begin with the secondary infusion if the data for the primary infusion rate and VTBI is not set m Select Piggyback from the Special Functions Menu and confirm with 4 m The change from the seconda
24. ected connected Operation connected disconnected Polarity of connexion is arbitrary max 24V 0 5A 12VA INSTRUCTIONS FOR USE ACCESSORY Chapter 10 PCA ACCESSORIES m Space PCA Kit REF 8713554 consisting of Demand button Hook and loop tape for fixation of the demand button at the patient s arm Line fixation connection between hook and loop tape and demand button Metal clip alternatively for fixation at the bed sheet Cable strap for wrapping the cable of the demand button PCA Key for locking the syringe holder or the Syringe Anti Removal Cap Fixation of the demand button at the wrist or at the bed sheet Usage of the cable strap 45 ORDERING Art No B Braun Infusomat Space P 100 240 V eeeescssssssssssssssseesseees 871 3070 Recommended accessories for the B Braun Infusomat Space P Space Statio a ai 871 3140 SpaceCover StaNdaldisinosnnnuisnknni a Gicannizeunis 871 3147 SpaceCover COMI ONE susia a a 871 3145 AETI E E E E A E 871 3130 Power Supply SP Euro Plug ssesssssssssscsssssssssssssssssssssseseesessssssssnsnsuseeseseseeeeseesees 871 3110A Power Supply SP UK Plug csccccsssssssssssssssssssssssssseesesseseseesseseesseseeseeseeseeteetesteets 871 3111A Power Supply SP US Plug 871 3112A Power Supply SP Australian Plug csssssssssssssssssessscsssssssssssnssssssesssseseesees 871 3113A Power Supply SP Universa
25. enu the drug name and the adjusted values of the data set will be loaded If a dose rate calculation has already been started a belated assignment of the drug name nevertheless is possible In the following the loading of a drug including the according parameters will be described m Open the drug library by pressing 4 m Navigate through list with H and select the drug from category in alphabetical order all drugs or within a category with 4 m Confirm the displayed drug information with 4 m Check if the drug short name in the Main Menu is the same as the selected drug Check the parameter in the Main Menu with H and start infusion with Hard Limits If the set rate dose bolus volume and bolus rate exceed the values stored in the drug library hard limits the drug will be rejected a hint will be displayed and the pump will fall back into the drug selection If this occurs while the pump is infusing the pump will continue to administrate Soft Limits For the same parameters so called soft limits can be preset via the Drug List Editor These can be exceeded without any constraint The following symbols 19 SPECIAL FUNCTIONS 20 Chapter 3 that describe the status with regard to the soft limits are being displayed The infusion is within the range of the minimum and maximum soft limits The infusion is within the range of the maximum soft limit The infusion is within the range of the mi
26. ff with o 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 as IV and filter patency Increase occlusion pressure if necessary KVO finished The KVO time has ended Continue therapy or set new therapy 29 ALARMS 30 Chapter 5 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 to use the pump without a battery pack Turn off pump and insert battery pack according to description Overview Infusomat Space P Drive blocked Stepper motor does not deliver due to excess pressure in the system Interrupt patient con
27. h to the Main Menu Select rate VTBI time with and press 4 in order to open the parameter m Enter new value with amp 8 and confirm with 0 Reset Status Menu Data The parameters intermediate volume and time can be reset when the pump is infusing or when the pump has stopped m Select Status in Main Menu with and press 4 m Highlight intermediate volume in ml or intermediate time in h min with Band open parameter with 4 m Reset values by pressing 4 Both parameter total volume and time are 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 whether the last therapy is to be used with u and reset the values with 4 The type of the inserted line is displayed in menu item Line and cannot be changed once it has been confirmed at the beginning of the infusion The drug info states the drug name the name of the drug list and its date of origin If the change from the secondary to the primary infusion will be performed manually or automatically will be displayed in line PGY change The current battery capacity in hours and minutes is displayed in the menu item Battery Cap and the current software version in menu item Version 17 SPECIAL FUNCTIONS 18 Chapter 3 SPECIAL FUNCTIONS 3 1 Dose Rate Calculation Overview The dose rat
28. he disposable used Deviations from the technical data of the pump cannot be excluded if lines disposables other than those stated in the order data are used Trumpet Curves Measured values for second hour in each 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 120 min Flow Q ml h 35 36 TECHNICAL DATA Chapter 8 TECHNICAL DATA Type of unit Volumetric infusion pump Classification acc to IEC EN 60601 1 w 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 m Rated voltage m 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 Connection Lead SP 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 m Relative humidity m Temperature m Atmospheric pressure Storage conditions m Relative humidity m Temperature m Atmospheric pressure 30 90 without condensation 10 40 C 500 1060 mbar
29. he 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 again Therapy data were reset Therapy data could not be restored Enter therapy again Data Lock An attempt was made to stop or switch the pump off without entering the code Enter the correct code in order to continue the therapy respectively turning the pump off The red LED doesn t extinguish until the administration is started again respectively the pump is turned off Caution If a wrench is displayed and or a yellow red and blue LED blink then the pump is in the service mode and is not permitted to be used on a patient The pump must then be checked by a service technician 5 3 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 activated a The display states Reminder alarm b The display states Config not finished Confirm alarm with 0 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 dispos
30. hen press 4 and set bolus dose by using amp amp Press to confirm bolus dose 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 mg h then the bolus will be given in mg You can use the service program to enter a default and a maximum bolus rate Once a new therapy is started 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 Note The infused volume during bolus with volume preselection counts up In order to purge the line at any time while the pump is stopped press Answer the following question by pressing 4 in order to start the purge process Cancel by pressing or any other key OPERATION Chapter 1 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 0x At low bolus volumes under dosages due to the start up characteristic of the pump and the tolerances in the infusion system cannot be excluded Disconnect patient while purging
31. ine Light y y y Special Alarm Drug Info Functions Volume y y y Options Date PGY Gai The pump can be customized y y y Status Time Batt cap by de activating the au y menu items of lacro Version Made the Start Up y except VTBI Lai n ces and Options y Menu as well as Upstream the bolus func Pressure k A D tion via the in dose mode service program Display of flow rate in large scale MENU STRUCTURE NAVIGATION MENU STRUCTURE NAVIGATION Display Meaning Last Therapy 1 At the top of the screen the last therapy is indicated Yes No question can be answered by pressing for yes or Y for no oR Confirm D Start Infusion Parameters which can be changed e g 4 rate in ml h are opened with 4 or ox When editing parameters switch EB Clear mish 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 0 start infusion with or clear rate by pressing Typical display during infusion Mains Set pressure limit and connection current pressure Battery Therapy profile i _ Active VIBI or time preselection C Scrolling arrows indicate pump is infusing Set rate can be opened with 4 mith Unit of drug application Total volume infused Alternatively the intermediate volume can be displayed Remaining
32. ing 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 33 BATTERY OPERATION AND MAINTENANCE 34 Chapter 6 Caution Batteries may explode or leak if they are opened or incinerated Consider disposal directions Battery maintenance To accurately balance the battery capacity a cyclical battery maintenance is necessary The pump asks the user to perform a battery maintenance every 30 days The battery maintenance mode detects a possible capacity loss e g through ageing of the battery pack and then the capacity running time will be calculated anew After a longer storage time or a longer operation without battery maintenance it can happen that the battery pre alarm time can no longer be maintained In this case it is necessary to perform a battery maintenance To initiate the discharge process the message Battery maintenance and the 0 key will be displayed after switching the pump off By pressing 0 and 4 the discharge process will start The process is interrupted by switching the pump on again If the battery maintenance is to be continued a new
33. k the parameters with H on plausibility before starting with Concentration and dose can belatedly be changed in the Main Menu in the same way as the rate VTBI and time compare 2 2 The effect of dose modifications on other parameters is shown at the bottom of the display Additionally the total and intermediate amount of the infused drug can be SPECIAL FUNCTIONS Chapter 3 taken from the Status Menu These can be checked and reset 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 3 3 Drug Library Up to 720 drug names including therapy data and information can be stored in 15 categories The loading process into the pump can be performed using a separate PC program Drug List Editor Space Note The drug library can be started over the Start Up and Special Functions Menu The user has to make sure prior to the therapy start that the drug library in the pump complies with the patient target group The name of the drug library see headline will be displayed on the pump There are different ways of activating the drug library This can be done while the infusion is running or when the pump is stopped On the one hand a drug name including the according therapy data can be taken from the drug library On the other hand if a rate VIBI and or time were already defined in the Main M
34. l Plug scssssssssssssssssssescccsssesssssssnssssessseseesessesees 871 3114A Power Supply SP RSA Plug 871 3115A Combi Lead SP 12 Vissscasvescosissescesosttecasussctoststedhaastecssececesisvieedtbstefestsniecctbansieiens 3133 Drop SENSON S Pinansin iR REN 3175 Short Stand S Pe ciccesec scat desesesssssazetcoststnosnspeesstiens aie tinetteoeeencedaneeaa ae 871 3135 Battery Pack SP NiMH scscscsssssscssssssscsssssscssssssssssssessssssecsssssseecssssseesssnneessens 871 3180 interface Lead CAN S Priania nisnin ia 871 3230 Connection Lead SP 12 V ccccsesessssscssesesssescsssessseesssesssssteessessssstesssmesseessases 871 3231 Connection Lead for Staff Call SP oo ecssseeessssetessssstessssessssneesssnees 871 3232 Infusomat Space P Lines Intrafix Primeline Classic 150 CM oecsscsessssssssssessessesessssesssssssessssssessensens 406 2957 Intrafix Primeline Comfort 180 CM ou sescsssessssessesscsessesesesessesseseseseeseenees 406 2981L Intrafix Primeline Comfort BEV 150 Ci oi icscscssssessessessesesseseeseesesseseeeee 406 3252 Intrafix Primeline Comfort BCV 180 Cin i eiccscessssssscssesessessestescesessessesseeee 406 3287 Intrafix Air P 180 CM sssrin 406 2981 Intrafix Air Py 230C Misrin 406 0407 Intrafix Air P with siliconised spike 180 cm Intrafix Air P with Y Injection Piece 230 cm ae Intrafix Air matic P 150 CM 406 3953 Intrafix Air matic P 180 em 406 3988 Intrafix Air matic P BCV 150 cm
35. lamp squeezes the lines flashing signal lamp goes out m Close the pump door Then select the inserted line with H and confirm it with 4 Open the roller clamp Caution If a wrong line is selected the time until the pump goes into a pressure alarm may be prolonged m Press 4 if the prime function is enabled to prime the infusion line with the rate displayed Cancel priming with 09 Repeat the procedure until the line is completely primed Then press Y 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 4 or Y 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 OPERATION Chapter 1 Note At rates smaller 1 ml h the detection of a closed roller clamp cannot always be ensured due to physical reasons Therefore it is recommended especially at small rates to use a drop sensor Adjusting the delivey rate m In the Main Menu open the rate with 4 and set it with E 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
36. lume e g 1000 ml with delivery bag volume rate 10 ml h with delivery rate 25 ml h Clamp Clamp Piggyback line Infusion pump To patient 23 OPTIONS 24 Chapter 4 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 Data Lock The data lock function protects the device against unauthorized access A four digit code default setting 9119 which can be changed via the service program activates this function in level 1 or level 2 There are three security levels Level 1 A modification of values as well as a bolus application are not possible but a change of the disposable can be conducted It is possible to navigate through all menus and status data can be checked Starting interrupting and switching the pump off is possible Level 2 This level has the same performance characteristic as described under level 1 and additional will not allow the change of disposable In orde
37. m with 0 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 13 OPERATION 14 Chapter 1 3 Infusion with time limit Enter rate and time The infusion volume 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 1 3 Bolus Application There are three ways to administer a bolus 1 Manual Bolus Press Then press and hold button Fluid is administered for as long as the button is held down The infused bolus volume is displayed The max bolus time is limited to 10 sec 2 Bolus with volume preselection Press Then press 4 and set bolus dose limit by using EEG Press to confirm and start bolus Depending on the service tool settings an acoustic signal will sound after finishing the bolus volume 3 Bolus with rate calculation Press T
38. ms 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 0 Display and LED stay in pre alarm until the operating alarm goes off Pre alarms don t lead to an interruption of the infusion ALARMS Chapter 5 Display message Pre alarm reason VTBI near end The preselected volume is nearly infused Time near end The preselected time is almost 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 Communication error The pump is located in a system in which at least one device is incompatible or defective The use of this device in a system is not permitted The system is to be checked by a service technician 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 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 o
39. ndicated for infusion therapy including but not limited to colloids and cristalloids blood and blood compo nents Total Parenteral Nutrition TPN lipids and enteral fluids The Infusomat Space Volumetric Infusion Pump System is intended to be used by trained healthcare professionals in healthcare facilities home care outpatient and medical transport environments Qualified medical staff should decide how the device should be used based on its features and specifications For more details please read the Instructions for Use Operation m The initial training of the Infusomat Space P is to be performed by B Braun sales personnel or other authorized persons After each software update the user is required to inform himself about the changes to 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 Only connect to patient once the line has been 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
40. nected The international standard IEC EN 60601 1 1 has to be taken into account Safety Standards Infusomat Space P 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 surgical equipment nuclear spin tomography units mobile telephones etc maintain the recommended protective distances from these devices The Infusomat Space P fulfils the applicable requirements of EN 13718 to be used in the air on the water and in difficult terrain During transport the Infusomat Space needs to be fixed on a suitable restraint system by means of SpaceStation or Pole Clamp SP When stored under temperature conditions beyond the defined operating conditions the Infusomat Space P needs to remain under room temperature at least one hour before usage As there is no dedicated norm existing for enteral feeding pumps the safety features of Infusomat Space P are also for enteral nutrition according to the a m norms Safety Instructions m Incase the demand button is used with SpaceStation the PCA pump has to be placed in the lowest slot of the lowest SpaceStation Access to the pump settings can be prohibited by DataLock 3 The code for DataLock level
41. nection and reinsert the line Calibrate device Pump calibration data have changed e g after an update Recalibrate device via the service program 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 VIBI time and proceed with therapy Check upstream The upstream sensor triggers an alarm Check if roller clamp is closed or infusion line is kinked If a drop sensor is connected the upstream alarm is deactivated Air bubble Accumulated air Air inside the system Check the line for small air bubbles and disconnect from patient to repeat priming if necessary 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 glass 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 ALARMS Chapter 5 Check t
42. nfirmed by choosing the last menu item at the bottom of the list and pressing 09 Then the desired language must be selected with H and confirmed with o Answer the following question with Y in order to activate the selected 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 The pump is per mitted to be used on a temperature scale from 18 35 C Do not use the pump be yond these temperatures Never leave the pump unattended when inserting the tube Caution Inserting different lines into the pump is identical Please see instructions and packaging of the different lines standard transfusion opaque enterel nutrition etc to receive information about preparation and usage of these lines 11 OPERATION 12 Chapter 1 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 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 c
43. nimum soft limit Violation of the upper soft limit ft Violation of the lower soft limit No soft limit is defined A Only a drug name is available W It is possible to select a drug name only from the drug library The limits of the drug library have to comply with the limits of the pump and the disposable Note An adequate monitoring when infusing highly potent drugs is recommended Note In case a drug from the drug library is selected and the pump is running under dose rate calculation the initial values will be overwritten by the drug library values if selected 3 4 Patient Controlled Analgesia PCA For PCA a drug list with at least one drug activating the profile PCA is necessary By this the conditions for an effective and safe therapy are defined Switch on pump with and wait until self check is finished Depending on the settings the choice of a drug is offered direcly or the pump is in Main Menu Select Special Functions with H from Main Menu and confirm with 4 After the selection the pump B Fentanyl 4 offers additional drug related Morphine bd Information which are confirmed a A by 4 Fentanyl ACA START Select profile PCA by using and Bol vol 10 meg 4 confirm with B The therapy set Limit 100 mes th 4 tings stored in the drug list are Lockout 0 05 h min displayed Bolus volume is the volume of a single bolus the patient may demand Max Limit is the amount of drug o
44. omat Space P 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 m ambient temperature m varying load e g frequent boluses The optimal life time of a battery pack will only be reached if it s ompletely discharged from time to time A maintenance mode which conducts this battery maintenance is built in This function should be activated once a month Furthermore m f possible only charge the battery if it has been completely discharged m Ifa 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 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 operat
45. onnected to SpaceControl ED SoH 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 E n Port P2 for power supply SpaceStation connection lead 12V combi lead and further accessory leads staff call service Port P3 for future options INFUSOMAT SPACE P OVERVIEW Pressure _ Air sensor sensor Opening lever 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 press release button on frame push handle down and pull PoleClamp bak kwards Transport
46. or 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 P 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 P 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 43 44 INSTRUCTIONS FOR USE ACCESSORY Chapter 10 turmedoff Mumeo tumedoff ee Narr i i l 1 Operation without Alarm Off Alarm Operation a P han Alarm Pp L__ in 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 disconn
47. r to prevent a data lock alarm the correct code must be entered within 20 sec after the pump was stopped Changing the disposable and switching the pump off is only possible after the code was entered Level 3 This level will allow starting and stopping the pump as well as switching off The code for this level may be different for each drug and is defined in the drug list A change of the syringe however is possible by using the code defined for the other levels An overview about the differences between the levels 1 2 and 3 is given by the following table OPTIONS Chapter 4 Event Level 1 Level 2 Level 3 Change of disposable v x v with code for level 1 2 Start of infusion v v Change of parameters x x Stop of infusion v v amp v Switching off pump Standby v x x B PCA bolus with pump based bolus button x x v Customisable screen x x v Acoustic feedback of demanded boli x x v Indicates denied PCA boli v v x v possible not possible amp followed by standby alarm Activation of the function m Open data lock in Options Menu with 4 m Select between level 1 2 or 3 if activated with and gt and confirm with 0 m Enter code with and press in order to activate data lock Changes to the protected values and the bolus function which are marked with are only possible after entering the code After 20 sec in the Main Menu Status Menu Special Functions Menu and
48. r volume a patient may demand within a certain time in total Lockout is the time in between two boli SPECIAL FUNCTIONS Chapter 3 Select drug list category and desired drug by using Bu The therapy can be started now with in case all values are defined Depending on the pre defined settings the therapy is started with an initial bolus and a basal rate or not Before leaving the patient the pump should be put into DataLock level 3 with in Menu Options This is necessary especially in case non authorised access to the settings can be anticipated The pump display now may look Tr like this es Analgesia 11 56 The code is entered with and confirmed with 0x In this state the patient is allowed to demand boli Depending on the status of the therapy these are either administered or denied Changing the syringe is also possible by using the code for level 1 or level 2 Altering the settings for PCA or other therapies however is only possible with the code for level 3 The status of the therapy can be checked in the menu Status Enter the Main Menu with and select the Status with B Seo C E The A D ratio indicates the Rem lock 0 03 h min percentage of administered and on pn iy h Ng demanded boli thus giving an idea E about the effectivity of the therapy An acoustic confirmation of demanded boli can be activated and modulated by B in Data Lock 3 Is a demand button connected th
49. ry to the primary infusion PIGY to PRIM can be done manually or automatically Correspondingly if an automatic change is to be made automatically or manually is to be answered with 4 or v m The rate and VIBI of the secondary infusion can be loaded via the dose rate calculation the drug library or are to be entered manually with EES m Start secondary infusion by pressing Device delivers the piggyback volume with the set piggyback rate Symbols in the headline of the run display PRIM or PIGY will indicate if the primary or secondary infusion is currently running When the piggyback volume is infused the pump automatically changes to the primary infusion if this was selected If the VTBI of Primary infusion is infused the pump will continue with the KVO rate respectively after the KVO operation the pump stops and activates an alarm If a manual change from secondary infusion to primary infusion was selected the pump will stop or continue with KVO after the secondary infusion is completed and the user manually has to change via the menu item Change to PRIM in the Main Menu to the primary infusion and start with Note Switching manually between primary and secondary infusion in the Main Menu is possible at any time while the pump is stopped It is recommended to keep the roller clamp of the non active infusion closed SPECIAL FUNCTIONS Chapter 4 Secondary infusion Primary e g 100 ml infusion bag vo
50. s the selected values have to be the medically correct ones for the given patient In case values relevant for the dose rate calculation are changing always the flow rate will be updated and the dose rate will be fix Enteral Nutrition The Infusomat Space may be used for entaral nutrition too Do not use enteral fluids for intravenous infusion as this may harm your patient For this reason only use disposables dedicated and labelled for enteral nutrition Transfusion The Infusomat Space may be uses for blood transfusion too For this therapy only use disposables dedicated and labelled for transfusion Other components m Use only pressure proof and compatible disposable items min 2 bar 1500 mm Hg to avoid influencing performance data which would result in impairing patient safety m 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 PATIENT SAFETY 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 con
51. will use standby OPERATION Chapter 1 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 bottom to 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 inserted Then the accumulated air volume and the max size of air bubbles is indicated which is triggering the air alarm of the device The pump offers the possibility to load up to four languages into the pump depending on the number of the language specific characters among which the user can choose during the operation of the pump During the first ever start up of the device the user is requested to select the languages and to mark them with 4 After that the selection has to be co
52. y Light Keypad Light 4 6 Alarm Volume 4 7 Date Time 4 8 Macro Mode 4 9 Language oe 4 10 Upstream Occlusion Pressure srianan aain Alarms 5 1 Device Alarms 5 2 Pre Alarms and Operating Alarms 5 3 Reminder Alarm 5 4 Alarm Hints Battery Operation and Maintenance uu eeesseecsssecsssseeesssstesssseessenee 33 Start Up Graphs and Trumpet Curves riasin 35 echnical D fasini cnans anaa apa i 36 Warranty Training TSC Service Cleaning Disposal 39 Instructions for Use ACCESSOLY s sssssssssessesssssseesseesssesseessneesneessteeseessee 41 iii nen isin abhi Allah Siedler 46 The availability of the listed features is depending on the configuration of the pump Technical Safety Check INFUSOMAT SPACE OVERVIEW INFUSOMAT SPACE P 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 bat Press to Yellow LED Pre alarm reminder alarm initiate Press to turn Green Red LED Infusion occuring device alarm bolus pump on off operating alarm Blue LED Currently c
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