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- Instructions For Use Manual
B. Braun Infusomat Space Instructions For Use Manual
Summary of Infusomat Space
Page 1
Infusomat® space and accessories instructions for use valid for software 686j gb it is recommended that all pumps at your ward are equipped with the same software version..
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2 contents infusomat® space overview...................................................................................................3 symbols on product ..................................................................................................................5 patient safety ................
Page 3
Port for drop sensor infusomat space® overview i n f u s o m at ® s pa c e o v e r v i e w 3 arrow up and -down scroll through menus, change setting of numbers from 0-9, answer yes/no questions. Arrow left and -right select data from a scale and switch between digits when numbers are entered. Open a...
Page 4
Infusomat® space overview 4 transport a maximum of three pumps (infusomat® space or perfusor® space) plus one spacecontrol may be stacked together (in ambulance cars and helicopters only one pump). Avoid external mechanical influence. Locking devices together line up the bar of the lower pump with t...
Page 5: Symbol
S y m b o l s o n p r o d u c t 5 caution, general warning symbol caution, see documentation supplied with the product symbol explanation type cf unit with defibrillation protection protection class ii device labeling of electric and electronic devices according to directive 2002/96/ec (weee) ce mar...
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Pat i e n t s a f e t y patient safety read instructions for use prior to use. The infusion device should only be used by specially trained staff. 6 intended use the infusomat® space volumetric infusion pump system includes an external transportable electronic volumetric infusion pump, dedicated adm...
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7 patient safety • only connect to patient once the line has been correctly inserted and completley primed. Interrupt connection during line change to prevent incorrect dose delivery. • select infusion line/catheter suitable for use with the intended medical application. • position the infusion line...
Page 8
8 patient safety 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 u...
Page 9
9 • as there is no dedicated norm existing for enteral feeding pumps the safety features of infusomat space are also for enteral nutrition according to the a.M. Norms. Safety instructions for using pca • in case the demand button is used with spacestation the pca pump has to be placed in the lowest ...
Page 10
10 patient safety • it is possible to completely switch off the tci mode to avoid the use of tci accidentally. • by using infusomat® space a change of drug concentration will not be possible within the same therapy..
Page 11: Cutline
11 at the top of the screen the last therapy is indicated. Yes/no question can be answered by pressing u for yes or d for no. Parameters which can be changed (e.G. Rate in ml/h) are opened with l or k . When editing parameters, switch digits/levels using l r . White background indicates current digi...
Page 12
12 menu structure / navigation n b has been pressed while the pump is infusing. Start manual bolus at 1200 ml/h by pressing k (see top of display) or proceed to set bolus limit with l (see bottom of display). All status information is available in the bottom line of the display. The desired informat...
Page 13: Operation
13 chapter 1 operation operation 1.1 start of infusion • ensure that the pump is properly installed. Check the equipment for completeness and damages. Do not attach the infusion bottle below the pump level. • put the spike vertically into the infusion bottle. Fill the bottom part of the drop chamber...
Page 14
14 operation chapter 1 • make sure the line is properly inserted into the sensors (especially the air-sensor needs an accurately inserted line). • close the pump door. Then select the inserted line with t and confirm it with l . Open the roller clamp. Caution: if a wrong line is selected the time un...
Page 15
15 pump jumps to the main menu. If you select d with no drop sensor connected, you must first enter a vtbi which is smaller than the container filling and confirm it with k . Note: at rates smaller 1 ml/h the detection of a closed roller clamp cannot always be ensured due to physical reasons. Theref...
Page 16: 1.3 Bolus Application
16 operation 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 volume will be calculated and displayed on the bottom of the display. Target: ...
Page 17: 1.5 End Of Infusion
17 chapter 1 operation 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 n b . Answer the following question by pressing u in order to start the purge process. Cancel by pressing k or any other key. Cautio...
Page 18: 1.6 Standby Mode
18 chapter 1 operation • press o 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. • press s f to stop the infusion. Then press o for le...
Page 19: Advanced Operations
19 advanced operations advanced operations 2.1 status request of pump when infusion is running press c to switch between run display and main menu while the device is infusing. Navigate through the menu using t to check parameters. In order to check the menu parameters in the status-/options menu, s...
Page 20: Special Functions
20 chapter 3 special functions special functions 3.1 dosing units and dose rate calculation (overview) the following table shows the dosing units of the gram and unit family and their conversion used in the pump: in addition to these dosing units the user can choose: • feeding: kcal, meq, mmol a kg ...
Page 21: 3.3 Drug Library
21 chapter 3 special functions a set the patient weight with q and confirm with k . A select the dose prescription with t and confirm it with l . A set the dose with q and confirm with k . The rate will be automatically calculated and displayed at the bottom of the display. A check the calculated ra...
Page 22
22 loading a drug (including the according parameters) from the main menu: • go to special functions menu and press l . • open the drug library by pressing l . • navigate through the list with t and select the care area with l . If you have already set the care area once on your pump this step will ...
Page 23
23 chapter 3 special functions the infusion is within the range of the maximum soft limit = the infusion is within the range of the minimum soft limit = violation of the upper soft limit = violation of the lower soft limit = no soft limit is defined = only a drug name is available = (it is possible ...
Page 24
24 chapter 3 special functions the therapy can be started now with s f 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 q in menu “o...
Page 25
25 chapter 3 special functions 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). 3.5 target controlled infusion (tci) introduction in tci the user is defining a desired concentration...
Page 26
26 b. Braun space is offering two modes for tci: • tci by targeting the plasma concentration in this mode the user selects the desired concentration of a drug in the blood plasma and the pk model is used to calculate the infusion rates required to achieve that concentration as quick as possible (unl...
Page 27
27 tci with b. Braun space is possible with two drugs: propofol and remifentanil. For propofol the user can choose between two parameter sets. The parameter sets used for these drugs are (not all parameter sets allow effect-site targeting): chapter 3 special functions drug / parameter v 1 [litre] pr...
Page 28
28 drug list the pre-installed drug list offers the following values: important note: before installing an additional drug list please contact your local b. Braun representative! Setting up the pump for tci a drug list with at least one drug activating the profile tci is necessary. The drug list in ...
Page 29
29 these steps are only necessary in case there are different options for that drug. Input of patient data depending on the parameter set one or more of the following data are necessary: • weight • height • gender • age the editing window appears with the initial setting “0” to make sure editing a v...
Page 30
30 confirm target with k . Tci can be started now with s f . After tci is started the screen looks the following: in the top line there is an icon indicating the parameter set and the mode (mode indi- cator) with following meaning: • “tci ma p”: tci marsh plasma targeting • “tci sc p”: tci schnider ...
Page 31: 3.6 Barcoding
31 chapter 3 special functions finishing tci there are two possibilities to finish the tci therapy (reversion of anaesthesia or sedation): • set target= 0 • stop pump it is recommended to simply stop the pump by pressing s f . Pressing r the pump offers additional information – in this case the info...
Page 32: 3.7
Chapter 3 special functions 32 3.7 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 administr...
Page 33
33 chapter 3 special functions • go to „set new piggyback” in the special functions menu and confirm with l . Note: resetting the data of the last secondary will also reset vtbi.
Page 34: 3.8 Ramp And Taper Mode
Chapter 3 special functions 34 3.8 ramp and taper mode the ramp and taper mode is designed to deliver infusions with gradual ramp up and taper down rates. The pump automatically calculates the rate increase and decrease required to match the total volume, time and ramp up/ramp down time parameters. ...
Page 35
35 starting ramp and taper via drug library: note: ramp and taper settings have been configured in the drug list manager before and have been uploaded into the pump. • switch on pump with o and wait until self-check is finished. • insert disposable and use the drug library according to the instructi...
Page 36
Chapter 3 special functions 36 taper phase note: after starting infusion it is only possible to change rates, time and vtbi in the continuous phase. By editing (increasing/decreasing) the plateau rate, the therapy is recalculated. With the increase/decrease of the plateau rate the volumes in the ram...
Page 37: 3.9 Program Mode
37 3.9 program mode program mode is for infusion requiring a non-standard delivery pattern. The user defines a series of intervals (max. 12 intervals) by certain parameters (rate, time, volume) for each cycle. The pump automatically gives each programmed period, one after the other. Example: program...
Page 38
Chapter 3 special functions 38 in the following screen the user has to confirm the number of steps for the therapy with k . The settings for the steps of the infusion are shown on the display. These settings, configured in the drug list editor, need to be confirmed with r . • to change the values, p...
Page 39: 3.10
39 number of cycles is defined by vtbi. Take care to set the vtbi in the correct relation to the volume of one cycle. Vtbi may needs to be adjusted after changing the intervals. The main menu informs about the current interval. The configerd paramters can be checked by program parameter menu in main...
Page 40
Chapter 3 special functions 40 starting intermittent mode via drug library: note: intermittent mode settings have been configured in the drug list manager before and have been uploaded into the pump. • switch on pump with o and wait until self-check is finished. • insert disposable and use the drug ...
Page 41: 3.11
41 during infusion it is possible to change the bolus volume, amount, vtbi as well as the time interval. • press c . • use t to navigate through the parameter list and select the parameter to be changed with l . • enter the new value and press k . The pump continues infusion. Changing the bolus afte...
Page 42
Total dose and the remaining time. In the main menu total dose, time and vtbi can be changed, also during run-mode. Other parameters (dose rate, basal rate, concentration, patient weight and patient height) cannot be changed. Note: the kvo function and bolus function are disabled during dose over ti...
Page 43
43 note: it is always possible to press the key c in the run menu and edit or check values in the main menu while the pump is delivering. Run menu: the time is used to control the therapy. For this reason the remaining time is shown big digits in menu run. The parameter in the lower left corner can ...
Page 44: O P T I O N S
44 chapter 4 options o p t i o n s 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 l . Then select desired function with t and follow the instructions for use as described. 4.1 occlusion pressur...
Page 45: 4.3 Bolus Rate
Activation of the function: • open data lock in options menu with l . • select between level 1, 2 or 3 (if activated) with l and r and confirm with k . • enter code with q and press k in order to activate data lock. Changes to the protected values and the bolus function which are marked with y are o...
Page 46: 4.6 Alarm Volume
46 chapter 4 options • open the kvo-mode in the options menu with l . • answer the yes/no question with u 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. • open contra...
Page 47: 4.9 Language
47 4.9 language this function enables a change of the pump language. • open language in the options menu with l . • select language with t then press l . • confirm yes/no question with u . 4.10 upstream occlusion pressure the device is equipped with an upstream pressure sensor that detects an occlus...
Page 48: Alarms
Chapter 5 alarms 48 alarm- type device alarm yes flashes flashes device alarm and alarm code (see service program) yes press o and follow the instruction on the display. Opera- tinga- larm yes flashes off see alarm de- scription yes pre- alarm yes off flashes see alarm de- scription (de-)activate vi...
Page 49
49 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. "communi...
Page 50
50 “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...
Page 51: 5.3 Reminder Alarms
51 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 again. "therapy dat...
Page 52: 5.4 Alarm Hints
52 chapter 5 alarms 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 so- unds. These hints disappear after a few seconds and don't need to be confirmed..
Page 53
53 battery operation and maintenance chapter 6 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 overcharg...
Page 54
54 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 m...
Page 55
55 start up graphs and trumpet curves chapter 7 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. Deviations from the technical data of the pump...
Page 56
56 t e c h n i c a l d ata type of unit volumetric infusion pump classification (acc. To iec/en 60601-1) defibrillator-proof; cf equipment protective class ii; protective class i in combination with spacestation class (acc. To directive 93/42 eec) iib moisture protection ip 22 (drip protected for ho...
Page 57
57 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 > 1 ml kvo-rate delivery rate 10 ml/h: kvo-rate 3 ml/h delivery rate delivery rate set rat...
Page 58
58 chapter 8 technical data 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). These technical data can change when using set configurations..
Page 59: Cleaning / Disposal
59 warranty / training / tsc* / service / cleaning / disposal chapter 9 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 equipm...
Page 60: Check Regularly
60 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 a self-test. Check the following items each time the pump is switched on: self-check, audible alarm, process- and alarm...
Page 61: Spacestation (8713140)
61 chapter 10 instructions for use accessory i n s t r u c t i o n s f o r u s e a c c e s s o r y 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...
Page 62: Drop Sensor Sp (8713175)
62 chapter 10 instructions for use accessory 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 ...
Page 63
63 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 sli...
Page 64
64 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. Turned off alarm operation alarm operation alarm operation turned on 1 sec 1 sec 1 sec turned off static without off- alarm* ) dynamic without...
Page 65
65 chapter 10 instructions for use accessory p c a - a c c e s s o r i e s • 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 a...
Page 66
66 ordering art. No. B. Braun infusomat® space (100 - 240 v) ...........................................871 3050 recommended accessories for the b. Braun infusomat® space: spacestation............... ........................................................................................871 3140 spa...
Page 67
67 ordering neonate dosifix® - 150 ml burette, neutrapur® with needle free safeflow y-port........................................................................................... 825 0245 sp dosifix® - 150 ml burette, dehp-free tubing with y-port for needle access....................................
Page 70
38911794 • drawing no. M686 70 02 01 f04 1110 • printed on pulp bleached 100 % chlorine-free date of last revision: november 2010 b. Braun melsungen ag sparte hospital care 34209 melsungen germany tel.: +49 (0) 56 61 71-0 fax: +49 (0) 56 61 71-20 44 www.Bbraun.Com manufactured by b. Braun melsungen ...