Sales Manual B.Braun Space Chapter 5.1 Chapter 5.1: B.Braun Space – Space pumps in detail Perfusor®Space, Infusomat®Space Safety features Therapy diversity Sales Manual B.Braun Space

B. Braun Space – Features & Benefits Perfusor® Space Infusomat® Space Sales Manual B.Braun Space

Features & Benefits: Perfusor-/ Infusomat Space 214 mm Small dimensions save Space… 68 mm 152 mm 249-373 mm 124 mm 68 mm Sales Manual B.Braun Space

Features & Benefits: Perfusor-/ Infusomat Space Break-through in the field of space saving technology ! You can see it… Sales Manual B.Braun Space

Features & Benefits: Perfusor-/ Infusomat Space Safe and easy transport because of a newly developed fixation mechanism Up to 3 pumps can be stacked together Easy to handle fixing levers Fixing lever Sales Manual B.Braun Space

Features & Benefits: Perfusor-/ Infusomat Space Safe and easy transport with the new SpaceClamp. Designed for fixing stand-alone pumps to infusion poles and wall rail systems. Up to 4 pumps can be carried with 1 clamp Optional short infusion pole Rotation mechanism for horizontal and vertical adaption of the pumps Integrated handle 12 V power supply Sales Manual B.Braun Space

Features & Benefits: Perfusor-/ Infusomat Space Syringe illumination Alarm indicators Graphic display with high resolution Guide rails for stackability and sliding pumps together Syringe holder with integrated piston brake Back-lit key pad Front door with magnifying glass Drive Head made of shock resistent material Sales Manual B.Braun Space

Features & Benefits: Perfusor-/ Infusomat Space Alarm indicators Front door with motor-driven lock mechanism Back-lit key pad Graphic display with high resolution Rubber feet for table usage Sales Manual B.Braun Space

Features & Benefits: Perfusor-/ Infusomat Space The rechargeable battery pack can be easily removed and exchanged on the ward. More than 8 h operating time Recharging when pump is connected to mains Recharging time 2 h NiMH technology to minimize memory effects Cost saving because of battery maintenance mode to increase life time Perfusor and Infusomat are using the same battery, this minimizes risk of confusion Cover of battery compartment Socket for 12 V, Interface, PCA, nurse call Socket for connection with SpaceControl Battery pack Sales Manual B.Braun Space

Perfusor Space / Infusomat Space Safety Features Perfusor® Space Infusomat® Space Sales Manual B.Braun Space

Safety: Perfusor Space - Automatic Drive Unit With Piston Brake Perfusor Space is equipped with a fully automatical drive mechanism. When the pump is turned off the parking position of the drive is closed by housing. A syringe only can be inserted after the pump is switched on. After the syringe is inserted and the syringe holder is closed the piston brake comes out of the syringe holder and blocks the plunger to prevent free-flow during syringe change. After the syringe plunger plate is detected and grasped by the claws of the drive head the piston brake releases the plunger again and drives backwards into its parking position. Sales Manual B.Braun Space

Safety: Perfusor Space - Automatic Drive Unit With Piston Brake The User benefits are: Optimal start-up characteristics at low infusion rates for higher therapy safety No bolus infusion during syringe change No free-flow during syringe change if patient connection was not interrupted Very easy handling to insert a syringe Sales Manual B.Braun Space

Safety: Infusomat Space with new Infusomat Space Line Setting a new standard in Europe New Infusomat Space Line with Set-Based Anti-Free-flow Clamp in each pump set Free-flow prevention also when the set is removed from the pump Against over dosages to minimize medication errors. Backwards compatible with Infusomat fm/fmS Anti free-flow clamp D.C. 2000 short pump segment new connection clips Sales Manual B.Braun Space

Safety: Infusomat Space with new Infusomat Space Line Pump-based anti-free-flow clamp Upstream sensor Release mechanism of Anti-Free-flow clamp Downstream pressure sensor Air sensor Sales Manual B.Braun Space

Safety: Infusomat Space with new Infusomat Space Line Downstream fixing clip of the pumping element Set-based Anti-Free-flow clamp Upstream fixing clip of the pumping element Peristaltic pump compartment, removable for cleaning Sales Manual B.Braun Space

Safety: Perfusor-/Infusomat Space – Uniform User Interfaces More than 80 % of Medication Errors (FDA) are based on handling failures because of different user interfaces between the devices in use Perfusor- and Infusomat Space are offering exactly the same handling structure. A nurse who is familiar with the handling of a Perfusor also will be able to handle the Infusomat Space B. Braun Space is the new Standard in the Hospitals and there should be only one pump (or let`s say two) to work with Standardization minimizes Medication Errors Sales Manual B.Braun Space

Safety: Perfusor-/Infusomat Space – Uniform User Interfaces Two pumps one user interface !! Special bolus key for quick bolus applications C key with double function: to clear value inputs go back into former menu ON/OFF key Door open key Start-/Stop key Communication key to SpaceControl or barcode data receipt OK key to confirm inputs Graphic display with high resolution and readability Cursor for navigation and value inputs Sales Manual B.Braun Space

Safety: Perfusor-/Infusomat Space – Uniform User Interfaces Start-Up Menu: Usable as a navigation guide through the functions Customized configuration of the menu due to the needs of the Hospital These 6 menu steps can be disabled, then a direct input of the rate is possible after syringe change Standard Mode The Start-up menu assists all users who are not working day by day with the pump. It is intuitively usable and gives the user a defined path to reach the required function. The Start-up menu can be disabled completely, so that it is possible to set the wanted delivery rate directly. Also parts of the Start-up menu can be disabled. That means: Customized configurations based on the clinical necessities offer the possibility for an optimal and safe operation of the pump. If data inputs only shall be taken place via the drug library the pump can be pre-configured that it automatically goes into the drug mode after the self-check procedure. Sales Manual B.Braun Space

Safety: Perfusor-/Infusomat Space – Uniform User Interfaces The Maim Menu ensures a clear overview about all functions Set Rate Set Volume Limit Time Limit Status of Infusion Total Volume Total Time Intermediate Volume Time Disposable in use Customized Options Occlusion pressure Clock Date Data Lock Alarm Volume Patient Data Bolus Rate Help texts on Macro Mode Special Functions Drug Library Dose Calculation Piggy back (only Infusomat) Main Menu Standard Mode Customized functions can be activated or disabled individually. The training courses for the users therefore can be limited only to the features which shall be used in practice. Sales Manual B.Braun Space

Perfusor® Space / Infusomat® Space Therapy Diversity Sales Manual B.Braun Space

Therapy Diversity: Perfusor Space / Infusomat Space Standard Mode Set Rate Set VTBD Set Time Limit 0.01-99.99 ml/h 100.0-999.9 ml/h 1000-1200 ml/h (only Infusomat) 0.01-99.99 ml 100.0-999.9 ml 1000-9999 ml (only Infusomat) 00 h : 01 m – 99 h : 00 m Parameters) Benefits Wide range of delivery settings for a flexible therapy control Comfortable calculation of the rate by setting volume over time Optimal overview about the remaining infusion volumes and times If 2 parameters are set the 3rd will be automatically calculated VTBD= Volume To Be Delivered (Volume limit in ml) Sales Manual B.Braun Space

Therapy Diversity: Perfusor Space / Infusomat Space Status of Infusion Total Volume Total Time Intermediate Volume IntermediateTime Disposable in Use Parameters) 0.01- 9999 (Perfusor) 0.01-99999 (Infusomat) 1 m – 99 h Display of selected syringe type or Infusomat Line Benefits Patient- and drug related Status Information Infusion status permanently displayed Via interface to PDMS Clears automatically if a new patient shall be treated or if a new drug is selected Intermediate Patient- and drug related Status Information which can be deleted during one therapy Sales Manual B.Braun Space

Therapy Diversity: Perfusor Space / Infusomat Space Customized Special Functions Drug Library Dose Calculation Piggy back (only Infusomat) Integrated Drug Drug Library Safe operation against wrong manual inputs of parameters. The Drug Library can be activated in the Start-up Menu (quick start) or via the main menu by selection within the Special Funstions menu. It is possible to select a drug at first or setting a rate quickly and in a 2nd step the drug can be selected during the infusion is running as well as in stop mode. Sales Manual B.Braun Space

Therapy Diversity: Drug Library The Drug library allows the user to select a certain drug/mode/fluid therapy fast and easily. Each Pump contains a total memory for max. 720 drugs including all necessary infusion parameters which are defined and configured via an external Drug List Editor (DLE). Categories: All drugs can be classified into one or up to 15 categories. Reduction of Medication Errors because of pre-set adjustments Nearly the complete range of relevant drugs can be integrated The categories e. g. can be therapy related (e. g. PCA, Ramp, Circadian or OTCI, Favourites) or related to active drug substances as well as related to different application areas. The final decision of the naming will be made by the doctor or the programmer of the contents of the Drud List Editot (DLE). The category specification also comes from the DLE. Category names are defined by the user of the DLE. If no categories were set in the DLE, the complete drug list is displayed and a special drug can be selected via the cursor directly by scrolling or via an alphabetical menu (see UI Structure doc.) Quick access to the wanted drug by selecting a category first Sales Manual B.Braun Space

Therapy Diversity: Drug Library Independently on the 10 categories each drug is related to a therapy mode which can be selected at the pump or at the SpaceControl. Via the user interface of the pumps only the drugs related to the “Continuous Mode” and “Piggyback (Infusomat) Mode” can be selected. Further Therapy Modes van be selected via SpaceControl: PCA Mode Ramp Mode Circadian Mode OTCI Mode After a therapy mode has been configured, the PM itself can handle the therapy with or without the CM. The parameters of the selected drugs can be changed manually in the pump in the range which was set in the DLE as far as no exception is defined in any other Mode of Operation. Dose limits or infusion rates in e. g. in “ml/h” or “mg/kg/h” for the continuous infusion rate and the bolus parameters are defined in the DLE. Calculation scheme see DLE doc. The drug can be chosen as a complete data file incl. all pre-set values or only as a drug name. Only when a single drug name was selected then the concentration can be set manually via dose Mode. After a drug was selected a drug information text (if available) appears. This has to be confirmed with OK before further steps are possible. Each Pump Module Type (SP or LVP) is having a different drug library. This is necessary due to the following situations: A VTBD is a must to be set manually at the LVP in case that no VTBD was set in DLE and no drip sensor is connected. Drugs for Piggyback Mode only can be infused with a LVP. Mixing containers require to assign 4 drugs with concentration values to one carrier solution. In this case the infusion rate is set in ml/h and the total amounts of the different up to 4 drugs are calculated e.g. in mg, mcg, IU, mmol. Sales Manual B.Braun Space

Therapy Diversity: Drug Library Pre-set dose guards lead to s safe operation because of prevention of potential over dosages. SpaceControl screen Pump display With the DrugList Editor it is possible to set soft- and hard limits of infusion rates (-dosages). A fixed hard limit cannot be exceeded, a soft limits can by confirming this input with the ok button. Sales Manual B.Braun Space

Therapy Diversity: Perfusor Space / Infusomat Space Customized Special Functions Drug Library Dose Calculation Piggy back (only Infusomat) Dose Calculation Comfortable calculation of the rate via the input of Dose mode is active when concentration and dose is set with value and unit. Dose mode activation Dose mode activation can be done by four different ways, if dose mode is inactive: 1. During Start-Up with the menu “Use Dose Mode ?” 2. From Option Menu with menu “Dose Mode”. This activation can be done while the pump is infusing or stopped. 3. From Start-Up via the menu “Drug Library” and “Use pre-set values?” yes. 4. From Option Menu via the menu “Drug Library” and “Use pre-set values?” yes. The dose rate may have a patient weight relation but does not require it. With dose mode active the infusion rate can be set in ml/h or in drug ingredient / time or drug ingredient / weight / time. All pump internal calculations, controls and limits use a ml based unit even if the dose mode is active. At the pump the ml based value is additionally visible to the drug related value, so the user is able to check the displayed drug related values against the ml based values. All displayed dose parameters are then only calculated values from the ml based values. During the input of dose parameters the ml based values are directly calculated from the dose parameters. With the confirmation of a dose parameter the calculated ml based rate is rounded to the nearest setable rate and with that ml based rate the dose parameters are recalculated. Because of rounding the rate to a settable value the afterwards calculated dose values may differ from the input value. Handling Steps (General Steps, Not Detailed) Menue Structure As An Overview To set dose mode active the following menus have to be passed in ascending order. Sales Manual B.Braun Space

Therapy Diversity: Dose Calculation The Dose Calculation mode offers the possibility to calculate the delivery rate on the basis of the following parameters: Concentration value Container size Dosage value Dosage unit Optional: patient weight Menu “Use dose mode” This menu “Use dose mode” can not be entered if dose mode or drug mode is already active. This menu must be confirmed with yes if you want to set dose mode. The Dose Mode can be activated as described under 2.2 Menu “Use patient weight” If this menu is quit with yes then a valid patient weight must be entered in the menu “edit patient weight”. Menu “Edit patient weight” If the patient data is existing then this weight is shown for confirmation. If patient data with weight is set, then this patient weight is set into display for confirming. If the patient weight is changed then the patient data weight is set to the new value. An unequal patient weight within the adjustable range must be entered. If a patient weight > <warning limit> is entered a hint is done because of this unusual patient weight. The warning limit is per default 120kg and can be changed via serviceprogram in the limits for patient weight (see patient data.doc). Menu “Edit Concentration unit” All units are selectable. Once this concentration unit is selected it is not changeable until dose mode is setup again. Settings in e.g. xx mg/ml or e.g. xx mg in xx ml. Concentration can also be calculated from the two values dose and filling volume of the syringe or bag ( UI simulation had to be extended for that). Menu “Edit Concentration value” A valid value for the concentration value must be entered. An invalid concentration value can not be confirmed. Menu “Edit Dosage unit” If the dosage unit is confirmed, then the dose mode is set to be active. The selected concentration unit determines the available units in this menu. Patient weight With no patient weight the Dosage units selectable are only units with no weight relation. Sales Manual B.Braun Space

Therapy Diversity: Dose Calculation When Dose Calculation is active the display is showing the infusion rate in dosage values, as mg/kg/h. Overview about the set parameters in the main menu IU Dosage unit IU / time is selectable. With patient weight it is also the IU / kg / time selectable. mmol Dosage unit mmol / time is selectable. With patient weight it is also the mmol / kg / time selectable. mEq Dosage unit mEq / time is selectable. With patient weight it is also the mEq / kg / time selectable. mg Dosage unit mg / time or mcg/time is selectable. With patient weight it is also mg / kg / time or mcg / kg / time selectable. mcg Dosage unit mg/time, mcg/time or ng/time is selectable. With patient weight it is also the mcg / kg / time as well as ng/kg/time selectable. ng Dosage unit ncg/time or mcg/time is selectable. With patient weight it is also the ng / kg / time or mcg/kg/time selectable. /min , /hr, /24hr For the dosage unit all times are selectable in combination with the available dose mass parameter ( ng, mcg, mg, IU, mmol, mEq ). Menu “Edit Dosage value” A value for the dosage can be entered and confirmed. During edit of the dosage value the infusion rate in ml/h is continuously calculated and also displayed. The calculated and displayed rate uses the complete adjustable rate range. Display when infusion is running A bolus also can be given with dose parameters. Sales Manual B.Braun Space

Therapy Diversity: Perfusor Space / Infusomat Space Customized Special Functions Drug Library Dose Calculation Piggy back (only Infusomat) Piggy back Administration of 2 infusions with only one pump. The Drug Library can be activated in the Start-up Menu (quick start) or via the main menu by selection within the Special Funstions menu. It is possible to select a drug at first or setting a rate quickly and in a 2nd step the drug can be selected during the infusion is running as well as in stop mode. Sales Manual B.Braun Space

Therapy Diversity: Piggy Back The Piggy back mode offers the possibility to switch between 2 infusions by using only one pump. A special Infusomat Space Line shall be developed to optimize the handling procedure. The history of Primary- and Secondary infusion is giving a complete overview about all therapy dosages. Each Infusomat Space will be equipped with this function which is used mainly in the OPM field for cythostatics. Sales Manual B.Braun Space

Therapy Diversity: Take-Over Mode The application of drugs with low half.life times (e. g. catecholamines) require a quick and safe change of an empty syringe into a new one. Swaying of the blood pressure cannot be avoided by changing the syringe manually. The new „Take-Over Mode“ offers the possibility that a second pump will be started automatically before the first pump with the same drug will go into syringe end alarm. Sales Manual B.Braun Space

Therapy Diversity: Take-Over Mode This function always is related to the drug library use and works without additional handling. The pumps have to be used in a SpaceStation and have to be positioned on top of one other. The 2nd pump has to be adjusted with the same drug as the 1st pump. Then the pump will show a message if it shall be used for the take-over mode. Benefit: Continuous application of catecholamines by minimization of blood pressure swaying. Sales Manual B.Braun Space

Perfusor Space / Infusomat Space Special Adjustments: Options Sales Manual B.Braun Space

Perfusor Space / Infusomat Space Options Customized Options Occlusion pressure Clock Date Data Lock Alarm Volume Patient Data Bolus Rate Help texts on Macro Mode Occlusion Pressure The occlusion pressure settings offer the possibility to set the optimal highest pressure to reduce bolus volumes and alarm triggering times in case of a closed infusion line. Sales Manual B.Braun Space

Options Occlusion Pressure There are 4 different operating modes which can be selected: Standard occlusion setting Perfusor Space: 9 steps 0.1-1.2 bar Infusomat Space: 3 steps 0.3-1.5 bar Pressure Pre-Alarm (not at launch) Automatic pressure setting (not at launch) Central in-line pressure setting (not at launch) Short Description Of The Function/Therapy The Occlusion Pressure Function offers the possibility to adjust an optimal pressure limit to shorten the alarm-triggering-time in case of an occlusion and to minimize bolus volumes. Bolus volumes and alarm-triggering times depend on the technical compliance of the system, set infusion rates and the used disposables (small/large syringes, Original Infusomat-Lines and PVC tubings and their shore hardnesses). The following descriptions does not include the mechanical issues as mentioned above, which are fixed in our mechanical specifications, but mainly the possible adjustments and the influences to the software programmings. The function will offer 4 different operating modes: Standard Occlusion setting Perfusor: Adjustment in 9 steps (0.1-1.2 bar) Infusomat: Adjustment in 3 steps (0.3-1.5 bar) After the pressure in an infusion system is reaching the set upper limit, then the PM goes into alarm. A permanent pressure indicator in the PM Display and the CM show the current pressure status (see also UI simulation). Immediate Pressure- Lost Alarm (Not avvailable at launch ) This function can be adjusted separately to the Standard Occlusion setting. In case of a sudden decrease of the system pressure the pump goes into an alarm and stops the running infusion. This function shall give information if the cannulae could be disconnected from the venuous access and a para-venuous infusion could be possible. It is acceptable that paravenuous infusion cannot be detected in general via this function. It depends on the user to activate this function or not. Pressure Pre-Alarm (Not available at launch ) If the pressure in the infusion line is permanently and slightly increasing, deviating from the previous pressure situation. The avoid artefact situations because of rate changes the minimum alarm-triggering time should be approx. 5 min as long as the adjusted pressure step limit is not reached. Automatic pressure Setting (Not available at launch ) The maximum pressure setting of the Standard Occlusion setting is the upper hard limit value in general. If this limit is reached a pressure alarm comes up. When the Automatic pressure setting is active and the pump is started it checks the pressure situation in the system for approx. 3 min. In 100 mmHg-steps an upper observation window limit has to be set. If this limit is reached the pump goes into alarm. The advantage of this function is that always the optimal pressure setting can be realized without the necessity to adjust the optimal pressure step manually. To avoid artefact alarms because of short-term pressure peaks the minimum alarm time after the observation limit is reached is adjustable in minute increments. In-Line Pressure detection (Minimum one year after launch available) This function needs to be validated and shall not be realized for a stand-alone pump but only in combination with a SpaceStation. One SpaceStation will check the total pressure of one venuous access . A central alarm and stop of all the connected pumps will be created by the paceStation in case of an occlusion. A detailed concept needs to be defined separately. Sales Manual B.Braun Space

Perfusor Space / Infusomat Space Options Customized Options Occlusion pressure Clock Date Data Lock Alarm Volume Patient Data Bolus Rate Help texts on Macro Mode Data Lock Prevention against non-authorized manipulations. Sales Manual B.Braun Space

Perfusor Space / Infusomat Space Data Lock Data Lock can be programmed in 2 levels: Level 1: No changes of values possible, stop, start, turning on/-off allowed Level 2: Same as Level 1, additionally no change of the disposable possible. Handling Steps General: Data Lock only can be activated if at least a rate had been set before. There is only one code independently if level 1 or level 2 shall be used. The same code also has to be set at first before the user can make adjustments inside the function. Setting the Data Lock Mode Go into Options to Data Lock Here select the Level. Set the Code with 4 digits Select the wanted level and confirm with ok. Setting the Data Lock is possible in Run or Stop mode. Data Lock is active after setting it in the Options. Afterwards no settings are possible. Changing data when Data Lock is active Go to the value to be changed by using the cursor. With the left cursor arrow the change of the selected parameter (e. g. the Rate) can be reached. Then a window opens and the user is getting the message to set the release code. After the code no. is set Data Lock is temporarily disabled. Then all inputs are possible (Rate, VTBD etc.) After the last handling step the pump goes back into Data Lock after 20 sec. or directly after the pump was started again. This is valid in STOP- and Run Mode. If the pump automatically returns to Data Lock the handling remains the same as without Data Lock, except that the code must be reentered to compete changing of values. In general all handling steps which lead to a change of parameters have to be released with the code, this includes also the change of a disposable. Leave Data Lock mode Go to Options and Data Lock function, set the code and switch off Data Lock.  Central data lock for all pumps within a system can be activated via SpaceControl ! Sales Manual B.Braun Space

Perfusor Space / Infusomat Space Options Customized Options Occlusion pressure Clock Date Data Lock Alarm Volume Patient Data Bolus Rate Help texts on Macro Mode Date & Clock For documentation reasons and the History Protocol. Automatic adjustment if connected to SpaceStation together with SpaceCom. Sales Manual B.Braun Space

Perfusor Space / Infusomat Space Options Customized Options Occlusion pressure Clock Date Data Lock Alarm Volume Patient Data Bolus Rate Help texts on Macro Mode Alarm Volume The loudness of the audible alarm signal can be adjusted to the environmental conditions in the hospital Sales Manual B.Braun Space

Perfusor Space / Infusomat Space Options Customized Options Occlusion pressure Clock Date Data Lock Alarm Volume Patient Data Bolus Rate Help texts on Macro Mode Patient Data are a safety feature which makes it possible to treat the right patient with the right drug Sales Manual B.Braun Space

Perfusor Space / Infusomat Space Options Customized Options Occlusion pressure Clock Date Data Lock Alarm Volume Patient Data Bolus Rate Help texts on Macro Mode Bolus Rate The max.bolus rate can be limited for safety reasons If the bolus rate is set to cero the bolus function is disabled. Sales Manual B.Braun Space

Perfusor Space / Infusomat Space Options Customized Options Occlusion pressure Clock Date Data Lock Alarm Volume Patient Data Bolus Rate Help texts on Macro Mode Macro Mode Individual adjustment of the display content. The user can decide if the delivery rate shall be screened in big numbers or smaller. Sales Manual B.Braun Space

Perfusor Space / Infusomat Space Options Customized Options Occlusion pressure Clock Date Data Lock Alarm Volume Patient Data Bolus Rate Help texts on Macro Mode Help Texts Intuitive handling with or without help texts. Help texts make it easier for new users to handle the pump and to reduce the risk of wrong handling. Sales Manual B.Braun Space