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One system for greater diversity

Profit from the flexibility to cover the entire therapy spectrum

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One system for greater diversity

When hospitals start projects to optimize processesacross all departments – they also pave the way formore effective, qualitatively superior therapy. Thisimproves the clinical outcome and also reduces theprocess costs.

Clinical pathways are becoming increasingly impor-tant, and with them the need for technical equip-ment – devices that are versatile enough for a varietyof areas and able to fulfill the individual requirements.

B. Braun: Sharing ExpertiseIn one form or another, almost every field of workwithin a hospital touches on infusion therapy.

B. Braun’s “One system for greater diversity” approach,makes it possible to use one pump along the entireclinical pathway, for all hospital applications, settingthe standard for clinical processes.

By working in partnership with a system suppliersuch as B. Braun, you instantly open the door toreduced costs, guaranteed levels of safety, simplicityand quality in one – from one and the same source.

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Automated Infusion Systems

Drug admixture 1Basic infusion therapy 2Advanced infusion therapy 3Clinical nutrition 4Pediatrics /neonatology 5Anesthesia 6Postoperative pain treatment 7Oncology 8Product specifications 9

Maximizing availability – minimizing logistic outlayB. Braun Space makes it possible to standardize infusion systemsthroughout an entire hospital – each individual Space pumpanswers the requirements of a variety of therapeutic fields.

For example, the next available Space pump in the OR can be usedfor standard applications, as well as a TCI pump for anesthesia orPCA pump for post-operative pain treatment.

As a result, the Space pump can replace several special pumps -B. Braun Space improves availability and simplifies logisticalprocesses.

Minimizing training – maximizing reliabilityThe beauty with Infusomat® and Perfusor® Space is that they both have the same user interface. By standardizing technicalequipment there is less need for time consuming user training. B. Braun Space reduces costs and saves staff time.

Minimizing maintenance costs – maximizing efficiencyBy reducing the variety and number of instruments, you also sim-plify maintenance and improve the efficiency of existing hospitalequipment. As a rule, equipment that can be used in all medicaldisciplines spends less time standing idle. B. Braun Space raisesusage levels and improves return-on-investment.

Patient record keeping – seamless IT integrationEspecially when automatic therapy documentation is required – oris scheduled for the future – it is essential to have standardizeddata protocols. B. Braun Space makes hospital wide plug-and-playIT integration viable.

Infusion technology by B. Braun

Always ideal for all needs:fluid administration and high-precision drug delivery


Drug admixture

To satisfy the needs of clinical drug admixture, not only shouldthe system improve the overall working environment in terms ofhygiene and process reliability, it should also tie up less of yourhealthcare team’s valuable time.

Simplify drug admixture in pharmacy, ward, OR and ICUEcoflac® plus, our new generation of infusion containers, offersoutstanding handling properties, virtually eradicating the sourcesof error.

The material is specially chosen for its compatibility with themaximum number of pharmaceuticals.

The separate resealing puncture areas of the Ecoflac® plus twincap are kept bacteria free by separate, easily removable sealantfoils. Prepare the solution with the prescribed drugs through thefirst port; the second port still remains bacteria-free – so it canbe used later on the ward. Once the drug admixture is ready,Ecoflac® plus can be used like a soft bag.

Needle and contamination-free fluid transfer from containers to syringesThe Ecoflac® plus also includes transfer devices for large con-tainers (Transofix®) and the Ecoflac® Mix transfer cap for vials.

To draw the fluid solution into Perfusor® syringes, it makes senseto use plastic micro pins as this avoids the risk for needle-stickinjury. The air-venting channel does away with the need forover-pressure release. Overall, this equates to less steps.

The Mini-Spike® is a vented dispensing pin for filtered with-drawal of fluid from vials. The bacteria air filter and 5 µm parti-cle fluid filter reduce the risk of drug contamination. The valveand the flip caps put an end to messy dripping.

Sterifix® filter straw

Ecoflac® Mixtransfer capfor vials

Ecopin® for tamper-evident closure

Mini-Spike® dispensing pin

Original Perfusor® Syringe 50/60 ml UV protect

Your benefits

� Streamline drug admixture process

� Ensure hygienic preparation

� Eliminate loss of liquid and dripping

� Avoid risk of needle-stick injuries

� Prevent drug mix-ups using Space barcoding*



Safe and reliable ampoule handling in every useThanks to Sterifix® filter straws, these days fluids can even bedrawn up out of glass ampoules without needles. An included5 µm filter reduces the risk of glass particle injection.

The Mini-Plasco® connect container eliminates needle-relatedinjury. It also prevents the type of jagged edges encounteredwhen opening glass ampoules. To eliminate loss of liquid anddripping, Luer-Slip and Luer-Lock type syringes fit tightly intothe innovative connector.

Light-sensitive medicinesWith light sensitive drugs such as nitroglycerin you should usespecial syringes, Perfusor® tubes and IV administration sets.

Closing Ecoflac® plus and syringes hygienicallyThe Combi-Stopper is designed for universal use to seal all typesof connectors: standard lock types (male and female) and stan-dard slip.

The tamper-evident syringe cap TEC1000 allows users to deter-mine if an Omnifix® syringe has been manipulated. The two-partdesign breaks off when somebody messes with it.

The Ecopin® offers tamper-evident closure of the Ecoflac® pluspuncture area.Mini-Plasco® connect

with Luer-Lock and Luer-Slip connector

Ecobag®

Omnifix® syringe 50/60 ml

Combi-StopperTamper-evident cap TEC1000

1


Basic infusion therapy

Our system solution for routine fluid administration is intrinsi-cally reliable. It helps streamline workflows, heightening effec-tiveness, safety and comfort for both nurse and patient.

Simplify infusion preparationEcoflac® plus combines the unbreakable, lightweight benefits ofa soft bag with all the advantages of a bottle, such as trans-parency and firm grip.

Our IV sets are compatible with a variety of optional add-ons –such as back-check valves (to prevent backflow), injection ports,or the highly innovative PRIME STOP technology, which auto-mates priming and ends messy dripping.

The protective cap PRIME STOP is lined with a hydrophobicmembrane making it possible to prepare several infusions atonce – more quickly and hygienically than ever before. No morefluid dripping on hands, the floor or bedding. The entire systemremains closed until final connection is made to the patient.

Reduce the risk of injuryWith our system approach you can protect yourself and yourhealthcare team from injuries and related infections.

The spike holder on the roller clamp acts as a protective coverfor the tip after use. With its handy grip, the injection portreduces the risk of needle injuries. The advantage with needle-free injection ports is that they not only offer 100% protectionfrom needle injury, they also help prevent bloodstream infections.

The patented safety clip on our IV catheter automatically covers thesharp tip of the needle the instant it is withdrawn from the vein.

Your benefits

� Silicon pump element and integrated free-flow protection simplify reliable drug delivery

� Drug library and uniform user interface of infusion and syringe pump for enhanced patient safety

� Improved mobilization of patients with the help of lightweight pumps and different line lengths

� One system heightening effectiveness, safety, and comfort for both nurse and patient

Infusomat® Space Line AIR STOP and PRIME STOP

AIR STOP simplifies infusion container changeovers. Also gravity lines no longer run dry.

The spike holder coversthe tip after use to

reduce risk of injury

Automatic free-flow-protection on pump and IV set

Air-bubble sensor

Silicone pump elementensures longtime accuracy

Needle-free port-system to ensure safe injection



Space simplifies fluid administrationThanks to Space infusion pumps, reliable drug administration ismuch easier than with IV gravity administration sets. Nurseswaste no time with constant drop speed readjustment.

With its integrated silicon pump element, the Infusomat® Spaceline guarantees long-term accuracy, unaffected by other influ-ences such as room temperature or fluid viscosity.

For added safety, the pump display shows the name of the drugbeing administered as well as the concentration and dosing rate.Each aspect of the therapy is automatically documented by thepump.

Thanks to its uniform user interface, the Perfusor® Space is assimple to operate as the Infusomat® Space.

Added patient comfortTo provide nursing staff with greater flexibility and more optionsfor treating patients (e.g. PCA), this system offers practical,lightweight pumps as well as IV sets and spiral lines of differentlengths.

Not only does this ease transport, it is much more convenient forpatients who are free to move around more – which is generallybeneficial to healing.

Carefully thought-through, hygienicsolutions: tubing can be hooked intoside notch for priming and stand-byprocedure.

PRIME STOP automates priming andends messy dripping. The systemremains closed until connected to thepatient.

Drug-resistant stopcock toavoid stress cracking and pre-vent air infusion and leakage

Discofix® C can becombined withextension lines

Guided set installationsimplifies handling

Self-activatingsafety clip

Introcan Safety®(Vasofix® Safety

see page 6)

2


The types of infusion systems used in modern intensive care havebecome so complex that doctors and nurses must be vigilant atall times.

Safety is never guaranteed unless each and every componentused within the process chain has been cross-matched to allothers. Everything has to work in synergy, making the systemintrinsically reliable.

The safety of a closed system with the reliability of a system providerUsed as an individual stopcock or in manifolds, the Discofix® Celiminates the risks of daily routine. Also with potent drugs suchas anesthetics, antibiotics, narcoleptics, and immunosuppres-sives, there is no risk of leakage and contamination. The rotatinglocking nut makes it quick, easy and safe to connect.

The Intrapur® plus 0.2 µm infusion filter offers you even moresafety by improving the retention of particle, bacteria and endo-toxins, with up to 96 hours’ application.

Because the access ports are needle-free, the system remainsclosed – even when disconnecting IV catheters, infusion lines orsyringes. The system is simple and hygienic – and it saves time.

Keeping the overview about complex systemsSpace System provides a perfect overview in the minimum amountof space. Even the most complicated infusion programs (with upto 24 pumps per bed) become simple and easy to manage.

Advanced infusion therapy

Your benefits

� Increase safety, decrease effort with Space drug libraryand pre-configured dose rate calculation

� An excellent overview of Space docking stations andpump displays, minimizing reaction time

� Cover the complete spectrum of modern infusion therapy just with B. Braun Space and disposables

� Benefit from plug-and-play PDMS connectivity with up to 24 pumps per bed

Discofix® C stopcocks

Original Perfusor® Syringe UV protect


Keeping reaction times to a minimumThe layout of the pump display has been speciallydesigned to show the operator all key information ata glance.

The pump database works out the right dosage foreach drug to be administered (e.g. ml/h, mg/h, IU/h,µg/kg/min). All parameters can be predefined in thedrug library increasing safety, decreasing effort.

Even from a distance, the name of the drug and thedosage is immediately clear. Depending on the situa-tion, users can add other useful information such asthe remaining infusion time.

One pump that covers the entire therapy spectrumBecause Space pumps can be used in combinationwith B. Braun disposables, they can be applied as auniversal solution across the entire therapy spectrum.So the solution not only encompasses syringes andinfusion lines for delivering light-sensitive medicinessuch as nitroglycerine, but also lines for parenteralnutrition or blood transfusions. No money wasted onadditional special pumps.

Patient Data Management SystemsEvery aspect of the therapy can be automaticallydocumented in the background – Plug-and-play IT-integration with up to 24 pumps per ICU bed.


Discofix® stopcocksmanifold

Infusomat® infusionlines used in bloodtransfusions

Intrapur® Lipid filter

Intrapur® plus filter

Original Perfusor® LineUV protect

Certofix® protect with up to 5 lumens

3


Clinical nutrition

Your benefits

� Protect your budgets by using Infusomat® Spacealso for enteral nutrition

� Prevent mix-up of enteral lines and IV access ports

� Benefit from plug-and-play PDMS integration

� Reduce nurse’s workloads and the total cost of preparation with ready-to-use 2 or 3-chamber bags

� End messy dripping of sticky fluids with PRIME STOP

Successful therapy requires adequate clinical nutrition – which iswhy we consider parenteral and enteral nutrition as an integralpart of modern fluid management systems.

Clinical nutritionModern nutrition therapy involves premixed “convenience”solutions or nutrition solutions specially made for the patient.

B. Braun standardized nutrition solutions are suitable for mostenteral and parenteral feeding of patients. This approach offerssignificant benefits as it prevents errors in administering theright therapy during the routine of daily clinical practice.Standardization also reduces nurse’s workloads and the totalcost of preparation.

Ready-to-use total parenteral nutritionThe B. Braun NuTRIflex® system comes in 2 and 3-chamber bags,offering the full metabolic and technical advantages of an all-in-one, integrated system. The bag has been designed speciallyto allow easy mixing of macro-nutrients: simply apply pressureto the chambers.

When administering infusions of nutrient solutions, we recom-mend PRIME STOP IV sets as they eradicate messy dripping, evenwith sticky substances.

Enteral nutritionB. Braun offers standard and special diets for enteral nutrition inglass bottles and bags. For the delivery of enteral nutrition solu-tions, we also offer resealable nutrition bags which have a fixed,attached tube for the Infusomat® Space.

Nutrition solutionsin glass bottles

Two-part universal adapteravoids mix-up with IV fluids

Nutrition solutionsin bags

Luer-Lock access port

Multiconnector line with maleLuer-Lock connector and

optional cone avoids mix-upswith IV ports



Avoid mix-ups between enteral and IV portsTo avoid mix-ups and eliminate the possibility of accidentallyconnecting lines to an IV access, an infusion line speciallydesigned for enteral nutrition* is available.

This line has an integrated two-part universal adapter designedto fit all standard bags and bottles used in enteral nutritiontherapy. Because of the shape and clear color-coding, it is notpossible to accidentally connect the line to an IV container.

At the patient end, both lines have a funnel and male Luer-Lockconnection to stop enteral nutrition accidentally being connect-ed to an IV access port.

Infusomat® Space – also ideal for clinical nutrition With this system, beds equipped with the Space system do notneed additional nutrition pumps. Not only does this save stafftime, because additional user trainings are no more required, italso cuts the cost of maintenance and service.

As well as preventing mix-ups with connections to IV access, itis also possible to show the name of the enteral nutrition solu-tion on the pump display, or simply label it as ”ENTERAL”. The dosage can be directly configured in kcal/24 hrs*.

When Space System is used in areas such as intensive care, itcan be connected via the regular SpaceStation to the PDMS,automatically capturing all details of the enteral nutrition therapy.

Nutritub® stomach tubewith funnel connector

Ready to use3-chamber bag

Enterofix® 1000 mlbag with integratedInfusomat® line

4

PRIME STOP ends messydripping of sticky solutions


In the field of pediatrics, one of the most important require-ments is that drugs are delivered precisely.

The Perfusor® Space makes it possible to deliver minimum vol-umes with ultimate precision. Disposables from B. Braun guaran-tee a minimal death space and safe handling.

High-precision drug deliveryBy using small syringes, you reduce the influence of disposableson precise administration at minimal dosing rates. This is whyPerfusor® Space has been designed to work with all syringe sizesfrom 2/3 ml to 50/60 ml.

The Space piston brake and fully-automated syringe fixationenhance the accuracy of drug delivery: undesirable bolus can beavoided safely. Unlike conventional mechanical systems,Perfusor® Space can eliminate the user-to-user variation.

Precise administrationPerfusor® Space is able to control the dosing rate in steps of0.01 ml/h. The pump can be configured in infusion rates (ml/h)or dose rates, and also patient weight-related rates.

All parameters can be preconfigured in the pump drug database,saving the user time and effort. With a minimum configurablebody weight of 250 g the special requirements of neonatologyhave also been taken into account.

Minimum dead space volumesWith extremely low dosing rates used commonly in pediatrics,each component in the infusion system is of central importance.

The recommended tubes for use in neonatology and pediatricsare PVC/DEHP free lines with a minimum internal diameter of0.5 -1 mm. To enable the retention of particles, bacteria, endo-toxins, fungi/spores and keep the dead space at the minimumspecial neonat /paed filters should be used.

Pediatrics and neonatology

Your benefits

� Ensure high precision drug delivery with syringes in sizes 2/3 ml, 5 ml, 10 ml, 20 ml, 50/60 ml

� Meet specific pediatrist requirements with minimal flow rates (0.01 ml/h), small patient weight (250 g) and patient-specific concentrations

� Space Datalock function to protect pump setting

� Optimal infusion system with minimal dead space using B. Braun product range

Intrapur® lipid neonat/paed filter with

0.7/1 ml dead space

IV administration lines with minimum dead space volume

Discofix® C 3-way stopcockwith tactile response

Intrapur® plus neonat/paed filter with 0.7/1 ml dead space


Pressure monitoring without additional accessoriesSpace generation syringe pumps are fitted with high-ly sensitive pressure sensors. These can detect block-ages quickly, doing away with the need for expensiveexternal IV in-line pressure sensors. The diagramshows the typical alarm time for small and largesyringes.

The 45° tactile response of the Discofix® C 3-waystopcock confirms you have the right setting.Accurate adjustments are quick and easy.

Sensor technology that sets the new standardInfusomat® Space is equipped with next generationsensor technology for detecting air bubbles. As wellas offering ultimate sensitivity (10 µl), this recentlydeveloped sensor also prevents false alarms (highspecificity), important in maintaining a sense of calmin pediatric wards.

More freedom to move around for smaller patientsUsing the lightweight Space pumps on pediatricwards together with spiral tubings gives children themaximum flexibility to move around. Integrated swiv-el nuts can be used to secure connections to preventaccidental disconnection.


Omnifix® syringes2/3 ml, 5 ml, 10 ml, 20 ml, 50/60 ml

PVC/DEHP

free5


When using Space equipment in operation theaters, you knowyou can depend on the system to provide the induction, opera-tion and recovery room functions that you need – exactly whenyou need them.

Space pumps have been designed for universal use and theirergonomic design makes handling the equipment simple andeasy.

Maximizing flexibility, minimizing set-up time Whether you are carrying out a minimal invasive operation orcomplex neuro/cardio surgery, Space has the solution you need.

In ORs already equipped with SpaceStations, you can expand the workplace simply by plugging in more pumps. The compactinstruments are easy to handle even under hectic operating conditions.

Fixed standards for added safety and reliability These pumps are suitable for the high precision administration of vasoactive drugs, and also for the application of anesthetics (e.g. TIVA/ TCI) and pain treatment (PCA). Therefore, you onlyneed one set of syringe and infusion pump equipment in theoperation theater. This simplifies logistical factors and equip-ment handling as all users in the operation theater only have to be trained to use one system.

Third generation TCI anesthesiaUntil now, using TCI algorithms had major financial implications.The first generation of TCI pumps also entailed using special glasssyringes. The second generation did allow for the use of Propofol,but equipment manufacturers still charged a high price for specialTCI pumps. B. Braun’s Space system marks the introduction of ”3rd generation TCI”: simply use the nearest available Space pumpas a temporary TCI pump – no matter whether it is a syringe pumpor an infusion pump.* Extra cost: zero.

Anesthesia

Your benefits

� Protect your budget – no extra investment and operationcosts for special pumps such as TCI or PCA

� Simplify handling and logistical effort using one pumpfor all therapies in clinical routine

� Plasma and effect site targeting for Propofol (Schnider,Marsh) and Remifentanil (Minto) on syringe and volumetric pump

� Plug-and-play electronical anesthesia record keeping

Ready to use TIVA sets

Integrated back-check valveto prevent backflow


Predefined therapy schemes save staff timeTo select the right drug, the pump provides a varietyof TCI algorithms (Propofol: Schnider, Marsh;Remifentanil: Minto) as well as user profiles (plasmatargeting/effect site targeting/navigation mode). Allyou have to do is input patient parameters and it isready to go.

This applies to all ”standard” Space pumps. As all TCIfunctions are also available on the infusion pump,the pump can take the drug straight from the infu-sion bottle.

Injectable drugs from B. BraunOur drug portfolio encompasses added-value prod-ucts as well as long established injectable drugs suchas Propofol-®Lipuro 1% and Propofol-®Lipuro 2%.

Propofol-®Lipuro 1% and Propofol-®Lipuro 2% arewidely used intravenous sedative-hypnotic agents forgeneral anesthesia. For in patients, out patients andsedation in intensive care.

Anesthesia record keeping By standardizing the equipment in the operation thea-ter, you create the basis for full automated electronicalanesthesia records.


Injectables by B. Braun

6

Vasofix® Safety(Introcan Safety®

see page 2)

Self-activatingsafety clip


Postoperative pain treatment

Effective intra- and postoperative pain management has beenproven to significantly reduce perioperative stress and facilitateearly rehabilitation.

Without a doubt, Patient Controlled Analgesia (PCA) is the mosteffective systemic procedure for managing acute pain.

Alternatively nerve blocks with its impressive clinical resultshave become established as the preferred way of managingpostoperative pain.

Profit from our customized system solutionsB. Braun has developed a comprehensive practice-oriented port-folio that keeps pace with the ever-changing requirements inthe field of anesthesia.

The range extends from products for systemic IV analgesia toregional anesthesia, including single-shot needles and sets forcatheter techniques. An extensive range of custom-designedtrays has also been developed to meet hospitals' specific needs.And every product can be individually adapted to your proce-dures and techniques.

Beyond providing excellent products, it is our commitment tosupport you with outstanding services.

Protect your budgetB. Braun Space lets you profit from the next generation of infusion pumps. This system fits perfectly into modern conceptslike hospital-wide pain services and fast-track surgery.

You no longer need to spend extra money on dedicated PatientControlled Analgesia (PCA) pumps. Simply connect a PCA buttonand Space turns into a PCA pump. Don’t burden your budgetwith daily costs for expensive dedicated IV sets.

Original Perfusor® Line PCA

Valve prevents backflowinto the container

Perifix® PinPad: Self-adhesive, latex-free

hypoallergenic foam pad

Perifix® filter providesadded safety and bacterial

infection control

Drug specific hints like ”IV Analgesia”, ”NERVE BLOCK”or ”EPIDURAL” to prevent the risk of mix-ups

Perifix® catheterconnector: easy-to-use catheterfixation with tac-tile and audiblefeedback

Your benefits

� Protect your budget by using Space PCA for both: IV- and regional analgesia

� Access codes for restricting use of pumps to specific departments

� Special ”analgesia screen layout”, simplifying identification of pain service pumps

� Predefined treatment and safety standards, saving valuable time


One system for both: IV and regional analgesiaPerfusor® Space is ideally suited for delivering small volumes (PCIA, PCEA). When larger volumes need to be infused over several days and a closed system is preferred (PCEA, PCRA),Infusomat® Space is the best choice.

Improve patient outcome and comfortThis "one-for-all” concept helps solve bottlenecks in PCA pumpavailability. The multiple access codes allow the hospital's painservice to limit or prevent the pumps from being used by otherdepartments. Thanks to the devices' light weight, your patientswill feel comfortable walking around the hospital. Faster recov-ery means earlier discharge.

Implement your therapy standardsWith B. Braun Space, it is easy to define and implement yourtherapy and safety standards in daily routine. Simply select yourpredefined drug profile. That reduces the time you need forpreparation.

Prevent complicationsThe clearly visible drug name, the customizable text in the dis-play together with the colored labeling on lines and catheter allhelp prevent mix-ups. The Space DoseGuard™ function givesnurses the flexibility – within a predefined corridor – to adjustthe dosage to each patient's needs.


Dedicated key locksthe syringe holder

Comfortable PCA button with fixation clip and patient wristband

Access code protectssettings and restrictsthe use by other wardsCA

Syringe anti-removal capprotects opioids from removal

K”

Perifix® catheter: highly flexible, kink-resistant polyamidecatheter

Labeling at the ends ofcatheter and lines preventthe risk of mix-ups 7


Oncology and bone marrow transplant wards have particularlystrict requirements when it comes to infusion system safety andreliability.

The integrated safety components in our oncology solution forma closed system – from the very first step to the very last, frompreparation to application.

Safe drug admixtureWhen it comes to complex and high-risk admixture routines,only a standing container is really safe and dependable. Ecoflac®plus is entirely non-PVC and meets the stringent demands ofmodern infusion containers.

Cyto-Set® Mix is a PVC/DHCP-free admixture system thatreduces the risk of contamination by adding cytostatic drugs tothe infusion without the use of needles.

For repeated admixtures or withdrawals, the Chemo Mini-Spike® Voffers ultimate safety. This spike reduces the risk of contamina-tion with toxic aerosols by using a 0.2 µm hydrophobic air filter.It also prevents free-flow caused by containers turning over orbeing tipped.

Safe administrationA variety of pharmacological substances and galenics are used inoncology, placing high demands on the materials used in infu-sion system components.

As a result, there is a predominance of PVC/DHCP-free lines inoncology wards, which can also be fitted with an integrated0.2 µm filter.

The Discofix® C stopcock has been uniquely engineered to keepconnections free from leaks, regardless of the drug used.

Oncology

Your benefits

� Mobilize your patients by using handy Space pumps

� Protect your patients with PVC free Space lines with 3 or 5 ports for cytostatic drugs

� Eliminate leakages by using Chemo Mini-Spike® V

� Take advantage from infusing with primary and secondary containers.

� Prevent drug and patient mix-ups with Space barcoding*

Infusomat® Space LineNeutrapur 0.2 µm filter

Chemo Mini-Spike® V reducesthe risk of contamination

Cyto-Set® Mixadmixture system

PVC/DEHP

free


Ultimate safety with Cyto-Set® Cyto-Set® removes the risk of preparing infusion systems forapplication. Cyto-Set® Mix prepared in the pharmacy can nowbe connected on the ward to Safsite® valves: as soon as every-thing is securely in place, you feel the click. Space pumps sup-port the use of primary and secondary containers. When usingthe system you simply switch between the different solutions(piggyback function).

Minimize time and effort with pre-assembled setsA variety of pre-assembled sets are available for use in oncology.These significantly reduce the amount of time preparing drugadmixtures and make it possible to standardize administration.

Keeping patients mobile – adding to patient comfortThe lightweight Space pumps with their powerful batteries allowpatients to say goodbye to the days when they were forced tostay in bed. Infusomat® Space does away with the need for dripdetectors, also making the system less prone to faults.

As short lines do not allow patients to enjoy the freedom tomove around, it makes sense to use tubing lines or spiral tubes.They are available in a variety of lengths up to 8 m as well asPVC/DEHP-free materials.

This oncology system solution improves safety and reliability,without tying up more staff time and resources. At the sametime, it enhances patient comfort and allows oncology patientsto become active earlier.


Cyto-Set® Mixadmixture system

Cyto-Set® Infusomat® Spacewith 3 or 5 Safsite®

Integrated swivel nut prevents accidental disconnection

Certofix® central venous

catheter

8


Product specifications

Drug admixture

Perfusor® syringes Description Size Latex PVC Sales unit Code No. (ml) free free Pcs. (REF)

Luer-Lock

UV protect, Luer-Lock

OPS 20 � � 100 8728615OPS with aspiration needle 20 � � 100 8728623Omnifix® 20 � � 100 4617207VOmnifix® with aspiration needle 30 � � 100 4617304FOPS 50/60 � � 100 8728844FOPS with aspiration needle 50/60 � � 100 8728810FOPS with aspiration needle, 15 µm particle filter 50/60 � � 100 8728852FOmnifix® 50/60 � � 100 4617509FOPS UV protected with yellow syringe 50/60 � � 100 8728801F

Admixture accessories Description Color Latex PVC Sales unit Code No. free free Pcs. (REF)

Transfer device � containers FDC 1000 Transofix®Ecoflac® Mix MAC 1002 MAT 4100

Transfer device � syringes MP 1000Mini-Spike® Plus Mini-Spike® Plus FilterMini-Spike® V FilterSterifix®

Closing conesCombi-Stopper

Stopper IN-Stopper SC 2000 TEC 1000 Ecopin

Fits into rubber stoppers 6.3 mm and bag set ports � � 100 415080 Transfer spike for containers with large cap diameters � � 200 4090500Standard vials, cap diameter 20 mm � Ecoflac® plus � � 250 16401 Multi-Ad system, container � containers � – 10 513508 MAC 1002 without spring loader syringe � – 20 513548

Non-vented micro pin, container � syringes � – 100 4150190.45 µm bacteria retentive air filter � � � 50 4550242+ 5 µm fluid filter � � � 50 4550234+ 2-way valve for free-flow protection � � � 50 45505794.5 cm filter straw with 5 µm particle filter � – 200 4550250 10 cm filter straw with 5 µm particle filter � – 200 4550200

Male/female Luer-Lock/Luer-Slip � � � 1000 4495101 � � � 1000 4495152 �� 1000 4495209

Female Luer-Lock �� 1000 4097076 + injection-port � � � 1000 4238010 Syringe cap in blister pack, one-hand attachment � � � 50 x 10 418012+ tamper-evident function � � � 50 x 10 418004Tamper-proof seal for Ecoflac® plus injection port �� 1000 4125002


Sterifix® injection filterSterifix® Pury

Injection and aspiration filter Description Particle Bacteria Pore size Latex PVC Sales unit Code No. retention retention (µm) free free Pcs. (REF)

Suitable as � � 0.2 � � 200 4099206syringe filter � – 5 � � 100 4551001

Back-check valves Description Latex PVC Sales unit Code No. free free Pcs. (REF)

For gravity infusion, suitable for parallel infusion � � 100 409400NFor pressure infusion or injection, normally closed � � 100 415062



IV administration sets Description Length Latex PVC Sales unit Code No. (cm) free free Pcs. (REF)

Intrafix® SafeSetGravity infusion+ back-check valve

Infusomat® Space Line

+ PRIME STOP/AIR STOPLength 3 mInjection port

with PRIME STOP and AIR STOP 180 � – 100 4063000with PRIME STOP, AIR STOP and back-check valve 180 � – 100 4063001

single packed 250 � – 100 8700036SP8700036SP in 10 unit ward pack 250 � – 100 8700435SPsingle packed with PRIME STOP and AIR STOP 250 � – 100 8701148SPsingle packed 300 � – 100 8270350SPwith handy grip plate 270 – – 100 8700087SPwith Y-injection port 270 � – 100 8751668SPneedle-free 270 � � 50 8700110SP

Stopcocks Description Color Extension Latex PVC Sales unit Code No. length (cm) free free Pcs. (REF)

Discofix® C 3-way stopcocks � 10 � – 50 16500C with 45° click �� 10 � – 50 16501C + extension line � 25 � – 50 16520C

� 50 � – 50 16540C � 75 � – 50 16551C � 100 � – 50 16560C

9

Spiral tubing Description Priming Inner ø Length Latex PVC Sales unit Code No. vol. (ml) (mm) (cm) free free Pcs. (REF)

Maximum flexibility 1.17 1.0 150 � � 50 40929374.7 2.0 150 � � 50 40903652.34 1.0 300 � � 50 40929459.4 2.0 300 � � 50 4090373


Infusion filter Particle Bacteria Fungi/spore Air Surface Latex PVC Sales unit Code No. retention retention retention elimination area (cm2) free free Pcs. (REF)

Intrapur® plus 0.2 µm

Intrapur® lipid 1.2 µmSterifix® 0.2 µm

Intrapur® filter set 0.2 µm

� � – � 10 � – 50 4099800� � – � 10 � � 50 4183916� – � � 10 � – 50 4099702 � � – � 10 � – 50 4099303� � – � 10 � � 50 4184637� � – – – � – 50 4086694


Infusomat® Space Line Description Length Latex PVC Sales unit Code No. (cm) free free Pcs. (REF)

Type Opaque

Type Transfusion

light protected, black tubing 250 � – 100 8700125SPlight protected, black tubing with injection port 250 � – 100 8250430SPwith 200 µm blood filter 250 � – 100 8270066SP

Extension and Description Priming Inner ø Length Latex PVC Sales unit Code No. connection tubings vol. (ml) (mm) (cm) free free Pcs. (REF)

0.2 0.9 30 � – 100 95000490.3 1.2 30 � – 100 42560342.1 3.0 30 � – 100 40973000.9 1.5 50 � – 100 82551720.5 0.9 75 � – 100 8722870

Venofix® G 25 needle 0.5 0.9 75 � – 100 87228895.3 3.0 75 � – 100 40971737.1 3.0 100 � – 100 40972629.9 3.0 140 � – 100 40974081.0 0.9 150 � – 100 82555042.6 1.5 150 � – 100 8722960

light protected – opaque 2.6 1.5 150 � – 100 8722919with Safsite® 2.6 1.5 150 � – 100 8722820

13.4 3.0 190 � – 100 40971903.5 1.5 200 � – 100 8722862

0.2 µm disc-filter 3.8 1.5 200 � – 50 8723001light protected – yellow 1.57 1.0 200 � – 100 4185838

4.4 1.5 250 � – 100 82554905.3 1.5 300 � – 100 825525322.6 3.0 320 � – 100 4097130

PVC/DEHP free lines see page 11 and 12, spiral tubings see page 9



Stopcocks & manifolds Color Rotation Proximal Extension Latex PVC Sales unit Code No. swivel lock stopcock (cm) free free Pcs. (REF)

Discofix® 3-way stopcocksLipid resistant

Discofix® C 3-way stopcockswith 45° clickDrug resistant

Discofix® C 3-gang-manifoldswith 45° clickDrug resistant

Discofix® 5-gang-manifolds

� – – – � � 200 4095111� – – – � � 200 4095120� – – – � � 200 4095138�� – – – � � 200 4095146

� � – – � � 100 16494C�� – – � � 100 16495C� � – – � � 100 16496C� � – – � � 100 16497C

� � � � – – � � 50 16600C� � � � – – � � 50 16605C� � � – � 180 � – 50 16611C� � � – � 150 � – 50 16610C� � � – 150 � – 50 16615C

� � �� – – – � � 50 4085450� � � � � – – – � � 50 4083059� � � � � � – 150 � – 50 4083377� � � � � � � 150 � – 50 4083407



Enteral nutrition with 1000 ml Enterofix® bag 230 � – 25 8250839SPMulti-connector for bottles and bags* 320 � � 50 8250857SP

Feeding tubes French Inner ø Outer ø Connector Lenght Latex PVC Sales unit Code No. (mm) (mm) Luer-Lock Funnel (cm) free free Pcs. (REF)

Pediatric tubeNutritub® Paed LL

Naso-gastric tubesNutritub® Gastral LLNutritub® Gastral LL/MNutritub® Gastral TR/MNutritub® Gastral TR/MNutritub® Gastral TR

Naso-intestinal tubesNutritub® Intestinal LL/MNutritub® Intestinal TR/MNutritub® Intestinal TR/M

6F 1.4 2.1 � – 60 � � 25 9246509

8F 1.9 2.8 � – 100 � � 25 92465178F 1.9 2.8 � – 100 � � 25 92465258F 1.9 2.8 – � 100 � � 25 924653312F 2.8 3.9 – � 100 � � 25 924654115F 3.6 5.0 – � 100 � � 25 9246550

8F 1.9 2.8 � – 120 � � 25 92465688F 1.9 2.8 – � 120 � � 25 924657612F 2.8 2.8 – � 120 � � 25 9246584

(LL=LuerLock, LL/M=Luer-Lock/Mandrin (stylet), TR=funnel connector, TR/M=funnel/stylet)

Clinical nutrition

10



Infusion filter Particle Bacteria Fungi/spore Endotoxin Air Dead Latex PVC Sales unit Code No. retention retention retention retention elimination space (ml) free free Pcs. (REF)

Intrapur® plus paed 0.2 µmIntrapur® plus neonat 0.2 µmIntrapur® lipid paed 1.2 µmIntrapur® lipid neonat 1.2 µmSterifix® paed 0.2 µmSterifix® neonat 0.2 µm

� � – � � 1.0 � – 50 4099753� � – � � 0.7 � � 50 4099451� – � – � 1.0 � – 50 4099850� – � – � 0.7 � � 50 4099460� � – – � 1.0 � � 50 4099354� � – – � 0.7 � � 50 4099257

IV administration sets Description Length Latex PVC Sales unit Code No. (cm) free free Pcs. (REF)

Intrafix® SafeSetGravity infusion

Infusomat® Space LineNeutrapur®

Dosifix®

Neutrapur® with PRIME STOP and AIR STOP 180 � � 100 4063002

PVC free line 250 � � 100 8250731SP+ injection port 250 – � 50 8250383SPwith 150 ml Dosifix® Burette 270 – – 25 8250294SP+ needle-free access port 270 – – 25 8250245SP


Luer-Lock 0.25 0.5 30 � � 100 40934370.4 1.0 50 � � 100 82550590.35 0.5 75 � � 100 4093445

with swivel nut 0.5 0.9 75 � – 100 87228700.8 1.0 100 � � 100 82550670.5 0.5 150 � � 100 4093054

with swivel nut 1.0 0.9 150 � – 100 8255504Additional extension lines see page 10 and 12, spiral tubings see page 9

Perfusor® syringes Description Size Latex PVC Sales unit Code No. (ml) free free Pcs. (REF)

Luer-Lock Omnifix® 2 � � 100 4617029V3 � � 100 4617022V5 � � 100 4617053V10 � � 100 4617100V

20 ml and 50/60 ml syringes see page 9

Pediatrics and neonatology



TIVA Set Description Sales unit Code No. Pcs. (REF)

Assembled set for one gravity infusion and two syringe pumps including two 3 way stopcocks and back-check valves

10 4187008

IV anesthetics Description Vol. (ml) Concentration Sales unit Code No. (mg/ml) Pcs. (REF)

Propofol-®Lipuro 1%

Propofol-®Lipuro 2%

Ampoule 20 10 5Glass bottle 50 10 10Glass bottle 100 10 10Glass bottle 50 20 10

PCA accessories Description Sales unit Code No. Pcs. (REF)

Original Perfusor® PCA line

Space PCA kit

Syringe anti removal cap

Y-port with back-check valves and slide clamps 50 8726019

Attachable PCA button, cable length 3m, fastener clip, holding loop for wrist 1 8713554

Protects opioids from removal 4 8713556

Anesthesia

Postoperative pain treatment

11



Preparation Description Length Latex PVC Sales unit Code No. (cm) free free Pcs. (REF)

Chemo Mini-Spike® PlusChemo Mini-Spike® VChemo Mini-Spike® Micro-TipCyto-Set® LineCyto-Set® Mix

0.2 µm toxic aerosol retentive air filter – � � 50 4550540+ 2-way valve for free-flow protection – � � 50 4550587Micro-Tip with a very small diameter – � � 50 4550536Secondary line 40 � � 20 A2581NFSecondary line + Safsite® injection port 40 � � 20 A2901N+ back-check valve 40 � � 20 A2902N


Neutrapur®Cyto-Set®

Piggyback

PVC free line with 0.2 µm Sterifix® Filter 250 � � 20 8700095SPwith 3 Safsite® ports 250 � � 20 8250910SPwith 5 Safsite® ports 250 � � 20 8250812SPwith 5 Safsite® ports and 0.2 µm Sterifix® filter 250 � � 20 8250413SPwith 5 Safsite® ports and back-check valve 250 � � 20 8250813SPInfusomat® Space Line needle-free access port 290 � � 100 8250710SPSecondary line 75 � � 100 4062877

Oncology


1.2 1.0 150 � � 100 8722935Light protected – opaque 1.2 1.0 150 � � 100 8723010

1.6 1.0 200 � � 100 87230602.0 1.0 250 � � 100 8272565

PVC lines see page 10, PVC/DEHP free lines page 11, spiral tubings see page 9


Performance data Description

Accuracy- Infusomat® Space- Perfusor® SpaceFlow rateDose rate calculationDrug libraryPCA profileTCI profile*Ramp/Taper profile*PiggybackTake-Over-Mode*Occlusion monitoringKeep vains open modeStandby modeDatalock

± 5% over 96 h with Original Infusomat® Space line± 2% in compliance with IEC/EN 60601-2-24Online rate modification without delivery interruption, predefined standard dosages via drug libraryFull-automatic via drug library or manually, integrated in start-up operationIntegrated in the start-up procedure or via special functionsVia drug library, all parameters can be pre-configuredVia drug library, all parameters can be pre-configuredVia drug library, all parameters can be pre-configuredAlso supported by drug libraryFull automatic overlapping syringe change9 occlusion pressure levels (0.1 - 1.2 bar), automatic bolus reduction to ≤ 0.2 mlDefault settings: user-defined configuration or deactivation of KVO rates possible1 min ... 24 hrs, drug name also visible in standby modeDatalock on 3 safety levels, Datalock 3 also with drug specific hints


B. Braun Space infusion pumps

Technical data

Disposables Description

Infusomat® Space

Perfusor® Space

PVC infusion lines with silicone pump element, optionally with:- injection port, needle-free access port- PRIME STOP/AIR STOPPVC/DEHP free infusion lines also as Cyto-Set®Sets for blood transfusion, enteral nutrition

B. Braun Original Perfusor® Syringe OPS: 20 ml, 50/60 mlB. Braun Omnifix®: 2/3 ml, 5 ml, 10 ml, 20 ml, 30 ml, 50/60 mlBecton Dickinson BD Plastipak: 3 ml, 5 ml, 10 ml, 20 ml, 30 ml, 50/60 mlBecton Dickinson BD Precise: 20 ml, 50/60 mlFresenius Injectomat: 50 mlTerumo: 3 ml, 5 ml, 20 ml, 30 ml, 50/60 ml, 60 mlTyco Monoject US: 3 ml, 6 ml, 12 ml, 20 ml, 35 ml, 50/60 mlTyco Monoject EU: 3 ml, 6 ml, 12 ml, 20 ml, 35 ml, 50/60 ml

12


Space drug library Description

Adjustable range Description Units

Flow rate

Quantity of active agentsVolume

Dose ratePatient weight

0 ... 99.99 in 0.01 increments ml/h100 ... 999.9 in 0.1 increments ml/h1000 ... 1800 in 1 increments ml/h0 ... 99,999 in 0.001 increments µg, mg, g*, mEq, IE, kIE*, mmol, kcal*0.1 ... 99.99 in 0.01 increments ml100 ... 999 in 0.1 increments ml1000 ... 9999 in 1 increments ml0 ... 99,999 in 0.001 increments unit (/patient weight) /min or /h or /24h250 g - 250 kg kg, g, lb

Technical data

Therapy profiles

DrugListEditor Space

Drug identification

Drug content

Drug properties

Navigation in the drug library

Updating/uploading

Microsoft® Windows® based database application, user authentification by passwordOne drug library file for Infusomat® Space and Perfusor® SpaceMinimal 720, typical 1500 drug profile settings per pump

Drug name with up to 24 charactersActive agent ID* as identifier for PDMS and barcoding*, up to 20 alpha-numeric charactersDrug ID as identifier for PDMS and barcoding*, up to 20 alpha-numeric characters

Quantity of active agent in: µg, mg, g*, mEq, IU, mmol, kcal*, kJ*Volume in mlContainer volume* for Infusomat® SpaceConcentration takeover from quantity of active agent/volume or patient specific concentration

Drug selectable on Infusomat® Space and/or Perfusor® SpaceProfiles (continuous infusion, PCA, TCI*) available for this drugPredefined start-up profile or user dialogFlow rate or dose rate as primary parameter selectableAlarm priority (low, medium and high) for alarm monitoringUser notification text, 3 lines with 25 charactersAutomatic Datalock with start (off, Datalock level 1, Datalock level 2, Datalock level 3)

15 ward profiles/categoriesIndex of all drugs, optionally disabledFast navigation thanks to ”ABC � DEF �...” fast forward jump marksBarcoding* for syringe and container identificationXML data interface to receive the list of prescriptions from PDMS

Automatic drug library version managementUploading the drug database to up to 24 Space pumps in one work stepMicrosoft® Windows® based service software tool using the USB port



Continuous infusion Description Lower Lower Standard Upper Upperhard limit soft limit dose soft limit hard limit

Initial bolusFlow rate- Infusomat® Space- Perfusor® SpaceVolume to be infused VTBITime pre-selectionDose rateQuantity of bolusBolus rate- Infusomat® Space- Perfusor® Space

0/0.1 ... 99.99 ml, 0 ... 99,999 unit (/patient weight) – � � � �

0.1 ... 1200 ml/h – � � � �

0.01 ... 999.9 ml/h – � � � �

0 ... 99,999 ml – – � – –1 min ... 99 hrs 59 min – – – – –0 ... 99,999 unit (/patient weight) /min or /h or /24h – � � � �

0 ... 99,999 ml, units, units/patient weight – � � � �

0.1 ... 1200 ml/h – � � � �

0.01 ... 1800 ml/h – � � � �

Patient Controlled Analgesia Description Lower Lower Standard Upper Upperhard limit soft limit dose soft limit hard limit

Observation time frameDose limitInitial bolusPCA bolus amountBolus rate- Infusomat® Space- Perfusor® SpaceLockout timeBasal rate- Infusomat® Space- Perfusor® Space

1 - 24 hrs � � � � �

0.1 ... 99,999 ml, 0.001 ... 99,999 dose – � � � �


0 ... 99.99 ml, 0 ... 99,999 unit (/patient weight) – � � � �

0.1 ... 1200 ml/h – � � � �

0.01 ... 1800 ml/h – � � � �

1 - 240 min � � � � �

optionally disabled0.1 ... 1200 ml/h – � � � �

0.01 ... 999.9 ml/h – � � � �

Target Controlled Infusion* Description Lower Lower Standard Upper Upperhard limit soft limit dose soft limit hard limit

AlgorithmModeTarget volumeInitial bolusBolus rate- Infusomat® Space- Perfusor® SpaceBasal rate- Infusomat® Space- Perfusor® Space

Propofol: Schnider, Marsh; Remifentanil: Minto – – – – –Plasma target, effect site target, navigation – – – – –Plasma or effect concentration – – � � �


0.1 ... 1200 ml/h – � � � �

0.01 ... 1800 ml/h – � � � �

0.1 ... 1200 ml/h – � � � �

0.01 ... 999.9 ml/h – � � � �

13



Propofol-®Lipuro 1% (10 mg/ml)Prescribing Information

Composition: 1 ml emulsion for injection or infusion containsPropofol 10 mg. Excipients: Soya-bean oil, medi-um-chain triglycerides, glycerol, egg lecithin, sodi-um oleate, water for injections.

Therapeutic indications: Propofol-®Lipuro 1% (10 mg/ml) ) is a short-act-ing intravenous general anaesthetic for induction and maintenance of general anaesthesiasedation of ventilated patients in the intensivecare unit, sedation for diagnostic and surgical pro-cedures, alone or in combination with local orregional anesthesia.

Contraindications: Propofol-®Lipuro 1% (10 mg/ml) must not be used – in patients with a known hypersensivity to

propofol or to any of the excipients of theemulsions

– in patients who are allergic to soya or peanut– in children younger than 1 month for induction

and maintenance of anaesthesia– in patients of 16 years of age or younger for

sedation in intensive care

Use during pregnancy and lactation: Propofol-®Lipuro 1% (10 mg/ml) crosses the pla-centa and may be associated with neonatal depres-sion. It should therefore not be used in pregnancyor for obstetric anaesthesia unless clearly necessary.High doses (more than 2.5 mg/kg body weight forinduction or more than 6 mg/kg body weight formaintenance of anaesthesia) should be avoided.Propofol enters breast milk in small amounts.Therefore, mothers should stop breastfeeding anddiscard breast milk for 24 hours after the adminis-tration of propofol.

Undesirable effects: Hypotension and transient apnoea may occurdepending on the dose of propofol, the type of pre-medication and other concomitant medication.Account should be taken of the possibility of asevere drop in blood pressure in patients withimpaired coronary or cerebral perfusion or thosewith hypovolaemia. During general anaesthesiabradycardia has occurred, occasionally with pro-gressive severity (asystole). During induction of anaesthesia spontaneous move-ments and myocloni are likely to be observed.Occasionally, dystonia and other involuntary move-ment disorders have been reported. During maintenance of anaesthesia and the recov-ery period coughing occasionally occurs. During

induction, singultus may occur. During the recoveryperiod, nausea, vomiting, headache, shivering andsensations of cold have seldom been reported aswell as euphoria and sexual disinhibition. Veryrarely, pancreatitis has been observed (causal rela-tionship unclear). Very rarely, after long-term infu-sion of high doses (more than 4 mg/kg bodyweight) for sedation in the ICU the so-called propo-fol infusion syndrome has been observed with thefollowing symptoms: rhabdomyolysis, metabolicacidosis, hyperkalaemia, and cardiac failure. Rarely, epileptiform convulsions including opistho-tonus may occur, in isolated cases delayed by hoursor days. In isolated cases, after administration toepileptic patients, convulsions have been observed. There have been reports of rare cases of postopera-tive fever and discoloration of urine following pro-longed administration as well as severe cases ofhypersensitivity reactions (anaphylaxis), which mayinclude Quincke’s oedema, bronchospasm, erythemaand hypotension. Isolated cases of pulmonary oede-ma have also been reported. Local pain may occurduring the initial injection. Thrombosis and phlebitisare rare. After co-administration of lidocaine thefollowing undesirable effects may occur: giddiness,vomiting, drowsiness, convulsions, bradycardia, car-diac arrhythmia and shock. There are isolatedreports of severe tissue reactions after accidentalextravascular administration.

Instructions for use/handling: Propofol-®Lipuro 1 % (10 mg/ml) is administeredintravenously. Containers should be shaken beforeuse. Propofol-®Lipuro 1 % (10 mg/ml) contains noantimicrobial preservatives. Therefore, Propofol-®Lipuro 1 % (10 mg/ml) is to be drawn up asepti-cally. Before use, the neck of the ampoule or thesurface of the rubber stopper of the bottle shouldbe cleaned with medicinal alcohol (spray orswabs). The contents are for single use in onepatient. Any portion of the contents remainingafter use must be discarded. Please see packageleaflet before application. Do not store above25°C. Do not freeze. Please keep out of the reachof children.

For prescription only!

Marketing authorisation holder: B. Braun Melsungen AG, 34209 Melsungen, Germany

Version: 03/2007

Propofol-®Lipuro 2% (20 mg/ml)Prescribing Information

Composition: 1 ml emulsion for injection or infusion containsPropofol 20 mg. Excipients: Soya-bean oil, medi-um-chain triglycerides, glycerol, egg lecithin, sodi-um oleate,water for injections.

Therapeutic indications: Propofol-®Lipuro 2% (20 mg/ml) is a short-actingintravenous general anaesthetic for induction andmaintenance of general anaesthesia, sedation ofventilated patients in the intensive care unit,sedation for diagnostic and surgical procedures,alone or in combination with local or regionalanesthesia.

Contraindications: Propofol-®Lipuro 2% (20 mg/ml) must not be used – in patients with a known hypersensivity to

propofol or to any of the excipients of theemulsions

– in patients who are allergic to soya or peanut– in children younger than 1 month for induction

and maintenance of anaesthesia (use ofPropofol-®Lipuro 2 % (20 mg/ml) is not recom-mended for induction and maintenance ofanaesthesia in children between 1 month and 3

years of age since the 2% strength is difficult tobe adequately titrated in small children.)

– in patients of 16 years of age or younger forsedation in intensive care

Use during pregnancy and lactation: Propofol-®Lipuro 2% (20 mg/ml) crosses the pla-centa and may be associated with neonatal depres-sion. It should therefore not be used in pregnancyor for obstetric anaesthesia unless clearly necessary.High doses (more than 2.5 mg/kg body weight forinduction or more than 6 mg/kg body weight formaintenance of anaesthesia) should be avoided.Propofol enters breast milk in small amounts.Therefore, mothers should stop breastfeeding anddiscard breast milk for 24 hours after the adminis-tration of propofol.

Undesirable effects: Hypotension and transient apnoea may occurdepending on the dose of propofol, the type of pre-medication and other concomitant medication.Account should be taken of the possibility of asevere drop in blood pressure in patients withimpaired coronary or cerebral perfusion or thosewith hypovolaemia. During general anaesthesiabradycardia has occurred, occasionally with pro-gressive severity (asystole). During induction of anaesthesia spontaneous move-

ments and myocloni are likely to be observed.Occasionally, dystonia and other involuntary move-ment disorders have been reported. During maintenance of anaesthesia and the recov-ery period coughing occasionally occurs. Duringinduction, singultus may occur. During the recoveryperiod, nausea, vomiting, headache, shivering andsensations of cold have seldom been reported aswell as euphoria and sexual disinhibition. Veryrarely, pancreatitis has been observed (causal rela-tionship unclear). Very rarely, after long-term infu-sion of high doses (more than 4 mg/kg bodyweight) for sedation in the ICU the so-called propo-fol infusion syndrome has been observed with thefollowing symptoms: rhabdomyolysis, metabolicacidosis, hyperkalaemia, and cardiac failure. Rarely,epileptiform convulsions including opisthotonusmay occur, in isolated cases delayed by hours ordays. In isolated cases, after administration toepileptic patients, convulsions have been observed. There have been reports of rare cases of postopera-tive fever and discoloration of urine following pro-longed administration as well as severe cases ofhypersensitivity reactions (anaphylaxis), which mayinclude Quincke’s oedema, bronchospasm, erythemaand hypotension. Isolated cases of pulmonary oede-ma have also been reported. Local pain may occurduring the initial injection. Thrombosis and phlebitisare rare. After co-administration of lidocaine the

following undesirable effects may occur: giddiness,vomiting, drowsiness, convulsions, bradycardia,cardiac arrhythmia and shock. There are isolatedreports of severe tissue reactions after accidentalextravascular administration.

Instructions for use/handling: Propofol-®Lipuro 2 % (20 mg/ml) is administeredintravenously. Containers should be shaken beforeuse. Propofol-®Lipuro 2 % (20 mg/ml) contains noantimicrobial preservatives. Therefore, Propofol-®Lipuro 2 % (20 mg/ml) is to be drawn up asepti-cally. Before use, the neck of the ampoule or thesurface of the rubber stopper of the bottle shouldbe cleaned with medicinal alcohol (spray orswabs). The contents are for single use in onepatient. Any portion of the contents remainingafter use must be discarded. Please see packageleaflet before application. Do not store above25°C. Do not freeze. Please keep out of the reachof children.

For prescription only!

Marketing authorisation holder: B. Braun Melsungen AG,34209 Melsungen, Germany

Version: 04/2007



To find out more about the * starred features in this brochure, ask your contact at B. Braun or visit www.space.bbraun.com.



� Reduced risk of needle-stick injuries

� Easy-to-use pumps, uniform user interface

� High battery capacity

� Long-term accuracy in fluid administration

� Drug name visible on display

� Patient-controlled analgesia (PCA)


� High-precision drug delivery for vasoactive substances

� Disposables for light-sensitive drugs

� Patient-controlled analgesia (PCA)

� One bedside pump rack system for completefluid management (nutrition, PCA, ...)

� Plug-and-play PDMS integration with up to 24 pumps/bed

� Point-of-care drug validation

Operation theater

� Handy pumps supporting the workflows in OT

� Dose rate calculation (e.g. for TIVA)

� TCI anesthesia for Propofol and Remifentanil

� Patient-controlled-analgesia (PCA)

� Volumetric PCA pump for nerve blocks

� One pump for all therapies

� Plug-and-play electronic anesthesia records

Pediatrics / neonatology

� Minimal volume, ultimate precision

� PVC/DEHP-free infusion, minimal dead space

� Minimal alarm reaction times

� Pump settings protected from tampering

Oncology

� Lightweight, handy pumps for easy patient mobilization

� PVC/DEHP-free administration sets

� Handling of primary/secondary infusion (piggyback)

unimportant … important

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Check out yourrequirements


The basic differences

� Is this device versatile enough to coverstandard and specialist applicationssuch as PCA, TCI, enteral nutrition,neonatology and oncology?Thanks to “One system for greater diversi-ty” you no longer burden your budgetwith additional investment and operatingcosts for additional dedicated pumps.

� Do the infusion and syringe pumps havethe same user interface to simplifyoperation?The volumetric infusion pump and syringepump are based on the same system.

� Can the bedside pump rack system beused with all pumps needed for moderninfusion therapy, including PCA andenteral nutrition?SpaceStation takes up minimum space,needs only one power cord, and gives youa simple overview.

� Can all therapy parameters be pre-defined to minimize configuration timeduring the routine of daily clinicalpractice?The DrugListEditor allows you to configureall drugs and therapy profiles (PCA, TCI, …)as well as standard and maximum dosages.

� Does the plug-and-play patient/anesthe-sia record keeping function span allpumps (PCA, TCI, nutrition, …)?Thanks to the university of Space pumpsthere is only one data protocol for com-plete fluid management required.

� Is the supplier in a position to bundle allcomponents into a customized solution?By working in partnership with a real sys-tem supplier such as B. Braun, you profitfrom our competence in modern infusiontherapy and regional anesthesia.

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B. BraunSpace

othersystem


B. Braun Melsungen AG

34209 MelsungenGermanyTel +49(0) 56 61 71-0

www.bbraun.comwww.space.bbraun.comB. 01. 04. 08/1 Nr. 606 4511


6064511 BBraun Space e 04 08 · from needle injury, they also help prevent bloodstream infections....

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