CE Marked medical device (typically Class IIb) under EU medical device regulations.
Designed and tested in accordance with IEC/EN 60601 1 (general safety) and IEC/EN 60601 2 24 (particular requirements for infusion pumps and controllers).
Subject to US FDA 510(k) clearance for the Perfusor Space Syringe Infusion Pump System for specified routes of administration and patient populations.
CE Marked medical device (typically Class IIb) under EU medical device regulations.
Designed and tested in accordance with IEC/EN 60601 1 (general safety) and IEC/EN 60601 2 24 (particular requirements for infusion pumps and controllers).
Subject to US FDA 510(k) clearance for the Perfusor Space Syringe Infusion Pump System for specified routes of administration and patient populations.
Conforms to applicable EMC and safety standards for use in professional healthcare environments.
Syringe Infusion Pump
Description
Perfusor Space is a compact, modular syringe infusion pump from B. Braun, designed for precise administration of small volumes of drugs, infusion and nutritional solutions. As part of the B. Braun Space system, it can be used as a standalone pump, in small therapy stacks or in complex multi-pump configurations. The pump supports advanced safety features, weight-based dosing, automatic rate calculation, and an integrated drug library, and can be networked into hospital data systems to support modern infusion management and documentation.
Bnefits
Compact and lightweight modular syringe pump that fits the B. Braun Space docking and infusion station concept, allowing flexible therapy configurations.
Automatic rate calculation based on volume over time and dose rate mode, enabling entry of drug concentration and dose (e.g. mg/kg/min) for accurate, weight-based infusions.
Integrated drug library supporting up to approximately 1500 drugs in multiple categories, with drug-specific soft and hard limits and default values to enhance medication safety.
Supports multiple care units and patient profiles, enabling standardised protocols across departments while tailoring dosing ranges to specific patient groups.
Standardised and intuitive user interface shared across B. Braun Space pumps, helping reduce user training time and operation errors.
Advanced safety concept including integrated piston brake to prevent free-flow during syringe change, automatic drive technology for safe start-up, and automatic bolus reduction after occlusion alarms.
Clear LED alarm indicators with detailed alarm messages on the display to support rapid troubleshooting and response.
Can be integrated into hospital data networks for central monitoring, documentation, and interoperability with clinical information systems.
Designed and tested according to international standards for infusion pumps, with high delivery accuracy suitable for adult, paediatric and neonatal patients.
Transportable design suitable for use on wards, in ICU, OR, ED and for intra-hospital or pre-hospital (transport) applications when configured appropriately.
Indications
Continuous and intermittent syringe-based infusion of drugs, fluids and nutritional solutions in hospital and clinical environments.
Conforms to applicable EMC and safety standards for use in professional healthcare environments.
Infusion therapy for adult, paediatric and neonatal patients where precise control of low to moderate infusion rates is required.
Intravenous, intra-arterial, subcutaneous, epidural and (when appropriately configured) enteral administration of compatible solutions, as defined in the official indications for use.
Use in operating rooms, intensive care units, high-dependency units, emergency departments, general wards and transport settings where syringe infusion pumps are indicated.
Composition
Electronic syringe infusion pump with microprocessor-controlled stepper motor drive and syringe plunger mechanism.
Housing constructed from injection-moulded thermoplastic materials designed for clinical use and easy cleaning.
User interface with backlit display, keypad and status LEDs for operation and alarm signalling.
Internal electronics comprising control board, power management and interfaces for networking and docking.
Rechargeable battery module to provide operation during transport and mains power interruptions.
Formulation
Syringe infusion pump designed for use with compatible disposable syringes (typically 3–60 ml depending on brand and configuration).
Programmable flow rate range approximately 0.01–999.9 ml/h (with larger syringes), with high accuracy in accordance with IEC/EN 60601-2-24.
Dose rate modes allowing programming in mass per time or mass per weight per time (e.g. mg/kg/min) when drug concentration is entered.
Part of the B. Braun Space family, compatible with SpaceStation docking units and central monitoring/IT connectivity modules.
Packaging
Single Perfusor Space syringe infusion pump unit.
Integrated or included pole clamp/mounting component depending on configuration.
Mains power adaptor or cable appropriate to the region, when supplied as a standalone unit.
User manual / instructions for use and safety information leaflet.
Device identification and regulatory labels on the pump housing.
Additional accessories such as docking stations or network modules available separately as part of the B. Braun Space system.
Usage
Only trained healthcare professionals familiar with syringe infusion pumps and institutional protocols should operate the device.
Before use, inspect the pump, power connections, battery status and syringe holder mechanism for integrity and proper function.
Select an approved syringe type and size, prepare and fill it with the prescribed medication using aseptic technique, remove air and close the syringe securely.
Mount the syringe in the pump according to on-screen instructions and the user manual, ensuring correct placement and recognition by the device.
Enter or confirm patient data as required (e.g. weight) and select the appropriate drug from the drug library or manually configure infusion parameters.
Program the infusion using volume/time or dose rate mode, verifying rate, volume to be infused and limits before starting the infusion.
Prime the line and connect to the patient’s access device following local policies, ensuring that the line is free of air and kinks.
Start the infusion and monitor pump alarms, line patency and the patient’s clinical status regularly; respond promptly to alarms such as occlusion, near-end of infusion, or low battery.
When changing syringes, follow the guided procedure; the integrated piston brake and automatic drive technology help to prevent free-flow and unintended bolus, but clinical vigilance remains essential.
After therapy, stop the infusion, disconnect and dispose of syringes and lines as clinical waste, and clean the pump according to manufacturer and infection control guidelines.
Contraindications
Use is contraindicated where syringe-pump infusion is not appropriate for the prescribed therapy or patient condition as determined by a clinician.
Do not use with syringe brands or sizes that are not approved or configured for the Perfusor Space, as this may compromise dosing accuracy and safety.
Do not operate the pump if there is visible damage, failed self-test, or unresolved error messages.
Avoid use in environments that exceed the specified operating conditions for temperature, humidity, atmospheric pressure or electromagnetic compatibility.
Unless specifically configured and approved, do not use in MRI environments or in the presence of strong electromagnetic fields.
Adverse Effects
Potential for under-infusion or over-infusion if parameters are incorrectly programmed, syringes are misloaded or alarms are ignored.
Risk of extravasation, infiltration, phlebitis or infection at the infusion site, as with any IV therapy, if general infusion-care precautions are not followed.
Introduction of air into the line and possible air embolism if priming and air-detection procedures are not properly followed.
Therapy interruption or changes in rate following mechanical or electronic failure, power loss or user error, which require immediate clinical assessment and intervention.
Alarm fatigue and user error if multiple alarms from multiple devices are not managed within institutional safety protocols.
Storage Conditions
Store and transport the pump in a clean, dry environment within the ambient temperature and humidity ranges specified by the manufacturer.
Protect the device from strong impacts, vibration, dust and direct sunlight during storage and transport.
Do not expose the pump to immersion in liquids or high-pressure water jets; the unit is splash-protected only to its specified IP rating.
For prolonged non-use, switch off the device and follow manufacturer recommendations for battery maintenance and periodic charging.
Keep the pump out of reach of unauthorised personnel and ensure it is only accessible to trained staff.
Duration
Treatment duration is fully programmable and can range from short bolus or short-term infusions to prolonged continuous therapy over many hours or days, depending on the prescribed rate, volume and clinical protocol.
Onset
Onset of clinical effect is determined by the medication, dose and patient factors; the pump begins delivering at the programmed rate immediately after infusion start, within its specified accuracy.
