Cyto-Set® Infusomat® Space

B. Braun of Canada
Cyto-Set® Infusomat® Space

IV administration set for the application of cytostatics. For infusion by compatible pumps.

with 5 needle-free valves
Cyto-Set® Infusomat® Space

Single-use, sterile infusion system for the preparation and administration of different cytotoxic drugs via one single closed line-system by gravity or pressure with bottles and bags according to the SPC (Summary of product characteristics) of the drugs/solutions. Cyto-Set® is used for the application of cytotoxic agents in a closed system.

 The Cyto-Set® system reduces the probability of contamination of person and environment when preparing and applying cytotoxic drugs ensured by its technical components forming a closed system and the resulting workflow.

 

Cyto-Set® Infusomat® Space

IV administration set for the application of cytostatics. For infusion by compatible pumps.

Connection set for the administration of cytostatic drugs by compatible pumps. Cyto-Set® Infusomat® Space is primed with a flushing solution (NaCl 0,9% or Glucose 5%). Cyto-Set® Mix or Cyto-Set® Line must be connected to the valve port of Cyto-Set® Infusomat® Space to administer the cytostatic drugs. One drug administration is always followed by a flushing step.

Cyto-Set® can be used for all patients to whom cytotoxic drugs are prescribed in hospitals. Depending on the particular therapeutical concept and sensibility of the tumor to one or more cytotoxic agents the administration of these drugs represents an important role besides surgery and radiation therapy.

Advantages

Chemical Contamination

  • Needle-free valve: Helps to reduce the risk of chemical contamination as the valves are designed for preventing spillage / drug exposure1

Microbiological Contamination

  • Finger stopper and finger grip: Reduction of microbial contamination due to the finger stopper and finger grip.2
  • PrimeStop: Improved safety against microbial contamination due to the hydrophobic, bacteria retentive PrimeStop cap on the patient connector which provides a closed system until connection to the patient.3, 4
  • Needle-free valve: Provides easy access, while helping to reduce the chance of accidental touch contamination.2
  • Air vent filter in the spike: The bacteria tight air vent filter in the spike reduces the contamination risk of the infusion solution.5

Drug Incompatibility

  • Grip plate with integrated back check valves: Integrated back check valves enable an improved safety standard and less risk of unmeant mixture of drugs due to the prevention of reflux.6 

Particulate Contamination

  • 15 μm filter in the drip chamber: A particle filter in the drip chamber with pore size of 15 μm prevents the infusion of particles from the infusion container.7
  • 0.2 μm Sterifix® filter: The 0.2 μm Sterifix® filter retains bacteria, fungi, particles and air.

Sharps Injury

  • Needle-free valve: Provides needle-free access, while eliminating the risk of needlestick injuries.8,9

Medication Error

  • Structure of the regime: Due to the 90° angle of the valves in the grip plate, the whole Cyto-Set® regime is structured well, which reduces the risk of mistaking the drugs within the therapy. 11

Air Embolism

  • AirStop: AirStop function in drip chamber reduces the risk of air embolism.10

DEHP Exposure

  • Not made with PVC / DEHP: All lines are PVC-free, there is no risk of DEHP exposure.12

Pump application
Compatible with Infusomat® Space

  • Pump segment for long term accuracy during usage with infusion pumps
  • Anti-freeflow clamp for automated freeflow protection when removing the line from the pump.13

Paediatric use:

  • Not made with PVC / DEHP: All lines are PVC-free, there is no risk of DEHP exposure.12

1 Abstract - Closed system test by means of Sodium Fluorescein signed by Dr. rer. nat. J. Brunke Quality Labs BT GmbH Nuremberg, Report 1816.3, 01.09.2015

2 Abstract - Evaluation of the microbial barrier performance of Cyto-Set® and Cyto-Set R Mix (NEW) signed by Prof. Dr. med. M.Exner and Dr. rer. nat. J. Gebel, Report DMT 2014-195, 23.02.2015

3 Test Report - Closed system test by means of Sodium Fluorescein signed by Dr. rer. nat. J. Brunke Quality Labs BT GmbH Nuremberg, Report 1678.3, 28.05.2013

4 Confirmation PrimeStop Cap - Bacteria tightness of PrimeStop Cap. Confirmation available.

5 Data on File

6 Data on File

7 ISO Standard - ISO 8536-4

8 American Nurses Association – Independent Study Module: Needlestick Safety and Prevention written by Mary Foley, MS, RN and Annemarie T. Leyden, EdD, RN

9 Review Article - Review on Needle Free Drug Delivery Systems, International Journal of Pharma Research & Review, written by Bhagyashri Chavan, Abha Doshi, Yashwant Malode, Balu Misal, Sept 2013; 2(9):30-36

10 Pheriphervenose Schwerkraftinfusionen – Intrafix® SafeSet mit Vorteilen gegenuber herkommlichen Infusionssystemen written by lic. rer. pol. Andreas Frei, Die Schwester Der Pfleger 43. Jahrg. 5/04

11 Data on File

12 Data on File

13 Data on File