Cyto-Set® Mix, Cyto-Set® Line
Connection system for Cyto-Set® gravity infusion-, Infusomat® Space, Infusomat® Plus sets.
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® Mix
Connection system for Cyto-Set® gravity infusion- and Infusomat® Space sets.
The Cyto-Set® Mix allows to connect a normal infusion container with a solution dedicated for cytotoxic drugs (NaCl 0,9% or Glucose 5%) to vent the line. The drug is put in the container via a needle-free injection valve. So the line of the Cyto-Set® Mix leading to Cyto-Set® Infusion, Cyto-Set® Infusomat® Space or Cyto-Set® Infusomat® plus is free of cytotoxic drugs.
Cyto-Set® Line
Connection system for Cyto-Set® gravity infusion- and Infusomat® Space sets.
Cyto-Set® Line connects primed solutions. This component consists of only one spike and a polyurethane transition tube, clamp and a fill-stop-cap (Prime Stop).
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 exposure.1
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
Particulate Contamination
- 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.6, 7
DEHP Exposure
- Not made with PVC / DEHP: All lines are PVC-free, there is no risk of DEHP exposure.8
Paediatric Use
- Not made with PVC / DEHP: All lines are PVC-free, there is no risk of DEHP exposure.8
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 American Nurses Association – Independent Study Module: Needlestick Safety and Prevention written by Mary Foley, MS, RN and Annemarie T. Leyden, EdD, RN
7 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
8 Data on File