Bio-Safety

SPIROS® CSTD MALE LUER

  • Closed System Prevents Leaks and Drug Vapor Escape in the Treatment Area
  • Needlefree Device Ensures Compliance with Needlefree Policies
  • Requires no Cumbersome Assembly of Components
  • Features Automatic Self-sealing Technology
Spiros® CSTD Male Luer

Automatically creates a needlefree closed system for the safe mixing, transfer, administration, and disposal of hazardous drugs.

 

Helping Prevent Leaks or Spills of Hazardous Drugs Throughout the Entire Safe Handling Continuum.

Spiros® creates a mechanically and microbiologically closed system to protect the integrity of the IV fluid container, whether it is on a syringe or on the end of an IV set.

Traditional methods of preparing chemotherapy drugs require the use of needles, resulting in open systems that allow for the escape of hazardous vapors, drips, and spills. Spiros® eliminates the use of needles and may be used to access any female luer or needlefree connector. Upon disconnecting from a needlefree connector, the Spiros® automatically self-seals and closes the system, preventing spills from syringes or IV sets, and remains closed until it accesses a standard needlefree connector.

Spiros® is available in both spinning and non-spinning models. The spinning Spiros® provides enhanced security because it permanently attaches to a device.

 

Functional Attributes:

  • Antineoplastic Drug Compatible
  • Mechanically and Microbiologically Closed
  • Contains No Latex, PVC or Phthalate

 

HOW IT WORKS
As part of the ChemoClave™ system, Spiros® helps keep healthcare workers safe and comply with OSHA, NIOSH, ASHP, ISOPP, and USP <797> safe-handling guidelines.

 

       Safe Preparation

  • When using the spinning Spiros, the integrated locking spin collar allows the device to remain permanently attached to any male luer device once it is activated and spinning.
  • The Spiros® only opens when it is attached to a female connector, including needlefree connectors.

       Safe Transportation

  • Spiros® creates a needlefree closed system for mixing and transfer.
  • Safely transport prepared syringes with hazardous medications throughout a facility.

      Safe Administration

  • Needlefree technology helps eliminate needlestick injuries.
  • When using the spinning Spiros, the locking spin collar eliminates the risk of tubing or syringe accidentally disconnecting from the Spinning Spiros.
  • Upon disconnect the Spiros® automatically self seals and closes the system.
  • Administration sets are also available with a bonded Spiros.

      Safe Disposal

  • Spiros® creates a closed system for disposal to protect against environmental contamination and the disposal of hazardous waste.
  • The Spiros® prevents leaks and drug vapor escape in the treatment area.

Accessing the Fluid Path

  1. The Spiros® is a passively Closed Male Luer that automatically seals off the fluid path of an administration set or syringe to prevent fluid leaks, or the ingress of bacteria.
  2. When the Spiros® is attached to a needlefree connector, the rim of the needlefree connector contacts and depresses the activation ears, which opens the fluid path. Fluid can then either be infused or aspirated through the Spiros.
  3. When the Spiros® is disconnected from the needlefree connector, either intentionally or by accident, the Spiros® automatically self-seals and closes off the fluid path to prevent any leaks.
 

 

PRESENTATION

Catalog Number Description
CH2000S Spinning Spiros® closed male connector. It keeps the infusion system closed during preparation, transport, administration, post intervention, and safe disposal. Generates a small negative pressure upon disconnection. Low dead space, internal fluid flow path, with male and female luer connectors. Flow Rate: 126 mL/min Back Pressure: 200 psig.  100/case
CH2000 Spinning SPIROS® closed male connector. It keeps the infusion system closed during preparation, transport, administration, post intervention, and safe disposal. Generates a small negative pressure upon disconnection. Low dead space, internal fluid flow path, with male and female luer connectors. Flow Rate: 126 mL/min Back Pressure: 200 psig.  100/case

Distributed by Victus, Inc.

All technical information obtained from the manufacturer’s website and technical sheets.

Flow Rate at Gravity 221 mL / minute
Backpressure When Unactivated 72 psig
Functional Activations 100
Priming Volume 0.1 mL
Negative Displacement Upon Disconnect 0.01 – 0.03 mL

Available Product Configurations

Spinning Spiros® Priming Volume: 0.1 mL
Case Quantity: 100
Non-spinning Spiros® Priming Volume: 0.1 mL
Case Quantity: 100

DIRECTIONS OF USE:

Connect to Protect

  • Attach a new Spiros® to an Administration set or Syringe by grasping Spiros® and twisting onto the device until secure. If using the Spinning Spiros, an audible ‘click’ will be heard when the spinning feature is engaged and the device will then rotate freely.
  • To prime the Spiros, remove the cover from the male luer and attach the priming cap to activate flow. Once the air has been purged, disconnect the priming cap and the Spiros® will automatically self seal and remain closed.
  • A specialized luer cover that does not activate the Spiros® is available for transport if desired. Do not use any other end cap as this may unintentionally activate the fluid path and allow flow.

Administer or Aspirate

  • The Spiros® will attach to all brands of needlefree connectors.
  • Grasp the Spiros® and needlefree connector and twist them together until secure. Connection will automatically activate the fluid path and allow flow. Fluid can then be infused or aspirated freely through the Spiros.
  • To disconnect, grasp the Spiros® and needlefree connector and twist them apart until loose. The Spiros® will automatically self-seal upon disconnection.
  • Flush the Spiros® after each use.

 

FREQUENTLY ASKED QUESTIONS

 

We have a Spiros® attached to the proximal end of the I.V. line. Is it mandatory to connect Spiros® to a CLAVE® connector?
No. Even though connection to a CLAVE®connector is highly recommended, it is not the only connector that will activate Spiros™. Any female luer connection may be used to activate Spiros®.

  • Spiros: Mechanically and Microbiologically Closed Male Luer
  • Evaluation of Surface Contamination with Cyclophosphamide Following Simulated Hazardous Drug Preparation Activities Using Two Closed-System Products Zock M, Soefje S, Rickabaugh K, Evaluation of Surface Contamination with Cyclophosphamide Following Simulated Hazardous Drug Preparation Activities Using Two Closed-System Products. Journal of Oncology Pharmacy Practice, Aug 10, 2010
  • Cost Determination Study of Closed System Transfer Devices. Presented at the California Society of Health System Pharmacists (CSHP)  Barnachea L., Lee T., Gitler J., Saria M.:  Cost Determination Study of Closed System Transfer Devices. Presented at the California Society of Health System Pharmacists (CSHP) Nov 4, 2011
  • Antineoplastic Drug Compatibility with the ChemoClave System
  • Dirty Little Secrets: Hazardous Drug Contamination at the Chairside. Hodges L., Caskey C. Section on Hematology and Oncology/Environmental Health and Safety Department, Wake Forest University School of Medicine

Spiros® CSTD Male Luer