One Link - Baxter Medication Delivery Products

1 One LinkNeedle-free IV ConnectorOne Simple SolutionA Neutral Design for PatientsFeaturing Bonded and Standard Bore Power Injectable SetsIV to the power of One- link connector s neutral fluid displacement is designed to help reduce the risk of thrombotic catheter occlusions compared to devices with higher reflux The clear housing can enhance clinical for simple performance 1 Neutral fluid displacement design helps reduce the risk of thrombotic catheter occlusions compared to devices with higher reflux volumes 2 Power injection compatible (up to 325 psi, 10 mL/second) helps minimize connector failure and change-outs Compatible, flexible design works with a variety of valved and non-valved vascular access catheters No clamping sequence required Simplifies training Clamp when not in use for patient safety Tested for use up to 7 days/200 actuations aligns with CDC 2011 guidelines for the prevention of intravascular catheter -related infections Saline or Heparin flush option allows clinician flexibility to follow facility protocols Note: refer to catheter manufacturers flushing instructions.

2 Replace per institution protocol. The One- link connector can be used for up to 200 actuations and over a period of 7 days. Replace device whichever comes LinkNeedle-free IV ConnectorOne Simple Solutionto meet patient and clinician needs* One- link Needle-free IV Connector (7N8399)Finger-grip design reduces the likelihood of touch contamination Smooth surface for easy cleansing reduces the risk of contamination Clear housing allows for visualization of the fluid path Double-seal design provides an effective barrier to microbial ingress Straight fluid path promotes thorough flushing Non-PVC* and Non-DEHP for patients with special requirements Meets power injection needs 1 Tubing and slide clamp identify maximum pressure for power injection compatible components Meets FDA labeling recommendations for use with power injectors 3* Prior to power injection, ensure all parts of IV system are compatible.

3 Replace if a pressure over 325 psi is applied to the connector. Compatible with power injection (up to 325 psi)* designed to prevent connector and tubing failure Helps minimize change-outs when used with compatible pressure rated catheter and extension set Maximum flow rate of 10 mL/second appropriate for a wide variety of patient types One Simple Solutionfor CT/MRI applicationsOne Simple Solutionfor your patient s needs Neutral fluid displacement design designed to help reduce the risk of thrombotic catheter occlusions, compared to devices with higher reflux volumes 1 Low priming volume of mL minimizes excessive flush volumes for fluid restricted patients Smooth surface, easy to cleanse promotes reduction of contamination Compatible with a variety of valved and non-valved vascular access catheters provides flexibility for use throughout the facility and may help reduce time and cost Double-seal design provides an effective barrier to microbial ingress Non-PVC and Non-DEHP for patients with special requirements Universally appropriate 1 One LinkNeedle-free IV ConnectorThe One- link IV connector is intended for single patient use with a vascular access device for the administration of drugs and solutions without needles and can be used to aspirate Simple Solutionfor your patient s needsAdapted from McKnight 2004.

4 Number of CVCs placed per year 5,000,000 Percent thrombotic 1058%Estimated annual central venous cathetersStudies have shown a relationship between the presence of thrombosis and Occlusions catheter occlusion is the most common noninfectious complication in the use of central venous catheters (CVCs) and occurs in approximately 33% of these ,10 A common cause for catheter occlusion is clotting of blood refluxed into the catheter . Blood reflux occurs when an administration set or syringe is connected to a positive displacement connector or disconnected from a negative displacement Cather occlusions can interrupt IV therapy, increase risk of serious complications, and add to the cost of Infections The FDA has expressed concern about several clinical reports regarding the association of BSIs with positive displacement Facilities and governments have increased pressure to reduce hospital-acquired infections (HAIs).

5 An estimated 248,000 bloodstream infections occur in hospitals each year with a large portion associated with These infections independently increase hospital costs and length of By several analyses the cost of these infections is substantial in terms of morbidity and financial resources Failure Connectors not designed to tolerate pressures used for power injection can fail and harm the Failure can delay treatment of Requirements Multiple connectors with varied techniques can cause confusion and increased potential for IV needleless connectors have become complex in Key Issues with IV ConnectorsThe Clinical EnvironmentOne LinkNeedle-free IV ConnectorThe One- link Connector is available in the following configurationsREFERENCES:1. Data on file. Baxter Healthcare Yacopetti N. Central Venous catheter -Related Thrombosis-A Systematic Review.

6 Journal of Infusion Nursing. July/August 2008; 31(4): Reminders from FDA Regarding Ruptured Vascular Access Devices from Power Injection. (January 2009).4. Hadaway L. Reopen the pipeline. Nursing. 2005; 35(8): 54-61. 5. FDA Alert Letter: Positive Displacement Needleless Connectors and Bloodstream Infections: Initial Communication. August 11, CDC June 2010: Central Line-Associated Bloodstream Infection (CLABSI) CDC June 2011: Central Line-Associated Bloodstream Infection (CLABSI) Pennsylvania Patient Safety Authority Vol 5, No 4-December 2008, CT Contrast Media Power Infectors Can Rupture Conventional IV Jarvis W. Choosing the Best Design for Intravenous Needleless Connectors to Prevent Bloodstream Infections. , posted 7/28 McKnight S. Nurse s Guide to Understanding and Treating Thrombotic Occlusion of Central Venous Access Devices.

7 MEDSURG Nursing. December 2004; 13(6): Carlo A. Standardization basics and why they are so important to the bottom line. Materials Management in Health Care. December simple solution for standardization 11 Allows for product standardization Streamlines ordering Helps reduce inventoryAlso available in other Products (tubing not rated for power injection)7N8378 One- link Non-DEHP Standard Bore catheter Extension SetNeedle-free IV Connector with Neutral Fluid Displacement7N8377 One- link Non-DEHP Y-Type Standard Bore catheter Extension Set Needle-free IV Connector with Neutral Fluid Displacement7N8371 One- link Non-DEHP Y-Type Microbore catheter Extension Set Needle-free IV Connector with Neutral Fluid DisplacementFor use with low pressure power injectors having a maximum pressure of 325 psi and a maximum flow rate of 10 mL/second7N8399 One- link Needle-free IV Connector With Neutral Fluid Displacement, Power Injectable (325 psi)

8 7N8300 One- link Non-DEHP Microbore catheter Extension Set Needle-free IV Connector with Neutral Fluid Displacement, Power Injectable (325 psi)7N8390 One- link Non-DEHP Bonded Microbore catheter Extension Set Needle-free IV Connector with Neutral Fluid Displacement, Power Injectable (325 psi)7N8310 One- link Non-DEHP Microbore catheter Extension Set Needle-free IV Connector with Neutral Fluid Displacement, Power Injectable (325 psi)7N8301 One- link Non-DEHP Standard Bore catheter Extension Set Needle-free IV Connector with Neutral Fluid Displacement, Power Injectable (325 psi)7N8391 One- link Non-DEHP Bonded Standard Bore catheter Extension Set Needle-free IV Connector with Neutral Fluid Displacement, Power Injectable (325 psi)325 PSI / 2241 kPa325 PSI / 2241 kPa325 PSI / 2241 kPa325 PSI / 2241 kPa325 PSI / 2241 kPa325 PSI / 2241 kPaRx Only. For safe and proper use of the One- link devices, refer to the appropriate Instructions for Use.

9 For safe and proper use of the SIGMA Spectrum pump, refer to the Operator s 11 Healthcare CorporationRoute 120 and Wilson RoadRound Lake, IL 60073 Baxter , One- link and SIGMA Spectrum are trademarks of Baxter International Inc.