equashield closed system drug transfer device ......a major route of exposure to hazardous drugs)....

TECHNICAL SPECIFICATIONEQUASHIELD® Closed System Drug Transfer Device

Equashield CSTD:- FDA ONB Code Cleared- Substantiated to Prevent Microbial Ingress for up to 7 Days- Tested for Leak Free Disconnects- Tested for Airtight Vapor Containment

Superior Safety and Ease of UseIntroducing the 2nd generation of EQUASHIELD® Closed System Drug Transfer Device

Covers more routes of exposure than alternative systems

• The only system that prevents syringe plunger contamination (repeatedly identified as a major route of exposure to hazardous drugs).

• Closed pressure equalization prevents the escape of drug or drug vapors.

• Dry connectors that remain free of drug residues upon disconnects.

• Cleared by the FDA under the ONB code and substantiated to prevent microbial ingress for up to 7 days.

• Clinically proven to be safe and efficacious.

Faster and Easier to use

• System was deemed fastest to use requiring fewest steps and least time in recent studies, compared to its peer.

• Fully preassembled syringe with connector, requiring no further setups or off the shelf syringes.

• Easy to use single motion sliding connectors.

• Audible click to signal secure connection during drug administration.

• Intuitive accessories such as catheter connector and syringe to syringe connector to ensure simplification of workflow.

The most closed system on the market

• The only system with encapsulated syringe barrel and plunger rod.

• Closed internal pressure equalization built into the syringe.

• Connector permanently welded to syringe to ensure compliance across the hazardous drug handling process.

• Encapsulated plunger rod that cannot be pulled out of the barrel.

• Pre-bonded y-site and available locking female connector maintain a closed system to reduce exposure.

Safe

Sim

ple

Clo

sed

System ComponentsCompounding

Syringe UnitEQUASHIELD’s fully encapsulated Syringe Units prevent syringe plunger contamination caused by hazardous drug handling. The system is equipped with a built-in closed pressure equalization with sterile air. The connector is permanently bonded onto the syringe body preventing accidental disconnections and house shielded needles to prevent risk of accidental needle sticks.

Vial AdaptorEQUASHIELD’s Vial Adaptor firmly snaps-on to a standard vial, providing a safe and contamination-free vial access port for the Syringe Unit. As part of EQUASHIELD’s connector system, the vial adaptor’s elastomeric membrane serves a dual purpose; to serve as a microbial barrier preventing microbial ingress for up to 7 days and to remain drug residue free for 10 repeated connections.

Spike AdaptorEQUASHIELD’s Spike Adaptors are designed to firmly connect between any standard IV bag and tubing set, enabling safe transfer of medication dose into the IV Bag. Recognizing that there are variations among various IV Bag manufacturers, and that no one IV port fits all bags, Equashield produces two SpikeAdaptors, SA-1T for regular ports and SA-1 for larger ports. The SA-W on the other hand is designed for safe and cost effective withdrawal of diluent for reconstitution with Syringe Units (SU).

System ComponentsAdministration

Luer Lock AccessoriesEQUASHIELD’s Luer Lock Adaptor and Female Luer Lock Connector are designed to convert any standard luer lock port into a closed system connection for leak free and dry connection. Equashield Female Connectors, FC-1 and FC-1S are designed to covert any tubing set with luer lock into an Equashield compatible set. FC-1 is a standard connector while FC-1S is a free swiveling connector designed to prevent accidental disconnections. The LL-1 Adaptor is locked onto a patient line for safe injection via a Syringe Unit (SU) or for safe infusion via a FC-1 or FC-1S connected at the end of an IV Bag line.

IV Tubing Sets• EQUASHIELD’s Tubing Sets contain Equashield’s Spike

Adaptor bonded to a tubing set with a drip chamber. These sets are designed to firmly fit into any standard IV bag, enabling safe and efficient transfer of medication dose into the IV Bag. Recognizing that there are variations among various IV Bag manufacturers and that no one IV port fits all bags, Equashield produces two Secondary Sets, SA-1ST for regular ports and SA-1S for larger ports. These sets help optimize the time and cost of drug delivery via Secondary IV Infusion.

• Spike Tubing short set with EQUASHIELD® Spike Adaptor, a roller clamp, a male luer lock with vented cap.

• Y-Site Tubing with EQUASHIELD® Luer Lock Adaptor, a female luer lock, a clamp, a male luer lock with vented cap

• EQUASHIELD’s Reconstitution Tubing Set is a closed system for batch drug reconstitution of lyophilized powder vials.

System ComponentsAccessories

Protective PlugEQUASHIELD’s Protective Plug is designed to fit Equashield Female Connectors (FC-1 and FC-1S) and Syringe Units (SU). The protective plug (PP-2) will come pre-assembled onto Equashield Female Connectors. PP-2 is available in individually wrapped packaging.

Luer Lock Adaptor CEQUASHIELD’s Catheter Adaptor is ideal for administering drugs using a Foley catheter for bladder instillation procedures. The LL-1C adaptor comes with a pre-bonded Equashield male luer lock adaptor to a conical catheter adaptor, saving valuable setup time and preventing opportunities for accidental luer disconnections and spills.

Luer Lock Adaptor DCEQUASHIELD’s Syringe to Syringe Adaptor is ideal for connecting and safely transferring medication between Equashield Syringes, also known as the QS procedure. The use of this adaptor makes the transfer between syringes easy with fewer components to retrieve, open and assemble. This adaptor has two access ports for Syringe Units at nominal priming volume.

Male Priming ConnectorEQUASHIELD’s Male Priming Connector is designed to enable priming of primary and secondary lines with Equashield Female Connector simple and effortless.

Product Catalog

Ref Item

SU-1/2 Syringe Unit 1ml







SU-EZ60/2 Syringe Unit EZ60ml

Ref Item

VA-13/2 Vial Adaptor 13mm

VA-13C/2 Vial Adaptor 13mm C – For Concave Vial Stoppers


VA-20C/2 Vial Adaptor 20mm C – For Concave Vial Stoppers




Ref Item

SA-1 Spike Adaptor 1

SA-1T Spike Adaptor 1T

SA-W Spike Adaptor W

Ref Item

LL-1 Luer Lock Adaptor

FC-1 Female Luer Lock Connector

FC-1S Female Luer Lock Connector Swivel

Syringe Unit

Vial Adaptor

Spike Adaptor

Connectors

Product Catalog

Ref Item

SA-1S Secondary Tubing

SA-1ST Secondary Tubing T

SA-1E Spike Tubing

LL-1Y Luer Lock Y-Site Tubing Accessory

LL-1R Reconstitution Tubing

Ref Item

PP-2 Protective Plug

LL-1DC Luer Lock Adaptor DC (Double Connector)

LL-1C Luer Lock Adaptor C

MC-2 Male Priming Connector

Tubing Sets

Accessories

Product Indications and Labeling

FDA 510(k) clearance: K170706 Product Code: ONB

Classification Name: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

Indications for Use (FDA): “Closed System drug Transfer Device (CSTD) for preparation, reconstitution, compounding and administration of drugs, including antineoplastic and hazardous drugs. This closed system mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills and also prevents microbial ingress up to 7 days.”

Instructions for Use: • This device should only be used under the supervision of a Pharmacist or Health Care Professional

upon careful review of the instructions for use.

• This device is not intended to be used with blood or blood products.

• This device is not to be used with high-pressure infusion systems.

• Prevention of microbial ingress has been substantiated to a time period of 7 days.

• Multiple reconnection of components has been substantiated up to 10 times.

• Disinfect the access port septum of the device before each repeated connection by wiping the septum in circular motions for at least 5 seconds with a sterile 70% isopropyl alcohol prep pad. Allow the alcohol to dry sufficiently before re-accessing. Do not use a pad if the pad packaging is damaged as the pad may not be sterile.

• Caution: U.S. law restricts this device to sale by or on the order of a pharmacist or health care professional. RX Only.

CE 0483

Single Use Only, do not re-use The device is not made with DEHP Do Not Use if package is damaged Sterilized using ethylene oxide

The device is not made with natural rubber latex Consult Instructions For Use Dispose of used materials safely, according to your local regulations

Do Not resterilizeProtective Plug (ref: PP-1) is sterilized using radiation

Fluid Path Materials

Ref Polypropylene Stainless Steel Silicone Polyisoprene Hydrophobic

Barrier PVC ABS

Syringe Unit x x x x

Vial Adaptor x x x

Spike Adaptors x

Female Connectors x x x

Luer Lock Adaptor x

Tubing Sets x

Y-Site x x

LL-1DC x

LL-1C x

MC-2 x

Materials Compatibility Statement

• Complies with USP Class IV guidelines• Compatible with use in Chemotherapy Compounding and Administration• DEHP, Latex and BPA free• Substiantiated for use with Busulfan, Etoposide, Paclitaxel and Treanda

Technical Specification

Ref Priming Volume Needle Size Needle Length Tubing Length/ Drip Chamber

Gravity Flow Rate

Syringe Unit

0.07ml for Syringes 1ml to 10ml 0.08 for all other syringes

19G for Syringes 1ml to 10 ml17G for all other syringes

1” (30mm) Non-coring pencil point tip; Needle never penetrates vial rubber stopper

Spike Adaptors 0.2ml 11 Liters/ hour1

Female Connectors 0.08ml 17G

1” (30mm) Non-coring pencil point tip; Needle never penetrates vial rubber stopper

4 Liters/ hour2

Luer Lock Adaptor

0.1ml (only 0.09ml with SU or FC attached)

Secondary Tubing Sets

6.5ml (excluding Drip Chamber)

45” / 115cm20 Drops/ml drip chamber

11 Liters/ hour3

Spike Tubing Set 2.5 ml 19” / 48cm 11 Liters/ hour3

Y-Site Tubing 3.2ml/1.6ml 9” / 21cm 13 Liters/ hour3

LL-1DC 0.10ml

LL-1C 0.10ml

1. Measured at 3’ height difference, fully assembled with IV bag and secondary tubing2. Measured at 3’ height difference with Female Connector + Luer Lock Adaptor fully assembled at one end of a secondary tubing

and IV bag + Spike adaptor on the other end.3. Measured at 3’ height difference fully assembled with IV bag and tubing

Instructions for Use

Transfer from Vial to Syringe Unit

Drug reconstitution with transfer from Syringe Unit to Vial

Withdrawal of diluent form a bag

1 2 3 4

Click the Vial Adaptor firmly onto the vial and ensure snapping of all 4 locking elements. Remove the protective cap.

Align red orientation marks and slide the Syringe Unit over the adaptor.

Invert and withdraw the liquid. Inject only to discard air and continue withdrawal.

Pull the Syringe Unit from the Vial Adaptor.

1 2 3 4

Align red orientation marks and slide the Syringe Unit with the diluent or drug over the adaptor.

Inject diluent or drug into the vial.

After dilution invert and withdraw the diluted drug. Inject only to discard air and continue withdrawal.

Pull the Syringe Unit from the Vial Adaptor.

1 2 3 4

Connect Spike Adaptor-W to a diluent bag. Spike Adaptor-W may only be used with non-hazardous fluids.

Using a new/unused Syringe Unit, align red orientation marks and slide Syringe Unit over Spike Adaptor-W.

Withdraw desired amount of diluent.

Pull the Syringe Unit from Spike Adaptor-W.


Injection into an infusion bag and infusion administration

1.a.1 1.a.2 1.a.3 1.a.4

Option a: Using Spike Adaptors (SA-1 or SA-1T).Connect Spike Adaptor to the infusion bag.

Open the spike port cap. Insert tubing set spike into the spike port.

Prime the IV line.

1.b.1 1.b.2 1.c.1 1.c.2

Option b: Using Spike Tubing (SA-1E).Close the clamp and insert spike into the IV bag.

Prime the |V line.Or

Option c: Using Secondary Tubing (SA-1S or SA-1ST). Close the regulating clamp and insert spike into the IV bag.

Fill drip chamber partially and prime the set, purge air and close the regulating clamp.

20 Drops/mLApprox.

Length:45" (1.15m)Approx.

2 3 4 5

Align red orientation marks and slide the Syringe Unit over the Spike Adaptor.

Inject the drug. Aspirate at least 0.5ml and reinject to flush the channels. Do not withdraw liquids from the bag when using this adaptor.

Pull the Syringe Unit from the Spike Adaptor.

Administer.


Priming of IV Line

Connection of two IV tubing segments for infusion administration

Connection of the Protective Plug

1 2 3 4

Connect the luer lock ports of the IV tubing to the Female Luer Lock Connector.

Align the red orientation marks and slide the Male Priming Connector into the Female Luer Lock Connector.

Prime the IV line. Pull to disconnect.

1 2 3 4

Connect the luer lock ports of the IV tubes to the Male and Female Luer Lock Connectors respectively.

Align red orientation marks and slide female connector over the male luer lock adaptor. Do not twist or rotate during or after connection.

Administer. Push the lever to disconnect and pull components apart.

1 2 3

Place protective plug onto any Equashield connector.

Equashield connectors are now closed.

Pull to disconnect.

OR


Injection into luer lock port

Injecting into a Catheter

Transfer from Syringe Unit to Syringe Unit

1a 1b

Option a: Using LL-1Y.Connect Luer Lock ports of LL-1Y onto respective tubing sets.

OrOption b: Using LL-1.Connect the Luer Lock Adaptor to a female luer lock port.

2 3 4

AndAlign red orientation marks and slide Syringe Unit over the Adaptor.

Inject the drug. Do not withdraw.

Push lever to dissconnect and pull the Syringe Unit.

1 2 3 4

Attach catheter by sliding the catheter over the adaptor.

Align red orientation marks and slide the Syringe Unit over the adaptor.

Inject. Push lever to dissconnect and pull Syringe Unit from the adaptor.

1 2 3

Align red orientation marks and slide the first Syringe Unit over the adaptor followed by the second Syringe Unit.

Transfer, as desired, from Syringe Unit to Syringe Unit.

To disconnect, pull the syringes from the adaptor.

/equashieldEQUASHIELD, LLC | 99 Seaview Blvd. Port Washington, NY 11050

855-EQUASHIELD | [email protected] | www.equashield.com

EQL-1625.1 ©2019 Equashield, LLC

equashield closed system drug transfer device ......a major route of exposure to hazardous drugs)....

Documents