EQUASHIELD II Closed System. Technical Spe. FDA cleared under ONB product code and substantiated to prevent microbial ingress up to 7 days

Transcription

1 EQUASHIELD II Closed System Technical Spe FDA cleared under ONB product code and substantiated to prevent microbial ingress up to 7 days

2 The System F E A T U R E S The clinically proven EQUASHIELD Closed System Transfer Device (CSTD)addresses the need for a safe and easyto-use drug transfer system for compounding and administeringof hazardous drugs. EQUASHIELD provides superior safety and exposure-free transfers in that it covers more routes of exposure than alternative systems. The system consists of a unique syringe that is the active closed transfer device and variety of adapters & connectors for vials, IV bags and tubing. EQUASHIELD offsets pressure differentials within a concealed system and effectively prevents the escape of vapors and aerosols. Through innovative design features, such as the encapsulated syringe & plungeror the dry connector with single motion simplicity, EQUASHIELD prevents microbial ingress in non-preserved drug vials while it protects healthcare workers from exposure to hazardous drugs. EQUASHIELD is fast and easy to use in that its unique syringes are factory preassembled with the connector while the system s large flow channels require less force to operate the syringe. Furthermore, the nurses administering drugs are protected by a set of connectors with single motion simplicityand EQUASHIELD safety. Safe & Closed Covers more routes of exposure E ncapsulated syringe barrel & plunger that prevents plunger contamination (identified by many studies as a major route of exposure to hazardous drugs). Closed internal pressure equalization built in to the syringe prevents the escape of drug and vapor. Dry connector permanently welded to syringe remains free of drug residuals. Cleared by the FDA under the ONB code and substantiated to prevent microbial ingress in drug vials for up to 7 days. C linically proven and meets NIOSH, USP, ASHP, ISOPP and ONS definitions for a CSTD. Encapsulated plunger that cannot be pulled out of the barrel. Needle safe even in case of malfunction. Ease of Use Fast and easy to use F ully preassembled syringe with connector, requiring no further setups or off the shelf syringes. Easy -to-use single motion connectors. Large flow channels require very low forces to operate the syringe.

3 System Components C O M P O U N D I N G Syringe Unit EQUASHIELD's fully encapsulated Syringe Unit prevents contamination of the plunger with drugs and is equipped with a built-in closed pressure equalization system with factory sealed sterile air chamber. The easy-to-use single motion connector prevents leaks & drug residuals on its surfaces and is factory welded to the syringe. Due to the airtight encapsulation of the syringe barrel the plunger cannot be pulled out of the syringe, providing additional layer of protection against spills. The factory preassembled Syringe Unit with its connector requires no further setups nor off-the-shelf syringes and is available in 1ml, 3ml, 5ml, 10ml, 20ml, 35ml and 60ml syringe volumes. The unique EZ60 is an ultra thin 60ml syringe that requires less force to operate than alternative 60ml syringes. Vial Adaptor EQUASHIELD's Vial Adaptor firmly snaps onto any standard vial, providing a safe and contamination-free vial access port for the Syringe Unit. An active guiding mechanism ensures centered spiking of the vial stopper. Adaptor s elastic access septum is part of EQUASHIELD's connector system; it serves as a microbial barrier and remains drug residual free even after multiple connections. The available vial neck sizes are: 13mm, 20mm and 28mm. An additional Vial Adaptor(Ref: VA-20C/2) is available for extra thick vial rubber stoppers (Concave stoppers).

4 Spike Adaptors The EQUASHIELD Spike Adaptor firmly connects between any standard IV bag and a tubing set, enabling safe injec on of the drug into the IV bag using a Syringe Unit and subsequent administra on through the tubing set. To address the danger of spikes sliding out from some types of IV bags with loose ports (such as some bags made of plas two types of Spike Adaptors are provided: the SA-1 that provides strong grip with loose ports and the SA-1T for regular ports. An add onal Spike Adaptor W (Ref: SA-W) is used with the Syringe Unit in order to withdraw diluents, such as Saline or sterile water, from an IV bag. A D M I N I S T R A T I O N Luer Lock Connectors EQUASHIELD's Female Luer Lock Connector (Ref: FC-1) and male Luer Lock Adaptors (Ref: LL-1) provide contamina onfree and closed system protec on to any standard luer lock ports. aching the connectors to luer ports converts the luers into closed connectors system. Such prote on is required when conne ng two IV tubing segments (Secondary to Primary) or for the safe IV Push or Bolus injec on of medica on using the Syringe Unit. A simple sliding of the two pieces in each other connects and locks them together. Conne on can be released by simply pushing the lever and pulling the pieces apart.

5 IV Tubing Sets EQUASHIELD's IV tubing sets provide a combina on of regular IV tubing sets with integrated EQUASHIELD closed system components. The use of these combined sets simplifies and reduces the me, the number of work steps and components needed, thereby increasing the overall hospital produ vity. The available tubing set types are: Secondary Tubing set (Ref: SA-1S) with EQUASHIELD Spike Adaptor, a drip chamber 20 drops/ml, a regula ng clamp, a male luer lock with vented cap, length 45 (1.15 meter). Spike Tubing short set (Ref: SA-1E) with EQUASHIELD Spike Adaptor, a clamp, a male luer lock with vented cap. Y-Site Tubing (Ref: LL-1Y) with EQUASHIELD Luer Lock Adaptor, a female luer lock, a clamp, a male luer lock with vented cap

6 Protective Plug EQUASHIELD's Pro ve Plug is an accessory providing add onal pro n layer for Female Luer Connector or the connector of the Syringe Unit. Once a ached it serves as a cap and maintains sterility on the connector s septum. Ordering Infor on Item Ref Units in Box Units in Master Case SYRINGE UNIT Syringe Unit 1ml SU-1/ Syringe Unit 3ml SU-3/ Syringe Unit 5ml SU-5/ Syringe Unit 10ml SU-10/ Syringe Unit 20ml SU-20/ Syringe Unit 35ml SU-35/ Syringe Unit 60ml SU-60/ Syringe Unit EZ60ml (ultrathin & low force) SU-EZ60/ Item Ref Units in Box Units in Master Case Vial Adaptor 13mm VA-13/ VIAL ADAPTOR Vial Adaptor 20mm VA-20/ Vial Adaptor 20mm C - for Concave vial stopper VA-20C/ Vial Adaptor 28mm VA-28/ Item Ref Units/Box Units/Master Case SPIKE ADAPTORS Spike Adaptor 1 SA Spike Adaptor T SA-1T Spike Adaptor W SA-W

7 Item Ref Units in Box Units in Master Case CONNECTORS Luer Lock Adaptor LL Female Luer Lock Connector FC Item Ref Units in Box Units in Master Case TUBING SETS Secondary Tubing with drip chamber Spike Tubing Y-Site Tubing SA-1S SA-1E LL-1Y Item Ref Units in Box Units in Master Case ACCESSORIES Protective Plug PP

8 Ind ons and Labeling CE 0483 (Europe) FDA (US) 510(k) clearance: K ONB Product Code Classi on Name: Closed An neoplas and Hazardous Drug Recon on and Transfer System. Prev on of microbial ingress has been substan ed to a me period of 7 days. Mu ple reconnec ons of components have been subs p to 10 mes. Disinfect the access port septum of this device before each repeated conne on by wiping the septum in circular mo ons over a minimum period of 5 seconds with a sterile 70% isopropyl alcohol prep pad. Allow the alcohol to dry for few seconds before re-accessing. Do not use a pad if the pad packaging is damaged as the pad may not be sterile. This device should only be used under the supervision of a Pharmacist or Health Care Professional and having read these instru ons carefully! Cau on: U.S. law restricts this device to sale by or on the order of a pharmacist or health care professional. RX Only. This device is not intended to be used with blood, or blood products. Not to be used with high-pressure infusion systems. Indic for Use (US FDA) Closed System drug Transfer Device (CSTD) for prepa on, recons u on, compounding and admin on of drugs, including an neop and hazardous drugs. This closed system mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentr ons outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills and also prevents microbial ingress. Single Use Only, do not re-use The device is not made with DEHP Do Not Use if package is damaged The device is not made with natural rubber latex Do Not Re-Sterilize Sterilized using ethylene oxide Dispose of used materials safely, according to your local regulations Consult Instructions For Use Pyrogen Free

9 Materials Item: Material Polypropylene Stainless Steel Syringe Unit Syringe Body, Connector housing Plunger rod, Screw, Cannulas Vial Adaptor Protective cap Spike Adaptor & Spike Adaptor-W Protective cap Female Connector Connector Housing Cannula Luer Lock Adaptor Protective Plug Tubing Sets Clamp, Luer cap, Protective cap (spike), Polyisoprene Piston, Septum Septum Septum Septum Septum Septum Septum POM Silicon EPDM Syringe Lid, Lid disc, Needle Compartment Seal Ring, Seal tube, Lubricant O-Ring External guiding ring Needle Compartment Lubricant Valve Seal tube, Lubricant ABS Handle Body Body Body Body Male luer lock, Female luer lock, Y- site, Regulating clamp, Body (Spike Adaptor), Body (Luer Lock Adaptor) PVC (DEHP Free) Hydrophobic Membrane Valve Valve Spike Port Tubing, Drip chamber Membrane Membrane Membrane Membrane Sterilization ETO ETO ETO ETO ETO R ETO Materials Compatibility Complies with USP Class IV guidelines Compatible for use in Chemotherapy Compounding and Administration DEHP, Latex and BPA free Substantiated for use with Busulfan, Etoposide and Paclitaxel

10 Technical Data Item: Syringe Unit Spike Adaptor & Spike Adaptor-W Priming Volume 0.07ml for syringes 1ml to 10ml. 0.08ml for syringes 20ml to 60ml Tubing Sets Female Connector Luer Lock Adaptor 0.2ml Secondary Tubing: 0.08 ml 0.1 ml (only 0.09ml 6.5ml (excluding with Syringe Unit or drip chamber). Female Connector Spike Tubing: 2.5ml. Y-Site Tubing: 3.2ml / 1.6ml. Needle Size G17 in syringes 20ml to 60ml. G17 Needle Length Needle Tip Tubing Length G19 in syringes 1ml to 10ml. 1 (25mm) 1 (25mm) Non-Coring Pencil-Point p; Needles never penetrate vial rubber stopper Secondary Tubing: 45 (115 cm). Non-Coring Pencil- Poin p; Needles never penetrate vial rubber stopper Spike Tubing: 19 (48 cm). Y-Site Tubing: 9 (23 cm). Drip Chamber 20 Drops/ml Gravity Flow Rate 11 Liter per hour at 3 height di erence, fully assembled with IV bag and secondary tubing Measured at 3 height di erence, fully assembled with IV bag & tubing Secondary Tubing: 11 Liter per hour. 4 Liter per hour at 3 height di erence, with Female Connector + Luer Lock Adaptor fully assembled at one end of a secondary tubing; and IV bag + Spike Adaptor on the other end Spike Tubing: 11 Liter per hour. Y-Site Tubing: 13 Liter per hour.

11 Instructions For Use Transfer from vial to Syringe Unit or Click the Vial Adaptor firmly onto the vial and ensure snapping of all 4 locking elements. Remove the protective cap.. Align Red to Red the orientation marks and slide the Syringe Unit over the adaptor. Invert and withdraw the liquid. Inject only to discard air bubble and continue withdrawal. Pull the Syringe Unit from the Vial Adaptor Drug reconstitution with transfer from Syringe Unit to vial Align Red to Red the orientation marks and slide the Syringe Unit with the diluent or drug over the adaptor. Inject the diluent or drug into the vial. After dilution invert and withdraw the diluted drug. Inject only to discard air bubble and continue withdrawal. Pull the Syringe Unit from the Vial Adaptor Injection into infusion bag and infusion administration using Spike Adaptor 5 Connect the Spike Adaptor to the infusion bag. Open the spike port cap. 6 Spike the spike port with a tubing set. 7 Prime the IV line. 8 Align the red orientation marks and slide the Syringe Unit over the Spike Adaptor. Inject the drug. Do not withdraw liquids from the bag when using this adaptor. Pull the Syringe Unit from the Spike Adaptor. Administer.

12 Withdrawal of diluent from a bag Connect Spike Adaptor-W to a diluent bag. Spike Adaptor-W may only be used with non-hazardous fluids. Use only a new unused Syringe Unit. Align the red orientation marks and slide the Syringe Unit over the Spike Adaptor-W. Withdraw the diluent. Pull the Syringe Unit from the Spike Adaptor-W Injection into luer lock port Connect the Luer Lock Adaptor to a female luer lock port. Align Red to Red the orientation marks and slide the Syringe Unit over the Luer Lock Adaptor. Inject the drug. Do not withdraw liquid. Push lever to dissconnect and pull the Syringe Unit from the adaptor Injection using Y-Site Tubing Connect both luer lock ports to respective luer lock ports of other tubing sets. Align the red orientation marks and slide the Syringe Unit over the Adaptor. Inject the drug. Do not withdraw. Push lever to dissconnect and pull the Syringe Unit.

13 1 2 3 Connection of two IV tubing segments Connect the luer lock ports of the IV tubings to the male and Female Luer Lock Connectors respectively. 4 Align the red orientation marks and slide the Female over the Male Luer Lock Adaptor/Connector. Do not twist or rotate during or after connection. Administer. Push the lever to disconnect. 1a 2a 3 20 Drops/mL Approx. Length: 45 (1.15m) Approx. Injection into infusion bag and infusion administration using the Secondary Tubing set 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. 7 Align the red orientation marks and slide the Syringe Unit over the port. Inject the drug. Do not withdraw liquids from the bag when using this tubing set. Pull the Syringe Unit from the port. Attach the male luer lock to the respective port of a primary infusion set and administer.

14 1a 2a 3 Injection into infusion bag and infusion administration using the short Spike Tubing set 5 Close the clamp and insert spike into the IV bag. 6 Align the red orientation marks and slide the Syringe Unit over the port. 7 Inject the drug. Do not withdraw liquids from the bag when using this tubing set. Pull the Syringe Unit from the port. Attach the male luer lock to the respective port of an infusion set and administer Connection of the Protective Plug Align the red orientation marks and slide the Protective Plug into any EQUASHIELD connector. Done. Pull to disconnect.

15 C l o s e d S y s t e m f o r H aza r dous D r u g s w w w. e q u a s h i e l d. c o m Equashield LLC. 99 Seaview Blvd. Port Washington, New York sales@equashield.com Tel: FAX: Toll Free: ( E Q U A S H I E L D )