EQUASHIELD® II Closed System

FDA cleared under ONB product code and substantiated

to prevent microbial ingress

up to 7 days

FEATURES

The System The clinically proven EQUASHIELD® Closed System Transfer Device (CSTD) addresses the need for a safe and easy-to-use drug transfer system for compounding and administering of 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 & plunger or 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 simplicity and EQUASHIELD® safety.

Safe & Closed

Ease of Use

Covers more routes of exposure

• Encapsulated 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 into 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.

• Clinically 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.

Fast and easy to use • Fully 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.

COMPOUNDING

System Components

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 an 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).

ADMINISTRATION

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 plastwo types of Spike Adaptors are provided: the SA-1 that

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.

Luer Lock Connectors

provides a strong grip with loose ports and the SA-1T for regular ports.

EQUASHIELD's Female Luer Lock Connector (Ref: FC-1) and male Luer Lock Adaptors (Ref: LL-1) provide contaminaon-free and closed system protecon to any standard luer lock ports. aching the connectors to luer ports converts the luers into closed connectors system. Such proteon is required when conneng two IV tubing segments (Secondary to Primary) or for the safe IV Push or Bolus injecon of medi-caon using the Syringe Unit. A simple sliding of the two pieces in each other connects and locks them together. Conneon can be released by simply pushing the lever and pulling the pieces apart.

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

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

SYRI

NG

E U

NIT

Syringe Unit 1ml

SU-1/2

60

240

Syringe Unit 3ml SU-3/2 60 240

Syringe Unit 5ml SU-5/2 60 240

Syringe Unit 10ml SU-10/2 70 140

Syringe Unit 20ml SU-20/2 60 120

Syringe Unit 35ml SU-35/2 50 100

Syringe Unit 60ml

SU-60/2 40 80

Syringe Unit EZ60ml – (ultrathin & low force)

SU-EZ60/2 30 60

Item Ref Units in Box Units in Master Case

VIA

L A

DA

PTO

R

Vial Adaptor 13mm

VA-13/2

120

480

Vial Adaptor 20mm

VA-20/2 100 200

Vial Adaptor 20mm C - for Concave vial stopper

VA-20C/2 100 200

Vial Adaptor 28mm

VA-28/2 25 100

Item Ref Units/Box Units/Master Case

SPIK

E A

DA

PTO

RS

Spike Adaptor 1

SA-1

120

240

Spike Adaptor T Spike Adaptor W

SA-1T SA-W

120

60

240

240

Item Ref Units in Box Units in Master Case

CON

NEC

TORS

Luer Lock Adaptor

LL-1

120

480

Female Luer Lock Connector

FC-1 120 480

Item Ref Units in Box Units in

Master Case

TUBI

NG

SET

S

Secondary Tubing – with drip chamber Spike Tubing Y-Site Tubing

SA-1S SA-1E LL-1Y

40

40

40

80

80

80

Item Ref Units in Box Units in

Master Case

ACC

ESSO

RIES

Protective Plug

PP-1

120

480

Ind ons and Labeling CE 0483 (Europe) FDA (US) 510(k) clearance: K132899 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

Pyrogen Free

Do Not Use if package is damaged

Consult Instructions For Use

Do Not Re-Sterilize

The device is not made with natural

rubber latex

The device is not made with DEHP

Sterilized using ethylene oxide

Dispose of used materials safely, according to your local regulations

Materials Item: Material

Syringe Unit Vial Adaptor

Spike Adaptor & Spike

Adaptor-W

Female Connector

Luer Lock Adaptor

Protective Plug

Tubing Sets

Polypropylene Syringe Body, Connector housing

Protective cap

Protective cap Connector Housing

Clamp, Luer cap, Protective cap (spike),

Stainless Steel Plunger rod, Screw, Cannulas

Cannula

Polyisoprene Piston, Septum Septum Septum Septum Septum Septum Septum

POM Syringe Lid, Lid disc, Needle Compartment

External guiding ring

Needle Compartment

Silicon Seal Ring, Seal tube, Lubricant

Lubricant Valve Seal tube, Lubricant

Valve Valve

EPDM O-Ring

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)

Spike Port Tubing, Drip chamber

Hydrophobic Membrane

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

Technical Data Item: Syringe Unit Spike Adaptor & Spike

Adaptor-W Tubing Sets

Female Connector Luer Lock Adaptor

Priming Volume

0.07ml for syringes 1ml to 10ml.

0.2ml 0.08 ml 0.1 ml (only 0.09ml

Needle Size

G17 in syringes 20ml to 60ml.

G17

Needle Length

1” (25mm) 1” (25mm)

Needle Tip

Non-Coring Pencil-Point p;

Needles never penetrate vial rubber stopper

Non-Coring Pencil-Poin p; Needles never penetrate vial rubber stopper

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

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

Secondary Tubing: 6.5ml (excludingdrip chamber).

Spike Tubing: 2.5ml.

Y-Site Tubing: 3.2ml / 1.6ml.

0.08ml for syringes 20ml to 60ml

G19 in syringes 1ml to 10ml.

Secondary Tubing: 45” (115 cm).

Spike Tubing:19” (48 cm).

Y-Site Tubing: 9” (23 cm).

Tubing Length

Secondary Tubing: 11 Liter per hour.

Spike Tubing:11 Liter per hour.

Y-Site Tubing: 13 Liter per hour.

with Syringe Unit or Female Connector

Instructions For Use

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

1

Align Red to Red the orientation marks and slide the Syringe Unit over the adaptor.

.

2 3

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

Pull the Syringe Unit from the Vial Adaptor.

4

1

Connect the Spike Adaptor to the infusion bag.

Inject the drug.Do not withdraw liquids from the bagwhen using this adaptor.

5

Pull the Syringe Unit fromthe Spike Adaptor.

7

Open the spike port cap.Spike the spike port with a tubing set.

Prime the IV line.

6

2 3 4

Administer.

8

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

or

ransfer fromvial to SyringeUnit

T

2 3 41

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.

Drugreconstitutionwith transfer from Syringe Unit to vial

Injection intoinfusion bagand infusionadministration using Spike Adaptor

Connect the Luer Lock Adaptor toa female luer lock port.

1 3

Inject the drug.Do not withdraw liquid.

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

42

Align Red to Red the orientation marks and slide the Syringe Unit over the Luer Lock Adaptor.

1 2 3 4

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

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 fromthe Spike Adaptor-W.

Connect both luer lock ports torespective luer lock ports of other tubing sets.

1 3

Inject the drug.Do not withdraw.

Push lever to dissconnect and pull the Syringe Unit.

42

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

Withdrawal ofdiluent froma bag

Injection intoluer lock port

Injection using Y-Site Tubing

Close the regulating clamp and insert spike into the IV bag.

Inject the drug.Do not withdraw liquids from the bagwhen using this tubing set.

4

Pull the Syringe Unit from the port.

65

2a 3

Attach the male luer lock to the respective port of a primary infusion set and administer.

7

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

1a

20 Drops/mLApprox.

Length: 45” (1.15m)Approx.

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

1

Connect the luer lock ports of the IV tubings to the male andFemale Luer Lock Connectors respectively.

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.

2 3

4

Push the lever to disconnect.

Connection oftwo IV tubingsegments

Injection intoinfusion bagand infusionadministration using the Secondary Tubing set

1

Done.Align the red orientation marks and slide the Protective Plug into any EQUASHIELD connector. Pull to disconnect.

2 3

Close the clamp and insert spike into the IV bag.

Inject the drug.Do not withdraw liquids from the bag when using this tubing set.

Pull the Syringe Unit from the port.

65

2a

Attach the male luer lock to the respective port of an infusion set and administer.

7

1a 3

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

Injection intoinfusion bagand infusionadministration using the short Spike Tubing set

Connection ofthe Protective Plug

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 11050 sales@equashield.com Tel: 1 516 684 8200. FAX: 1 516 684 8202 Toll Free: 1 855 378 2744 ( E Q U A S H I E L D )

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