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 [email protected] 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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