ProSealTM

closed system transfer deviceProSeal is a closed system for the transfer of drugs

from vial to patient.

ProSeal Vial Adaptor, ProSeal Injector and ProSeal

Connector are intended for closed drug

preparation and is compatible with standard vials

with 20mm neck diameter.

ProSeal closed transfer system will help prevent

microbial ingress for up to 168 hours when the

system is used in a class V or higher environment

with proper aseptic techniques before connecting

devices.

Indication for use statement

The ProSeal Closed System drug Transfer Device

(CSTD) mechanically prohibits environmental

contaminants from entering the system and the

escape of drug or vapor concentrations from the

system, thereby minimizing individual and environ-

mental exposure to drug vapor, aerosols, and spills.

The ProSeal system also prevents microbial ingress

up to 7 days (168 hours).

420010 ProSeal Vial Adaptor Fits Vial Neck 20 mm

421010422010

ProSeal InjectorProSeal Connector

Instructions For UseREF

Attach ProSeal Vial Adaptor until it snaps

securely to vial.Push the vial adptor downwards towards vial until the internal spike perforates the

vial stopper.

Connect ProSeal Injector to a Luer Lock Syringe.

Flip open the top cap of the

ProSeal Vial Adaptor. Push the ProSeal Injector with the

syringe attached onto the membrane

interface.

Perform drug transfer.Pull to detach ProSeal Injector with the �lled syringe from ProSeal Vial Adaptor.

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Withdrawing drugs from vial

7800

28 R

ev.0

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ContraindicationsThe device is contraindicated whenever:• The drug to be prepared is contraindicated topolycarbonate, ABS, stainless steel, polypropylene, and thermoplastic elastomers.Warnings• Use accepted IV and pharmacy practice.• When using drug vials with thick concavestoppers , ensure that the vial claws of thedevice secures firmly to the vial neck and that pressure equalization works.• The performance of the self-sealing membrane ofthe device is reduced after multiple perforations.• Do not re-use to avoid contamination.Precautions• Do not use when caps and /or components areloose.• The device is sterile unless packaging is damaged.Do not use when packaging is damaged.• Rx Only . Follow aseptic techniques and local guide-lines for safe handling of hazardous and facilityprotocoll for drug administration including disinfec-tion of all vascular access ports and ProSeal compo-nents. Ensure all luer lock connections are securelytightened.

Instructions For Use

Injecting drugs from syringe with injector to IV line or access ports with ProSeal Connector

MT Promedt Consulting GmbHAltenhofstr.80

66386 St. Ingbert Germany+49-6894-581020

Epic International Thailand Co., LtdHemaraj Eastern Seaboard Industrial Estate

500/73 M.2 Tasit , Pluakdaeng RayongThailand 21140

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Attach syringe with ProSeal Injector to ProSeal Connector.

Attach ProSeal Connector to the

vascular access port.

To detach syringe with ProSeal injector from ProSeal Connector , pull away the syringe while pushing down the unlock ring of the ProSeal Connector.

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Push plunger to inject drug through ProSeal Injector and ProSeal Connector.

Discard used syringe with ProSeal Injector in accordance to disposal procedures for bio hazardous materials of your facility.ProSeal Connectors should remain

connected to the IV line and may be used for additional IV adminstration or IV push procedures.Dispose ProSeal Connectors without disconnecting from tubing.

Unlock Ring

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