Flowonix PROMETRA REF 91825 User manual

REFILL KIT (REF 91825)
For use with Prometra®Programmable Infusion Systems
KIT DI RIEMPIMENTO (REF 91825)
Per utilizzo con i sistemi di infusione programmabili Prometra®
NACHFÜLL-KIT (REF 91825)
Für die Verwendung mit Prometra®programmierbaren
Infusionssystemen
KIT DE LLENADO (REF 91825)
Para uso con los sistemas de infusión programables Prometra®

English
REFILL KIT, For use with Prometra® Programmable Infusion Systems
Explanation of Symbols
Refer to the package and product labeling to see which symbols apply to this product.
Catalog number
LOT Batch code
Use by date
Date of Manufacture
Sterilized using ethylene oxide
Do not re-use
Caution, consult accompanying documents
Do not use if package is damaged
EC REP
Authorized Representative in the European Community
Nonpyrogenic Non-pyrogenic
Latex-Free No patient or fluid contact with latex components
Rx only Caution: Federal Law (USA) restricts this device to sale by or on the order of a
physician.

English
English
REFILL KIT, For use with Prometra® Programmable Infusion Systems

English
REFILL KIT, For use with Prometra® Programmable Infusion Systems
Contents
Contents........................................................................................................................................1
Description ....................................................................................................................................1
Indications.....................................................................................................................................2
Contraindications............................................................................................................................2
Warnings........................................................................................................................................2
Precautions....................................................................................................................................2
Adverse Events...............................................................................................................................2
Equipment.....................................................................................................................................2
Instructions....................................................................................................................................3
Emptying the Drug Refill/Reservoir ...............................................................................................3
Filling the Drug Refill/Reservoir....................................................................................................6
Suspending Drug Therapy - Pump Rinse .......................................................................................8
Calculations ...................................................................................................................................9

English
English
REFILL KIT, For use with Prometra® Programmable Infusion Systems

REFILL KIT, For use with Prometra® Programmable Infusion Systems Page 1
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Contents
2 - Adhesive Bandages, Round
1 - Calibrated Syringe Barrel, 12 mL
1 - Syringe Cap
1 - Stopcock
1 - CSR Wrap
1 - Extension Tubing, 20 cm (8 in.), with Clamp
1 - Fenestrated Drape
1 - Filter, 0.22 micron
4 - Gauze Pads, 10 cm x 10 cm, (4 in. x 4 in.)
2 - Non-Coring Needles, 0.7 mm (22G) x 38 mm (1.5 in.)
1 - Refill Template
Description
The Refill Kit contains two (2) non-coring needles, a bacterial filter and other accessories for Drug Refill/
Reservoir Access to the Programmable Pump.
Refill Kit for Prometra®Programmable Infusion Systems

Page 2 REFILL KIT, For use with Prometra® Programmable Infusion Systems
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Indications
The Refill Kit is indicated for use in patients with a Prometra Programmable Infusion System. It is
intended for use in refilling the Drug Reservoir of the Pump.
Contraindications
The Refill Kit is contraindicated when the presence of infection, bacteremia or septicemia is known or
suspected.
Warnings
• The Refill Kit is supplied sterile and non-pyrogenic. The package should be examined carefully prior to
opening. Do not use the contents if there is any evidence of damage to the package or package seal that
could compromise sterility. Do not resterilize contents of any damaged or opened packages.
• After use, this product is a potential biohazard. Handle and discard in accordance with accepted
medical practice and all applicable laws and regulations.
• Pain on injection that was not noted during previous injections may be an early sign of infection.
• Use of this device should only be conducted by qualified medical personnel specifically trained in its
use. Use of this device by non-qualified or untrained personnel could lead to serious consequences
involving under- or over-medication. In the event of over-medication, refer to the approved drug labeling
for appropriate treatment.
• Prior to infusion of any substance into the pump, medical personnel should be familiar with and
observe all warnings, cautions, contraindications, and instructions as specified by the manufacturer of
the infusate.
Precautions
• Read and follow all instructions.
• Do not inject contrast media into the drug refill/reservoir septum as this may impair or damage the
pump operation.
• Examine the package carefully before opening to confirm its integrity and that the expiration date has
not passed.
• If therapy is discontinued for an extended period, the pump should be emptied of the drug and filled
with a preservative-free sterile saline solution to maintain catheter patency.
Adverse Events
The use of implanted pumps provides an important means of treating patients with intractable pain.
However, the potential exists for serious complications. Please refer to the appropriate Prometra
Programmable Pump instructions for a complete list.
Equipment
• Prometra Refill Kit
• Prometra Programmer (not sterile)
The following items may be needed and are not provided:
• Sterile programmer sleeve
• Refill syringe, 20 mL
• Drug solution (infusate) for refill, not to exceed 20 mL
• Sterile preservative-free 0.9% saline
• Sterile pen
• Medical grade printer (not sterile)
• Programmer printer cable (not sterile)

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Instructions
Before refilling or suspending drug therapy of the Programmable Pump, the drug refill reservoir must be
emptied.
Emptying the Drug Refill/Reservoir
1. Place sterile programmer sleeve over Programmer. Turn the Programmer ON and press INQ. Place the
Prometra Programmer over the pump. An audible beep sounds during inquiry of the pump. Check the
Pump Status screen and note the Reservoir Volume. The Reservoir Volume is the expected volume of
fluid remaining in the pump.
2. USE STERILE TECHNIQUE. Always inspect and aseptically prepare the site according to standard
practice.
3. Locate the drug refill/reservoir septum with palpation and by placing the refill access template over the
pump and aligning the edges of the template with the edges of the pump. Use a sterile pen to mark
the site for needle entry. Set template aside.
Warning: Always use the Prometra Refill Access Template to ensure proper access to the drug refill/
reservoir septum. Using the incorrect template may result in drug overdose or infusate delivery into
the pump pocket. If you are unsure of the proper access, use image guidance to verify proper needle
placement.
4. Attach one of the 22G non-coring needles to the extension tubing.
Warning: Use only the 22G non-coring needle supplied in the Refill Kit to access the drug refill/
reservoir septum.
5. Slide the extension tubing clamp as far as possible toward the loose end of the tubing and close
the clamp.
6. Attach the stopcock to the extension tubing. Turn the stopcock to the OFF position, perpendicular to
the extension tubing.
Refill Access Template

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Instructions
Emptying the Drug Refill/Reservoir
7. Attach the syringe barrel to the stopcock. Place the syringe cap on the open en dof the syringe barrel.
Warning: Use only the calibrated syringe barrel supplied in the Refill Kit to collect infusate from the
drug reservoir.
Caution: Always make sure all connections are secure before addressing needle to skin. This will
prevent leaks.
8. Insert the needle through the center of the drug refill/reservoir access septum, perpendicular to
the skin and the pump. Advance the needle until the needle tip resides completely inside the refill
chamber.
Caution: Do not force the needle. Excessive force on the needle may damage the needle tip. Do not
rock the needle sideways as this may damage the septum or cause drug to leak into the pump pocket.
Emptying Setup
Emptying Setup in Pump

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Instructions
Emptying the Drug Refill/Reservoir
9. The Empty Volume must be entered in the Prometra Programmer. The measurement of this volume
is important to ensure that the pump is working properly. Always carefully measure and record empty
volume.
10. If the Reservoir Volume is less than 10 mL, open the clamp on the extension tubing. Slowly turn
the stopcock from perpendicular to inline with the extension tubing to open the stopcock. Allow the
internal pump pressure to push the contents of the pump into the syringe barrel. This is the Empty
Volume.
11. If the Reservoir Volume is greater than 10 mL, then the Empty Volume must be collected in two steps
using the same emptying setup.
Step One
11.1. Open the clamp on the extension tubing. Slowly turn the stopcock from perpendicular to inline
with the extension tubing to open the stopcock.
11.2. Using the stopcock valve as a volume control device, collect approximately half of the expected
reservoir volume in the syringe barrel. Turn the stopcock valve to the OFF position and close
the clamp on the extension tubing. For example, if the expected return volume is 10 mL, then
collect 5 mL.
11.3. Disconnect the stopcock with its attached syringe barrel from the extension tubing. Holding the
syringe barrel vertical and at eye level, read the bottom of the meniscus formed by the fluid to
the nearest 0.2 mL. Record the syringe barrel volume as Step One Empty Volume.
11.4. Place the stopcock-syringe barrel assembly over the sterile Refill Kit Tray.
11.5. Turn the stopcock valve to the ON position to discard the Step One Empty Volume. When the
syringe barrel and stopcock are empty, turn the stopcock valve to the OFF position.
12
11
10
9
8
7
6
5
4
3
2
1
Meniscus Eye Level

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Instructions
Emptying the Drug Refill/Reservoir
Step Two
11.6. Reattach the stopcock-syringe barrel assembly to the extension tubing. Open the clamp on
the extension tubing. Slowly turn the stopcock from perpendicular to inline with the extension
tubing.
11.7. Slowly turn the stopcock valve to the ON position to collect the remaining fluid.
11.8. Disconnect the stopcock with its attached syringe barrel from the extension tubing. Holding the
syringe barrel vertical and at eye level, read the bottom of the meniscus formed by the fluid to
the nearest 0.2 mL. Record the syringe barrel volume as Step Two Empty Volume.
11.9. The total Empty Volume (mL) is the sum of the Step One Empty Volume and the Step Two
Empty Volume minus 0.3 mL, the second volume in the extension tubing. Record the Empty
Volume.
Empty Volume = Step One Volume + Step Two Volume – 0.3
12. Disconnect the stopcock with its attached capped syringe barrel from the extension tubing. Set the
stopcock aside and discard the syringe barrel.
13. Compare the Empty Volume to the Reservoir Volume to confirm that the pump is flowing properly.
Filling the Drug Refill/Reservoir
A refill procedure should be scheduled to avoid interruption of drug therapy. Please refer to the
Calculations Guide for any needed formulas or calculations.
1. USE STERILE TECHNIQUE. Always inspect and aseptically prepare the site according to standard
practice.
2. Before refilling or suspending drug therapy of the Programmable Pump, the drug refill/reservoir must
be emptied. Refer to Emptying instructions.
3. If changing drug concentration, refer to the supplementary Calculations Guide to determine the refill
syringe concentration.
Warning: If changing drug concentration, always adjust the concentration in the refill syringe to
account for the residual current drug concentration and volume in the drug reservoir.
4. Obtain refill syringe with 20 mL or less of the prescribed drug solution. Confirm that the volume of the
infusate in the syringe does not exceed 20 mL, the reservoir volume of the pump.
5. Attach 0.22 micron filter to the refill syringe containing the prescribed infusate. Prime filter with
infusate to remove air. Confirm and record the volume of infusate remaining in the syringe, accounting
for any that was lost when priming the filter.
6. Attach the filter-syringe assembly to the extension tubing already attached to the needle in the pump
to create the refill setup. Verify that there is no air in the system.

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7. If the needle is not already in the septum from the emptying procedure, insert the needle through the
center of the drug refill/reservoir access septum, perpendicular to the skin and the pump. Advance the
needle until the needle tip resides completely inside the refill chamber.
Caution: Do not force the needle. Excessive force on the needle may damage the needle tip. Do not
rock the needle sideways as this may damage the pump or cause drug to leak into the pump pocket.
8. Keeping downward pressure on the syringe plunger, open the extension tubing clamp, and begin slowly
infusing the refill solution into the drug reservoir. At every 5 mL increment, release pressure on the
syringe plunger to allow 1 mL of infusate back into the syringe. This will verify that the needle is in the
correct position and the drug refill reservoir is being filled.
Caution: If the infusate does not return back into the syringe when pressure to the syringe plunger is
released, do not continue to infuse until proper placement of the needle has been verified.
Instructions
Filling the Drug Refill/Reservoir
Refill Setup
Refill Setup in Pump

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Instructions
Filling the Drug Refill/Reservoir
9. When refill of the drug reservoir is completed, maintain downward pressure on the syringe plunger,
clamp the extension tubing, and remove the needle from the refill septum. Discard the tubing,
syringe and the needle.
Caution: Do not rock the needle sideways as this may damage the pump or cause drug to leak into
the pump pocket.
10. Using the Prometra Programmer, program the empty and refill information into the pump. If the drug
flow rate has been changed, program the new drug flow rate.
Caution: Always program a dose of 0.1 mg/day or greater to maintain catheter patency.
11. If you have changed drug concentration, you must calculate and program a bridge bolus to deliver
the residual drug in the pump and implanted catheter at the new rate. Refer to the supplementary
Calculations Guide to make this calculation and to the Catheter Access Kit instructions for use to
perform the bridge bolus(es).
12. Once the bridge bolus(es) is completed, the new drug regimen starts, using the new drug
concentration in the reservoir.
Suspending Drug Therapy - Pump Rinse
Always empty then flush the pump twice with two 20mL volumes of sterile preservative-free 0.9% saline
when suspending drug therapy. It is important to empty and flush the pump twice to dilute residual drug
left in the pump to non-therapeutic levels.
1. USE STERILE TECHNIQUE. Always inspect and aseptically prepare the site according to standard
practice.
2. Before refilling or suspending drug therapy of the Programmable Pump, the drug refill/reservoir must
be emptied. Refer to Emptying instructions.
3. If required, drug remaining in Intrathecal Catheter and Catheter Fluid Pathway can be removed via
aspiration. Refer to the Catheter Access Kit instructions for use to perform the aspiration.
Warning: If the Catheter Access chamber is not aspirated the drug in the pump fluid pathway and
catheter will be administered to the patient at the flow rate programmed after the pump rinse.
Warning: After aspiration, the pump fluid pathway contains approximately 0.137 mL of drug at the
concentration previously in the reservoir. This volume of drug will be administered to the patient at the
drug flow rate programmed into the pump after pump rinse. Refer to the Calculations Guide for more
information.
4. Fill a 20 mL syringe with sterile preservative-free 0.9% saline solution.
5. Attach 0.22 micron filter to the saline-filled syringe and prime the filter with saline to remove air.
Confirm that the syringe still contains 20 mL, the reservoir volume of the pump, or fill with sterile
preservative-free 0.9% saline solution to 20 mL.
6. Attach the filter-syringe assembly to the extension tubing already attached to the needle in the pump.
Verify that there is no air in the system. Set aside this Pump Rinse setup.
7. Open the extension tubing clamp. Keep downward pressure on the needle and begin slowly infusing
the saline solution into the drug reservoir. At every 5 mL increment, release pressure on the syringe
plunger to allow 1 mL of saline back into the syringe. This will verify that the needle is in the correct
position and drug reservoir is being filled.
Caution: If the sterile saline solution does not return back into the syringe when pressure to the syringe
plunger is released, do not continue to infuse until proper placement of the needle has been verified.
8. When all of the saline solution is in the pump reservoir, allow the contents of the pump to empty back
into the 20 mL syringe. When the pump is empty, clamp the extension tubing.
9. Disconnect the syringe and discard the saline.

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Instructions
Suspending Drug Therapy - Pump Rinse
10. Repeat Steps 4 through 9for the second pump rinse.
11. After the second rinse, repeat Steps 6 and 7 to refill the pump reservoir with 20 mL sterile saline
solution.
12. When the pump refill is completed, clamp the extension tubing and remove the needle from the refill
septum. Discard the tubing, syringe and the needle.
13. Program the refill using the Prometra®Pump Programmer.
Calculations
Please refer to the appropriate supplementary Calculations Guide.
Trademarks are the property of their respective owners.
US and Foreign patents issued and pending. Please consult flowonix.com for the most up-to-date
information.
Rx Only

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KIT DI RIEMPIMENTO, Per utilizzo con i sistemi di infusione programmabili Prometra®

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KIT DI RIEMPIMENTO, Per utilizzo con i sistemi di infusione programmabili Prometra® Pagina i
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Spiegazione dei simboli
Fare riferimento all’etichetta sulla confezione e sul prodotto per vedere i simboli che si applicano a
questo prodotto.
Numero di catalogo
LOT Codice di lotto
Data di scadenza
Data di produzione
Sterilizzato con gas di ossido di etilene
Non riutilizzare
Attenzione, consultare i documenti di accompagnamento
Non utilizzare qualora la confezione risulti danneggiata
EC REP
Rappresentante autorizzato nella Comunità Europea
Nonpyrogenic Non pirogenico
Latex-Free Assenza di contatto del paziente o del fluido con i componenti in lattice
Rx only Attenzione: le leggi federali (USA.) limitano la vendita di questo dispositivo da
parte o per ordine di un medico.

ItalianoItaliano
KIT DI RIEMPIMENTO, Per utilizzo con i sistemi di infusione programmabili Prometra®

Italiano
KIT DI RIEMPIMENTO, Per utilizzo con i sistemi di infusione programmabili Prometra®
Italiano
Contenuto
Contenuto......................................................................................................................................1
Descrizione ....................................................................................................................................1
Indicazioni.....................................................................................................................................2
Controindicazioni............................................................................................................................2
Avvertenze .....................................................................................................................................2
Precauzioni....................................................................................................................................2
Eventi avversi.................................................................................................................................2
Apparecchiatura .............................................................................................................................2
Istruzioni .......................................................................................................................................3
Svuotamento di riempimento/serbatoio del farmaco .......................................................................3
Riempimento del serbatoio/riempimento del farmaco .....................................................................6
Sospensione della terapia farmacologica – risciacquo della pompa ..................................................8
Calcoli...........................................................................................................................................9

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KIT DI RIEMPIMENTO, Per utilizzo con i sistemi di infusione programmabili Prometra®
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