Brief Description of Device

• Provides continuous fluid delivery at pre-determined fixed rate with attached administration set.
• A silicone balloon is used as both the fluid reservoir of the device and also the pressure (energy) source.
• Flow rate is controlled by the length and lumen size of a micro-bore tube.
• The pump is a disposable device intended for single patient use. It is portable and therefore will not restrict ambulation of the patient.

Brief Description of Intended Use & Indication of Use

• For general infusion use. Routes of infusion include intravenous, subcutaneous, and epidural into the intra-operative (soft tissue / body cavity) site.
• General infusion may include analgesic drugs for pain management; infusion of chemotherapy drugs, and antibiotics.
  
  
  
  

Features & Benefits

• Products

Features	Benefits
Fixed flow rate with dosage varied by drug concentration	Adjustment by patients neither required or possible
Completely self-powered Self-generated by pressure from elastomeric balloon	No electricity / battery required Eliminates gravity flow problem
Filling port equipped with one-way injection valve	Activated by connecting to luer lock or luer slip syringe Allows easy and safe filling Prevent back-flow of fluid
Pre-attached administrative tubing	Easy (almost instant) priming Air being flushed out from tubing while the balloon is being filled
0.2 micron filter	Eliminates air bubbles Filter bacteria

 

• Users

For the Healthcare Team	For the Patient
Complete infusion system Accurate medication delivery Positive pressure eliminates gravity flow problem. No IV pole required Minimal training time for use of device Supplied ready-to-use Adaptable to a variety of therapies No capital outlay (vs. electronic pumps) Eliminates maintenance, servicing and tracking of equipment	Ambulatory – device is completely portable and can be carried in a pouch. Requires little to no management or intervention by the patient (or caregiver). Light, compact, silent operation No part to assemble (home care) No control to set or battery to recharge (home care) Reduces costly hospitalization charges (early hospital discharge to recuperate at home)

Principle of Operation

• Both AccuFlo & AccuFlux infusion pump has an elastomeric balloon-like reservoir for containing drug or fluid intended for infusion.
• The silicone-made balloon exerts mechanical pressure, thereby forcing the drug or fluid through the tubing.
• Fluid will flow at a pre-determined flow rate which is controlled by the lumen size & length of the micro-bore tube (the section connecting to the micron filter) and /or glass orifice (for pump with very slow flow rate such as < 2.0ml / hour).
• The device is designed to deliver the nominal volume +/- 10% of the nominal delivery time. Flow rate may vary with changes in temperature & viscosity of drugs.
• Because the device does not depend on gravity, it can be carried along with the patient.

Procedures / Method for Safe Use

   Filling the Device

• Close the clamp on the extension tubing.
• Flip open the top cap.
• The pump can be filled with a syringe (preferably a Luer-Lock type to be more secured).  Use the syringe to aspirate drugs / fluid, remove all air; attach the syringe to the fill port, push the plunger to dispense the drugs into the balloon reservoir. Multiple filling will be required if a small volume syringe is used.
• Remove syringe from the fill port. Screw the cap (provided in unitized packing) on to the fill port.
• Flip the top cap closed.
• Label with appropriate pharmaceutical and patient information.
  Priming the Administration Tubing

• Remove the cap from the end of the tubing set.
• Open the tubing clamp. Fluid will begin to flow to fill the entire administration tube and to expel all air.
• Close the clamp on the administration set after priming.

Starting the Infusion

• Infusion should preferably be started 0-8 hours after filling. Prolonged storage may result in longer delivery time (vs. nominal time)
• Verify the clamp is closed
• Connect the tubing to the intravenous or epidural catheter. (Use aseptic technique to clean patient access site as directed by hospital / healthcare provider).
• Open the clamp to start infusion.

Drug Mixing and Concentration

• Refer to drug manufacturer’s package insert for drug reconstitution / dilution and storage procedures.
• Calculate fill volume by multiplying the desired infusion time (hours) by the nominal flow rate (ml/hr) and adding the residual volume.
• Alteration of dosage is achieved by adjusting the drug concentration since the flow rate is predetermined and fixed.

 

Precautions

• Do not use if package is damaged or opened.
• For single use only. Discard after use in accordance to local regulations.
• Do not exert pressure or play with filled device. Take caution when used with immobilized patients to avoid device being slept on, which may lead to rupture or breakage.
• Do not use with pressure infusion device.
• Store at cool, dry place; avoid direct sunlight.
• Infusion should be started within 8 hours after filling. Storage of the filled device beyond 8 hours may result in a longer delivery time.
• If the filled device needs to be stored in refrigerator or freezer, allow it to warm to room temperature before infusion.

Contra-Indications

• Infusion of blood or blood components.
• Infusion of insulin.
• Infusion of lipid or fat emulsions.
• Infusion of critical or life-supporting medications whose stoppage, interruption, over-delivery or under-delivery would likely cause serious injury or death.
• Infusion of any solution that is not compatible with the materials of the device.  (refer to “chemical stability” section)

Key Functional Elements / Materials

Parts	Material	Intended Use
Valve cap	PE	To protect the filling port from contamination.
One-way injection valve (fill port)	PE	For filling of fluid to the silicone sleeve balloon reservoir.  The valve to be activated by a syringe.
Rubber ring	NR	To tighten the PVC outer sleeve onto the core.
Sliding core	ABS	For mounting the silicone sleeve on, and to channel the fluid to / from the balloon reservoir. The sliding core helps to reduce filling pressure, and also reduces initial “spike” in flow rate compared to other elastomeric pumps.
Silicone sleeve	Silicone	To act as a balloon reservoir for the medication and to exert pressure to generate flow.
Outer sleeve	PVC	An outer layer to protect the silicone balloon.
Extension tube	PVC (DEHP free)	To channel fluid / medication.
Clamp	PP	To stop the flow if necessary.
Filter	Hydrophobic Membrane	To eliminate air bubbles and to filter bacteria.
Micro-bore tube	Rigid PVC	To channel fluid and to control the drop size & flow rate

         Note:  all component parts are Latex-Free and biocompatible        

 

Chemical Stability
                The pumps are indicated for continuous infusion of medications for antibiotic therapy, chemotherapy, and pain management. AccuFlo pump has been tested by independent laboratory in France (report on file with Medpro) with respect to its chemical stability with various types of drugs, which are listed below:
AMIKACIN                                            GANCICLOVIR                      
CEFOTAXIME                                       GENTAMYCIN
CEFTAZIDIME                                       IMIPENEM
CISPLATIN                                            PIPERACILLIN
DEFEROXAMINE                                  RIFAMPIN
DOXORUBICIN                                     TOBRAMYCIN
FOLINIC ACID                                       VANCOMYCIN

The laboratory test concluded that after fourteen days of conservation in refrigerator (2 deg C to 8 deg C) and after 24 hours at 25 deg C, there is no significant evolution to the physiochemical characteristics of the drugs; and the drugs remain conform to their proposed specifications.

Note: the pharmacist or medical personnel dispensing the drug is responsible for ensuring proper preparation using validated aseptic techniques to prevent microbiological contamination.               

 

Manufacturing Qualification

• Manufactured under ISO13485, ISO9001 Certified Quality System.
• Conforms to following standard:
• European Community (CE Mark) Class 2B Medical Device Directive (MDD)
• Product certified by RWTUV NB NO. 0044 in accordance to 93/42/EEC Annex 11
• IEC 60601-2-24 particular requirement for the safety of infusion pumps and controllers

Sterility Method

• The whole unit of AccuFlo and AccuFlux is sterile; using ETO (Ethylene Oxide).
• Expiry date of the device is 3 years from manufactured date.

Technical Information

Nominal capacity	50 – 120 ml	150 – 240 ml	250 – 275 ml
Maximum capacity	120 ml	240 ml	275 ml
Total residual volume (tubing + reservoir)	< 2.5 ml	< 3.5 ml	< 5.0 ml
Weight including packaging	61 grams	71 gram	95 grams
Size of reservoir (length x diameter)	80 mm x 20 mm	100 mm x 20 mm	120 mm x 26 mm
Length of infusion line	1450 mm +/- 50 mm
Mean infusion pressure	220 mmHg – 350 mmHg
Maximum filling pressure	< 780 mmHg
Infusion duration accuracy (normal saline at 32 deg C)	+/- 10% of the nominal volume over nominal time
Manual flow stop	Clamp
Storage conditions	Temperature < 38 deg C, away from direct sunlight
Effect of partial filling on flow rate	<Nominal volume à slower flow rate >Nominal volume à faster flow rate
Effect of temperature on flow rate	Increase in temperature à increase flow rate Decrease in temperature à decrease flow rate Change in temperature by 1 deg C affects flow rate by 2%
Effect of viscosity on flow rate	10% slower flow rate with 5% Dextrose  (D5W)
Effect of height between pump and infusion site	Every 10 cm increase in height will approximately increase flow rate by 2-3%

Device Packaging

• 1 piece per pouch (with Tyvek paper & clear plastic)
• 10 pieces per box
• Box dimension: 
• AccuFlo – 24.0 x 26.0 x 13.0cm
• AccuFlux – 36.5 x 40.0 x 10.0cm