Do the precision and accuracy of delivery meet specifications?
Precision and accuracy are guaranteed by thorough validation of SmartDose^® infusion sets, SmartDose^® infusion pumps and all intermediates. Especially the valves responsible for keeping a constant pressure within the system are individually calibrated and tested.
As stated in the Summary of Product Characteristics, the product is not recommended for drugs, which require dosing in mg/kg of body weight per minute.

Is SmartDose^® compatible with a wide range of delivered drugs?
The compatibility of SmartDose^® with acid and alkaline drugs has been demonstrated over a range of pH between 2 and 11. SmartDose^®, sodium chloride 0.9% is appropriate for the administration of any drug compatible with sodium chloride and without a known interaction with polypropylene. Compatibility of SmartDose^® and the following products (among others) has been studied in the US: tobramycin sulfate; ceftazidime; ranitidine; nafcillin sodium and ampicillin sodium.

Is the SmartDose^® empty a CE labelled medical device?
The SmartDose^® infusion container is CE marked since 14 April 2001. Our notified body is TÜV Product Service Munich. Only CE labelled products are available on the European market.

What training of patients or medical personnel is required to ensure efficacy?
All aspects of proper use, handling, reconstitution and operation are comprehensively covered in the Summary of Product Characteristics and Product Information Leaflet supplied with the product and show clinicians, carers and patients the correct use of SmartDose^®. However the manufacturer recommends and provides upon request training through dedicated field support staff to both distributors and hospital staff members.

Can the internal pressure remain constant?
As mentioned in the SPC (summary of product characteristics), the internal pressure will remain constant at 0.63 bars for a minimum period of 2 1/2 hours . Any excess in pressure is evacuated through a specially designed relief valve. This valve is individually calibrated and checked during the manufacturing process and contributes to the SmartDose^® delivery precision and efficiency.

What is the power cell waste?
The power cell contains citric acid (lemon juice equivalent) and sodium carbonate. The completion of the reaction results in a harmless aqueous solution of buffered sodium citrate.

Can the gas or chemical tablet solution be in contact with the NaCl solution for infusion?
No, the chemical reaction (effervescent tablet) is completely isolated from the Sodium chloride , solution for infusion. Situated in a separate compartment, the chemical solution is maintained by a hydrophobic belt which only lets through gas particules.
The gas generated is itself separated from the solution for infusion by a six () layers membrane. As gas is accumulated in the gas chamber, the membrane moves downward and compresses the fluid outwards through the outlet valve and into the infusion set. This double isolation is controled individually through out the manufacturing process.

Once the infusion is finished, is there a possible back flow, from the patient back into the administration set?
No. SmartDose^® maintains a positive pressure for a minimum of 12 hours, after end of the infusion.The remaining liquid between filter and patient being trapped, prevents any risk of backflow. This gives considerable time freedom for a qualified person to disconnect the set from the patient and to clean infusion port.

Does the flow rate depend on altitude (helicopter, air ambulance)?
The pressure inside SmartDose^® which generates the driving force for infusion does not depend on altitude. The change of the venous pressure is of minor significance as deviations are compensated to a high degree by the fluid pressure generated in SmartDose^®.

Does temperature affect the flow rate?
Temperature does not affect the mechanical and chemical properties of the SmartDose^® infusion system.
Temperature will affect the viscosity of the drug and thus the flowrate as per the Poiseuille law.

Can we freeze the SmartDose^® pump?
Absolutely, SmartDose^® may be frozen. It will keep its technical properties when brought back to room temperature for a future use.
However, microwave heating to warm up the SmartDose^® is not recommended.

How do I know that the SmartDose^® pump has been activated?
SmartDose^® power cell is composed of a white tablet and a liquid. Once the tablet is pressed in the liquid through a membrane, the power cell will change color from white transparent to blue color. If the color has changed, you are sure that SmartDose^® has been activated. You will also notice that the liquid container will become stiffer as gas is being released.

If we misuse the administration set and invert the orientation of the set and thus connect the blue luer connection to the patient, does the SmartDose^® still work?
Yes in 90 % of the cases. In other cases the air filter may block the infusion. Thus it is necessary that the blue luer lock be connected to the SmartDose^® pump only. By doing so, effective infusion is assured every time. Each set is delivered with a label tag to indicate proper connection.