How does CytoCare deal with syringe “coring” – when the needle cylinder punctures the rubber and a piece of
the rubber is either stuck in the needle or knocked into the container?
Special "non-coring" needles are used (Baxa model Two-Fer)
Can a user define the speed, duration and number of revolutions on the reconstitution wheel in each plane for
different admixtures in order to ease the potential concern that certain proteins cannot be rotated in two planes
because they are likely to coagulate inappropriately?
Yes. Speed and duration are drug-specific and can be stored in the internal database in order to adapt the reconstitution to the
specific drug properties.
How does the laser-driven syringe driver prevent aspiration or aeration, especially caused by pressure
imbalances?
Pressures imbalances are compensated using vented needles.
Based on user preference, can CytoCare suspend reconstitution until the operator visually confirms the
mixture is complete before proceeding to the next step?
Yes, this is a standard feature that can be activated according to the user's preferences..
DoesCytoCare allow drawing liquids with high viscosity or are there problems (like having to change the
needle)?
No need to change needles. The 16G needles which are currently used fit all kind of liquids while granting precision through a
laser controlled syringe activation mechanism.
Does CytoCare insert a pin into the cavity left by the needle?
No, it does not need to. Usually the vials' rubber caps are especially designed to avoid generation of cavities after the needle is
taken out. Besides, the machine uses special non-coring needles to avoid this problem.
Is it possible to extract liquid from a final container prior to injecting the medication?
The system allows you to partially or totally retrieve the required quantities. You can extract from the final container excess fluid
if you want the final solution to have a precise weight. You can also use part of a medication vial and leave the rest for a
second preparation
How can Cytocare be more precise than a human while dosing liquids with syringes?
Syringes themselves are rather inaccurate. The first problem is related to syringe markers, the second problem to the dead
space at the end of the plunger’s route. The ISO standard 7881-1 on syringes allows low precision levels (4% is tolerated). When
an operator is manually filling the syringe, he/she is likely to be very inaccurate, as he/she relies on markers printed on the
syringe itself. Cytocare does not rely on markers, as it measures the exact plunger’s travel with two different and parallel
systems. It uses an optic encoder on the motor moving the piston and a laser pointer. The precision level Cytocare can reach is
thus by far higher than a human. We expect a no worse than 1% low precision on doses higher than 1ml.
What is the minimum dose that Cytocare can draw?
0.5 ml
Are the drug vials completely emptied?
Cytocare can draw the entire content of the vial
Does Cytocare somehow identify possible deficits or surpluses of drug volumes inside the drug vials, and if so
how?
Yes. Drugs vials are weighted on a precision balance prior their use.
When entering the drug to the IV final container, does the needle empty fully or is some drug left there? How
one can guarantee this?
The max amount of liquid that can remain within a needle is 0.02ml, which is rather irrelevant.
Can you calibrate the machine to adjust for syringes’ tolerance levels?
Every time a syringe lot is changed, Cytocare uses its weighing system to get the calibration factor of that given syringe lot. This
is necessary because, according to the ISO standard, syringes are allowed a variation up to 4% between lots. Because
Cytocare wants to provide a higher precision, this calibration step is put in place.
Does the Cytocare software comply with quality standards?
The Cytocare software complies with the validation path identified in the ISO norm 12207:1995 “Software Life Cycle Processes”,
which is also the reference document for the FDA guidelines for Pharmacy Compounding Systems.
the rubber is either stuck in the needle or knocked into the container?
Special "non-coring" needles are used (Baxa model Two-Fer)
Can a user define the speed, duration and number of revolutions on the reconstitution wheel in each plane for
different admixtures in order to ease the potential concern that certain proteins cannot be rotated in two planes
because they are likely to coagulate inappropriately?
Yes. Speed and duration are drug-specific and can be stored in the internal database in order to adapt the reconstitution to the
specific drug properties.
How does the laser-driven syringe driver prevent aspiration or aeration, especially caused by pressure
imbalances?
Pressures imbalances are compensated using vented needles.
Based on user preference, can CytoCare suspend reconstitution until the operator visually confirms the
mixture is complete before proceeding to the next step?
Yes, this is a standard feature that can be activated according to the user's preferences..
DoesCytoCare allow drawing liquids with high viscosity or are there problems (like having to change the
needle)?
No need to change needles. The 16G needles which are currently used fit all kind of liquids while granting precision through a
laser controlled syringe activation mechanism.
Does CytoCare insert a pin into the cavity left by the needle?
No, it does not need to. Usually the vials' rubber caps are especially designed to avoid generation of cavities after the needle is
taken out. Besides, the machine uses special non-coring needles to avoid this problem.
Is it possible to extract liquid from a final container prior to injecting the medication?
The system allows you to partially or totally retrieve the required quantities. You can extract from the final container excess fluid
if you want the final solution to have a precise weight. You can also use part of a medication vial and leave the rest for a
second preparation
How can Cytocare be more precise than a human while dosing liquids with syringes?
Syringes themselves are rather inaccurate. The first problem is related to syringe markers, the second problem to the dead
space at the end of the plunger’s route. The ISO standard 7881-1 on syringes allows low precision levels (4% is tolerated). When
an operator is manually filling the syringe, he/she is likely to be very inaccurate, as he/she relies on markers printed on the
syringe itself. Cytocare does not rely on markers, as it measures the exact plunger’s travel with two different and parallel
systems. It uses an optic encoder on the motor moving the piston and a laser pointer. The precision level Cytocare can reach is
thus by far higher than a human. We expect a no worse than 1% low precision on doses higher than 1ml.
What is the minimum dose that Cytocare can draw?
0.5 ml
Are the drug vials completely emptied?
Cytocare can draw the entire content of the vial
Does Cytocare somehow identify possible deficits or surpluses of drug volumes inside the drug vials, and if so
how?
Yes. Drugs vials are weighted on a precision balance prior their use.
When entering the drug to the IV final container, does the needle empty fully or is some drug left there? How
one can guarantee this?
The max amount of liquid that can remain within a needle is 0.02ml, which is rather irrelevant.
Can you calibrate the machine to adjust for syringes’ tolerance levels?
Every time a syringe lot is changed, Cytocare uses its weighing system to get the calibration factor of that given syringe lot. This
is necessary because, according to the ISO standard, syringes are allowed a variation up to 4% between lots. Because
Cytocare wants to provide a higher precision, this calibration step is put in place.
Does the Cytocare software comply with quality standards?
The Cytocare software complies with the validation path identified in the ISO norm 12207:1995 “Software Life Cycle Processes”,
which is also the reference document for the FDA guidelines for Pharmacy Compounding Systems.
© 2006 Health Robotics. All rights reserved.
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