A
Hello,
We are a medical design company and we developed an advanced infusion pump, the first local infusion pump of Turkey.
I wanted to ask your opinion about free-flow clamp. Our infusion pump will only be used by our own administration sets, that?s why we want to add something unique to make the device only usable with our sets.
We are thinking on adding the free-flow clamp on our administration set. The device will not have free-flow clamp if it is not used by our sets. Do you know is there is a restriction about the place of free-flow clamp on infusion pumps?
The standard 60601-2-24 says that: ?Means shall be provided to protect the PATIENT from overinfusion as a result of FREE FLOW conditions. This requirement applies as soon as the ADMINISTRATION SET is installed in the EQUIPMENT in accordance with the manufacturer?s instructions for use.?
So as long as the hospital uses my set, there will be no free flow occurrence. Will I comply with this criteria with my set with free-flow clamp and no free flow clamp on my device, do you have any idea or comment?
We are a medical design company and we developed an advanced infusion pump, the first local infusion pump of Turkey.
I wanted to ask your opinion about free-flow clamp. Our infusion pump will only be used by our own administration sets, that?s why we want to add something unique to make the device only usable with our sets.
We are thinking on adding the free-flow clamp on our administration set. The device will not have free-flow clamp if it is not used by our sets. Do you know is there is a restriction about the place of free-flow clamp on infusion pumps?
The standard 60601-2-24 says that: ?Means shall be provided to protect the PATIENT from overinfusion as a result of FREE FLOW conditions. This requirement applies as soon as the ADMINISTRATION SET is installed in the EQUIPMENT in accordance with the manufacturer?s instructions for use.?
So as long as the hospital uses my set, there will be no free flow occurrence. Will I comply with this criteria with my set with free-flow clamp and no free flow clamp on my device, do you have any idea or comment?