... how to benefit from using Rugloop in your all-day practice as a medical professional ....
For those who are interested: some background on European / CE regulations with respect to TCI ...
Since we strongly believe in the capabilities of RugloopII, capable of driving multiple intravenous drugs simultaneously, we can support your work with the following Rugloop versions:
* for countries that are not under CE regulations or for studies that are compliant to the regulations as mentioned above, we will provide you Rugloop with full TCI capability. More information.
* for all other cases and for all-day clinical practice by medical professionals, we have decided to derive the RugloopII tracker version. This program will track your manual actions on the connected infusion pumps and calculate the resulting TCI concentrations from it. More information.
See some References to TCI
Your benefits in using Rugloop:
* we envision a target price for Rugloop TCI or Rugloop Tracker of +/-499,- Euro for an initial subscription, and 99,- Euro per year support fee. All software is node-locked.
* Rugloop software is plug-and-play, and comes with an extensive user manual. If you have a PC running Windows 98, Windows NT, Windows 2K or XP, installation is straightforward. You will need 1 serial port per pump to control. If you are reluctant modifying your PC, please contact us for installation support. We can arrange hardware packages with serial ports, or even a full installation on your (or a new) PC.
* Pump manufacturers: if you are interested to allow TCI/Tracking on your devices as well, please contact us.
* we are still working on all this. If you would like to be kept up-to-date with news about Rugloop / Rugloop TCI / Rugloop Tracker, please fill in the form below to be added to the Rugloop mailing list. REMARKS: the Rugloop mailing list is only used by Demed to inform you about news related to Rugloop & the companion program Labgrab.
The European community, CE regulations & TCI
Some years ago, the Belgian Pharmaceutical inspection asked us to withdraw RugloopI (at that time including TCI algorithms for realtime control of intravenous infusion) from our website. Under the regulations of the European Community 93/42/EEC (the Medical device directory), RUGLOOP has been classified as a medical device. After some research, here is our interpretation of CE regulations:
Within all countries applying CE, it is ILLEGAL to use non-CE-marked software for realtime control of infusion devices. ( this includes ALL programs like Rugloop, Stanpump, ... !!! )
The exceptions to this are very restrictive:
For countries that are not under CE regulations or for studies that are compliant to the regulations as mentioned in The European community, CE regulations & TCI, we will provide Rugloop with full TCI capability. We will send you a contract where you confirm that it is allowed to use Rugloop-like software in the circumstances you intend to. For Europe, we will also ask for the notification to your national authorities. (we can be held responsible for abuse of the program, so we have to take our precautions, unfortunately). Please contact us.
For all other cases, also for all-day clinical practice by medical
professionals, our logical decision was to derive the RugloopII tracker
version. This program will track your manual actions
on the connected infusion pumps, and calculate an estimated plasma concentration
for the set drug & infusate concentration. In addition, it will provide a
trajectory presentation of the
expected concentration in time at the currently set infusion rate.
We would like to stress that Rugloop will NOT control the pump: YOU ARE. YOU take all decisions concerning infusion rate and administered volumes. Rugloop is only monitoring. The calculated concentrations are given to you for information. YOU decide.
What are the advantages for you:
... to be used as a starting point...
Comparison of Plasma Compartment versus Two Methods for
Effect Compartment-controlled Target-controlled Infusion for Propofol
Influence of Age and Gender on the Pharmacokinetics and
Pharmacodynamics of Remifentanil I. Model Development
Nomenclature for Computer-assisted Infusion Devices