medical device quality manual

Denotes the indicator function of the set.
The relative severity computations are performed separately and independently on each different parameter configuration's set of detection clusters.
As discussed, synchronization may also be utilized in either the hybrid or implanted systems.
Corresponding data (e.g., detected frequency, duration, intensity, and extent of the electrographical spread) is isofter dvd platinum serial number collected for both detection clusters, in which stimulation is applied, and detection clusters, in which stimulation is not applied.An external component may be removed for different reasons.Also, since direction of current vespa scooter gt200 service manual pdf flow may determine the response to electrical stimulation, the anode and cathode may be reversed.Other embodiments may support different forms of treatment, including drug infusion or a combination of electrical stimulation and drug infusion.When microcontroller 1119 determines that a channel shall be able to receive a neurological signal, an analog to digital converter (ADC) 1113 samples the neurological signal at a desired rate (e.g., 250 times per second).Also, the set of channels that are software blanked may be different from the set of channels that are hardware blanked.) In the embodiment, hardware blanking interval 2325 and software blanking interval 2329 may be predetermined, in which intervals 23 may be programmable or non-programmable.Other monitoring elements such as Carbon dioxide gas sensors or other sensors that can detect the physiological parameters such as those listed above will be clear to those skilled in the art.Our customers is looking for to achieve the above goals and we do what we can to correspond their expectations.ECoG recordings may also be obtained from the DBS leads.
Alternatively, the physician may instruct external system 100 to bypass step 2170 and to perform step 2171, in which the electrodes are reconfigured.In general, the stimulation board of the medical device system provides continuous stimulation where stimulation is turned on and remains on until it is explicitly turned OFF.External system 100 may produce a seizure trending report that identifies whether a trend in seizure activity is present, along with graphical and summary information.In step 2171, the electrodes may be reconfigured and step 2153 may be repeated.Diagraming the design flow is helpful for seeing a more detailed picture of the validation and verification of a product against its intended use model and, specifically important to the FDA, seeing that each and every stage of the process is well-reviewed and documented.To avoid interference, the relaying module 1415 may communicate with the external and implanted components using differing communication schemes.External system 100 has the capability of estimating current density at any contact site.For example, the medical device systems described herein may be utilized to provide vagal nerve stimulation, for example, as disclosed.S.Patents assigned to Medtronic provide example of nervous system disorders that can be treated.