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Cranial Pressure & Patient Monitor

Case Study - Cranial Pressure MonitorBandaged Head

Product for the measurement of pressure via a probe inserted in a patient's head.

The Challenge:

To produce a Signal Conditioning Unit that integrated with a Standard Bedside Monitor and a silicon-based Pressure Transducer connected to a wire Catheter.

ISO13485MLE Value Add:

We designed a simple "rolling graph" LCD display and proposed battery capability to allow operation of the probe independent of the bedside monitor, e.g. on a trolley. There was an added temperature compensation to allow for a functionality check at room temperature and the temperature of the patient and we provided a calibration management system via a single wire chip inserted into the probe plug for the recording of data and serial number, for the traceability of each probe. A calibration rig was supplied to the probe manufacturer to facilitate this.

Approvals:

We supplied software documentation for FDA and full documentation for ISO 6060I

Patient Bedside Monitor

 

Case Study - Patient Bedside Monitor

The design brief was to take an existing medical product and upgrade it due to obsolescence of the display.

The Challenge

To provide an end product that presented a seamless transition for the end user.

MLE Value Add

By understanding the original product a new display module was designed that incorporated a clever processor and driver device. This enabled the new display to integrate with the existing product enabling a "look and feel" superior to the existing product and designed in such a way as to minimise the FDA re: qualification.

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