Project 2 - Clinical Investigation Plan

Introduction

Patient monitor is a device that is used to get the vitals of ther patient. The device helps the doctor witrh daignosis, tells the support staff about how the patient is doing and if they need any attending to do. Since, the nurses cannot be with just one patient all the time, this device helps with the problem of having an attendant 24/7 with the patient. This device monitors the patient's blood pressure, sugar levels, pulse etc.

Types of patient monitors

Bedside Patient Monitors: These types of patient monitors are the patient monitors that are used in the hospitals. These are used in departments such as NICU, PICU and all major ICUs. They are even used in the Operation Theatres. These monitors can be carried along with the patients since they are portable type opf monitors. These monitors are of two types namely basic and advanced bedside patient monitors. This means that the person or orgaization can decide onto which tfeatures they wish for in the monitor and which they do not need.

Cardiac Monitors: These are monitors which are specific to the departments which deal with the heart. This means the departments such as CCU etc. who have to monitor the patient's cardiac activity more than the other aspects need these monitors. This does not mean that these monitors lack other features. They do have other features but cardiac monitoring is their main features. These monitors are not carried along with the patient and the monitor is changed from carisac to normal patient monitor upon the switching of departments of the patient.

Now for the Clinical Investigational Report the report is focused mainly on the Bedside patient monitor and not the cardiac patient monit

Technical Specifications

• The device has a 12 inch touch display with buttons on the outer of the display.

• The device can display upto 10 functions at a time.

• The battery of the device has a 3 hour backup.

• The device has a capacity of storing 3 days worth of ECG reading.

• The device can be used for Adult, Pediatric as well as for neonatal.

• There is a thermal printer embedded in the machine incase the physian requires a print.

• The machine has an ethernet connection incase the department wishes to get the machine connected to the Patient Monitoring System.

• The machine has several modes with the minimum with 3 lead connections and maximum going upto 5 lead connections.

• It has several alarm modes so that the patient is not left unattended in the time of need.

Risk, Risk Assessment and Risk Management

The risks that are involved with the patient monitor is that what if the machine catches fire or if the machine gives out inadequate pressure to the cuff or over pressuries the cuff. Also the risk the machine carries is battery exploding as well as the PCB not getting protected against accidental drops from high altitudes. Also the loss of data adds to the list of risk. So for this risk assessment the machine was actually run and dropped several times during the time of testing. Also the batteries were overcharged and seen if the PCB does not catch fire due to longer working hours. Now to make sure this does not happen, the machine's touch panel is made of material which has a protective layer over the glass panel of the touch panel. Because of this, the machine even if it breaks the glas will not go on and splatter around the floor rather stay intact. The machine still is operational with the help of the buttons that are present on the bottom right of the patient monitor. As for the batteries exloding, since overcharging a lithium-ion battery might lead it to exploding after sometime, the machine rejects the batterries before the window closes. Now how would the user know the machine has rejected the battery you may ask? The machine has an alarm in it, not with sevre warning but with the least amount of alarm severity. As for the machine's integrity for regarding the PCB not getting burnt and breaking when the machine falls. The machine is equipped with cooling mechanism which cools the PCB time to time. The housing of the PCB is made in such a way that when the machine if falls by accident the PCB does not feel the impact as much as it should so that its integrity is maintained.

Purpose of Investigation

This is an observational, cohort-based, single-site, prospective study conducted in accordance with ISO standards. The primary objectives are to evaluate the accuracy of the device's measurements/readings in comparison to a gold standard or standard of care patient monitor.

Objective of investigation

This is an observational, cohort-based, single-site, prospective clinical study enrolling up to 100 patients who are hospitalized in the internal ward. There is no control group. The primary objectives of the study are:

• Evaluate the body temperature measured by the ear unit and validate its accuracy.

• Evaluate the accuracy of SPO2 signals and results by comparing the readings to a gold standard device with a finger sensor.

• Evaluate the ECG and respiration signals recorded by the patch device by comparing them to the signals recorded by a patient monitor with standard leads.

The study will asses if the machine is working with keeping the safety of the patient in regard and is not causing any harm to the patient rather than proving useful for the patient.

Population criteria for eligibility

Everyone who is 18 years and older is eligible for the test. The patient whi wishes to apply for the trial needs to be hospitalized already in a hospital. Should allow the hospital to share their medical data with the company executive to check if the patient is eligible in the criteria. The test will be done on 100 consequent people and the results will then be checked with the other standard patient monitors already available in the market to see if the patient monitor do cross the required mark for the certification.

Justification

If the company does diagnosis on the people with the problems that are linked to the patient monitor like arrythymia. Now the company will get to check on the new features that it has on the people. Of course people in extreme conditions will be excluded from this test since, they cannot be taken risk with. Their body might have adjusted to the old monitor and when the new monitor with new set of probes and functions will take over, maybe the body will not respond to that, but if the people who can move around but still need monitoring for those things use the monitor they might be the exclusive users of the new features that the machine has to offer in turn help the company gather the data. This will be benficial for both parties. Also going from hospital to hospital has a benefit. This means that patient does not go through any discomfort of switching hospitals and they will have new features right from the hospital bed where they have been residing in.

Material Used

Now for the PCB the material that is used is the standard material that is in use. But for the machinery casing, the PCB has a cushion around it and the outer covering is made of an alloy of plastic and carbon fiber. Now you may ask why these two on a 50-50 basis. This is to provide the strength as well as longetivity to the machine. look with carbon fiber, it will light and with plastic it will have the same texture and since carbon fibre is used, the machine outer casing will not break easily. As for the screen it is fitted at a place where it will get the minimised impact.

Hypothesis

• ECG: +-5% error with continuous usage

• SPO2: +-7% error with continuous usage

• Heartbeat: +-2% error with continuous usage

• Pulse: No error

• Blood Pressure: +-5% error with continuous usage

Conclusion

The machine had a prety good response to the parameters that it had promised. Out of 100 machines 90 machines gave the ideal output as predicted by the manufacturer. The remaining 10 machines 5 had battery failures while others had some measuring problems and neeed to be recallibrated. Overall the Clinical Investigation of the machines was a success as the machines came through to their promises.