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Distinctive Monitor Starts from Here

By Yan Jianqiang from Laws and Regulations Dept.

[Retrospection]

“In 2010, the People’s Hospital of Jiangsu Province bought more than several monitors from Comen. This was a big order for it meant our products have gained more and more customers’ recognition. But it was embarrassing because our monitor couldn’t monitor the vital signs of neonates. Director of Jiangsu Office of Comen came to the hospital and suggested that we add configuration to the old 8000C, like neonatal BP cuff. But the result wasn’t desirable. Later, the hospital used monitors from many other companies, but they still had the same problem. ”

“After the headquarter received the feedback from Jiangsu Office, it immediately convened the management and the R&D director to discuss this problem. After detailed discussion, they reached a consensus: remove the adult mode and produce a monitor that is specialized for neonates. ”

“In less than a year, the neonatal specialized monitor came into being. In 2011, this new product was used on the nation’s first ‘two-head double-arm single-heart deformed babies’. In their life of 150 days and 19 hours, the two-head girl babies in Suining, Chongqing were saved for times by our specialized neonatal monitor successfully from apnea.”

“Life is the one and only. It is like tender flower that needs special care. Also, from the first cry of a baby after birth, he needs more extra special care.”

“Sales figure is just some cold digit and should not be the only objective of an enterprise. Rather, seeking better from good, making excellent products to share with the world and to bring health to the public are our missions and honor.”

This is the original remarks from the manager of Marketing and Strategic Development Department, Mr. Yi Mingsheng. It was also the story of the advent of C60 neonatal specialized monitor. C60 filled in the blank of China having no specialized neonatal monitor and its clinical trial intrigued many people. With the same curiosity, I asked Mr. Yan Jianqiang who is responsible for the neonatal specialized monitor registration, to introduce this “distinctive monitor” from a professional angle.

The following content is summarized from Comen C60 Neonatal Specialized Monitor Clinical Trials Report and the dictation of engineer Yan.

Trial Objective:

This monitor has passed software and hardware performance tests, functional safety test and simulator test after repetitive trials and has reached the intended target: it can meet the same requirements for accuracy, validity, stability and safety as other on-market products.

Test Content:

Verify the accuracy of ECG, RESP, SPO2, PR, NIBP, TEMP, EtCO2 and O2, the of apnea wakeup function and the stability and safety of the whole machine.

General clinical information:

We randomly choose 60 newborns that need vital signs monitoring (their family agree to do so), of which 38 are baby boys and 22 are baby girls; 15 are premature infants and 45 are normal ones; the oldest is 19 days and the youngest is 10 minutes; the heaviest is 4.47 kg and the lightest is 0.88 kg. And 3 of them have symptoms of apnea.

Trial methods:

The overall design of this trial is multi-centered, random, open, paired and having positive control. We choose a patient monitor in the market as reference to compare parameters such as ECG, RESP, SPO2, PR, NIBP, TEMP, EtCO2 and O2.

1. ECG and RESP measuring method:

Place two sets of ECG electrodes nearby on the body, and then connect the two lead cables respectively to the monitor tested and the referenced monitor. Set the two monitors into the same monitoring mode (diagnosis, monitoring or surgery). Give preference to lead II ECG waveform for overall estimation of ECG monitoring. At the same time, observe the RESP performance of the two monitors and record HR and RESP every five minutes. If arrhythmia occurs, record the arrhythmia type and number of times every minute analyzed by the tested monitor as well as the referenced monitor for totally 20 sets of data of each parameter.

2. SpO2 and PR measuring method:

Attach SpO2 detectors of the tested machine and the referenced machine to the same side of the subject’s hand or foot and record the SpO2 and PR of the two monitors for totally 20 sets of data.

3. NIBP measuring method:

4. TEMP measuring method:

Attach the same type of TEMP sensors of the tested monitor and the referenced monitor to the subject to see if his temperature is stable (on the same body part) and record the values of the two monitors every five minutes.

5. EtCO2 measuring method:

Place EtCO2 tubes of the tested monitor and the referenced monitor on the nose of the newborn and record the values of the two monitors every five minutes.

6. Oxygen concentration measuring method:

Place oxygen concentration detectors of the tested monitor and the referenced monitor in the newborn’s surrounding and record the values of the two monitors every five minutes.

7. Apnea wakeup function test method:

Choose a newborn that have apnea history. Put ECG cable and neonatal SpO2 detector in relevant positions and tie the apnea wakeup sensor onto the arch of the foot. When apnea occurs, observe breathing rate and SpO2 on the monitor. If there is apnea alarm; if apnea wakeup sensor vibrates; if the vibration solve breathing stop problem? If it can’t, timely human intervention is urgent to prevent something bad from happening. Record relevant data.


Test evaluation criteria:

Evaluation criteria of the accuracy and effectiveness of each parameter is as follows:


* The above criteria comes form Medical Device Registration Standards (neonatal specialized monitor) and YY0670 (automatic NIBP measurement standards).

Statistical method:

Use IBM SPSS19.0○R and SAS9.2 statistical approach. Use two-sided test as conventional statistical test, take α=0.05 as inspection level. Confidence interval of parameter might be 95%. Data like averages, standard deviation and confidence interval should be provided and also min value, max value, P25, median and P75 if it is needed. Average and standard deviation should be provided in paired data. Count data should have frequency distribution and relative percentage. Analyze the effectiveness of indicator and describe difference values in detail, supplemented by Bland-Altman diagram. Use paired T-test for deduction. Use point estimation as criteria. If the inferred result P>0.05, it is effective clinically. Multi-test don’t perform α level correction.

Clinical trial result:

60Judging from the clinical trial results of 60 cases, the average deviation and standard deviation (or root-mean-square value) between the tested monitor and referenced monitor for parameters like ECG, RESP, SpO2, PR, NIBP, TEMP, EtCO2 and O2, can all meet clinical standards.

Note: * represents root-mean-square value.

From the three apnea cases studies, when a newborn stops breathing, it will trigger apnea wakeup device to vibrate so as to help the baby resume breathing. Vibration will also be trigger when SpO2 ≤81% to strengthen the baby’s spontaneous breathing and increase SpO2. This means neonatal apnea wakeup function in the tested machine is effective.

The stability, interface operation and specific function effectiveness of the tested monitor have 100% excellent performance. There is no adverse effect and side effect during the whole trial.

Clinical trial result analysis:

Neonatal specialized monitor is to clinically monitor newborn patients’ vitals. It not only guarantees a newborn’s vitals stability during treatment, but also help medical workers to make a correct treatment proposal. In neonatology, there are many kinds of monitors for clinical application, but most of them are just accessories of adult monitors. They can’t meet the requirements of neonates in terms of measuring, monitoring and safety. Comen’s Neonatal Specialized Monitor took full consideration of the characteristics of neonatal cardiovascular system and developed ExNeo (neonatal ECG technology) and Adap-DSP (adaptive signal & BP measurement technology). It also uses the world-leading OxiMax (neonatal SpO2 technology) to eliminate interference and improve the measurement of low perfusion. It is also supported by SatSeconds intelligent alarm management technology and equipped with neonatal accessories that have passed bio-compatibility test. Its unique apnea wakeup function will stimulate the baby when it detects no breathing, which saves the baby from the danger.

Clinical trial conclusion:

Compared with traditional patient monitor, C60 Neonatal Specialized Monitor has stable performance, accurate and reliable data, effective specific function, strong anti-interference ability, quick response when pressing buttons, and long working hours without any adverse effect.

(Editor:admin)
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