NIHON KOHDEN CardioLife TEC-8300K Series Defibrillators Equipped With A High-acuity Monitor

Category: High-end NIHON KOHDEN CardioLife TEC-8300 series biphasic defibrillators, Acti-Biphasic waveform. In this article we examine all aspects of the five types of CardioLife TEC-8300 series defibrillators.

 

 

There are five basic rigid models of the CardioLife TEC-8300K series defibrillators and they are

1. CardioLife TEC-8321K defibrillator

2. CardioLife TEC-8322K defibrillator

3. CardioLife TEC-8332K defibrillator

4. CardioLife TEC-8342K defibrillator

5. CardioLife TEC-8352K defibrillator 

 

It is incomprehensible why many items could not be offered as optional, that they must instead be assembled in the factory before delivery when other manufacturers can do it in the field.

 

It means high inventory cost for distributors and dealers trying to sell the defibrillators!

 

The rigid models implies the lack of designing skills and a burden to users; it is impossible to upgrade a model in the field and a customer must buy a new model if such a need arises.

 

Which of the five models should you keep stock when your competitors only need to keep one?

The CardioLife TEC-8300K series defibrillators cannot meet networking expectations

 

The NIHON KOHDEN CardioLife TEC-8300K series Defibrillators was intended as an advanced model incorporating a high-acuity patient monitor into the bi-phasic defibrillators. The more common defibrillator design like the CardioLife TEC-5600 series defibrillators are only equipped with a low-acuity patient monitor.

Launched in August 2011, the high-acuity Monitor in the defibrillator must have a network capability comparable to any high-acuity patient monitor in the hospital, with the ability to connect to a Central Nurse Station, the ability to upload to a ECG Data management server for 12-lead ECG reports of the monitored patient etc. This is typically realized through Ethernet LAN networking capability on the patient monitor. 

 

We were puzzled to find the TEC-8300 series defibrillators does not even have an Ethernet LAN output. This clearly meant it does not connect to a monitoring Central Nurse Station or send 12-lead ECG Reports to a ECG Data Management Server while still in the hospital, so how are they going to do it from outside of the hospital? This is important missing specification and we wondered how this product could meet the needs of the export markets?

 

It is clear again this can only be accepted in the domestic market in Japan, which is protectively-insulated from international high-tech competition, and where the bargaining power of buyers is poor.
 

Do you notice the defibrillators are sending back 12-lead ECG reports in a technically crude way?

 

The 12-lead ECG files of TEC-8300 are similar to that from the CardioLife TEC-7600 series and CardioLife TEC-7700 series; these files can be viewed on a PC using a proprietary viewer software from the manufacturer.

 

It is surprising to note the CardioLife TEC-8300 series defibrillators does not have the technology to send the 12-lead ECG report files directly from the defibrillator to the Internet!

 

To send 12-lead ECG Reports back to the hospital, the TEC-8300 series must first transfer them via Bluetooth to a third-party device (such as a mobile phone). The transferred electronic file is then manually sent out as email attachment using the third party device. This is too amateurish for any salesman to confidently present the product to a knowledgeable audience.

 

A highly simplistic way of sending electronic 12-lead ECG report files back to the hospital

Over at the hospital receiving end, an exclusive mail server for the sole purpose of receiving the attachments must be set up; a PC/ laptop installed with the proprietary viewer software and QP-832VK TECLink software can access the mail server to retrieve and view the attachments. In appearance it looks like something similar to other manufacturers but in essence the structure is actually primitive and simplistic.

In the absence of technology to send 12-lead ECG reports directly from the defibrillators, one purchasing evaluation committee in Singapore (who had rejected the product) suggested in jest product improvement of just equipping the defibrillators with simple built-in fax capability allowing a hospital to receive the reports using a fax machine.

We know advanced defibrillators should behave like other high-acuity bedside monitors in the hospital

 

Below image shows a competing Philips HeartStart MRx with a Central Nurse Station; the HeartStart MRx was launched almost eight years before the CardioLife TEC-8300 series defibrillators. 

The HeartStart MRx can be monitored as a bedside monitor on the ICU Central Nurse Station while inside the hospital, as well as when outside of the hospital. Similarly, the 12-lead ECG reports can also be uploaded to the ECG Data Management Server from the defibrillator when it is inside or outside of the hospital.

 

A competing Philips HeartStart MRx could be linked to IntelliVue Information Center (Central Station) like any bedside monitor inside the hospital

 

Advanced defibrillators should have continued monitoring connectivity even when outside of the hospital

 

When an advanced defibrillator is outside in the field, it is expected to continue the network link (using the internet) with the hospital, similar to the way real-time stock/ Forex prices are communicated. Such network link allows remote real-time monitoring by hospital physicians to make preliminary diagnosis and care decisions while patient is en route to hospital; this important capability will save valuable time if the patient needs immediate surgery or transfer to another hospital with more appropriate Specialists and facilities.

 

Remote real-time monitoring en route to hospitals is expected as standard for the TEC-8300 series defibrillators

WATCH OUT the dangerous use of uncertain semi-quantitative CO2 measurements and displaying a flawed CO2 waveform

 

Nihon Kohden lacks sidestream CO2 sampling expertise and buys OEM units to offer them as expensive standalone. The AG-400 CO2 unit as shown, for example, is technology from Oridion Medical. For monitoring such as post-surgery recovery, integration of the sidestream CO2 into the monitor is a mandatory requirement because an external unit requires additional power socket besides necessitating the use of a trolley.

 

For some unknown reason, Nihon Kohden monitors could not offer integrated sidestream CO2 unit.

 

The inability to integrate the sidestream CO2 unit into the patient monitor main unit

The adoption of semi-quantitative mainstream CO2 measurement was to reduce cost and its simplicity also help in miniaturization of the transducers. The first solution offered by Nihon Kohden was the mainstream cap-ONE TG-920P CO2 sensor kit (order code P907) that can be used on non-intubated patients.

 

The cap-ONE TG-920P CO2 sensor kit (order code P907) has very small sensors because semi-quantitative measurement is adopted, the method is not commonly seen and many are not aware of the risks of obtained CO2 readings from the semi-quantitative CO2 kit sets, and to make matter worse, the semi-quantitative measurements are also being made used of to display a flawed continuous CO2 waveform.

Nihon Kohden cap-ONE P907 (TG-920P) mainstream CO2 sensor kit

How to remove a relatively big disposable adapter from the two tiny transducers after use?

 

When the sensors become smaller, it also means the disposable adapter becomes relatively much bigger as seen in this below picture. When trying to remove the disposable adapter from the transducers, it is difficult to separate the two because of the latching mechanism. A small size transducer means anything that latches onto it must be even smaller.

It is not easy to separate the disposable adapter from the Cap-ONE transducers after use

 

When removing disposable adapter from the mini sensors, users tend to just pull from the cables and this action quickly weakens the joint holding the sensors and cables. The action will cause stress to the two joints and quickly degenerate the performance of the transducers. This means the transducers are unlikely to last.

 

Users just doing the inevitable

 

Shown below is another TG-900P etCO2 kit set (order code P903) that makes semi-quantitative CO2 measurements on a traditional mainstream CO2 sensor. The TG-901T3 kit set (order code P906) is the same thing but using a non-coded connection plug. The medical devices from same manufacturer that make use of semi-quantitative CO2 kit sets for patient CO2 measurements and waveform include:

- Life Scope patient monitors

- Vismo patient monitors

- Cap-STAT OLG-2800

- CardioLife defibrillators

- Neurofax EEG machines etc.

 

Nihon Kohden semi-quantitative CO2 kit sets with traditional mainstream transducer

 

Do the users know semi-quantitative CO2 measurements are only estimations?

    

To save costs, the semi-quantitative kit sets do not make measurement during the inspiration phase. The important point is there is a measurement duty cycle and it is as shown; there is no way to know the actual CO2 measurements during the inspiration phase because CO2 measurements are not made.

Semi-quantitative means there is a duty cycle, and measurements are not continuous

 

Semi-quantitative measurement is also of low-accuracy type, performed using one IR detector instead of the usual two to save cost. This is reflected in the measurement tolerance.

 

Contrasting, quantitative measurement delivers high accuracy for critical care. To ensure the necessary high accuracy, quantitative measurement employed two IR detectors for simultaneous CO2 measurements at different wavelength for results comparison. CO2 measurements are also being made continuously.

 

Quantitative measurement employs two detectors to make continuous measurement at different wave-lengths to compare readings for high accuracy

NIHON KOHDEN specification for TG-901T CO2 sensor kit shows even the specified low accuracy of CO2 measurement using semi-quantitative method no longer holds true once CO2 is present during the inspiration phase.

This is because actual CO2 value will be more.

It is impossible for users to know if measurements are reliable when they cannot tell if CO2 is present during inspiration!

  

Measurements are invalid when CO2 is present during inspiration, but CO2 is not measured during this period

 

As seen from the duty cycle, there is no measurement being made during the inspiration phase, how does the manufacturer assure measurement accuracy? The specified measurement tolerance has no meaning for the users!

It should be clear each semi-quantitative CO2 measurement is only an estimation since its accuracy is rendered uncertain by the inability to confirm if CO2 is present during the inspiration phase.

Since the users are also not alerted on screen there is no CO2 measurement being made during the inspiration phase, they are unknowingly made to take on unnecessary risk.

 

Semi-quantitative methodology means cost-effective estimations and the design cannot be used in a general way, only on a selective basis with known risks

 

 

For example, semi-quantitative methodology can be used as a simple estimation tool for obtaining the numerical value of End-tidal Carbon Dioxide level (etCO2).

 

Below picture shows the semi-quantitative method in the way it was intended for, estimating only the etCO2 numerical value for purpose of airway tube placement confirmation. It is not for continuous waveform display.

A hand-held semi-quantitative etCO2 estimation tool (with SpO2) for airway tube placement confirmation

 

 

A misleading continuous CO2 waveform is being displayed when your semi-quantitative measurement kits do not have the ability to make continuous measurements

 

 

NIHON KOHDEN also allows data from semi-quantitative measurements to be displayed on screen with the non-measurement period reset to zero level. The insistence to display a continuous waveform using discontinuous measurement data from semi-quantitative mainstream CO2 estimation kits is unacceptable; the manufacturer is just subjecting the monitored patients and users to dangerous misinterpretation risks.

 

A zero CO2 reading on the waveform means zero measured value. No measurement can only mean a defective sensor, not by design!

Note the end tidal CO2 (etCO2) value shown is also not alerted as "estimated etCO2" only.

 

A flawed CO2 waveform with non-measurement intervals reflected as zero measured CO2 value

As seen from the two true CO2 traces below, expiratory upstrokes do not always start from zero CO2 level!

 

Quantitative measurements confirming expiratory upstrokes do not always start from zero CO2 level

  

Check the latest updated table to make sure you only use quantitative method for critical measurements and true CO2 waveform display on screen.

 

Use only quantitative method for waveform display; the quantitative TG-950P (P905) shown here was already discontinued.

 

 

How about fully-quantitative type miniaturized mainstream CO2 sensor?

 

The TG-907P CO2 Sensor kit (order code P909) shown in above table is declared as using quantitative method. This sensor was designed for non-intubated adult CO2 monitoring, as well as neonatal CO2 monitoring. Nihon Kohden is thus offering an alternative to sidestream CO2 sampling methodology.

 

The miniaturized CO2 sensor is easily broken by the bigger and stronger adapter

 

 

In addition to the dead space problem, they had not foreseen miniaturized mainstream CO2 sensors could be easily broken by the disposable adapters. This happened because the disposable adapters are now relatively bigger and stronger!

These are common defects of a TG-970P CO2 sensor kit (P909). The design is impractical.

 

 

The fragile miniaturized CO2 sensor is clearly of poor design, and easily broken

 

 

The key point is, it does not last

 

CardioLife TEC-8300 series defibrillators are described as using the Acti-Biphasic defibrillation shock energy

From the operating and service manuals of CardioLife Acti-Biphasic defibrillators, we know the Acti-Biphasic waveform looks like what is shown in below picture.

THE DECLARED WAVEFORM

Declared characteristics of the Acti-Biphasic waveform

The basic concept of a bi-phasic shock energy is to add a negative follow-up phase to the conventional mono-phasic shock to achieve the same defibrillation result using lesser energy

 

 

 

 

The characteristics of NIHON KOHDEN Acti-Biphasic defibrillation can be summarized as:

 

1. First (Launch) Phase

The Acti-Biphasic waveform is seen as operating in an open loop during the first phase (period).

 

- It is a positive truncated exponential pulse with a duration depending on the patient impedance.
- It is of a longer duration than the second period.

 

 

2. Second (Follow-up) Phase

The Acti-Biphasic waveform operates in a closed loop during the second phase. In a closed loop the duration of the width can be deliberately set to a specific duration.

 

- This phase is shorter in duration and of negative polarity.
- The duration in this phase is fixed to a constant 3.4ms duration regardless of patient impedance. How was the optimal duration of 3.4ms arrived at? It is also not clear how was the maximum energy of 270 Joules concluded?

 

Note the first phase (period) is positive and a wider pulse than the second phase

 

The first to use the Acti-Biphasic waveform were the TEC-7700 series defibrillators

 

 

The first Acti-Biphasic defibrillators

Output of CardioLife TEC-7700K series is consistent with the declared waveform

 

The output waveform of the CardioLife TEC-7700K series on a recorder is as shown below. The recording correctly shows the first phase is a positive pulse.

 

The recording shows the voltage first swings to the top (positive saturation), then to negative saturation after some time; this is fully consistent with the official description of the Acti-Biphasic waveform.

The reason we are not seeing the full shape of the Acti-Biphasic waveform on the recording is because the sensitivity is set to see the smaller ECG waveform, and not the defibrillation shock which are much higher in magnitude.

 

Output of CardioLife TEC-7700K series is consistent with the declared description

  

How can we know if the Acti-Biphasic defibrillation shock actually works on patients?

 

The margin of error is high for data from a small 75 investigated cases

 

There is no white paper available. The Acti-Biphasic defibrillators were hurriedly launched (for export) before completion of proper clinical validation and the small sample size of seventy five investigated cases meant a high margin of error; we cannot be sure the Acti-Biphasic defibrillation shock works on patients! In addition, how can we be sure the investigated cases were done in an acceptable manner?

As the mono-phasic defibrillators are not predicate devices so the FDA 510(K) process cannot be used to clear the product for sales in the US market. Since the clinical data and methodology adopted by NIHON KOHDEN fell short of US FDA guide for safety and effectiveness, the Acti-Biphasic defibrillation shock is not allowed for sales in the US market; Nihon Kohden could have engaged a consultant to ensure a proper and acceptable clinical validation process if they had wanted to do it right.

The persistent remarks we often heard from NIHON KOHDEN marketing staff on American Heart Association recommendations are in reality, meaningless to Acti-Biphasic defibrillators.

Outside of the US market, we need to question the point of buying such critical treatment devices and placing them on standby to save lives? It is so unfair to the patients needing immediate treatment in a life-threatening situation!

Biphasic Defibrillation Was A Nightmare, One That Caught NIHON KOHDEN off guard

In May 1997 Nihon Kohden released a new defibrillator with a semi-automatic AED mode for export using mono-phasic defibrillation. The details of this TEC-2200K series can be found in the 1997 Product Guide.

The monophasic CardioLife TEC-2200K series was launched for export in May 1997

This was a mono-phasic model using the non-proprietary Edmark single-phase pulse as illustrated and the use of rechargeable battery for energy made it very inconvenient for public use.

Edwark, Single Phase Pulse defibrillation waveform used by monophasic CardioLife TEC-2200K series in 1997

Just a few months after the TEC-2200 series was released, then market leader Hewlett Packard made announcement to acquire Heartstream Inc. in a stock-swap deal.

Heartstream ForeRunner

Biphasic defibrillation waveform was becoming the new preference as it allowed for a smaller and lighter defibrillator design; more importantly it uses less current and this means less damage defibrillation will do to the heart and skin. The deal with Heartstream was how the then defibrillator market leader HP acquired biphasic technology, since to develop one would take time.

 

On the other hand, there was zero interest in the monophasic TEC-2200 series defibrillators offered by Nihon Kohden for ex-Japan market and the products had to be withdrawn from exporting.

 

Unlike the monophasic pulse, biphasic waveform comes in various forms; each type of shape is proprietary and cannot be copied freely. This means the energy envelopes of manufacturers in the market are all different. For some waveform, the manufacturers only recommend a maximum of 200 joules while another can recommend energy as high as 360 joules. Since there is practically no limits to the type of biphasic defibrillation waveform shape a manufacturer could come up with, all manufacturers must justify the use of their proprietary output waveform in some reasonable ways, preferably in accordance with US FDA guide for safety and effectiveness, which calls for clinical research validations or published clinical papers which are subjected to peer review.

NIHON KOHDEN was unprepared for the global shift to biphasic defibrillation technology

It was a market disruption that caught NIHON KOHDEN by surprise. After more than four years, NIHON KOHDEN remained unable to offer biphasic defibrillators and the company was at a loss how to make it happen.

When the demand for biphasic AEDs emerged in the Japanese domestic market, the company opted to rely on finding a suitable partner with biphasic technology for co-operation. A strategic OEM distribution agreement was announced in January 2002 that Nihon Kohden would market Cardiac Science's line of AEDs under Nihon Kohden's trade name. This arrangement was a big success and many AED-9200 and AED-9231 were sold in Japan as reflected in annual reports and presentations.

NIHON KOHDEN CardioLife AED-9200 and AED-9231 were highlighted to have very good sales in FY2006 financial results presentation

The Cardiac Science STAR biphasic waveform (see white paper) was validated by researchers at Cleveland Clinic and Cedars-Sinai Medical Center in accordance with US FDA guides for Safety and Effectiveness

 

The success of the STAR biphasic shock in the domestic market however, could not be replicated for exports to foreign markets since distributors could buy the original Powerheart models at much cheaper prices from Cardiac Science directly.

Instead of licensing the proprietary biphasic defibrillation design from Cardiac Science, we were surprised a few engineers in NIHON KOHDEN could just by experimenting biphasic circuitry on pigs easily concluded a workable, proprietry Acti-Biphasic shock circuitry. It was done internally with minimal clinical supervision and collaboration, the company thus had great difficulty securing the necessary clinical support to advance the number of investigated cases for proper clinical validation. To date, there is not a single clinical paper published on Acti-Biphasic defibrillation.

 

Customers were buying unproven defibrillators based on blind faith

Before completion of proper clinical validation, the company was bold enough to go ahead with exporting the unproven TEC-7700 series Acti-Biphasic defibrillators from November 2002, relying solely on reputation of being an existing supplier of mono-phasic defibrillators. The customers bought them based on blind faith, not facts, for there was no published clinical paper to show that it works. This November 2002 export launch was three long years ahead of the date Japan MHLW officially approved its use for the domestic market.

The Absence of Internal Safeguards

The desperate action was taken in response to the rapid changing preference for biphasic defibrillators in the market but the process totally overlooked the seriousness of mandatory successful clinical studies before marketing; the fact that Ministry of Health, Labour and Welfare (MHLW) had not yet approved the sales of TEC-7700 series defibrillators in Japan domestic market reflected the disturbing absence of internal safeguards in corporate conduct.

 

Up to this point, the company had never exported a new product before first launching it in Japan, showing the company was in complete disarray. It is not just loss of credibility in overseas markets as a leading defibrillator exporter from Japan but a ticking time bomb with important issues left unaddressed.

 

Before completion of proper clinical validation, Nihon Kohden began exporting proprietary Acti-Biphasic defibrillators in 2002

It took Japanese Regulatory Authority three long years to grant approval for the TEC-7700 series to be allowed for sales in Japan

 

This implied the application was turned down several times and serious doubts by the Regulatory Authority to grant its use. What prompted the decision to clear it after three years' wait is something we should know. By the time of receiving approval to sell in Japan, many CardioLife TEC-7700 series defibrillators were already exported.

 

NIHON KOHDEN was only able to announce the launch of TEC-7700 series defibrillators for sales in Japan market on December 1st, 2005.

 

There was an unlikely event before the above annoucement. More than a year prior to the annoucement, Nihon Kohden had incredibly gone on to launch another unproven Acti-Biphasic TEC-5500 series defibrillators for export sales in August 2004. Why was the need to launch the TEC-5500 series without Regulatory Authority approval for TEC-7700 series defibrillators? This made the urgent launch of TEC-5500 series defibrillators highly suspicious and illogical.

We later found the Acti-biphasic waveform discharged by the TEC-5500 series defibrillators is flipped vertically upside down from that of the TEC-7700 series defibrillators! The change in the shape of the discharge waveform was not disclosed at the time of launch, it was only discovered later by accident.

It means the manufacturer decided at this point not to continue with the declared waveform that is being published on the service and operator manuals!

 

To reiterate, CardioLife TEC-5500 defibrillators was the series later found to have Acti-Biphasic discharged waveform flipped vertically upside down from that of the TEC-7700 series and it was happening right before Japan MHLW granted approval for the TEC-7700 series, and without showing any clinical studies done to support its use!

 

Unproven CardioLife TEC-5500K series started to be exported from August 2004, when Japan MHLW had not approved the sales of CardioLife TEC-7700 series

 

The Timeline

Export of CardioLife TEC-5500K series started in August 2004, more than one year before Japan MHLW actually approved the TEC-7700 series

CardioLife TEC-5500 series defibrillators were quickly approved for sales in Japan based on the principle of declared substantial equivalence with the newly-approved TEC-7700 series, so the Acti-biphasic discharged waveform of Japanese version TEC-5500 series defibrillators are unlikely to be different from that of the TEC-7700 series defibrillators in Japan.

The TEC-5500 series, TEC-5600 series and TEC-8300 series export models were all found by us to have their waveform inverted, but submission documents to foreign regulatory authorities were all based on the TEC-7700 series. Are the regulatory approvals valid?

 

 

A top prestigious University Hospital in Taiwan was the first to find the polarity of TEC-5500K discharged waveform inverted from what was declared in the operator and service manuals

 

In the image below, we were greatly puzzled to learn of an adverse report from a competent Biomedical Engineering Team in National Taiwan University Hospital (Taipei City) that the polarity of measured waveform discharged by two tested CardioLife TEC-5500K series defibrillators were inverted (i.e. opposite in polarity) from what the manuals had described.

The tests were a result of investigation after a serious performance failure incident that raised doubts about its efficacy. The investigation brought up many unanswered questions and only the IEC60601-2-2:2002 electrical safety compliance was put to rest. We should be clear the issue was not about safety, but effectiveness of defibrillation.

  

There was no doubt since they had tested both models TEC-5521K (S/N 09xx4) and TEC-5531K (S/N 05xx4) to arrive at the same conclusion; the suffix K is for export models using English language as interface (for example the suffix J is for Japan domestic models), indicating more than 9000 units of TEC-5521K and more than 5000 units of TEC-5531K had been produced before the two tested units respectively. Detailed comparison was also done with defibrillators from another manufacturer (Philips) using the same testing equipment (Fluke Impulse 7000DP with 7010 Selectable Load) and the polarity was consistent with the manual descriptions of Philips.

 

This was an input from professionals that the Acti-Biphasic waveform discharged by CardioLife TEC-5500K series defibrillators starts with a negative polarity and ends with a positive polarity; it is the exact opposite of what were shown on the operator and service manuals. As far as we know, there is no known manufacturer with a biphasic waveform that starts with a negative polarity, NIHON KOHDEN is unique in this approach but there is no clinical research done to validate its use on patients!

Is this equivalent to a delayed fixed-width monophasic discharge?

 

The next image showed the illustration from another distributor (Thailand) sending in a Nihon Kohden defibrillator analyzer AX-103VK (OEM device) for repair.

The AX-103VK defibrillator analyzer has a discharge waveform output on the rear panel for oscilloscope display

The analyzer was concluded by their technical staff to be defective because the display on the oscilloscope was inverted; the analyzer was of course working fine. Said Thailand distributor is top distributor who had sold the highest number of CardioLife TEC-7700K series defibrillators in the world and knew too well what is the "Correct Graph", confident of the defect conclusion. The conclusion turned out to be erroneous because the service manual wrongly informed them a TEC-5500K series defibrillator has similar output as a TEC-7700K series defibrillator.

Guess what? someone in Tokyo has the audacity to ask the distributor staff to "just flip the APEX/ STERNUM connections" to get the polarity right!

 

Changing "Evaluation machine" from a TEC-7700K defibrillator to a TEC-5500K defibrillator

What could be the reason for the sudden change of mind? Was it due to copyright pressure? Does the inverted waveform only apply to export models since Japan MHLW solely approved the TEC-7700 series version?

 

The declared current flow direction of NIHON KOHDEN Acti-Biphasic shock energy is the one on the left while we discovered actual biphasic flow is the one shown on the right

The clinical trial data cited to regulatory authorities is based on the TEC-7700 series defibrillators for all Acti-Biphasic defibrillators, including the TEC-5500 series, TEC-8300 series and latest TEC-5600 series.

 

There were only some clinical data from TEC-7700 series defibrillators

 

 

When the discharge waveform is flipped upside down, the TEC-7700 series clinical data cited becomes irrelevant

 

It is serious matter if the actual output waveform is different from the manual descriptions, as well as any inaccurate description documents submitted together with operator/ service manuals to regulatory authorities.

It means there is no approval from regulatory authorities to use a discharge waveform that is flipped upside down, and this is a ticking time bomb.

 

Change in current direction demands fresh clinical trial and validation

As a responsible company, NIHON KOHDEN must act fast and should have by now long recalled all Acti-Biphasic defibrillators from the market. There is no denying customers are still buying Acti-Biphasic defibrillators based on blind faith.

 

 

The Acti-Biphasic defibrillation output discharged by AED-2100 series AED defibrillators is seen avoiding the declared waveform in a mono-phasic way

 

The AED-2100K defibrillator was announced for export from October 2009 (Signal SE.C-19), it retained many features and appearance of the Cardiac Science OEM models except the proprietary output waveform.

 

CardioLife AED-2100K is exported to many parts of the world, albeit in small quantity; exception seems to be Taiwan and South Korea. It is not exported to the US market where it does not have US FDA clearance for the use of the Acti-Biphasic output waveform.

 

CardioLife AED-2100K seen distributed in Taiwan

The model AED-2100K did not have a screen display, which a later model was added in January 2012 with this feature. A more compact and lower-cost AED-3100 has now replaced AED-2100 series with some small changes.

 

The defibrillation success stories of AED-9200 and AED-9231 in Japan are routinely cited to sell later models but this is a misrepresentation

Current offer of AED-1252 and AED-3100 defibrillators are not authorized to use the STAR biphasic waveform and had nothing to do with earlier OEM models in terms of defibrillation technology.

 

The defibrillation success stories of AED-9200 and AED-9231 in Japan are routinely cited to sell later models but this is a misrepresentation that should be dropped immediately; the success stories cannot be linked to the latest AED-3100 defibrillator! Unlike the STAR biphasic defibrillation output, the Acti-Biphasic defibrillation output employed by CardioLife AED-3100 defibrillator does not meet US FDA approval for use in the USA market.

 

AED images from Japan

 

 

 

How can a user view the "Acti-Biphasic" output waveform from a defibrillator?

The QP-551VK defibrillator report viewer software can be used on a PC or laptop to review event recorded by any CardioLife defibrillator, including the AED-2100K defibrillator.

 

The defibrillator report viewer can be used to review events recorded by a NIHON KOHDEN defibrillator

Below shows a review screen of an AED-2100 defibrillation event using the QP-551VK software; the event was recorded using a simulator with TTR value of 49 ohm.

 

Notice the output waveform of AED-2100 is the same as older TEC-2200K which discharges a monophasic output waveform

The discharge output waveform of AED-2100 series (and AED-3100) are the same as the monophasic defibrillator TEC-2200K series AED defibrillators released in May 1997

The TEC-2200K series monophasic discharge waveform dated April 1995

What is the American Heart Association (AHA) recommendation for shock energy of mono-phasic defibrillators?

In the TEC-2200K series manual mode, the monophasic defibrillator energy storage has the following choices:

25J, 50J, 100J, 150J, 200J, 300J or 360J

When arrhythmia requiring defibrillation is detected in the semi-automatic mode, the defibrillator will automatically charge to the energy according to the following defibrillation sequence:
First  Defibrillation: 200J
Second Defibrillation: 300J
Third  Defibrillation: 360J

 

This is consistent with American Heart Association recommendations for a monophasic defibrillator, which Nihon Kohden is allowed to sell in the US market.

The above implies AED-2100K, AED-2150K. AED-2151K, AED-3100 do not comply with AHA recommendations for a monophasic defibrillator.

 

And why are the operator/ service manuals not reflecting the shape we had observed?

 

 

Output waveform expected from AED-2100K shown on user manual

We should pause and think about the seriousness of the points raised on the Acti-Biphasic defibrillation output.

Is there a good reason the CardioLife TEC-8300 series defibrillators choose to use Smart Cables for monitoring mainstream CO2, IBP and Temperature?

 

Why share connector sockets?

It is claimed that a monitor making use of Smart Cables has high flexibility amounting to modular capability; is this true? So far, it remains an assertion and the manufacturer does not provide supporting evidence to back it up.

THE SMART CABLES ARE JUST MEASUREMENT CABLES EMBEDDED WITH A CODE

If you have misconception there are monitoring hardware embedded in the Smart Cables, we are going to show you beyond any doubt there is no active electronics in the Smart Cables. The marketing messages "New Modular Technology" and "The Module is in the cable!" are mere imaginations of people without the necessary electronics knowledge.

What do the manufacturer mean by this statement? 

It started with the Life Scope TR (BSM-6000) series monitors in the USA market and gradually adopted officially for International markets. These are precise statements.

Keep in mind, the continued repetitions of an assertion without the ability to show proof does not make it the truth!

This is just assertion without showing any proof

 

Chip makers need huge demand to justify each of their products, so which chip manufacturer is supplying NIHON KOHDEN the variety of analog chips given the extremely low volume in demand? If we were to open up the plug of a Smart Cable, what do we see? A small PC board is seen attached to the pins of the socket as shown.

 

A small PC Board is soldered to some pins of the yellow connection plug

 

The PC board confirms a cheap digital EEPROM chip is being used to code the Smart Cable.

 

A cheap digital EEPROM chip was what we found inside the yellow Smart plug

If we were to open up the plug of a compatible IBP cable from China suppliers, what do we see? It is the same thing, a plug with a digital code defined by NIHON KOHDEN.

Under US FDA rule, a cable is only a cable if it does not change the signal that passes through it. A Smart Cable with a hexadecimal code is just a cable and does not change a signal passing through it, but if it has an amplifier it becomes a medical device and requires FDA registration. Can you find any stand-alone Smart Cables registered with US FDA as a medical device?

When the Smart Cables are used with serial kit sets, such as mainstream CO2 kit sets or the NMT AF-101P kit set, the registration is for the active serial kit set and not the passive Smart Cable. 

Clear proof the IBP amplifier hardware is embedded inside the monitor, an important fact withdrawn from later monitor manuals

 

The Life Scope BSM-2301 Service Manual provided details on the design; manuals for later models stop providing such information. The major move to curb details in manuals started from Life Scope J (BSM-9101) Bedside Monitor.

In below BSM-2301 service manual, you can see the IBP and thermistor respiration are internal hardware inside the Life Scope BSM-2301 monitor. These hardware are linked to the MULTI-parameter socket, and to make use of either hardware, a Smart Cable with the correct code must be plugged into the MULTI socket.

 

Can you see the IBP amplifier and thermistor respiration hardware are internal components of the Life Scope BSM-2301 monitor?

The MULTI-parameter socket doubles as a serial port without any need for internal monitoring hardware, only as a link to the monitor. In the block diagram below, the processed digital serial data from a CO2 kit set goes straight to the digital microcontroller APU (Analog-block Processing Unit) and is forwarded to the DPU.  For a parameter using the internal analog hardware, the analog signal needs to pass through an Analog-Digital converter before going to the APU for digital processing. 

Relevant page in the combined Service Manual for BSM-2301A, BSM-2301K, BSM-2303K, BSM-2304A

It should be clear the capability of IBP and Temperature comes from hardware embedded inside the defibrillator while the mainstream CO2 comes from a self-contained serial kit with digital processed output making use of the yellow MULTI-parameter socket only as a serial port.

There are two blocks of patient monitoring hardware in the TEC-8321 defibrillator, with one of the block only uses coded measurement cables known as Smart Cables for connection.

(ORDINARY BLOCK) The hardware using ordinary measurement cables:

- ECG

- SpO2

(MULTI-PARAMETER UNIT) The hardware in this block only use Smart Cables for connections:

- 1-ch IBP

- 1-ch Temperature

The mainstream CO2 comes in the form of a self-contained serial kit set, utilizing the MULTI socket only as a serial port.

(II) In the TEC-8322 defibrillator, the two blocks of patient monitoring hardware are:

(ORDINARY BLOCK) The hardware using normal measurement cables:

- 1-ch Temperature

- ECG

- SpO2

(MULTI-PARAMETER UNIT): The hardware in this block only use Smart Cables for connections:

- 2-ch IBP

- 1-ch Temperature

The mainstream CO2 comes in the form of a self-contained serial kit set, utilizing the MULTI socket only as a serial port.

(III) The two blocks of patient monitoring hardware in the TEC-8332 defibrillator are:

(ORDINARY BLOCK) The hardware using normal measurement cables:

- 1-ch Temperature

- ECG

- SpO2

- Pacing

(MULTI-PARAMETER UNIT) The hardware in this block only use Smart Cables for connections:

- 2-ch IBP (2 MULTI sockets = 2-ch IBP)

- 1-ch Temperature

The mainstream CO2 comes in the form of a self-contained serial kit set, utilizing the MULTI socket only as a serial port.

(IV) The two blocks of patient monitoring hardware in the TEC-8342 defibrillator are:

(ORDINARY BLOCK) The hardware using ordinary measurement cables:

- 1-ch Temperature

- ECG

- SpO2

- NIBP

(MULTI-PARAMETER UNIT) The hardware in this block only use Smart Cables for connections:

- 2-ch IBP

- 1-ch Temperature

The mainstream CO2 comes in the form of a self-contained serial kit set, utilizing the MULTI socket only as a serial port.

(V) The two blocks of patient monitoring hardware in the TEC-8352 defibrillator are:

(ORDINARY BLOCK) The hardware using ordinary measurement cables:

- 1-ch Temperature

- ECG

- SpO2

- NIBP

- Pacing

(MULTI-PARAMETER UNIT) The hardware in this block only use Smart Cables for connections:

- 2-ch IBP

- 1-ch Temperature

The mainstream CO2 comes in the form of a self-contained serial kit set, utilizing the MULTI socket only as a serial port.

Manufacturers make their profits by providing product benefits to users but the value captured by the users using Smart cables is negative. The TEC-8300 series defibrillators do not have a no good reason to make use of Smart Cables for monitoring mainstream CO2, IBP and Temperature.

 

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