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

 

 

The 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

Is there a good reason the CardioLife TEC-8300 series defibrillators choose to share connector sockets for monitoring mainstream CO2, IBP and Temperature?

 

Why share connector sockets?

It is claimed that a monitor sharing connector sockets 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 yellow adapting MULTI sockets are part of a legacy circuit known as a Multi-parameter Unit; there are concessions in exchange for using it, but this is not explained to the market and easily lead customers into having an unrealistic expectation of what the yellow MULTI sockets can actually deliver.

The Multi-parameter Unit was originally devised only to solve a product issue

 

 

In the 1990s, when developing the first digital modular monitor, the development team encountered a problem of insufficient front panel space for connector sockets on the first digital multi-parameter module being made. A few sockets were specially adjusted for time-sharing use by a group of five types internal analog hardware to overcome the space limitation; to differentiate them, they were colored yellow and known as MULTI sockets.

 

At the time NIHON KOHDEN was responding to an important emerging trend of using a high-density digital multi-parameter module as basic building block for modular monitors

 

In analog modular monitors, only single parameter modules were produced by NIHON KOHDEN. When designing the first digital modular monitor, the company discovered the critical care market had already moved to using a digital multi-parameter module with higher density of electronic components as a basic building block for modular monitors.

 

Apart from the higher electronic density, the difference between a single parameter module and a multi-parameter module is the presence of a CPU processor in the latter; the output of a multi-parameter module is thus processed digital data. This new development of distributed processing made it possible for patient data to be stored and moved with the module. Digital modules can also be connected directly to a (proprietary) digital data-exchange network as a node.

 

NIHON KOHDEN wanted to follow the trend by offering the first digital multi-parameter module, and the first digital multi-parameter module made by the company was named the Saturn module.

 

Responding to new trend in the 1990s using multi-parameter module as a basic building block for modular monitors

 

Even occupying a 3-slot width of the module rack, the Saturn multi-parameter module (August 1998) was not big enough to hold all necessary connector sockets

 

Nihon Kohden intended a module rack integrated physically with the main unit to form a limited footprint just big enough to stack the display monitor on top of it (see below illustration). The physical size of the Saturn module was therefore constrained; in addition, the multi-parameter module must work in combination with other parameter modules like recorder, sidestream CO2, BIS, EEG, Flow/ PAW, SvO2 in the module rack.

The Saturn module was intended to be physically small in size

 

The elegant but expensive solution from NIHON KOHDEN for the physical size limitation of the Saturn module was to adjust two of the connector sockets for sharing use

 

Two yellow MULTI sockets had to be adjusted for time-sharing use because there was not enough free space on the Saturn module for more sockets

There are two blocks of patient monitoring hardware in the Saturn module.

(PART A) The hardware using dedicated connector sockets:

- ECG

- SpO2

- NIBP

(PART B) The hardware sharing the two yellow adapting MULTI sockets in a separate Multi-parameter Unit:

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

- 4-ch Temperature (2 MULTI sockets = 4-ch TEMP)

- Cardiac Output

- FiO2

- Thermistor Respiration

The adapting MULTI sockets were additionally allowed to be diverted to act as a costly digital serial ports so that mainstream CO2 digital serial kit sets can also use it; this being an easy task since no internal analog hardware is being involved.

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

Remember this is for purpose of minimizing connector sockets on the Saturn multi-parameter module, as it does not make sense outside this context. In the next section, we will explain what is a Multi-parameter Unit in the Saturn module.

The label for the yellow MULTI socket indicated the five specific hardware plus mainstream CO2 using it as a serial port.

 

The label for the yellow MULTI sockets

 

Time-sharing means only one type of the internal hardware sharing the connector sockets has exclusive use of it at any point of time

 

There are cheaper and more practical alternatives to solving the problem of insufficient space on the input panel, such as commonly integrating more than one signal onto a socket and using an external splitter to resolve the signals.

 

Example of resolving integrated signals to individual P1 and P2

 

So far, time-sharing of connector sockets is only done by NIHON KOHDEN and not repeated by any other leading manufacturers of patient monitors for obvious reasons.

It is foremost important to know the cost is very high to share connector sockets.

 

The connector sockets that were being time-shared are known as MULTI Sockets and colored yellow. The yellow MULTI sockets must be used in conjunction with coded measurement cables known as Smart Cables, and the plug of a Smart Cable has the same color as the MULTI sockets. The Smart Cables are each marked with a digital hexadecimal code to identify the purpose of the measurement cable.

 

Overview

 

The digital code is stored in an EEPROM chip mounted on a small flexible PC board electrically wired to the pins of the cable plug. The hexadecimal code in the EEPROM is inserted at the factory and not allowed to change after production.

 

A code is stored in the plug of the measurement cable to give specific switching instruction to an engaged MULTI socket

 

The code in the plug makes known what parameter a measurement cable is meant for and it is the specific instruction to the engaged MULTI socket to link internally to any of the five types of parameter hardware, namely:

 

Temperature, Invasive Blood Pressure, Thermo-dilution Cardiac Output, Thermistor Respiration and FiO2

 

In short, the so-called "Smart Cables" make it possible for exclusive uses of the engaged yellow MULTI sockets via internal switching among five types of specific hardware mentioned above.

 

The MULTI socket is therefore an adapter socket with the ability to take specific switching instruction from the digital code stored in a measurement (Smart) cable

 

Principle of Operation

 

The Multi-parameter unit (MPU) in the Saturn module

 

In addition to expensive coded Smart Cables, there must also be costly mechanism internally to select the correct active hardware corresponding to the particular code of the cable being used.

The hardware sharing the two MULTI sockets are components of the Multi-parameter unit, together with internal mechanism needed to support the time-sharing. When a measurement cable with a Cardiac Output code is plugged into a MULTI socket, the internal Cardiac Output hardware will have exclusive use of the engaged MULTI socket. If a hexadecimal code is not detected (such as a damaged Smart Cable plug), the MPU would not do anything and none of the internal hardware would be linked.

 

Sharing of connector sockets is made possible by coded measurement cables and an internal Multi-parameter Unit

 

The MULTI PARAMETER UNIT is an official term found in the service manual

 

A yellow shared-use MULTI socket is a high-cost serial port when it does not select any hardware

 

MULTI socket poorly utilized as a costly serial port

The initial arrangement was only for mainstream CO2 serial kit sets, but later extended enthusiastically to BIS kit set, 2nd-SpO2 kit set, APCO kit set, NMT kit set etc., whose motivation is highly questionable given this greatly increases the interface cost compared to a plain serial port.

 

Make no mistake, the serial kit sets are self-contained and whether a particular kit set is supported depends on the system software, not on the type of connector sockets being used.

 

To reiterate, there is no difference if you connect digital serial data to the monitor through a yellow MULTI socket or an ordinary serial port

 

This is how you connect the BIS processor kit to a yellow MULTI socket

The multi-parameter unit is configured

The yellow MULTI socket by itself does not automatically mean all the five types of mentioned parameters are available for measurements; it still depends on whether any of the five types of active hardware are actually being placed inside the multi-parameter unit. The amount of configured hardware inside each multi-parameter is always different; so is the system support for serial kits. If a model is not equipped with FiO2 hardware internally, no amount of yellow MULTI sockets can provide this measurement capability.

In other words, it is the built-in hardware that determine the parameter capability; and in the case of serial kit sets, the system software. This of course, is the same description as a configured patient monitor

 

 

Actual internal hardware and system support for serial kits varies for each multi-parameter unit

This means a CardioLife TEC-8300 defibrillator/ monitor making use of the Multi-parameter Unit is still configured. The manufacturer has no reason to use the MULTI-parameter Unit; it is not flexibility, but dabbling with distortions and limitations.

The manufacturer must make skewed defibrillators that have more parameters to measure than the available MULTI sockets to share the use of connector sockets. What value can the users capture from using multi-parameter units that suffered from deficiency of connector sockets?

(I) There are two blocks of patient monitoring hardware in the TEC-8321 defibrillator.

(PART A) The hardware using dedicated connector sockets:

- ECG

- SpO2

(PART B) The hardware sharing the one yellow MULTI sockets in the Multi-parameter Unit:

- 1-ch IBP (1 MULTI socket = 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) The two blocks of patient monitoring hardware in the TEC-8322 defibrillator are:

(PART A) The hardware using dedicated connector sockets:

- 1-ch Temperature

- ECG

- SpO2

(PART B) The hardware sharing the two yellow MULTI sockets in the Multi-parameter Unit:

- 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.

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

(PART A) The hardware using dedicated connector sockets:

- 1-ch Temperature

- ECG

- SpO2

- Pacing

(PART B) The hardware sharing the two yellow MULTI sockets in the Multi-parameter Unit:

- 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:

(PART A) The hardware using dedicated connector sockets:

- 1-ch Temperature

- ECG

- SpO2

- NIBP

(PART B) The hardware sharing the two yellow MULTI sockets in the Multi-parameter Unit:

- 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.

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

(PART A) The hardware using dedicated connector sockets:

- 1-ch Temperature

- ECG

- SpO2

- NIBP

- Pacing

(PART B) The hardware sharing the two yellow MULTI sockets in the Multi-parameter Unit:

- 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.

Manufacturers make their profits by providing product benefits to users but the yellow MULTI sockets is a negative value captured by the users. The TEC-8300 series defibrillators have no good reason to share connector sockets for monitoring mainstream CO2, IBP and Temperature.

 

WATCH OUT the dangerous use of semi-quantitative estimation data for uncertain measurements and concurrently 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

Nihon Kohden solution was to offer miniaturized 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 alerted to the risk of using data from semi-quantitative etCO2 kit sets for critical measurements and true CO2 waveform display.

 

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.

 

Users just doing the inevitable

 

Shown below is another TG-900P etCO2 kit set (order code P903) that makes semi-quantitative CO2 measurements; the TG-901T3 kit set (order code P906) is the same thing using a different connection plug. The medical devices from same manufacturer that uses semi-quantitative etCO2 kit sets for patient CO2 waveform monitoring have Life Scope patient monitors, Vismo patient monitors, Cap-STAT OLG-2800, CardioLife defibrillators and Neurofax EEG machines etc.

 

Nihon Kohden semi-quantitative etCO2 kit sets

 

A highly relevant question: Can users accept estimated measurements for patient monitoring?

    

To save costs, the semi-quantitative kit sets do not make measurement during the inspiration phase, the measurement duty cycle is as shown. This means semi-quantitative CO2 measurements are not made continuously.

Semi-quantitative means there is a duty cycle, and measurement is 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.

As seen from the duty cycle, there is no measurement being made during the inspiration phase; how do the users know specified measurement accuracy is valid?

  

Measurements are invalid when CO2 is present during inspiration, but CO2 is not measured during this period; can you have confidence in the measurements?

 

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. The specified measurement tolerance therefore has no meaning for the users!

 

The users are also not alerted on screen there is no CO2 measurement being made during the inspiration phase, and unknowingly made to take an 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

 

 

How is it feasible to display a true continuous CO2 waveform when the 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 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 using quantitative method as declared. This sensor was designed for non-intubated adult CO2 monitoring, as well as neonatal CO2 monitoring. In short, Nihon Kohden is trying not to rely on others for sidestream CO2 sampling expertise.

 

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.

 

Undeniable confirmation the fragile miniaturized CO2 sensor is of poor design, and easily broken

 

 

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.

 

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

  

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

 

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! The clinical data and methodology fell short of US FDA guide for safety and effectiveness, and Nihon Kohden could have engaged a consultant if they had respected the validation process. The Acti-Biphasic defibrillation shock cannot meet the requirements to be allowed for sales in the US market; note the US FDA 510(K) process could not be used to clear the product since mono-phasic defibrillators are not predicate devices in the market. The often mentioned American Heart Association recommendations are therefore meaningless to Acti-Biphasic defibrillators.

Outside of the US market, we must ask what is 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 In Fact A Game Changer for NIHON KOHDEN

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, 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. With the deal with Heartstream, HP acquired the Heartstream biphasic technology and also expanded the line of external defibrillators to include lay responders users. 

 

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.

The global shift to biphasic defibrillation technology was an unexpected market disruption for NIHON KOHDEN

 

 

After more than four years, NIHON KOHDEN remained unable to offer biphasic defibrillators and the company had no choice but to look for a suitable partner with biphasic technology for the Japanese domestic market when the demand for biphasic AEDs emerged. 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

 

It was however impossible for NIHON KOHDEN to get any success outside of Japan since distributors could buy the original models at cheaper prices, directly from Cardiac Science.

 

Instead of licensing the design from Cardiac Science, a few engineers in NIHON KOHDEN quietly started to experiment with biphasic defibrillation on pigs and came up with the proprietary Acti-Biphasic defibrillation shock. It was done with minimal external 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.

 

 

The Absence of Internal Safeguards

 

Before completion of proper clinical validation, the company was bold enough to go ahead with exporting the first newly-designed Acti-Biphasic defibrillators from November 2002, relying solely on reputation of being an existing supplier of mono-phasic defibrillators. The November 2002 export launch was three long years ahead of the date Japan MHLW officially approved its use for the domestic market.

 

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

Japanese Regulatory Authority three (3) 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.

 

When the TEC-7700 series defibrillators had not even obtained approval from MHLW to sell in Japan, a new defibrillator series was launched with undisclosed Acti-Biphasic waveform flipped vertically upside down

 

Yes, before the TEC-7700 series defibrillators were allowed for sales in Japan, Nihon Kohden had incredibly gone on to launch another Acti-Biphasic TEC-5500 series defibrillators for export sales in August 2004. Why was the need to launch the TEC-5500 series when it was crystal clear the TEC-7700 series application with Regulatory Authority would take time for approval? This made the urgent launch of TEC-5500 highly suspicious and illogical.

We only learned later that for some unknown reasons, the manufacturer had surreptitiously decided not to continue with the original waveform!

 

 

This was the series later found to have Acti-Biphasic 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, without showing any clinical studies done to support its use.

 

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

The reason CardioLife TEC-5500 series defibrillators were quickly approved for sales in Japan was based on the principle of declared substantial equivalence with the newly-approved TEC-7700 series

 

Current TEC-5600 series, TEC-8300 series output waveform are similar to TEC-5500 series defibrillators, how about submission documents for foreign regulatory approval which are all based on the TEC-7700K series? We also could not help wondering if the domestic and export versions of the Acti-Biphasic shock energy are currently identical?

 

 

A top prestigious University Hospital in Taiwan was the first to find the polarity of TEC-5500K output waveform inverted from the original shown on the manual

 

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 from 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. The investigation raised many questions and only the IEC60601-2-2:2002 electrical safety compliance was put to rest.

  

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 output waveform from the 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!

 

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 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

Does the inverted waveform only apply to production batches meant for export?

 

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.

 

Change in current direction demands fresh clinical trial and validation

As a responsible company with a Corporate Social Responsibility (CSR) policy in place, NIHON KOHDEN must act fast and should have by now long recalled both the TEC-7700 series and TEC-5500 series defibrillators from the market.

 

 

 

The Acti-Biphasic defibrillation output of AED-2100 series is seen avoiding the original waveform in a different 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

 

The newer CardioLife AED-1200K series and AED-3100 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 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 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 with its monophasic discharge waveform dated April 1995

 

 

Be warned that a mono-phasic defibrillation must be able to deliver a 360J shock energy

 

 

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 recommendation for monophasic defibrillator, which Nihon Kohden is allowed to sell in the US market.

 

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.

 

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