Export of unproven NIHON KOHDEN Acti-Biphasic Defibrillators In November 2002

Category: NIHON KOHDEN (日本光電) Life Scope monitoring history from the 1990s; In this article we look at the company-wide confusion prevalent in November 2002 such that a new biphasic defibrillation discharge design was launched for export sales without ascertaining its clinical efficacy on human patients. NIHON KOHDEN could not obtain approval from Japan Regulatory Authority for sales of her first biphasic defibrillator in Japan until December 2005 (i.e. three years later).

 

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NIHON KOHDEN Life Scope Patient Monitors Struggling The Disruptive Digital Revolution (IV)

What Not To Do Is Fundamental

The essence of strategy is choosing what not to do - Michael Porter

 

 

The second major export after patient monitors is defibrillators for NIHON KOHDEN CORPORATION. The low volumes of sales for neurodiagnostic equipment, ECG machines, blood cell counters, ventilators etc. means each only individually accounted for a small percentage of export sales for the manufacturer.

The ticking time bomb

 

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 in May 1997, 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. 

 

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in the monophasic TEC-2200 series defibrillators offered by Nihon Kohden for ex-Japan market and the products had to be withdrawn from exporting.

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

 

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.

Biphasic defibrillation was a nightmare, one that caught NIHON KOHDEN off guard

It was a market disruption that NIHON KOHDEN was unprepared for. The company was at a loss for the next four years how to obtain the technology to offer biphasic defibrillators.

When the demand for biphasic AEDs emerged in the Japanese domestic market, the company had 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 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.

The Acti-Biphasic waveform is seen as operating in an open loop during the first phase and in a closed loop during the second phase. It is a positive pulse during the first phase and of variable duration dependent on patient impedance. In a closed loop during the second phase, the duration of the width is therefore constant and being set to 3.4ms; it is not clear why 3.4ms constant width during second phase is optimal and why 270 Joules maximum energy is sufficient.

 

The first phase 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 discharged by CardioLife TEC-7700K series defibrillators is consistent with the declared waveform

 

The discharge waveform of the CardioLife TEC-7700K series on a strip chart is as shown below. The recording correctly reflects the first phase as 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

 

This strip chart recording shows 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 absolutely 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. This implies the design is not yet good for use, and further improvements are needed for it to meet US FDA requirements.

It is additionally needed to clarify current CE certification is no guarantee of clinical performance since clinical validation is not included.

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? Remember, compliance to just safety standards is no guarantee of performance! It is so unfair to the patients needing immediate treatment in a life-threatening situation!

Customers were sold 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, taking advantage of its established distribution network for mono-phasic defibrillators. The sales were done based on blind faith, 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 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 unattended.

 

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

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

 

The long three years period 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 defibrillator 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.

The hidden REGRESSION to a totally-untested new type of Acti-Biphasic defibrillation output energy

 

However, there was a totally unexpected event before the above-said announcement.

 

More than a year prior to above announcement, 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 before Regulatory Authority approval for TEC-7700 series defibrillators? It does not make sense, the urgent launch of TEC-5500 series defibrillators for export was thus a dubious event without a satisfactory explanation.

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

 

This means that at this point, the manufacturer had already quietly decided to stop the continued use of declared discharge waveform (for export) that is still being published on the service and operator manuals.

This was happening right before Japan MHLW granted approval for the TEC-7700 series, and without showing any clinical evidence to support its use!

 

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

 

The Timeline

Export of dubious 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 waveform of Japanese version TEC-5500 series defibrillators are unlikely to be different from the biphasic shock waveform of TEC-7700 series defibrillators in Japan.

However, the TEC-5500 series, TEC-5600 series and TEC-8300 series export models were all found to have their discharge 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 discharge waveform inverted from what was declared in the operator and service manuals

In the image below, we were greatly confused 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 is 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 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 wave 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 a top distributor who had sold the highest number of CardioLife TEC-7700K series defibrillators in the world and knew too well 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 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 discharged waveform is flipped upside down, the already-scanty TEC-7700 series clinical data cited becomes totally 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.

Users were not impressed with use of Smart Cables on Life Scope BSM-2300K series bedside monitors

In 2001, a popular Life Scope BSM-2301K (also known as Life Scope i) was launched and many customers bought it for standalone applications not restricted by system compatibility. It was popular because the Life Scope BSM-2300K series range of monitors were the first in the industry to adopt the new-generation type 8.4-inch high-resolution touchscreen introduced by the electronics industry. The new touchscreen display was a huge jump in touchscreen technology and made for highly-intuitive operation, hence its popularity. The company tried to attribute its popularity to the use of Smart Cables and Multi-parameter Unit.

 

The portable 8.4-inch Life Scope i (BSM-2301K)

 

A flexible socket does not replace two missing connector sockets

To insist use of Smart Cables, the Life Scope BSM-2301K monitor has one MULTI-parameter socket for three types of measurements, namely:

 

a. Invasive Blood Pressure

b. Thermistor Respiration

c. Digital self-contained mainstream CO2 serial kit sets.

 

The MULTI-parameter socket does not mean flexibility and is a burden because you can only do one of the above parameter at any one time. Common sense tells us three dedicated sockets is far superior; why suffer the pain of two missing sockets?

 

Life Scope-i does not have enough connector sockets

 

The use of a MULTI socket in Life Scope BSM-2301 bedside monitor is self-contradictory from the start. We have to ask why is the monitor avoiding the use of the MULTI socket to access the Temperature hardware if sharing is a preferred capability? This is a slap on the face for anyone proposing use of MULTI sockets on bedside monitors!

The two blocks of patient monitoring hardware in the Life Scope BSM-2301 bedside monitor are:

NORMAL BLOCK

(These hardware use dedicated sockets and ordinary measurement cables)

- 1-ch TEMP

- ECG

- SpO2

- NIBP

MULTI-PARAMETER UNIT with one MULTI-parameter socket

(These hardware only use Smart Cables for connections)

- 1-ch IBP

- Thermistor Respiration

< Self-contained kit sets using Multi-parameter socket as serial port>

- mainstream CO2

The reality is the shortage of two connector sockets, and the flood of complaints from users insisting the single MULTI connector socket on the BSM-2301K was not enough. The manufacturer was pressured to respond with an updated model (BSM-2303K) with an isolated MULTI socket added. The isolation was done so as not to disturb existing Multi-parameter Unit with an additional MULTI socket. It means the additional MULTI socket is not a functional MULTI socket; to be fair, the label for this non-functional MULTI socket was not indicated as a MULTI socket but as IBP.

 

The isolated MULTI-parameter socket was intended solely for IBP monitoring, effectively relieving the existing functional MULTI-parameter socket to only measure either Thermistor Respiration or act as serial port for the mainstream CO2 kit set. The solution was only partial, and it reduced two missing sockets to one missing socket; a total solution would have been just using dedicated sockets as there is no need for socket sharing. There was no need for the Smart Cables.

There was no actual demand for additional IBP channel, but the BSM-2303 bedside monitor was camouflaged as an upgraded monitor with 2 channels of IBP.

Under pressure, an additional isolated MULTI socket acting solely as an IBP amplifier had to be introduced

The success of the BSM-2300 series was not sustainable since touchscreen technology was not proprietary and it just prompted every patient monitor manufacturer on earth to respond to the popularity of touchscreen technology, with Philips as the most aggressive. Philips product range is wide, most models also had a non-touchscreen version preferred by some users; the approach by Philips greatly segmented the patient monitors market and presents a major challenge for Life Scope monitors with only a limited product range. The problem is even larger if other range from Philips such as Goldway, Efficia etc. are taken into consideration.

The configured Life Scope BSM-2300 series was succeeded by the 10.4-inch Vismo series configured multi-parameter monitors, as well as configured Life Scope VS (BSM-3000) series monitors using bigger 12-inch and 15-inch screens. The later series monitors stubbornly keep the yellow MULTI sockets and continue to promote use of Smart Cables, for a reason that will become clearer later in this article.

 

 

The dangerous use of semi-quantitative CO2 measurements and ignorantly 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 have never been able to offer benefits of integrated sidestream CO2 measurement.

 

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 (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

 

Is the manufacturer even aware that semi-quantitative CO2 measurements are only estimates?

 

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

The manufacturer is ignorantly displaying a flawed continuous CO2 waveform using semi-quantitative measurement kits that do not have 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 to display a true CO2 waveform on the screen.

 

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

 

What you should know about fully-quantitative type miniaturized mainstream CO2 sensors

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 are clearly of poor design, and easily broken

The key point is, it does not last

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👉 Chapter Five:  Life Scope J camouflaged as a Digital Modular Monitor after failed attempt to make one

^^^