NIHON KOHDEN Life Scope Patient Monitors Struggling The Disruptive Digital Revolution

 
 
 

It is recorded and shared so that true history shall always be remembered as it was.
 
In this record we traced the reasons for the perpetual struggle by NIHON KOHDEN with the disruptive digital revolution since the 1990s, and this is still current ongoing (but unacknowledged) dire situation! The incompetence to complete a comprehensive real-time digital communication networks for the Life Scope Patient Monitors led to denial and taking ill-considered risks in exporting unproven new-type biphasic defibrillators in November 2002. Subsequent events were even incomprehensible, it is now a ticking time bomb waiting to explode with many key issues unaddressed.
 
The detailed chronological events that led to NIHON KOHDEN giving up the development work to make digital modular monitors should surprise many, given the great efforts put in to hide this poor state of affairs; to move forward positively, the absurdity highlighted in this article must be first set right.
 
 

(I)

Back To The Future In The 1990s

The longer you can look back, the farther you can look forward -  Winston Churchill


A profitable and comfortable position was taken away from NIHON KOHDEN by the Digital Revolution

 
First, for perspective: The highest revenue for NIHON KOHDEN CORPORATION from exports comes from patient monitors, followed by defibrillators, together they formed more than 70% of the company's sales in foreign markets. All other products contribute only a small part to the export business.

The disruptive digital revolution brutally pushed back by decades the technological progress of NIHON KOHDEN, whose strength is mainly in traditional analog electronics; many of you will be stunned to learn what is the company's current digital capability for patient monitoring. The details are available in this article for your critical evaluation.

During the 1990s, the company was seen grappling with a huge technological gap to catch up with International players; the overall situation was so bad that an overhaul of the entire product range was needed. Speed and intense investment were the two critical elements to make up for the lost time but the company relented after encountering the first failures. NIHON KOHDEN had lost the opportunity to catch up, and the company is way far behind international competitors today.
 
When digital Ethernet networking had become the norm in foreign markets, Nihon Kohden Corporation in Japan was still helplessly struggling with the outdated analog type signal exchangers. The only reason the company is still around today is due to the fact Japanese domestic market for medical equipment is a protective one, and domestic companies are insulated from competing directly with foreign companies on the basis of technologies.
 


NIHON KOHDEN patient monitoring products were shunned in foreign markets

The problem faced by the company in foreign markets has always been how to create value using outdated technology! The absence of know-how to offer even basic level of digital networking (LAN) in Patient Monitors in the 1990s meant the collapse of NIHON KOHDEN export sales for Life Scope Patient Monitors; the only exception was export sales linked to Japanese Government ODA projects. As seen in the USA market, sales recovery was so gradual and hardly noticeable that many from the younger generation had erroneously mistaken it as a new emerging brand in the market!
 
For a good SUMMARY of the Patient Monitoring market up to the late 1980s, Michael E. Porter had one in his book The Competitive Advantage of Nations (1990; Republished with a new introduction, 1998).

From the early 1990s the Life Scope Patient Monitoring Systems had already shown rapid technological irrelevance. In August 1998, Nihon Kohden finally launched the first Life Scope modular monitor using a digital interface between monitor main unit and modules, but this turned out to be a failure and the company lost the willpower to continue.
 
It was only five years later, in September 2002, through the examination of a new Life Scope A series monitors could any observer confidently conclude the poorly-designed network platform for digital measurement data was already abandoned and everything from then on are just for show.

Instead of confronting it squarely as a representative patient-monitoring brand from Japan, the company kept busy thinking about all the means possible to hide their incompetence for scalability of monitoring parameters using digital networking. The analog yellow MULTI-parameter sockets was chosen to pass off absurdly as digital nodes connecting to a non-existent measurement data network platform.



What are the types of patient monitoring products NIHON KOHDEN was exporting in 1997?

Take a look at this scanned copy of the Nihon Kohden 1997 Product Guide (click for PDF), the booklet contained the details of CardioLife TEC-2200 series defibrillators which were officially launched in May 1997, thus May 1997 sets the earliest possible publication date of this product guide beyond the slightest doubt.
 
https://drive.google.com/file/d/1Fl5-oOOLnXyxQpldbqKvY1gS8iDdxNCe/view


The patient monitors in the said guide show product details of Life Scope 9, Life Scope 14, Life Scope LC etc. linking to CNS-8300 Central Monitors via bulky analog signal exchangers instead of compact digital network hubs.
 
Information about USA FDA registrations during this period for Nihon Kohden patient monitoring products are readily accessible on the Internet.

 
The legacy analog signal exchange network was the only type available for sales in 1997



Without doubt, the 1997 patient monitoring product range lacked digital era displays, connectivity and storage

The CNS-8311 Central Monitors (released in mid-1995) shown in the network diagram was developed in a US software workshop (Nihon Kohden USLab) using a proprietary GUI (graphical user interface) running on top of Microsoft MS-DOS operating system.

This PC-based Central Monitor, however, could not enjoy the benefit of an Ethernet link because there was no place to connect to. The Ethernet factor was something prospects were so keen to first inspect for networking but prominently missing in NIHON KOHDEN portfolio. This was the year there was a big surge in Ethernet networking knowledge after Microsoft released the Windows 95 operating system which kick-started the mass adoption of the Internet and Ethernet. In 1995, the Ethernet card was still expensive and sold as an option to the basic PC; Internet IP was not common knowledge yet but an Ethernet LAN setup allowed multiple PCs to share internet access using only a single dial-up router (via a telephone line) to a service provider.
 
The outdated analog signal exchanger on roller wheels (left) offered by NIHON KOHDEN in 1997

  
The analog signal exchanger for linking bedside monitors to the Central Monitor used by NIHON KOHDEN was heavy, bulky and outdated. It stood out prominently as highly crude against international competitors like SpaceLabs or Marquette patient monitors who were using state of the art digital Ethernet LAN for communication as standard.
 
Each cable running between bedside monitor and said signal exchanger was loaded with 37 strands of thick wires in it and was heavy, making it clear the installation cost was also very high; there could not be any profit for system sales even if customers could be found.
The chances to find buyers were very low for the outdated analog type exchange network and if it was not for the fact information search was not yet well-developed, there would not even have any prospect from less advanced economies (that were not well-informed enough). In the USA market for example, sales plunged from tens of millions US dollars in annual turnover to practically nothing! That was the reality the company had to face.

Imagine the Life Scope 8 bedside monitor launched in August 1993 was still using a 7-inch monochrome analog CRT as display when digital type Electroluminescent Displays (EL flat panels) was already the default standard in ex-Japan market for this product class.
 
Customers outside of Japan were no longer looking for bedside monitors using CRT display

There was no demand for such export from Japan and Life Scope 8 bedside monitor was of course short-lived for the export business, how could it be otherwise?

The patient monitoring products are grouped together in the image below to give a better visualization of the Life Scope product range at the time. The Life Scope LC was the first and only model with a digital display released in October 1996 but it had a color LCD screen. This Life Scope LC monitor was not relevant for the export market since color display was still expensive and a niche segment for brand loyalty; it was a product targeting the Japanese domestic market.
 
NIHON KOHDEN in 1997 had a range of products with a huge digital gap to close

The processing unit of Life Scope 14 (launched in July 1992) at 18kg was huge, and complemented by an even larger 25Kg monster display (above image). As a comparison the equivalent processing unit (Computer Module) of HP Merlin (M1176A) together with the display was less than 20kg and the market leader was selling it at a cheaper price.


Life Scope monitoring products were not saleable in foreign markets even as stand-alone devices (i.e. without the need for digital networking)

The only viable business for the export business was to sell a single or scant few standalone monitors to more remote places where the competitors were neglecting due to the miserably low volume; a purchase order of just three monitors made an exciting big deal!

 Fortunately, Nihon Kohden was able to benefit from sales to the Japanese Government through their Official Development Assistance (ODA) projects which was a good source of income for export. The selling prices were based on domestic market prices which were twice that of the export market and exclusive to only domestic bids from Japanese companies.
 

(II)

Exporting Without A Strategy

A Strategy delineates a territory in which a company seeks to be unique -  Michael Porter
 
 
How was it possible for a business relationship to exist between Nihon Kohden Corporation and Marquette Electronics, Inc. in the 1990s?
 
Below image shows the Marquette bedside patient monitors range (Eagle Monitors for standard monitoring while Solar Monitors for premium cardiac care) in the 1990s.

 
Marquette Eagle and Solar monitors in the 1990s

Marquette was using high-contrast digital EL flat screens for the monochrome Eagle Patient Monitors. While the Eagle 3000 could have optional recorder attached, the Eagle 4000 monitors could only use a network recorder which was vocabulary unknown yet to a legacy NIHON KOHDEN Life Scope network.
 
Marquette Bedside Monitors using monochrome digital EL screens


While Marquette was already declaring the Unity network IEEE 802.3 compliance at the system level, NIHON KOHDEN could not yet produce a single monitor with this compliance. At the time, we were seeing market players with Ethernet Connectivity competing who could offer the most digital connection nodes on an Ethernet Network

Marquette Unity network

With such a busy digital battleground around the world, it is thus noteworthy to know that Nihon Kohden Corporation in December 1994 concluded an agreement with Marquette Electronics to sell and service Marquette products in Japan. Marquette Electronics was looking for a distribution channel for their products in Japan and selected Nihon Kohden Corporation as their distribution partner. Marquette Electronics had the advanced Cardiology solutions (not limited to patient monitors) badly needed by Nihon Kohden for their business in Japan, while distribution choices for Marquette Electronics were limited.



Substantial current incomes and profits are derived from being an importer of medical devices

In the domestic market in Japan, Nihon Kohden Corporation has two equally important roles, that of manufacturer and also a protected leading distributor for imported products. For example, the company imports Hamilton Medical ventilators, anesthesia machines, BIS (Bispectral Index) monitor, branded consumables and many more, to sell them in the domestic market for a profit.

NIHON KOHDEN is also able to combine technologies of complementary imported products with their own to create valuable customer solutions in Japan. In reality, the company picks and chooses from the product range of foreign manufacturers, leaving out the ones that compete directly with their own products; the reason they can do so is because the company owns protected distribution channels in Japan, it is impossible for foreign manufacturers to set up their own distribution outlets. Thus, a big proportion of the corporate incomes and profits in each fiscal year are generated from selling products in Japan made by third-party world-renowned companies, and it should be of interest to foreigners how these incomes and profits are being reflected on the balance sheet.

Since captive customer solutions in Japan are a combination of own and distributed products, such solutions cannot be exported due to strict restrictions of distribution territory. Customer solutions are badly needed for oversea markets, as they provide the better margin needed for business growth; this is the major weakness of NIHON KOHDEN as an exporter for solutions.
 
It is no coincidence good market reports on the Asia-Pacific region typically do not include the Japanese market; the prices for patient monitors in the Japanese domestic market (being a highly-guarded closed market) are well-inflated to double what are found in foreign markets. This means the turnover of a company operating in Japan is double that of a similar company operating in another country, and a direct comparison is meaningless. Without doubt, NIHON KOHDEN should see the competitive and turnover situation in Japan taking a drastic turn for the worse if the domestic market has to be opened up in a trade negotiation.

The domestic and export businesses are worlds apart; the roles played by the products that are only meant for domestic distribution will be the product gaps for the export business! This naturally limits the business potential of any accessible market and making published market reports irrelevant. Distribution partners who are already suffering badly from the product gaps, must still face a highly subjective evaluation from NIHON KOHDEN who is relying on published market reports and GDP growth figures to judge the performance of distributors.


The current export business model of NIHON KOHDEN is not competitive and is deplorable

Based on Michael E. Porter's Competitive Five Forces, the business model is one of major strengths in the protected domestic market with market entry barriers greatly favoring the company but glaring weaknesses and limitations when moving out of the comfort zone into the International arena.

Product gaps mentioned earlier greatly limits the realizable sales potential in any market and significantly enhances the bargaining power of the buyers, making it very challenging for any seller to capture value in highly competitive markets.

Besides the product gaps and with limited development resources, product designs are only fine-tuned to the peculiarities of the domestic demand with very selective responses to the outside world demand. For consumables made by NIHON KOHDEN, the prices are way off the mark compared to market prices; for example, quality 3M disposable ECG electrodes are sold to end-users only at a fraction of the prices Nihon Kohden ECG electrodes are offered to distributors! In practice, distributors can only focus on the NIHON KOHDEN hardware and sell consumables from alternative manufacturers who can meet the market prices (although strictly speaking, this is not allowed under the distribution agreement). Consumables sales for the export market only represents a small percentage of the annual export sales and the bulk of it are from the customer's initial hardware purchase. To show there is indeed meaningful consumables sales, what used to be standard accessories for equipment were repacked as consumables and counted as such when a hardware sales in transacted.

Without sizeable recurrent consumable sales, each new fiscal year's export sales is only about selling new hardware with a high degree of uncertainty, and therefore revenue volatility. Reports of consistent positive growth from any sales office should therefore be taken with a big pinch of salt; there is just no competitive advantage at all for the export market! In the absence of a product strategy for the export business, the export operation is only surviving on a business of selling hardware as cheap as possible each new fiscal year, and year after year, years after years.


NIHON KOHDEN has no unique value proposition and is long stuck in a commodity market segment of the highly competitive export markets

There is currently no solution at the system level to acquire, or to lock in high-value customers, denying NIHON KOHDEN resellers (including subsidiaries) the better margin needed to sustain their business growth; a big order simply means a purchase order with exceptionally low margin, as is the case for any commodity sales.

When the acquired customers become successful, their needs move from hardware purchase to paying for monitoring solutions; it is a day of extreme pain for NIHON KOHDEN resellers when this happens. They literally have to surrender the hard-earned customers to competitors who had been waiting patiently for this D-day.

It is highly frustrating for NIHON KOHDEN resellers to keep spending time and money to acquire new customers, only to painfully see them leave through no fault of theirs. Like clockwork precision, the successful customers will leave at the point the resellers could benefit most profitably from the acquired (but now lost) customers.

A good product strategy does not need any business from World Bank projects, this is one exposed manifestation example the kind of business the company is going after. This is a subsidiary, not a distributor; what is driving them to do this?


No sustainable export sales growth is possible without a unique proposition

 
Technical co-operation with big players outside of Japan is impossible to realize because of the company's perpetual fear of bringing these players into the protected Japanese domestic market, NIHON KOHDEN therefore offers very little co-operation compared to other manufacturers when system integration is needed for their products. This approach clealy shrinks the accessible market further, how can anyone keep growing the business?

When under siege, the company's survival instinct is to hold on to the domestic market at the expense of the export market, wasting years of efforts by individuals in foreign markets.



(III)

Digital Defeat: A Crushing Blow That Echoes Endlessly

 
Our greatest glory is not in never failing, but in rising every time we fall -  Confucius


It was exciting time for NIHON KOHDEN in August 1998, as the company was preparing for the launch of the first digital modular monitor and expecting the worst to be finally over. It was unsuspectingly the onset of a much bigger crisis.
 
With the race against time, the 1997 Asian Financial Crisis was a relief from the red-hot Asian markets where competitors were all having a great time growing their businesses exponentially while Nihon Kohden was only getting a few crumbs! Against such a battered backdrop, the focus for NIHON KOHDEN cannot be on innovation but getting the first digital-based monitors out as soon as possible. Any claim of innovation from this period is doubtful and should be questioned.
 
NIHON KOHDEN's attempt to make digital modular monitors was a failure, one that was unfortunately disastrous.


The failure to make bona fide digital modular monitors
 
The moment came that Life Scope S (BSS-9800) Bedside Station as the first Life Scope model to offer Ethernet LAN connectivity was finally launched in August 1998 (Signals 354) internationally. For a while it did seem that the worst was finally over, but it was game over even before the product could be launched in the biggest US market.
 
The failure turned disastrous as it led NIHON KOHDEN to initiate an all-out effort to hide the incompetence to make digital modular monitors, and also took ill-considered risks to export unproven new type biphasic defibrillators three years ahead of official approval for domestic use in Japan.
 
The first NIHON KOHDEN digital modular monitor launched in August 1998

 
The Life Scope S Bedside Station was to replace top-model Life Scope 14 (BSM-8800) and herald to the export market NIHON KOHDEN was finally into the digital age.
 
Life Scope S Bedside Station unfortunately, was a product failure

 
The Life Scope S bedside station was launched with many missing software, scheduled for gradual upgrading over time. When the Life Scope S product development was suddenly suspended about a year from its export launch, these planned upgrades were left unfinished.

The top-model Life Scope S bedside station was complemented by a lower-priced Life Scope M (BSM-9510) bedside monitor, using the same measurement data-exchange network platform as Life Scope S. The Life Scope M bedside monitor had lower processing power, only capable of sharing basic modules with Life Scope S bedside station.

As shown, the Life Scope M bedside monitor had a built-in six-slot module rack.

Lower-priced Life Scope M (BSM-9510) modular bedside monitor complemented the Life Scope S bedside station

 
Life Scope M modular monitor was launched in June 1999, only to be abruptly withdrawn from the market just not long after launch. The abrupt end to BSM-9510 (Life Scope M) modular monitor showed there was serious doubts about the performance of the new modular bedside monitor even as a basic patient monitor.
 
There remained no official confirmation of product withdrawal, so it certainly looked like the problem could be fixed with time; this, unfortunately, is the usual way NIHON KOHDEN keeps subsidiaries and distributors motivated. The assumption was not realistic, only to be negated three years later when configured Life Scope A (BSM-5100) series monitors was tacitly released as replacement for Life Scope M modular monitor.

Life Scope M (BSM-9510) modular monitor suffered the terrible destiny of a quick death
 

Life Scope S (BSS-9800) Bedside Station was responding to 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. However, when designing new digital modules for the Life Scope S bedside station and Life Scope M bedside 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.

 
Marquette modular monitors distributed by NIHON KOHDEN in Japan

In Life Scope S BSS-9800 Bedside Station and Life Scope M BSM-9510 Bedside Monitor, Nihon Kohden wanted to follow the trend, which was to release multi-parameter modules for the first time, similar to what Marquette was already offering for Solar 7000/8000 modular monitors.
 
There were many types of Marquette multi-parameter TRAM modules to choose as basic building block
 
For Nihon Kohden to offer a variety of multi-parameter modules would only exacerbate a long-standing delivery problem, it was eventually decided to offer only one type of multi-parameter module for all prospects. This meant only one comprehensive type of multi-parameter module was offered and it was named the Saturn module. The manufacturer could do it because it has strong bargaining power in the protected Japanese domestic market.

NIHON KOHDEN offered only one type multi-parameter module as mandatory building block for modular monitor

Not all the hardware were needed by each prospect but there was only one type multi-parameter module, it was either take it or none; if you have a small need, this module is not what you want. Obviously this is not acceptable in ex-Japan market when facing strong competitors with various multi-parameter modules for customization. Many prospects could not even pronounce the brand correctly outside of Japan. Shown below is BSS-9800 brochure offering only one type of multi-parameter module at its launch in August 1998.
 
The bargaining power of NIHON KOHDEN in Japan
 

Being small, the Saturn multi-parameter module (August 1998) lacks the space for 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 multi-parameter was therefore constrained; in addition, the multi-parameter module must still work in combination with other parameter modules like recorder, sidestream CO2, BIS, EEG, Flow/ PAW, SvO2 in the module rack. In conclusion, we ended up seeing a small Saturn module with insufficient space to hold all the necessary connector sockets.

The Saturn module was intended to be physically small in size


The solution for panel space limitation of Saturn module was to introduce a MULTI-parameter Unit with many hardware sharing two yellow sockets
 

The concept of a MUTLI-parameter Unit (MPU)

NIHON KOHDEN identified five types of analog hardware that can be linked from the inside onto the MULTI-parameter sockets, and to make use of these hardware, a cable with the correct digital code on its plug must be inserted into one of the yellow MULTI-parameter sockets. These cables with coded plugs are collectively cited as Smart Cables by the manufacturer and the codes are also known as parameter codes. Each MULTI-parameter socket selects only one channel of the hardware, except for Temperature allowing two channels of hardware to be selected.

Take note the hardware mentioned here are linked to the yellow Multi-parameter socket internally, and not from the outside.
 
A measurement cable with the correct code in its plug can make use of any of the internally configured hardware shown here

The configured hardware are grouped into a block known as MULTI-parameter Unit. It is the hardware rule that all MULTI-parameter sockets must be able to do IBP monitoring, each socket comes attached with its own exclusive IBP hardware to adhere to this rule. The term "exclusive" means the IBP hardware attached to each yellow socket is not intended for sharing by other MULTI-parameter sockets. A MULTI-parameter socket makes use of its own IBP hardware when a measurement cable with an IBP code is plugged into it. For non-IBP monitoring, the socket can access a common pool of Temperature, Cardiac Output, Thermistor Respiration and FiO2 hardware in the MPU, which are designed for sharing use by all yellow MULTI-parameter sockets.
 
The Saturn module turned to two shared-use connector sockets as solution to the constraint of space

In the Saturn module, the hardware are divided into two blocks, a normal block and a MULTI-parameter Unit.

NORMAL BLOCK
(These hardware make use of dedicated sockets and ordinary measurement cables)
- ECG
- SpO2
- NIBP

MULTI-PARAMETER UNIT with two yellow sockets
(These hardware share the yellow sockets and only make use of Smart Cables for connections)
- 2 channels of IBP  (2 MULTI-parameter sockets = 2-ch IBP)
- 4 channels of Temperature  (2 MULTI-parameter sockets = 4-ch TEMP)
- Cardiac Output
- FiO2
- Thermistor Respiration
   < Self-contained kit sets using Multi-parameter sockets as serial ports includes mainstream CO2 only>

Huge amount of hardware had to share only two modified connector sockets as a compromise

Notice the MULTI-parameter Unit design has many hardware sharing only two MULTI-parameter sockets, this is because it was devised to solve the problem of limited panel space. When panel space is enough to accommodate all needed connector sockets, it is effectively throwing money away to adopt this design; seeing this in use in later monitors when space is plentiful means caution there is more than meets the eye.

Given the large amount of hardware in the MPU block, more MULTI-parameter sockets should be added whenever possible, to make good use of the hardware that would otherwise gone unutilized; this is actually done by using an external expansion box filled with MULTI-parameter sockets, each with its own IBP amplifier hardware.

Analog solution of adding more sockets, not monitoring parameters

The additional sockets are added using analog interface, and limited to a maximum four MULTI-parameter sockets, to avoid signal deterioration caused by voltage drop and noise.

The image gives an impression of scalability but this is scalability of connector sockets, and not the scalability of monitoring parameters that is being sought after by the market. All necessary hardware are already configured in the Saturn module except for additional IBP amplifier which must always come with each MULTI-parameter sockets. A MULTI-parameter socket must make use of its own IBP hardware when a Smart Cable with an IBP code is plugged into it; for the other four parameters, the sockets are linked to the common pool of Temperature, Cardiac Output, Thermistor Respiration and FiO2 hardware already embedded in the the MULTI-parameter Unit of Saturn module.

It is the hardware rule that all MULTI-parameter socket must be able to do IBP monitoring, each socket has its own IBP hardware that is not shared

What you are seeing is making use of external space to add up to four missing sockets to the Saturn module. The extension Smart module is therefore a 2-channel IBP box with two usable MULTI-parameter sockets.

The MULTI-parameter 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 is the part that involves using external monitoring hardware, but the external mainstream CO2 unit is self-contained and supplying a processed digital serial output, using the Multi-parameter socket only as a link to the monitor. We must remember this is for purpose of minimizing connector sockets on the Saturn multi-parameter module, and it does not make sense outside this context.


Bear in mind, a yellow MULTI-parameter socket is a high-cost serial port when it does not select any internal hardware
 
MULTI-parameter 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.

The use of Smart Cables for serial communication does give a false illusion of mighty MULTI-parameter sockets but the capabilities are in reality coming from the system software.
 
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 repeat, there being no difference connecting digital serial data to the monitor using Smart Cables or ordinary serial cables
 

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

Using Smart Cables for serial interface means an unnecessary jump in demand for more yellow MULTI-parameter sockets and there is no technical need for the serial kit sets to use the yellow MULTI-parameter sockets. Putting things into perspective, most patient monitoring parameters cannot be made into self-contained serial kits; for example, the AE-918P Neuro Unit or a strip chart recorder cannot be linked to a yellow MULTI-parameter socket as serial kit as shown. They are connected as external devices to a monitor.
 
The AE-918P Neuro unit and recorder module are examples that cannot make use of the yellow MULTI sockets


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


The Saturn module, together with two satellite boxes adding 4 channels of IBP to the Saturn module is shown below. The four MULTI-parameter sockets on the satellite boxes can also access the MPU of the Saturn module. Together, six IBP channels and six shared-use MULTI-parameter sockets are available to the users.

The sockets on the satellite boxes compensate for the missing connector sockets on the Saturn module

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.

Putting it in perspective, the only advantage of sharing connector sockets is the utilization of lesser panel space. The saving from hardware cost is negligible; the cost needed for connector socket sharing, in contrast, is way far higher.
 
 
The two modular monitors that made use of the Saturn module were failures

When BSS-9800 Life Scope S Bedside Station was finally released in 1998, the first problem spotted was the outdated Ethernet Port. Reflecting a much-delayed launch under tremendous stress, the Ethernet port was an outdated AUI port (10Base5 Thick Ethernet) instead of a up-to-date RJ45 Port (10Base-T) which had become the standard installation. A costly AUI-RJ45 transceiver was needed in order to allow it to connect to a 10BaseT Ethernet hub; Life Scope S was far from being ready.
 
The first unexpected sight on the Life Scope S (BSS-9800) Bedside Station was the outdated Ethernet AUI network socket

 
The Ethernet output was also not isolated and an additional Network Isolation unit was needed to protect the patient.
 
Linking BSS-9800 Bedside Station to a Ethernet Hub


The Life Scope S was described as a Bedside Station instead of just bedside monitor because the BSS-9800 Bedside Station was fashioned after the SpaceLabs UCW
 

The Life Scope S can be configured as a 16-bed Central Nurse Station

  
Like the SpaceLabs UCW model, the Life Scope S main unit can be utilized as a Central Monitor. This capability allowed a all-Life-Scope-S system installation. The workstation ambition was to be achieved using a slot-in PC card, but it had to be abandoned with the suspension of product development for Life Scope S.
 

The overall ambition was to eventually offer a system configuration close to what SpaceLabs was already offering in 1998 as shown below. This proved lofty with the failure of Life Scope S bedside station and only remained relevant as an active topic for new product development discussions.
 
SpaceLabs UCW has network access to the PCMS multi-disclosure Workstation and Chartmaster Server (Clinical Information System)


From the US FDA records, you could tell that Life Scope S and Life Scope M were not launched in the US market

The two modular monitors were found lacking before they could be marketed in the USA market.

The cause of the failure for Life Scope S and Life Scope M modular monitors was the problematic network infrastructure needed by modular monitors for data exchange between modules and main unit. This resulted in Life Scope S bedside station functioning only as a limited monitor while the Life Scope M bedside monitor had to be withdrawn from the market due to insufficient processing power.

There were two digital real-time data network infrastructures used by BSS-9800 Life Scope S bedside station. The software supporting the Ethernet network linking patient monitors to the Central Nurse Station proved stable but the software supporting the network linking the modules to the main units of BSS-9800 bedside station/ BSM-9510 bedside monitor was unreliable and further development work on the network infrastructure was stopped to avoid incurring unbearable losses.

The network for data exchange between main unit and modules could not work well
 
The product failure was huge financial losses incurred at a time when the company was already suffering badly from poor sales due to the lag in digital technology know-how.

NIHON KOHDEN gave up solving the communication problem between main unit and modules
 

Failure to make a functional measurement data-exchange network meant NIHON KOHDEN was downgraded to be a manufacturer only capable of making configured patient monitors
 
After the failure to make a functional measurement data-exchange network, NIHON KOHDEN decided to keep alive the Smart Cables as a means to convince the market it still has a functional network needed for measurement data.

In line with the release of CNS-9300 series Central Monitors, a new 12.1-inch Life Scope P (BSM-4100 series) configured color bedside monitors were released in late 2000.

An additional 12.1 inch configured model, the BSM-5100 series (Life Scope A) bedside monitors were added in September 2002.
 
In markets outside Japan, it was ludicrous BSM-4100 and BSM-5100 series (left) had to compete against modular IntelliVue MP40/ MP50

Before the launch of Life Scope A (BSM-5100 series) configured monitors, no one could be sure if the problematic modular data-exchange platform could be fixed. The launch of a configured Life Scope A series bedside monitors using only the legacy Multi-parameter Unit in September 2002 confirmed what we needed to know, and the company could not hide the new reality.
 
Date of first introduction and use

Why was high-end Life Scope A configured instead of modular???
 
Distributors were disappointed when the configured Life Scope A (BSM-5100) series bedside monitors were launched, and vigorously questioned its relevance to the market need. It eventually dawned on the knowledgeable ones NIHON KOHDEN had already lost the ability to make new modular monitors.
 

Life Scope A monitor had no reason to keep the MULTI-parameter Unit

Configured Life Scope A (BSM-5100) series monitors was a monster monitor with plenty of panel space, yet filled with so many illogical yellow MULTI-parameter sockets. The manufacturer was fully aware of the contradiction yet chose to proceed, this can be seen from the fact two extra Temperature channels were accessed using dedicated sockets instead of using the MULTI-parameter sockets, which of course was done to mitigate the socket shortages.
 
The reason behind the illogical use of the Multi-parameter sockets finally surfaced when the configured Life Scope J bedside monitor was launched in June 2007, five years after the configured Life Scope A series bedside monitors.
 

 
Configured Life Scope A series bedside monitors replacing the withdrawn Life Scope M modular monitor implied NIHON KOHDEN had already given up making modular monitors!

Without doubt, sales for the expensive configured BSM-5100 series bedside monitors was very bad for the export market. It was not the target market, as configured Life Scope A series bedside monitors were designed to fill the vacuum vacated by Life Scope M modular bedside monitor in the Japanese domestic market.

With the passage of time, things only got worse.
 
 
 

(IV)

What Not To Do Is Essence Of Strategy


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

This is certainly not something NIHON KOHDEN should have done!
 

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.


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 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 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 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 so 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, are the investigated cases 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 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; Nihon Kohden could have engaged a consultant to ensure a proper and acceptable validation process if they had wanted to do it right. This implies further improvements are needed for the design to meet US FDA requirements; note 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 (AHA) 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!

Customers were buying unproven deifbrillators 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 established distribution network for mono-phasic defibrillators. The customers were buying them 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

It took Japan Regulatory Authority three long years to finally grant approval for the TEC-7700 series 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.

There was an unlikely event before the above annoucement. More than a year prior to the 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 without Regulatory Authority approval for TEC-7700 series defibrillators? The urgent launch of TEC-5500 series defibrillators for export was highly suspicious and illogical.

We later found the Acti-biphasic waveform discharged by TEC-5500 series defibrillators is 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 the manufacturer decided at this point not to continue with the declared waveform published in 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 domestic sales of CardioLife TEC-7700 series
 

The Timeline
Export of unproven 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.

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 on 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 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 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.



Users rejected the use of Smart Cables when out-of-context

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

 
An interesting question to ask is "Why is the manufacturer asking the users to ensure pain of two missing connector sockets in order to gain the use of one flexible socket?"

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

 

NIHON KOHDEN failed to justify use of the Smart Cables when out-of-context

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 bottom line 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.

The isolated MULTI socket is solely for IBP monitoring, effectively relieving the MULTI socket of existing MPU 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 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 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 have never been able to offer benefits of integrated sidestream CO2 measurements.

 
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
 

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

 
 
Is the manufacturer aware that they are 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.
 
 

  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




(V)

The Denial Of Reality

 Where fear is, there is your task -  Carl Jung
 
 
To avoid being seen as a failure, the company tried to hide the truth
 
In order not to reveal to the market NIHON KOHDEN had given up development to make modular monitors, the modular Life Scope S and Life Scope M were still being actively promoted on brochures. Since it could not be for sales improvement, its real purpose was to lie that the company is still capable of making modular monitors.
 
The failed modular monitors that still appeared in this brochure was to hide the truth from the market

 
About 9 years after the launch of modular Life Scope S Bedside Station, a new Life Scope J (BSM-9101) purporting to be a modular bedside monitor was released for export. The monitor was a bizarre attempt to hide the missing technology platform essential for modular monitors.
 



Life Scope J (BSM-9101) Bedside Monitor was released in June 2007 using MU-910R as main unit, and an AY-920PA with four yellow MULTI sockets as the input unit.

AY-920PA Input Unit with expansion box

The four yellow MULTI-parameter sockets tells us this input unit has to be equipped with four channels of configured IBP amplifiers. We can conclude the rest of hardware after knowing all parameters that can be measured.

We first filter out the serial kit sets; mainstream CO2, 2nd SpO2, BIS and NMT hardware are supplied as self-contained serial kit sets with digital serial processed data.

The patient monitoring hardware in the AY-920PA Input Unit are concluded as:

NORMAL BLOCK
(These hardware make use of dedicated sockets and ordinary measurement cables)
- 2 channels of Temperature
- ECG
- SpO2
- NIBP hardware using dedicated sockets.


MULTI-PARAMETER UNIT BLOCK with four MULTI-parameter sockets
(These hardware only use Smart Cables for connections)
- 4 channels of IBP (4 MULTI sockets = 4-ch IBP)
- 6 channels of Temperature (3 MULTI sockets = 6-ch TEMP)
- Cardiac Output
- Thermistor Respiration
- FiO2
< Self-contained kit sets using Multi-parameter sockets as serial ports>
- BIS, 2nd SpO2, mainstream CO2 and NMT

Note:
Not using the MULTI-parameter sockets are Sidestream CO2, Multi-gas, EEG etc., which are connected using external device interface.


The configured Life Scope J bedside monitor was dressed up to be a modular monitor
 
The market communication was meticulously executed to portray Life Scope J (BSM-9101) bedside monitor as a modular monitor when it is a true-blue configured monitor.
 
Life Scope J bedside monitor appears to be a modular monitor in this brochure image

In above brochure image, Life Scope J (on the right) is shown using 12 yellow MULTI-parameter sockets, which is an impossible configuration. There is obvious intention to hide the fact only four MULTI-parameter sockets can be added using an external box, because this will expose the solution is analog, not digital.

Electrically, AY-920PA Input Unit can only make use of one AA-910P expansion unit

In the next picture, you can see the AY-920PA Input Unit was designed in a shape that when combined with the recorder make Life Scope J (BSM-9101) bedside monitor (left) closely resemble the Life Scope S (BSS-9800) bedside station with a 8-slot module rack filled with modules (right).

Life Scope J bedside monitor was configured while Life Scope S bedside station was modular

In other words, Life Scope J bedside monitor was specially designed in appearance to look like an updated version of the Life Scope S bedside station.

The components making up a Life Scope J (BSM-9101) bedside monitor system is shown in next picture. The connection from MU-910R Main Unit to AY-920PA Input Unit is using the same connector type utilized by BSS-9800 bedside station; the old modular racks can therefore theoretically be daisy-chained to the AY-920A Input Unit.

Why offer the same old thing that caused the failure of both Life Scope S bedside station and Life Scope M bedside monitor? The problematic module racks and old modules cannot be merchantable since there was no longer any new module under development!
 
Life Scope J Bedside Monitor was just pretending to be a modular monitor
 
The purpose of the questionable module racks and old modules were there for the powerful association of Life Scope J with modular monitors in the minds of the intended audience (including foreign employees). It was a powerful way to get the audience to nod their heads when making claim that the Life Scope J is a modular monitor.

Without offering a new network infrastructure for measurement data, connecting to the old module racks (from BSS-9800 modular monitor) is meaningless. This pretense can no longer be feigned after discontinuity of old module racks and associated modules without replacements.


There was no replacements for discontinued module rack and modules

 
The Input Unit and expansion box of Life Scope J bedside monitor is only the equivalence of Life Scope S modular monitor's Saturn module and extension. The rest of the other modules are being solved by using external device interface, a truly configured monitor.

Life Scope J bedside monitor has to depend on external device interface for expansion


The Life Scope J (BSM-9101) Bedside Monitor is relying on using external device interface on the AY-920PA Input Unit or MU-910R Main Unit to third party devices.
 




 

(VI)

Throwing Good Money After Bad

Those who cannot remember the past are condemned to repeat it -  George Santayana
 

Life Scope TR (BSM-6000 series) Bedside Monitors

Strategy is really about resource allocation, Life Scope TR (launched internationally less than a year after Life Scope J) in April 2008 persisted to continue with the yellow shared-use MULTI sockets, indicating there was no intention to change. Life Scope TR (BSM-6000 series) bedside monitors was a continuation of the Life Scope J (BSM-9101) bedside monitor, masquerading as digital modular monitors after an earlier failed attempt in the 1990s to make one.

NIHON KOHDEN was still unable to deliver a new real-time network for the exchange of digital measurement data in Life Scope TR; the development team continued to shy away from the difficult task of working on a new measurement data-exchange network platform to do away with the yellow shared-use sockets as camouflage.

Life Scope TR was a decision to invest in continued weakness, it was throwing good money after bad. Instead of just one type input unit, Life Scope TR (BSM-6000 series) went on to offer a main unit with choice of input units and socket boxes.

Compared to Life Scope J, Life Scope TR bedside monitors have more than one type of Input Unit to choose from


 
Similar to Life Scope J bedside monitor, Life Scope TR bedside monitors are not digital modular monitors
 
The structure of a Life Scope TR Input Unit with its expansion unit corresponds to a Philips MMS module with its extension. These are operating at the configured level, not modular. It will be unmistakable Life Scope TR bedside monitors are configured if there are no yellow time-shared MULTI sockets on the input units and extensions to confuse you.

 

  The Philips MMS modules (initiated by Hewlett Packard) are however additionally capable of being linked to a measurement data network using Ethernet
   
Remember the HP Agilent M3/M4 portable monitors?

While the Philips MMS modules can be upgraded using extensions, it also has an IP address on the measurement Ethernet network, and can be expanded by linking to a module rack with individual modules. This way, those expensive individual modules can be easily shared.

On the contrary, NIHON KOHDEN failed to realize a workable Measurement Network and the Life Scope TR Input Units do not have IP addresses for networking. There is no way to scale monitoring parameters or sharing expensive modules using networking, only via serial kit sets or linking to independent devices using custom interfaces.
 
 
   Think about the flexibility of a printer with network interface compared to one only equipped with a direct connection
  
The Philips MMS module (and extension) serves as the basic module and can be expanded using a measurement LAN which the Life Scope TR input units lack

The configured BSM-6000 series monitors are priced and marketed as modular monitors but without the capability. Many monitoring hardware inside the AY-663P Input Unit are not made clear in basic product communication to the market, and that was intentionally done to hide the fact the input units are configured.

Take a closer look at the AY-663P Input Unit shown below, it needs at least ten sockets for carefree use but the manufacturer can only provide three yellow MULTI-parameter sockets for time-sharing use. This means only three of the ten connectable cables can plug into the input unit at any one time. The input unit is so short of connector sockets, why would anyone need such a skewed input unit?

The reason AY-663P Input Unit cannot come with more MULTI-parameter sockets is because only three IBP amplifier hardware are specified for said input unit. Since each MULTI-parameter socket comes with its own one-channel IBP hardware, the manufacturer cannot provide more than three MULTI-parameter sockets. Notice the two channels of Temperature hardware in the shown input unit are not making use of the yellow MULTI-parameter sockets for connections, this is to provide relief to the three yellow MULTI-parameter sockets which are not enough for use.

Delivering pains of limitations and distortion, not flexibility

Next comes the fascinating offer to add more yellow MULTI-parameter sockets to supplement the three already on the AY-663P Input Unit. Electrically, the manufacturer can add more MULTI-parameter sockets to the AY-663P Input Unit using an external box (AA-674P) which comes with four MULTI-parameter sockets.

The link from AA-674P expansion box to AY-663P is an analog interface, not digital; as such, only a maximum of four MULTI-parameter sockets can be added. The limitation is due to signal deterioration caused by voltage drop and noise pickup.

Shown below is a Life Scope TR bedside monitor main unit (on the right) with the input unit (AY-663P) on the immediate left of its side. On the extreme left is a satellite box with four supplementary MULTI-parameter sockets (AA-674P) that can also link to hardware already configured in the AY-663P Input Unit.

The external expansion box (AA-674P) on the extreme left not only contains 4 MULTI sockets, but also 4 channels of IBP hardware

It is obvious the manufacturer should have designed an input unit with enough connector sockets in the first place, but there is a reason for wanting to do it. The purpose is to imitate the process of parameter scalability when MULTI-parameter sockets are shown visually being added to the input unit, but the manufacturer is adding sockets and not monitoring parameters. A bedside monitor using AY-663P Input Unit and AA-674P expansion box is not modular in design.

Beware scalability of monitoring parameters is the one sought after by the market
 
What we see here is scalability of the MULTI-parameter connector sockets, not monitoring parameters. It is still not so straightforward as thought; the act of adding four MULTI-parameter sockets using the AA-674P expansion box also means adding four channels of IBP hardware to what are already configured in the AY-663P Input Unit. Do you need seven channels of IBP hardware? This is how Life Scope TR bedside monitor got its maximum ability to do seven channels of IBP monitoring; it is either three channels of IBP monitoring using AY-663P alone or seven channels of IBP monitoring using both AY-663P and AA-674P.

The limitation of only four MULTI-parameter sockets can be added means it is not possible for the AY-663P Input Unit to make use of two AA-674P expansion boxes.

Elaborate time-sharing are applied to things that are expensive (therefore rare), and not worth the efforts for things that are cheap (therefore plentiful) like connector sockets! It only makes economic sense to see productive efforts being made to time-share a CPU, a car, a hotel room, a yacht, an airplane but not a calculator, a pencil or a pair of scissors.
 
Time-sharing of an expensive hotel room creates value for the customers but time-sharing of a cheap connector socket does not

The next picture shows another manufacturer time-sharing one channel bio-amplifier hardware between IBP and Temperature measurements, but not any connector socket; this is exactly the opposite of what Nihon Kohden is doing. The said manufacturer merely ensures physically it is not possible to make use of both the PRESS and the TEMP socket at the same time.
 
Time-sharing of expensive hardware, not the cheap sockets
 


  The use of Smart Cables does not upgrade a configured monitor
 
A yellow MULTI-parameter socket by itself does not automatically mean all the five types of mentioned parameters are available for measurements; it still depends on whether what hardware are actually being placed inside for selection. The amount of configured hardware linked to each multi-parameter socket varies, 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.

Examples of configured hardware and serial kit sets making use of Smart Cables

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


The input units or monitors using Smart Cables are still configured. The only advantage of using Smart Cables is the sharing of connector sockets, which are of negligible hardware cost. It is illogical and the real purpose is to take your attention away from something the manufacturer does not want you to know.



    The Parameter Codes Embedded in the Smart Cables are not active electronics
 
The marketing messages "New Modular Technology" and "The Module is in the cable!" are wild 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.

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

Pure assertion without the honor to show 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 some pins of the yellow plug.

 
Size of the PC Board relative to 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 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 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 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 internally 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. 


The challenge of monitoring a patient during transportation
 
The idea of turning the Input Unit on a host monitor into a Transport Monitor was not yet conceived when Life Scope TR (BSM-6000 series) monitors were first designed, the initial design was to follow GE Marquette way, transferring the input unit from Life Scope TR bedside monitor (BSM-6501 or BSM-6701) to a compact 10.4-inch Life Scope TR (BSM-6301) to fulfill the transport role.
 
The original way was to use Life Scope TR 10.4 inch model as transport monitor


Change of mind from following GE Marquette to Philips IntelliVue MMS X2
 
Due to market pressure, a transport monitor was realized by the addition of touch-screen, storage memory and rechargeable battery to the multi-parameter input unit, doing away the need to attach it to a monitor during patient transfer; the design is an adaptation to imitate the Philips IntelliVue MMS X2.
 
Before the introduction of transport monitor Life Scope PT, Nihon Kohden first released the Data Acquisition Units for the BSM-6000 series bedside monitor in April 2009. These Data Acquisition Units (DAU) are connected to the main unit directly using point-to-point digital serial communication and there were two types; the JA-690PA Data Acquisition Unit has no yellow shared-use MULTI sockets while the JA-694PA Data Acquisition Unit has four MULTI sockets.
 
The JA-690PA and the JA-694PA Data Acquisition Units are linked directly by point-to-point serial communication to the Life Scope TR main unit

The JA-690PA and JA-694PA data acquisition units were designed so that an Input Unit can be placed next to the patient while allowing the main unit with the screen to be mounted at a suitable height (away from the patient) for purpose of convenient viewing.

The main purpose of JA-690PA and JA-694PA Data Acquisition Units is to bring the Input Unit nearer to the patient

The Life Scope PT acts as an input unit when placed on the Data Acquisition Unit (DAU) linked to a host monitor to a host monitor such as Life Scope TR or Life Scope G9, and becomes an independent transport monitor upon its release from the DAU.

  Life Scope J discarded AY-920PA to make use of Life Scope PT as transport monitor
 
Since it was not possible for Life Scope J bedside monitor MU-910R main unit to link directly to JA-690PA or JA-694PA data acquisition unit, a new costly QI-930P Interface Unit had to be introduced (as shown). This new arrangement makes AY-920PA Input Unit redundant.
 
By discarding the original AY-920PA Input Unit, Life Scope J could make use of Life Scope PT as a transport monitor

A new Genesis Life Scope G9 bedside monitor was born when a new Core Unit replaced both the QI-930P Interface Unit and the MU-910R main unit.
 

Life Scope TR updated to Life Scope Genesis G5 bedside monitor

The updated model of Life Scope TR is Life Scope G5 bedside monitors; the main unit of Life Scope G5 bedside monitor is Life Scope TR main unit updated with an integrated panel PC replacing previous LCD display. The main unit is now known as Core Unit like Life Scope G9.

There is an alternative model to Life Scope G5 bedside monitors, known as Life Scope G7 bedside monitors. The latter model makes use of a Panel PC as main unit and rely on the data acquisition unit to interface with input units or Life Scope PT transport monitor.

As shown below, the main unit is the panel PC with touchscreen sizes of 15.6-inch and 19-inch. Notice the Input Units (originally designed for Life Scope TR) cannot be placed on the main unit, and a data acquisition unit is mandatory for use. Life Scope G7 monitor configuration makes it redundant to have Life Scope G5 bedside monitor using a data acquisition unit. The external socket box for Life Scope G7 bedside monitor is the same one (AA-174P) as Life Scope G5, with MULTI sockets arranged horizontally and must be linked to a new type Data Acquisition Unit (JA-170PA).

The system weakness discussed in BSM-1700 From Input Unit to Transport Monitor applies to Life Scope G9, G7, G5 bedside monitors as host monitor since it is regardless of the type of Host Monitor being deployed. Essentially, Life Scope PT (BSM-1700 series) has no wireless mechanism to continue linking with the central nurse station the moment it is detached from Life Scope G9 Host Monitor to operate as an independent transport monitor. The Central Nurse Station simply has no idea what is happening to the patient during the period of transport and can only be updated after the transport monitor is attached back to another Host Monitor (i.e. completion of patient transfer). This effectively means using the BSM-1700 as a transport monitor for Life scope G9 and others should be re-examined.

 

Conclusion:

The Challenges Ahead

The competitors are fast-moving targets for NIHON KOHDEN outside of Japan and they have no reason to wait. We had anticipated new type Genesis patient monitors could only mean the returning to plain connectors and a working modular infrastructure for measurement data finally introduced. Genesis is a powerful word suggesting the starting of everything anew but it is just talks without the costly action.

Clearly, investment on the Multi-parameter Sockets had consumed tremendous amount of Capital and efforts, it is therefore difficult to let go! Life Scope G9, Life Scope G7 and Life Scope G5 monitors are all using the same Life Scope TR hardware. Fresh huge investments are urgently needed for new generation monitors just to catch up with the rest of the world.
 
History repeats, and we can already see the future from the past. In an age of new innovative products from digital transformation, NIHON KOHDEN is unfortunately ill-equipped to compete outside the protected Japanese market.
 

END
 

 

 

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