Category: NIHON KOHDEN (日本光電) Life Scope monitoring history from the 1990s, Life Scope monitors networking; Nihon Kohden Life Scope BSM-8000 series bedside monitors, Life Scope S (BSS-9800) bedside station, Life Scope M (BSM-9501) modular monitor, Life Scope J (BSM-9101) bedside monitor, Life Scope TR (BSM-6000 series) bedside monitor, Life Scope G5 (CSM-1500 series) bedside monitor, Life Scope G7 (CSM-1700 series) bedside monitor, Life Scope G9 (CSM-1901) bedside monitor.

NIHON KOHDEN has been struggling with the disruptive digital revolution since the 1990s, first they failed to make two workable digital modular monitors and made an extremely unwise move to cover this up with being the first in the world to promote the use of flexible sockets when there was no demand in the market for socket flexibility. All of the efforts were just to avoid spending time and money to develop a measurement-data network for bona fide modular monitors.

The weak financial situation led to poor internal safeguards in corporate conduct, initially exporting unproven and unapproved new-type bi-phasic defibrillators in November 2002; with passing time, subsequent events turned even more bizarre. A hidden ticking time bomb is just waiting to explode with many key issues unaddressed.

(I)

Back To The Future In The 1990s

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

The Digital Revolution dealt not only a heavy, but lasting blow to NIHON KOHDEN as a manufacturer

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).

The types of backward and embarrassing 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. Such a central monitor could not be competitive because others were running on cost-effective Microsoft GUI (Windows Operating System).

This PC-based Central Monitor was not enjoying the benefit of an Ethernet link because there was no place to connect to. Instead, the PC-based Central Monitor needs two custom long ISA cards (one for analog waveform and one for digital data) to interface with the analog signal exchanger as shown in below image. The custom ISA cards, of course, made the Central Monitor even more expensive.

The Ethernet factor was something institutional prospects were so keen to first inspect for networking capability 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.

Stark comparison of an outdated analog signal exchanger on roller wheels (left) against the outside world (right) 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.

This monitor was launched for export when 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.

All products have huge digital gaps to close (1997)

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 basic monitors made for an exciting big deal and a cause for celebration!

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. For recipients of Japan ODA projects, they of course cannot look into the mouth of the gift horses.

(II)

Clueless Exporting Without A Proper 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 an unbelievable good 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 in the current environment. Thus, a big chunk 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 every reader how these incomes and profits are actually being reflected on the balance sheet. You should realize the balance sheet does not tell you the company is actually a major re-seller of BIS monitors in the world, and there are many ways to hide how badly the company is performing as a manufacturer.

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 expansion and growth; this is the key weakness of NIHON KOHDEN as an exporter for solutions. This fully explains why NIHON KOHDEN can never be a significant player in any major foreign market.

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 is pressured to open up in a trade-war 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 greatly limits the business potential of any accessible foreign 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 clueless, non-competitive and 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 the first two 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.

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 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 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 released as a shocking 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 the 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 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.

Take it or leave it bargaining power 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. With so many hardware in the Saturn module, the small front panel did not have sufficient area to mount all the necessary connector sockets. A solution had to be found to solve this problem.

The Saturn module was intended to be physically small in size

The solution for panel space limitation of the Saturn module was to introduce a MULTI-PARAMETER UNIT (MPU) with a community of hardware sharing only two sockets

NIHON KHODEN identified five types of analog hardware (Temperature, IBP, Cardiac Output, Thermistor Respiration, FiO2) to form a hardware community that link to only two sockets meant for sharing use. These flexible communal sockets are known as MULTI (short for multi-parameter) sockets and colored yellow.

The hardware community, known as a MULTI-PARAMETER UNIT (MPU), was a design to minimize the number of physical sockets on a front panel with limited space area, and has an unusual characteristics of having more hardware than MULTI sockets.

To access each type of hardware, an external measurement cable with a digital parameter code stored in its plug needs to be inserted into one of the two MULTI sockets. These measurement cables that come with yellow coded plugs are collectively cited as Smart Cables by the manufacturer and each embedded digital parameter code pinpoints the exact type of internal hardware and software needed by a particular measurement cable.

Each yellow MULTI socket selects only one channel of the internal hardware, except for Temperature allowing two channels of hardware to be selected.

An external measurement cable with a valid digital code embedded in its plug pinpoints the internal hardware needed

Below image shows the MULTI-PARAMETER UNIT (MPU), complete with two yellow MULTI sockets for communal sharing. An external Smart Cable with a valid parameter code selects the needed hardware in the MPU using one of the two MULTI sockets.

Based on the fact both MULTI sockets must be capable of doing IBP monitoring, and the logic that IBP hardware should not be more than the number of MULTI sockets, the IBP hardware are therefore not placed in the common pool for sharing; instead, each MULTI socket comes with its own dedicated IBP hardware.

A MULTI socket can only access its own dedicated IBP hardware, and makes use of its when an IBP measurement cable is plugged into it. For non-IBP monitoring, both MULTI sockets can access the common pool of hardware comprising Temperature, Cardiac Output, Thermistor Respiration and FiO2 hardware in the MPU.

This is a process of adding sockets, not monitoring parameters

Given the large amount of hardware in the MPU, more MULTI sockets are needed to make good use of the hardware that would otherwise be idling. As illustrated, this is achieved by using an external expansion box filled with more MULTI sockets (each with own dedicated IBP amplifier hardware).

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

The MULTI sockets are additionally diverted to be serial ports to save on one more physical socket

A MULTI socket can be diverted to be a serial port by bypassing the internal analog hardware

The design concept of MPU was to solve the problem of limited panel space area, and by using MULTI sockets as serial port does help in furthering the reduction of a physical socket on the front panel. The serial port in the original design was only for use by the mainstream CO2 serial kit sets.

Shown above is the original label for the two yellow MULTI sockets. It shows the socket can be utilized for IBP, Temperature, Cardiac Output, FiO2, Thermistor Respiration monitoring, and also be diverted to be a serial port for mainstream CO2 kit sets.

The term "MULTI PARAMETER UNIT" can be found in older service manuals

Inside the Saturn module, there is a conventional block and an MPU block. The conventional block uses dedicated sockets and ordinary measurement cables while the MPU block makes use of Smart Cables with different parameter code for different hardware.

CONVENTIONAL BLOCK
- ECG
- SpO2
- NIBP

MPU BLOCK with two yellow common-use sockets
- 2 channels of IBP (2 MULTI sockets = 2-ch IBP)
- 4 channels of Temperature (2 MULTI sockets = 4-ch TEMP)
- Cardiac Output
- FiO2
- Thermistor Respiration
- <MULTI sockets as serial ports> Mainstream CO2

The outcome of the MPU solution is shown below. The Saturn module, with two expansion boxes are housed in a 8-slot module rack. The four sockets on the expansion boxes (satellite module) can access the common hardware pool in the MPU inside the Saturn module; together six MULTI sockets and six channels of IBP are made available to the users.

The MPU is meaningless without the module rack

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 manufacturers of patient monitors.

The two bona fide modular monitors that made use of the Saturn module were failures

When BSS-9800 Life Scope S Bedside Station was finally released for export in 1998, the first telling 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

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 remained elusive to this day.

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 Life Scope S and Life Scope M monitors were not launched in the US market

The two genuine 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 unstable network 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.

To clarify, there are two digital real-time data network infrastructures needed by modular monitors. The Ethernet network linking patient monitors to the Central Nurse Station proved stable but the network linking the modules to the main units of BSS-9800 bedside station/ BSM-9510 bedside monitor was unstable and full of performance issues; this latter network was abandoned by NIHON KOHDEN.

The network for data-exchange between main unit and modules was unstable and full of performance issues

The product failure was happening at a time when the company was already suffering badly from poor sales due to the lag in digital technology know-how. Senior key engineers were removed from their jobs and younger risk-averse juniors took over. There was no longer any new ideas for products except working on what was left behind.

NIHON KOHDEN gave up for good trying to solve the network performance issues between main unit and modules

Failure to succeed in the measurement data-exchange network infrastructure 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.

A new 12.1-inch Life Scope P (BSM-4100 series) configured color bedside monitors were released in late 2000, and an additional 12.1 inch configured model, the BSM-5100 series (Life Scope A) bedside monitors were added in September 2002. Both continued the use of the yellow MULTI sockets which was developed for the legacy Saturn module housed in a module rack.

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 MPU in September 2002 confirmed what we needed to know, and the company could not hide the new reality.

Date of first introduction and use

Distributors were left wondering 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 worriedly questioned its relevance to the market need. It eventually dawned on the knowledgeable ones NIHON KOHDEN had already lost the ability to make new bona fide modular monitors!

Look at the abundant panel space, Life Scope A monitor had no reason for an MPU

Configured Life Scope A (BSM-5100) series monitors was a monster monitor with plenty of panel space, yet filled with five yellow MULTI sockets. Still, the MULTI sockets were not enough for use; this can be seen from the fact two Temperature channels were accessed using dedicated sockets instead of MULTI sockets. Subsequent events allowed us to conclude this was actually intentionally irrational behavior.

The continued use of the yellow MULTI sockets reached a new frontier when configured Life Scope J bedside monitor was launched in June 2007 masquerading as a modular monitor, which was five years later.

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

Without doubt, sales for the expensive configured BSM-5100 series bedside monitors was very bad for the export market. The true target was not the export market, as the withdrawal of Life Scope M modular monitor left a vacuum in the Japanese domestic market and configured Life Scope A series bedside monitors were quickly designed to fill in this domestic market segment.

(IV)

What Not To Do Is Fundamental

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

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

The ticking time bomb

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

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

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

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

Just a few months after the TEC-2200 series was released in May 1997, Hewlett Packard made announcement to acquire Heartstream Inc. in a stock-swap deal.

Heartstream ForeRunner

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

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

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

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

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

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

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

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

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

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

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

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

The first phase is positive and a wider pulse than the second phase

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

The first Acti-Biphasic defibrillators

Output discharged by CardioLife TEC-7700K series defibrillators is consistent with the declared waveform

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

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

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

This strip chart recording shows output of CardioLife TEC-7700K series is consistent with the declared description

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

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

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

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

It is necessary here to clarify current CE certification does not guarantee clinical performance since clinical validation is not included.

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

Outside of the US market, we need to question the point of buying such critical treatment devices and placing them on standby to save lives? Remember, compliance to just safety standards is no guarantee of performance! It is so unfair to the patients needing immediate treatment in a life-threatening situation!

It is deplorable customers were sold unproven defibrillators based on blind faith

Before completion of proper clinical validation, the company was bold enough to go ahead with exporting the unproven TEC-7700 series Acti-Biphasic defibrillators from November 2002, taking advantage of its established distribution network for mono-phasic defibrillators. The sales were done based on blind faith, for there was no published clinical paper to show that it works. This November 2002 export launch was three long years ahead of the date Japan MHLW officially approved its use for the domestic market.

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

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

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

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

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

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

The apparent REGRESSION to untested new type of Acti-Biphasic defibrillation output energy

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

More than a year prior to above announcement, Nihon Kohden had incredibly gone on to launch another unproven Acti-Biphasic TEC-5500 series defibrillators for export sales in August 2004. Why was the need to launch the TEC-5500 series before Regulatory Authority approval for TEC-7700 series defibrillators? It does not make sense, the urgent launch of TEC-5500 series defibrillators for export was thus a dubious event without a satisfactory explanation.

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

This means that at this juncture, for whatever reason, the manufacturer was pressured to quietly stop the continued use of the declared discharge waveform (for export) that is still currently being published on the service and operator manuals.

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

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

The Timeline

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

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

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

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

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

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

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

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

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

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

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

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

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

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 Acti-Biphasic shock energy is the one on the left while we discovered actual biphasic flow is the one shown on the right

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

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

When the discharged waveform is flipped upside down, the already-scanty TEC-7700 series clinical data cited becomes totally irrelevant

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

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

Change in current direction demands fresh clinical trial and validation

As a responsible company, NIHON KOHDEN must act fast and should have by now long recalled all Acti-Biphasic defibrillators from the market.

The first warning shot to give up the MULTI sockets (case study of Life Scope BSM-2300K series bedside monitors)

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

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

A flexible socket does not replace two missing physical connector sockets

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

a. Invasive Blood Pressure

b. Thermistor Respiration

c. Mainstream CO2 serial kit sets.

Without any use of Smart Cables, all IBP, Thermistor Respiration and mainstream CO2 are freely available for carefree use via their respective dedicated sockets. The use of Smart Cables makes things unnecessarily complicated and requires deliberate operator attention and choice to choose one among three (IBP, Thermistor Respiration and mainstream CO2), but why introduced a need to choose?

This is obviously unwarranted stress and inconvenience, what is wrong with the conventional way of using three dedicated sockets for the job? If MULTI socket is such a superior proposal, why is the Temperature socket a dedicated one?

Life Scope-i does not have enough physical connector sockets

The patient monitoring hardware in the Life Scope BSM-2301 bedside monitor are divided into a conventional block and an MPU block. The conventional block uses dedicated sockets and ordinary measurement cables while the MPU block makes use of Smart Cables with different parameter code for different hardware.

CONVENTIONAL BLOCK

- 1-ch TEMP

- ECG

- SpO2

- NIBP

MPU BLOCK with one MULTI socket

- 1-ch IBP

- Thermistor Respiration

- <MULTI socket as serial port> Mainstream CO2 Kit Sets

The reality is the shortage of two physical connector sockets, and an avalanche of complaints from users. The manufacturer was pressured to respond with an updated model, BSM-2303K. The solution from new model BSM-2303K is to add a new isolated yellow MULTI socket.

The MPU of the Life Scope BSM-2301K was not designed to take on expansion, and any additional MULTI socket will load the operation of existing MPU, causing it to malfunction. The additional (fake) MULTI socket is not linked to the MPU, just an independent socket with its own dedicated IBP amplifier hardware.

The new socket relieved existing functional MULTI socket to only measure either Thermistor Respiration or act as serial port for the mainstream CO2 kit set, leaving the former to just focus on doing IBP monitoring. It was ironical, a solution relying on a dedicated socket for IBP; it was clear the complaints was the result of using a flexible socket and the solution offered by BSM-2303K was to return back one of the two missing sockets.

It was the first warning shot to the manufacturer to give up the MULTI sockets, but this was not music to the ears.

Under pressure, the manufacturer returned to users a dedicated physical socket for IBP

The touchscreen technology was not proprietary and thanks to the Life Scope BSM-2300 series monitors, the popularity prompted every patient monitor manufacturer on earth to respond to the use of touchscreen technology, with Philips as the most aggressive. Philips product range is real 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.

There is no demand in the market for flexible connector sockets on a bedside monitor

Undeterred, NIHON KOHDEN again launched the Life Scope VS bedside monitors in early 2011, with the BSM-3500 series monitors having two MULTI sockets while the BSM-3700 series monitors have three.

The patient monitoring hardware inside the Life Scope BSM-3500 series (12-inch) bedside monitors are divided into a conventional block and an MPU block. The conventional block uses dedicated sockets and ordinary measurement cables while the MPU block makes use of Smart Cables with different parameter code for different hardware.

CONVENTIONAL BLOCK

- ECG

- SpO2

- NIBP

MPU BLOCK with two MULTI sockets

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

- 2 channels of TEMP (1 MULTI socket = 2-ch TEMP)

- Cardiac Output

- <MULTI sockets as serial ports> BIS, APCO, mainstream CO2 and NMT

Note:

Other third party parameter options are connected using the external device interface, not by using the MULTI sockets.

Hardware in the MPU of BSM-3500 series bedside monitors

The difference between the VSM-3500 series (12.1-inch screen) and BSM-3700 series (15-inch screen) is an additional MULTI socket for the latter, and of course this also means an additional channel of IBP hardware.

The use of Smart Cables has unintentional negative captured value for the users, as can be seen from below illustration. Users of the left monitor (BSM-3500 series with 2 channels of IBP) requires five physical connection sockets but only two yellow shared-use sockets are provided for a 2/5 sharing ratio. The manufacturer cannot provide more than two MULTI sockets because the IBP hardware channels intended for this model is only two, and therefore limited to two MULTI sockets.

Without any use of Smart Cables, all five parameters are freely available for carefree use via their respective dedicated sockets. The use of Smart Cables just makes things unnecessarily complicated and requires deliberate operator attention and a conscious efforts to choose two among the five; this is unwarranted attention, stress and inconvenience. What is wrong with using five dedicated sockets, which is a far superior norm since all parameters are available for connections at any time without hesitation. What user benefit is the manufacturer trying to provide?

Similarly, users of the right monitor (BSM-3700 series with 3 channels of IBP) requires six physical connection sockets for carefree use but the manufacturer insists three shared-use sockets are enough. This means the manufacturer only wants to place 3 channels of IBP hardware in the MPU of the BSM-3700 series monitors and ignore the user's pain; this kind of forceful approach can only happen in a protected Japanese market when users bargaining power is low. It is another matter for the export markets.

How does such dire shortage of connector sockets benefit a user? Adoption of the yellow MULTI sockets therefore clearly has negative captured value for the users.

These monitors are in dire shortage of physical connector sockets, the value captured by users is negative

As expected, users soon found out the small number of MULTI sockets on Life Scope VS bedside monitors are not enough for use. The situation for Life Scope VS series bedside monitors is the same as Life Scope BSM-2301K bedside monitor, customers just want their physical sockets back and have nothing to do with the MULTI sockets!

Life Scope VS series bedside monitors were not designed for expansion, although we were not surprised to find expansion units from Life Scope TR belatedly being offered as solution to the demand from users for more physical connector sockets. The makeshift solution makes the bedside monitor look awkward, resembling a product prototypes still undergoing tests.

The way to return the missing physical sockets

These are again futile efforts, what you have just seen is resetting the monitors back to using dedicated sockets, but with high costs! The underlying problem is the wrong adoption of an MTU block when there is no problem of panel space area. The failure has the same message as Life Scope BSM-2301K and should not be ignored again.

This picture tells us users want all their physical sockets back!

It is most likely the many MULTI sockets on the expansion units have to be isolated from the MPU of existing monitors because Life Scope VS bedside monitors were originally not designed for socket expansion. Users now have to pay additional unnecessary attention to socket selections, a far cry from the care-free use of dedicated sockets.

An adventure into dangerous use of estimated CO2 values 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 measurement.

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

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

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

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

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

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


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

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

Users just doing the inevitable

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

- Life Scope patient monitors

- Vismo patient monitors

- Cap-STAT OLG-2800

- CardioLife defibrillators

- Neurofax EEG machines etc.

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

The manufacturer is not aware semi-quantitative CO2 measurements are only estimates and sell them as cheap alternative to quantitative type

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.

The manufacturer using a semi-quantitative design cannot assure the measurement tolerance specified because CO2 level is not measured during each inspiration phase!

Measurements are invalid when CO2 is present during inspiration, but the design does not measure CO2 level during this period

As seen from the duty cycle, there is no measurement being made during the inspiration phase, how does the manufacturer know CO2 level is indeed zero and that there is no interference from this phase? The specified measurement tolerance is conditional on this assurance and the CO2 value shown to users is therefore misleading!

Each semi-quantitative CO2 measurement is in fact only an estimation.

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

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

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

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

The manufacturer ended up ignorantly displaying a flawed continuous CO2 waveform using semi-quantitative measurement kits that do not have ability to make continuous measurements

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

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

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

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

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

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

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

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

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

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

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

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

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

The key point is, it does not last

(V)

Denial Of Reality

Where fear is, there is your task - Carl Jung

Taking the MULTI sockets to the "next level"

In order not to reveal to the market NIHON KOHDEN had already 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 continued to appear in later promotion brochure in order 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. This 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 as the input unit.

Like the Saturn module, the AY-920PA contains huge amount of hardware and has an internal MPU with four yellow MULTI sockets for communal sharing. These four yellow sockets are of course not enough, additional MULTI sockets can be linked to AY-920PA Input Unit using an external AA-910P expansion box. The integration of AA-910P to AY-920PA is analog, and limited to a maximum of four MULTI sockets to avoid signal degradation.

AY-920PA Input Unit with AA-910P expansion box

The patient monitoring hardware inside the AY-920PA Input Unit are divided into a conventional block and an MPU block. The conventional block uses dedicated sockets and ordinary measurement cables while the MPU block makes use of Smart Cables with different parameter code for different hardware.

CONVENTIONAL BLOCK

- 2 channels of Temperature

- ECG

- SpO2

- NIBP

MPU BLOCK with four MULTI sockets

- 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

- <MULTI socklets as serial ports> mainstream CO2, 2nd SpO2, BIS and NMT

Note:

Other options such as Sidestream CO2, Multi-gas, EEG etc., are connected using the external device interface, and not via MULTI sockets.

The configured Life Scope J Bedside Monitor was masquerading as 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 sockets was an impossible configuration; there was obvious intention to hide the fact only four MULTI sockets can be added using an external box.

This is a fake configuration, since 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 intentionally 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 module rack that caused the failure of both Life Scope S bedside station and Life Scope M bedside monitor? The shown module rack and old modules are not merchantable since there was no longer any new module under development!

Life Scope J Bedside Monitor is not a genuine modular monitor

The purpose of the old module rack 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 Life Scope J is a modular monitor.

Without offering a new network infrastructure for measurement data, connecting to the old module rack was just a pretense, and can no longer be feigned after they were discontinued 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 expansion boxes.

Life Scope J bedside monitor has to depend on external device interface for real 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, just like any configured patient monitor in the market.

(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 is version of Life Scope J bedside monitor using a built-in display

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 MULTI 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 real-time measurement data network using Ethernet

Remember the HP Agilent M3/M4 portable monitors?

While the Philips MMS modules can be upgraded using extensions, each also has an IP address for linking onto the Measurement Ethernet network, allowing direct communication between the main unit and each module. Scalable monitoring is achieved by slotting individual modules into a module rack linked to the Measurement Network; in the same way, expensive modules can be 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.

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.

A skewed input unit delivering pain of not having enough connector sockets

What the market really wants is scalability of patient-monitoring parameters!

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 Philips time-sharing one channel bio-amplifier hardware between IBP and Temperature measurements, and there was no sharing of 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, and the purpose is to make it possible for the same hardware to be used for different purpose at different time.

This design shares the expensive hardware, not the cheap sockets

It is simple-minded to think use of Smart Cables can actually upgrade a configured monitor to be modular

With the use of a MTU block, 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 by Smart Cables.

Additional monitoring parameter capability can be added to a configured monitor using serial kit sets or via interfaces to external equipment, but these are realized through the system software of the monitor and has nothing to do with the type of sockets or cables being used.

Putting things into perspective, most patient monitoring parameters cannot be added using self-contained serial kit sets. As shown, the AE-918P Neuro Unit or strip chart recorder are examples, and they are not linked using a MULTI socket, but as any external third-party device (and powered separately).

When the MTU block of a monitor is not equipped with FiO2 hardware internally, no amount of yellow multi-parameter sockets is going to provide this measurement capability. The amount of configured hardware linked to each multi-parameter socket varies, so is the system support for serial kits and external interfaces.

Examples of configured hardware and serial kits using Smart Cables

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 MPU

It is obvious monitors with input units using Smart Cables are still configured monitors. The only advantage of using Smart Cables is to allow sharing of connector sockets, which are of negligible hardware cost; on the other hand, the cost needed to make use of Smart Cables is way far higher! Customers are paying for the unnecessary higher costs, only to be led into having an unrealistic expectation of The Smart Cables and MULTI sockets can actually deliver.

Regret there is no patient-monitoring hardware embedded in the NIHON KOHDEN Smart Cables

Under US FDA rule, a cable is only a cable if it does not change the signal that passes through it. A Smart Cable embedded with a non-volatile digital 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 definitely requires FDA registration. Can you find any stand-alone NIHON KOHDEN Smart Cable registered with US FDA as a medical device? We do not.

Make no mistake, 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 (just like any other manufacturers) and not the passive Smart Cable.

It is unsubstantiated marketing messages and the manufacturer should not have condoned it. We are going to show you beyond any doubt, there is absolutely no active electronics in the Smart Cables. Messages such as "New Modular Technology" and "The Module is in the cable!" are just the 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.

The continued repetitions of an assertion without the ability to show any proof does not make it the truth!

Pure assertion without showing any proof

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

Irrefutable proof the IBP amplifier hardware is configured internally, an important fact no longer shown on later monitor manuals

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

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

How to monitor 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 stationary Life Scope TR bedside monitor (BSM-6501 or BSM-6701) to a compact mobile 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

The decision to change from following GE Marquette to follow Philips IntelliVue MMS X2

Due to changing market need, 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 had released the JA-690PA and JA-694PA Data Acquisition Units for the BSM-6000 series bedside monitor in April 2009.

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 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), and becomes an independent transport monitor when it is released from the DAU.

Life Scope J main unit using Life Scope PT as transport monitor

The Life Scope J bedside monitor MU-910R main unit cannot link directly to JA-690PA or JA-694PA data acquisition unit, a new costly QI-930P Interface Unit was needed. The AY-920PA Input Unit was not needed when using Life Scope PT as transport monitor.

By discarding the original AY-920PA Input Unit, Life Scope J could make use of Life Scope PT as a transport monitor

To cut cost, the extra QI-930P Interface Unit was dispensed with, and an updated new core unit was introduced which has direct interface to the JA-690PA or JA-694PA data acquisition unit. A new Genesis Life Scope G9 bedside monitor was thus born.

Life Scope TR bedside monitors updated to be Life Scope Genesis G5 bedside monitors using panel PCs as display

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 doing away with the MULTI sockets and a working modular infrastructure for measurement data finally introduced. Genesis is a powerful word suggesting the starting of everything anew but it is again just talks without the costly action.

By now, investment in the yellow MULTI sockets is too deep in the sand and it is therefore difficult to let go!

History repeats, and we can already see the future from the past. NIHON KOHDEN is unfortunately ill-equipped to compete outside the protected Japanese market.

END

Medical Devices Sanity

NIHON KOHDEN Life Scope Patient Monitors Struggling The Disruptive Digital Revolution

(I)

Back To The Future In The 1990s

The Digital Revolution dealt not only a heavy, but lasting blow to NIHON KOHDEN as a manufacturer

(II)

Clueless Exporting Without A Proper Strategy

(III)

Digital Defeat: A Crushing Blow That Echoes Endlessly

(IV)

What Not To Do Is Fundamental

(V)

Denial Of Reality

(VI)

Throwing Good Money After Bad

Conclusion:

The Challenges Ahead