NIHON KOHDEN Life Scope Patient Monitors Struggling The Disruptive Digital Revolution

 


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 digital measurement LAN 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 and buried.

(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 a heavy and irrecoverable 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had become the norm in foreign markets, Nihon Kohden Corporation in Japan was still helplessly struggling with the outdated analog type signal exchangers.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 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


The 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 also 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.
 
NIHON KOHDEN routinely got struck out in the first round of any project screening; the Ethernet factor was something institutional prospects were so keen to first inspect for networking capability but prominently missing in the company's product range. 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 contrast is seen when comparing an outdated Nihon Kohden 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 as highly crude against international competitors 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. The Life Scope 8 bedside monitor was of course not sold in the USA market.
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, except of course for Japanese Government ODA projects. 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 when the main demand was monochrome; this product was only targeting a niche in 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.
 

The products were not saleable in foreign markets even without need for 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 open only to bids from Japanese companies. For recipients of the Japanese ODA projects, they of course cannot look into the mouth of the gift horses.
 


(II)

Long Stuck In A Rut Without A Proper Export Strategy

A Strategy delineates a territory in which a company seeks to be unique -  Michael Porter
 
 
The relationship 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


 
NIHON KOHDEN had a lot to learn for digital networking

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. NIHON KOHDEN had a lot to learn from Marquette indeed.
 
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 to only two.
 
Mark this December 1994 date, and subsequent release of first digital modular monitor (Life Scope BSS-9800 Bedside Station) by NIHON KOHDEN in August 1998. 
 
 
Substantial current incomes and profits come from being a Japanese importer of medical devices

In the domestic market in Japan, Nihon Kohden Corporation has two equally important businesses, that of being a manufacturer and also a protected leading distributor of imported medical 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.
 
A big chunk of the corporate incomes and profits in each fiscal year are therefore 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 not many are aware NIHON KOHDEN is also a distributor for Metran Co., Ltd in Japan from 2010; the latter being a manufacturer of HFO ventilators, and the technology supplier for the core of current NIHON KOHDEN ventilator range. The annual reports do not tell us about the significant business of distribution, so there are just so 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 easily exported due to manufacturer restrictions on 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 the company as an exporter for solutions, and 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 limits to a large extent 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.
 

Current export business model of NIHON KOHDEN is meaningless

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 shrinks the realizable sales potential in any market, and significantly enhances the bargaining power of the buyers, making it very challenging for any seller to get a fair profit in highly competitive markets.

Besides the product gaps and with very limited development resources, product designs are only fine-tuned to the peculiarities of the domestic demand with only 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 and for decades, only the Asia-Pacific subsidiary business is consistently profitable without any help from Head Office! 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.


The export business is long stuck in a commodity market segment
 
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.
 
A good product strategy does not need any business from World Bank projects, this is one 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

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. The reason for this phenomenon is because 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 have been waiting patiently for this D-day.
 
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 turf-protection approach further shrinks the accessible market, 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)

Saddled And Downgraded By The Digital Revolution

 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 big failure, one that is still painful today.
 

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 eventually led NIHON KOHDEN to initiate an all-out efforts to hide the incompetence to make digital modular monitors, and even 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 abandoned.

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 LAN 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 and could only make use of four types of modules.
Lower-priced Life Scope M (BSM-9510) modular bedside monitor and the Life Scope S bedside station made up the range of modular monitors

Life Scope M modular monitor was launched in June 1999, only to be abruptly withdrawn from the market just not long after launch. It was very confusing moments, the abrupt end to BSM-9510 (Life Scope M) modular monitor showed the seriousness of the problem encountered by development team.
 
There remained no official confirmation of product withdrawal, so it certainly looked like the problem could be fixed with time. The assumption was not realistic, as a younger team of engineers with lesser experience had taken over key positions. Three years later, when two configured Life Scope A (BSM-5100) series monitors were released as shocking replacements for a single Life Scope M modular monitor, we know it was the end of efforts by NIHON KOHDEN to make modular monitors.
 
Life Scope M (BSM-9510) modular monitor suffered the terrible destiny of a quick death

 

Emergence of Distributed Processing
 
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
 
Nihon Kohden then had a standing long-delivery problem, it was eventually decided to offer only one type of multi-parameter module for all prospects in order not to make it worse. This meant only one comprehensive type of multi-parameter module and the manufacturer could do it because it has strong bargaining power in the protected Japanese domestic market. The first multi-parameter module was named the Saturn module.
 
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.
 
Take it or leave it bargaining power in Japan

Nihon Kohden intended a module rack integrated physically with the main unit to form a limited footprint just big enough to stack the display monitor on top of it (see below illustration). The physical size of the Saturn module was therefore constrained; in addition, the 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 connection sockets. A solution had to be found to solve this problem.
 
The Saturn module needed to be physically small in size

The problem was not unique to NIHON KOHDEN, and the most common solution in the market is to integrate more than one signal onto a socket and using an external splitter to obtain back the original individual signals. The thought-provoking solution from NIHON KOHDEN, was to frugally share a small number of common sockets.
 
 
Frugal sharing of two common sockets was the solution for the Saturn module

NIHON KOHDEN development team managed to identify five types of analog hardware (Temperature, IBP, Cardiac Output, Thermistor-method Respiration, FiO2) to form a hardware group frugally sharing only two sockets that are flexible for group use. These two flexible sockets are known as MULTI (short for multi-parameter) sockets and are specially colored yellow for easy identification.
 
The hardware group and sockets together made up the MULTI-PARAMETER UNIT (MPU), and was a peculiar design to minimize the number of physical sockets needed on a front panel with a limited space area; thus, the MPU has the special characteristic of possessing more hardware than physical sockets. It is a design to optimize a few physical sockets for frugal sharing, and is therefore operating under constraint of limited sockets.
 
The MPU must be viewed from the right perspective, that it is illogical to use when there is no lack of panel space, because we should typically be optimizing use of expensive hardware instead of cheap sockets.

It was a design to optimize a fraction of total needed physical sockets for sharing, and is operating under constraint of limited 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 custom 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. Thus, the mission of the Smart Cables is to make use of digital codes to share the yellow MULTI sockets.

The digital hexadecimal parameter code is programmed into a non-volatile EEPROM chip (Electrically Erasable Programmable Read-only Memory) mounted on a small flexible PC board and wired to the plug of a Smart Cable at the factory; users cannot change the code after production using settings on the monitors. The Smart Cables are priced highly by the manufacturer, and only the common IBP cable can be sourced from China suppliers at a reasonable price.
 

  
Each yellow MULTI socket can only link to one channel of the internal hardware, except for Temperature which can accommodate up to two.
 
As an exception, a MULTI socket can link up to two channels of internal analog Temperature amplifiers
 
 
The hardware mentioned here are linked to the flexible MULTI socket internally, and not from the outside
 
Temperature, IBP, Cardiac Output, Thermistor-method Respiration and FiO2 hardware are placed internally for activation.
 
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 group 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-method Respiration and FiO2 hardware in the MPU.
 
Given the large amount of hardware idling in the MPU, 
more physical sockets are needed to access the MPU for these valuable hardware; yet, only physical sockets in the form of MULTI sockets can access the MPU. The arrangement to add more physical sockets is thus achieved using external expansion boxes filled with two or more MULTI sockets (each with its own dedicated IBP amplifier hardware). It is important at this point to be clear the purpose is to add more physical sockets linking to the existing MPU, and not to add more monitoring parameters.
 
This is a process of adding more physical sockets, and not more monitoring parameters

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

A MULTI socket can additionally switch to be a pass-through path for any serial kit set

This is done via the parameter code, bypassing internal hardware and go directly for digital processing. 
 
Using parameter codes, a MULTI socket can switch to be transit point for digital serial signals by bypassing internal hardware

The purpose 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 initial design was to save on one physical serial port 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 monitoring IBP, Temperature, Cardiac Output, FiO2 and Thermistor-method Respiration, as well as a pass-through path for mainstream CO2 serial kit sets.
 
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 MULTI sockets
- 2 channels of IBP
- 4 channels of Temperature (2 MULTI sockets = 4-ch TEMP)
- Cardiac Output
- FiO2
- Thermistor Respiration
- <MULTI sockets as serial ports> Mainstream CO2 kit
 
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 modules) can access the hardware in the MPU common pool inside the Saturn module; together six MULTI sockets and six channels of IBP are made available to the users. It was possible to use the Saturn module alone, but the two MULTI sockets would not be enough.
 
The MPU is meaningless without the module rack

Unfortunately, the digital measurement LAN network for data communication between module rack housing and monitor main unit was unstable with plenty of performance issues, and had to be finally given up for good. This means the first two digital modular monitors developed by the manufacturer were failures, and they were withdrawn before registration in the biggest US market.
 
Note the failed measurement LAN network is not referring to the real-time clinical LAN network for data exchanges between bedside monitors and central nurse stations.
 

 
After the decision to stop development work on the measurement LAN network, a younger team of risk-averse engineers took over key positions and decided to keep the MPU, and using the expansion sockets to simulate scalability. This is desperate and unprofessional behavior, because they did it to avoid working on a new measurement LAN; at the same time, they also knew they could get away with it in Japan given the low bargaining power of users in the domestic market.
 
The MPU was only a compromise to accommodate limited panel space area and should never be mistaken as an innovation; without the module rack, the MPU is meaningless and most importantly, there is no demand for socket flexibility outside of Japan.
 
Besides, there are also 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 back the original signals.
 
Example of resolving back an integrated signal into original P1 and P2

So far, time-sharing of connector sockets is only done by NIHON KOHDEN, and avoided by all other manufacturers of patient monitors.
 

The two modular monitors that made use of 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 already 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 because it was also a workstation
 
The Life Scope BSS-9800 Bedside Station was fashioned after the SpaceLab UCW, and can work as a workstation using a slot-in PC card. The workstation ambition was still work-in-progress when development work for Life Scope BSS-9800 Bedside Station had to be suspended.
 
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 complete ICU installtion without waiting for a new compatible central monitor.
 
 
NIHON KOHDEN was way far behind Spacelabs, the latter could already offer installation of the following entire system when NIHON KOHDEN was just working on one of the components .
 
SpaceLabs UCW has network access to the PCMS multi-disclosure Workstation and Chartmaster Server (Clinical Information System)


US FDA records show Life Scope S and Life Scope M were not launched in the US market

The two modular monitors were failures even before they could be marketed in the USA market. The cause of the failure was the unstable measurement LAN network for data exchange between modules and main unit. The problematic measurement LAN needed a lot of processing and resulted in Life Scope S bedside station functioning only as a limited monitor while the Life Scope M bedside monitor had to be completely withdrawn due to insufficient processing power.

There are two real-time LAN networks needed by modular monitors, the clinical LAN network linking patient monitors to the Central Nurse Station proved stable but the measurement LAN network linking the modules to the main units of BSS-9800 bedside station/ BSM-9510 bedside monitor was problematic. This latter network was abandoned by NIHON KOHDEN without replacement.
 
There are two real-time LAN networks needed by Life Scope S modular monitors
 
Shown below is the real-time measurement LAN network allowing direct data communication between main unit and individual module.
 
NIHON KOHDEN gave up trying to solve the LAN network performance issues between main unit and modules

 
NIHON KOHDEN is no longer a manufacturer capable of making modular patient monitors

After the failure to make a functional measurement LAN network, NIHON KOHDEN decided to keep alive the Smart Cables as a means to hide from the market the company does not have a functional measurement LAN network to offer modular monitors.

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 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 measurement LAN network could be fixed.
Date of first introduction and use

A new configured series replaced the Life Scope M modular monitor

We assumed the distributors had understood the implication when two configured Life Scope A (BSM-5100) series bedside monitors were launched to replace a single Life Scope M modular monitor.
 
The abundant panel space tells us the Life Scope A monitors had no reason to use the yellow flexible MULTI sockets

Configured Life Scope A (BSM-5100) series monitors were monster monitors 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 provided using dedicated sockets.


 
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. Without doubt, sales for the expensive configured BSM-5100 series bedside monitors was very bad for the export market.
 

 

(IV)

A Strategic Disaster

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; the product is clearly targeting hospital 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. 
 
With a changing trend in the international market, there was therefore 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 biphasic 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; this means the company's defibrillator development team was helpless in the face of disruption from changing technology. It was obvious to any observer they could only solve the problem by buying the technology from someone.

When the demand for biphasic AEDs emerged in the Japanese domestic market, the company resorted to find 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.
 
Mark the date January 2002, and subsequent release of first Acti-Biphasic defibrillators (CardioLife TEC-7700 series) by NIHON KOHDEN in November 2002.
 
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 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.
 
To our surprise, instead of licensing the proprietary biphasic defibrillation design from Cardiac Science, a few engineers in NIHON KOHDEN could suddenly conclude a workable, proprietary Acti-Biphasic shock waveform just by playing with biphasic circuitry on pigs with minimal clinical supervision and collaboration, it is no wonder that the company 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 Acti-Biphasic waveform were the CardioLife TEC-7700K series defibrillators

The CardioLife TEC-7000 series defibrillators had two models, the CardioLife TEC-7721K and CardioLife TEC-7731K (built-in pacing unit).
 
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 marketNihon 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. This means you need clinical papers in addition to CE certification.

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 by taking advantage of their good 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.
 
Nihon Kohden began exporting unproven proprietary Acti-Biphasic defibrillators in 2002, before completion of proper clinical validation
 

Japanese Regulatory Authority took three long years to grant sales approval for the TEC-7700 series defibrillators 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.

Did NIHON KOHDEN give up exporting the original Acti-Biphasic defibrillation output waveform?
 
Nihon Kohden incredibly launched another unproven "Acti-Biphasic" TEC-5500 series defibrillators for export sales in August 2004, more than a year before the above announcement; it was as if the two are unrelated. The urgent launch of TEC-5500 series defibrillators for export did not make sense, the event sent a subtle message something fundamental had changed.

We were therefore not surprised to later find the waveform discharged by the TEC-5500 series defibrillators different from the TEC-7700 series defibrillators. It is 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 in the field.
 
Was the manufacturer under pressure to stop using the declared discharge waveform (that is still currently being published on the service and operator manuals)?

This was happening prior to Japan MHLW approval for the TEC-7700 series, and without showing any clinical evidence to support its use!
 
CardioLife TEC-5500K series started export from August 2004, when Japan MHLW had not approved domestic sales of CardioLife TEC-7700 series
 

The Timeline

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

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

However, the export models of TEC-5500 series, TEC-5600 series and TEC-8300 series 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 these 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 received 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.

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 what should be the "Correct Graph". 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 (engineer) in Tokyo has the audacity to ask distributor staff to "just flip the APEX/ STERNUM connections" to get the polarity right! This is desperate advice, and confirmation.
 
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 discharge 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 should have by now long recalled all Acti-Biphasic defibrillators from the market.
 
 

The manufacturer quietly conceded the flexible sockets are indeed poor man's sockets
 
The manufacturer made the mistake of thinking a flexible MULTI socket exhibits characteristics similar to what a modular monitor offers, only to learn painfully from market rejections flexible sockets are indeed poor man's sockets. It was unnecessary lessons, and expected if you understand the operating principles.
 

 
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)
 

How can one flexible socket do the jobs of three fixed-purpose sockets?
 
To insist the use of Smart Cables, the Life Scope BSM-2301K monitor has a yellow flexible MULTI socket for three types of measurements, namely:
 
1. Invasive Blood Pressure
2. Thermistor-method Respiration
3. Mainstream CO2 serial kit sets.
 
Without any use of Smart Cables, all IBP, Thermistor-method 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-method 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 each doing their own job using three dedicated sockets? If MULTI socket is such a superior proposal, why is the Temperature socket a dedicated one?
This is a compromised usage, like a poor man affording only one physical socket for three types of use

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 (one MULTI socket)
- 1-ch IBP
Thermistor-method Respiration
- <MULTI socket as serial port> Mainstream CO2 Kit Sets
 
The reality is the shortage of two physical sockets for users. However, one of the parameter for the yellow MULTI socket is thermistor-method respiration, which is for use in the operating room to overcome electrical noise interference; this parameter is therefore not for use in the ward. The real shortage felt by users is only one missing physical socket, and they are not hesitating to demand it back. Imagine the initial wonder of a flexible socket turned into an outrage for being shortchanged!
 
Users do not want to be shortchanged with a poor man's socket

The manufacturer was pressured to respond with an updated model, Life Scope BSM-2303K. The solution from new model BSM-2303K was to add a new yellow socket only for IBP.
 
The MPU of the Life Scope BSM-2301K was not designed to take on expansion, and any additional MULTI socket could load (disturb) the operation of existing MPU, causing it to malfunction. An additional MULTI socket not linked to the MPU is just an independent socket with its own dedicated IBP amplifier hardware. Such was the socket offered for Life Scope BSM-2303K, noting there was a need to recognize the IBP Smart Cable.
 
With a new socket for IBP, the existing yellow MULTI socket can move away from doing IBP monitoring, and just focus on being a serial port for mainstream CO2 or being an amplifier for respiration monitoring using a thermistor transducer.
 
It was ironical, a solution relying on an extra dedicated socket for IBP; there are now two IBP amplifier hardware in the monitor, which was not the original intention. It was clear the complaints were market rejections of sharing a flexible socket and the solution offered by Life Scope BSM-2303K was to return back the missing physical socket demanded by users.
Market rejection forced the manufacturer to return back the missing physical socket demanded by users


An even greater number of physical sockets had to be returned for later Life Scope BSM-3000 series bedside monitors

Undeterred, NIHON KOHDEN again launched the Life Scope VS bedside monitors in early 2011, with the Life Scope BSM-3500 series monitors (12.1-inch display) having two yellow flexible MULTI sockets while the Life Scope BSM-3700 series monitors (15-inch display) have three yellow flexible MULTI sockets. The values captured by users of both models are negative.
 
The conventional and MPU blocks of Life Scope BSM-3500 series (12-inch) bedside monitors are shown below; 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 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.
 
In below image, users of the left monitor (BSM-3500 series) requires five physical connection sockets but only two yellow shared-use sockets are provided for a 2/5 availability ratio. The manufacturer cannot provide more than two MULTI sockets because the IBP hardware channels intended for this model is only two, and therefore fixed at two MULTI sockets. 
 
Note that without any use of Smart Cables/ MULTI sockets, all five parameters are freely available for carefree use via their respective dedicated sockets. The use of Smart Cables/ MULTI sockets just makes things unnecessarily complicated and requires deliberate operator attention to consciously choose two among the five needed; 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 where bargaining power of users is low. It is another matter for the export markets, the manufacturer has to respond to such complaints as long as they still want to export their monitors.
 
How does such dire shortage of connector sockets benefit a user?
These monitors are in dire shortage of physical connection sockets, the values captured by users are 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 want their physical sockets back because they need it! The manufacturer offers AA-372P Smart Expansion Unit to return back two missing physical sockets and the AA-374P Smart Expansion Unit to return back four missing physical 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 connection socketsThe makeshift solution makes the bedside monitor look awkward, resembling a product prototypes still undergoing tests.
These are futile efforts, what you have just seen is as good as using back dedicated sockets! The underlying problem is the use of an MTU block when there is no problem of panel space area.
 
 
Since the Life Scope VS bedside monitors were originally not designed for socket expansion, there should be limitations and users may have to pay additional attention to correct socket selections as a result.