NIHON KOHDEN Life Scope Patient Monitors Struggling The Disruptive Digital Revolution

 
 
 


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

(I)

Back To The Future In The 1990s

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

A profitable and comfortable position was taken away from NIHON KOHDEN by the Digital Revolution!
 
 
First, for perspective: The highest revenue for NIHON KOHDEN CORPORATION from exports comes from patient monitors, followed by defibrillators, together they formed about 70% of the company's sales in foreign markets. All other equipment only make up a small part of the export business.

The disruptive digital revolution brutally pushed back by decades the technological progress of NIHON KOHDEN, and many will be stunned to learn what is current digital capability status of the LIFE SCOPE brand bedside monitoring systems. The details are available in this article for your critical evaluation.

During the 1990s, the company actually had to grapple with a huge technological gap in order to catch up with International players; the overall situation was so bad it actually demanded an overhaul of the entire product range just  to stay relevant. Speed and intense investment were the two critical elements to make up for the lost time but the total failure in developing a modular exchange platform for measurement data had led to the company giving up developing beyond the first two failed modular monitors. NIHON KOHDEN had lost the golden opportunity to catch up, and the company is far behind international competitors today.
 
Unknown to many, when digital Ethernet networking was already the norm from successful international competitors like SpaceLabs and Marquette Electronics for patient monitoring, Nihon Kohden Corporation in Japan was still helplessly struggling with the outdated analog type signal exchangers, which was (and still is) a protected market insulated from the high-tech foreign competitive forces.
 




NIHON KOHDEN patient monitoring products were shunned in foreign markets
 
It was impossible 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 to Japanese Government ODA projects. As seen in the USA market, sales recovery was so gradual and hardly noticeable that many from the younger generation had erroneously mistaken it as a new emerging brand in the market!
 
For a good SUMMARY of the Patient Monitoring market up to the late 1980s, Michael E. Porter had one in his book The Competitive Advantage of Nations (1990; Republished with a new introduction, 1998).

From the early 1990s the Life Scope Patient Monitoring Systems had already shown rapid technological irrelevance. In August 1998, Nihon Kohden finally launched the first Life Scope digital modular monitor but it soon turned out to be a failure.
 
By September 2002 it became obvious to observers the poorly-designed digital measurement data-exchange network platform (necessary for modular monitors) had already been given up to avoid further losses Nihon Kohden Corporation could ill afford. Instead of confronting it squarely as a representative brand from Japan, the company resorted to putting in great efforts just to hide the reality (and therefore kept the helpless state of being without a modular data-exchange platform). The counterproductive analog yellow MULTI sockets are currently being passed off absurdly as modular communication nodes connecting to a non-existent measurement data network platform; this is but a fraction of the disruption faced by NIHON KOHDEN from the digital revolution.


How can we know what types of patient monitoring products were Nihon Kohden 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 1997 patient monitoring product range lacked digital era displays, connectivity and storage
 

The CNS-8311 Central Monitors (released in mid-1995) shown in the network diagram was developed in a US software workshop (Nihon Kohden USLab) using a proprietary GUI (graphical user interface) running on top of Microsoft MS-DOS operating system. This PC-based Central Monitor could not have any Ethernet link because there was no place to connect to. The Ethernet link was something prospects were so keen to first inspect; this was the year there was a big surge in Ethernet networking knowledge after Microsoft released the Windows 95 operating system which kick-started the mass adoption of the Internet and Ethernet. In 1995, the Ethernet card was still expensive and sold as an option to the basic PC; Internet IP was not common knowledge yet but an Ethernet LAN setup allowed multiple PCs to share internet access using only a single dial-up router (via a telephone line) to a service provider.
 
The outdated analog signal exchanger on roller wheels (left) offered by NIHON KOHDEN in 1997

 
The analog signal exchanger for linking bedside monitors to the Central Monitor used by NIHON KOHDEN was heavy, bulky and outdated. It stood out prominently as highly crude against international competitors like SpaceLabs or Marquette patient monitors who were using state of the art digital Ethernet LAN for communication as standard.
 
Each cable running between bedside monitor and said signal exchanger was loaded with 37 strands of thick wires in it and was heavy, making it clear the installation cost was also very high; there could not be any profit for system sales even if customers could be found.

The chances to find buyers were very low for the outdated analog type exchange network and if it was not for the fact information search was not yet well-developed, there would not even have any prospect from less advanced economies (that were not well-informed enough). In the USA market for example, sales plunged from tens of millions US dollars in annual turnover to practically nothing! That was the reality the company had to face.

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

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

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

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


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

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

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


(II)

Exporting Without A Strategy

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


How was it possible for a business relationship to exist between Nihon Kohden Corporation and Marquette Electronics, Inc. in the 1990s?
 
 
Below image shows the Marquette bedside patient monitors range (Eagle Monitors for standard monitoring while Solar Monitors for premium cardiac care) in the 1990s.
 
Marquette Eagle and Solar monitors in the 1990s

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

 
While Marquette was already declaring the Unity network IEEE 802.3 compliance at the system level, NIHON KOHDEN could not yet produce a single monitor with this compliance. At the time, we were seeing market players with Ethernet Connectivity competing who could offer the most digital connection nodes in 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 Not From Being A Manufacturer
 
 
In the protected domestic market in Japan, Nihon Kohden Corporation has two equally important roles, that of manufacturer and also a leading distributor for imported products such as ventilators from Swiss manufacturer Hamilton Medical AG, anesthesia machines, BIS (Bispectral Index) monitor, branded consumables and many more. NIHON KOHDEN created value in Japan by providing solutions with the help of technologies from complementary imported products. A big portion of the corporate income and profit in each fiscal year are generated from selling products in Japan made by third-party world-renowned companies, and it should of interest to learn how these are being reflected on the balance sheet.

As captive customer solutions in Japan are typically a combination of own and distributed products, such solutions cannot be exported due to strict restrictions of distribution territory. This is the major weakness of NIHON KOHDEN as an exporter for solutions.
 
It is no coincidence good market reports on the Asia-Pacific region typically do not include the Japanese market; the prices for patient monitors in the Japanese domestic market (being a highly-guarded closed market) are well-inflated to double what are found in foreign markets. NIHON KOHDEN should see the competitive situation in Japan taking a drastic turn for the worse if the domestic market has to be opened up in a trade negotiation.

The domestic and export businesses are worlds apart; the roles played by the products that are only meant for domestic distribution will be the product gaps for the export business! This is a very serious matter when you know it limits the business potential of any accessible market and making published market reports irrelevant. Distribution partners are of course greatly weakened by the product gaps, rendering meaningful performance appraisals a tricky affair, and highly subjective in nature.

 

The current export business model of NIHON KOHDEN is not 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 therefore only represents a small percentage of the annual export sales and the bulk of it are from the customer's initial hardware purchase. 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 lock in high value customers, depriving NIHON KOHDEN resellers (including subsidiaries) the necessary margin needed to sustain their business growth; a big order simply means a purchase order with exceptionally low margin.


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

It is painful and frustrating for NIHON KOHDEN resellers to keep spending time and money to acquire new customers, without the ability to retain them when they reached the doomed success point. This is also the point resellers could benefit most profitably from the 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 also impossible to realize because of the perpetual fear of bringing them into the protected Japanese domestic market, and for this reason NIHON KOHDEN products cannot be compared to other manufacturers in the market which are more co-operative with system integrations.
 

When under siege, the company will 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 inability to complete all necessary aspects of making a digital modular monitor
 
 
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 soon game over before the product could be launched in the biggest US market.
 
It was a major product development failure not only adding to the financial woes but propelled the ongoing crisis into a dire despair. 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 the risk to export new type biphasic defibrillators before the design was found clinically sound for use, and long before it was approved for domestic use in Japan.
 
The first NIHON KOHDEN digital modular monitor launched in August 1998

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

 
The Life Scope S bedside station was launched with many missing software, scheduled for gradual upgrading over time. When the Life Scope S product development was suddenly suspended about a year from its export launch, these planned upgrades were left unfinished.
 
The failure meant NIHON KOHDEN did not succeed in making modular monitors, and it was a major defeat in executing digital transformation strategy the company had yet to admit publicly.

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

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

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

 
Life Scope M modular monitor was launched in June 1999, only to be abruptly withdrawn from the market just not long after launch. The abrupt end to BSM-9510 (Life Scope M) modular monitor showed there was serious doubts about the performance of the new modular bedside monitor even as a basic patient monitor.
 
There remained no official confirmation of product withdrawal, so it certainly looked like the problem could be fixed with time. This assumption was finally negated with the release of configured Life Scope A (BSM-5100) series monitors.

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

At the time NIHON KOHDEN was responding to an important emerging trend of using a high-density digital multi-parameter module as basic building block for modular monitors
 
 
In analog modular monitors, only single parameter modules were produced by NIHON KOHDEN. However, when designing new digital modules for the Life Scope S bedside station and Life Scope M bedside monitor, the company discovered the critical care market had already moved to using a digital multi-parameter module with higher density of electronic components as a basic building block for modular monitors.

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

 
Marquette modular monitors distributed by NIHON KOHDEN in Japan


In Life Scope S BSS-9800 Bedside Station and Life Scope M BSM-9510 Bedside Monitor, Nihon Kohden wanted to follow the trend, which was to release multi-parameter modules for the first time, similar to what Marquette was already offering for Solar 7000/8000 modular monitors.

 
There were many types of Marquette multi-parameter TRAM modules to choose as basic building block
 

For Nihon Kohden to offer a variety of multi-parameter modules would only exacerbate a long-standing delivery problem, it was eventually decided to offer only one type of multi-parameter module for all prospects. This meant only one comprehensive type of multi-parameter module was offered and it was named the Saturn module. The manufacturer could do it because it has strong bargaining power in the protected Japanese domestic market.

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


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

 
There is only one type of multi-parameter module in this brochure
 
 

  Even occupying a 3-slot width of the module rack, the Saturn multi-parameter module (August 1998) was not big enough to hold all necessary connector sockets required by the large amount of hardware
 
Nihon Kohden intended a module rack integrated physically with the main unit to form a limited footprint just big enough to stack the display monitor on top of it (see below illustration). The physical size of the Saturn multi-parameter was therefore constrained; in addition, the multi-parameter module must still work in combination with other parameter modules like recorder, sidestream CO2, BIS, EEG, Flow/ PAW, SvO2 in the module rack. In conclusion, we ended up seeing a small Saturn module with insufficient space to hold all the necessary connector sockets.

The Saturn module was intended to be physically small in size


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

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


The method selected by NIHON KOHDEN was to make use of coded measurement cable cited as "Smart Cables" to share two connector sockets. The patient monitoring hardware can be separated into two blocks in the Saturn module:

(BLOCK A) The hardware using dedicated sockets and ordinary measurement cables:
- ECG
- SpO2
- NIBP

(BLOCK B) The hardware sharing the two adapting MULTI sockets in a separate Multi-parameter Unit using only coded measurement cables for connections:
- 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

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

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

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

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

The label for the yellow MULTI sockets on the Saturn module
 


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

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

 
Example of resolving integrated signals to individual P1 and P2



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

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

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

It is actually not difficult to make these Smart Cables but they are being priced highly by the manufacturer; only the common IBP cable can be sourced from China suppliers at a reasonable price.

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

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

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

Thus, a coded "Smart Cable" makes it possible for exclusive use of an engaged MULTI sockets via internal switching among five types of specific hardware.

The MULTI sockets are therefore adapter sockets with the ability to take switching instructions from the digital codes stored in coded measurement cables known as Smart cables
  
Principle of Operation

 

The Multi-parameter unit (MPU) in the Saturn module
 
In addition to coded Smart Cables, costly mechanism must be in place internally to select the correct active hardware corresponding to the specific code of the measurement cable being used.

The hardware sharing the two MULTI sockets are internal components of the Multi-parameter unit, with necessary mechanism to support the time-sharing. For example, when a measurement cable with a "Cardiac Output" code is plugged into a MULTI socket, the internal Cardiac Output hardware will have exclusive use of the engaged MULTI socket. If a hexadecimal code is not detected (such as a damaged Smart Cable plug), the MPU would not do anything and none of the internal hardware would be linked.
 
Sharing of connector sockets is made possible by coded measurement cables and an internal Multi-parameter Unit
 

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





  Extension is badly needed for the MULTI-PARAMETER UNIT in the Saturn module
 
Notice the two shared-use sockets on the Saturn module are not enough for use, more sockets are badly needed. This is solved by having one or more satellite boxes containing two usable MULTI sockets each, placed next to the Saturn module. The image gives an impression of scalability when skipping the details, but the necessary hardware are already embedded in the Saturn module except for additional IBP amplifiers which must be tied to the number of available MULTI sockets.

What you are seeing is making use of space external to the Saturn module to mount the missing connector sockets

The deficiency of connector sockets is addressed by making available additional MULTI connector sockets placed on external boxes


Since the Saturn module had only two yellow MULTI sockets, it is impossible to perform more than two channels of IBP monitoring; this means IBP hardware must always correspond to the number of MULTI sockets available. For this reason, each MULTI socket comes with their own one-channel IBP hardware.


Temperature hardware is not an issue since each MULTI socket can take two channels of Temperature measurements


The extension Smart module is therefore a 2-channel IBP box using two yellow shared-use MULTI sockets that can also access the Multi-parameter unit to make use of the Temperature, Cardiac Output, Thermistor Respiration and FiO2 hardware already embedded in the Saturn module.

The necessary hardware are already embedded in the Saturn module except for additional IBP amplifiers tied to number of available MULTI sockets


So, there is clearly an unexpressed MULTI sockets hardware rule that is being kept under wraps by the manufacturer:

"Each functional yellow MULTI socket always come with their own one-channel IBP amplifier hardware"

This of course, turns into a limitation when the MULTI sockets are being used out of context.


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

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



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


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

The use of Smart Cables for serial communications, however, gives the false illusion of a mighty MULTI socket when the capabilities are in reality coming from the system software.

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

To reiterate, there is no difference if you connect digital data to the monitor using Smart Cables or ordinary serial cables.



 
Life Scope S Bedside Station Was Not Yet Ready Even After Long Delays

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

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



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

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

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

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


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

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

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

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

The network for data exchange between main unit and modules was disappointing

 

The product failure was huge financial losses incurred at a time when the company was already suffering badly from poor sales due to the lag in digital technology know-how.


NIHON KOHDEN could not solve the communication problem between main unit and modules
 


Failure to make a functional measurement data-exchange network meant NIHON KOHDEN was downgraded to be a manufacturer only capable of making configured patient monitors
 
 
After the Life Scope S (BSS-9800) bedside station and Life Scope M (BSM-9510) bedside monitor, a CNS-9300 series Central Monitors by NIHON KOHDEN USLab was launched in 2000 which could take data from both analog and digital networking making it possible for old and new monitors to co-exist. Although hybrid network would help to sell newer models to existing customers, it of course did not appeal to new customers.
 
CNS-9300 series Central Monitor was meant to support customers in Japan for mixing older monitors with new


 
 
Keeping alive the Multi-parameter Unit as a future smoke screen to hide the missing modular platform
 
In line with the release of CNS-9300 series Central Monitors, a new 12.1-inch Life Scope P (BSM-4100 series) color monitors were released in late 2000 to make it possible for existing customers to add it to their installed system using said hybrid CNS-9300 series Central Monitor. It should be obvious not many customers would be willing to buy an additional new CNS-9300 series Central Monitor just to add one or two Life Scope P; the demand of the products were from the Japanese domestic market.

An additional 12.1 inch model, the
BSM-5100 series with more universal MULTI sockets were added in September 2002.
 
In ex-Japan market, 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 configured monitor, no one could be sure if the problematic modular data-exchange platform could be fixed. The launch of a configured Life Scope A (BSM-5100) series bedside monitors using only the legacy Multi-parameter Unit in September 2002 confirmed what we needed to know, and the start of a new reality.
 
Date of first introduction and use

Those who had wondered why Life Scope A (BSM-5100) configured series was not designed as a modular monitor eventually realized NIHON KOHDEN had already lost the ability to make new modular monitors.

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


Configured Life Scope A (BSM-5100) series monitors was a shocking and painful sight to behold; it was a monster monitor with plenty of panel space, yet filled with so many yellow shared-use MULTI sockets. It also caught our attention the manufacturer had knowingly added two extra dedicated Temperature sockets to mitigate the socket shortages, fully acknowledging their awareness of the basic facts. 
 
It was not possible for NIHON KOHDEN to have mistaken Life Scope A as having similar size limitation problem as the Saturn module, use of the Multi-parameter Unit here must be seen as intentionally extending its life cycle for a purpose which becomes crystal clear after the Life Scope J bedside monitor was released.
 


A configured Life Scope A bedside monitor replacing the withdrawn Life Scope M modular monitor implied Nihon Kohden could not solve the problem of the software for measurement data-exchange infrastructure used by Life Scope S bedside station, and that the company is also not working on any replacement. The company has totally given up making modular monitors!

 
NIHON KOHDEN has given up making modular monitors
 
 
Without doubt, sales for the configured BSM-5100 series monitors could not be good for the export market. It was there to fill the vacuum vacated by Life Scope M modular bedside monitor in the Japanese domestic market.

The problem is, it did not just stop here.
 
 

 

(IV)

What Not To Do Is Essence Of Strategy


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

NIHON KOHDEN was stumped by another game changer!
 

The next major export after patient monitors is defibrillators for NIHON KOHDEN CORPORATION. Neurology, ECG, Cell counters etc. accounted only for a small percentage of export sales for the manufacturer.


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

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

 
This was a mono-phasic model using the non-proprietary Edmark single-phase pulse as illustrated and the use of rechargeable battery for energy made it very inconvenient for public use.
 
Edwark, Single Phase Pulse defibrillation waveform used by monophasic CardioLife TEC-2200K series in 1997

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

Heartstream ForeRunner



Biphasic defibrillation waveform was becoming the new preference as it allowed for a smaller and lighter defibrillator design; more importantly it uses less current and this means less damage defibrillation will do to the heart. With the deal with Heartstream, HP acquired the Heartstream biphasic technology and also expanded the line of external defibrillators to include lay responders users. 
 
There was zero interest in the monophasic TEC-2200 series defibrillators offered by Nihon Kohden for ex-Japan market and the products had to be withdrawn from exporting.
 

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.



The global shift to biphasic defibrillation technology was an unanticipated market disruption for NIHON KOHDEN
 
 
After more than four years, NIHON KOHDEN remained unable to offer biphasic defibrillators and the company had no choice but to look for a suitable partner with biphasic technology for the Japanese domestic market when the demand for biphasic AEDs emerged. A strategic OEM distribution agreement was announced in January 2002 that Nihon Kohden would market Cardiac Science's line of AEDs under Nihon Kohden's trade name. This arrangement was a big success and many AED-9200 and AED-9231 were sold in Japan as reflected in annual reports and presentations.
 

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


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

It was not possible for Nihon Kohden to get any success outside of Japan as it was cheaper for distributors to buy directly from Cardiac Science the original models.
 
Instead of licensing the design from Cardiac Science, a few engineers in NIHON KOHDEN started to experiment with biphasic defibrillation on pigs and came up with the proprietary Acti-Biphasic defibrillation shock. It was done with minimal external collaboration, the company thus had great difficulty securing the necessary clinical support to advance the number of investigated cases for proper clinical validation. To date, there is not a single clinical paper published on Acti-Biphasic defibrillation.
 
The Acti-Biphasic waveform is seen as operating in an open loop during the first phase and in a closed loop during the second phase. It is a positive pulse during the first phase and of variable duration dependent on patient impedance. In a closed loop during the second phase, the duration of the width is therefore constant and being set to 3.4ms; it is not clear why 3.4ms constant width during second phase is optimal and why 270 Joules maximum energy is sufficient.
 
The first phase is positive and a wider pulse than the second phase


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

 
The first Acti-Biphasic defibrillators

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

The output waveform of the CardioLife TEC-7700K series on a recorder is as shown below. The recording correctly shows the first phase is a positive pulse.
 

The recording shows the voltage first swings to the top (positive saturation), then to negative saturation after some time; this is fully consistent with the official description of the Acti-Biphasic waveform.
 
Output of CardioLife TEC-7700K series is consistent with the declared description
  
 

How can we know if the Acti-Biphasic defibrillation shock actually works?
 
The margin of error is so high for data from a small 75 investigated cases
 
 
There is no white paper available. The Acti-Biphasic defibrillators were hurriedly launched (for export) before completion of proper clinical validation and the small sample size of seventy five investigated cases meant a high margin of error; we cannot be sure the Acti-Biphasic defibrillation shock works on patients! The clinical data and methodology fell short of US FDA guide for safety and effectiveness, and Nihon Kohden could have engaged a consultant if they had respected the validation process. The Acti-Biphasic defibrillation shock cannot meet the requirements to be allowed for sales in the US market; note the US FDA 510(K) process could not be used to clear the product since mono-phasic defibrillators are not predicate devices in the market. The often quoted American Heart Association recommendations are meaningless to Acti-Biphasic defibrillators.

Outside of the US market, we must ask what is the point of buying such critical treatment devices and placing them on standby to save lives? It is so unfair to the patients needing immediate treatment in a life-threatening situation!
 

Before proper completion of clinical validation, the company was bold enough to go ahead with exporting the first newly-designed Acti-Biphasic defibrillators from November 2002, purely relying on reputation of being an existing supplier of mono-phasic defibrillators. The November 2002 export launch was three long years from 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 waiting to explode with important issues left unaddressed.
 
Before completion of proper clinical validation, Nihon Kohden began exporting proprietary Acti-Biphasic defibrillators in 2002

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

The long three years period implied the application was turned down several times and serious doubts by the Regulatory Authority to grant its use. What prompted the decision to clear it after three years' wait is something we should know. By the time of receiving approval to sell in Japan, many CardioLife TEC-7700 series defibrillator were already exported.
 
NIHON KOHDEN was only able to announce the launch of TEC-7700 series defibrillators for sales in Japan market on December 1st, 2005.
 

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

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

We only learned later that for some unknown reasons, the manufacturer had surreptitiously decided not to continue with the original waveform!
 
 
This was the series later found to have Acti-Biphasic waveform flipped vertically upside down from that of the TEC-7700 series and it was happening right before Japan MHLW granted approval for the TEC-7700 series.
 
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 CardioLife TEC-5500K series started in August 2004, more than one year before Japan MHLW actually approved the TEC-7700 series


The reason CardioLife TEC-5500 series defibrillators were quickly approved for sales in Japan was based on the principle of declared substantial equivalence with the newly-approved TEC-7700 series
 
Current TEC-5600 series, TEC-8300 series output waveform are similar to TEC-5500 series defibrillators, how about submission documents for foreign regulatory approval which are all based on the TEC-7700K series? We also could not help wondering if the domestic and export versions of the Acti-Biphasic shock energy are currently identical?

 
 
A top prestigious University Hospital in Taiwan was the first to find the polarity of TEC-5500K output waveform inverted from the original shown on the manual
 
In the image below, we were greatly puzzled to learn of an adverse report from a competent Biomedical Engineering Team in National Taiwan University Hospital (Taipei City) that the polarity of measured waveform from two tested CardioLife TEC-5500K series defibrillators were inverted (i.e. opposite in polarity) from what the manuals had described. The tests were a result of investigation after a serious performance failure incident. The investigation raised many questions and only the IEC60601-2-2:2002 electrical safety compliance was put to rest.
  
There was no doubt since they had tested both models TEC-5521K (S/N 09xx4) and TEC-5531K (S/N 05xx4) to arrive at the same conclusion; the suffix K is for export models using English language as interface (for example the suffix J is for Japan domestic models), indicating more than 9000 units of TEC-5521K and more than 5000 units of TEC-5531K had been produced before the two tested units respectively. Detailed comparison was also done with defibrillators from another manufacturer (Philips) using the same testing equipment (Fluke Impulse 7000DP with 7010 Selectable Load) and the polarity was consistent with the manual descriptions of Philips.
 
This was an input from professionals that the Acti-Biphasic output waveform from the CardioLife TEC-5500K series defibrillators starts with a negative polarity and ends with a positive polarity; it is the exact opposite of what were shown on the operator and service manuals. As far as we know, there is no known manufacturer with a biphasic waveform that starts with a negative polarity, NIHON KOHDEN is unique in this approach but there is no clinical research done to validate its use on patients!


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

 
The AX-103VK defibrillator analyzer has a 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 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

Does the inverted waveform only apply to production batches meant for export?
 
What could be the reason for the sudden change of mind? Was it due to copyright pressure? Does the inverted waveform only apply to export models since Japan MHLW solely approved the TEC-7700 series version for the domestic market?
 
More about this deploring development in another article.



Out-of-context use of the Multi-parameter Unit and Smart Cables
 

Why the pain of two missing connector sockets to gain the use of just one flexible socket?
 
In 2001, a popular Life Scope BSM-2301K (also known as Life Scope i) was launched and many customers bought it for standalone applications not restricted by system compatibility. It was popular because the Life Scope BSM-2300K series range of monitors were the first in the industry to adopt the new-generation type 8.4-inch high-resolution touchscreen introduced by the electronics industry. The new touchscreen display was a huge jump in touchscreen technology and made for highly-intuitive operation.
 
The portable 8.4-inch Life Scope i (BSM-2301K)

 

To insist use of Smart Cables, the Life Scope BSM-2301K monitor has a MULTI-parameter Unit with only one yellow MULTI socket for three types of measurements, namely:
 
a. Invasive Blood Pressure
b. Thermistor Respiration
c. Digital self-contained mainstream CO2 serial kit sets.
 
The MULTI socket does not mean flexibility because you can only do one of the above parameter at any one time. Common sense tells us three dedicated sockets is far superior; why suffer pain of two missing sockets to gain use of one flexible socket?
 
Life Scope-i does not have enough connector sockets
 


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


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

(BLOCK A) The hardware using dedicated sockets and ordinary measurement cables:
- 1-ch TEMP
- ECG
- SpO2
- NIBP

(BLOCK B) The hardware sharing the single adapting MULTI socket in the Multi-parameter Unit using only Smart Cables for connections:
- 1-ch IBP
Thermistor Respiration

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


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

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

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

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

You will find important facts being withdrawn from later monitor manuals
 
BSM-2301 (Life Scope-i) Service Manual is clear on the design; manuals for later models stop providing details.
 
Block diagram on BSM-2301 (Life Scope-i) Service Manual


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


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



There is no customer value created by sharing cheap connector sockets

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. The legitimate resources for a patient monitor to time-share are obviously the amplifier hardware and not the connector sockets or switches; this way there would not have any idling costly hardware leading to inefficient use of valuable resources!
 
Time-sharing of an expensive hotel room creates value for the customers but time-sharing of a cheap connector socket does not

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


The dangerous use of semi-quantitative estimation data for uncertain measurements and concurrently displaying a flawed CO2 waveform
 
NIHON KOHDEN lacks side-stream 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 side-stream CO2 into the monitor is a mandatory requirement because an external unit requires additional power socket besides necessitating the use of a trolley.
 
For some unknown reason, Nihon Kohden monitors could not offer integrated side-stream CO2 unit.

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


Nihon Kohden solution was to offer miniaturized mainstream cap-ONE TG-920P CO2 sensor kit (order code P907) that can be used on non-intubated patients.
 
The cap-ONE TG-920P CO2 sensor kit (order code P907) has very small sensors because semi-quantitative measurement is adopted, the method is not commonly seen and many are not alerted to the risk of using data from semi-quantitative etCO2 kit sets for critical measurements and true CO2 waveform display.
 

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


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

It is not easy to separate the disposable adapter from the Cap-ONE transducers after use
 
When removing disposable adapter from the mini sensors, users tend to just pull from the cables and this action quickly weakens the joint holding the sensors and cables. The action will cause stress to the two joints and quickly degenerate the performance of the transducers.
 
Users just doing the inevitable

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

A highly relevant question: Can users accept estimated measurements for patient monitoring?
    
To save costs, the semi-quantitative kit sets do not make measurement during the inspiration phase, the measurement duty cycle is as shown. This means semi-quantitative CO2 measurements are not made continuously.

Semi-quantitative means there is a duty cycle, and measurement is not continuous
 

Semi-quantitative measurement is also of low-accuracy type, performed using one IR detector instead of the usual two to save cost. This is reflected in the measurement tolerance.
 
Contrasting, quantitative measurement delivers high accuracy for critical care. To ensure the necessary high accuracy, quantitative measurement employed two IR detectors for simultaneous CO2 measurements at different wavelength for results comparison. CO2 measurements are also being made continuously.
 
Quantitative measurement employs two detectors to make continuous measurement at different wave-lengths to compare readings for high accuracy

 
NIHON KOHDEN specification for TG-901T CO2 sensor kit shows even the specified low accuracy of CO2 measurement using semi-quantitative method no longer holds true once CO2 is present during the inspiration phase.

This is because actual CO2 value will be more.


As seen from the duty cycle, there is no measurement being made during the inspiration phase; how can users know specified measurement accuracy is valid?
  
Measurements are invalid when CO2 is present during inspiration, but CO2 is not measured during this period; can you have confidence in the measurements?

 
It should be clear each semi-quantitative CO2 measurement is an estimation since its accuracy is rendered uncertain by the inability to confirm if CO2 is present during the inspiration phase. The specified measurement tolerance therefore has no meaning for the users!
 
The users are also not alerted on screen there is no CO2 measurement being made during the inspiration phase, and unknowingly made to take an unnecessary risk.
 

Semi-quantitative methodology means cost-effective estimations and the design cannot be used in a general way, only on a selective basis with known risks
 
 
For example, semi-quantitative methodology can be used as a simple estimation tool for obtaining the numerical value of End-tidal Carbon Dioxide level (etCO2).
 
Below picture shows the semi-quantitative method in the way it was intended for, estimating only the etCO2 numerical value for purpose of airway tube placement confirmation. It is not for continuous waveform display.

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

 
 
How is it feasible to display a true continuous CO2 waveform when the semi-quantitative measurement kits do not have the ability to make continuous measurements?
 
 
NIHON KOHDEN also allows data from semi-quantitative measurements to be displayed on screen with the non-measurement period reset to zero level. The insistence to display a continuous waveform using discontinuous measurement data from semi-quantitative mainstream CO2 estimation kits is unacceptable; the manufacturer is just subjecting the monitored patients and users to dangerous misinterpretation risks.
 
A zero CO2 reading on the waveform means zero measured value. No measurement can only mean a defective sensor, not by design!

Note the etCO2 value shown is also not alerted to users as estimated etCO2 only.
 
A flawed CO2 waveform with non-measurement intervals reflected as zero measured CO2 value


As seen from the two true CO2 traces below, expiratory upstrokes do not always start from zero CO2 level!
 
Quantitative measurements confirming expiratory upstrokes do not always start from zero CO2 level

  
Check the latest updated table to make sure you only use quantitative method for critical measurements and true CO2 waveform display on screen.
 
Use only quantitative method for waveform display; the quantitative TG-950P (P905) shown here was already discontinued.
 
 

  How about fully-quantitative type miniaturized mainstream CO2 sensor?
 
The TG-907P CO2 Sensor kit (order code P909) shown in above table is using quantitative method as declared. This sensor was designed for non-intubated adult CO2 monitoring, as well as neonatal CO2 monitoring. In short, Nihon Kohden is trying not to rely on others for sidestream CO2 sampling expertise.
 
The miniaturized CO2 sensor is easily broken by the bigger and stronger adapter
 
 
In addition to the dead space problem, they had not foreseen miniaturized mainstream CO2 sensors could be easily broken by the disposable adapters. This happened because the disposable adapters are now relatively bigger and stronger!
These are common defects of a TG-970P CO2 sensor kit (P909). The design is impractical.
 
 

  Undeniable confirmation the fragile miniaturized CO2 sensor is of poor design, and easily broken
 
 
Key point is, it does not last

 



(V)

The Denial Of Reality

 Where fear is, there is your task -  Carl Jung
 
 
To avoid being seen as a failure, the company tried to hide the truth
 
In order not to reveal to the market NIHON KOHDEN had given up development to make modular monitors, the modular Life Scope S and Life Scope M were still being actively promoted on brochures. Since it could not be for sales improvement, its real purpose was to lie that the company is still capable of making modular monitors.
 
No one should need the Life Scope M service manual, yet it had always been available on the Internet for download.
 
The failed modular monitors that still appeared in this brochure was to hide the truth from the market

 

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



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

 
AY-920PA Input Unit with a four-socket Multi-parameter Unit 


The undeclared MULTI sockets hardware rule tells us this input unit has to be equipped with four channels of built-in IBP amplifiers. What other hardware are inside the input unit? The two blocks of patient monitoring hardware in the AY-920PA Input Unit are:

(BLOCK A) The hardware using dedicated sockets and ordinary measurement cables:
- 2 channels of Temperature
- ECG
- SpO2
- NIBP hardware using dedicated sockets.


(BLOCK B) The hardware sharing the four adapting MULTI sockets in a separate Multi-parameter Unit using only Smart Cables for connections:
- 4 channels of IBP (4 MULTI sockets = 4-ch IBP)
- 6 channels of Temperature (3 MULTI sockets = 6-ch TEMP)
Cardiac Output
Thermistor Respiration
- FiO2

Note:
1. The mainstream CO2, 2nd SpO2, BIS and NMT hardware come in the form of self-contained serial kit sets utilizing the MULTI sockets only as serial ports.

2. Sidestream CO2, multi-gas, EEG etc. are connected as external devices (not using the MULTI sockets).


The configured Life Scope J bedside monitor was dressed up 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 truly configured monitor.
 
Life Scope J bedside monitor does not support more than eight channels of IBP monitoring

 

In above brochure image, Life Scope J (on the right) is shown using 12 yellow shared-use MULTI sockets.  The operation manual of Life Scope J bedside monitor, however, tells us the bedside monitor only supports up to eight channels of IBP monitoring; this means the maximum number of MULTI sockets Life Scope J can have is limited to eight, so this is an impossible configuration and we should ask why is the manufacturer showing this?

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) resemble closely a Life Scope S (BSS-9800) bedside station with a 8-slot module rack filled with modules (right)

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


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.

As a matter of fact, the module racks and surviving five modules had no practical functionality. The problematic module racks and old modules were not merchantable since there were no longer new module under developmentTo be realistic, many other modules such as CCO (continuous cardiac output), SvO2 (mixed venous oxygen saturation)tcpO2, tcpCO2, 2nd SpO2 for neonatal intensive care, PiCCO, NMT, Intravascular Oxygen Saturation etc. were additionally needed.
 
Life Scope J Bedside Monitor was not a bona fide modular monitor
 
 
The real purpose of the questionable module racks and old modules were there for the powerful association of Life Scope J with modular monitors in the minds of the intended audience (including foreign employees). It was a powerful way to get the audience to nod their heads when making claim that the Life Scope J is a modular monitor.

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


There was no replacements for discontinued module rack and modules

 
The 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, and not operating as a modular monitor.
 
 


The Multi-parameter Unit is being used as a smoke screen to hide the missing network infrastructure necessary for modular monitors
 
It would have been obvious Life Scope J is configured when presented without the modular rack, the reason why the old modular racks and modules formed part of Life Scope J bedside monitor product communication to the market. The Input Unit and expansion box of Life Scope J bedside monitor is only the equivalence of Life Scope S modular monitor's Saturn module and extension. The rest of the other modules are being solved by using external device interface, a truly configured monitor.

Life Scope J bedside monitor depends on external device interface for expansion


The AY-920PA Input Unit was designed intentionally as a skewed device with more parameter measurements than available MULTI sockets. This means the required connector sockets were deliberately under-provided.

The manufacturer is offering the Input Unit as a basic block with insufficient connector sockets, and users have the option to restore those missing sockets using the shown expansion box (AA-910P) which has four MULTI sockets that can also access the hardware already in the multi-parameter unit inside the AY-920PA Input Unit. The purpose of doing this is to make use of space outside of the Input Unit to restore the socket deficiency, mimicking scalability.

The input unit is a basic block with insufficient connector sockets whose deficiency can be relieved using sockets from an external 4-channel IBP box


In the AA-910P expansion box, there are not only four MULTI sockets, each MULTI socket is also tied to one channel of IBP amplifier. The additional IBP hardware are redundant if the users do not need it, and should not be paying just to get their sockets back.


Additional struggle in using serial kit sets to improve credibility of Multi-parameter Unit
 
To improve credibility, more self-contained serial kit sets are insisted to pass through a yellow MULTI socket as mandatory path instead of just using a direct digital serial interface.

Using serial kit sets to further associate the MULTI sockets with scalability


The net effect of the move increases the cost of the serial interface, and the unnecessary jump in demand for more yellow MULTI sockets.
 
Forceful diversion of signal path to pass through the MULTI sockets

There is no technical need for the serial kit sets to use the yellow time-shared MULTI sockets
 
 
The digital serial data does not need to pass through a MULTI socket
 
 
The serial kit sets are independent self-contained packages with electronic boxes, drawing only power from the MULTI sockets. A small connector socket is all it needs for handling such digital serial data.
 
Only a small connector socket is needed for handling a one-bit digital data
 
Placing the serial interface in perspective, most patient monitoring parameters cannot be made into serial kits; it is the exception rather than the rule. Thus, although serial kit sets could be used by configured monitors for capability expansion but it is limited in scope and does not upgrade a configured monitor to be modular.
 
For example, the AE-918P Neuro Unit or a strip recorder cannot be linked to a yellow MULTI socket as serial kits.
 
The AE-918P Neuro unit and recorder module are examples that cannot make use of the yellow MULTI sockets
 
AY-920PA was specially designed as the input unit but subsequent popularity of transport monitor in the market favored using Life Scope PT (BSM-1700 series) transport monitor as updated input unit.



 

(VI)

Throwing Good Money After Bad

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

Life Scope TR (BSM-6000 series) Bedside Monitors


Strategy is really about resource allocation, Life Scope TR (launched internationally less than a year after Life Scope J) in April 2008 persisted to continue with the yellow shared-use MULTI sockets, indicating there was no intention to change. Life Scope TR (BSM-6000 series) bedside monitors was a continuation of the Life Scope J (BSM-9101) bedside monitor, masquerading as digital modular monitors after an earlier failed attempt in the 1990s to make one.
NIHON KOHDEN was still unable to deliver a new real-time network for the exchange of digital measurement data in Life Scope TR; the development team continued to shy away from the difficult task of working on a new measurement data-exchange network platform to do away with the yellow shared-use sockets as camouflage.

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

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


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

 

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

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

On the contrary, NIHON KOHDEN Life Scope TR Input Units cannot be linked using networking because the manufacturer had failed to achieve this technical capability. This is the reason Life Scope TR is not a digital modular monitor, and the manufacturer is using the yellow MULTI sockets as smoke screen to hide this weakness.
 
 
 
   Think about the flexibility of a printer with network interface compared to one only equipped with a direct connection
  
The Philips MMS module (and extension) serves as the basic module and can be expanded using a measurement LAN which the Life Scope TR input units lack


The configured MULTI-parameter Input Units and extension modules only corresponded with the basic multi-parameter unit and the socket boxes used by Life Scope S modular monitor, how about other modules? Just think about how flexible an inkjet printer with a network connection can be compared to an old printer with only a direct connection.
 

A network platform for the exchange of digital measurement data is missing
 

Notice the shaded configured MPU area are no longer highlighted or labeled upon transiting to BSM-6000 series.
 

Like an addiction, the analog MULTI sockets are now disguised to appear even more like digital modular communication links.



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

In other words, it is the built-in hardware that determine the parameter capability; and in the case of serial kit sets, the system software. This of course, is the same description as a configured patient monitor
 
 
Actual internal hardware and system support for serial kits varies for each multi-parameter unit


This means Life Scope TR bedside monitors making use of the Multi-parameter unit is still a configured monitor. The manufacturer has no reason to use the Multi-parameter Unit; it is not flexibility, but dabbling with distortions and limitations.


The configured BSM-6000 series was priced and marketed as modular monitors but without the capability. Many dormant hardware inside the Input Units 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.

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

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



The manufacturer is offering the Input Unit as a basic block with insufficient connector sockets, and users have the option to restore those missing sockets using the shown expansion IBP box (AA-674P) which has four MULTI sockets that can also access the hardware already in the AY-663P Input Unit. The purpose of doing this is to make use of space outside of the input unit to restore the socket deficiency, mimicking scalability.

In the AA-674P expansion box, there are not only four MULTI sockets, each MULTI socket is also tied to one channel of IBP amplifier. The additional four channels of IBP hardware are redundant if the users do not need it, and should not be paying just to get their sockets back.

Flexibility of the yellow MULTI connector sockets comes with trade-offs; the manufacturer must make skewed input units and monitors with more parameter measurements than the number of available MULTI sockets to share use of connector sockets. We need to ask what value can the users capture from using input units and monitors that suffered from deficiency of connector sockets?
 
The Input Units of the Life Scope TR bedside monitors are using the yellow time-shared MULTI sockets when there is no physical space limitation; the first vehement complaint from users is always the yellow MULTI sockets are not enough for use! When you add more MULTI sockets, you are at the same time adding the same number of IBP channels.

The AY-663P Input Unit of Life Scope TR needs at least ten sockets for smooth unconstrained use but only three shared-use MULTI sockets are provided. The Input Unit is so short of connector sockets and where is the flexibility coming from?

The pain of limitations and distortion, not flexibility



The two blocks of patient monitoring hardware in the above-shown AY-663P Input Unit are:

(BLOCK A) The hardware using dedicated connector sockets and ordinary measurement cables:
- 2 channels of Temperature
- ECG
- SpO2
- NIBP

(BLOCK B) The hardware sharing the three adapting MULTI sockets in the Multi-parameter Unit and using only Smart Cables for connections:
- 3 channels of IBP (3 MULTI sockets = 3-ch IBP)
- 2 channels of Temperature (1 MULTI socket = 2-ch TEMP)
- Cardiac Output
- FiO2
- Thermistor Respiration

The mainstream CO2, 2nd SpO2, BIS and NMT hardware come in the form of self-contained serial kit sets utilizing the MULTI sockets only as serial ports.


It is reasonable to assume we should not be seeing a lot of time-shared MULTI sockets on any device since doing so defeats the purpose of time-sharing the sockets. When many time-sharing MULTI sockets are needed, it is silly not to just connect directly to each hardware for efficiency.
 
Taking the rationalization of the shared-use MULTI sockets to the next level, the marketing messages "New Modular Technology" and "The Module is in the cable!" was the new wild imagination.



It started with the Life Scope TR (BSM-6000) series monitors in the USA market and gradually adopted officially for International markets.


There is no proof the module in the cable (click image for PDF)

 
We do not know of any expertise in 1998 to miniaturize circuitry found in traditional modules and embed it into the cable. Since Nihon Kohden is not from the semiconductor industry, someone must supply them the variety of analog chips; have the marketing team thought about the demand justification to make such analog chips?
 
With the question in mind, if we were to open up the plug what do we see?
 
A cheap digital chip was what found inside the yellow Smart plug

As it is impossible to sell something you do not believe in, many senior Sales and Marketing staff had by and large made their exit from the company before the fiscal year ended on March 31, 2015. From another perspective, it certainly looks like the discontinuity in product knowledge was part of a bigger era-change company plan.
 
Why are the Input Units so big when everything are from the outside?


The FDA records do not tell us the Smart Cables are medical devices

Under US FDA rule, a cable is only a cable if it does not change the signal that passes through it. A Smart Cable with a hexadecimal code is just a cable and does not change a signal passes through it, but if it has an amplifier it becomes a medical device and requires FDA registration. 

US FDA records tell us there is no module embedded in the cable

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



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

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

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

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


  How can Life Scope J adapt to make use of Life Scope PT as transport monitor?
 
When releasing Life Scope PT (BSM-1700 series) in May 2013 as transport monitors for Life Scope TR (BSM-6000 series), Life Scope J configuration was also modified that it could make use of Life Scope PT as a transport monitor. The only way to link with Life Scope PT is via any of the Data Acquisition Units designed for Life Scope TR.

Since it was not possible for Life Scope J bedside monitor MU-910R main unit to link directly to JA-690PA or JA-694PA data acquisition unit, a new costly QI-930P Interface Unit had to be introduced (as shown). This meant AY-920PA Input Unit was no longer needed.
 
By discarding the original AY-920PA Input Unit, Life Scope J could make use of Life Scope PT as a transport monitor

 
The costly QI-930P Interface Unit was eventually dispensed with when a newer so-called Core Unit replaced the MU-910R main unit with a direct interface to the JA-690PA or JA-694PA data acquisition unit. This simple step created a new Genesis model known as Life Scope G9 bedside monitor.
 


Life Scope G9 makes use of hardware originally designed for Life Scope TR (BSM-6000 series) bedside monitors, only with a new processing Unit
 

The JA-690PA or JA-694PA data acquisition unit (DAU) is linked to the processing unit using digital serial interface without networking capability


Before Life Scope G9 (CSM-1901), none of the Life Scope patient monitors (including Central Monitors) had ever been able to access external servers for images of Ultrasound, CT, MRI, Laboratory test results, clinical decision support etc. These servers usually utilize portal technology for access and a patient monitor needs a web browser as well as an additional non-realtime network path to access them for services.

NIHON KOHDEN was finally able to introduce the first monitor with built-in web browsing capability after learning how Philips made use of UPS in a Central Monitor. To maintain system stability, the PC unit is not integrated into the monitoring block in Life Scope G9 because of the lack of such experiences; the trick is to use the monitoring block to keep an eye on the PC Unit and reset it when it hangs or freezes. The independent PC sub-unit is the reason for the Core Unit's large physical size.

The company was very late in introducing such a capability, a clear indication how far they are behind the international brands for patient monitors, reflecting the extent of protectiveness insulating the domestic market in Japan from foreign competition.
 
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.

Using a panel PC on a patient monitor is an existing trend in the market, and allows the Life Scope G5 bedside monitors to follow the Life Scope G9 in using the PC's web browsing capability for clinical support services.

The four MULTI sockets in the expansion box are laid horizontally instead of vertically, similar to the Life Scope J expansion box.

Life Scope G5 bedside monitors has an integrated panel PC instead of just LCD display


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

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



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



 

Conclusion:

The Challenges Ahead

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

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


END