Medical Devices Sanity: Life Scope G9 (CSM-1901) Patient Monitor and Measurement Data Network from NIHON KOHDEN

Category: Product Review, NIHON KOHDEN (日本光電) Life Scope J (Jupiter) to Genesis series Life Scope monitors (CSM-1000 series); the missing digital modular platform in Life Scope G9 (CSM-1901), Life Scope G7 (CSM-1700 series) and Life Scope G5 (CSM-1500 series) bedside monitors.

Life Scope G9 (CSM-1901) Bedside Monitor is repackaging of Life Scope J (BSM-9101) Bedside Monitor

The first of NIHON KOHDEN Genesis series bedside monitors started with a high-end model, Life Scope G9 (CSM-1901) Bedside Monitor. The other two models similar in structure are Life Scope G5 and Life Scope G7 bedside monitors.

The common setup for Life Scope G9 bedside monitor comprises of the Core unit, a 19-inch display monitor (three display monitors can be supported), and a configured BSM-1700 (Life Scope PT) transport monitor placed on a JA-694PA Data Acquisition Unit (DAU).

Take note the shown JA-694 DAU unit is a serial device and does not have an IP address for networking flexibility, and link directly to the Core Unit using serial interface.

There are two types of Data Acquisition Units that the BSM-1700 transport monitor can make use of; the JA-694 DAU has four yellow flexible MULTI sockets for expansion while the JA-690 DAU has none. How these MULTI sockets work will be explained in due course.

Almost all cases the JA-694P is the default choice

There are four models of Life Scope PT (BSM-1700) transport monitor to select from, the difference being the SpO2 algorithm.

The four models of Life Scope PT (BSM-1700 series) transport monitors are:

1. Life Scope BSM-1773 transport monitor (Nihon Kohden older version SpO2 algorithms)

2. Life Scope BSM-1763 transport monitor (Nihon Kohden current version SpO2 algorithms)

3. Life Scope BSM-1753 transport monitor (OEM SpO2 board supplied by Nellcor)

4. Life Scope BSM-1733 transport monitor (OEM SpO2 board supplied by Masimo)

A Life Scope PT transport monitor placed on JA-694P DAU unit (left)

The difference among the four transport monitor models is the SpO2 algorithm

The four types of Life Scope PT transport monitors

The two models (BSM-1773 and BSM-1763) on left side of above table make use of Nihon Kohden SpO2 algorithms but they have different version of SpO2 algorithm. The SpO2 algorithm for the USA market and ex-USA market are not the same version, so it is a puzzle why the latest version should be refrained from use in the USA market by the manufacturer.

The Life Scope PT transport monitor acts as an input unit when placed on the Data Acquisition Unit (DAU) linked to the Core Unit of Life Scope G9, and upon mechanically released from the DAU will turn into an independent transport monitor.

The below picture shows how Life Scope J bedside monitor was gradually being repacked into the Life Scope G9 bedside monitor. When Life Scope J was first released, there was no market demand for transport monitor yet; after the Life Scope PT transport was released, the configuration changed to the one in the center, with Life Scope PT on the DAU unit. There was a need for an expensive QI-930P Interface Unit to link the DAU unit to the Life Scope J main unit (MU-910R) when a transport monitor is needed. Life Scope G9 interfaces directly with the DAU unit and saves the cost of the expensive QI-930P Interface Unit.

The QI-930P Interface Unit was done away with in Life Scope G9 bedside monitor

The Core Unit is the new name for the usual main unit, the name update is because this time a completely independent PC unit is enclosed in the main unit. Yes, a PC block can be found inside the Core Unit, that is why it is so big.

The independent PC unit is a wonderful piece of addition that makes it possible for Life Scope G9 bedside monitor to have web browsing capability, the first time ever for a Nihon Kohden Life Scope bedside monitor! Other than the Core Unit being new, the rest of the items mentioned above are all existing hardware initially designed for Life Scope TR (BSM-6000 series) bedside monitors.

The problem with Life Scope PT as a transport monitor

There are only two ways a Life Scope PT transport monitor (BSM-1700) can have direct communication with a central monitor.

The two methods are:

1. Using a telemetry transmitter attached to its side.

2. Using the Ethernet port of the SC-170R AC Cradle, when the monitor is placed on it.

When a Life Scope BSM-1700 PT monitor is acting as an input unit to a Host Monitor, it should like what is shown below. When the input unit leaves the Host Monitor to become a transport monitor, it switches to using a telemetry transmitter to keep in contact with the Central Monitor.

As an input unit, Life Scope PT monitor communicates with the Central Station as a part of the Host Monitor.

The picture below illustrates the optional ZS-900PK transmitter cannot be attached to the transport monitor when the latter is placed on a DAU unit acting as Input Unit to a Host Monitor.

Life Scope PT transport monitor when placed on a DAU unit cannot have a telemetry transmitter

It should be clear when a BSM-1700 transport monitor leaves the Host Monitor, it does not have a telemetry transmitter attached to its side, and does not have any mean to communicate with the Central Monitor. This is an unacceptable shortcoming you should know before committing; the problem is not from design, but the outdated protocols of the monitoring network (officially known as LS-NET).

The communication link is re-established only after the Transport Monitor is again attached to a Host Monitor as Input Unit; once this is condition is met, the patient data stored in the Life Scope PT during the transport period will be synchronized to the Central Monitor.

This is not what the users want, since the patient should be monitored on the Central Monitor during transportation.

The telemetry transmitter option can only be used on BSM-1700 monitor operating as a stand-alone monitor. The monitor obviously will be over-priced for such use and an unlikely installation outside of Japan.

The above image shows a Life Scope BSM-1700 transport monitor equipped with a ZS-900PK telemetry transmitter. The brochure talked about continuous monitoring using telemetry but such communication does not exist when Life Scope PT acts as a transport monitor.

Why is this description so out of context?

The reason Philips IntelliVue MMS X2 has continuous link with Central Monitor after leaving the Host Monitor

The Philips IntelliVue MMS X2 is similarly a transformation of MMS (multi-measurement server module) into a compact monitor with display and battery, primary purpose to link an MMS module to a patient and follow the patient's movement.

IntelliVue MMS X2 was launched long before BSM-1700

When the IntelliVue MMS X2 is connected to a Host Monitor, it has two options to connect to the Central Monitor.
1. via the Host Monitor (wired Ethernet or WiFi)
2. via its own wireless telemetry transceiver

The option 2 should be selected; it means patient identity is by the telemetry transceiver, and the Host Monitor is automatically paired to it for monitoring at the Central Station.

During patient transfer, the IntelliVue MMS X2 disconnects from Host Monitor and the latter is no longer paired to it. The transport monitor now operates as an independent monitor, and communication link with central station is not broken since the telemetry transceiver is always inside the IntelliVue MMS X2.

When the patient arrives at a new location, a new Host Monitor is now paired to the transport monitor's telemetry transceiver for monitoring at the Central Station. Such patient transfer is truly seamless at the system level.

The telemetry transceiver in the IntelliVue MMS X2 is the token for tracking the patient

In fact, the Philips IntelliVue MMS X2 was released much earlier than the Life Scope BSM-1700 transport monitor, so there was no reason the project leader of BSM-1700 could be unaware of this important requirement. It was ignored due to the outdated protocols of the LS-NET clinical monitoring network; the said outdated protocols currently do not support patients moving together with a monitor (from one location to another).

It should also be mentioned that there is a big difference in Telemetry Technology.

The Outdated Clinical Network Protocols

Using the SC-170R AC Cradle, a stand-alone BSM-1700 monitor (not acting as input unit to a host monitor) can connect to a Central Nurse Station using wired Ethernet.

Shown below is how a BSM-1700 monitor resting on an SC-170R AC Cradle is connected to the LS-NET. The SC-170R AC Cradle also provides the power for a BSM-1700 monitor placed on it, as well as charging its internal battery for transport use.

The SC-170R AC Cradle does not make practical sense

When a BSM-1700 monitor is placed on a SC-170R AC Cradle, its function is only an ordinary stand-alone monitor but the price of a purpose-built BSM-1700 is twice that of an ordinary monitor with equivalent monitoring capability. The higher price would be justifiable if Life Scope BSM-1700 monitor can be utilized as a "PICK and GO" monitor.

The problem is the outdated network protocols of LS-Net, which define behaviors for communications on the network connecting bedside monitors and central monitors; this protocols is still at the first-generation version and needs a major revision.

The said LS-NET protocols only work when the monitors do not move with their patients; it was developed at a time when a monitor is always stationary at a fixed location, and only the patients were being transferred from one location to another. Patient identity was by a combination of both monitor and location, with assumption of a stationary monitor; the protocols now needs a fundamental revamp to allow patients moving together with their monitors.

This means although a BSM-1700 monitor placed on a SC-170R AC Cradle is easily released mechanically by a lever, the BSM-1700 monitor cannot be used a valuable "PICK and GO" monitor.

The manufacturer had confirmed there would be patient location confusion at the Central Nurse Station for such a setup.

Life Scope PT placed on an SC-170R AC Cradle causes confusion when used with a Central Monitor

In the above monitoring setup with a Central Monitor, the Central Monitor would still remember the last bed locations even if the patients (together with the Life Scope PT monitor) had been swapped between BED ONE and BED TWO. This is serious matter.

Instruction not to link the AC Cradle to a CNS Central Monitor

Above image shows the relevant explanation to sales teams. There is no clear indication the company is capable of fixing it yet.

Thus, the SC-170R AC Cradle is only meaningful for telemetry use in Japan where there is government subsidy for monitors making use of telemetry, one of entry barrier for foreign competitors. There is no similar subsidy system for telemetry monitor outside of Japan.

When a transport monitor is not needed, the choice is to put an input unit on the DAU unit

Below image shows the three types of Input Unit,

1. AY-663P Input Unit uses NIHON KOHDEN SpO2 algorithm

2. AY-653P Input Unit uses Nellcor OxiMax SpO2 algorithm

3. AY-633P Input Unit the Masimo SET SpO2 algorithm

<Only input units using Nellcor and Masimo algorithms are available in the US market.>

Similarly configured input units with different SpO2 algorithms

NIHON KOHDEN is so late in web browsing 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 had never been confident enough to use a PC in a monitor because of stability concern. The opportunity only came after having accidentally learned from a subsidiary office the trick Philips uses to restart a hanged PC Central Monitor. So, for the first time in Life Scope G9 bedside monitor, a standalone PC unit was included but not integrated into the monitoring block. Instead, the monitoring block keeps an eye on the PC Unit and resets it when it hangs or freezes. The independent PC unit is the reason for the Core Unit's large physical size. The Life Scope G5 bedside monitor (replacing the Life Scope TR bedside monitor) relies on a panel PC (whose screen is the monitor display) instead of such a big PC block.

NIHON KOHDEN took a long time to release a patient monitor with a web browser

An old slide of Philips introducing the (long-discontinued) IntelliVue MP20/ MP30 patient monitors should make clear our point.

"Portal technology compatible" bedside monitors from a leading competitor

The Philips slide showed the middle to high end products (namely IntelliVue MP40, MP50, MP60, MP70, MP90) all have web browsers already incorporated at that point of time. In the year 2013, the IntelliVue MP20, MP30 patient monitors were already replaced by newer IntelliVue MX400/ MX450 patient monitors. The events just described had taken place long before the launch of Life Scope G9 bedside monitor, making clear this can only be tolerated in the domestic market in Japan, which is protectively insulated from international high-tech competitions.

Portal Technology application illustration

What we are seeing is a demonstration to the world how extreme is NIHON KOHDEN behind the international competitors in digital technology.

Life Scope G9 bedside monitor is only good for the kind of protected sales the manufacturer enjoys in Japan

Do you understand what does this mean? The writer had nothing to say.

Life Scope G9 bedside monitor is being promoted as a modular monitor; a modular monitor needs a real-time measurement LAN network for data exchange between main unit and individual modules, what you find are single multi-parameter modules or transport monitors that link directly to a main unit, with analog extensions as options.

Not only there is a missing measurement LAN network, there are shortages of physical sockets on the input units or the Life Scope PT transport monitors acting as an input unit.

The distinctive feature of the AY-663P/653P/663P Input Units (or Life Scope PT transport monitors) is the utilization of three flexible MULTI (short for multi-parameter) sockets that are meant for frugal sharing by a group of internal hardware, and can also switch to be a pass-through path for digital communications from serial kit sets. These sockets are specially colored yellow for easy identification.

The yellow flexible MULTI sockets can be utilized for IBP, Temperature, Cardiac Output, FiO2 and Thermistor-method Respiration, plus a variety of digital serial kit sets supported by system software. There is no free lunch, so what costs are incurred to achieve the flexibility of the yellow MULTI sockets?

What does this mean?

The first cost comes from the measurement cables; ordinary measurement cables cannot be used on such flexible sockets, and additional expenses are needed to pay for custom measurement cables that must be embedded with digital parameter codes in their yellow plugs. This is a necessary basic step because a flexible MULTI socket, by definition, must accept more than one type of measurement cable; the parameter code in the plug is the method adopted to differentiate the cables, and inform the monitor what internal hardware/ software are needed for support when a measurement cable is being plugged in.

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

The consequence of using flexible sockets for general use actually translates to insufficient physical sockets for users, and the deprived users are not hesitating to demand back their missing sockets. How can there be any customer value from socket flexibility when its use creates a shortage of physical sockets for users? The manufacturer had failed to make socket flexibility relevant.

This specific MULTI-PARAMETER UNIT (MPU) design from the 1990s is responsible for the manufacturer's woe

Veiled in secrecy, NIHON KOHDEN does not explain to the market how they could make sockets that are flexible enough for a total five types of internal hardware, as well as being diverted for use as serial ports for self-contained kit sets. Almost all sales and marketing people employed in Japan Head Office have no engineering background, how could anyone discuss anything of substance with the distributors or customers (except for prices and deliveries)?

Here are the historical facts, and it was just a quest to find the solution for a module with a small front panel that did not have enough space to mount all the numerous connection sockets needed.

The small panel space needing a solution

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

That was in the 1990s, and NIHON KHODEN development team managed to identify five types of analog hardware (Temperature, IBP, Cardiac Output, Thermistor-method Respiration, FiO2) to form a hardware group frugally sharing just two sockets that are flexible for group use. The two flexible sockets are known as MULTI (short for multi-parameter) sockets and are specially colored yellow for easy identification.

The hardware group and flexible sockets together made up the MULTI-PARAMETER UNIT (MPU), and was only a peculiar design to minimize the number of physical sockets needed on a front panel with a limited space area; thus, the MPU has the special characteristic of possessing more hardware than physical sockets. It is a design to optimize a small number of physical sockets for frugal sharing, and is therefore operating under constraint of limited sockets.

The MPU must be viewed from the right perspective, that it is illogical to use when there is no lack of panel space, because we should typically be optimizing use of relatively expensive hardware instead of cheap sockets.

It was a design to optimize a fraction of total needed physical sockets for sharing, and is operating under constraint of limited sockets

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

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

A non-volatile code is embedded in the plug of a Smart Cable

Each yellow MULTI socket can only link to one channel of the internal hardware, except for Temperature which can accommodate up to two.

As an exception, a MULTI socket can link up to two channels of internal Temperature hardware

The hardware mentioned here are linked to the flexible MULTI socket internally, and not from the outside

The hardware are Temperature, IBP, Cardiac Output, Thermistor-method Respiration and FiO2; if specified, the included hardware are placed internally in the MPU before leaving the factory, just like any configured monitor.

An external measurement cable with a valid digital code embedded in its plug selects the intended internal hardware (available only if already pre-installed at factory)

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

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

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

Given the large amount of hardware idling in the MPU, more physical sockets are needed to make good use of these valuable hardware; yet, only physical sockets in the form of MULTI sockets can access the MPU. The arrangement to add more physical sockets is thus achieved using external expansion boxes filled with two or more MULTI sockets (each with its own dedicated IBP amplifier hardware). It is important at this point to be clear the purpose is to add more physical sockets linking to the existing MPU, and not to add more monitoring parameters.
This is a process of adding more physical sockets, not more monitoring parameters

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

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

Again, like a configured monitor, the MPU can accept use of serial kit sets for capability extension (supported by necessary software). This is done via the parameter code, whose execution means to bypass the internal analog hardware and go directly for digital processing. The plugged-in serial kit set is identified from the header of the data packet; it will not be processed if the system software does not support it.

Using a parameter code, the MULTI socket can switch to be a transit point for any digital serial signal

The purpose of the MPU was to solve the problem of limited panel space area, and by using MULTI sockets as serial ports does help in furthering the reduction of one more physical socket on the front panel. The initial design was to save on one physical socket and meant only for use by the mainstream CO2 serial kit sets.

Shown above is the original label for the two MULTI sockets. It shows each socket can be used for monitoring of IBP, Temperature, Cardiac Output, FiO2, Thermistor-method Respiration, as well as diverted to be a serial port for mainstream CO2 kit sets.

The small module mentioned earlier was named Saturn multi-parameter unit and the outcome of the MPU solution is as shown below. The Saturn module is housed in a 8-slot module rack, with two expansion boxes next to it; altogether there were six MULTI sockets (with six channels of IBP hardware) available for use in this arrangement. It was possible to use the Saturn module alone, but the two MULTI sockets would not be enough.

The MPU block without the module rack housing is meaningless

Unfortunately, the measurement LAN network for data communication between module rack housing and monitor main unit was unstable with plenty of performance issues, and had to be finally given up for good. This means the first two modular monitors developed by the manufacturer were failures, and they were withdrawn before registration in the biggest US market.

Note the failed LAN network is not referring to the real-time clinical LAN network for data exchanges between bedside monitors and central nurse stations.

After the decision to stop development work on the digital measurement LAN network, a younger team of risk-averse engineers took over key positions and decided to keep the MPU and using the expansion sockets to simulate scalability. This is desperate and unprofessional behavior, because they did it to avoid working on a new measurement LAN; at the same time, they also knew they could get away with it in Japan given the low bargaining power of users in the domestic market.

The MPU was only a compromise to accommodate limited panel space area and should never be mistaken as an innovation; without the module rack, the MPU is meaningless and most importantly, there is no demand for socket flexibility outside of Japan.

Professionally, many are puzzled by the behaviors of the MPU but refrained from asking or faced with a wall of silence. The situation was so acute that at one point we had regular telephone calls and letters from undergraduates around the world (excluding Japan) hoping to understand the principle behind the MULTI sockets; we of course could not help them in any way then. When we have ample panel space area, there is no need for such a compromise and the use of an MPU (with its Smart Cables and MULTI sockets) actually becomes a burden and is a waste of money. Its continued use regardless of need is the very reason for its eventual failure.

Besides, there are other cheaper and practical ways to solve the problem of insufficient panel space on the input panel, such as commonly integrating more than one signal onto a socket and using an external splitter to resolve back the original signals.
Example of resolving an integrated signal back into original P1 and P2

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

Variations to the basic theme
There are variations to the basic theme, such as
a. doing without use of external expansion box,
b. increasing the number of multi-parameter sockets in the MPU,
c. reducing the hardware configured in the MPU.

We also found a standalone yellow MULTI socket that does not have any IPB amplifier attached, such a socket can be found on the CardioLife TEC-5600 series defibrillators. The naked yellow MULTI socket on said TEC-5600 series defibrillators is just a serial port dressed as a flexible socket and the system software only supports TG-900P mainstream CO2 serial kit sets (P903).

The weak arguments for using the yellow flexible MULTI sockets are falling apart

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

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

The key issue is one multi-purpose socket cannot concurrently do the jobs of three fixed-purpose sockets

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

1. Invasive Blood Pressure
2. Thermistor-method Respiration
3. Mainstream CO2 (using self-contained serial kit sets)

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

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

This is compromised usage, like a poor man affording only one physical socket for three types of use

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

CONVENTIONAL BLOCK
- 1-ch TEMP
- ECG
- SpO2
- NIBP

MPU BLOCK with one MULTI socket
- 1-ch IBP
- Thermistor-method Respiration
- [MULTI socket as serial port] Mainstream CO2 Kit Sets

The reality is the shortage of two physical sockets for users. However, one of the parameter for the yellow MULTI socket is thermistor-method respiration, which is for use in the operating room to overcome electrical noise interference; this parameter is therefore not for use in the ward. The real shortage felt by users is only one missing physical socket, and they are not hesitating to demand it back. Imagine the initial wonder of a flexible socket turned into an outrage for being shortchanged!

Users do not want to be shortchanged with a poor man's socket

The manufacturer was pressured to respond with an updated model, Life Scope BSM-2303K. The solution from new model BSM-2303K is to add a new dedicated IBP socket.

The MPU of the Life Scope BSM-2301K was not designed to take on expansion, and any additional MULTI socket could load (disturb) the operation of existing MPU, causing it to malfunction. An additional MULTI socket not linked to the MPU is just an independent socket with its own dedicated IBP amplifier hardware. Such was the socket offered for Life Scope BSM-2303K, noting there was a need to recognize the IBP Smart Cable.

With a new socket for IBP, the existing yellow MULTI socket can move away from doing IBP monitoring, and just focus on being a serial port for mainstream CO2 or being an amplifier for respiration monitoring using a thermistor transducer.

It was ironical, a solution relying on an extra dedicated socket for IBP; there are now two IBP amplifier hardware in the monitor, which was not the original intention. It was clear the complaints was the market rejection of sharing a flexible socket and the solution offered by Life Scope BSM-2303K was to return back one physical socket demanded by users.

Market rejection forced the manufacturer to return back the missing physical socket demanded by users

More physical sockets had to be returned for later Life Scope BSM-3000 series bedside monitors

Undeterred, NIHON KOHDEN again launched the Life Scope VS bedside monitors in early 2011, with the BSM-3500 series monitors (12-1-inch display) having two yellow flexible MULTI sockets while the BSM-3700 series monitors (15-inch display) come with three yellow flexible MULTI sockets. The values captured by users for both models are again negative.

In below image, users of the left monitor (BSM-3500 series) requires five physical connections sockets for carefree use, but only two shared-use MULTI sockets are provided for a 2/5 availability ratio. The use of Smart Cables/ MULTI sockets just makes things unnecessarily complicated and requires deliberate operator attention to consciously choose two out of the five. This is unwarranted attention, stress and inconvenience; what is wrong with using five dedicated sockets, which is a far superior norm in the industry since all parameters are available for connections at any time without hesitation. What user benefit is the manufacturer trying to provide?
These monitors are in dire shortage of necessary connector sockets, the values captured by users are negative

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

As expected, users soon found out the small number of MULTI sockets on the Life Scope VS monitors are not enough for use. The situation for Life Scope VS series bedside monitors is the same as Life Scope BSM-2301K bedside monitor, customers want their physical sockets back because they need it!

NIHON KOHDEN reluctantly had to offer two options for solution, the AA-372P Smart Expansion Unit returns two missing physical sockets while the AA-374P Smart Expansion Unit returns four missing physical sockets. The AA-374P expansion unit with four sockets is shown in below picture.

If you look at the below picture, it is as good as going back to using dedicated sockets, but at a high cost. The rejection messages from the market are consistent and enough for the manufacturer to drop the flexible sockets for future products.

This picture tells us the manufacturer is returning back to users four missing physical sockets

Turning To Magic Show

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.

Instead of a working on a new measurement LAN as replacement, what we saw was a bizarre attempt to hide the missing technology platform essential for modular monitors. The Corporate Director spearheading the Life Scope J bedside monitor project was finally asked to step down in 2006, and had to leave the company at the same time because of the seriousness of his incompetence (this happened before June 29, 2006).

From subsequent behavior, we know the manufacturer had already crossed the Rubicon, and there was no turning back on Life Scope J bedside monitor. The show just had to go on.

Life Scope J (BSM-9101) Bedside Monitor was finally released in June 2007 (after what was an unusually long delay, apparently as a result of new information curtailment policy and staying vague).

The processing main unit for Life Scope J bedside monitor was MU-910R, complete with an AY-920PA Input Unit similar in structure to the Saturn module. The Saturn module was housed in a module rack but AY-920PA Input Unit was not; it meant AY-920PA Input Unit does not need the yellow MULTI sockets.

The AY-920PA Input Unit follows the Saturn multi-parameter module, containing huge amount of hardware and continued to use an internal MPU with yellow flexible MULTI sockets. Unlike the Saturn module, the MPU of AY-920PA Input Unit has four yellow MULTI sockets instead of two. Given the many hardware in the MPU, these four yellow MULTI sockets are not enough for use, but the manufacturer needed to show scalability, so an external AA-910P expansion box was offered to add four more physical sockets in the form of yellow MULTI sockets. Since four yellow MULTI sockets are not enough, the AA-910P is not really an option but mandatory add-on; it would be cheaper to put all the MULTI sockets in the AY-920PA Input Unit.

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

CONVENTIONAL BLOCK
- 2 channels of Temperature
- ECG
- SpO2
- NIBP

MPU BLOCK with four MULTI sockets
- 4 channels of IBP
- 6 channels of Temperature (3 MULTI sockets = 6-ch TEMP)
- Cardiac Output
- Thermistor-method Respiration
- FiO2
- <MULTI socklets as serial ports> Mainstream CO2, 2nd SpO2, BIS and NMT

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

# The configured Life Scope J Bedside Monitor was found masquerading as a modular monitor
The market communication was meticulously executed to portray Life Scope J (BSM-9101) bedside monitor as a modular monitor when the manufacturer is fully aware it is a true-blue configured monitor.

Life Scope J bedside monitor appears to be a modular monitor in this brochure image

In above brochure image, Life Scope J (on the right) shown using 12 yellow MULTI sockets was an impossible configuration; there was obvious intention to hide the fact only four MULTI sockets can be added using an external box. If 12 MULTI sockets are realized, it also means 12 channels of IBP; we should be reminded this is a patient monitor, not a diagnostic polygraph system.

This is a fake configuration, since AY-920PA Input Unit can only make use of one AA-910P expansion unit

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

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

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

Why offer the module rack that caused the failure of both Life Scope S bedside station and Life Scope M bedside monitor? The shown module rack and old modules are not merchantable since there was no longer any new module under development!
Life Scope J Bedside Monitor is not a bona fide modular monitor

The purpose of the questionable module racks and old modules were there for the powerful association of Life Scope J with modular monitors in the minds of the intended audience (including foreign employees). It was a powerful way to get the audience to nod their heads when making claim that the Life Scope J is a modular monitor. It was a magic show.

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

The Input Unit and expansion box of Life Scope J bedside monitor is only the equivalence of Life Scope S modular monitor's Saturn module and expansion boxes.
Life Scope J bedside monitor has to depend on external device interface for real expansion

Without a measurement LAN network, The Life Scope J (BSM-9101) Bedside Monitor main unit cannot reach any individual module, including the recorder. If you inspect the connection, the recorder can only be connected to the main unit by direct wire. External device interface on the AY-920PA Input Unit or on MU-910R Main Unit links to third party devices to add more monitoring parameters, in addition to using serial kit sets. It is just like any configured patient monitor in the market.

Life Scope TR Bedside Monitors
After Life Scope J monitor, NIHON KOHDEN went on to develop the Life Scope TR (BSM-6000 series) monitors; they are versions of Life Scope J bedside monitor using a built-in display, instead of an external display. The development team continued to shy away from the difficult task of working on a new measurement LAN to do away with the yellow MULTI sockets as camouflage. Life Scope TR was thus a decision to continue investing in weakness, throwing good money after bad. Life Scope G9 inherits the input units and expansion boxes from the Life Scope TR series. In other words, the magic show continues.

Life Scope main unit can hold one input unit plus an attached expansion box

Since Input Units and socket expansion units designed for Life Scope TR bedside monitors are inherited by Life Scope G9 bedside monitor, let's take a closer look at the AY-663P Input Unit (using Nihon Kohden SpO2 algorithm) which is shown below.

It needs at least ten physical sockets for carefree use but the manufacturer can only provide three yellow MULTI sockets on a ratio of 3/10 time-sharing use. This means only three of the ten connectable cables can plug into the input unit at any one time. The input unit is so short of physical sockets, why would anyone need such a skewed input unit? This is worse than the Life Scope VS bedside monitors, and obviously incomplete.

A skewed input unit delivering pain of insufficient physical sockets

The AA-674P box adds four physical sockets together with four channels of IBP hardware to AY-663P Input Unit

Four yellow flexible MULTI sockets can be found on JA-694A DAU

This design optimizes use of hardware, not sockets

Case study using Philips modular monitor

The AY-663P Input Unit together with AA-674P expansion box corresponds to a Philips MMS module with an extension. These are operating at the configured level, not modular, and the expansion or extension are made using analog interface.

The Philips MMS modules (initiated by Hewlett Packard) are however additionally capable of being linked to a real-time measurement LAN network using Ethernet (digital extension)

Remember the HP Agilent M3/M4 portable monitor?

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

On the contrary, NIHON KOHDEN failed to realize a working digital Measurement LAN Network and the Life Scope TR Input Units do not have IP addresses for digital networking. There is no way to scale monitoring parameters or sharing expensive modules using networking, only via serial kit sets or linking to independent devices using custom interfaces.

The Philips MMS module (and extension) serves as the basic module and can be expanded using a digital measurement LAN

The Huge Amount Of Hardware Inside The AY-663P Input Unit

The patient monitoring hardware inside the AY-663P Input Unit are divided into a conventional block and an MPU block. The conventional block uses dedicated sockets and ordinary measurement cables while the MPU block makes use of Smart Cables with different parameter code for different hardware.

CONVENTIONAL BLOCK

- 2 channels of Temperature

- ECG

- SpO2

- NIBP

MPU BLOCK with three MULTI sockets
- 3 channels of IBP
- 2 channels of Temperature (1 MULTI socket = 2-ch TEMP)
- Cardiac Output
- FiO2
- Thermistor-method Respiration
- <MULTI sockets as serial ports> BIS, 2nd SpO2, mainstream CO2, NMT

The hardware in the MPU block

In the AA-674P expansion box, each MULTI socket comes with its own IBP hardware and can access the common hardware pool in the MPU of AY-663P Input Unit.

The hardware in the AA-674P expansion box

Instead of using AA-674P expansion box, the additional four MULTI can also be arranged horizontally using the AA-174P expansion box. This is the version used by Life Scope G5 and Life Scope G7 bedside monitors.

The hardware in the AA-174P expansion box are similar to AA-674P expansion box

Another way to add four MULTI sockets to the AY-663P Input Unit or Life Scope PT transport monitor is of course using JA-694P Data Acquisition Unit. However, the limitation of a maximum of four MULTI sockets always apply.

Life Scope J bedside monitor using Life Scope PT as transport monitor

The Life Scope J bedside monitor MU-910R main unit cannot link directly to JA-690PA or JA-694PA data acquisition unit, a new costly QI-930P Interface Unit was needed. The AY-920PA Input Unit was no longer needed when switching to using Life Scope PT as transport monitor.

Life Scope J with Life Scope PT as input unit and transport monitor

It is only wishful thinking to believe the use of Smart Cables and MULTI sockets upgrades a configured monitor to be modular

With the use of an MTU block, a MULTI socket by itself does not automatically mean all the five types of mentioned parameters are available for measurements; it still depends on which hardware are decided for placement inside for selection by Smart Cables.

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

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

When an MPU is not equipped with FiO2 hardware internally, no amount of MULTI sockets is going to provide this measurement capability. The amount of hardware placed in each MPU varies, so is the system support for serial kits and external devices (and powered separately).
Examples of configured hardware and serial kits using Smart Cables

# It is the built-in hardware that determine the parameter capability; and in the case of serial kit sets and external interfaces, the system software. This of course, is the same description as a configured patient monitor
Actual internal hardware composition and system support for serial kits varies for each MPU

Input units and monitors using Smart Cables are therefore still configured monitors. It is precisely to forestall the market from making this conclusion that we began to see wild claims of "proprietary Smart Cables technology miniaturizes circuitry found in traditional modules and embed that capability into the cable". The manufacturer is trying to argue the hardware are in the cable and therefore the design is modular in nature; we have explained the cable is just the code to select the hardware and software which are already embedded inside the monitor, and can identify the exact official block diagram details as proof. We show beyond any doubt, there is absolutely no need for any active electronics in the Smart Cables.

The only advantage of using Smart Cables is to allow sharing of connector sockets (which are of negligible hardware cost), but the cost needed to make use of Smart Cables is far way higher. The customers are paying for the unnecessary higher costs, only to be led into having an unrealistic expectation of what the Smart Cables and MULTI sockets can actually deliver.

Messages such as "New Modular Technology" and "The Module is in the cable!" are just the wild imaginations of people without the necessary electronics knowledge. These are unsubstantiated marketing messages and the manufacturer should not have condoned it.

What do the manufacturer mean by this statement?

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

Remember, the constant iteration of the same assertion while avoiding to provide any proof does not make it the truth!

This is just wild assertion without offering any proof

Which chip manufacturer is willing to take a big loss to supply NIHON KOHDEN the variety of analog chips given the extremely low volume in demand? When we opened up the plug of a Smart Cable, we found a small PC board being soldered to some pins of the yellow plug (as shown below).

A small PC Board is soldered to some pins of the yellow connection plug

Upon inspection, the PC board confirms a cheap non-volatile digital EEPROM chip is being made used of to custom code each Smart Cable.

A cheap digital EEPROM chip was what we found inside the yellow Smart Cable plug

The same thing can be found in the plug of a compatible IBP cable from China suppliers, they just copied the digital code defined by NIHON KOHDEN. Do you really think they managed to put an active IBP amplifier inside?

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

Make no mistake, when the Smart Cables are used with serial kit sets, such as mainstream CO2 kit sets or the NMT AF-101P kit set, the registration is for the active serial kit set (just like any other manufacturers) and not the passive Smart Cable.

Below service screen shows the MPU knows what cable is being inserted by reading the parameter codes in the plugs. MP1 is identified as an IBP measurement cable, MP2 as a Temperature measurement cable, while MP3 has blank reading (no sign of any measurement cable). The "loop check" shows error for MP1 and MP2 because the two measurement cables do not have any transducer attached.

Remember, three things are needed to make it work. Each MULTI socket always come with an IBP amplifier, so an IBP measurement cable always work as long as it has an IBP transducer. However, it is not the case when you test the other parameters, internal hardware may or may not be present depending on specifications.

# Here is the irrefutable proof the IBP amplifier hardware is located internally, an important fact no longer acknowledged in later monitor manuals

The Life Scope BSM-2301 bedside monitor was launched in 2001, and the Service Manual is clear on the design; manuals for later models stop providing such information. The major move to curb details in manuals started from Life Scope J (BSM-9101) Bedside Monitor, which was launched in June 2007. The Life Scope TR bedside monitors also do not provide details, as it was launched in April 2008 (after Life Scope J monitor).

In BSM-2301 service manual, you can see the IBP and thermistor-method respiration are internal hardware inside the Life Scope BSM-2301 monitor. These hardware are clearly shown being linked internally to the MULTI socket, and to make use of either hardware, a Smart Cable with the valid code must be plugged into the MULTI socket.

The block diagram also tells us the MULTI socket of Life Scope BSM-2301 monitor cannot measure Temperature because there is no Temperature hardware internally linked to it, and the sole Temperature amplifier hardware is dedicated to an external jack. The observation is confirmed by the label for the yellow MULTI socket indicating PRESS/ CO2/ RESP, i.e. no TEMP.
This manual confirms the IBP amplifier and thermistor-method respiration hardware are internal components of the Life Scope BSM-2301 monitor

# The above block diagram means there is no need for any amplifier hardware in the NIHON KOHDEN Smart Cables

The MULTI socket when used as a serial port bypasses the internal analog hardware, going straight to the digital APU (Analog-block Processing Unit) and onward to the DPU. For a parameter using the internal analog hardware, the analog signal needs to be converted to digital before it can go to the APU for digital processing.

Life Scope TR bedside monitors are updated to be Life Scope Genesis G5 bedside monitors using panel PCs as display
The updated model of Life Scope TR is Life Scope G5 bedside monitors; the Life Scope G5 series bedside monitors are released as part of new Genesis family series and there are two models:
1. CSM-1501 bedside monitor has a 12.1-inch panel PC
2. CSM-1502 bedside monitor has a 15.6-inch panel PC

The Life Scope G5 bedside monitors are updated versions of the Life Scope TR (BSM-6000 series) bedside monitors with the LCD display unit replaced by a panel PC. The new web browsing capability of Life Scope G5 bedside monitor comes from the panel PC.
Life Scope G5 series bedside monitor makes use of the same Input Unit as Life Scope TR series

Similar to Life Scope TR, a Life Scope G5 bedside monitor uses the AY-663P or Life Scope PT bedside monitor as an Input Unit. When using a Life Scope PT transport monitor as an input unit, it can act as transport monitor upon detachment from the Life Scope G5 main unit.

When a transport monitor is not required, the choice is to use the AY-663P Input Unit.

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.

Take note the mandatory need for network isolation units when connecting Life Scope G9 Bedside Monitor to a Central Nurse Station

When connecting to the real-time patient-monitoring LAN network, it is mandatory for Life Scope G9 Bedside Monitor to observe patient electrical safety by using a network isolation unit. The network isolation unit is needed because the Ethernet LAN interface on the bedside monitor is not isolated for patient safety.

NIHON KOHDEN network isolation transformer

When an isolated monitor with an non-isolated Ethernet port is connected to a hardwired network, it is no longer a medical device unless the above-shown network isolation transformer is introduced between the monitor and network. Dangerous electric shocks can be delivered to the monitored patient through the wired Ethernet network if such a network isolation is not installed. The dangerous electric shocks are potentially lethal and should not be ignored.