NIHON KOHDEN Life Scope PT (BSM-1700 Series) Transport Monitor and Data Non-Continuity

Category: NIHON KOHDEN Life Scope TR (BSM-6000 series), Life Scope PT (BSM-1733, BSM-1753, BSM-1763, BSM-1773), Life Scope Telemetry, Life Scope J (BSM-9101) bedside monitor, Nihon Kohden SpO2 algorithm type, semi-quantitative Waveform, Host Monitor, MULTI connectors, discontinuous seamless monitoring, IntelliVue X2, patient monitoring

Life Scope PT transport monitors are derived from the bulky input units of Life Scope TR (BSM-6000 series) bedside monitor

These 5.5-inch transport monitors are adapted from the three types of multi-parameter Input Units designed initially for configured Life Scope TR (BSM-6000 series) bedside monitors, and both transport monitors and Input Units are later extended to subsequent Life Scope J (BSM-9101) bedside monitor, Life Scope G9 (CSM-1901) bedside monitor, Life Scope G5 (CSM-1500 series) bedside monitors, and Life Scope G7 (CSM-1700 series) bedside monitors. 

 

The transport monitors were realized by the addition of touch-screen, storage memory and rechargeable battery to the existing Input Units, doing away the need to attach it to a portable monitor during patient transfer; this means Life Scope PT transport monitor first act as an Input Unit to a Host Monitor, and upon detachment as input unit, becomes a transport monitor. The design is an attempt to imitate the Philips IntelliVue MMS X2, but with an unfavorable difference. This is because it is not a system design from scratch, the transport monitors when detached from the host monitors have no wireless link to the central monitor! This flaw at the system level will be discussed in details later in this same article.

 

Configured Input Units made into Transport Monitors imitating Philips IntelliVue MMS X2

There are three types of Input Units, but four types of Life Scope PT transport monitors.

 

Before the Life Scope PT transport monitor, Nihon Kohden offered three types of Input Units used by Life Scope TR (BSM-6000) bedside monitors for export. The AY-663P Input Unit uses NIHON KOHDEN SpO2 algorithm while AY-653P Input Unit offers Nellcor OxiMax SpO2 algorithm, and the AY-633P Input Unit offers 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

On the other hand, there are four models of Life Scope PT (BSM-1700 series) transport monitors, namely

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

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

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

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

Life Scope PT transport monitor with telemetry transmitter

The only difference among the four models is the SpO2 algorithms.

The four types of Life Scope PT transport monitors

 

The two models (BSM-1773 and BSM-1763) on left side of above image 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, the manufacturer is of course not obliged to explain the reason why the latest version is refrained from use in the USA market.

The remaining two models on the right side of above image, namely BSM-1733 and BSM-1753 are using SpO2 OEM boards supplied by Masimo and Nellcor respectively.

Some sales people are very excited about the bigger screen of Life Scope PT in the market but overlooked their own lack of knowledge why the configured multi-parameter Input Units of Life Scope TR (BSM-6000 series) bedside monitors are so different and big from the competitions that a 5.7 inch screen can just be mounted on their sides!

 

Why are the Input Units of Life Scope TR so big and different from the competitions?

Why so big and different? This is because they are configured with plenty of hardware inside.

 

The shown input unit is in fact, heavily loaded with patient-monitoring hardware inside, and avoided for mention in product communication to the market, intentionally done to hide the fact the input units are not modular in design

 

 

Many internal hardware are not made clear in product communication to the market

The prominent feature of the AY-663P Input Unit (or Life Scope PT transport monitor) is the utilization of flexible common-use multi-parameter sockets that are colored in yellow. These yellow common-use sockets do not accept ordinary measurement cables but only measurement cables that have NIHON KOHDEN digital parameter codes embedded in their yellow plugs. The end result of using these yellow flexible connector sockets means a good amount of needed connector sockets are removed from the monitor, which is undesirable. In reality, there is zero benefit from offering socket flexibility since the shortage of connector sockets will lead to serious usage inflexibility for users!

The archaic 1990s concept of a MULTI-PARAMETER UNIT (MPU)

 

Veiled in secrecy, NIHON KOHDEN does not explain to the market how they could make sockets that are flexible for five types of internal hardware, as well as being able to accept a number of independent self-contained serial kit sets whose output are processed data in serial digital format. Almost all sales and marketing people employed in Japan Head Office have no engineering background, so there is no shortage of "company secrets" that must not be discussed with the distributors or customers.

Here are the relevant facts. Back in the 1990s,  NIHON KHODEN identified five types of analog hardware (Temperature, IBP, Cardiac Output, Thermistor Respiration, FiO2) that can be linked from the inside onto the yellow flexible common-use multi-parameter sockets and to make use of these internal hardware, an external measurement cable with a valid digital code on its plug needs to be inserted into one of the yellow common-use sockets. These measurement cables that comes with coded plugs are collectively cited as Smart Cables by the manufacturer and the embedded digital codes are also known as parameter-selection codes.

 

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

Note the hardware mentioned here (Temperature, IBP, Cardiac Output, Thermistor Respiration and FiO2) are linked to the yellow flexible socket from the inside, and not from the outside

 

An external measurement cable with a valid digital code embedded in its plug can make use of the corresponding internal hardware if available

 

The configured hardware using the Smart Cables are grouped into an electronic block known as MULTI-PARAMETER UNIT (MPU), complete with a small number of yellow common-use multi-parameter sockets. The number of yellow multi-parameter sockets in the MPU cannot be arbitrary, and must correspond to the number of internal IBP hardware channels specified.

It is the design rule that all yellow multi-parameter sockets must be able to do IBP monitoring, and to adhere to this rule each socket comes with its own exclusive IBP hardware. The term "exclusive" denotes the attached IBP hardware to each yellow socket is not intended for sharing by other multi-parameter sockets in the MPU block.

Principle of operation

During use, a multi-parameter socket makes use of its own associated IBP hardware when a measurement cable with an IBP embedded code is plugged into it. For non-IBP monitoring, the socket can access a common pool comprising Temperature, Cardiac Output, Thermistor Respiration and FiO2 hardware in the MPU, which all common-use multi-parameter sockets can access.

 

Given the large amount of hardware in the MPU block, more yellow multi-parameter sockets should be added whenever possible, so as to make good use of the hardware that would otherwise be idling in the MPU. As shown in above image, this is done by using an external expansion box filled with more yellow multi-parameter sockets (each with own associated IBP amplifier hardware).

The yellow common-use sockets are added using analog interface and limited to four, this is to avoid signal deterioration caused by voltage drop and noise.

 

Many are actually puzzled by the contents of the MPU but refrained from asking or simply faced with a wall of silence, why is this a design that has many internal hardware queuing up just to share a limited number of common-use sockets for availability to users? The truth is because the design was originally devised to solve the problem of limited panel space to mount many needed connector sockets! In situations where panel space is enough to accommodate all the necessary connector sockets, it is just a waste of money to adopt such a design; clearly, its continued use regardless of need indicates there is more than meets the eye.

 

The manufacturer does not discuss this, but users can always find out by yourself how many channels of internal IBP hardware are supplied

 

Knowing a functional yellow common-use multi-parameter socket always come with its own associated one-channel IBP hardware, a user can accurately and conclusively tell how many IBP monitoring hardware channels are supplied with any monitor just by tallying the total number of available yellow multi-parameter sockets. For example, if your monitor is delivered with five functional yellow common-use sockets, you had paid for five built-in IBP hardware channels when you indeed only need one or two.

This being the design rule, and the key word is "functional" because a non-functional (fake) multi-parameter socket does not need to care about the capability to do IBP monitoring, such a socket can be found on the CardioLife TEC-5600 series defibrillators. The fake yellow multi-parameter socket on said TEC-5600 series defibrillators is just a serial port dressed as a common-use socket that cannot be used for any other parameter except mainstream CO2 kit sets.

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.

In the AY-663P, AY-653P, AY-633P Input Units (or Life Scope PT transport monitors), 3 channels of IBP amplifiers, 2 channels of Temperature, one channel each of Thermistor Respiration, FiO2 and Cardiac Output are configured in the MPU for use by Smart Cables.

As the hardware in the AY-663P, AY-653P and AY-633P Input Units are extensive, they were designed to work with external expansion boxes (such as AA-674P expansion box or the expansion panel on the JA-674P Data Acquisition Unit) which can add two or four yellow common-use multi-parameter sockets to access the hardware already in the MPU of input units.

The NIBP, SpO2, ECG and two channels of Temperature in said input units or monitors are configured using dedicated measurement cables and are therefore not part of the Multi-parameter Unit

 

The digital hexadecimal parameter code is stored in a non-volatile EEPROM chip (Electrically Erasable Programmable Read-only Memory) mounted on a small flexible PC board electrically wired to the pins of the cable plug. It is not costly to make the 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 non-volatile digital parameter code is embedded in the plug of the measurement cable

One multi-parameter socket can select two Temperature hardware channels.

Each multi-parameter socket can take two channels of Temperature measurements

 

The common-use yellow multi-parameter sockets are additionally diverted to serve as digital serial ports

This is the part that involves using external monitoring hardware, but these are all self-contained kit set units with an already-processed digital output in serial format, using the yellow connector socket only as a link to the digital processing stage of the monitor.

As explained earlier, the design concept of MPU was to solve the problem of limited panel space, by using the common-use multi-parameter sockets as serial ports does help in the further reduction of mounted sockets and is the reason for this arrangement. This being an easy task since there is no need for additional internal analog hardware; the processed digital signals from the serial kit sets just bypass the analog stage and go straight to the digital processing stage of the monitor.

Shown below is the original label for the yellow multi-parameter socket, indicating the five specific hardware and also serving as serial port for mainstream CO2 serial kits; the purpose of this arrangement was to minimize the number of sockets being used on a limited panel space. Outside of this context, the arrangement does not make sense because of cost.

 

The original label for the yellow multi-parameter sockets when they were first used

 

Straying from the original intention, which was only for mainstream etCO2 serial kit set, there is now proliferation of self-contained digital serial kits using the multi-parameter sockets as serial ports to link to the monitor when there is no problem of limited panel space.

 

Currently, 2nd SpO2, BIS and NMT kit sets etc.are also using the common-use multi-parameter sockets as serial ports, which is a costly arrangement when there is no panel space problem. 

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

 

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 by the system software of the monitor and not by the type of sockets or cables being used.

 

With the use of a MTU block, a yellow multi-parameter socket by itself does not automatically mean all the five types of mentioned parameters are available for measurements; it still depends on whether what hardware are actually being placed inside for selection by Smart Cables.

 

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

Examples of configured hardware and serial kits using Smart Cables

It is the built-in hardware that determine the parameter capability; and in the case of serial kit sets and external interfaces, 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

It is clear monitors with input units using Smart Cables are still configured monitors. The only advantage of using Smart Cables is to allow sharing of connector sockets (which are of negligible hardware cost), but the cost needed to make use of Smart Cables is far way higher. It is just a magic show and illogical for practical use; we are therefore justified to look for the real motive behind its continued use.

The manufacturer has no clue the captured value from using Smart Cables is negative for users!

Take a closer look at the AY-663P Input Unit shown below, it needs at least ten sockets for carefree use but the manufacturer can only provide three yellow multi-parameter sockets for 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 connector sockets, why would anyone need such a skewed input unit?

 

The number of yellow multi-parameter sockets on AY-663P Input Unit is not arbitrary, but dependent on the number of IBP hardware intended for said Input Unit, which is three IBP amplifier hardware specified. Since each yellow multi-parameter socket comes with its own associated one-channel IBP hardware, the manufacturer cannot provide more than three multi-parameter sockets.

 

Notice the two channels of Temperature hardware in the shown input unit are not making use of the yellow MULTI-parameter sockets for connections, this is to provide relief to the three yellow multi-parameter sockets which are not enough for use.  

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

The BIS, Second SpO2, ETCO2 and NMT parameters are self-contained kit sets with processed digital serial data using the input unit only as a link to the monitor, they have no reason to queue for the scarce yellow MULTI-parameter sockets.

What value can the users capture from using input units that come with deficiency of connector sockets?

The next item to appear is an external box (AA-674P) which comes with four MULTI-parameter sockets, which is meant to add more yellow multi-parameter sockets to supplement the inadequate three on the AY-663P Input Unit. This is not a choice, the three flexible multi-parameter socket on the AY-663P Input Unit is definitely not enough for use!

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

The AA-674P box makes up for four missing sockets but at the same time adds four channels of IBP hardware

The number of multi-parameter sockets that can be added to AY-663P Input Unit is limited to four (see earlier explanation), which means the maximum number of multi-parameter sockets available for use is seven. It is obvious the AY-663P Input Unit is incomplete without the AA-674P expansion box, and the manufacturer should have just designed an input unit with enough connector sockets in the first place? So, why are they not doing it?

 

The purpose of this odd arrangement is to imitate the scalability process of adding patient-monitoring parameters when yellow multi-parameter sockets are being shown visually added to the input unit; but what you should know is the fact the manufacturer is only adding sockets, and not patient-monitoring parameters. This is just a magic show.

 

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

The scalability of patient-monitoring parameters is the one being sought after by the market, not scalability of usable connector sockets. The act of adding four yellow multi-parameter sockets using the AA-674P expansion box also means adding another four more IBP hardware channels to what are already configured in the AY-663P Input Unit; do you really need seven channels of IBP hardware?

 

The AY-663P Input Unit is incomplete without the AA-674P expansion box, it means users are paying for seven pieces of configured IBP hardware in one go, which is quite rare a requirement!

 

The limitation of only four additional multi-parameter sockets also means it is not possible for the AY-663P Input Unit to make use of two AA-674P expansion boxes; be sure to ask for a field demonstration to verify the truth if any salesman insists on this possibility!

Elaborate time-sharing are applied to things that are expensive (high in demand, an asset), and not worth the efforts for things that are cheap (high in supply, a commodity) like a connector socket or a switch!

The next picture shows Philips time-sharing one channel bio-amplifier hardware between IBP and Temperature measurements, and there was no sharing of connector socket; this is exactly the opposite of what Nihon Kohden is doing. The said manufacturer merely ensures physically it is not possible to make use of both the PRESS and the TEMP socket at the same time, and the objective is to make it possible for the same hardware to be used for different purpose at different time.

 

This design shares the expensive hardware, not the cheap sockets

 

Case study using Philips modular monitors

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.

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

 

Remember the HP Agilent M3/M4 portable monitor?

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

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

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

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

 

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

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

 

It is unsubstantiated marketing messages and we are going to show you beyond any doubt, there is absolutely no active electronics in the Smart Cables. Messages such as "New Modular Technology" and "The Module is in the cable!" are just the wild imaginations of people without the necessary electronics knowledge.

What do the manufacturer mean by this statement? 

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

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

This is just assertion without offering any proof

 

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

 

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

 

The PC board confirms a cheap non-volatile digital EEPROM chip is being used to code the Smart Cable.

 

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

If we were to open up the plug of a compatible IBP cable from China suppliers, what do we see? It is the same thing, a plug with a digital code defined by NIHON KOHDEN.

 

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

The Life Scope BSM-2301 bedside monitor was launched before the Life Scope TR bedside monitors, 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, launched before the Life Scope TR bedside monitors.

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

 

Can you see the IBP amplifier and thermistor respiration hardware are internal components of the Life Scope BSM-2301 monitor?

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

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

You should know by now the three IBP amplifier hardware inside the AY-663P Input Unit or Life Scope PT transport monitor is the reason they can each perform three channels of IBP monitoring.

Knowing there are three built-in IBP amplifier hardware inside the AY-663P Input Unit easily allows us to conclude the rest of the configured hardware after confirming all parameters that can be measured by the input unit.

The huge amount of hardware inside the AY-663P Input Units

 

First we filter out the parameters using self-contained serial kit sets, and they are mainstream CO2, 2nd SpO2, BIS and NMT hardware for the AY-663P Input Unit.

We can conclude the patient monitoring hardware in the AY-663P Input Unit to be:

NORMAL BLOCK

(The hardware using dedicated sockets and ordinary measurement cables)

- 2 channels of Temperature

- ECG

- SpO2

- NIBP

MULTI-PARAMETER UNIT BLOCK with three MULTI-parameter sockets

(The hardware only use 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

Also using the three Multi-parameter sockets are self-contained BIS, 2nd SpO2, mainstream CO2 and NMT serial kit sets utilizing the sockets as serial ports

These configured hardware in the Multi-parameter Unit of AY-663P is the reason for its size

In the AA-674P expansion box, each of the four MULTI sockets makes use of its own IBP hardware when a IBP Smart Cable is plugged in; for the other four parameters, the sockets can access and make use of the Temperature, Cardiac Output, FiO2 and Thermistor Respiration hardware already configured in the Multi-parameter Unit of AY-663P Input Unit.

The hardware in the AA-674P expansion box

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

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

Another way to add four MULTI-parameter sockets to the AY-663P Input Unit or Life Scope PT transport monitor is the use of the JA-694P Data Acquisition Unit. It is of course not possible to add more than four sockets in total due to the interface limitation.

There was no proper viability assessment for the liberal use of Smart Cables and it is only leading customers into having an unrealistic expectation of what these cables can actually deliver. The apparent flexibility of the MULTI sockets is in reality an adoption with negative captured value for the users.

 

 

Origin and purpose of the MULTI-parameter Unit (MPU) design from the previous century

 

In the 1990s, when developing the first digital modular monitor, the development team encountered a problem of insufficient front panel space for all needed connector sockets on the first digital multi-parameter module being made. The Smart Cables were originally devised only to resolve this product issue.

 

 

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 monitor, and NIHON KOHDEN wanted to be seen as responsive to this market development.

 

Such a multi-parameter module means there is need for more connector sockets on the front panel. The first digital multi-parameter module made by the company was named the Saturn module and you can see from below illustration the panel space is very limited for this Saturn module.

The Saturn module was intended to be physically small in size

The solution from NIHON KOHDEN for panel space limitation of the Saturn module was to introduce a MULTI-parameter sub-unit with five types of hardware (IBP, Temperature, Cardiac Output, FiO2 and Thermistor Respiration) which were found to be suitable for sharing two common-use sockets and colored it yellow.

 

The Saturn module turned to sharing two modified connector sockets as solution to the constraint of space for more sockets

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

ORDINARY BLOCK

(These hardware make use of dedicated sockets and ordinary measurement cables)

- ECG

- SpO2

- NIBP

MULTI-PARAMETER UNIT with two yellow sockets

(These hardware only use Smart 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

Also using the two Multi-parameter sockets are self-contained mainstream CO2 serial kit sets utilizing the sockets as serial ports

Huge amount of configured hardware in the Saturn module

The MPU design has many hardware sharing only two multi-parameter sockets, this is to solve the problem of limited panel space. This, however, is only part of the solution.

More multi-parameter sockets are of course needed to make good use of the hardware that would otherwise be idling in the MPU. This is done by using an external expansion box containing only multi-parameter sockets, each with its own IBP amplifier hardware.

Analog solution of adding more sockets, not more monitoring parameters

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

 

The image gives an impression of scalability but this is scalability of connector sockets, and not the scalability of patient-monitoring parameters that is being sought after by the market. All necessary hardware are already configured in the Saturn module except for additional IBP amplifier which must always come with each multi-parameter sockets.

 

A MULTI-parameter socket makes use of its own IBP hardware when a Smart Cable with an IBP code is plugged into it; for the other four parameters, the sockets are linked to the common pool of Temperature, Cardiac Output, Thermistor Respiration and FiO2 hardware already configured in the the MPU of Saturn module.

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

The extension Smart module is therefore a 2-channel IBP box adding two MULTI-parameter sockets for use by the Saturn module. Remember, the analog interface limits the number of Smart modules that can be added to the Saturn module to two, making a total of four additional yellow common-use sockets.

The MULTI-parameter sockets were additionally allowed to be diverted to act as a costly digital serial ports so that mainstream CO2 digital serial kit sets can also use it; we must remember this is for purpose of minimizing connector sockets on the Saturn multi-parameter module, as it does not make sense outside this context.

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

MULTI-parameter socket poorly utilized as a costly serial port

The initial arrangement for the Saturn module 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. after the liberal use of Smart Cables was adopted by the manufacturer. The move is highly questionable given this greatly increases the interface cost compared to a plain serial port.

The use of Smart Cables for serial communication does give a false illusion of mighty MULTI-parameter sockets but the capabilities are in reality coming from the system software, and not from the type of connector socket being used.

 

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. 

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

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

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

 

The AE-918P Neuro unit and recorder module are examples that cannot make use of the yellow MULTI sockets

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

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

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

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

 

Example of resolving integrated signals to individual P1 and P2

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

The two bona fide modular monitors that made use of the Saturn multi-parameter modules were failures

 

The two modular monitors that could make use of the first Multi-parameter Module (Saturn module) made by NIHON KOHDEN were Life Scope S (BSS-9800) bedside station and Life Scope M (BSM-9510) bedside monitor; the software supporting the network infrastructure exchanging digital measurement data between the Saturn module and main units was unfortunately, not reliable and both modular monitors ended up as failures.

Life Scope S (BSS-9800) bedside station was a bona fide digital modular monitor

 

Lower-end Life Scope M bedside monitor was using a (6-slot) built-in module rack. The Life Scope M (BSM-9510) bedside monitor has lower processing power compared to the Life Scope S bedside station.

 

 

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

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

The cause of the failure for Life Scope S and Life Scope M modular monitors was the 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 exchange of measurement data between main unit and modules was the problem

The product failures were huge financial losses incurred at a time when the company was already suffering badly from poor sales due to the lack of digital technology know-how.

NIHON KOHDEN gave up trying to solve the communication problem between main unit and modules

Failure to succeed in the measurement data-exchange network infrastructure meant NIHON KOHDEN was downgraded to be a manufacturer only capable of making configured patient monitors

 

To avoid being seen as a failure, the manufacturer continued to promote the MULTI-PARAMETER UNIT with socket boxes as options, without real access to an exchange network for measurement data. The Input Unit and expansion box of Life Scope TR bedside monitor is only the equivalence of the Saturn module and its extensions in Life Scope S bedside station. The rest of the other modules are being solved by using external device interface like any configured monitor in the market.

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

 

A standalone BSM-1700 monitor can only have Telemetry or wired Ethernet link to the Central Monitor

 

Note a BSM-1700 monitor can only link to a central monitor using telemetry or wired Ethernet when not acting as an input unit. It is important to know the BSM-1700 transport monitor cannot communicate directly with a Central Monitor via WiFi. Though the BSM-1700 monitor can make use of a telemetry transmitter, there is no way to mount the optional ZS-900PK transmitter when the monitor is operating as an Input Unit to a host monitor.

 

Life Scope PT transport monitor has no user benefit in a stand-alone operation

A stand-alone BSM-1700 monitor (i.e. when not acting as input unit to a host monitor) can be connected to a Central Nurse Station via the LS-NET real-time data network using wired Ethernet provided by the SC-170R AC Cradle.

Shown below is how a BSM-1700 monitor resting on an SC-170R AC Cradle is connected to the LS-NET patient monitoring network. The Ethernet socket is at the rear of the cradle and it is mandatory to protect the patient with an Ethernet isolation unit when connecting to a network.

 

The SC-170R AC Cradle does not make sense outside of Japan

 

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. Apart from cost, there is another problem.

Outdated Clinical Network Protocols

The failure of the two modular monitors (BSS-9800, BSM-9510) was a big setback to developments efforts, as many experienced engineers were being sidelined. The clinical network protocols, which define behaviors for communications on the network connecting bedside monitors and central monitors, is now only in maintenance mode and lacking new initiatives.

The Life Scope Real-time patient monitoring Ethernet Protocols only work when the monitors do not move from place to place. Before the SC-170R, the monitors were always fixed to each location and patient would only be transferred from one monitor to another. With the advent of the SC-170R, the assumption no longer holds true and the old protocols need a fundamental revamp to accommodate patients moving together with their monitors while maintaining links to a central monitor.

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. The SC-170R AC Cradle provides the power for a BSM-1700 monitor placed on it, as well as charging its internal battery for transport use. There is no similar subsidy system for telemetry monitor outside of Japan.

 

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 as a "PICK AND GO" monitor due to the outdated LS-NET clinical networking protocols.

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

 

Life Scope PT placed on a 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.

 

Below shows part of the relevant Note to sales teams. There is no indication that the company is capable of fixing it yet.

 

Do not link the AC Cradle to a central monitor

The LS-NET patient monitoring protocols is outdated

 

The LS-NET network protocols needs an overhaul

The reason Philips IntelliVue MMS X2 has continued 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. In fact IntelliVue MMS X2 was released much earlier than BSM-1700, so there was no reason the project leader of BSM-1700 was unaware of this important need.

 

IntelliVue MMS X2 was launched long before BSM-1700

 

When the IntelliVue MMS X2 is connected to a host monitor, it has the option of wired Ethernet or WiFi via the host monitor OR through its own wireless telemetry transceiver to link with the Central Station. To maintain network continuity when the IntelliVue MMS X2 changes from being a MMS to transport monitor, it must choose the wireless telemetry option only. When the IntelliVue MMS X2 is assigned to a telemetry transceiver at the Central Station, patient identity is by the telemetry transceiver, thus the host monitor is automatically paired to it. The IntellieVue MMS X2 and Host Monitor together are recognized as one telemetry device to the central station.

During patient transfer, the IntelliVue MMS X2 disconnects from host monitor and operates as an independent transport monitor but communication link between MMS X2 and central station is not broken since telemetry transceiver in inside the IntelliVue MMS X2.

In addition, consider the patient arrives at a new location, the new host monitor is now paired to the IntelliVue MMS X2's telemetry transceiver monitored 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

The Phillips Telemetry System The official name for current Philips telemetry system is IntelliVue Instrument Telemetry System (IIT) and this is a newer generation bi-directional communication system operating in groups of channels within the 2.4GHz ISM band utilizing frequency hopping algorithm. Frequency hopping technology originated from electronic warfare and is a technique to avoid enemy eavesdropping or high-power CW jamming by continuously switching the transmitting frequency (and therefore the receiving frequency). In healthcare, there is no enemy determined to jam you in every move so you do not have to anticipate the enemy. It is an adapted version to improve real-time performance in a crowded band since the 2.4GHz ISM band is a real radio waves jungle today. In the US market, Philips also offers the same IIT system using the protected WMTS bands in line with FCC initiative. This is done easily by replacing the internal ISM adapter (for International market) with WMTS adapter.

 

 

The Life Scope PT monitor is limited by original design not to exactly follow Phillips after leaving a Host Monitor as input unit

Despite the fact BSM-1700 monitor has a wireless option using a ZS-900PK telemetry transmitter to link to the Central Station, the telemetry transmitter cannot be attached to the BSM-1700 when it is acting as an Input Unit to a host monitor. This is because the design to have BSM-1700 as a transport monitor to a Host Monitor was an after-thought, and there is difficulty to switch to telemetry after detaching from a Host Monitor. 

 

The initial decision was to follow GE Marquette

 

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

 

This naturally extends to the Data Acquisition Unit (DAU) which is a repeater interface between input unit and monitor.

 

The BSM-6000 series main unit was designed long before Philips introduced the idea of turning input unit into a transport monitor

Thus, although the BSM-1700 monitor has a wireless option using a ZS-900PK telemetry transmitter to link to the Central Station, a telemetry transmitter cannot be attached to BSM-1700 when it is acting as an Input Unit to a host monitor as illustrated below.

A telemetry transmitter cannot be attached to a BSM-1700 series monitor when it is on the DAU

To attach a telemetry transmitter onto a BSM-1700 monitor requires the service of a qualified technical staff, it is therefore impossible for a BSM-1700 to change from being an Input Unit to a Transport Monitor with telemetry connectivity at short notice.

This means the telemetry transmitter can only be used on BSM-1700 monitor operating as a stand-alone monitor, which obviously will be an over-priced monitor and an unlikely installation.

 

BSM-1700 series monitors are not priced for stand-alone telemetry use

 

In the above image, the BSM-1700 monitor is equipped with a ZS-900PK telemetry transmitter linking to a Telemetry Central Monitor.

This is the misleading "continuous monitoring while wirelessly transmitting patient data and waveforms to a central monitor" mentioned in the brochure for use as a standalone monitor, which is meaningless to the target market outside of Japan.

 

Why is this description so out of context?

It is reminded the BSM-1700 does not have a built-in power unit and in telemetry mode cannot be charged directly from an AC outlet, the SC-170R AC Cradle or special external charger is additionally needed for its proper operation.

Flaw exists at the system level when switching to follow Philips

The idea of turning the Input Unit on a host monitor into a Transport Monitor was not conceived yet when BSM-6000 series monitor was first designed, it was considerable time after Philips had introduced the IntelliVue MMS X2 that Nihon Kohden decided to copy the idea.

 

Life Scope PT has a serious problem of radio silence during patient transport when copying the Philips way. The image below illustrates a LIFE SCOPE BSM-1700 sitting on a Data Acquisition Unit (DAU) and connected to a Life Scope TR (BSM-6000) series host monitor. The BSM-1700 monitor in this setup is acting as an Input Unit only and master control is on the host monitor. The BSM-6000 monitor as host monitor not only provides DC Power to charge BSM-1700's internal battery, it also provides the Ethernet path (either wired or WiFi depending on BSM-6000 setting) to the Central Monitor.

 

Life Scope PT as Input Unit to a host monitor will turn into a transport monitor when detached

When BSM-1700 is removed from the host monitor, it can no longer use the latter's Ethernet path to the Central Monitor but it does not have its own path to the Central Monitor after leaving the host monitor. We had mentioned earlier that the BSM-1700 series monitors does not have independent WiFi ability.

Radio silence means there can be no seamless monitoring at the central monitor

The communication link can only be re-established after the Transport Monitor is attached again to another Host Monitor as Input Unit. Upon re-attaching back to another host monitor, the patient data stored in the Life Scope PT during the transport period will then be synchronized to the Central Monitor.

 

Removing a BSM-1700 monitor as Input Unit on a DAU turns it offline to the Central Monitor

Critical central station surveillance is therefore not available for the BSM-1700 transport monitor during patient transfer from one host monitor to another. There is a critical missing specification at the system level.

The BSM-1700 relies on built-in memory to store the patient data during transport and only able to upload it to the Central Station via a Host Monitor after the transfer is completed.

Seamless data review though available at the Central Monitor, it does not equate seamless monitoring

 

The Central Station can be updated only after the BSM-1700 transport monitor is eventually linked to another Host Monitor as Input Unit. This synchronization will make the data on the Central Station seamless but it is not seamless monitoring.

 

As a comparison, Draeger does not need to change IP because their concept is not "from Input Unit to Transport Monitor".

>> See Draegar's "Pick And Go" Concept.

WATCH OUT the dangerous use of semi-quantitative CO2 measurements and ignorantly displaying a flawed CO2 waveform

Nihon Kohden lacks sidestream CO2 sampling expertise and buys OEM units to offer them as expensive standalone. The AG-400 CO2 unit as shown, for example, is technology from Oridion Medical. For monitoring such as post-surgery recovery, integration of the sidestream CO2 into the monitor is a mandatory requirement because an external unit requires additional power socket besides necessitating the use of a trolley.

 

For some unknown reason, Nihon Kohden monitors have never been able to offer benefits of integrated sidestream CO2 measurement.

 

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

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

 

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

 

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

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

 

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

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

 

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

 

Users just doing the inevitable

 

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

- Life Scope patient monitors

- Vismo patient monitors

- Cap-STAT OLG-2800

- CardioLife defibrillators

- Neurofax EEG machines etc.

 

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

 

The manufacturer has not noticed Semi-quantitative CO2 measurements are only estimates

 

To save costs, the semi-quantitative kit sets do not make measurement during the inspiration phase. The important point is there is a measurement duty cycle and it is as shown; there is no way to know the actual CO2 measurements during the inspiration phase because CO2 measurements are not made.

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

 

Semi-quantitative measurement is also of low-accuracy type, performed using one IR detector instead of the usual two to save cost. This is reflected in the measurement tolerance.

 

Contrasting, quantitative measurement delivers high accuracy for critical care. To ensure the necessary high accuracy, quantitative measurement employed two IR detectors for simultaneous CO2 measurements at different wavelength for results comparison. CO2 measurements are also being made continuously.

 

Quantitative measurement employs two detectors to make continuous measurement at different wave-lengths to compare readings for high accuracy

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

This is because actual CO2 value will be more.

The design does not assure users the CO2 level is indeed zero during the inspiration phase

 

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

 

As seen from the duty cycle, there is no measurement being made during the inspiration phase, how does the manufacturer assure measurement accuracy? The specified measurement tolerance is conditional and has no meaning for the users!

Each semi-quantitative CO2 measurement is therefore only an estimation.

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

 

Semi-quantitative methodology means cost-effective estimations but 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

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

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

 

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

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

 

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

 

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

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

  

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

 

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

 

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

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

 

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

 

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

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

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

The key point is, it does not last