Category: NIHON KOHDEN (日本光電) Life Scope monitoring history from the 1990s. This chapter discussed the Life Scope TR monitor and succeeding Genesis models Life Scope G5 series (CSM-1501, CSM-1502), Life Scope G7 series (CSM-1701, CSM-1702) and Life Scope G9 (CSM-1901) bedside monitors. The new monitors are duplicating the a familiar attempt by Life Scope J (BSM-9101) bedside monitor to pass off the yellow shared-use MULTI sockets as an innovative modular design. This chapter also debunks the story that each Smart Cable comes with a module embedded.

NIHON KOHDEN Life Scope Patient Monitors Struggling The Disruptive Digital Revolution (VI)

THROWING GOOD MONEY AFTER BAD

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

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, Life Scope G5 and Life Scope G7 bedside monitors inherit the input units from the Life Scope TR series bedside monitors.

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

Compared to Life Scope J bedside monitor, there are more input units being offered for choice but no genuine scalability of patient-monitoring parameters.

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

Similar to Life Scope J Bedside Monitor, Life Scope TR Bedside Monitors are not digital modular monitors

The structure of a Life Scope TR Input Unit with its expansion unit corresponds to a Philips MMS module with its extension. These are operating at the configured level, not modular. It will be unmistakable Life Scope TR bedside monitors are configured if there are no yellow time-shared MULTI sockets on the input units and extensions to confuse you.

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

Remember the HP Agilent M3/M4 portable monitors?

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 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 network which NIHON KOHDEN does not have

The configured BSM-6000 series monitors are priced and marketed as modular monitors but without the capability. Many monitoring hardware inside the AY-663P Input Unit are not made clear in basic product communication to the market, and that was intentionally done to hide the fact the input units are configured.

Take a closer look at the AY-663P Input Unit shown below; the Input Unit needs at least ten physical connection 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 case of Life Scope VS bedside monitors, so the reaction from users is not unexpected.

Note that a

A skewed input unit delivering pain of not having enough connection 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 sockets.

The next item to appear is an external box (AA-674P) which comes with four MULTI sockets, which is meant to add additional MULTI sockets to supplement the inadequate three on the AY-663P Input Unit.

Due to use of analog integration, the number of MULTI sockets that can be integrated to AY-663P Input Unit is limited to four sockets to avoid signal degeneration. The maximum number of MULTI sockets intended for use by AY-663P Input Unit is therefore seven.

The image below shows 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 the satellite box with four additional MULTI sockets (AA-674P) that can be integrated to the MPU of the AY-663P Input Unit.

The AA-674P expansion box returns four missing physical sockets but at the same time adds four channels of IBP hardware

This is the tricky part, the purpose of this odd arrangement is to imitate the scalability process of adding patient-monitoring parameters when identical yellow MULTI sockets are being shown visually added to the input unit. However, we should know the manufacturer is only adding sockets, and not patient-monitoring parameters.

Now, it is clear the three physical MULTI sockets on the AY-663P Input Unit are not enough for use, which means the customers have to buy the AY-663P Input Unit and AA-674P expansion box in one go. The act of adding four MULTI sockets using the AA-674P expansion box also adds another four IBP hardware to the three already configured in AY-663P Input Unit. Do you really need seven channels of IBP hardware? This is indeed quite rare a requirement, and you should not buy more than what you need.

The limitation of four additional MULTI 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. By the way, that means eleven channels of IBP monitoring!

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

Elaborate time-sharing are applied to things that are expensive (therefore rare), and not worth the efforts for things that are cheap (therefore plentiful) like connector sockets! It only makes economic sense to see productive efforts being made to time-share a CPU, a car, a hotel room, a yacht, an airplane but not a cheap connection socket.

Time-sharing of an expensive hotel room creates value for the customers but time-sharing of a cheap connector socket does not

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

This design optimizes the use of the hardware, instead of the cheap sockets

It is simple-minded to think use of Smart Cables and MULTI sockets can actually upgrade a configured monitor to be modular
With the use of a MTU block, a yellow multi-parameter socket by itself does not automatically mean all the five types of mentioned parameters are available for measurements; it still depends on whether what hardware are actually being placed inside for selection by Smart Cables.
Additional monitoring parameter capability can be added to a configured monitor using serial kit sets or via interfaces to external equipment, but these are realized through the system software of the monitor and has nothing to do with the type of sockets or cables being used.

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

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

Examples of configured hardware and serial kits using Smart Cables

It is the built-in hardware that determine the parameter capability; and in the case of serial kit sets, the system software. This of course, is the same description as a configured patient monitor

Actual internal hardware and system support for serial kits varies for each MPU

Monitors and input units using Smart Cables and MULTI sockets 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 Cable technology miniaturizes circuitry found in traditional modules and embed that capability into the cable", which we will refute with details.

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

We are going to show you beyond any doubt, there is absolutely no need for any 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. These are unsubstantiated marketing messages and the manufacturer should not have condoned it.

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.

What do the manufacturer mean by this statement?

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

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

Pure assertion without showing any proof

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

Size of the PC Board relative to pins of the yellow connection plug

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

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

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

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 it has an IBP transducer. However, it is not the case when you test other parameters, internal hardware may or may not be present depending on specifications.

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

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

The manual confirms the IBP amplifier and thermistor respiration hardware are internal components of the Life Scope BSM-2301 monitor

The above block diagram also confirms beyond doubt there is no need for any amplifier hardware to be embedded in the NIHON KOHDEN Smart Cables

The MULTI socket when used as a serial port bypasses the 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 converted to digital before it can go to the APU for digital processing.

Monitoring a patient during transportation

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

The original way was to use Life Scope TR 10.4 inch model as transport monitor

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

Due to changing market need, a transport monitor was realized by the addition of touch-screen, storage memory and rechargeable battery to the multi-parameter input unit, doing away the need to attach it to a monitor during patient transfer; the design is an adaptation to imitate the Philips IntelliVue MMS X2.

Before the introduction of transport monitor Life Scope PT, Nihon Kohden had released the JA-690PA and JA-694PA Data Acquisition Units for the BSM-6000 series bedside monitor in April 2009.

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

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

The Life Scope PT acts as an input unit when placed on the Data Acquisition Unit (DAU), and becomes an independent transport monitor when it is released from the DAU.

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

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

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

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

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

The updated model of Life Scope TR is Life Scope G5 bedside monitors; the main unit of Life Scope G5 bedside monitor is Life Scope TR main unit updated with an integrated panel PC replacing previous LCD display. The main unit is now known as Core Unit like Life Scope G9.

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

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

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

Conclusion:

The Challenges Ahead

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

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

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

END

Medical Devices Sanity

Life Scope G9, G7, G5 (CSM-1901, CSM-1700 series, CSM-1500 series) and TR (BSM-6000 series) bedside monitors

THROWING GOOD MONEY AFTER BAD

Conclusion:

The Challenges Ahead