(V)

The Careless and Dangerous use of estimated CO2 values

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

The tiny transducers and relatively bigger disposable adapter is a recipe for disaster

When a sensor becomes 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 two tiny transducers, it is difficult to separate the them 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 causes stress to the two joints and quickly degenerate the performance of the transducers, which 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

Semi-quantitative CO2 measurements are not a cheap substitute to quantitative CO2 measurements

To save costs, the semi-quantitative kit sets do not make measurement during the inspiration phase. There is a measurement duty cycle and it is as shown in below picture.

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

Semi-quantitative measurements are also of low-accuracy type, performed using one IR detector instead of the usual two to save cost.

Contrasting, quantitative measurements delivers high accuracy for critical care. To ensure the necessary high accuracy, quantitative measurements employ two IR detectors for simultaneous CO2 measurements at different wavelength for results comparison. CO2 measurements are also being made continuously, which means it can be fed to display a waveform on screen.

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 level can be much higher.

In other words, it is an acknowledgement that:

1. The measured CO2 value is not the true CO2 level,

2. The true CO2 level = (measured CO2 value + x), where x is an unknown CO2 value carried forward from the inspiration phase. Only when x = zero will the measured CO2 value reflect the true CO2 level.

It is thus unprofessional to specify a measurement tolerance when there is an unknown in the equation

This is not professional specifications

As seen from the duty cycle, there is no measurement being made during the inspiration phase, how do the manufacturer or users know the measured CO2 value is the true CO2 level?

The specified measurement tolerance is conditional on this assurance and the CO2 values shown to users are therefore wrong and misleading! Each semi-quantitative CO2 measurement is in fact only an estimation, because the users have no way to tell if the value of x is indeed zero. It is only assumed to be zero.

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

Semi-quantitative measurements are for selective uses with known risks

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 to estimate the value of etCO2 for airway tube placement confirmation. It cannot be be a feed for continuous waveform display.

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

It is a flawed continuous CO2 waveform when fed by a source that does not have the ability to make continuous measurements

The manufacturer ended up carelessly displaying a flawed continuous CO2 waveform using semi-quantitative measurement kits that do not have ability to make continuous measurements. This is unacceptable, as the manufacturer is subjecting the monitored patients and users to dangerous misinterpretation risks.

When there is no measurement being made during the inspiration phase, the displayed CO2 level is forced by the manufacturer to a clean zero by design. Is the manufacturer aware that a zero CO2 reading on the waveform means zero measured value, not that you are not measuring? This is basic professional knowledge.

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

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

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

What you should also know about miniaturized fully-quantitative 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/ neonatal CO2 monitoring, Nihon Kohden is thus offering this as an alternative to sidestream CO2 technology.

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 sensors are of poor design and easily broken

The key point is, it does not last

(VI)

Turning To Magic Show

Where fear is, there is your task - Carl Jung

In order not to reveal to the market NIHON KOHDEN had already given up development to make modular monitors, the modular Life Scope S and Life Scope M were still being actively promoted on brochures. Since it could not be for sales improvement, its real purpose was to continue the impression the company is still capable of making modular monitors.

The failed modular monitors continued to appear in later promotion brochure in order to hide the truth from the market

About 9 years after the launch of modular Life Scope S Bedside Station, a new Life Scope J (BSM-9101) purporting to be a modular bedside monitor was released for export.

Instead of working on a new measurement LAN, 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 from the board 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 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 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 the 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 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 intentionally 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, to give the impression the old modular racks can be daisy-chained to the AY-920A Input Unit.

Why was there a need for a failed module rack? The module list also confirmed there was no new module added.

Life Scope J Bedside Monitor is not a modular monitor

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

Without offering a new measurement LAN network, connecting to the old module rack was just a pretense, and exposed after they were discontinued without replacements.

There was no replacements for 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 and on MU-910R Main Unit is the link 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.

(VII)

Throwing Good Money After Bad

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

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, Life Scope G5 and Life Scope G7 bedside monitors inherit the input units from the Life Scope TR series bedside monitors. In other words, the magic show continues.

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

There are three types of Input Units that can be used on Life Scope TR (BSM-6000) bedside monitors, and only input units using Nellcor and Masimo algorithms are available in the US market.

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

Similarly configured input units with different SpO2 algorithms; what are these yellow connection sockets?

Other than placing the input unit directly onto the monitor main unit, it is possible to place the input unit closer to the patient by using an extension known as Data Acquisition Unit (DAU). Note a DAU unit is a serial device and connects to the main unit using only serial communication, it does not have an IP address for networking flexibility. There are two types of DAU units, the JA-694 DAU unit has four additional yellow MULTI sockets for use by the input unit while the JA-690 DAU unit comes without any yellow MULTI sockets (see below picture).

When a transport monitor is needed, the input unit is replaced by a Life Scope PT transport monitor; the transport monitor works as an input unit when attached to a main unit known as the Host Monitor, and becomes an independent transport monitor upon release from the Host Monitor.

There are four models of Life Scope PT (BSM-1700 series) transport monitors:
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 a JA-694P DAU unit (left)

The difference among the four transport monitor 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 table make use of Nihon Kohden SpO2 algorithms but they have different version of SpO2 algorithm. The version for US market is using the previous-generation algorithm, and why would the US market need an older version of current SpO2 algorithm is really a puzzle.

Life Scope TR series monitors had been upgraded to Life Scope G5 series monitors by using panel PCs as displays

The updated model of Life Scope TR is the Life Scope G5 bedside monitors; a main unit of Life Scope G5 bedside monitor is a Life Scope TR main unit updated with an integrated panel PC replacing previous LCD display.

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

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

The Input Units are again short of physical sockets

The inputs units used by Life Scope TR series and Life Scope G5 series are the same; let's take a closer look at the AY-663P Input Unit which is being shown below. It needs at least ten physical sockets for carefree use but only three sockets are provided for sharing use. So, only three of the ten connectable cables can plug into the input unit at any one time, i.e. 3/10 availability ratio.

The input unit is so short of physical sockets, why would anyone need such a skewed input unit? This is actually worse than the Life Scope VS bedside monitors, and obviously incomplete.

A skewed input unit delivering pain of insufficient physical connection sockets

The BIS, Second SpO2, ETCO2 and NMT parameters are self-contained kit sets with processed digital serial data using the MULTI sockets only as pass-through paths to the monitor, they have no reason to queue for the scarce yellow MULTI sockets. It was done merely to show the flexibility of the MULTI sockets.

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 box adds four physical connection sockets together with four channels of IBP hardware to AY-663P input unit

Since AY-663P Input Unit is incomplete without the AA-674P expansion box, why didn't the manufacturer just design an input unit with the intended seven MULTI sockets?

Like Life Scope J bedside monitor, the manufacturer wanted to show scalability by taking out some of the needed physical sockets in the Input Unit and placed them in an optional expansion box. 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.

What the market really wants is scalability of patient-monitoring parameters, not more or less flexible sockets.

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 as a mandatory requirement. 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 be buying 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!

When using a DAU unit, the four additional MULTI sockets are made available on the JA-694PA DAU. In the case of Life Scope G5 bedside monitor, the AA-174P expansion unit can also be used.

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

Sharing must make economic sense

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 switch.

Time-sharing of a car (an asset) 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.

This design optimizes the use of expensive hardware, not the cheap sockets

Case Study

The structure of a Life Scope TR Input Unit with its expansion unit corresponds to a Philips MMS module with an extension. These are operating at the configured level, not modular, and the expansion or extension is made using analog interface.

The MMS modules are capable of further linking to a real-time measurement LAN (Ethernet) network

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.

It is only wishful thinking to believe 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 kit sets using MULTI sockets

It is the same description as a configured monitor

It is the built-in hardware that determine the parameter capability; and in the case of serial kit sets, the system software.

Delete what are not applicable

Input units and monitors 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 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 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).

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.

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.

Rems.

Here is irrefutable proof the IBP amplifier hardware is located internally

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 sockets indicating PRESS/ CO2/ RESP, i.e. no TEMP. This block diagram clearly shows there is no reason for any amplifier hardware to be placed inside the NIHON KOHDEN Smart Cables.

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

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.

Transport monitoring

When Life Scope TR (BSM-6000 series) monitors were first designed, the way to monitor a patient during transportation was to transfer the Input Unit to a more compact 10.4-inch monitor unit (Life Scope BSM-6301). The flow is as shown below.

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

Life Scope PT transport monitor was designed after the Philips IntelliVue MMS X2; this is a transport monitor acting as input unit when attached to a host monitor, and upon release from host monitor becomes an independent monitor.

Life Scope J can also switch to using the Life Scope PT 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 not using 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. The Core Unit of Life Scope G9 is much bigger than predecessor MU-910R because a whole PC unit is now packed inside to provide web browsing capability!

Life Scope PT (BSM-1700) transport monitors have no link to the Central Monitor after leaving the host monitor

Note a Life Scope PT transport monitor (BSM-1700) can only link to a central monitor using telemetry or wired Ethernet when not acting as an input unit. Thus, when a BSM-1700 transport monitor leaves a Host Monitor, its only way to keep in contact with the Central Monitor is using a telemetry transmitter. Without a telemetry transmitter attached to its side, there is no other way to communicate with the Central Monitor.

It is, however, impossible to attach the optional ZS-900PK transmitter to the transport monitor when the latter is placed on a DAU unit (acting as an Input Unit to a Host Monitor). This is illustrated in below picture.

A telemetry transmitter cannot be attached to a Life Scope PT transport monitor when it is placed on a DAU unit

It is clear when a BSM-1700 transport monitor leaves a Host Monitor, it is not attached with a telemetry transmitter, and loses contact with the Central Monitor. This is a terrible design flaw that you should know before committing.

The communication link is re-established when the Transport Monitor is again attached to a Host Monitor as Input Unit; once this is done, the patient data stored in the Life Scope PT during the transport period will be updated 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 MMS X2 now operates as an independent transport 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 outdated protocols of the clinical monitoring network (officially named as LS-NET); this said protocols currently do not associate patients with devices, only locations. 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 Ethernet socket is at the rear of the cradle, and 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. To justify the higher price, Life Scope BSM-1700 monitor must qualify 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 standards and needs a major upgrading.

The said LS-NET protocols only work when the monitors do not move from one location to another; it was developed at a time when a monitor always stay at a fixed location, and patients were being transferred from one location to another but the monitors stay. Patient identity was by a combination of both monitor and location, with assumption of a stationary monitor. With patients moving together with their monitors, the old way of identifying a patient no longer holds true and the protocols need a fundamental revamp to keep up with 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 as a valuable "PICK and GO" monitor due to the outdated network protocols of LS-NET.

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

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 clear indication the company is capable of fixing it yet.

Instruction not to link the AC Cradle 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. There is no similar subsidy system for telemetry monitor outside of Japan.

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

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

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