Category: Product Review, Patient Monitoring
It is the first being designed and with all parts sourced in China
Do note it is not NIHON KOHDEN Life Scope SVM-7000 series monitors but just NIHON KOHDEN SVM-7000 series monitors.
The SVM-7000 series has the following models from China
1. SVM-7501 10.4-inch monitor
2. SVM-7503 10.4-inch monitor
3. SVM-7521 12.1-inch monitor
4. SVM-7523 12.1-inch monitor
The SVM-7000 series monitors are the first being designed by a team from Shanghai Kohden with all the parts sourced entirely in China; SVM stands for "Shanghai (Kohden) Vital (Signs) Monitor". Compare the statement with that of the Vismo PVM-2700 series which are designed in Japan while the parts are sourced in China. Vismo stands for "Vital signs monitor". Before the Vismo monitors, the Life Scope BSM-2300 series monitors were designed by a team in Japan with parts sourced domestically.
The SVM-7000
series multi-parameter patient monitors are the first in the series;
this means all components, quality control and design are handled from
China. The quality of the product is of course similar to manufacturers
in China who are getting their components from the same sources as NIHON
KOHDEN.
| No Certificate of Free Sales is available from China for SVM-7000 series with invasive IBP |
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Notice
there are models with Invasive IBP parameter, and these need
clinical trials in China for approval to sell in the country. The models with invasive IBP parameter are not allowed for sales in China
Thus, Certificate of Free Sales therefore cannot be provided
for all models. For some models, only Certificate for Export Sales from China are available.
 |
| Standard models from CHINA |
In order to meet distributors' need for Certificates of Free Sales, an alternative assembling site in Malaysia was selected. In
Malaysia, it seems there is no problem to get approval for domestic
sales for the models with invasive BP parameter even the models are not
yet been approved in China or Japan.
The models assembled in Malaysia are assigned a different number for the same model assembled in China.
The SVM-7000 series has the following models from Malaysia
1. SVM-7601 10.4-inch monitor
2. SVM-7603 10.4-inch monitor
3. SVM-7621 12.1-inch monitor
4. SVM-7623 12.1-inch monitor
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| Standard models from MALAYSIA |
There
are two types of colored frames. The standard color of the frame is white
while the models with black frame are reserved models for OEM negotiation with interested parties.
This
effectively means distributors who are successful with the standard
white frame models face the possibility of additional supply coming into
the market in the form of the black frame models as competitors.
 |
| Standard frame is the white one while versions with black frame are open for OEM negotiation |
To
bring down the cost of a product, manufacturers typically reduce the
amount of total hardware used and also saving cost by using cheaper
components which are of a lower MTBF (mean time between failures).
Contrasting against the SVM-7000 series monitors by Nihon Kohden are
products from Edan Instruments, Inc. from China whom we are aware could offer monitors with high MTBF comparable to those produced in Japan.
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| The types of SVM-7500 and SVM-7600 series patient monitors |
The
operation of the monitors is only by touchscreen and with two
display sizes, at 10.4 and 12.1 inches with a 800x 600 resolution.
Below table shows the details of various models from China and Malaysia respectively (including the versions with black frames); there are two models for 10.4 inch display screen and another two models for 12.1 inch display screen. According to the table there is no difference between SVM-7501 (China) and SVM-7601K (Malaysia) for example, only the assembly location.
Below table shows the details of various models from China and Malaysia respectively (including the versions with black frames); there are two models for 10.4 inch display screen and another two models for 12.1 inch display screen. According to the table there is no difference between SVM-7501 (China) and SVM-7601K (Malaysia) for example, only the assembly location.
 |
| SVM-7500 series models from CHINA and SVM-7600 series from MALAYSIA |
There is no reason to restrict assembling sites to just China and Malaysia
| How can we check if the country of origin is Japan? |
|---|
Officially,
you should know the country of origin in writing for an export; the product label is another source of information from the factory.
Below picture shows the product label for ECG-1150 ECG machine, whose production site is in China. The product label does not indicate the country of origin is Japan, since there is no specific mention of "Made in Japan". Do not mistake the corporate address as production site.
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| The Product Label for above ECG-1150 whose Country of Origin is China has no "Made in Japan" declaration |
In next picture,
the product label for BSM-1102 similarly has no indication "Made in Japan"
because this was a third-party product made outside of Japan. The
address just indicates ownership of the product model. In the same
picture, the lower label for Telemetry Central Monitor WEP-4208A
clearly show the product was made in Japan.
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| If Country of Origin is Japan, it is indicated on the product label "Made in Japan" |
| The monitors are not for sales in Japan |
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There is no provision of interface for the digital telemetry networking
which is standard for a Life Scope Patient Monitor. Clearly,
this range is not sold in the Japanese domestic market and there cannot
be any Free Sales Certificate from Japan MHLW.
The SVM-7000 series monitors cannot be mixed with Life Scope or Vismo monitors in a patient monitoring network
There is strangely no brand identity for the SVM-7000 series patient monitors since it is not associated with Vismo or Life Scope brands, just the generic parent brand. Brand identities of Vismo and Life Scope are not strong any way, they are mostly just known as Nihon Kohden monitors.
However, while Vismo and Life Scope patient monitors can work together in the same real-time network (inter-bed, central monitoring), the SVM-7500/ SVM-7600 series patient monitors do not share the latest networking protocols and cannot be on the same monitoring network.
A new monitor brand is clearly needed to identify this range of patient monitors to set them apart.
However, while Vismo and Life Scope patient monitors can work together in the same real-time network (inter-bed, central monitoring), the SVM-7500/ SVM-7600 series patient monitors do not share the latest networking protocols and cannot be on the same monitoring network.
A new monitor brand is clearly needed to identify this range of patient monitors to set them apart.
| Users should aware the mandatory need for electrical safety of monitored patients |
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When networking a patient to a hardwired Ethernet network, the typical non-isolated Ethernet from NIHON KOHDEN is a danger to patient electrical safety. Network Isolation Units are mandatory to ensure safety of patient from electrical shocks.
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| NIHON KOHDEN network isolation transformer |
When an isolated monitor with an non-isolated Ethernet port is connected to a hardwired network, it is no longer a medical device unless the above-shown network isolation transformer is introduced between the monitor and network. If the network isolation transformer is not installed, dangerous electric shocks can be delivered to a monitored patient through the wired Ethernet network. Such dangerous electric shocks are potentially lethal and no hospital should ignore this mandatory requirement.
iNIBP measurement is not yet deployed in the SVM-7500 and SVM-7600 series
We
can see the SVM-7500/ SVM-7600 series multi-parameter patient
monitors do not yet make the iNIBP measurement during the
cuff-inflation phase (iNIBP). This technique is similar to Welch Allyn's SureBP technology introduced way back in 2006 and a technique widely acknowledged to be pioneered by Collin Corporation of Japan. Collin Corporation was a business partner to Nihon Kohden Corporation supplying NIBP components running on older Life Scope 8000 series patient monitors.
When in the case of an iNIBP measurement being unsuccessful (i.e. not completed after a certain time), the monitor can only obtain a reading using the conventional deflation measurement algorithm; this means you have to add the iNIBP measurement time to the conventional method, which will be exceptionally long.
In addition, the success of a Nihon Kohden iNIBP measurement requires the use of special YAWARA CUFF 2 type NIBP cuff for performance delivery; Yawara cuff (without the 2) or other cuffs are not recommended for iNIBP measurements. The 5cm and 7cm YAWARA CUFF 2 (meant for Infants and Children) are also too small for iNIBP use and these sizes must only use the deflation measurement algorithm. The market expectation is Nihon Kohden should achieve quick NIBP measurement with inflation-phase algorithm using only ordinary cuffs.
| WATCH OUT the dangerous use of semi-quantitative estimation data for uncertain measurements and concurrently displaying a flawed CO2 waveform |
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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 could not offer integrated sidestream CO2 unit.
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| The inability to integrate the sidestream CO2 unit into the patient monitor main unit |
Nihon
Kohden solution was to offer miniaturized mainstream cap-ONE TG-920P CO2 sensor kit (order code P907) that can be used on non-intubated patients.
The
cap-ONE TG-920P CO2 sensor kit (order code P907) has very small sensors because semi-quantitative measurement is adopted, the method is not
commonly seen and many are not alerted to the risk of using data from semi-quantitative etCO2 kit sets
for critical measurements and true CO2 waveform display.
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| Nihon Kohden cap-ONE P907 (TG-920P) mainstream CO2 sensor kit |
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| TG-921T4 etCO2 sensor kit for SVM-7000 series monitors |
| How to remove a relatively big disposable adapter from the two tiny transducers after use? |
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| 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.
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| Users just doing the inevitable |
Shown
below is another TG-900P etCO2
kit set (order code P903) that makes semi-quantitative CO2 measurements; the TG-901T3 kit
set (order code P906) is the same thing using a different connection plug. The medical
devices from same manufacturer that uses semi-quantitative etCO2 kit
sets for patient CO2 waveform monitoring
have Life Scope patient monitors, Vismo patient
monitors, Cap-STAT OLG-2800, CardioLife defibrillators and Neurofax EEG
machines etc.
 |
| Nihon Kohden semi-quantitative etCO2 kit sets |
| A highly relevant question: Can users accept estimated measurements for patient monitoring? |
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To
save costs, the semi-quantitative kit sets do not make measurement
during the inspiration phase, the measurement duty cycle is as shown. This means semi-quantitative CO2 measurements are not made continuously.
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| Semi-quantitative means there is a duty cycle, and measurement is not continuous |
Semi-quantitative measurement is also of low-accuracy type, performed using one IR detector instead of the usual two to save cost. This is reflected in the measurement tolerance.
Contrasting, quantitative measurement delivers high accuracy for critical care. To ensure the necessary high accuracy, quantitative measurement employed two IR detectors for simultaneous CO2 measurements at different wavelength for results comparison. CO2 measurements are also being made continuously.
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| Quantitative measurement employs two detectors to make
continuous measurement at different wave-lengths to compare readings for high accuracy |
NIHON KOHDEN specification
for TG-901T CO2 sensor kit
shows even the specified low accuracy of CO2 measurement using semi-quantitative
method no longer holds true once CO2 is present during the inspiration
phase.
This is because actual CO2 value will be more.
| As seen from the duty cycle, there is no measurement being made during the inspiration phase; how do the users know specified measurement accuracy is valid? |
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| Measurements are invalid when CO2 is present during inspiration, but CO2 is not measured during this period; can you have confidence in the measurements? |
The specified measurement tolerance therefore has no meaning for the users!
The users are also not alerted on screen there is no CO2 measurement being made during the inspiration phase, and unknowingly made to take an unnecessary risk.
| Semi-quantitative methodology means cost-effective estimations and the design cannot be used in a general way, only on a selective basis with known risks |
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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.
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| A hand-held semi-quantitative etCO2 estimation tool (with SpO2) for airway tube placement confirmation |
| How is it feasible to display a true continuous CO2 waveform when the semi-quantitative measurement kits do not have the ability to make continuous measurements? |
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NIHON KOHDEN also allows data from semi-quantitative measurements to be
displayed on screen with the non-measurement period reset to zero level. The insistence to display a continuous waveform using discontinuous measurement data from
semi-quantitative mainstream CO2 estimation kits is unacceptable; the
manufacturer is just subjecting the monitored patients and users to dangerous
misinterpretation risks.
A zero CO2 reading on the
waveform means zero measured value. No measurement can only mean a defective sensor, not by design!
Note the etCO2 value shown is also not alerted as estimated etCO2 only.
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| 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! |
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| Quantitative measurements confirming expiratory upstrokes do not
always start from zero CO2 level |
Check
the latest updated table to make sure you only use quantitative method for
critical measurements and true CO2 waveform display
on screen.
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| Use only quantitative method for waveform display; the quantitative TG-950P (P905) shown here was already discontinued. |
| How about fully-quantitative type miniaturized mainstream CO2 sensor? |
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The TG-907P CO2 Sensor kit (order code P909) shown in above table
is using quantitative method as declared. This sensor was designed for
non-intubated adult CO2 monitoring, as well as neonatal CO2 monitoring.
In short, Nihon Kohden is trying not to rely on others for sidestream
CO2 sampling expertise.
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| The miniaturized CO2 sensor is easily broken by the bigger and stronger adapter |
The model for use by the SVM-7000 series monitors is shown below.
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| TG-971T4 CO2 sensor kit for SVM-7000 series monitors |
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| These are common defects of a TG-970P CO2 sensor kit (P909). The design is impractical. |
| Undeniable confirmation the fragile miniaturized CO2 sensor is of poor design, and easily broken |
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| Key point is, it does not last |
Avoid the sharing of connector sockets at all costs!
It is foremost important to know the cost is very high to time-share connector sockets, it is thus fortunate the yellow shared-use MULTI sockets are not yet been found on the SVM-7000 series monitors.
The yellow MULTI sockets are part of a legacy circuit known as a Multi-parameter Unit; sacrifices must be made to make use of them, but this is not explained to the market and easily lead customers into having an unrealistic expectation of what the yellow MULTI sockets can actually deliver.
The legacy Multi-parameter Unit was originally devised only to solve a product issue. In
the 1990s, when developing the first digital modular monitor, the
development team encountered a problem of insufficient front panel space for connector sockets on the first digital multi-parameter module being made. A few sockets were specially adjusted for time-sharing use by a group of five types internal analog hardware to overcome the space limitation; to differentiate them, they were colored yellow and known as MULTI sockets.
At the time NIHON KOHDEN was responding to an important emerging trend of using a high-density digital multi-parameter module as basic building block for modular monitors |
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In analog modular monitors, only single parameter modules were produced by NIHON KOHDEN. When designing the first digital modular monitor, the company discovered the critical care market had already moved to using a digital multi-parameter module with higher density of electronic components as a basic building block for modular monitors.
Apart from the higher electronic density, the difference between a single parameter module and a multi-parameter module is the presence of a CPU processor in the latter; the output of a multi-parameter module is thus processed digital data. This new development of distributed processing made it possible for patient data to be stored and moved with the module. Digital modules can also be connected directly to a (proprietary) digital data-exchange network as a node.
NIHON KOHDEN wanted to follow the trend by offering the first digital multi-parameter module, and the first digital multi-parameter module made by the company was named the Saturn module.
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| Responding to new trend in the 1990s using a multi-parameter module with higher electronic density as a basic building block for modular monitor |
| Even occupying a 3-slot width of the module rack, the Saturn multi-parameter module (August 1998) was not big enough to hold all necessary connector sockets |
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Nihon Kohden intended a module rack integrated physically with the main unit to form a limited footprint just big enough to stack the display monitor on top of it (see below illustration). The physical size of the Saturn module was therefore constrained; in addition, the multi-parameter module must work in combination with other parameter modules like recorder, sidestream CO2, BIS, EEG, Flow/ PAW, SvO2 in the module rack.
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| The Saturn module was intended to be physically small in size |
| The elegant but expensive solution from NIHON KOHDEN for the physical size limitation of the Saturn module was to adjust two of the connector sockets for sharing use |
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| Two yellow MULTI sockets had to be adjusted for time-sharing use because there was not enough free space on the Saturn module for more sockets |
There are two parts to the hardware in the Saturn module.
(a) The hardware sharing the two yellow MULTI sockets in the multi-parameter unit:
- 2 channels of IBP (note: 1 MULTI socket = 1-ch IBP)
- 4 channels of Temperature (note: 1 MULTI socket = 2-ch TEMP)
- Cardiac Output
- FiO2
- Thermistor Respiration
Note: The mainstream CO2 comes in the form of a self-contained serial kit set, utilizing the MULTI socket only as a serial port. What is a Multi-parameter Unit in the Saturn module will be soon explained.
(b) The hardware using dedicated connector sockets, external of the Multi-parameter Unit:
- ECG
- SpO2
- NIBP
The adapting MULTI sockets were additionally allowed to be diverted to act as a costly digital serial ports