- Nihon Kohden Monitors User's Guide
- Nihon Kohden Tec-5631 User Manual Instructions
- Nihon Kohden Tec 5631
- Nihon Kohden Polysmith Manual
User manual instruction guide for WMTS TRANSMITTER ZM-531PA Nihon Kohden Corporation. Setup instructions, pairing guide, and how to reset. Care Cycle Solutions We support the community and play an active role outside the hospital. This section shows solution to this Care Cycle.
CardioLife TEC-5600 series defibrillators product review- Products We have continued to provide various medical electronic equipment that are used in more than 120 countries around the. TEC-5600 series. Nihon Kohden's unique ActiBiphasic technology provides more efficient defibrillation than conventional biphasic circuits by maintaining constant second phase pulse width for high.
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As we had cautioned in 'Semi-quantitative method for mainstream etCO2 measurement should not be allowed for waveform display in patient monitoring', the semi-quantitative CO2 sensor kit TG-900P (P903) is only suitable for estimating the etCO2 value for purpose such as checking proper endotracheal tube placement but highly inappropriate and misleading for waveform display. This kit is also an option for the latest CardioLife TEC-5600 defibrillator series.
The use of semi-quantitative method (instead of fully-quantitative) is to save cost and no measurement being made during the inspiration phase, only assuming it to be zero. For critical patient monitoring, there should not be any assumption and the user is taking an unnecessary risk.
When a CO2 waveform displayed on screen is derived from low-cost semi-quantitative method, it is incorrectly displaying non-continuous periodic measurements as a continuous trace and this is not professional in approach!
On screen, since there is no measurement during the inspiration phase, the manufacturer just forced the value to be an artificial zero trace on the CO2 waveform during inspiration.
In Engineering, a continuous wave means all points of the wave are instantaneous values with respect to time obtained from actual measurements. Without any warning on screen, an educated user will interpret there is no CO2 present during the inspiration phase and this can lead to serious unintended consequences.
Manufacturers should not be allowed the unconventional practice of displaying non-continuous CO2 measurements as a misleading continuous trace and labelled it as CO2 waveform on screen.
| Picture 1: A CardioLife TEC-5600 defibrillator and its side connectors |
In Picture 1, it can be seen the connector socket for the mainstream etCO2 is different from previous model necessitating a new set of accessory even though the transducer is the same old one. The new connector is the Universal MULTI socket used in Life Scope patient monitors and is YELLOW in color. The yellow connector socket corresponds with the yellow color of the TG-900P (P903) connection plug or any other mainstream etCO2 sensor kits (such as TG-920P, TG-970P). Nihon Kohden promotes this kind of universal MULTI connector socket as a mean to flexible monitoring but in this case the connector socket can only take mainstream etCO2 and nothing else. What is flexible monitoring in this situation?
| Picture 2: The TG-900P mainstream Serial etCO2 kit set (P903) is connected to the TEC-5600 series defibrillators using a yellow plug |
For those who already had the sensor kit for TEC-5500 series, this is just additional expenditure with no new benefit.
The yellow MULTI connector sockets are obsolete remains salvaged from a failed Life Scope BSS-9800 Bedside Station launched way back in August 1998 and it is
meaningful only from the manufacturer's perspective. There is no customer value in replacing the DSI sockets used in the TEC-5500 series defibrillators.| Picture 3: The P903 on the left is for TEC-5600 series while the P906 on the right is for TEC-5500 series. The two are identical except for the connector plug. |
Both CardioLife TEC-5600 series and TEC-5500 series use the ActiBiphasic Waveform (picture 4) for shock delivery; the TEC-5600 series being the latest models. Many had complained they got a waveform different in polarity as well as shape from what was shown in picture 4. Some had even thought their measuring equipment was faulty and sent them for checking and repair! There are also those people who ignorantly told us the polarity is not important; really? that should invalidate all clinical papers supporting its use. There is no clinical paper to support its use anyway.
Acti-Biphasic defibrillation waveform currently does not have US FDA approval for sales in the US market and in addition we could not find any clinical paper to support its efficacy.
| Picture 4: Declared ActiBiphasic waveform of TEC-5600 series defibrillators |
| Significant anomaly encountered |
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In Images 4a,4b, we were greatly puzzled to learn of an Adverse Report from a competent Biomedical Team from a certain University Hospital (Taiwan) that the polarity of measured waveform from a CardioLife TEC-5500 series defibrillator was different (and upside down) from what the manual described. There was no doubt since they had tested both TEC-5521 and TEC-5531 models to arrive at the same conclusion. Comparison was also done with defibrillators from another manufacturer (Philips) using the same testing equipment. This was therefore an input from professionals that the ActiBiphasic waveform starts with a negative polarity and ends with a positive polarity; it is the exact opposite of what were portrayed in the operation and service manuals.
| Image4a: The polarity of the measured Biphasic waveform was not as we had expected |
| Image4b: The 'ActiBiphasic' waveform discharged by TEC-5500 series as recorded on print (with magnification). This was a standard Apex(+) with respect to Sternum(-) measurement. |
You should also find it strange that the ActiBiphasic waveform used by TEC-7700 series defibrillators and AED-2100 series defibrillators were not the same when they should be.
The TEC-7700 series defibrillators was the first to use the ActiBiphasic waveform for defibrillation. As it turned out, there was real concern by the Japanese Regulatory Authority and it took three years to obtain their approval for the TEC-7700 series to be allowed for sales in Japan. Meanwhile, before their approval Nihon Kohden had gone on to launch the CardioLife TEC-5500 series defibrillators in August 2004; this was more than a year before the Japan FMDA approval allowing CardioLife TEC-7700 series defibrillators to be sold in Japan. How was the approval obtained? Was the change in waveform part of the requirements for approval?
The older TEC-5500 series had two basic models, one with non-invasive transcutaneous pacing output while another without. This is a long-standing major design weakness of CardioLife defibrillators since major competitors like Philips always offer the non-invasive transcutaneous unit as an option and is upgradable in the field as an add-on.
| Picture 5: Field Upgradability is the known winning formula |
| Picture 6: Usual tender requirement for upgrading flexibility |
For TEC-5500 series, owners of the non-pacing model TEC-5521, upgrading the defibrillator to include pacing capability is NOT an option!
Instead, a completely different model (namely TEC-5531) was needed to have pacing capability. This design not only causes problem to customers wanting to upgrade but also to dealers who had to stock up both models instead of just one since the pacing unit should be just an add-on option.
| Picture 7: There was no good reason to have two distinct models TEC-5521 and TEC-5531. The pacing unit should be an upgrade item like others |
Note: The suffix behind each model indicates the different versions. TEC-5521K and TEC-5531K are models for most of the markets; the same goes for TEC-5621K and TEC-5631K.
It is strange that with the CardioLife TEC-5600 series, the same inflexible arrangement stubbornly remains for the pacing unit as an option. This is most likely a technical issue, and not design; if so, this is a major relative weakness. Dealers that had been selling previous models and hoping for a change in the new still face the same old problem to stock the correct amount of TEC-5621 and TEC-5631 at the right time. Customers must decide at the time of purchase if they should need the pacing or not at all. Big buyers of defibrillators usually do not subject themselves to such limitation.
| Picture 8: CardioLife TEC-5600 series comparison table |
As seen in the table in Picture 8, the TEC-5521/ TEC-5531 are directly replaced by TEC-5621/ TEC-5631.
There are two more models in TEC-5600 series to reach market segments that had not been targeted before. TEC-5601 is a new type low-cost bare basic model, it has no ECG monitoring, no AED mode, no recorder and no disposable pads connection possible.
TEC-5611 is like a public access defibrillator using only disposable defibrillation pads. This model is different from AED as it is using rechargeable battery and has a manual defibrillation mode for medical professionals (See also CardioLife TEC-2200).
| Picture 9: Which of four models should you keep stock? |
The connection panel with both SpO2 and Universal MULTI Connector Socket is an option for all models.
Recently, we were told by the sales team an EXTERNAL iNIBP BOX has become available as an option to TEC-5600 series defibrillators, we have not seen such a design before and understand NIBP option should be integrated into the TEC-5600 main unit. Is this just for meeting tender specification?
| Picture 10: NIBP box option for TEC-5600 series |
In the case of TEC-5500 series, we have feedback it is NOT POSSIBLE to use DISPOSABLE INTERNAL PADDLES; it is also NOT POSSIBLE for the paddle electrodes to be SEPARATED from the handles so that only the paddle electrodes need sterilization INSTEAD OF the ENTIRE SET including the CABLE AND CONNECTOR.
Nihon Kohden Monitors User's Guide
| Picture 11: Paddle electrodes cannot be separated from the handles for easy sterilization |
The TEC-5600 series offers Bluetooth short range RF connection as an option. This short range radio allows the manual transfer of data to another device such as a nearby patient monitor or PC (equipped with Bluetooth) but the data just stays at the patient monitor without any onward connectivity concept (since this data cannot be seen at the Central Monitor or Gateway Server). There is No LAN Capability and of course data may just be transferred using SD card. Defibrillation DATA MANAGEMENT software is also NOT AVAILABLE (*this is different from defibrillation files viewer software).
Nihon Kohden Tec-5631 User Manual Instructions
Nihon Kohden Tec 5631
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Your new battery comes in a discharged condition and must be charged before use (refer to your Medical Equipment for charging instructions). Upon initial use (or after a prolonged storage period) the battery may require two to three charge/discharge cycles before achieving maximum capacity.
When charging the battery for the first time your Medical Equipment may indicate that charging is complete after just 10 or 15 minutes. This is a normal phenomenon with rechargeable batteries. Simply remove the Nihon Kohden battery from the Medical Equipment and repeat the charging procedure.
It is important to condition (fully discharge and then fully charge) battery every two to three weeks. Failure to do so may significantly shorten the battery's life (this does not apply to Li-Ion batteries, which do not require conditioning). To discharge, simply run your device under the battery's power until it shuts down or until you get a low battery warning. Then recharge the battery as instructed in your user's manual.
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A charged battery replacement will eventually lose its charge if unused. It may therefore be necessary to recharge the battery after a storage period.
Nihon Kohden Polysmith Manual
Note:Most Medical Equipment of Nihon Kohden and GE should set up again after replaced the battery. The battery data should cleared or reset, otherwise your machine will warn error. That not mean the battery is no good. Please set up your machine and go on use the batteries.