LD TECHNOLOGY - We are Listening to the body Signals!

ES TECK PEMS

EC marks (Class IIa) , Health Canada (Class III) , and FDA 510k Clearance

>Description of the features
The ES Teck System is a programmable electro medical system (PEMS) including:
•USB plug and play hardware device including an electronic box , 3 disposable electrodes, reusable Adult SpO2 probe and reusable cables
•Software installed on a computer.
E.S Teck system is a combination of 2 devices (or modules) with specific features controlled by unique software:
- Pulse Oximeter displays SpO2%, pulse rate value and vertical bar graph pulse amplitude. The photoelectrical Plethysmograph’ feature (PP) analyzes the pulse waveform provided by the oximeter.
- HRV (Heart Rate Variability) evaluates the variation of the heart rate, both in the time domain (statistical methods) and in the frequency domain (spectral analysis). Each QRS complex is detected and the so-called normal-to-normal (NN) or Rate-to-Rate (RR) intervals between adjacent QRS complexes are resulting from sinus node depolarization.

>Indications / Intended uses
Each module has specific feature and intended use
1.Pulse Oximeter:
•To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate.
•To analyze the pulse waveform (Photoelectrical Plethysmography or PP) provided by the oximeter. It only provides mathematical analyses of the input of the SpO2.

2.Heart rate variability (HRV) :
•To analyze the basic rhythms of the NN or RR intervals in heart rate, both in the time domain and in the frequency domain (short time 5 minutes). It only provides mathematical analyses of the input of the heart rate variability.

The mathematical analysis of Photoelectrical Plethysmography and HRV are not intended use for diagnosis.
The software provides a visual alarm for the values of the heart rate and/or SpO2 percent out of the normal range and for the bad quality signal transmission.
The data are stored in PC in the Backup system of the ES Teck software.
The device is intended use only for adult subjects (> 20 years old)
This Oximeter is intended to be used in spot-checking (2 minutes)
The device is intended use in licensed practitioner’s office
This device is no intended to be used at home, in hospital or out-of-hospital transport
The device is not intended use in support life and not for continuously monitoring
The system will be use by licensed practitioner.

>Screen Shoots

PEMS