About the VedaPulse® Professional Device
General information
Data entry device - attachment to the computer "VedaPulse® Professional" is designed for registering the heart rate (НR) and heart rate variability (HRV) signals and entering the obtained data into РС in order to assess the functional state and resources of the body.
The product is not designed for medical purpose nor being а medical equipment.
The product complies with requirements of Russian Federation Standard GOST IЕС 60950-1-2014 оп electric safety for class III equipment, and with requirements of Russian Federation Standards GOST 30805.22-2013 and GOST CISPR 24-2013 оп electromagnetic compatibility.
The product registers heart rate bу means of two electrodes applied to the limbs of the body, in the standard version to the right and left hands. The product is connected to а personal computer via standard USB port.
The product is not intended for:
- functional diagnosis in cardiovascular diseases!
- use by children under age of 12 years and persons with disabilities.
The product does not affect the human body in any way and has по absolute contraindications for use.
The service life of the product is 5 (five) years.
Complete set
Complete set of the data entry device - computer peripheral equipment "VedaPulse® Professional", TU 4033-002-95477555-2014, voltage 5V, includes:
- "VedaPulse® Professional" device – 1 pc
Contents:
- Signal cable – 1 pc
- Limb electrodes – 2 pc
- USB cable 2.0 Am/Bm 1.8 m – 1 pc
- USB software security key – 1 pc
- Warranty certificate – 1 pc
- Storage and transportation case – 1 pc
Warnings and recommendations
- Make sure that the surface of the skin where the electrodes аге applied is not dirty, not too dry and not covered with а large amount of hair, otherwise the quality of recording signal may be poor;
- Do not use the product for purposes other than HR registration and HRV analysis;
- Do not use the product when walking or moving on any vehicle;
- Do not expose the product to strong hitting or vibration;
- Before using the product, remove the static charge from your body;
- Do not attempt to disassemble, repair or modify the product by yourself;
- Do not sterilize the product;
- Do not use the product if the electrodes are dirty;
- Do not use the product at the same time as an MRI examination;
- Do not use the product in combination with defibrillator;
- Keep the product away from children and other people not able to use the device according to its purpose;
- Do not twist, bend, or wind the signal and USB cables around the device;
- Do not pull the wire to disconnect the signal cable from the device or the limb electrodes, use the connector housing and the plastic coverage of the tips for that;
- In case any liquid gets to the device, disconnect it from the computer immediately.
Transportation and storage conditions
Transportation of the product is allowed in all types of covered vehicles in accordance with the rules of transportation applicable to this type of transport. The placement and fastening of boxes with products shall ensure their stable position, excluding the possibility of displacement of boxes and their collisions with each other and against the wall of the vehicle.
Storage of the product in the manufacturer's packaging is allowed in closed or other premises with natural ventilation, at air temperature from -50 to +40°С.
Storage of the product is not allowed:
- at temperature below -50 or above +40°С;
- in direct sunlight;
- in humid areas where water сап enter the product;
- in dusty areas;
- close to the open fire;
- in the strong electromagnetic fields’ areas.
Usage and maintenance conditions
Usage of the device is allowed in closed ventilated premises with artificially regulated climatic conditions with the absence of direct sunlight, atmospheric precipitations, wind, sand and dust at temperatures from +10 up to +35°С with relative humidity not higher than 80%. After transportation of the device in subzero temperature conditions, it should stay atа room temperature not less than 12 hours before usage.
Usage of the device is not recommended:
- at temperatures below +10 or above +35°С. Because these conditions are not comfortable for the user, unless it is not explicitly specified by study design;
- near audio, video, wireless networks equipment and mobile phones because interference in the recording may occur;
- in strong electromagnetic fields, for example, near powerful radio transmitters, high voltage power lines etc.
Usage of the device is prohibited:
- at temperature below +1 or above +40°C;
- at relative humidity higher than 80%;
- in humid areas or near water, for example near pools.
The device does not require maintenance except for:
- after each use of the device contact surfaces of the electrodes should be wiped with а cloth soaked in 30-50% alcohol solution to maintain their cleanness;
- use hygienic tissue to clean the outer surface of the device.
Troubleshooting
Find the description of your problem in the table below and use the Troubleshooting steps.
If you did not succeed or you find it difficult to do it by yourself, please contact Technical Support by calling +7 913 452 09 03, or by sending а message to support@vedapulse.com.
| Problem description | Troubleshooting |
|---|---|
| When monitoring signal amplitude decreases gradually; signal disappears periodically or permanently turning into isoline. | Remove the electrodes, moisten the skin under the electrodes. Use tap water. Do not use distilled water or reverse osmosis water. Put the electrodes оп the wrists. Make sure that signal appears. |
| Green LED light is not switched оп when the device is connected to the computer. | Switch the USB cable to another USB port. Check/replace the USB cable. |
| After the device is connected to the computer, green LED flashes with а long pause between the flashes. | Wait until USB driver installation is complete. Switch the USB cable to another USB port. Check/replace the USB cable. |
| When running the assessment, an informational window appears with the message "Device is not initialized". | Check connection of the device to the computer. Check installation of the USB driver. Check/replace the USB cable. |
Technical features
| № | Parameter | Value |
|---|---|---|
| 1 | Number of simultaneously recorded leads | 1 |
| 2 | Signal sampling rate | 1024 Hz |
| 3 | Data width | 12 bit |
| 4 | Input signal amplitude range | from ±2 to ±1000 µV |
| 5 |
Deviation of the signal amplitude at the output of the complex from the input value at a frequency of 15 Hz:
|
±20% ±10% ±5% |
| 6 | Input signal frequency range | from 1 to 35 Hz |
| 7 |
The ratio of the signal value at the output of the complex to the signal at the input with an input signal swing of 2000 μV:
|
70-75% 80-100% |
| 8 | Natural noise amplitude, reduced to the input, not more than | ±2 µV |
| 9 | Leakage current оп the patient in single fault condition at а voltage of 500V, not more than | 5 mA |
| 10 | Communication interface with а computer | USB |
| 11 | Input voltage | 5V, from the USB port |
| 12 | Input current, not more than | 200 mA |
| 13 | Device dimensions | 150 х 95 х 30 mm |
| 14 | Device weight, not more than | 300 g |
Labeling:
| № | Character | Meaning |
|---|---|---|
| 1 |
|
Refer to user manual or operation manual |
| 2 |
|
Manufacturing date |
| 3 |
|
Serial number |
| 4 |
|
Information on the manufacturer |
| 5 |
|
Waste Electrical and Electronic Equipment |
| 6 |
|
Sensitive to electrostatic discharge |
| 7 |
|
Direct current |