DynoSense Corp 9990010001 Manuale Utente
DynoSense Corp. – PRQ-00100-01, Rev A
Page 7 of 19
Chapter 1 – General Information
DynoSense V1000 system consisting of Dyno100 (Device+Case+Charging Cable, Hydrogel and Sanitizing
Wipe) is a vital monitoring system intended to measure Electrocardiograph (ECG), functional oxygen
saturation of arterial hemoglobin (SPO2), photoplethysmography (PPG), Respiration Rate (RR), Oral Body
Temperature (TEMP), and Breath Alcohol Content (Ethanol) percentage.
Wipe) is a vital monitoring system intended to measure Electrocardiograph (ECG), functional oxygen
saturation of arterial hemoglobin (SPO2), photoplethysmography (PPG), Respiration Rate (RR), Oral Body
Temperature (TEMP), and Breath Alcohol Content (Ethanol) percentage.
Wireless Technology
DynoSense System uses wireless techniques to transmit data. The wireless link uses the Bluetooth BLE V4.1,
transmitting at 2.4GHz. As with any wireless system, it is possible to disrupt communications if there is a
high amount of RF interference or if the maximum wireless link range has been exceeded. The maximum
range specified for this technology is about 10 feet, line of sight. If too much interference is detected or if the
user has gone out of range, the link between the sensor and iPhone will be suspended.
transmitting at 2.4GHz. As with any wireless system, it is possible to disrupt communications if there is a
high amount of RF interference or if the maximum wireless link range has been exceeded. The maximum
range specified for this technology is about 10 feet, line of sight. If too much interference is detected or if the
user has gone out of range, the link between the sensor and iPhone will be suspended.
Patient data and configuration are transmitted through a secure, encrypted link in order to protect the user
from unauthorized access.
from unauthorized access.
iOs Device is compatible and is version V5.0 or higher. Wireless internet connection provide by a router is
compatible with Wi-Fi IEEE 802.11 b/g standard and supports WEP WPA and WPA2 personal security
modes.
compatible with Wi-Fi IEEE 802.11 b/g standard and supports WEP WPA and WPA2 personal security
modes.
Indications for Use
DynoSense system consisting of multi-functional scanner and cradle is intended for monitoring physiological
data within inpatient, outpatient or home settings. This includes: Electrocardiograph (ECG), functional
oxygen saturation of arterial hemoglobin (SPO2), photoplethysmography (PPG), Respiration Rate (RR), Oral
Body Temperature (TEMP), and Volatile Organic Compounds (VOC) level.
data within inpatient, outpatient or home settings. This includes: Electrocardiograph (ECG), functional
oxygen saturation of arterial hemoglobin (SPO2), photoplethysmography (PPG), Respiration Rate (RR), Oral
Body Temperature (TEMP), and Volatile Organic Compounds (VOC) level.
The system is intended for use on general care patients (including home use) who are at least 18 years of age.
It is not intended for use on critical care patients.
It is not intended for use on critical care patients.