Search Results

The Aulisa Oximeter Module (2nd Gen.) is indicated for spot-checking and/or continuous monitoring SpO2 and pulse rate of adult and pediatric patients during non-motion and under well-perfused conditions in hospitals, medical facilities, home care, and subacute environments. The parameters derived by the Aulisa Oximeter Module (2nd Gen.) are transmitted to a commercially available mobile device that runs an Aulisa-developed application for display and review.

The Aulisa Oximeter Module (2nd Gen.) is a wireless, wrist-worn Sensor Module (SM) specifically designed to continuously measure and display a patient's pulse rate and oxygen saturation (SpO2). It uses non-invasive red and infrared technology to measure the vital signs and sends the data to an Aulisa-developed software application as cleared through previous Premarket Notification 510(k) submissions under Guardian Angel Rx GA1000 Series Digital Vital Sign Monitoring System (K162580) & Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (K203208) using Bluetooth technology. If the physiological data sent from the subject device to the software application falls outside of pre-set limits or when a technical error is detected, both auditory and visual alarm signals are generated through the software application while the subject device backlight of the vital sign will turn to RED colour as a visual alarm signal, to alert the caregiver. The sensor module uses Bluetooth technology to interact with a commercial, third-party mobile device whether under iOS or Android operating system, such as iPad, iPhone, Google Pixel ... etc. which is not part of this submission. The vital-signs are transmitted to mentioned mobile device that runs Aulisa-developed application for displayed and reviewed. The software application can be download from an official APP store, such as iOS APP store or Google Play.

The Aulisa Infant Oximeter Module (2nd Gen.) is indicated for spot-checking and/or continuous monitoring SpO2 and pulse rate of infant patients during non-motion and under well-perfused conditions in hospitals, medical facilities, home care, and subacute environments. The parameters derived by the Aulisa Oximeter Module (2nd Gen.) are transmitted to a commercially available mobile device that runs an Aulisa-developed application for display and review.

The Aulisa Infant Oximeter Module (2nd Gen.) is a wireless, foot-worn Sensor Module (SM) specifically designed to continuously measure and display a patient's pulse rate and oxygen saturation (SpO2). It uses non-invasive red and infrared technology to measure the vital signs and sends the data to an Aulisa-developed software application as cleared through previous Premarket Notification 510(k) submissions under Guardian Angel Rx GA1001 Series Digital Vital Sign Monitoring System (K182822) & Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (K203208) using Bluetooth technology. If the physiological data sent from the subject device to the software application falls outside of pre-set limits or when a technical error is detected, both auditory and visual alarm signals are generated through the software application while the subject device flashes LED light as a visual alarm signal, to alert the caregiver. The sensor module uses Bluetooth technology to interact with a commercial, third-party mobile device whether under iOS or Android operating system, such as iPad, iPhone, Google Pixel ... etc. which is not part of this submission. The vital-signs are transmitted to mentioned mobile device that runs Aulisa-developed application for displayed and reviewed. The software application can be download from an official APP store, such as iOS APP store or Google Play. The subject device contains an Oximeter Box and an Oximeter Sensor resulting in device configuration and model names as listed below.

Aulisa Temperature Module (TM0002) is a battery-operated electronic device with indication for use in continuously measuring and monitoring armpit body temperature of adults, pediatrics, and infants and transmission of the measuring result via wireless signal. Aulisa Temperature Module (TM0002) is a non-invasive and reusable device for single patient use with intended environments of use are hospitals, medical facilities, home care, and subacute environments. The parameters derived by the Aulisa Temperature Module (TM0002) are transmitted to a commercially available mobile device that runs an Aulisa-developed application for display and review.

The Aulisa Temperature Module (TM0002) is indicated for continuous armpit body temperature monitoring of adults, pediatrics, and infants which measures body temperature and sends the physiological data to an Aulisa-developed software application as cleared through previous Premarket Notification 510(k) submissions under Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (K203208) using Bluetooth technology. If the physiological data sent from the subject device to the software application falls outside of pre-set limits or when a technical error is detected, both auditory and visual alarm signals are generated through the software application to alert the caregiver. The sensor module uses Bluetooth technology to interact with a commercial, thirdparty mobile device whether under iOS or Android operating system, such as iPad, iPhone, Google Pixel ... etc. which is not part of this submission. The vital-signs are transmitted to mentioned mobile device that runs Aulisa-developed application for display and review. The software application can be downloaded from an official APP store, such as iOS APP store or Google Play. The Subject Device is reusable, and its intended environments of use are hospitals, medical facilities, home care, and subacute environments.

The Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (Model GA2000) is indicated for use in measuring, recording, and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR), The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device. The Oximeter Module(s) is indicated for spot-checking and/or continuous monitoring of SpO2 and PR of adults and pediatrics during non-motion and under well-perfused conditions. The Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (Model GA2001) is indicated for use in measuring, recording, and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device. The Oximeter Module(s) is indicated for spot-checking and/or continuous monitoring of SpO2 and PR of pediatrics and infants during non-motion and under well-perfused conditions. The Guardian Angel Rx GA2000 Series Digital Vital Sigm Monitoring System (Model GA2002) is indicated for use in measuring, recording, and displaying body temperature. The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device. The Thermometer Module is indicated for continuous armpit body temperature monitoring of adults, pediatrics, and infants. The Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (Model GA2100) is indicated for use in measuring, recording, and displaying function of arterial hemoglobin (SpO2) and pulse rate (PR) and body temperature. The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device. The Oximeter Module(s) is indicated for spot-checking and/or continuous monitoring of SpO2 and PR of adults and pediatrics during non-motion and under well-perfused conditions. The Thermometer Module is indicated for continuous armpit body temperature monitoring of adults, pediatrics, and infants. The Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (Model GA2101) is indicated for use in measuring, recording, and displaying function of arterial hemoglobin (SpO2) and pulse rate (PR) and body temperature. The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device. The Oximeter Module(s) is indicated for spot-checking and/or continuous monitoring of SpO2 and PR of pediatrics and infants during non-motion and under well-perfused conditions. The Thermometer Module is indicated for continuous armpit body temperature monitoring of adults, pediatrics, and infants.

The subject device is a digital vital sign monitoring system that measures and displays a patient's vital signs, i.e. pulse rate, oxygen saturation (SpO2) and body temperature. It is also equipped with an audio/video camera to monitor the patient in real time. In addition, the subject device provides visual and auditory alarms that alert the caregiver when a patient's vital signs fall outside of pre-set limits or when a technical error is detected. During a physiological alarm event, the vital sign data along with the audio/video data are recorded automatically by the subject device. The caregiver can review the historical data whenever needed. The sensor module(s) of the subject device detects vital signs and sends out the data to the Receiver/Transponder using Bluetooth technology. The Receiver/Transponder then transmits, via a customer Wi-Fi network, the physiological data along with audio/video signals obtained by an embedded camera to an Aulisa-supplied tablet (i.e. the Display Unit). The subject device contains a total of three Aulisa sensor modules, Adult/Pediatric Oximeter Module, Infant Oximeter Module, and Thermometer Module. The three Aulisa sensor modules connect to the Receiver/Transponder either independently or simultaneously, resulting in five system configurations and system model names as listed below.

The Aulisa Multiple Patient Digital Vital Sign Monitoring System, MP1000, is intended to provide remote central monitoring and display of information as recorded by multiple Aulisa single-patient monitoring systems, on a central remote screen. The system can be used in a hospital type and clinic environment.

The Aulisa Multiple Patient Digital Vital Sign Monitoring System, MP1000, operates through an Aulisa-developed software installed on a standard personal computer. The system interlinks multiple Aulisa single-patient monitoring systems to display the information as recorded by each single-patient monitoring system on a central remote screen. The system uses standard off-theshelf communication and IT hardware for data transmission. The information transmitted from single-patient monitoring systems to the MP1000 system includes the physiological parameters and alarm indications. Adjusting alarm settings can only be performed on the Aulisa Display Unit of the single-patient monitoring system. If configured, the MP1000 screen can also be accessed through remote devices, such as other PCs. In addition, patient history data and report files can be viewed, exported, and/or printed.

The Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is indicated for spot-checking and/or continuous monitoring of pediatrics and infants during non-motion and under well-perfused conditions. The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device.

The subject device is a digital vital sign monitoring system that measures and displays a patient's pulse rate and oxygen saturation (SpO₂). It is also equipped with an audio/video camera to monitor the patient in real time. In addition, the subject device provides visual and auditory alarms that alert the caregiver when a patient's pulse rate and/or SpO2 falls outside of preset limits or when a technical error is detected. During a physiological alarm event, the pulse rate and SpO2 data along with the audio/video data are recorded automatically by the subject device. The caregiver can review the historical data whenever needed. The system consists of a self-contained foot-worn Sensor Module, a Receiver/Transponder with an embedded audio/video camera and a portable, table-top wireless Display Unit. It uses non-invasive red and infrared technology to measure the pulse rate and SpO2. The measurements are taken by the Sensor Module and are transmitted to the Receiver/Transponder which delivers the measurements along with audio/video signals to the Display Unit for display, wherein Bluetooth technology is used to transmit data between the Sensor Module and the Receiver/Transponder, and data is transmitted from the Receiver/Transponder to the Display Unit via the Wi-Fi 802.11 band.

The Guardian Angel Rx GA1001 Digital Vital Sign Monitoring System is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is indicated for spot-checking and/or continuous monitoring of pediatrics and infants during non-motion and under well-perfused conditions. The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device.

The subject device is a digital vital sign monitoring system that measures and displays a patient's pulse rate and oxygen saturation (SpO2). The subject device consists of a selfcontained foot-worn sensor module (SM) and a portable, table-top wireless display unit (DU). It uses non-invasive red and infrared technology to measure the pulse rate and SpO2. The measurements taken by the SM are wirelessly transmitted to the DU for display using Bluetooth technology. The subject device also provides visual and auditory alarms that alert the caregiver when a patient's pulse rate and/or SpO2 falls outside of preset limits or when a technical error is detected.

The Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients. It is indicated for spot-checking and/or continuous monitoring of patients during non-motion and under well-perfused conditions. The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device.

The subject device is a digital vital sign monitoring system that measures and displays a patient's pulse rate and oxygen saturation (SpO₂). It is also equipped with an audio/video camera to monitor the patient in real time. In addition, the subject device provides visual and auditory alarms that alert the caregiver when a patient's pulse rate and/or SpO2 falls outside of preset limits or when a technical error is detected. During a physiological alarm event, the pulse rate and SpO2 data along with the audio/video data are recorded automatically by the subject device. The careqiver can review the historical data whenever needed. The system consists of a self-contained wrist-worn Sensor Module (SM), a Receiver/ Transponder (RT) with an embedded audio/video camera and a portable, table-top wireless Display Unit (DU). It uses non-invasive red and infrared technology to measure the pulse rate and SpO2. The measurements are taken by the SM and are transmitted to the RT which delivers the measurements along with audio/video signals to the DU for display, wherein Bluetooth technology is used to transmit data between the SM and the RT, and data is transmitted from the RT to the DU via the Wi-Fi 802.11 band.

The Guardian Angel GA1000 Digital Vital Sign Monitoring System is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients. It is indicated for spot-checking and / or continuous monitoring of patients during non-motion and under well-perfused conditions. The intended environment of use is hospital. This system is a reusable device.

Aulisa's GA1000 is a digital vital sign monitoring system that measures and displays a patient's pulse rate and oxygen saturation level. The system includes a self-contained wrist-worn Sensor Module and a portable, table-top wireless Display Unit. The Guardian Angel GA1000 Digital Vital Sign Monitoring System is also equipped with an alarm system that alerts the caregiver when a patient's pulse rate is too low or too high and when the patient's SpO2 is too low or too high. Guardian Angel GA1000 Digital Vital Sign Monitoring System contains the following components. - Sensor Module ● - Display Unit ● - Finger Sensor ● - Sensor Module wristband ● - Sensor Module Charging Adaptor ● - Display Unit Charging Adaptor ● - . Display Unit Stand The GA1000 measures SpO2 and pulse rate based on transmittance technology, measuring the absorbance of red and infrared light passed through the tissue. The GA1000 uses Bluetooth v4.0 to transmit data between the wrist-worn Sensor Module and the wireless Display Unit. Both the Sensor Module and the Display Unit is Bluetooth® 4.0 compatible. The GA1000 uses non-invasive red and infrared LED sensors to measure the functional blood oxygen saturation and pulse rate. The measurements are wirelessly transmitted to the Display Unit, which displays the measurements using a Liquid-Crystal-Display (LCD) panel. The system provides adjustable visual and audio oxygen saturation, and pulse rate alarms through the LCD panel and speakers. Additional alarms are featured, including low battery on the Sensor Module, Sensor Cable disconnection, Sensor Module disconnection, Sensor Cable Probe fault, Sensor Probe detached from patient, Display Unit battery low.