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510(k) Data Aggregation
K Number
K150512Device Name
STAR 90
Manufacturer
SKANRAY TECHNOLOGIES PVT LTD.
Date Cleared
2015-06-17
(110 days)
Product Code
MWI
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
SKANRAY TECHNOLOGIES PVT LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The STAR 90 multi-parameter Patient Monitoring system is intended to monitor a single adult, pediatire or neonatal patient's vital signs at the bedside or during intra-hospital transport along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3 lead / 12 Lead), SpO2, Respiration, Temperature and Capnography (CO2) , IBP. It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic and Mean), Temperature , IBP , EtCO2 and FiCO2 readings.
The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The monitor is not intended for home use.
Device Description
The STAR 90 Multi-Parameter Patient Monitoring System is a Semi Modular Patient monitor with a wide range of communication options, touch screen and capacitive sensing buttons.
Modularity in this monitor is achied by providing 3 slots wherein the parameter modules that fit into these modules are hot swappable i.e. they can be connected or disconnected from the unit without switching off the unit. The module is detected at run time. Patient monitoring modules include:
- . ECG+RESPIRATION+TEMPERATURE MODULE: This module is divided in area and functionality between the interface card and the ECG child card. The Temperature section and the DC-DC section of the ER2T lie in the interface card.
- SpO2: This module is inbuilt inside the monitor on the interface card, but there is ● an option to jack an external SpO2 module in one of the jackable slots. It is used to measure the partial pressure of oxygen in the human body.
- NIBP: This module is inbuilt inside the monitor on the interface card. It is used to non-invasively measure the systolic and diastolic blood pressure.
- CO2: This module can be jacked into one of the jackable slots. It is used to measure the level of CO2 in the blood (EtCO2 & FiCO2). When AGM is used this module will not be available
- . IBP: STAR 90 can support 2 IBP modules. For ease of understanding we shall name the 1st IBP as IBP ½ and the 2nd IBP as IBP ¾. IBP ½ module is inbuilt in the interface card, whereas the IBP ¾ can be jacked in one of the slots. It is used to invasively measure the systolic and diastolic blood pressure
- . AGM: The connectivity for this module is inbuilt inside the interface card of the system, but the AGM module has to be connected through the connector provided. It is used to measure anesthesia gas concentration, CO2 and O2.This is optional module in place of CO2 module.
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