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The Globalcare GUS610 automatic Blood Pressure Monitor is indicated for home use for the non-invasive measurement of diastolic and systolic blood pressures and pulse rate of adults by means of an inflatable cuff which is wrapped around the upper arm. The cuff circumference is limited to 22 to 52 cm.

The Globalcare GUS610 Blood Pressure Monitor is an automatic upper arm blood pressure monitor intended for non-invasive measurement or monitoring of adults' arterial blood pressure and pulse rate. The device is powered by batteries or by a mains-connected power adapter and is designed for home use. The Globalcare GUS610 Blood Pressure Monitor is supplied complete with the following components: - Blood pressure monitor main device - 1 - Upper arm cuff 22-42 cm - 1 - 1.5 V LR03 AAA batteries - 4 - Storage bag - 1 - Instructions for use - 1 - 100-240 VAC 50/60 Hz power supply (optional) - 1 None of the parts included with the device are supplied in a sterile condition. The Globalcare GUS610 Blood Pressure Monitor main unit is an electronic unit incorporating a screen that displays results and other information relevant to device operation. The device is powered by batteries or by a mains-connected power adapter and is designed for home ('OTC') use. The clinical outputs from the GUS610 Blood Pressure Monitor are: - Systolic pressure (mm Hg) - Diastolic pressure (mm Hg) - Pulse rate (1/min) - Cardiac arrhythmia (Irregular heartbeat (IHB)) symbol - Level of risk - Hemodynamic Rest Condition (HSD) indication The GUS610 Upper Arm Cuff, with a circumference range of 22 cm to 42 cm, is manufactured by Globalcare China. The cuff is manufactured from gray color Polyester 200D (CAS n. 80595-68-2), supplied by Anhui Wuyixing Fabric and Weaving. This is identical to the cuff provided with the predicate device cited in K222160. The purpose of this Special 510(k) is to add to the availability of an accessory for the GUS610, this being an optional Upper Arm Cuff with an increased circumference range of 42 to 52 cm. The testing undertaken for the predicate device in accordance with ISO 81060-2:2018, 'Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type', has been repeated with the new larger cuff, with 88 subjects having upper arm circumferences between 42 and 52 cm screened, from which 259 effective analysis datasets were obtained from 87 subjects. Gender distribution met the requirements of the standard (M: 55.2 % / F 44.8 %), arm size distribution met the requirements of the standard, and blood pressure measurements met the requirements of the standard clause 5.2.4.1.2 for Criterion 1 'mean difference' and 'standard deviation' for SBP and DBP, and also for Criterion 2 for SBP and DBP 'standard. deviation'. The accuracy of the BP and pulse rate measurements also met the manufacturer's specifications for accuracy. There were no adverse incidents during the investigation and no failed measurements. There were no protocol deviations or violations. A third party test house (TUV SUD China) has assessed the continued compliance of the GUS610 subject device when used together with the new optional XL cuff in accordance with IEC 80601-2-30 and found that the combination continues to meet the requirements of this standard.

The Globalcare GUS610 Automatic Blood Pressure Monitor is indicated for the non-invasive measurement of diastolic and systolic blood pressures and pulse rate of adults by means of an inflatable cuff which is wrapped around the upper arm. The cuff circumference is limited to 22 to 42 cm.

The Globalcare GUS610 Blood Pressure Monitor is an automatic upper arm blood pressure monitor intended for non-invasive measurement or monitoring of adults' arterial blood pressure and pulse rate. The device is powered by batteries or by a mains-connected power supply. The Globalcare GUS610 Blood Pressure Monitor comprises the following parts: Blood pressure monitor main device x1, Upper arm cuff x1, 1.5 V LR03 AAA batteries x4, Storage bag x1, Instructions for use x1, 100-240Vac 50/60Hz power supply (optional) with USB cable x1. None of the parts included with the device are supplied in a sterile condition. The Globalcare GUS610 Blood Pressure Monit is an electronic unit incorporating a screen that displays results and other information relevant to device operation. The device is powered by batteries or by a mains-connected power adapter and is designed for home ('OTC') use. The clinical outputs from the GUS610 Blood Pressure Monitor are: Systolic pressure (mm Hq), Diastolic pressure (mm Hq), Pulse rate (1/min), Cardiac arrhythmia (Irregular heartbeat (IHB)) symbol, Risk indicator (WHO color scale), Hemodynamic Rest Condition (HSD) indication. The device operates on the oscillometric method: pressure sensors on the cuff are used to capture pulse waves during constricted blood flow and the device then computes the results for display by means of an algorithm which analyses the pressures transmitted during arterial oscillations that occur during cuff inflation. Irreqular heartbeat (IHB) is detected by measuring the interval time between each heartbeat and comparing these values with the average heartbeat interval (heartbeat per minutes shown on the display). If the difference between any heartbeat interval and the average is higher or lower than 25 %, the device shows the irregular heartbeat (IHB) symbol on the display. The pulse rate is determined by calculating the frequency of the cuff, which are cardiac synchronous. The GUS610 is controlled by software which calculates the blood pressure (diastolic and pulse rate by the oscillometric method. To do this, it also controls the pneumatic components to inflate the cuff (with a pump), holds the cuff pressure, and then deflates the cuff (by means of a solenoid valve). The software collects the relevant data from the pressure sensor during inflation. The software also drives the LCD display, from which the user can read the result of the blood pressure and pulse rate measurements and undertakes the Hemodynamic Rest Condition (HSD) detection calculations, and reports whether any irregular heartbeat is occurring.

GUS831 compressor nebulizer is designed for the production of compressed air to operate a nebulizer kit for the production of medical aerosol for respiratory disorders. The nebulizer kit is intended for multiple use by single patient for single medication. GUS831 compressor nebulizer is intended for domestic use with children from 5 years old, adolescent and adult patients and requires the order of a physician for medical use.

GUS831 Compressor Nebulizer is a portable aerosol nebulizer electronically powered by an external power adapter and by an internal rechargeable lithium polymer battery. The compressed air, created by the membrane pump of the device, flows into the nebulizer container kit. The air pressure forced the liquid through the nozzle where it is atomized against a plate within the container. The device is equipped with a mouthpiece to easily delivery the medical aerosol.

The Globalcare GUS622 automatic Blood Pressure Monitor is indicated for the non-invasive measurement of diastolic and systolic blood pressures and pulse rate of adults by means of an inflatable cuff which is wrapped around the upper arm. The cuff circumference is limited to 22 to 42 cm.

The Globalcare GUS622 Blood Pressure Monitor is an automatic upper arm blood pressure monitor intended for non-invasive measurement or monitoring of adults' arterial blood pressure and pulse rate. The device is powered by batteries or by a mains-connected power supply. The Globalcare GUS622 Blood Pressure Monitor comprises the following parts: Blood pressure monitor main device x1, Upper arm cuff x1, 1.5 V LR03 AAA batteries x4, Storage bag x1, Instructions for use x1, 100-240Vac 50/60Hz power supply (optional) x1. None of the parts included with the device are supplied in a sterile condition. The Globalcare GUS622 Blood Pressure Monit is an electronic unit incorporating a screen that displays results and other information relevant to device operation. The device is powered by batteries or by a mains-connected power adapter, and is designed for home ('OTC') use. The clinical outputs from the GUS622 Blood Pressure Monitor are: Systolic pressure (mm Hg), Diastolic pressure (mm Hg), Pulse rate (1/min), Cardiac arrhythmia (Irregular heart beat (IHB)) symbol, Level of risk, Hemodynamic Rest Condition (HSD) indication. The device operates on the oscillometric method: pressure sensors on the cuff are used to capture pulse waves during constricted blood flow and the device then computes the results for display by means of an algorithm which analyses the pressures transmitted during arterial oscillations that occur during cuff deflation. Irregular heart beat (IHB) is detected by measuring the interval time between each heart beat and comparing these values with the average heart beat interval (heart beat per minutes shown on the display). If the difference between any heart beat interval and the average is higher or lower than 25 %, the device shows the cardiac arrhythmia (IHB) symbol on the display. The pulse rate is determined by calculating the frequency of the cuff, which are cardiac synchronous. The GUS622 is controlled by software which calculates the blood pressure (diastolic and pulse rate by the oscillometric method. To do this, it also controls the pneumatic components to inflate the cuff (with a pump), holds the cuff pressure, and then deflates the cuff (by means of a solenoid valve). The software collects the relevant data from the pressure sensor during deflation. The software also drives the LCD display, from which the user can read the result of the blood pressure and pulse rate measurements, and undertakes the Hemodynamic Rest Condition (HSD) detection calculations, and reports whether any irregular heart beat is occurring.