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MIR SMART ONE OXI

MIR SMART ONE OXI

Product catalog summary
Applicable Standards: The MIR SMART ONE OXI device complies with several standards including ATS/ERS updates from 2005 and 2019, ISO standards such as 26782:2009, 23747:2015, 10993-1:2018, and others related to medical device safety and performance.
Technical Specifications - Spirometry: The device features a bi-directional digital turbine flow sensor with dimensions of 49 mm width, 109 mm length, and 21 mm thickness. It weighs 60.7 g including batteries. The flow range is 16L/s, and the volume range is 10 L with a volume accuracy of ±2.5% or 0.05 L. Peak flow accuracy is ±10% or 0.33 L/s, and dynamic resistance is less than 0.5 cm H2O/L/s at 12 L/s. The turbine does not include a temperature sensor.
Single Patient Reusable Turbine: Comes with a mouthpiece (code 910013) and supports peak flow tests. Measured parameters include FEV1 and PEF. Data is stored via an application on a remote device.
Oximetry Specifications: Utilizes a double wavelength measuring method with a %SpO2 range of 70%-100% and accuracy of ±1.9%. The mouthpiece diameter is 30 mm. The device is powered by two AAA batteries, with a consumption of max 12 mA and an average of 8 μA in standby. Pulse rate range is 30-200 BPM with an accuracy of ±3%. The device has a Bluetooth® 4.0 connectivity and an IP protection level of IP22.
Safety and Conditions: The device is classified as Type BF for shock hazard protection and is designed for continuous use. It operates within a temperature range of +5 °C to +40 °C and humidity of 10% to 93% RH. Storage and shipping conditions allow for temperatures from -25 °C to +70 °C.
Certification and Registration: The device holds CE 0476 and MED 9826 certifications, with FDA 510(k) and Health Canada approvals pending. It is identified by CND Code Z12150102 and GMDN Code 46906.
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Catalog excerpts

MIR SMART ONE OXI-1

AW MIR MEDICAL INTERNATIONAL RESEARCH MIR SMART ONE OXI data sheet code 911120 Width Length Thickness Weight Spirometry Flow sensor Flow range Volume range Volume accuracy Peak Flow accuracy Dynamic resistance Temperature sensor Available test Measured parameters Technical specification bi-directional digital turbine 16L/s (960 L/m) 10 L ±2.5% or 0,05 L ±10% or 0,33 L/s <0.5 cm H2O/L/s (@ 12 L/s) none Peak Flow FEV1, PEF Memory capacity the application on the remote device (smartphone/tablet) memorizes data Mouthpiece Power supply Consumption Autonomy IP protection level Connectivity Type of electrical protection 0 30 mm (1.18 inches) 2 batteries AAA 1.5 V max 12 mA average 8 pA (Stand by) 5-10 years (Stand by) IP22 Bluetooth® 4.0 Internally powered Measuring method double wavelength %SpO2 range 70%-100% Average number of beats 12 beats for the calculation % SpO2 Pulse Rate range Pulse Rate accuracy Average interval for BPM calculation Quality signal indicator Available tests Measured parameters Safety level for Type BF Apparatus shock hazard Conditions of use Apparatus for continuous use Wavelength sensors 30-200 BPM ±3% 12 seconds 0-8 lines spot %SpO2MIN, %SpO2MEAN, %SpO2MAX, BPMmin, BPMmean, BPMmax, Ttotal Red 660 nm Infrared 880nm Storage conditions Temperature: Humidity: Operating Conditions Temperature: Humidity: Shipping conditions Temperature: Maximum optical output power 1.2 mW Certification & registration CE 0476 FDA 510 (k) Health Canada CND Code GMDN Code

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.