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MIR Spirobank OXI

MIR Spirobank OXI

Product catalog summary
Applicable Standards: The MIR Spirobank OXI complies with several standards including ATS/ERS updates from 2005 and 2019, multiple ISO standards (26782:2009, 23747:2015, 14971:2019, 10993-1:2018), the 2011/65/UE Directive, and various IEC and EN standards related to medical electrical equipment.
Technical Specifications - Spirometry: The device measures 49 mm in width, 109 mm in length, and 21 mm in thickness, weighing 60.7 g with batteries. It features a bi-directional digital turbine flow sensor with a flow range of 16L/s and a volume range of 10 L. Volume accuracy is ±2.5% or ±0.05L, and flow accuracy is ±5.0% or 0.20 L/s. The turbine's dynamic resistance is less than 0.5 cm H2O/L/s at 12 L/s. The device supports FVC tests and measures parameters such as FEV1, PEF, FVC, and others.
Oximetry Specifications: The oximetry function uses a double wavelength measuring method with a %SpO2 range of 70%-100% and accuracy of ±1.9%. It operates on two AAA batteries with a power consumption of max 12 mA. The pulse rate range is 30-200 BPM with an accuracy of ±3%. The device is Bluetooth® 4.0 enabled and has an IP protection level of IP22.
Conditions of Use: The device is designed for continuous use with storage conditions ranging from -25 °C to +70 °C and humidity between 10% RH and 93% RH. Operating conditions are between +5 °C and +40 °C with similar humidity requirements.
Certification & Registration: The device holds CE 0476 certification, with FDA 510(k) and Health Canada approvals pending. It is identified by Codice CND Z12150102 and Codice GMDN 46906.
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Catalog excerpts

MIR Spirobank OXI-1

MIR Spirobank OXI data sheet codice 911125xx Applicable standards Technical specification Width Length Thickness Weight Flow sensor Flow range Volume range Volume accuracy Flow accuracy Dynamic resistance Temperature sensor Available test Measured parameters Turbine Reusable Turbine with plastic Mouthpiece (code 910013) Disposable Turbine (code 910004) Additional parameters available with F/V version Memory capacity bi-directional digital turbine 16L/s (960 L/m) 10 L ±2.5% o ±0.05L ±5.0% o 0,20 L/s <0.5 cm H2O/L/s (a 12 L/s) none FVC FEV1, PEF, FVC, FEV1/FVC, FEV6, FEF2575 FIVC, FIV1, PIF FEF25, FEF50, FEF75, EVol, FEV05, FEV075, FEV2, FEV3, FET, PEF Time the application on the remote device (smartphone/tablet) memorizes data Oximetry Mouthpiece Power supply Consumption Autonomy IP protection level Connectivity Type of electrical protection Safety level for shock hazard Conditions of use Storage conditions Operating Conditions Shipping conditions Ø 30 mm (1.18 inches) 2 batteries AAA 1.5 V max 12 mA average 8 A (Stand by) 5-10 years IP22 Bluetooth® 4.0 Internally powered Type BF Apparatus Apparatus for continuous use Temperature: MIN -25 °C, MAX + 70 °C Humidity: MIN 10% RH; MAX 93% RH Temperature: MIN + 5 °C, MAX + 40 °C Humidity: MIN 15% RH, MAX 93% RH Temperature: MIN -25 °C MAX + 70 °C Humidity: Measuring method double wavelength %SpO2 range 70%-100% %SpO2 accuracy ±1.9% Average number of beats 12 beats for the %SpO2 calculation Pulse Rate range 30-200 BPM Pulse Rate accuracy ±3% Average interval for 12 seconds Pulse rate calculation Quality signal indicator 0-8 lines Available tests spot Measured parameters %SpO2MIN, %SpO2MEAN, %SpO2MAX, BPMMIN, BPMMEAN, BPMMAX TTOTAL Wavelength sensors Red 660 nm Infrared 880 nm Maximum optical 1.2 mW output power Certification & Registration CE 0476 FDA 510 (k) Health Canada Codice CND Codice GMDN

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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.