NuvoAir ANMD01 Air Next Spirometer User Manual Users manual

NuvoAir AB Air Next Spirometer Users manual

Users manual

AIR NEXT USER MANUAL
2WHAT’S IN THE BOXEN
3SETTING UP YOUR DEVICEDownload the NuvoAir app from AppStore or GooglePlay Store.Enable Bluetooth on yourmobile device. Allow theapp to access and useBluetooth and follow theinstructions on the screen.The spirometer lights up when it is connected to the mobile device.1 2 3EN
4PERFORM A LUNG FUNCTION TESTInsert a new turbine by sliding it through the device.Turn the turbineclockwise until itlocks into place.Create an account or sign in to an existing one and select your prole.Tap the plus buttonto perform a lung function test.1 2 3 4EN
Test2s5Take a slow deep breath - as deep as you can.Close your lips around theopening of the turbine.Blow as hard and as fast as you can into the mouthpiece.5 6 7PERFORM A LUNG FUNCTION TESTYour exhalation should exceed 6 seconds in order to obtain a high quality test.EN
Test6sResults ResultsFlowVolumeBattery: 100 %6PERFORM A LUNG FUNCTION TEST BATTERY CHECKKeep going until you have completely emptied your lungs.You should rest 15 to 30 secondsbefore starting anew test.Perform a minimumof 3 tests for highquality results. The app displays the best result.Open app settings to check battery levels.8 9 10You can share the test via e-mail.EN
7INDICATIONS FOR USEAir Next is intended to be used by:• Healthcare professionals trained to perform spirometry tests on patients of age ≥ 5 years old, > 10 kg and ≥ 110 cm.• Adults trained by healthcare professionals (”competent adults”). Competent adult can assist a child who is ≥5 years old, >10kg and ≥110 cm. Air Next is intended to perform basic lung function and spirometry testing.The actual diagnosis shall be done by a healthcare professional so home use is only for indicative purpose.GENERAL INFORMATIONAir Next works with iOS and Android devices and connects via bluetooth. Air Next is powered by 2 x 1.5 V AAA alkaline batteries. If the batteries are replaced or when the device is discarded, dispose the device as electronic waste. Air Next is designed to work with single-use NuvoAir disposable turbines. When perform- ing a spirometry test, the user exhales into the turbine. The air- ow generated sets a rotor in mo-tion. Air Next registers the speed of the spinning rotor, converts it and transfers the data via Blue-tooth to the smartphone app.LIMITATIONS OF USE &CONTRAINDICATIONSA spirometry test should only be carried out when the user is at rest (i.e. does not experience shortness of breath) and in good health, and thus in a suitable condition for the test. An analysis of the results of a spirometry test alone is not sucient to make a diagnosis of a clinical condition. Test interpretation and suggested treatment must be pro-vided by a Healthcare professional.A correct spirometry test depends on the user’s capability to inhale and exhale all air completely and as fast as possible. If these fun-damental conditions are not re-spected then the results obtained during spirometry testing will not be accurate, and therefore the test results are “not acceptable”.The acceptability of a test is the responsibility of the user. Special attention should be given whentesting the elderly, disabled and children.EN
8The device should never be used when it is possible or probable that the validity of the results may be compromised due to any external factors.Some conditions may pose a relative danger to a patient or aect the validity of spirometry performance and results. These include, but are not limited to the following: unstable cardiovascularstatus, unstable angina, recent myocardial infarction (within one month) or pulmonary embolism, haemoptysis of unknown origin, recent pneumothorax, thoracic, abdominal or cerebral aneurysms, recent thoracic, abdominal or eye surgery, acute disorders such as nausea or vomiting, severe respiratory distress, physicallimitations, cognitive impairment, dementia.IMPORTANT SAFETY WARNINGSAir Next should never be used with a charging phone. Make sure the phone is unplugged before con-ducting a spirometry test. Don’t use the device with a connected AC/DC adaptor.Once removed from its packaging, check that there is no visible dam-age on the device. In the case ofdamage do not use it and return it to the seller.Air Next has been examined by an independent laboratory which has certied the conformity of the device to the European Safety Standards EN 60601-1 and guarantees the EMC Requirements within the lim-its set in the European Standard EN 60601-1-2 and ETSI’s EN 300 328. It is a medical device class IIa (“two a”) product. Air Next is constantly controlled during its production, therefore the product conforms to the essential require-ments set by the Council Directive 93/42/EEC for medical devices.• Use only with iOS and Android devices specied on our website www.nuvoair.com.• Use only in environments speci-ed in this user manual. • Do not expose to liquids.• Air Next is not made with natural rubber latex.• Should you lose the battery hatch with required and device specic information on it, the guarantee will no longer be valid and NuvoAir cannot provide further support or guarantee the condition or functionality of the product.EN
9Explanation of the safety signs and symbols marked on the device: Manufacturer’s name and address. CE mark: indicates that the device is certied that it conforms to the requirements of the 93/42/EEC medical device directive. IP classication: indicates that the device is protected against solid objects over 2.5 mm entering as well as faling drops of water, if the case is disposed up to 15° from vertical. Waste electrical and electronic equipment: Dispose accordingly. Do not dispose as unsorted municipal waste. Manufacturer’s LOT batch/lot code. Follow operating instructions: Indicates the need for the user to consult the instructions for important information. The symbol is used in accordance with IEC 60601-1-2:2014 (ED. 4) for products including radio trans- mitters and in accordance with EN 300 328. Type BF applied part: Device that has conductive contact or medium to long term contact with the patient in order to fulll the intended use. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. FCC ID Identication showing traceability to FCC compliance. Caution: Federal law restricts this device to sale by or on the order of a physicianOPERATING ENVIRONMENTAir Next has been designed for use in a doctor’s oce, in a hospital setting or at home.Air Next is not intended for use in an operating theatre nor in the presence of inammable liquids or detergents, nor in the presence of inammable anaesthetic gases (oxygen or nitrogen). The device is not designed to be used in direct air currents (e.g. wind), sources of heat or cold, direct sun rays or other sources of light or energy, dust, sand or any other chemical substances.NUVOAIR DISPOSABLE TURBINEAir Next is designed to be used with NuvoAir disposable single use turbines. The disposable turbine is indicated for single use single patient only. The integrity and functionality is guaranteed by:• Never holding the turbine under a jet of water or air and never let it come into contact with high temperature uids.• Not allowing dust or foreign0598IP32EN
10 bodies to enter the turbine sensor, in order to avoid incorrect functioning and possible damage. The presence of any impurities such as hair, sputum, threads etc. within the body of the turbine sensor may seriously compromise the accuracy of the measurements.• Avoiding environmental contamination by cleaning waste products, the user must adhere to all relevant regulations.The single use turbine cannot be used to perform a spirometry test on another individual (person). You can purchase new single use turbines at www.nuvoair.comCAUTION: RISK OF CROSSCONTAMINATIONEach new individual that uses Air Next shall use a new unused disposable NuvoAir disposable turbine. If the turbine is not replaced between individuals there is a high risk of infectious cross contamination.AIR NEXT TESTS PARAMETERS SUCH AS:FEV1 (Forced Expiratory Volume in 1 second) The volume of air (l) exhaled in the rst second during a forced maximal expiratory eort after a full inspiration.FVC (Forced Vital Capacity) The total volume of air (l) exhaled dur-ing a forced maximal expiratory eort after a full inspiration.FEV1/FVC (Ratio) The calculated result obtained by dividing FEV1with FVC.PEF (Peak Expiratory Flow) The maximum ow rate (l/s) during a forced maximal expiratory eort after a full inspiration.The nal results displayed in the application are always the best values obtained after performingthe desired number of tests included in a session. The rec-ommended number of tests per session is 3, however the user can perform up to 8 tests.Displayed test are compared to a reference table (GLI) and displayed as percent predictive value (%pred.).The reference used in Air Next uses expected normal lung func-tion values such as for FEV1,FVC, FEV1/FVC and PEF are based on ethnicity, gender, age and height.Interpretation of spirometry results should be made by a physician or allied health care professional with sucient training in the performance and interpretation of spirometry.Note: Home use of Air Next is in-tended only for indicative purpose. Interpretation of the test results and diagnosis shall be done by ahealthcare professional.EN
11MAINTENANCEHandle Air Next device carefully.Store it in clean and moisture free conditions. Before use, always check that the device is free from dust, contamination or any particles.Air Next does not require profes-sional maintenance. If, however, the outside of the device needs to be cleaned make sure to only use a damp cloth without any detergents.The batteries of Air Next are replaceable.ACCESS TO BLUETOOTHEnable Bluetooth on your mobile device in order to pair with the Air Next. You can enable Bluetooth in your mobile device settings. Check your device manual on how to do this.ELECTROMAGNETIC COMPATABILITY EN
12 BLUETOOTH PROXIMITYMake sure that the Air Next is within the Bluetooth proximity of your phone. If your phone is too far away from the Air Next, the connecton could be lost.FCC RADIO FREQUENCY INTER-FERENCE STATEMENTThis equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interfer-ence will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment o and on, the user is encouraged to try to correct the interference by one or more of the following measures:· Reorient or relocate the receiving antenna.· Increase the separation between the equipment and receiver.· Connect the equipment into an outlet on a circuit dierent from that to which the receiver is connected.· Consult the dealer or an experienced radio/TV technician for help.NuvoAir is not responsible for any radio or communication interfer-ence caused by using other than specied or recommended cables and battery or by unauthorized changes or modications to this equipment. Changes or modi-cations not expressly approved by the manufacturer could void the user’s authority to operate the equipment.This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:1. This device may not cause harmful interference, and2. This device must accept any interference received, including interference that may cause unde-sired operation.EN
13TROUBLESHOOTING• Make sure that the NuvoAir Disposable Turbine is correctly inserted into Air Next.• Make sure that the turbine is not spinning before you do a test.• Make sure that Air Next has sucient battery levels.• Make sure that Bluetooth is enabled on your mobile device.• Make sure the app is allowed to use Bluetooth.• The device can be aected by its environment if it is too bright. Try dimming the light or move to a darker location.EN
14TECHNICAL FEATURESEnvironment of use All settingsPatient Population Adults and pediatric patients over 5 years oldTechnology for measure ow and volume Bidirectional turbine with infrared interruptionEnergy Type Two AAA 1.5V Alkaline batteriesPhysical Conguration Touchscreen on smartphone or tabletOperating environment T: min +10°C/max +40° C RH: min 10 %/max 95 % ALT: max 2000 mConditions of storage T: min -20°C/max +60° C RH: min 10 %/max 95 % P: min 500 mBar / max ALT: ≤ 5000 mDimensions 98 x 62 x 26 mmWeight 75gVolume accuracy ±3% of reading or ±0.050 L, whichever is greaterVolume range 0.5-8LEN
15Flow range 0-14L/sFlow accuracy ±5% or 200 mL/sFlow resistance <0.5 cmH2O/L/sCommunication BluetoothCoaching Display of ow-time curves, timer and eort during testLife expectancy 10 yearsRegulations applicable: MDD 93/42 /EECISO 26782ISO 23747Electrical Saftey IEC 60601-1Electro Magnetic Compability IEC 60601-1-2EN 300 328FCC Part 15, Subpart B, CRF emissions CISPR 11 Group 1RF emissions CISPR 11 Class BEN
16NuvoAir ABRiddargatan 17D, SE-11457 Stockholm, SwedenVersion 1.0 © 2018 NuvoAir ABNuvoAir AB guarantees that the product is free from material and fabrication defect, under normal use conditions and under the warranty period. For more information about the warranty, for reclamation or to provide feedback, please visit www.nuvoair.com
NuvoAir ABRiddargatan 17D, SE-11457 Stockholm, SwedenVersion 1.0 © 2018 NuvoAir AB

Navigation menu