Spirobank Oxi ENGLISH Oxi Before you use your Spirobank Oxi, please read this user manual, the labels and all the information provided with the product. User Manual Rev 1.5 Publication date 04.02.2022 0476 WARNING: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR BY REQUEST OF A PHYSICIAN Ver. 1.
Spirobank Oxi ENGLISH CONTENTS 1. INTRODUCTION ....................................................................................................................... 4 Intended use................................................................................................................. 4 1.1.1 Restrictions on Use ................................................................................................... 4 1.2 Description of product ..........................................................
Spirobank Oxi ENGLISH Thank you for choosing a MIR MEDICAL INTERNATIONAL RESEARCH product. Before you use your Spirobank Oxi, please read this user manual, the labels and all the information provided with the product. Before connecting Spirobank Oxi to a smartphone, install the MIR SPIROBANK application, available by smartphone in both iOS and Android operating systems. The application enables display of the data measured by the device.
Spirobank Oxi ENGLISH MIR cannot be held responsible for any damage caused by users failing to follow these instructions and/or the warnings contained in this manual. 1. INTRODUCTION 1.1 Intended use Spirobank Oxi, spirometer and pulse oximeter, is intended to be used by a physician or by a subject under the instruction of a physician or the patient to assess lung function.
Spirobank Oxi ENGLISH 1.
Spirobank Oxi ENGLISH • • • • • • FEV05 - Forced Expiratory Volume in the initial 0,5 seconds of the test FEV075 - Forced Expiratory Volume in the initial 0,75 seconds of the test FEV2 - Forced Expiratory Volume in the initial 2 seconds of the test FEV3 - Forced Expiratory Volume in the initial 3 seconds of the test FET - Forced Expiratory Time PEF Time - Time to achieve 90% of the PEF Also in the F/V version, the Flux / Volume curve (expiratory and inspiratory) is enabled in real time during the executi
Spirobank Oxi ENGLISH 1.3 Information on the parameters measured by Spirobank Oxi Spirometry tests PEF is the maximum speed of the air when you exhale as hard as possible after filling your lungs completely. FEV1 is the volume of air expelled during the first second of the same exhalation. FVC is the volume of air expelled during the total exhalation. FEF2575 is the average flow between 25% and 75% of the total volume of air expelled during the total exhalation (FVC).
Spirobank Oxi ENGLISH Spirobank Oxi is a valid help in identifying whether there is an obstruction at a determined time and of what type of obstruction it is. Regular use of the device enables tracing the possible variations of the parameters. These variations might require suitable treatment, according to the prescription of the physician. As well as viewing the measurements of the respiratory parameters, the device also provides a normal baseline value.
Spirobank Oxi ENGLISH 1.4 Determining your baseline values The importance of any changes in airflow from one measurement to the next depends upon how much they are different from the baseline value you should reach when you are in healthy physical condition. The application can calculate the predicted value, i.e. the expected value for healthy people, depending on age, height, gender, and origin.
Spirobank Oxi ENGLISH 2.3 Connection between Spirobank Oxi and smartphone The connection between the Spirobank Oxi and the smartphone is automatic. To check whether there is a connection, read the messages from the application. 2.4 Performing the spirometry test To perform the test correctly, follow the instructions below. Push the FLowMir® turbine into the slot until it stops 1 Turn the turbine clockwise until it stops 2 Ver. 1.
Spirobank Oxi ENGLISH Insert the mouthpiece at least 0.5 cm into the turbine socket 3 Pick up the Spirobank Oxi with your hands as if it were a mobile phone. Make sure not to obstruct the turbine with your hand. 4 Insert the mouthpiece in your mouth beyond your teeth, and close your lips tightly over it so that the air you breathe has to pass only through the mouthpiece. To prevent turbulence that might otherwise affect the results do not put your tongue in the mouthpiece. Do not bend your neck.
Spirobank Oxi ENGLISH Take a deep breath and blow out as hard as you can. It is best to do the test standing or sitting upright. (it makes no difference to test results) 7 After exhalation, slowly remove the device from the mouth and check the data on the smartphone. 8 After taking the mouthpiece out of your mouth, avoid sudden movements because this will push air into the turbine and a flow value will be measured that may affect the test results. Repeat the test three times.
Spirobank Oxi ENGLISH 2.5 Performing the oximetry test To perform the test correctly, follow the instructions below. Place the thumb of the hand holding the Tap the "Start Test" icon under OXIMETRY Spirobank Oxi on the sensor as in the image on the MIR SPIROBANK application. 1 2 During the test the perfusion index is reported with a bar indicator. Minimum duration of a test is 30 seconds.
Spirobank Oxi ENGLISH 2.6 Evaluating the test For the spirometry measurements, three individual tests are made in each test, after which the MIR SPIROBANK application automatically selects the highest value and compares it with the baseline value (personal best value) set during configuration. For the oximetry measurements, each test saved in the memory appears in the Results section, which contains the value of SpO2, the value of cardiac frequency, the date and time of the test and any notes.
Spirobank Oxi ENGLISH 2.6.1 Results diary The test results are automatically stored on the smartphone and can be displayed later. 2.7 Important safety warnings Warning: indicates a potentially hazardous situation which, if not prevented, could result in minor or moderate injury to the user or patient or damage the device. For monitoring elderly patients and children, and differently-able persons, the supervision of an adult is required.
Spirobank Oxi ENGLISH Do not modify the device without authorization from the manufacturer. All modifications, adjustments, repairs, reconfigurations must be performed by the manufacturer or by authorized personnel. If problems arise, do not try to repair the device yourself. 2.8 Data security warnings The smartphone stores the user’s personal data.
Spirobank Oxi ENGLISH 2.9 Warnings for use in electromagnetic environments Due to the increasing number of electronic devices (computers, cordless phones, cell phones, etc.) medical devices may be susceptible to electromagnetic interference from other equipment. This electromagnetic interference could cause the medical device to malfunction, such as an accuracy of measurement that is lower than the declared one, and create a potentially unsafe situation.
Spirobank Oxi ENGLISH determined by turning the equipment off 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 different from that to which the receiver is connected. − Consult the dealer or an experienced radio/TV technician for help. 3.
Spirobank Oxi ENGLISH 3.1 Cleaning of the reusable turbine The following instruction should be applied in a case of reusable turbine. If the FlowMir is used, replace it after each session. To avoid irreparable damage to the turbine, do not use detergents including alcohol or oily substances and do not immerse the turbine in water or solutions at high temperatures. Never try to sterilise the turbine in boiling water. Never try to clean the turbine under a direct jet of water or other liquids.
Spirobank Oxi ENGLISH The hand dishwashing detergent that was tested includes the following ingredients: Aqua, coco glucoside, myristyl glucoside, lauryl glucoside, sodium chloride, sodium gluconate, sodium citrate, allyl caproate, ethylene brassylate, methyldihydrojasmonate). Rinse in clean water and shake gently to remove any excess water. Allow to air dry on a towel. Store in a clean, dry place in your home.
Spirobank Oxi ENGLISH • Sodium hypochlorite bleach (10% diluted) • Hydrogen peroxide (1.5%) Do not use alcoholic solutions. The use of such solutions can cause cloudiness on the surface. Moisten a soft cloth with a recommended solution, but not so much that the cloth drips, and lightly wipe the surface for 30 seconds. Let it air dry. Never immerse the device in water or other fluids. 3.5 Replacing batteries The device continuously monitors the battery level.
Spirobank Oxi ENGLISH Reposition the battery cover. Used Spirobank Oxi batteries should only be disposed of in special containers or preferably returned to the dealer or to a special collection centre. In any case, all applicable local regulations must be complied with. 3 Ver. 1.
Spirobank Oxi ENGLISH 4. ERROR MESSAGES & TROUBLESHOOTING 4.1 Error messages If you encounter any problems when using the Spirobank Oxi, a message will appear on the smartphone display to warn of the malfunction. MESSAGE Bluetooth POSSIBLE CAUSE Bluetooth is deactivated Battery low When the Spirobank Oxi batteries are below 15% charge 4.2 SOLUTION To perform measurements with the device, you must activate Bluetooth on the smartphone.
Spirobank Oxi ENGLISH PROBLEM POSSIBLE CAUSE The test was wrongly performed The turbine has not been inserted properly The test lasted less than 30 The oximetry test has seconds or the average value not been stored of the finger pressure was unsatisfactory 5. SOLUTION Repeat the test, following the directions displayed on the screen. Avoid sudden movements when you finish exhaling Insert the turbine from the front of the device by pushing it all the way down and turning it clockwise.
Spirobank Oxi ENGLISH Time zero = tPEF - (VPEF/PEF) Where PEF is the peak expiratory flow; tPEF is the elapsed time at PEF; VPEF is the expired volume at PEF For the oximetry measurements, the device conforms to the requisites of the following standard: ISO 80601-2-61:2017 Medical electrical equipment – particular requirements for basic safety and essential performance of pulse oximeter equipment Range (SpO2) Arms (%) 70-100 % 70-80 % 80-90 % 90-100 % ± 1.90 ± 2.32 ± 1.71 ± 1.
Spirobank Oxi ENGLISH 6. LABELS & SYMBOLS ID label The label shows: Symbol Description Model: Product Name Series number of the device SN Manufacturer’s name and address: MIR s.r.l.
Spirobank Oxi ENGLISH Symbol Description The symbol is used to indicate that the product contains RF transmitters. FCC ID Identification showing traceability in compliance with FCC Standards Instructions for use symbol.
Spirobank Oxi ENGLISH Additional measured spirometry parameters in the F/V version only: Peak Inspiratory Flow PIF (L/min) Inspiratory Volume in one second of the inspiration FIV1 (L) Forced Inspiratory Vital Capacity FIVC (L) Expiratory Volume in the initial 0,5 seconds of the test FEV05 (L) Expiratory Volume in the initial 0,75 seconds of the test FEV075 (L) Expiratory Volume in the initial 2 seconds of the test FEV2 (L) Expiratory Volume in the initial 3 seconds of the test FEV3 (L) Maximum Flow at 25%
Spirobank Oxi ENGLISH Cardiac frequency measurement range BPM accuracy Communication interface Electrical power supply Measurements Weight Type of electrical protection Level of electrical protection IP protection level Applicable standard 30-200 BPM Conditions of use Conservation conditions Device for continuous use Temperature: MIN -25°C, MAX +70°C Humidity: MIN 10% UR; MAX 93% UR Temperature: MIN -25°C, MAX +70°C Humidity: MIN 10% UR; MAX 93% UR Temperature: MIN +5 °C, MAX +40 °C Humidity: MIN 15% UR
Spirobank Oxi ENGLISH Mean maximum optical power in 1.2 mW output ** this information can be useful for the physician. Warning: Life time - the expected life time (or service life) of the device if properly used and stored is 5 years. 8.
Spirobank Oxi ENGLISH Bluetooth Profiles supported: Authentication and Encryption: Encryption Key Size: changes status, from connected to not-connected, and becomes immediately available for a connection. Profile based on GATT Supported AES 128 bit with Counter Mode CBC-MAC and application level defined by the user The Bluetooth® word mark and logo are registered trademarks owned by Bluetooth SIG, Inc. 8.
Spirobank Oxi ENGLISH not occur in a particular installation. The device causes damaging interference with the reception of radio or tv signals, which can arise by switching the equipment on or off; the user is advised to try to correct the interference by increasing the distance separating the equipment from the receiver. Ver. 1.
Spirobank Oxi ENGLISH 9. WARRANTY TERMS Spirobank Oxi is guaranteed for: • 12 months in the case of professional use (physician, hospital structure, etc.) • 24 months if the product is bought directly by the final user. The warranty period is effective from the date of purchase, which must be proven by an invoice or sales receipt. The device must be checked at the time of purchase, or upon delivery, and any claims must be made immediately in writing to the manufacturer.
