eResearchTechnology SPS001 SpiroSphere is a diagnostic compact device to measure inspiratory and expiratory lung function parameters User Manual

eResearchTechnology GmbH SpiroSphere is a diagnostic compact device to measure inspiratory and expiratory lung function parameters

2AAUFSPS001 UserMan

781235Version 00.16Instructions for UseSpiroSphere®

$SpiroSphere® Instructions for UsePage 2/84 9HUVLRQ0$<Product names or services are trademarks of their respective companies.All rights, including those of translations, are reserved. Written permission of eResearchTechnology (ERT) shall be obtained for the reproduction of this manual or any excerpt WKHUHRIE\DQ\PHDQVLQFOXGLQJSULQWLQJSKRWRVWDWLFGXSOLFDWLRQPLFUR¿OPVRUDQ\RWKHUprocesses.eResearchTechnology GmbHSieboldstrasse 3 97230 Estenfeld, GermanyTel: +49 9305 720-9891Fax: +49 9305 720-7891www.ert.com© 2017 eResearchTechnology GmbH. All rights reserved.The SpiroSphere is a diagnostic compact device to measure inspiratory and expiratory lung function parameters in adults and children. In addition the SpiroSphere can collect, store and transfer vital data from other external devices.,WFDQEHXVHGE\SK\VLFLDQVLQWKHRI¿FHRUKRVSLWDODQGLQRFFXSDWLRQDOPHGLFLQHIndications for UseFederal U.S. law restricts this device to sale by or on the order of a physician. (Rx only)$

SpiroSphere® Instructions for UsePage 3/849HUVLRQ0$<Table of ContentsIndications for Use ...........................................................................................................2Notes on Safety in this Instruction Manual ......................................................................4Declaration of Conformity ................................................................................................4Device Description...........................................................................................................5Unpacking and Starting Operation ..................................................................................5The SpiroSphere ............................................................................................................6Start-Up ...........................................................................................................................7Troubleshooting ...............................................................................................................9LED Status SpiroSphere .................................................................................................9LED Status SpiroSphere Sensor .....................................................................................9Sensor insert .................................................................................................................10Setup ..........................................................................................................................11The Home Screen .........................................................................................................13Sensor Check ...............................................................................................................14Calibration Check ..........................................................................................................14Linearity Check ..............................................................................................................16Add Patient ....................................................................................................................17Search Patient ...............................................................................................................19Actions ..........................................................................................................................21Preparing a Measurement .............................................................................................22Perform a Forced Spirometry Measurement .................................................................23Perform a Slow Spirometry Measurement.....................................................................28Dosing ..........................................................................................................................31Perform a Post Spirometry Measurement .....................................................................32Adhoc Test .....................................................................................................................34Perform an Adhoc Test ..................................................................................................34Assign Adhoc Test now ..................................................................................................35Assign Adhoc Test later .................................................................................................36Show, Edit, Delete and Print Tests ................................................................................37Print Recorded Results..................................................................................................40Settings and Tools .........................................................................................................41User Management .........................................................................................................54Update ..........................................................................................................................69About Device .................................................................................................................69Restore Default Settings................................................................................................69Factory reset..................................................................................................................69Cleaning/Hygiene ..........................................................................................................70General Safety Precautions...........................................................................................72Graphical Symbols ........................................................................................................77Notes on EMC according to EN60601-1-2 ..................................................................80Technical Data ...............................................................................................................81Item Numbers of Disposables and Accessories ............................................................83

$SpiroSphere® Instructions for UsePage 4/84 9HUVLRQ0$<Declaration of ConformityNotes on Safety in this Instruction ManualFollowing the ANSI (American National Standards Institute) recommendations for safety notes, VSHFL¿FSDVVDJHVRIWKLVLQVWUXFWLRQPDQXDODUHFOHDUO\PDUNHGDVVDIHW\QRWHVDegree of Danger Meaning of IndicatorInjury to personsDamages to propertyX(X)DANGER indicates an immediate hazardous situation, which, if not avoided, may result in serious injury or death. Limited to extremely dangerous situations. WARNING indicates a potential hazardous situation, which, if not avoided, may result in serious injury or death. Caution indicates a potential hazardous situation, which, if not avoided, may result in minor or slight injury. Also used to indicate precarious procedures. Additional icons used in this manual:XXImportant information on operation and other useful information. Does not warn of dangerous or harmful situations. Tips, general information and information on operation.The original Declaration of Conformity document can be obtained from ERT.$

$SpiroSphere® Instructions for UsePage 5/849HUVLRQ0$<Device DescriptionThe SpiroSphere is a compact spirometry device. Its Sensor Unit is battery-powered. The Main Unit can be powered by battery or power supply. The SpiroSphere is used to measure inspiratory and expiratory lung function parameters in adults and children. The measured data is saved into the device and can be read out at any time. The disposable easy-to-exchange, high-quality pneumotach guarantees a high degree of patient safety and provides precise recording results.The Main Unit is equipped with a graphical LCD touch display, providing a state of the art solution for selection of menu functions and the navigation throughout the menu.The SpiroSphere Sensor is paired via Bluetooth with the Main Unit.A printer can be connected with the SpiroSphere and all needed data can be printed. Moreover, it is possible to transfer data via USB, WiFi, 3G and Ethernet.7KHGHYLFHFDQEHXVHGE\SK\VLFLDQVLQWKHRI¿FHRUKRVSLWDODVZHOODVLQRFFXSDWLRQDOPHGLFLQHUnpacking and Starting OperationSpiroSphere is delivered with the following accessories*:1 Main Unit1 SpiroSphere Sensor1 Power Supply4 ERT PT with Mouthpiece2 Nose clips and Pads1 Instruction manual* Depending on the type of equipment either included in the delivery or available as an option Death due to suffocation may occur if packing material is swallowed.Store packing material out of reach of children and dispose of properly!Use only ERT approved accessories and spare parts for this medical device.7KH5HWXUQRI*RRGVLQ0HGLFDO,QVWLWXWLRQ&HUWL¿FDWHRI+\JLHQHLVSURYLGHGDVDVHSDUDWHGRFXPHQWÀ\HU$

SpiroSphere® Instructions for UsePage 6/84 9HUVLRQ0$<The SpiroSphere Main Unit:Main UnitSpiroSphere SensorLCD touch displayFingerprint SensorPower On/OffPowerUSBSpeakerUSBLANPower On/OffLED Status IndicatorERT PT with MouthpieceSpiroSphere Sensor:Charging CradleFront view:Rear view:

SpiroSphere® Instructions for UsePage 7/849HUVLRQ0$<Start-Up1. Connect the SpiroSphere to a power source complying with local regulations. 3. Use the Power On switch located at the front of the main unit to switch on the SpiroSphere Main Unit. LANPower Supply Connection2. Put the SpiroSphere Sensor into the slot of the main unit as shown below.Power supply:The operating status of the device is indicated via an LED on the main unit and on the SpiroSphere Sensor.Mains adapter

$SpiroSphere® Instructions for UsePage 8/84 9HUVLRQ0$< 3ULRUWRWKH¿UVWXVDJHVZLWFKRQWKH6SLUR6SKHUH6HQVRUE\SUHVVLQJWKHPower On" switch located at the back side of the SpiroSphere Sensor.ERT PT with mouthpieceERT PT is only for single use. Do not reuse the ERT PT due to risk of cross contamination.Do not remove the mouthpiece from the ERT PT. Only use the ERT PT with connected mouthpiece.3ULRUWRWKH¿UVWXVHPDNHVXUHWKDWWKH6SLUR6SKHUH6HQVRULVIXOO\FKDUJHG5. Ensure an ERT PT is inserted into the SpiroSphere Sensor.The maximum temperature of the SpiroSphere Sensor Unit can get up to 47°C.Spirometry should only be performed by patients who can cooperate in the performance.Shut down1. To switch off the SpiroSphere Main Unit, press the Power On/Off switch located at the front of the main unit. Disconnect the main unit from the power source.2. Switch on the SpiroSphere Sensor by pressing the "Power Off" switch located at the back side of the SpiroSphere Sensor. Disconnect the SpiroSphere Sensor from the main unit.'RQRWSRVLWLRQWKH3RZHU6XSSO\DQGWKH6SLUR6SKHUHVRWKDWLWLVGLI¿FXOWto operate the disconnection of the device from the mains supply.$

SpiroSphere® Instructions for UsePage 9/849HUVLRQ0$<LED Status SpiroSphere SensorOnly the highest priority LED at a time is turned on (LED priority: Orange - Blue).Orange LED On Charging in cradleOrange LED Off No charging/ charging complete in cradleOrange LED blinking slowly Low battery Put the SpiroSphere Sensor into the cradle of the Main UnitOrange LED blinking fast Indicates an error in the SpiroSphere SensorBlue LED blinking slowly SpiroSphere Sensor is actively transferring data to the Main UnitBlue LED Off Device in sleep mode Put the device into the charging dock or press the Power On switchBlue LED blinking fast Device powered on and paired with Main UnitLED Status SpiroSphereBlue LED On Main Unit powered on N/ABlue LED Off Main Unit powered off N/ABlue LED Pulse Main Unit Standby N/AOrange LED On ChargingOrange LED Off Not charging/ charging completeOrange LED blinking Low battery Connect Main Unit to a power socketTo do:TroubleshootingError Messages

SpiroSphere® Instructions for UsePage 10/84 9HUVLRQ0$<Sensor insertTake care that you have aligned the rail with the sensor holes of the PT tube with the grooved edge of the SpiroSphere Sensor (as below) when inserting the ERT PT into the SpiroSphere Sensor:The ERT PT should be inserted fully without force.rail with sensor holes

$SpiroSphere® Instructions for UsePage 11/849HUVLRQ0$<3ULRUWRWKH¿UVWXVHDV\VWHPVHWXSQHHGVWREHSHUIRUPHG$IWHUVZLWFKLQJRQWKH6SLUR6SKHUHIRUWKH¿UVWWLPHIROORZLQJVFUHHQDSSHDUVEnter the Global Password and press <OK>. (The preset global password is "691982".)The System Setup wizard starts automatically. 1. Language Settings Select the appropriate language DQGFRQ¿UPZLWKNext>.2. Date & Time Settings Select the appropriate settings DQGFRQ¿UPZLWKNext>.Follow the system setup steps (step 1 - 6) and enter or select the appropriate settings. Tap on <Next!WRFRQ¿UPWKHUHVSHFWLYHVHWWLQJVDQGWRFRQWLQXHZLWKWKHQH[WVWHSSetup$

SpiroSphere® Instructions for UsePage 12/84 9HUVLRQ0$<3. Sensor Settings Tap on <Scan> to scan for available sensors. Tap on the sensor you want to pair the SpiroSphere with and select <Pair> from the dropdown menu. &RQ¿UPZLWKNext>.4. Ethernet Settings Choose the appropriate settings DQGFRQ¿UPZLWKNext>. (Refer to chapter "Communication".)5. WiFi Settings Choose the appropriate settings DQGFRQ¿UPZLWKNext>. (Refer to chapter "Communication".)6. User Management Settings Choose the appropriate settings DQGFRQ¿UPZLWKNext>.Complete the initial setup of the device by tapping on <Yes>.

$SpiroSphere® Instructions for UsePage 13/849HUVLRQ0$<The Home ScreenAfter the SpiroSphere has been set up, upon powering on the device the following screen appears:Here, you can select the submenus "Add Patient", "Search Patient", "Sensor Check", "Adhoc Test" as well as "Settings and Tools" by tapping on the respective button. Add Patient Enter patient data for a new patient into your patient directory and start a test.Search Patient 6HDUFKIRUDVSHFL¿FSDWLHQWLQ\RXUSDWLHQWGLUHFWRU\6HOHFWDVSHFL¿Fpatient from the list to perform a test or to edit his/her data.Sensor Check Perform a volume or linearity check.Adhoc Test Immediately perform a test without entering patient data or searching for a VSHFL¿FSDWLHQW¿UVWSettings & Tools Change settings.$

SpiroSphere® Instructions for UsePage 14/84 9HUVLRQ0$<Calibration CheckThe sensor check consists of a calibration check as well as a linearity check.In order to perform a calibration check, tap on <Calibration Check>. Following screen appears:Ensure a new ERT PT (with mouthpiece removed) is connected to the 3 L calibration syringe via an adapter (as shown).Proceed by tapping <OK>. A zero adjustment of the connected SpiroSphere Sensor will be performed automatically.Tapping on the "i"- symbol will display information on the respectively selected check type.Tap <Sensor Check> to perform a sensor check.Sensor Check The ERT PTs included with the delivery are pre-calibrated as part of manufacture. $VHQVRUFKHFNFDQEHSHUIRUPHGWRFRQ¿UPDFFXUDWHPHDVXUHPHQWGDWD

$SpiroSphere® Instructions for UsePage 15/849HUVLRQ0$<The calibration checkLVXVHGWRFKHFNWKHYROXPHDFFXUDF\ZLWKLQGLIIHUHQWÀRZUDQJHV With each syringe stroke, the volume accuracy should be within ± 3 %.High ExMid ExLow ExLow InMid InHigh In± 3 %End the calibration check by tapping on <Save>.better than ± 3 % X worse than ± 3 %Screen display after a total of three syringe strokes:,WLVLPSRUWDQWWRSXPSZLWKRXWLQWHUUXSWLRQIURPLPSDFWWRLPSDFW7KH¿UVWSXPSVWURNHis not relevant and will be discarded. There should be one pump stroke in each of the IROORZLQJÀRZUDQJHVORZPLGDQGKLJKUDQJH1 syringe stroke = pump twice, i.e. from impact to impact.$

$SpiroSphere® Instructions for UsePage 16/84 9HUVLRQ0$<End the linearity check by tapping on <Save>.Screen display after a total of 9 syringe strokes:better than ± 3 % X worse than ± 3 %In order to perform a linearity check, tap on <Linearity Check>. Proceed as described in the "Calibration Check" section.'XULQJDOLQHDULW\FKHFNYROXPHDFFXUDF\DWGLIIHUHQWÀRZVLVWHVWHG7KUHHV\ULQJHVWURNHVDWDORZWKUHHDWDPLGUDQJHÀRZDQGWKUHHDWDKLJKÀRZDUHUHTXLUHGWith each syringe stroke, the volume accuracy should be within ± 3 %.Linearity Check,WLVLPSRUWDQWWRSXPSZLWKRXWLQWHUUXSWLRQIURPLPSDFWWRLPSDFW7KH¿UVWSXPSVWURNHis not relevant and will be discarded. Three pump strokes are required in each of the IROORZLQJÀRZOHYHOVORZPLGDQGKLJKUDQJH1 syringe stroke = pump twice, i.e. from impact to impact.$

$SpiroSphere® Instructions for UsePage 17/849HUVLRQ0$<To add a new patient to your patient directory, tap on the "Add Patient" button on the Home Screen. The following screen appears:(QWU\¿HOGVZLWKinstructions on enteringTouchscreen KeyboardHide KeyboardReturn to the Home Screen(QWHUWKHDSSURSULDWHSDWLHQWGDWDXVLQJWKHWRXFKVFUHHQNH\ERDUGDQGFRQ¿UPZLWK<Enter!7KHFXUVRUDXWRPDWLFDOO\MXPSVWRWKHQH[WHQWU\¿HOGAdd PatientThe following data must be entered:,GHQWL¿HU (QWHUWKH3DWLHQW,GHQWL¿HULast Name: Enter the Patient's last nameFirst Name: (QWHUWKH3DWLHQWV¿UVWQDPHDate of Birth: Select appropriate Day, Month and Year of Birth and continue by tapping on <Return>.%HIRUHPHDVXULQJDSDWLHQWIRUWKH¿UVWWLPHWKHSDWLHQWVSHUVRQDOGDWDKDVWREHentered. Predicted values are calculated from patient data, so verify that the entered data are correct. Incorrect patient data produces incorrect predicted values! Enter$

SpiroSphere® Instructions for UsePage 18/84 9HUVLRQ0$<Age: The Patient's age will be calculated automatically from the entered date of birthGender: Select appropriate genderHeight: Enter the Patient's heightWeight: Enter the Patient's weightEthnicity: Select the appropriate ethnicityAdditionally, there is an option to enter:Technician: Enter the Technician's namePhysician: Enter the Physician's nameSet A Name 1:Set A Name 2: As soon as all required patient data is entered, tap on <Save> to save the patient to your patient directory.If you want to discard all data just entered, tap on <Clear Form>. All ENTRYlELDSWILLBECLEAREDScreen display after patient data input:Patient data Available Actions (Type), and list of tests already performed (Previous Tests)

$SpiroSphere® Instructions for UsePage 19/849HUVLRQ0$<Tap on the "Search Patient" button on the Home Screen to open the list of all patient data saved in the database. data of a new Patient can be enteredDisplay all tested patientsDisplay all Patients tested today Display all Patients tested yesterdayDisplay all Patients tested this weekDisplay all Patients tested this month 6HDUFKIRUVSHFL¿F3DWLHQWVE\HQWHULQJKLVKHUODVWQDPHRU,'(QWHULQJWKH¿UVWOHWWHURUWKH¿UVWFKDUDFWHURIWKHSDWLHQWV,'LVVXI¿FLHQWDVZHOO,IHJ6is entered, all patients whose last names start with "S" are displayed. Search PatientThe following screen appears:List of all patients When a patient whose data is already stored in the database comes for another visit, you can reload his/her data from the patient directory. You do not have to enter the data again.$

$SpiroSphere® Instructions for UsePage 20/84 9HUVLRQ0$<,IDOLVWHGSDWLHQWLVVHOHFWHGWKHIROORZLQJÀ\RXWPHQXDSSHDUVTap on <Start> to display the patient's personal data on the left.The "Previous Actions" section shows the actions already performed for the VSHFL¿FSDWLHQWTap on <Edit> to display the patient's demographic information. If incorrect patient data was entered or if the patient data need to be updated (e.g. due to weight or height change in children), the respective data can be edited and will be used for future tests.In the "Actions"section, all conductable actions are listed.$

SpiroSphere® Instructions for UsePage 21/849HUVLRQ0$<Each patient can be completely deleted from the patient directory by tapping <Delete>. Actions SpiroSphere is capable of performing different types of measurements. Forced Pre Spirometry Forced Spirometry (Flow/Volume loop) pre bronchospasmolysisForced Post Spirometry Forced Spirometry (Flow/Volume loop) post bronchospasmolysisSlow Pre Spirometry Slow Spirometry pre bronchospasmolysisSlow Post Spirometry Slow Spirometry post bronchospasmolysisDosing Input Medication, Medication time and TechnicanTapping on "Yes" will irrevocably delete the selected patient including all saved measurements performed for that patient!A "Warning" appears:The different options are displayed on the screen.

SpiroSphere® Instructions for UsePage 22/84 9HUVLRQ0$<Preparing a MeasurementSelect a measurement (e.g. <Forced Pre Spirometry>) via tapping.The measurement is started by tapping on <Start>.The "Ambient Conditions" window appears:Current room temperature (°C)Current relative humidity (%)Current barometric pressure (hPa)Please observe the instructions for hygiene of your system. Verify that a new ERT PT with mouthpiece is attached in the SpiroSphere Sensor. The patient must not interact with the SpiroSphere Main Unit.As soon as the zero adjustment is completed, the patient should close his/her nose with the nose-clip, take the mouthpiece between his/her teeth and seal his/her lips tightly around the mouthpiece. Check the correct position of the mouthpiece!When the test is started, an automatic zero adjustment of the connected ERT PT is performed. Hold the SpiroSphere Sensor still and wait for the zero adjustment to be completed before approaching the mouthpiece.

$SpiroSphere® Instructions for UsePage 23/849HUVLRQ0$<The SpiroSphere must not be exposed to direct sunlight nor positioned immediately near heating elements.The current ambient conditions are to be entered manually. In this case, the ambient data should be updated if the room temperature changed by more than 2°C or if relative humidity changed by more than 10%.Tap on <Continue> to apply the ambient data entered.Perform a Forced Spirometry Measurement7KHSDWLHQWEUHDWKHVQRUPDOO\¿JXUH 1) until a steady tidal breathing is shown. From tidal EUHDWKLQJWKHSDWLHQWLVLQVWUXFWHGWRLQKDOHDVGHHSO\DVSRVVLEOHLQKDOHWR7/&¿JXUH 2).127KH$73%736FRUUHFWLRQIDFWRUVIRULQVSLUDWRU\DQGH[SLUDWRU\ÀRZVDQGYROXPHVZLOOEHdetermined from the ambient data. Therefore, ambient data must be updated at regular intervals. Incorrect or imprecise ambient data will result in incorrect measurement results.Make the proper preparations according to ATS/ERS guidance.Please note: During the whole examination the patient must stay on the mouthpiece.to TLC$

SpiroSphere® Instructions for UsePage 24/84 9HUVLRQ0$<Screen display:Tapping on the "i"-symbol will display information on the measurement procedure.Flow-Volume curve Volume-Time tracingWithout interruption, the patient should immediately exhale as fast and as much (FEV1) and as ORQJ)9&DVSRVVLEOH¿JXUH3). According to the ATS/ERS guidelines, exhalation should be for a minimum of 6 sec for adults, and 3 sec for children. The maneuver is usually completed by an inhalation ¿JXUH 4).6 sFEV1/FVCFVCin34Screen display:Tap <Evaluate!WRHQGWKH¿UVWeffort.End of Test criteria is displayed as dynamic icon (time of exhalation and plateau).Small tick indicates 6 seconds reached.Large tick indicates 6 seconds reached and plateau.

$SpiroSphere® Instructions for UsePage 25/849HUVLRQ0$<6FUHHQGLVSOD\DIWHUWKH¿UVWHIIRUWStart the next effort by tapping on <Start Effort>.If necessary, it is possible to terminate the test prematurely. In this case, a warning message is displayed.* Literature: MR Miller et al. Series “ATS/ERS Task Force: Standardisation of Lung Function Testing“, StandardisationRI6SLURPHWU\(XU5HVSLU-&RS\ULJKW(56-RXUQDOV/WGScroll down to display further parameters (if applicable)The upper left part of the chart section shows the recording of the ÀRZYROXPHORRS7KHXSSHUULJKWpart shows the volume-time tracing.The lower section of the screen displays the predicted values calculated from the patient data and the actual values measured from ¿UVWHIIRUWPred = Predicted valueBest = Best value of all valid efforts. %Pred = Best value in % of predicted values Screen display after three efforts:The "Best" column displays the best value out of all valid efforts. 'H¿QLWLRQRIWKHEHVWHIIRUWGHSHQGVon the Settings selected (see: >Settings Spirometry >Forced Spirometry >Measurement).7KHTXDOLW\RIWKHÀRZYROXPHORRSGHSHQGVRQWKHSDWLHQWµVFRRSHUDWLRQ In order to assess repeatability and quality, it is recommended to perform at least 3 efforts according to ATS/ERS guidelines. The results of the best and the second best effort for FEV1 and FVC may differ by P/RU)RU)9&/DGLIIHUHQFHRIP/LVYDOLG$

$SpiroSphere® Instructions for UsePage 26/84 9HUVLRQ0$<The lower section displays the quality assessment according to ATS/ERS 2005 guidelines: = no acceptability errors = minor errors present = major errors present6FUHHQGLVSOD\ÀRZYROXPHDQGtiffaneau curve: Screen display volume-time curve:Change View:Curves superimposed:Tap on the curve you want to be displayed.Print ReportReturn to Patient DetailsReturn to Home ScreenOverall Repeatability = Not enough effort performed = Enough efforts, but one or more repeatability criteria are not met = Enough efforts and all repeatability criteria are metIndividual parameter Repeatability = Parameter repeatability criteria not met = Parameter repeatability criteria met$

SpiroSphere® Instructions for UsePage 27/849HUVLRQ0$<End and save the test by tapping on <Finish>. Deactivate/reactivate efforts,IVHYHUDOHIIRUWVZHUHSHUIRUPHGLQGLYLGXDOHIIRUWVHJHIIRUWVZLWKLQVXI¿FLHQWSDWLHQWFRRSHUDWLRQcan be deactivated. The system can also automatically deactivate efforts as a result of system detected ATS/ERS acceptability errors. Behaviour FDQEHFRQ¿JXUHGLQ6HWWLQJVProcedure:Mark the effort to be deactivated (in our example Effort 4). Following window appears:Tap on <Deactivate>. Tapping on <OK> will deactivate the selected effort. Successfully deactivated efforts will appear as a dashed line at the top of the column.Deactivated trialAn effort deactivated by mistake can be reactivated again by tapping on the respective effort again. Tap on"Reactivate"in the following window to reactivate the effort.Deactivated efforts will not be taken into consideration when calculating the Best Effort and Predicted Calculations.

$SpiroSphere® Instructions for UsePage 28/84 9HUVLRQ0$<Tidal breathingThe two columns displayed show how constantly the patient is EUHDWKLQJRYHUWKHODVW¿YHEUHDWKLQJF\FOHVG97 YDULDWLRQFRHI¿FLHQWRIYDULDWLRQRIWKHWLGDOYROXPHdFRC = variation of the breathing baselineThe lower the variation the more regular the breathing.As soon as the display changes from "red" to "green", a stable breathing baseline has been reached.1Performance of an "ERV Maneuver":Tidal breathing should be continued for a longer period of time ¿JXUH 1). A stable breathing baseline is absolutely required to determine the lung volumes ERV and IC correctly.Tapping on the "i"-symbol will display information on the measurement procedure.Perform a Slow Spirometry MeasurementAs soon as the zero adjustment is completed, the patient should close his/her nose with the nose-clip, take the mouthpiece between his/her teeth and seal his/her lips tightly around the mouthpiece. Check the correct position of the mouthpiece!When the test is started, an automatic zero adjustment of the connected ERT PT is performed. Hold the SpiroSphere Sensor still and wait for the zero adjustment to be completed before approaching the mouthpiece.Make the proper preparations according to ATS/ERS guidance.$

$SpiroSphere® Instructions for UsePage 29/849HUVLRQ0$<ERV/VCin7KHSDWLHQWVKRXOGH[KDOHVORZO\VHH1RWHEHORZDQGFRPSOHWHO\(59¿JXUH 2) followed by DVORZDQGFRPSOHWHLQKDODWLRQ9&LQ¿JXUH 3). Then, continue to breathe normally.ERV6 s2VCin3Tap on <Evaluate!WRHQGWKH¿UVWHIIRUWIn order to reach the end-expiratory level the following two criteria must be complied with according to ATS/ERS.1. Duration of expiration (ERV) Patients must exhale for at least 6 seconds.2. End of Test Criteria (ERV)Towards the end of the expiration it is important to motivate the patient to try hard. Within the last second of expiration the exhaled volume must not exceed 25 mL.$

$SpiroSphere® Instructions for UsePage 30/84 9HUVLRQ0$<The upper section of the chart section shows the recording of the volume-time curve.The lower section of the screen displays the predicted values calculated from the patient data and the actual values measured from ¿UVWHIIRUW If necessary, it is possible to terminate the test prematurely. In this case, a warning PHVVDJHLVGLVSOD\HGWRFRQ¿UPWKDWWKHWHVWVKRXOGEHHQGHGTap on <Start Effort> to start the next maneuver.6FUHHQGLVSOD\DIWHUWKH¿UVWHIIRUWScreen display after two efforts:Scroll down to display further parameters (if applicable)The lower section of the screen displays the predicted values calculated from the patient data and the actual values measured during the test. Pred = Predicted valueBest = Best values from all efforts%Pred = Best value in % of predicted valuesThe "Best" column displays the best value out of all valid efforts. 'H¿QLWLRQRIWKHEHVWHIIRUW KLJKHVW9&PD[(see: >Settings Spirometry >Slow Spirometry> Measurement)According to ATS/ERS criteria, at least three efforts should be performed. If the difference between the best and second best effort is greater than 0.150 L, further efforts should be performed.$

SpiroSphere® Instructions for UsePage 31/849HUVLRQ0$<Before the post-measurement is started you can input Medication, the Medication time and the Technician name.Tap on <Enter Dosing>Tap <Dosing>.The following data can be entered:Medication: Enter the Medication, e. g. Albuterol/SalbutamolMedication time: Enter the time the Medication was given, hh:mmTechnician: Enter the Technician nameTap on <Save> to save the dosing to your patient directory.Dosing

$SpiroSphere® Instructions for UsePage 32/84 9HUVLRQ0$<Screen display after the "Pre Measurement":Perform a Post Spirometry MeasurementThe Flow-Volume curve shows the immediate bronchospasmolytic effect. The expiratory portion of the Flow-9ROXPHFXUYHDQGFRQVHTXHQWO\PD[LPDOSHDNÀRZ3()forced expiratory volume after 1 sec (FEV1) as well as forced vital capacity (FVC) changes.Screen display after the "Post Measurement":Pre Measurement (green)Post Measurement (purple)$

SpiroSphere® Instructions for UsePage 33/849HUVLRQ0$<3UH3RVW Report:

SpiroSphere® Instructions for UsePage 34/84 9HUVLRQ0$<Adhoc TestWith the Adhoc Test application it is possible to perform a Spirometry measurement without having to register the patient beforehand. For example: An Adhoc test can be performed if a prompt measurement of a patient is urgently required (e.g. in an emergency situation). It is possible to assign the measurements performed to a patient after the measurement has been completed or at some point later. Perform an Adhoc TestTap on the "Adhoc Test¿HOGRQWKH+RPH6FUHHQThe "Ambient Conditions" window appears and zeroing occurs:Tap on <Continue> to apply the ambient data entered and perform three successive "Forced Spirometry" maneuvers as described. Once the test is completed, the following window appears:

SpiroSphere® Instructions for UsePage 35/849HUVLRQ0$<Tap on <Yes>. The "Patient Directory" is displayed:Assign Adhoc Test nowTap on <Add> and enter the respective patient data (see chapter "Add Patient" for details).Following window appears:Finish by tapping <OK>.

SpiroSphere® Instructions for UsePage 36/84 9HUVLRQ0$<Assign Adhoc Test laterTap on <No>. Tap on <Add> to enter the appropriate patient data.The patient which is not registered yet will appear as "Adhoc Patient" in the "Patient Directory". In order to assign a patient to the Adhoc test performed, tap on "Adhoc Patient".

$SpiroSphere® Instructions for UsePage 37/849HUVLRQ0$<6HOHFWDFRPSOHWHGWHVW7KHIROORZLQJÀ\RXWPHQXDSSHDUVTap on <Show> to display the results of the selected test on the screen:Show, Edit, Delete and Print Tests$

SpiroSphere® Instructions for UsePage 38/84 9HUVLRQ0$<Existing patient data can be edited (if e.g. the patient's body weight or height (e.g. in children) has changed in the meantime) by tapping on <Edit>.The selected test can be deleted with <Delete>:Tap on <Print> to print the selected test or send a PDF-report to a designated e-mail address. For more detailed information, see chapter "Print Recorded Results". Tapping on <Yes> will irrevocably delete the selected test!

SpiroSphere® Instructions for UsePage 39/849HUVLRQ0$<The selected patient including all measurements performed with the respective patient can be deleted by tapping on <Delete Patient>:Tap on <Delete All Tests> to delete all measurements performed with the selected patient:Tapping on <Yes> will irrevocably delete the selected patient and all respective tests!Tapping on <Yes> will irrevocably delete all tests assigned to the selected patient!

$SpiroSphere® Instructions for UsePage 40/84 9HUVLRQ0$<As soon as a measurement is completed, the results can be printed by means of a connected USB*1 SULQWHU,WLVDOVRSRVVLEOHWRFUHDWHD3')¿OHZKLFKFDQEHVHQWWRDSUHGH¿QHGHPDLOaddress*2 or saved to an USB stick. Preset: send PDF to an e-mail address (see >Setting Report & Printing)*1 For this option, an USB printer needs to be connected to the SpiroSphere *2 For this option, the SpiroSphere needs to be connected to the network*3 See chapter "Settings and Tools > Report & Printing"Tap on the Printer icon.7DSRQWKH5HSRUW6HOHFWLRQ¿HOGPrint Recorded ResultsTap on <Return> to create the report. The "Print Result" window appears:Tap on <OK> to send the report to WKHSUHGH¿QHGHPDLODGGUHVVBest Effort Report a report displaying the best effort is createdAll Effort Report a report displaying all efforts is createdScreen Capture Report a screen capture report is created7KHUHSRUWZLOOEHVHQWWRWKHHPDLODGGUHVVGH¿QHGRQ\RXU6SLUR6SKHUH7KHUHSRUWODEHOZLOOLQFOXGHWKHGDWHDQGLGHQWL¿FDWLRQQXPEHU7KH¿OHZLOOEHSDVVZRUGSURWHFWHGDVGH¿QHGSpiroSphere Report: BestEffortReport_20160815_155247+0200.zip$

SpiroSphere® Instructions for UsePage 41/849HUVLRQ0$<The following includes a short description of settings which are not required for daily routine work.Tap on the "Settings & Tools" button on the Home Screen. The following will appear:Timezone Date & Time2SWLRQV 'H¿QLWLRQ &KRRVH3UHVHW select actual Country select timezone CityON/OFF ON24h/12h 24h set actual TimeYYYY.MM.DD 2016.08.16DD.MM.YYYY 16.08.2016 DD-MM-YYYYDD-MMM-YYYY 16-AUG-2016MM/DD/YYYY 08/16/2018 set actual DateGeneralTap on "General"Settings and Tools

$SpiroSphere® Instructions for UsePage 42/84 9HUVLRQ0$<RegionalSetting options: Preset:English (US), German English (US)cm. in cmkg. lb kgSoundSetting options: Preset:select 50%Power Management Preset:select 100%select 100%select 5 minselect 2 minselect 10 minselect 5 minselect 20 minselect 20 min7KHVHVHWWLQJVLQÀXHQFHWKHEDWWHU\OLIHRIWKH6SLUR6SKHUH$

SpiroSphere® Instructions for UsePage 43/849HUVLRQ0$<Spirometry SettingsTap on "Spirometry Settings"Spirometry Settings - SensorSensor ConnectionActive: The SpiroSphere Sensor is connected to the SpiroSphere via Bluetooth Not paired: The SpiroSphere Sensor is not connected to the SpiroSphereBattery: Indicates the battery status of the SpiroSphere Sensor

SpiroSphere® Instructions for UsePage 44/84 9HUVLRQ0$<Predicted ValuesSetting options: Preset:None GLI 2012GLI 2012NHANES IIIECCS/ZapletalKnudson/CrapoExtrapolate Limits from Author Limits from AuthorNo calculation outside limitsModule Age range Height range Differentiation acc. to RaceGLI 2012 3-95 years no limitation EthnicityNHANES III 8-80 years 110-200 cm African-Descent Mexican-American all other groupsECCS/Zapletal 5-17 years (Zapletal) 18-70 years (ECCS 93)107-182 cm (for Zapletal only) African-Descent 0.87 for volume (18 - )Knudson/Grapo 6-90 years no limitation African-Descent 0.88 for volume all other groups1 For an age between 19 and 25, the calculation is based on the age of 25Spirometry Settings - General

SpiroSphere® Instructions for UsePage 45/849HUVLRQ0$<Sensor CheckSetting options: Preset:1, 2, 3 3 1, 2, 3, 4 12, 3, 4, 5, 6, 7, 8 3ON, OFF ON2))&RQ¿UP(QIRUFH &RQ¿UP2))&RQ¿UP(QIRUFH &RQ¿UPAmbient ConditionsSetting options: Preset:% %°C, °F °ChPa, mmHg hPaUnit GroupsSetting options: Preset:mL, L LmL, L mLL/s, mL/s, L/min L/sL/s, mL/s, L/min L/sL/min L/mins, ms ss, ms ms1, % %L*L/s, mL*L/s L*L/s

SpiroSphere® Instructions for UsePage 46/84 9HUVLRQ0$<DecimalsSetting options: Preset:0, 1, 2, 3, 4 20, 1, 2, 3, 4 00, 1, 2, 3, 4 20, 1, 2, 3, 4 00, 1, 2, 3, 4 00, 1, 2, 3, 4 00, 1, 2, 3, 4 20, 1, 2, 3, 4 00, 1, 2, 3, 4 2MeasurementSpirometry Settings - Forced SpirometryExample: Preset 0: Preset 1: Preset 2:FVC [L] 5 5,1 5,10Scroll down to display further settings (if applicable)

$SpiroSphere® Instructions for UsePage 47/849HUVLRQ0$<Diagram Scaling AdultDiagram Scaling ChildIf “Automatic³LVVHOHFWHGDQGWKHEUHDWKLQJÀRZLVJUHDWHURUOHVVWKDQWKHSUHVHWÀRZD[LVWKLVD[LVZLOOEHUHVFDOHGDXWRPDWLFDOO\Setting options: Preset:Automatic Automatic16 L/s, 12 L/s, 8 L/s , 4 L/sFVC as FEV2FVC as FEV3FVC as FEV6&KRRVH  3UHVHWON, OFF OFFON, OFF OFFON, OFF OFFIf “ON“ is selected, the value for the respective parameter is used as the FVC value.Expiratory Back ExtrapolationInspiratory Back ExtrapolationSetting options: Preset:Always, Never Alwayscorrect incorrectExample: 4.6 liters Example: 3.8 litersWhy Back Extrapolation?A delayed start of the expiration in the forced expiration breathing maneuver provides incorrect results for various parameters. Back extrapolation means that in case of a delayed expiration the system determines the correct start of expiration.Criterion 5% of FVCStart of expiration calculated by extrapolationExpiration curveTimeVolumeWhy inspiratory back extrapolation?In case of a delayed inspiration during the FIV1 breathing maneuver and if “always“ is preset, the computer determines the correct start of inspiration.$

$SpiroSphere® Instructions for UsePage 48/84 9HUVLRQ0$<FEF calculation BaseFIF calculation BaseSetting options: Preset:individual FVC individual FVCVC maxIf “individual FVC“ is selected, the FEF or the FIF values will be calculated based on FVC.If several breathing maneuvers are performed within one test cycle, the software determines the best breathing maneuver within this trial according to preset criteria.Best ExpirationSetting options: Preset:FEV1 + FVC FEV1 + FVCFEV1FVCFVC + FERV1 + 1/3*PEFFEV0.5 + FVCFEV0.5Best Inspiration Setting options: Preset:FVCin + PIF FVCin + PIFFVCin + 0.1*PIFFVCin + FIV1FVCinFIV1Use best EXSummary default ViewSetting options: Preset:Flow/Volume Flow/VolumeTiffenauSpirogramIf “Flow/Volume³LVVHOHFWHGWKHUHVXOWVFUHHQZLOOGLVSOD\WKHÀRZvolume curve. If "Tiffeneau" is selected, the tiffenau curve will be displayed.$

SpiroSphere® Instructions for UsePage 49/849HUVLRQ0$<Display InspiratorySetting options: Preset:ON, OFF ONON means: the inspiratory portion of the Flow-Volume curve is displayed.OFF means: the inspiratory portion of the curve will not be displayed.The setting can be changed during the measurement. Inspiratory PositionSetting options: Preset:TLC, RV TLCThe inspiratory and expiratory phase of the Flow-Volume curve can be referred to TLC or RV. TLC RVDisplay Predicted CurveSetting options: Preset:ON, OFF ONIf activated (ON), a predicted curve will be displayed in the diagram as reference.Pred

$SpiroSphere® Instructions for UsePage 50/84 9HUVLRQ0$<Quality FeedbackSpirometry Settings - Forced SpirometrySetting options: Preset:ON, OFF ONON, OFFON, OFFError ErrorOFFWarning&RQ¿UPDWLRQQuality Feedback documented in an "Example" report:ABG means: errors A, B, G are presentATS error codesAs the quality of a spirometry measurement strongly depends on the patient's FRRSHUDWLRQWKHFULWHULDGH¿QHGE\WKH$76PXVWEHPHW,IWKHUHVSHFWLYHFULWHULDDUHQRWPHWWKH\ZLOOEHGLVSOD\HGLQWKHUHVXOWVVFUHHQDQG¿QDOO\GRFXPHQWHGLQWKHUHSRUW$

SpiroSphere® Instructions for UsePage 51/849HUVLRQ0$<Spirometry Settings - Slow SpirometrySetting options: Preset:Automatic, 12, 9, 6, 4 L AutomaticAutomatic, 12, 9, 6, 4 L AutomaticVCin, VCex, VCmax, IC, ERV VCmax ERV VC-, IC VC-Maneuver ERV VC-ManeuverMeasurementQuality FeedbackSetting options: Preset:Error ErrorOFFWarning&RQ¿UPDWLRQQuality Feedback documented in an "Example" report:N means: the criteria N are not metATS error codes

SpiroSphere® Instructions for UsePage 52/84 9HUVLRQ0$<Forced Spirometry - Displayed ParametersThe"Not active parameters" column displays all parameters which can be selected to be shown during a measurement.Scroll down to display further parameters (if applicable)The"Shown Parameters" column displays the parameters shown in the result screen of the forced spirometry measurement.Preset:FEV1FEV1/FVCFVCMMEFFVCinParameter SelectionAdd a parameter to the "Shown Parameters" column:Double-tap on the required parameter in the "Not active parameters" column. The parameter will immediately be added to the "Shown Parameter" list.Remove a parameter from the "Shown Parameters" column:Double-tap on the parameter you want to delete. Tap on <Undo> in order to undo the recent changes.Forced Spirometry - Printed Parameters"see above"

SpiroSphere® Instructions for UsePage 53/849HUVLRQ0$<Slow Spirometry - Displayed ParametersThe "Shown Parameters" column displays the parameters shown in the result screen of the slow spirometry measurement.Preset:VCinICVCmaxVTBFScroll down to display further parameters (if applicable)The "Not active parameters" column displays all parameters which can be selected to be shown during a measurement.Slow Spirometry - Printed Parameters"see above"Add a parameter to the "Shown Parameters" column:Double-tap on the required parameter in the "Not active parameters" column. The parameter will immediately be added to the "Shown Parameter" list.Remove a parameter from the "Shown Parameters" column:Double-tap on the parameter you want to delete. Tap on <Undo> in order to undo the recent changes.

$SpiroSphere® Instructions for UsePage 54/84 9HUVLRQ0$<From "Settings" select "User Management"This tool enables an authorized person to create an Administrator account. The newly created administrator will then be able to create additional accounts for individuals authorized to work with the SpiroSphere. Additionally, it is possible to register your ¿QJHUSULQWVLQRUGHUWRXWLOLVHWKH¿QJHUSULQWUHDGHUIRUV\VWHPDFFHVVTap the switch to activate User ManagementThe following screen appears:Enter the Global Password (“691982”) and tap <OK>.User Management$

$SpiroSphere® Instructions for UsePage 55/849HUVLRQ0$<The following screen appears:(QWHUWKHGHWDLOVIRUWKHXVHUIRU¿UVWXVHUWKLVPXVWEH$GPLQLVWUDWRUUROH2SWLRQDOO\\RXFDQFKRRVHWRUHJLVWHU\RXU¿QJHUSULQWVLQRUGHUWRXWLOLVHWKH¿QJHUSULQWUHDGHUIRUsystem access.Patients Administrator User SupportNew patient X XSearch patient X X XView patient details X X XChange patient demographics XXView measurements X X XPerform measurements X XPrint reports X X XSensor CheckCalibration Check X X XLinearity Check X X XCalibration CheckLog X X XLinearity CheckLog X X X ToolsCreate backup X X XView system info X X XOptions for role type:AdministatorUserSupport$

$SpiroSphere® Instructions for UsePage 56/84 9HUVLRQ0$<System AdministrationAdd or change user X X XDeactivate/activate user X XRecover X X XChange date and time settings XXXUpdate software X X XSelect <YES> to register ¿QJHUSULQWVTap <Next!WRPRYHWRWKH¿QJHUSULQWUHJLVWUDWLRQ,I\RXFKRRVHQRWWRUHJLVWHU¿QJHUSULQWVWKLVEXWWRQLVODEHOOHG³Save”.)The following screen appears:7DSWKHLPDJHRIWKH¿QJHU\RXZLVKWRUHJLVWHU$

$SpiroSphere® Instructions for UsePage 57/849HUVLRQ0$<3ODFH\RXU¿QJHURQDQGRIIWKH¿QJHUSULQWUHDGHUDVSHURQVFUHHQLQVWUXFWLRQVDSSUR[WLPHVLQRUGHUWRUHJLVWHU\RXU¿QJHUSULQW,IWKH¿QJHULVQRWSODFHGFRUUHFWO\IHHGEDFNLVSURYLGHG$

$SpiroSphere® Instructions for UsePage 58/84 9HUVLRQ0$<<RXPD\UHJLVWHUDVPDQ\¿QJHUVDV\RXOLNH:KHQ¿QLVKHGWDSSave>.The following screen appears:Tap <Yes!WRVDYHWKH¿QJHUSULQWVRIthe respective user.$

$SpiroSphere® Instructions for UsePage 59/849HUVLRQ0$<$IWHUVDYLQJWKH¿UVWXVHU\RXZLOOEHVHQWWRWKH/RJLQSDJHYou can login via entry of Username and Password.,I\RXUHJLVWHUHG\RXU¿QJHUSULQW\RXFDQXVHWKH¿QJHUSULQWUHDGHU7ZRWRXFKHVDUHUHTXLUHGWKH¿UVWWRXFKLGHQWL¿HVWKHXVHUWKHVHFRQGYHUL¿HVWKHXVHUWhen User Management is active, additional items appear in the Settings screen:The User Directory is displayed:User DirectorySelect "User Directory"$

$SpiroSphere® Instructions for UsePage 60/84 9HUVLRQ0$<7DSSLQJWKHFXUUHQWO\ORJJHGLQXVHULQWKHGLUHFWRU\ZLOORSHQDÀ\RXWPHQXAccess to the User details, and Change password function is availableTo set a new password, tap <Change Password>. The following screen appears:Make the appropriate entries and tap <Save> to save the new password.Add UserIt is possible to add a new user from the User Directory. To add a new user, tap <Add User>. Make the appropriate entries and, if GHVLUHGUHJLVWHU¿QJHUSULQWVVHHDERYHChange Password$

$SpiroSphere® Instructions for UsePage 61/849HUVLRQ0$<To edit the currently selected user, tap <User Details!LQWKHÀ\RXWPHQX7KHIROORZLQJVFUHHQappears:Make the appropriate changes and tap <Next!WRPRYHWRWKH¿QJHUSULQWregistration (see above).,I\RXFKRRVHQRWWRUHJLVWHU¿QJHUSULQWVWKLVEXWWRQLVODEHOOHG³Save”.)An Administrator is able to activate/ deactivate a user and to reset the password (with a temporary SDVVZRUGIRUDQRWKHUXVHUIURPWKHÀ\RXWPHQXLQWKH8VHU'LUHFWRU\Edit UserDeactivate User /Reset PasswordTap <Deactivate User> to deactivate the selected user.$

$SpiroSphere® Instructions for UsePage 62/84 9HUVLRQ0$<From "User Management SettingsD6HFXULW\4XHVWLRQDQG$QVZHUFDQEHGH¿QHGIRUWKHcurrent user.To reset the password for another user, tap <Reset Password>. The following screen appears:The user will be required to change their password upon their login.Change Security QuestionMake the appropriate entries and tap <Save> to save the Security Question.$

SpiroSphere® Instructions for UsePage 63/849HUVLRQ0$<Backup & RecoverBackupTap on "Backup & Recover". Alternatively, tap on the "No backup performed¿HOGRQWKHHome Screen.If “Perform Backup“ is selected, the message "Please ensure a Backup USB Stick is Inserted" appears.Tap on “Start Backup³WRFUHDWHDEDFNXS¿OHand save it to the USB stick!Insert USB stickA backup of all saved patient- and test data should be performed and saved to a USB-Stick on a regular basis.

SpiroSphere® Instructions for UsePage 64/84 9HUVLRQ0$<RecoverIf “Perform Recover“ is selected, the message "Please ensure USB Stick for Recover is Inserted" appears.Tap on “All Data“ to reload all data into the patient directory of your SpiroSphere.Insert Backup USB stick

$SpiroSphere® Instructions for UsePage 65/849HUVLRQ0$<CommunicationTap on "Communication"Network RequirementsWiFi,WLVSRVVLEOHWRFRQ¿JXUHWKH&RPPXQLFDWLRQVHWWLQJVIURPWKH&RPPXQLFDWLRQPHQXZLWKLQSettings.6HOHFWWKH&RPPXQLFDWLRQPHWKRGWRRSHQWKHUHVSHFWLYHFRQ¿JXUDWLRQVHWWLQJVTap on the desired WiFi network.Tap <Connect> to initiate the connection.7KHIROORZLQJÀ\RXWPHQXDSSHDUV$

SpiroSphere® Instructions for UsePage 66/84 9HUVLRQ0$<Enter the password as applicable and tap <Connect>.EthernetIf DHCP is set on "Off", then you can manually enter the appropriate settings.Choose the appropriate settings.

SpiroSphere® Instructions for UsePage 67/849HUVLRQ0$<Report & PrintingTap on "Report & Printing"PrinterSetting options: Preset:Printer, PDF via Email, PDF via USB PDF via EmailON, OFF OFFsee belowsee belowColor, Black & White ColorA4, Letter A4Send test page to Default PrinterEmail Address: Enter the Email address of the person the reports should be sent to. Zip File Password: Set the password the recipient is required to enter in order to open the "zip" folder. See chapter "Print Recorded Results".SpiroSphere allows for reports to be printed with an external printer. In addition, 6SLUR6SKHUHZLOODOORZWKHXVHUWRJHQHUDWHUHSRUWVDVD3')¿OHZKLFKFDQEHWUDQVIHUUHGWRDQH[WHUQDOGHYLFHLHYLDD86%VWLFNRUHPDLOHGWRDVSHFL¿HGrecipient.

SpiroSphere® Instructions for UsePage 68/84 9HUVLRQ0$<ReportsSetting options: Preset:Input Customer NameInput Customer AddressBest Effort Report Best Effort Report All Efforts Report EmailPrint JobPrint jobs state Input UsernameInput PasswordInput Email AddressInput Server NameInput PortInput SSL

SpiroSphere® Instructions for UsePage 69/849HUVLRQ0$<A detailed description of this tool is not part of this Instructions for Use.Update Tap on <Search for Update>. The device will search for updates on the connected USB stick.Tap on <Start Update> to begin the update process.List of available updatesAbout DeviceRestore Default SettingsFactory reset

$SpiroSphere® Instructions for UsePage 70/84 9HUVLRQ0$<In the course of lung function testing, certain parts of the equipment can be contaminated by germs, which creates the risk that these germs can be transferred to the next test subject. For cross-contamination to occur, the test subject would need to be in direct contact with the contaminated object or transport media such as droplets or aerosols. Contaminated aerosols may EHWUDQVSRUWHGWKURXJKWKHUHVSLUDWRU\ÀRZDQGPD\DIIHFWWKHQH[WWHVWVXEMHFW6LQJOH8VH(5737ZLWKPRXWKSLHFHDispose after every patientHow often should contaminated parts be exchanged?Reuse may lead to patient infections.Wiping disinfectionSurface Cleaning and DisinfectionThe surface disinfection of the Main unit and other contaminated surfaces, such as the SpiroSphere Sensor, must be performed on a regular basis (e.g. Main Unit daily).If there has been direct contact with the skin or if the case history/diagnosis of the patient requires it, a surface disinfection has to be performed directly after the application. Cleaning/Hygiene6LQJOHSDWLHQWXVH1RVHFOLSDispose nose clips after every patientReuse may lead to patient infections.The possible risk of infection can only be avoided if all of the contaminated parts are thoroughly disinfected!Hygiene Regulations:In case of normal contamination all single-use items can be disposed of with the regular waste. In case of dangerous infectious diseases (e.g. tuberculosis, blood...) single-use items must be disposed of through hazardous waste.ERT PT and mouthpiece are parts for single use only. These parts must be disposed after each single use. If reused, infection may occur. Reprocessing may deteriorate the part, resulting in reduced stability and leakage through micro cracks or releasing micro particles that could be inhaled. Should any of these parts be recycled and misused intentionally, ERT takes no responsibility nor can be made liable for the consequences arising from reusing these parts.Always be sure to disconnect the devices/systems from the mains power before cleaning or disinfecting.$

$SpiroSphere® Instructions for UsePage 71/849HUVLRQ0$<If the patient's history shows a dangerous infectious disease (e.g. tuberculosis), all parts which had been in direct or indirect contact with the patients must be disinfected. Precleaning and Disinfection$WKRURXJKSUHWUHDWPHQWFOHDQLQJLVDSUHFRQGLWLRQIRUDQHI¿FLHQWGLVLQIHFWLRQRIFRQWDPLQDWHGparts. Protein residue on these parts might prevent an effective disinfection.ERT recommends the following disinfectants:Precleaning and Disinfection:Product Manufacturer Concentration/Reaction timemikrozid®sensitive wipes Schuelke & Mayr GmbH 1 minuteCaviWipes Metrex 1 minute3URFHGXUH8VHWKH¿UVWFOHDQLQJZLSHWRFRYHUDOOVXUIDFHVZLWKWKHGHWHUJHQW5HSHDWWKHprocedure with a second wipe for disinfection. Let the surface dry.Disposal of single use items / damaged reusable itemsTake precautions to avoid contaminating yourself (e.g. use gloves). All single patient use items can be disposed of as domestic waste if there is a normal degree of contamination. In case of dangerous infectious diseases (e.g. tuberculosis) it is necessary to dispose of the single patient use items in special designated containers. ,QDGGLWLRQSOHDVHQRWHFRXQWU\VSHFL¿FGLVSRVDOUHJXODWLRQV. Do not clean or disinfect the Main Unit or the SpiroSphere Sensor while the devices are in operation.Please observe the instructions with regard to concentration and reaction time!If a different substance is used, please follow the manufacturer's instructions.The use of detergents and disinfectants which have not been recommended by the manufacturer might damage the products.The manufacturer's information on the cleaning of accessories provided separately must be observed! With suspected tuberculosis or other resistant germs, the use of an appropriate disinfectant (CaviWipes, Reaction time >3 minutes) is required.Protein residue on parts which are to be disinfected prevents effective disinfection. Therefore all protein residue must be removed prior to disinfection. In case of persistent residues please use an appropriate tool (e.g. soft brush) to remove the residues.$YRLGFRQWDPLQDWHGÀXLGVHJEORRGWRJHWLQWRWKH6HQVRU8QLW,QFDVHRILQJUHVVRIFRQWDPLQDWHGÀXLGVGRQRWXVHWKH6HQVRU8QLW$

$SpiroSphere® Instructions for UsePage 72/84 9HUVLRQ0$<General Safety PrecautionsThe Instructions for Use describes the present state of the device/system, including software and accessories, with regard to the fundamental requirements of the MDD 93/42/EEC.Exact adherence to the instructions issued is a prerequisite for perfect and intended functioning of ERT instruments.The Instructions for Use is regarded as part of the instrument, and should always be kept on hand.Deviation from Intended UseAny non-observance of the procedures (such as preparation for a measurement and methods, disinfection procedures, use of accessories and replacement parts etc.) described in the Instructions for Use results in a deviation from intended use.In case of a deviation from intended use, the operator/user has to supply proof of meeting all corresponding fundamental requirements. The operator/user is responsible for performing the conformity assessment correctly and is also completely liable for defective products - i.e. the operator/XVHULVOLDEOHIRUKLVKHUPRGL¿FDWLRQRIWKHPHGLFDOSURGXFWERT only guarantees for the safety, reliability and functionality of the instrument if LQVWDOODWLRQH[WHQVLRQPRGL¿FDWLRQVDQGUHSDLUVDUHH[FOXVLYHO\FDUULHGRXWE\personnel authorized for these tasks by ERT. WKHURRPLQZKLFKWKHHTXLSPHQWLVRSHUDWHGFRPSOLHVZLWKWKHFRXQWU\VSHFL¿Finstallation standard.- the unit can be plugged into a socket with protective conductor system.- the ambient conditions at the place of installation are suitable for the unit.- the unit is used according to the Instructions for Use.Unpack your medical device. Please check if the unit is damaged. If so, do not use it and return it for a replacement.3DWLHQW6DIHW\DFFRUGLQJWR(1This medical device safely insulates the subject from the mains power supply as required in the safety regulations on leakage current according to EN 60601-1, Type BF. Nevertheless, a VXEMHFWHQYLURQPHQWPXVWEHGH¿QHG7KHVXEMHFWKDVWRNHHSDGLVWDQFHRIDWOHDVWPIURPDOOopen interfaces and connectors of the SpiroSphere Main Unit to avoid any contact with electrical voltage.The physician/operator must not touch any voltage-carrying parts (e.g. USB Plug, Ethernet Plug) and the subject at the same time.$

$SpiroSphere® Instructions for UsePage 73/849HUVLRQ0$<The connection of further power-operated units to your ERT unit may cause all the leakage currents to add-up and the safety of the subject is reduced. Due to this, the connection of further units may only be carried out on consultation with the ERT Customer Care. $FFHVVRU\HTXLSPHQWFRQQHFWHGWRWKHLQWHUIDFHVPXVWEHFHUWL¿HGDFFRUGLQJWRthe respective EN standards (e.g. EN 60950 or EN 60601-1). Everybody who connects additional equipment to the signal input part or signal RXWSXWSDUWFRQ¿JXUHVDPHGLFDOV\VWHPDQGLVWKHUHIRUHUHVSRQVLEOHWKDWthe system complies with the requirements of the valid version of the system standard (IEC 60601-1). If in doubt, consult the technical service department or your local representative.8VHRI0XOWL3OXJ6RFNHWVMedical devices/systems must only be connected to multi-plug sockets if all regulatory requirements are met.- Additional mobile multi-plug sockets must not be connected to power sockets of medical devices/systems.- Mobile multi-plug sockets of medical devices/systems must not be placed RQWKHÀRRU- Equipment (for example vacuum cleaner, radio, etc.) and devices which are not part of the medical device/system must not be connected to the multi-plug sockets.Radiated InterferenceThe ERT device meets the regulations according to EN 60601-1-2 (CISPR 11 Group 1 class B) regarding the interference radiated and received. The device should not be installed in the vicinity of high-frequency devices, X-ray equipment, motors or transformers with high installed power rating since electric RUPDJQHWLFLQWHUIHUHQFH¿HOGVPD\IDOVLI\WKHUHVXOWRIPHDVXUHPHQWVRUPDNHtaking measurements impossible. Due to this, the vicinity of power lines is to be avoided as well. Existing environmental interferences may cause deviations of the measurement values without impairing the device’s function. Therefore, it is recommended to keep a distance of about 2 meters from possible error sources when using the device.This device should not be operated in immediate vicinity to or stacked with other devices since this could lead to an incorrect operation. However, if an operation in the described manner is necessary, this device as well as the other devices should be carefully observed to ascertain a proper operation.Using other accessories, other transformers and other cables than those VSHFL¿HGRUSURYLGHGE\WKHGHYLFHVPDQXIDFWXUHUFDQUHVXOWLQLQFUHDVHGelectromagnetic radiation or reduced electromagnetic immunity of the device and can lead to an incorrect operation.Portable RF communications equipment (transmitters) (including appropriate accessories such as aerial wires and external antennas) should be operated with a minimum distance of 30 cm (21 inch) to the SpiroSphere's components DQGFDEOHVVSHFL¿HGE\WKHPDQXIDFWXUHU1RQREVHUYDQFHPD\OHDGWRDreduction of the device's performance.$

$SpiroSphere® Instructions for UsePage 74/84 9HUVLRQ0$<Ambient ConditionsThe medical device must not be operated in rooms with the presence of ÀDPPDEOHDQDHVWKHWLFPL[WXUHZLWKDLURUÀDPPDEOHDQDHVWKHWLFPL[WXUHwith oxygen or nitrous oxide. The medical device must be operated in rooms ZKHUHRQO\QRQFRQGXFWLYHSROOXWLRQRFFXUVKRZHYHURFFDVLRQDOWHPSRUDU\conductivity due to condensation is to be expected. The medical device is designed for operation in medically used rooms. The medical device has to be effectively protected against moisture. Ventilation slots must be kept free of obstructions in order to enable air circulation. Putting the Unit into OperationTemperature changes may give rise to condensation in the device. Consequently, the device has to adapt to the ambient temperature before putting it into operation.Always consult the nameplate on the device/system for compliance of the unit’s own data with those of the local power supply system (mains voltage and mains frequency) before actually connecting the unit. Connect only if all data comply! Inspect the mains connection cable, plug, and receptacle for visible damages prior to establishing the connection. Damaged cables or plugs must be replaced immediately. Installation and assembly of the device must be done only in compliance with this Instructions for Use. $IWHUWKH¿UVWVHWXSRULIWKHVHWXSKDVEHHQFKDQJHGHJH[FKDQJLQJRIWKHSpiroSphere Sensor), a function test (e.g. calibration check) has to be performed.The Main Unit must be placed outside the patient environment during measurement.Medical Supervision'XULQJWKHPHDVXUHPHQWWKHSDWLHQWPXVWQRWEHXQDWWHQGHG$TXDOL¿HGphysician must reassess all measurements. An interpretation by the medical GHYLFHLVVLJQL¿FDQWRQO\ZKHQFRQVLGHUHGWRJHWKHUZLWKRWKHUFOLQLFDO¿QGLQJVThe performance of the spirometer can be affected by the patient spitting or coughing into the spirometer during expiration or by extremes of temperature, humidity and altitude.ContraindicationsAccording to ‘‘ATS/ERS TASK FORCE: STANDARDISATION OF LUNG FUNCTION TESTING’’ (ERS Journals Ltd 2005) performing lung function tests can be physically demanding for a minority of patients. It is recommended that patients should not be tested within 1 month of a myocardial infarction. In rare cases spirometry testing can lead to syncope due to extensive exhalation.In the S2 guideline "Spirometry" (German Airway League, German Respiratory Society and German Society of Occupational and Environmental Medicine, 2015), contraindications of spirometry are divided into absolute and relative contraindications:Absolute contraindications for Forced ManeuversAcute, life threatening diseases of every description, e.g. $FXWH0\RFDUGLDO,QIDUFWLRQ $FXWH)XOPLQDQW3XOPRQDU\(PEROLVP$

$SpiroSphere® Instructions for UsePage 75/849HUVLRQ0$<Cleaning and HygienePrior to every application, all parts which come in contact with the patient and which are intended for reuse must be cleaned or disinfected (unless otherwise instructed).Prior to taking measurements of a patient, his/her medical history is to be checked in order to avoid a contamination of the device and a resulting cross-contamination of the next patient.While performing a calibration check, a new disposable Pneumotach must be used to prevent cross-contamination between the calibration syringe and the parts. This will prevent contamination of the syringe and allow for its reuse. Always be sure to disconnect the devices/systems from the mains power before cleaning or disinfecting. The Main Unit corresponds to protection class IP21, the SpiroSphere Sensor to class IP20. The device may not be soaked in liquid of any kind. Liquid inside the device/system may lead to harm of the user and can destroy the device. The device can be cleaned with a damp (but not soaked) cloth, which does not produce lint. More detailed information can be found under “Hygiene“ in this Instructions for Use. Detergents and chemicals required for cleaning and disinfection must always be stored in specially marked containers to prevent any accidental improper use.  /DUJH$VFHQGLQJ$RUWLF$QHXU\VP 7HQVLRQ3QHXPRWKRUD[Relative contraindications for Forced Maneuvers 0DVVLYH3QHXPRWKRUD[ZLWKLQWKH¿UVWZHHNV $EGRPLQDORU7KRUDFLF6XUJHU\GHSHQGLQJRQWKH¿QGLQJVWRZHHNVpost-operatively) 6XUJHU\RIWKH(\HV%UDLQRU(DUVYDULDEOHFRQVXOWDWLRQZLWKWKHsurgeon) 6SHFLDOFDUHPXVWEHWDNHQZKHQGHDOLQJZLWK+HPRSW\VLVRIXQNQRZQoriginBiocompatibilityComponent MaterialMouth piece Styrolution PS 454N HIPSBiocompatibility of the material has EHHQFRQ¿UPHGHousing parts of the sensor unit and the main unit Cycoloy CX2244MEBiocompatibility of the material has EHHQFRQ¿UPHGPT-tube Styrolution PS 454N HIPS$

SpiroSphere® Instructions for UsePage 76/84 9HUVLRQ0$<Recurrent TestMedical Electrical equipment needs a recurrent testing after repair of the equipment according to IEC 62353.The calibration syringe itself has to be calibrated at regular intervals as determined by the manufacturer and as indicated on the syringe. The calibration syringe must be checked for an accuracy of ± 12 mL.RecyclingAdhere to the national law of the country when disposing the medical device and its accessories.Improper disposal of the device and/or its accessories can result in serious environmental hazards. MaintenanceNo part of the medical device may be replaced by the customer.Use only ERT approved accessories and spare parts for this medical device. If applied parts (e.g. SpiroSphere Sensor) have been exposed to extreme mechanical stress, a function test (e.g. volume calibration check) has to be performed. If function is lost, the defective part is to be replaced. Damaged parts, e.g. frayed plugs, receptacles, a damaged handle, and defective cables should be replaced immediately by an authorized specialist or engineers from ERT Customer Care. The device must not be opened. If it is opened without authorization the guarantee entitlement expires. ERT Customer Care is always at your disposal with help and assistance in case of problems.Before turning on the device/system you should always check whether the power cable, power plug, outlet and power input of the device are free from defects.Before turning on the device/ system the following issues have to be checked visually on a daily basis:- the display glass is undamaged- the unit has not been mechanically stressed in the extreme (e.g. damage to the housing, the cable is made defective by running over it with a heavy object or dragging it)- no liquid got inside the unit- the SpiroSphere Sensor is not damaged- cables and/or multiple connectors are not defective- coverings are not brokenAn unattended child should not get into contact with disposables, accessories and packing material as well as cleaning and disinfection substances.

$SpiroSphere® Instructions for UsePage 77/849HUVLRQ0$<Graphical SymbolsAlternating currentAttention!ON/OFF (device connected to/disconnected from the power supply system) Follow the instructions for Use!Year of ProductionManufacturerApplied part of Type BFSingle useDisposal of electronic devices in compliance with WEEEBarometric pressure limitsCAUTION: FEDERAL U.S. LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.Packaging can be recycledTemperature limitSerial numberReference number3URWHFWLRQDJDLQVWLQWUXVLRQRIVROLGVPPGLDPHWHUQRSURWHFWLRQDJDLQVWLQJUHVVRIOLTXLGV3URWHFWLRQDJDLQVWLQWUXVLRQRIVROLGVPPGLDPHWHUSURWHFWLRQDJDLQVWFRQGHQVDWLRQ&(VLJQZLWKFRGHQXPEHURIWKH1RWL¿HG%RG\7KHFHUWL¿HGTXDOLW\PDQDJHPHQWV\VWHPRIeResearchTechnology GmbH corresponds to the international standard of ISO 13485.Possible source of interferenceRx onlyIP20IP21The typeplate can be found at the rear side of the Main Unit.The typeplate on the SpiroSphere sensor is positioned at the left side.$

$SpiroSphere® Instructions for UsePage 78/84 9HUVLRQ0$<Parts of the software are developed under the GPL software license. The source code of these parts can be obtained from ERT. The conditions and a copy of the GPL can be obtained at: "http://www.fsf.org/licenses/gpl.html" or from: Free Software Foundation, Inc., 51 Franklin Street, Fifth Floor, Boston, MA 02110-1301, USAThis product is based in part on Evas, Copyright© 2000 - 2005 by Carsten Haitzler and various contributors, and on the work of the FreeType team.Safety Precautions for Lithium Ion Rechargeable BatteriesThe SpiroSphere Sensor is powered by an internal Lithium-Ion Polymer battery.The SpiroSphere Main Unit can also be powered by an internal Litihium-Ion Polymer battery.The following safety precautions are valid for Lithium-Ion batteries:- Dispose of Lithium-Ion batteries according to local regulations.- Do not shortcut the battery.- Protect the battery against excessive heat!- Protect the battery against direct sun light! 3URWHFWWKHEDWWHU\DJDLQVW¿UH- Do not dismantle or manipulate the battery. 'RQRWUHSODFHWKHEDWWHU\,PSURSHUUHSODFHPHQWFDQOHDGWR¿UHH[FHVVLYHKHDWRUH[SORVLRQ 7KHÀXLGLQWKHEDWWHU\LVWR[LFDQGÀDPPDEOHOHDN\EDWWHULHVRUEDWWHULHVZLWKGHQWVPXVWQRWbe used any longer! 'RQRWFRPHLQFRQWDFWZLWKWKHÀXLGLQWKHEDWWHU\,IWKHÀXLGFRPHVLQFRQWDFWZLWK\RXUVNLQimmediately rinse the affected part with water and contact a doctor!- To charge the SpiroSphere Sensor, use only the Main Unit Cradle and observe the instructions in the manual!- To charge the Main Unit, use only the provided power supply.The safety precautions and operational procedures indicated in this chapter refer to Germany. Different regulations and standards may apply to other countries.$

SpiroSphere® Instructions for UsePage 79/849HUVLRQ0$<CanadaThis device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.Le présent appareil est conforme aux CNR d’Industrie Canada applicables aux appareils radio exempts de licence. L’exploitation est autorisée aux deux conditions suivantes : (1) l’appareil ne doit pas produire de brouillage, et (2) l’utilisateur de l’appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d’en compromettre le fonctionnement.SpiroSphere - Main Unit: IC: 11335A-SPS001SpiroSphere - Sensor Unit: IC: 11335A-SPS002“This device complies with Part 15 of the FCC Rules. Operation is subjected to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including that may cause undesired operation.“SpiroSphere - Main Unit: FCC-ID: 2AAUFSPS001SpiroSphere - Sensor Unit: FCC-ID: 2AAUFSPS002USAFrequency Band Transmission Frequency Range Maximum Output Power GainUMTS B1 1922 to 1978 MHz 23 dBm (+/- 2dBm) Class 3bis -1.74 dBiUMTS B2 1852 to 1908 MHz 23 dBm (+/- 2dBm) Class 3bis -1.1 dBiUMTS B5 826 to 847 MHz 23 dBm (+/- 2 dBm) Class 3bis-3.31 dBiUMTS B6 832 to 838 MHz 23 dBm (+/- 2 dBm) Class 3bisUMTS B8 882 to 913 MHz 23 dBm (+/- 2 dBm) Class 3bisUMTS B19 832.4 to 842.6 MHz 23 dBm (+/- 2 dBm) Class 3bisGSM 850 824 to 849 MHz 2 Watts GSM, GPRS and EDGEE-GSM 900 880 to 915 MHz 2 Watts GSM, GPRS and EDGEDCS 1800 1710 to 1785 MHz 1 Watt GSM, GPRS and EDGE -1.1dBiPCS 1900 1850 to 1910 MHz 1 Watt GSM, GPRS and EDGEERT complies with EMC guidelines according to EN60601-1-2. ERT can provide further information on EMC properties on request.

$SpiroSphere® Instructions for UsePage 80/84 9HUVLRQ0$<Notes on EMC according to EN60601-1-2 The use of accessories not recommended by ERT may result in an increased electromagentic radiation or a reduced interference immunity of the SpiroSphere.*XLGDQFHDQG0DQXIDFWXUHUµV'HFODUDWLRQ±(OHFWURPDJQHWLF(PLVVLRQVDQG,PPXQLW\The SpiroSphere uses RF energy for internal function. Therefore, its RF emissions are very low and are not likely to cause any interference to nearby electronic equipment. The SpiroSphere is suitable for use in all establishments including domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. IEC 60601 directive Compliance levelRF emissions CISPR 11 Group 1 Class BElectrostatic discharge (ESD) IEC 61000-4-2 ± 8 kV indirect contact ± 15 kV direct air direct contact not possibleRadiated RF IEC 61000-4-3 10 V/m from 80 MHz to 2700 MHz applied to 4 devices orientations each with vertical and horizontal antenna polarisationElectrical fast transient/burst IEC 61000-4-4 ± 2 kV for power supply lines ± 1 kV for input/output linesSurge IEC 61000-4-5 0.5 kV differential mode1 kV differential modeConducted RF IEC 61000-4-6 3 V(rms) from 150 kHz to 80 MHz 6 V(rms) in ISM bandsVoltage dips IEC 61000-4-11 tested at 100 and 240 V power supply input lines < 5% @ 0.5 cycles and 45 degree sync angle steps< 5% @ 1 cycle <70% @ 25 cycles and 50 Hz<70% @ 30 cycles and 60 HzShort interruptions and voltage variations IEC 61000-4-11 tested at 100 and 240 V power supply input lines< 5% @ 250 cycles and 50 Hz< 5% @ 300 cycles and 60 Hz$

eResearchTechnology SPS001 SpiroSphere is a diagnostic compact device to measure inspiratory and expiratory lung function parameters User Manual

eResearchTechnology GmbH SpiroSphere is a diagnostic compact device to measure inspiratory and expiratory lung function parameters

2AAUFSPS001 UserMan

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