Page 1 Instructions for Use SpiroSphere ® 781239 Version 02.02...
Page 2: Indications For Use
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Page 3 SpiroSphere ECG Instructions for Use ® Due to increases in intracranial/intraocular pressure • Cerebral aneurysm • Brain surgery within 4 weeks • Recent concussion with continuing symptoms • Eye surgery within 1 week Due to increases in sinus and middle ear pressures •...
Page 4: Table Of Contents
Unpacking and Starting Operation ....................8 The SpiroSphere ..........................9 Start-Up ............................10 Shut down............................11 LED Status SpiroSphere ......................12 LED Status SpiroSphere Sensor ....................12 Troubleshooting ..........................13 Sensor Insert and Remove ......................15 Setup .............................. 16 The Home Screen .......................... 19 Sensor Check ..........................
Page 5 Graphical Symbols ........................118 UDI ............................118 MD ............................118 SN ............................118 REF ............................118 Electromagnetic Emission and Immunity SpiroSphere ECG ............122 Bluetooth Wireless Communication ..................127 ® Technical Data Spirometry......................128 Technical Data Flow Sensor ....................129 Technical Data ECG ........................
Page 6: Notes On Safety In This Instruction Manual
Important information on operation and other useful information. Does not warn of dangerous or harmful situations. Tips, general information and information on operation. Declaration of Conformity The original Declaration of Conformity document can be obtained from ERT. Page 6/136 Version 02.02 • 04AUG2022...
Page 7: Graphical Symbols On The Ecg Ampli Er
SpiroSphere ECG Instructions for Use ® Graphical Symbols on the ECG ampli er Symbol Description Applied Part of type CF, De brillation-proof (ECG unit cable variant) Disposal of electronic devices in compliance with WEEE IP classi cation according to IEC60529...
Page 8: Device Description
16 years and for pacemaker ubjects. It is not intended for intra-cardial use. The minimum age for ECG application is 4 years. The SpiroSphere is intended to be used in a professional healthcare facility environment.
Page 9: The Spirosphere
LCD touch display Rear view: Speaker Charging Cradle Power SpiroSphere Sensor: LED Status Indicator ERT PT with Mouthpiece Power On/Off The SpiroSphere must not be exposed to direct sunlight nor positioned immediately near heating elements. Version 02.02 • 04AUG2022 Page 9/136...
Page 10: Start-Up
SpiroSphere Main Unit. The operating status of the device is indicated via an LED on the main unit and on the SpiroSphere Sensor. Please refer "LED Status SpiroSphere and "LED Status SpiroSphere Sensor" on page 9. Page 10/136...
Page 11: Shut Down
ERT PT with mouthpiece rail with sensor holes ERT 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.
Page 12: Led Status Spirosphere
Orange LED Off Not charging/ charging complete Orange LED Low battery Connect Main Unit to a blinking mains supply LED Status SpiroSphere Sensor Orange LED On Charging in cradle Orange LED Off No charging/ charging complete in cradle Orange LED...
Page 13: Troubleshooting
Problem Troubleshooting SpiroSphere Main Unit SpiroSphere Main Unit is not switched on. Try to switch on with the does not start power button (press the button for at least 3 seconds). Power supply is not connected and the battery discharged. Connect the power supply and let the SpiroSphere Main Unit charge for a few minutes.
Page 14 Check if the SpiroSphere sensor is inserted correctly in the cradle. SpiroSphere Sensor might be fully discharged; place it in the cradle and wait a few minutes then try to power on the SpiroSphere Sensor by pressing the power button for more than 3 seconds.
Page 15: Sensor Insert And Remove
Sensor Insert and Remove Take 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: rail with sensor holes The ERT PT should be inserted fully without force.
Page 16: Setup
ECG Instructions for Use ® Setup Prior to the rst use, a system setup needs to be performed. After switching on the SpiroSphere for the rst time, following screen appears: Enter the Global Password and press <OK>. (The preset global password is "691982".) The System Setup wizard starts automatically.
Page 17 Con rm with <Next>. (Refer to chapter "Settings & Tools >Spirometry Settings - Sensor") Note that pairing is only possible for 90 seconds after the SpiroSphere Sensor is placed in the cradle. 4. Ethernet Settings Choose the appropriate settings and con rm with <Next>. (Refer to chapter "Communication".)
Page 18 (Refer to chapter "User Management"). Complete the initial setup of the device by tapping on <Yes>. All settings made in "SpiroSphere Setup" can be changed at any time should be changed. For detailed information please refer to chapter "Settings & Tools". Page 18/136...
Page 19: The Home Screen
® The Home Screen After 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.
Page 20: Sensor Check
Following screen appears: Calibration Check Ensure a new ERT PT (with mouthpiece removed) is connected to the 3 L calibration syringe via an adapter (as shown). In order to perform a calibration check, tap on <Calibration Check>. An automatic zero adjustment is performed.
Page 21 SpiroSphere ECG Instructions for Use ® The calibration check is used to check the volume accuracy within 3 different ow ranges. With each syringe stroke, the volume accuracy should be within ± 3 %. High Ex Mid Ex Low Ex...
Page 22: Linearity Check
SpiroSphere ECG Instructions for Use ® Linearity Check In order to perform a linearity check, tap on <Linearity Check>. Proceed as described in the "Calibration Check" section. During a linearity check, volume accuracy at different ows is tested. Three syringe strokes at a low, three at a mid-range ow and three at a high ow are required.
Page 23: Add Patient
SpiroSphere ECG Instructions for Use ® Add Patient Before measuring a patient for the rst time, the patient's personal data has to be entered. Predicted values are calculated from patient data, so verify that the entered data are correct. Incorrect patient data produces incorrect predicted values! To add a new patient to your patient directory, tap on the "Add Patient"...
Page 24 SpiroSphere ECG Instructions for Use ® Age: The Patient's age will be calculated automatically from the entered date of birth Gender: Select appropriate gender Height: Enter the Patient's height Weight: Enter the Patient's weight Ethnicity: Select the appropriate ethnicity Additionally, there is an option to enter:...
Page 25: Search Patient
SpiroSphere ECG Instructions for Use ® Search Patient 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.
Page 26 SpiroSphere ECG Instructions for Use ® If a listed patient is selected, the following y-out menu appears: Tap on <Start> to display the patient's personal data on the left. In the "Actions"section, all conductable actions are listed. The "Previous Actions"...
Page 27: Actions
A "Warning" appears: Tapping on "Yes" will irrevocably delete the selected patient including all saved measurements performed for that patient! Actions SpiroSphere is capable of performing different types of measurements. The different options are displayed on the screen. Forced PRE Spirometry...
Page 28: Preparing A Spirometry Measurement
ECG Instructions for Use ® Preparing a Spirometry Measurement Please observe the instructions for hygiene of your system. Verify that a new ERT PT with mouthpiece is attached in the SpiroSphere Sensor. Select a measurement (e.g. <Forced PRE Spirometry>) via tapping.
Page 29: Perform A Forced Spirometry Measurement
Perform a Forced Spirometry Measurement When the test is started, an automatic zero adjustment of the sensor unit is performed. Hold the SpiroSphere Sensor still and wait for the zero adjustment to be completed before approaching the mouthpiece. 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.
Page 30 SpiroSphere ECG Instructions for Use ® Without interruption, the patient should immediately exhale as fast and as much (FEV1) and as long (FVC) as possible ( gure ). 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...
Page 31 SpiroSphere ECG Instructions for Use ® Screen display after the rst effort: The upper left part of the chart section shows the recording of the ow-volume loop. The upper right part shows the volume-time tracing. The lower section of the screen...
Page 32 SpiroSphere ECG Instructions for Use ® Change View: Screen display ow-volume and Screen display volume-time tiffaneau curve: curve: Curves superimposed: Return to Home Screen Return to Patient Details Print Report The lower section displays the quality assessment according to ATS/ERS 2005 guidelines:...
Page 33 SpiroSphere ECG Instructions for Use ® Deactivate/reactivate efforts If several efforts were performed, individual efforts (e.g. efforts with insuf cient patient cooperation) can be deactivated. The system can also automatically deactivate efforts as a result of system detected ATS/ERS acceptability errors. Behaviour can be con gured in Settings.
Page 34: Perform A Slow Spirometry Measurement
Perform a Slow Spirometry Measurement When the test is started, an automatic zero adjustment of the sensor unit is performed. Hold the SpiroSphere Sensor still and wait for the zero adjustment to be completed before approaching the mouthpiece. 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.
Page 35 SpiroSphere ECG Instructions for Use ® The patient should exhale slowly (see "Note" below) and completely (ERV - gure ) followed by a slow and complete inhalation (VCin - gure ). Then, continue to breathe normally. VCin ERV/VCin In order to reach the end-expiratory level the following two criteria must be complied with according to ATS/ERS.
Page 36 SpiroSphere ECG Instructions for Use ® Screen display after the rst effort: 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 rst effort.
Page 37: Medication Dosing Record
SpiroSphere ECG Instructions for Use ® Medication Dosing Record Before the post-measurement is started you can input Medication, the Medication time and the Technician name. Tap <Dosing>. Tap on <Enter Dosing> The following data can be entered: Medication: Enter the Medication, e. g. Albuterol/Salbutamol...
Page 38: Perform A Post Spirometry Measurement
SpiroSphere ECG Instructions for Use ® Perform a Post Spirometry Measurement The Flow-Volume curve shows the immediate bronchospasmolytic effect. The expiratory portion of the Flow- Volume curve and consequently, maximal peak ow (PEF), forced expiratory volume after 1 sec (FEV1) as well as forced vital capacity (FVC) changes.
Page 39 SpiroSphere ECG Instructions for Use ® Pre Post Report: Version 02.02 • 04AUG2022 Page 39/136...
Page 40: Adhoc Test
SpiroSphere ECG Instructions for Use ® Adhoc Test With 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.
Page 41: Assign Adhoc Test Now
SpiroSphere ECG Instructions for Use ® Assign Adhoc Test now Tap on <Yes>. The "Patient Directory" is displayed: Tap on <Add> and enter the respective patient data (see chapter "Add Patient" for details). Following window appears: Finish by tapping <OK>.
Page 42: Assign Adhoc Test Later
SpiroSphere ECG Instructions for Use ® Assign Adhoc Test later Tap on <No>. 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".
Page 43: Show, Edit, Delete And Print Tests
SpiroSphere ECG Instructions for Use ® Show, Edit, Delete and Print Tests Select a completed test. The following y-out menu appears: Tap on <Show> to display the results of the selected test on the screen: Version 02.02 • 04AUG2022 Page 43/136...
Page 44 SpiroSphere ECG Instructions for Use ® 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>: Tapping on <Yes>...
Page 45 SpiroSphere ECG Instructions for Use ® The selected patient including all measurements performed with the respective patient can be deleted by tapping on <Delete>: Tapping on <Yes> will irrevocably delete the selected patient and all respective tests! Tap on <Delete All Tests> to delete all measurements performed with the selected patient: Tapping on <Yes>...
Page 46: Print Recorded Results
Tap on <OK> to send the report to the prede ned e-mail address. The report will be sent to the email address de ned on your SpiroSphere. The report label will include the date and identi cation number. The le will be password protected as de ned.
Page 47: Settings And Tools
SpiroSphere ECG Instructions for Use ® Settings and Tools 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: General Tap on "General"...
Page 48 Power Management Preset: select 100% select 100% select 5 min select 2 min select 10 min select 5 min select 20 min select 20 min These settings in uence the battery life of the SpiroSphere. Page 48/136 Version 02.02 • 04AUG2022...
Page 49 SpiroSphere Sensor unit to the cradle. Active: The SpiroSphere Sensor is connected to the SpiroSphere via Bluetooth Not paired: The SpiroSphere Sensor is not connected to the SpiroSphere Battery: Indicates the battery status of the SpiroSphere Sensor Version 02.02 •...
Page 50 SpiroSphere ECG Instructions for Use ® Select "Pair" to pair a new SpiroSphere Sensor Select "Unpair" to unpair the SpiroSphere Sensor Select "Activate" to make this SpiroSphere Sensor the active sensor for measurements Select "Identify" to trigger an LED response on active SpiroSphere Sensor...
Page 51 SpiroSphere ECG Instructions for Use ® Spirometry Settings - General Predicted Values Setting options: Preset: None GLI 2012 GLI 2012 NHANES III ECCS/Zapletal Knudson/Crapo Extrapolate Limits from Author Limits from Author No calculation outside limits Module Age range Height range Differentiation acc.
Page 52 SpiroSphere ECG Instructions for Use ® Sensor Check Setting options: Preset: 1, 2, 3 1, 2, 3, 4 2, 3, 4, 5, 6, 7, 8 ON, OFF OFF, Con rm, Enforce Con rm OFF, Con rm, Enforce Con rm Ambient Conditions...
Page 53 SpiroSphere ECG Instructions for Use ® Decimals Possible Setting Options for Decimals: Preset: Decimals of Volume [L] - 0, 1, 2, 3 Decimals of Volume [mL] - 0 Decimals of Flow [L/Sec] - 0, 1, 2, 3 Decimals of Flow [mL/Sec] - 0...
Page 54 SpiroSphere ECG Instructions for Use ® Setting options: Preset: Automatic Automatic Diagram Scaling Adult Diagram Scaling Child 16 L/s, 12 L/s, 8 L/s , 4 L/s If “Automatic“ is selected and the breathing ow is greater or less than the preset ow axis, this axis will be rescaled automatically.
Page 55 SpiroSphere ECG Instructions for Use ® Setting options: Preset: FEF calculation Base individual FVC individual FVC FIF calculation Base VC max If “individual FVC“ is selected, the FEF or the FIF values will be calculated based on FVC. Setting options:...
Page 56 SpiroSphere ECG Instructions for Use ® Setting options: Preset: Display Inspiratory ON, OFF ON 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.
Page 57 SpiroSphere ECG Instructions for Use ® Spirometry Settings - Forced Spirometry Quality Feedback Setting options: Preset: ON, OFF ON, OFF ON, OFF Error, OFF, Warning, Con rmation Error Error, OFF, Warning, Con rmation Warning Error, OFF, Warning, Con rmation Warning...
Page 58 SpiroSphere ECG Instructions for Use ® Spirometry Settings - Slow Spirometry Measurement Setting options: Preset: Automatic, 12, 9, 6, 4 L Automatic Automatic, 12, 9, 6, 4 L Automatic VCin, VCex, VCmax, IC, ERV VCmax ERV VC-, IC VC-Maneuver ERV VC-...
Page 59 SpiroSphere ECG Instructions for Use ® Parameter Selection Forced Spirometry - Displayed Parameters The"Shown Parameters" column displays the parameters shown in the result screen of the forced spirometry measurement. Preset: FEV1 FEV1/FVC MMEF FVCin Scroll down to display further parameters (if applicable) The"Not active parameters"...
Page 60 SpiroSphere ECG Instructions for Use ® Slow Spirometry - Displayed Parameters The "Shown Parameters" column displays the parameters shown in the result screen of the slow spirometry measurement. Preset: VCin VCmax Scroll 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.
Page 61: Resting Ecg
ECG Instructions for Use ® Resting ECG SpiroSphere ECG allows recording of a 12-lead resting ECG measurement. Information on ECG Recording An electrocardiogram (ECG) is a graphic recording of the changes occurring in the electrical potentials (millivolt changes) at de ned sites on the skin. The continuously changing electrical elds are the result of depolarization and polarization of the heart and are distributed in the body without any delay.
Page 62 SpiroSphere ECG Instructions for Use ® ECG Leads To minimize artifacts, the skin of the de ned lead positions has to be prepared thoroughly. Preparing the sub ect s skin: 1. Identify the (10) electrode sites on the torso by referring to the picture and description below.
Page 63 When connecting the electrodes to the ECG unit, the tiny and fast potential differences originating from the heart can be detected on the surface of the body between either two individual electrodes or between one individual electrode and a group of combined electrodes and recorded by SpiroSphere ECG. Version 02.02 • 04AUG2022 Page 63/136...
Page 64 SpiroSphere ECG Instructions for Use ® The different measurement setups are commonly referred to as leads. For a standard 12-lead ECG, four electrodes are placed at the limbs and six at the chest. The 12 leads are: Three bipolar limb leads: I, II and III (according to Einthoven)
Page 65 The subject should try to avoid movement during the measurement because this can lead to motion artifacts. Only use original electrode cables delivered by ERT. If the wrong cable is used the de brillation energy delivered to the patient can decrease, the device can be damaged, or electric shock to the operator or other persons occur.
Page 66: Performing An Ecg Recording
Performing an ECG Recording SpiroSphere ECG allows the recording of a 12-lead resting ECG measurement. Add a <New Patient>, or <Select a Patient> from the "Search Patient" option. Scroll the list of Actions down to the action "ECG" within the Patient Details screen: Page 66/136 Version 02.02 •...
Page 67 SpiroSphere ECG Instructions for Use ® Power on the ECG unit by pressing the power button. The LED will turn blue indicating the ECG unit is powered on. If the battery is low, the LED will blink. Power button Select <Next> to continue.
Page 68 SpiroSphere ECG Instructions for Use ® The electrodes can be visually checked (“running lights”), starting with “V1” and end with “LL”. Look for the “e” shape to con rm correct lead placement. Press <Next>. Prior to the ECG recording, an Impedance Check will be performed to con rm good contact with the skin.
Page 69 SpiroSphere ECG Instructions for Use ® Adhesive electrodes are for single use only. Comply with the instructions for use of the elctrodes used. The electrodes must only be applied to intact skin. Do not use electrodes that have exceeded their expiration date or have dried electrode gel.
Page 70 SpiroSphere ECG Instructions for Use ® Pacemaker Quality issue Scaling and Filter You can adjust the view of the online recording by changing the settings for Gain and Speed. You can also apply lters to the view. Note: The on-screen scaling has been adapted to t the aspect ratio of the display. It should not be used for direct on-screen measurement (e.g.
Page 71 SpiroSphere ECG Instructions for Use ® 10 mm/mV Scaling Line gap no reference value Line gap no reference value Line gap no reference value Line gap no reference value 5 mm/mV Scaling Line gap no reference value Line gap no reference value...
Page 72: Ecg Results
SpiroSphere ECG Instructions for Use ® ECG Results After 10 seconds the <Evaluate> button will become available to allow you to end your recording. Inspect the recording quality of the signals. If the signals are free of drift and noise, press <Evaluate> to end the recording. The ECG Result screen will...
Page 73 SpiroSphere ECG Instructions for Use ® If you are happy with the recording select <Finish> to save the ECG. The ECG can be printed by selecting the <Print> icon. You can also print your ECG afterwards from the Patient Details screen, via the y-out menu: Version 02.02 •...
Page 74: Ecg Evaluation
Automatic interpretation of the ECG is not possible for pediatric subjects with an age below 16 years and for pacemaker subjects. A quali ed physician has to reassess all SpiroSphere ECG measurements. An interpretation by SpiroSphere with ECG is only signi cant when considered together with other clinical ndings.
Page 75: Ecg Settings
SpiroSphere ECG Instructions for Use ® ECG Settings Settings for ECG can be found under “ECG Settings”: ECG Unit connection: Activate, Pair or Unpair an ECG Unit Pacemaker detection: ON/OFF: Enables or disable check for Possible Pacemaker Textual interpretation: ON/OFF:...
Page 76: Connecting An Ecg Unit
SpiroSphere ECG Instructions for Use ® ECG Printed Parameters: This con gures the parameters that will be displayed on the printed ECG Report. The parameters can be added or removed in this section, by either double tapping or dragging across the respective parameter to either Not active (not shown), or Shown Parameters.
Page 77 SpiroSphere ECG Instructions for Use ® Select “ECG Unit connection” from the ECG Settings menu. 1. On your ECG Unit press and hold the power button until the blue LED blinks fast. This will take approximately 20 seconds. 2. After further few seconds, the ECG unit will be listed in the above screen.
Page 78: 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 ngerprints in order to utilise the ngerprint reader for system access.
Page 79 SpiroSphere ECG Instructions for Use ® The following screen appears: Select whether or wish to use your ngerprint reader for access to the system Enter all the required information to create your user: Options for role type: Administator User Support Enter the details for the user (for rst user of the system this must be Administrator role).
Page 80 SpiroSphere ECG Instructions for Use ® Overview who has which user rights: Patients Administrator User Support New patient Search patient View patient details Change patient demographics View measurements Perform measurements Print reports Sensor Check Calibration Check Linearity Check Calibration CheckLog...
Page 81 SpiroSphere ECG Instructions for Use ® Register ngerprints: Select <YES> to register ngerprints. Tap <Next> to move to the ngerprint registration. (If you choose not to register ngerprints this button is labelled “Save”.) The following screen appears: Tap the image of the nger you wish to register.
Page 82 SpiroSphere ECG Instructions for Use ® Place your nger on and off the ngerprint reader as per on-screen instructions (approx. 5 times) in order to register your ngerprint. If the nger is not placed correctly, feedback is provided: Page 82/136...
Page 83 SpiroSphere ECG Instructions for Use ® You may register as many ngers as you like. When nished tap <Save>. The following screen appears: Tap <Yes> to save the ngerprints of the respective user. Version 02.02 • 04AUG2022 Page 83/136...
Page 84 SpiroSphere ECG Instructions for Use ® After saving the rst user, you will be sent to the Login page: You can login via entry of Username and Password. If you registered your ngerprint, you can use the ngerprint reader. Two touches are required (the rst touch identi es the user, the second veri es the user).
Page 85 SpiroSphere ECG Instructions for Use ® Add User It is possible to add another new user from the User Directory. To add a new user, tap <Add User>. Make the appropriate entries and, if desired, register ngerprints (see above). Change Password...
Page 86 SpiroSphere ECG Instructions for Use ® Edit User To edit the currently selected user, tap <User Details> in the y out menu. The following screen appears: Make the appropriate changes and tap <Next> to move to the ngerprint registration (see above).
Page 87 SpiroSphere ECG Instructions for Use ® 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 Question From "User Management Settings" a Security Question and Answer can be de ned for the current user.
Page 88: Backup & Recover
SpiroSphere ECG Instructions for Use ® Backup & Recover A backup of all saved patient- and test data should be performed and saved to a USB- Stick on a regular basis. Tap on "Backup & Recover". Alternatively, tap on the "No backup performed"...
Page 89 If “Perform Recover“ is selected, the message "Please ensure USB Stick for Recover is Inserted" appears. Recover Insert Backup USB stick Tap on “All Data“ to reload all data into the patient directory of your SpiroSphere. Version 02.02 • 04AUG2022 Page 89/136...
Page 90: Communication
SpiroSphere ECG Instructions for Use ® Communication Tap on "Communication" It is possible to con gure the Communication settings from the Communication menu within Settings. Select the Communication method to open the respective con guration settings. Network Requirements WiFi Tap on the desired WiFi network.
Page 91 SpiroSphere ECG Instructions for Use ® Enter the password as applicable and tap <Connect>. Ethernet Choose the appropriate settings. If DHCP is set on "Off", then you can manually enter the appropriate settings. Version 02.02 • 04AUG2022 Page 91/136...
Page 92 SpiroSphere ECG Instructions for Use ® You can check the status of the connection by selecting "Check the network connection". Upon con rmation of a successful connection, following message box is displayed: 3G (only applicable for optional 3G module) Enter the appropriate Access Point Name and the Service Number.
Page 93: Local It Guide For Ethernet (Lan), Wi-Fi (Wlan) Or Optional 3G (Mobile Network)
3G (Mobile Network) which requires access to the Internet. 3G is only applicable for the optional 3G module. Since the SpiroSphere system would for Ethernet (LAN) or WIFI (WLAN) be part of your local network, this guide explains how the system behaves and needs to be con gured.
Page 94 Speci cation of network connection The SpiroSphere can be connected to an IT network in order to send a pdf report to a designated email address. In order to use this functionality, the SpiroSphere must be connected to an IT- network with TCP/IP connectivity via Ethernet, WLAN (or optional 3G) with routing to the Internet.
Page 95: Report & Printing
SpiroSphere allows for reports to be printed with an external printer. In addition, SpiroSphere will allow the user to generate reports as a PDF- le which can be transferred to an external device (i.e. via a USB stick), or e-mailed to a speci ed recipient.
Page 96 SpiroSphere ECG Instructions for Use ® Reports Setting options: Preset: Input Customer Name Input Customer Address Best Effort Report Best Effort Report All Efforts Report Email Input Username Input Password Input Email Address Input Server Name Input Port Input SSL...
Page 97: Update
The pdf report is secured by a user con gurable password, to ensure that the report could not be opened by other persons than the intended recipient. As the SpiroSphere just sends data over the network there are no risk or hazards for the patient resulting out of the non availability of network services.
Page 98: About Device
SpiroSphere ECG Instructions for Use ® About Device You can view system information under the About Device section. Restore Default Settings The system settings can be restored to the defaults using Restore Default Settings Factory Reset A detailed description of this tool is not part of this Instructions for Use.
Page 99: Cleaning/Hygiene Spirometry
Disposable mouthpiece is to be used in combination with the tube portion of the ERT PT. ERT PT and mouthpiece are parts for single use only. These parts must be disposed after each single use. If reused, infection may occur.
Page 100 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. Do not clean or disinfect the Main Unit or the SpiroSphere Sensor while the devices are in operation. Precleaning and Disinfection A thorough pretreatment/cleaning is a precondition for an ef cient disinfection of contaminated parts.
Page 101 With suspected tuberculosis or other resistant germs, the use of an appropriate disinfectant (CaviWipes, Reaction time >3 minutes) is required. Avoid contaminated uids (e.g. blood) to get into the SpiroSphere Sensor. In case of ingress of contaminated uids, do not use the SpiroSphere Sensor anymore.
Page 102: Hygiene Ecg
Reprocessing may deteriorate the part, resulting in reduced stability and leakage through micro cracks or releasing micro particles. Should any of these parts be recycled and misused intentionally, ERT seeks no responsibility nor can be made liable for the consequences arising from reusing these parts.
Page 103: Functional Check Ecg
If continuous failure contact ERT Customer Care The distance between the ECG unit and the SpiroSphere main unit impacts the quality of the Bluetooth connection. Keep it as short as possible and free of objects between both, e.g. furniture. If Bluetooth transmission fails for more than 10 seconds, the old ECG data are dismissed by the device and therefore lost for the recording.
Page 104 SpiroSphere ECG Instructions for Use ® Malfunction Cause of the Malfunction Removal of the Malfunction The ECG unit cannot be Battery discharged below Change battery for either a new or switched on. minimum power requirements. (re)charged one. Check polarity of the inserted energy source.
Page 105: Return Of Goods In Medical Institutions
SpiroSphere ECG Instructions for Use ® Return of Goods in Medical Institutions Recommendations for action - for all staff members having contact with potentially contaminated returns. Returns or returned goods are all products returned to the producer or the supplier, irrespective of whether or not they have been used, e.g.
Page 106 3 and 2 according to the regulation on biological substances and that are thus classi ed as Transport Category B: Please contact ERT before returning the goods and observe the regulations for the transport of dangerous goods.
Page 107 If the procedures described under point 2 and 3 are not applied, the contaminated product has to be returned in a combined packing complying with the packaging instruction P 650 ADR after contacting ERT, if necessary. Proceed as follows: a) Put the product into a liquid-tight, sealable packing (e.g. tearproof plastic bag)
Page 108 This certificate must be attached to ANY product complaint, ANY return of medical products and accessories, ANY repair order and ANY return of studies. Name of product: REF (ERT item no.): LOT (batch no.): It is herewith confirmed by signature that (please mark appropriate box): the enclosed medical product had no contact with blood or other body fluids so that it is hygienically safe.
Page 109: General Safety Precautions
EN 60601-1, Type BF. Nevertheless, a subject environment must be de ned. The subject has to keep a distance of at least 1.5 m from all open interfaces and connectors of the SpiroSphere Main Unit to avoid any contact with electrical voltage.
Page 110 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 and cables speci ed by the manufacturer. Non-observance may lead to a reduction of the device's performance.
Page 111 Instructions for Use. After the rst setup or if the setup has been changed (e.g. exchanging of the 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.
Page 112 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.
Page 113 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.
Page 114: Safety Precautions Ecg
SpiroSphere ECG Instructions for Use ® Safety Precautions ECG Read these instructions for use carefully. They are part of the device and must be available at all times. Do only use the device for the intended purpose described in this document (see chapter “Indications for Use“).
Page 115: Operation Cautions And Warnings
SpiroSphere ECG Instructions for Use ® The signals emitted by the measuring device do not comply with the alarmstandard for medical electrical devices, DIN EN 60601-1-8. All parts of the medical device, including the equipment, which come into contact with the patient when operating the device in accordance to the regulations, meet the applicable biocompatibility standards.
Page 116 SpiroSphere ECG Instructions for Use ® Motion artefacts adulterate the measurements. They might result in an incorrect interpretation by the operator and, as a consequence, lead to a wrong or delayed therapy. When wearing other electronic devices, e. g. pacemakers, other implanted or body- worn devices, errors or mutual interaction might possibly occur.
Page 117 SpiroSphere ECG Instructions for Use ® Do not touch the device during shock release! Do not use or store the device in dusty, wet or dirty environments. Make sure to always keep the environment conditions for storage and transport that are listed in the chapter “Technical Data”.
Page 118: Graphical Symbols
The typeplate can be found at the rear side of the Main Unit. Applied Part of type CF, De brillation-proof The typeplate on the SpiroSphere (ECG unit cable variant) sensor is positioned at the left side. Typeplate including optional 3G module...
Page 119 Do not come in contact with the uid in the battery. If the uid comes in contact with your skin, 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.
Page 120 • Consult the dealer or an experienced radio/TV technician for help. Any changes or modi cations not expressly approved by ERT could void the user's authority to operate the equipment. Canada This 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.
Page 121 SpiroSphere ECG Instructions for Use ® Frequency Band and Transmittet power: 3G (optional): Frequency Transmission Frequency Maximum Output Power Gain Band Range UMTS B1 1922 to 1978 MHz 23 dBm (+/- 2dBm) Class 3bis -1.74 dBi UMTS B2 1852 to 1908 MHz 23 dBm (+/- 2dBm) Class 3bis -1.1 dBi...
Page 122: Electromagnetic Emission And Immunity Spirosphere Ecg
For more information, refer to the EMC tables of the instructions for use of your device/system. The SpiroSphere is intended to be used in professional healthcare facility environment like doctor’s of ce or hospital. SpiroSphere conforms to basic standard IEC 60601-1.
Page 123 The SpiroSphere has been tested for radiated RF immunity only at selected frequencies. A use nearby emitters of other frequencies could result in improper operation. Keep a distance of about 2 meters from possible error sources when using the device.
Page 124 SpiroSphere Guidance and Manufacturer s Declaration Electromagnetic Emissions 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. EMC Basic Standard...
Page 125 SpiroSphere ECG Instructions for Use ® ECG ampli er Guidance and Manufacturer s Declaration Electromagnetic Emissions The ECG unit is intended for use in the electromagnetic environment speci ed below. The customer or the user of the ECG unit should assure that it is used in such an environment.
Page 126 SpiroSphere ECG Instructions for Use ® Test Speci cations for Immunity to RF Wireless Communications Equipment Test Band Service Modulation Maximum Distance Immunity frequency power test level (MHz) (MHz) (V/m) 380 - 390 TETRA 400 Pulse modulation 18 Hz 430 - 470 GMRS 460;...
Page 127: Bluetooth ® Wireless Communication
SpiroSphere ECG Instructions for Use ® Bluetooth Wireless Communication ® Bluetooth is a wireless technology standard for exchanging data over short distances from xed and mobile devices and building personal area networks (PANs). IEEE standardized Bluetooth as IEEE 802.15.1. The maximum output power the Bluetooth radio is 2.5mW. The typical range of operation is approximately 30 feet (10 meters).
Page 128: Technical Data Spirometry
3 h. Full charging: 2 h Cycle life: 70% of rated capacity after 350 cycles SpiroSphere Sensor Built-in rechargeable lithium-ion battery 3.7 V, 640 mAh. Battery will last under standard operating conditions for about 3 days in standby and 2.5 h operation.
Page 129: Technical Data Flow Sensor
± 3% of reading or ± 0.050 L Resistance Spirometer max. 135 Pa/L/s at 14 L/s Instantaneous Flow 0.1 – 14 L/s: +/- 5% or 0.2 L/s The expected operational lifetime of the SpiroSphere is 7 years. Version 02.02 • 04AUG2022 Page 129/136...
Page 130: Technical Data Ecg
SpiroSphere ECG Instructions for Use ® Technical Data ECG Feature Value Product class according to 93/42/ EWG (MDD) Dimensions W x H x D in cm 8,0 x 9,3 x 2,1 (3.3 x 3.7 x 0.8 in) Weight, incl. cable / without cable 200 g (0.4 lbs) / 81 g (without battery)
Page 131 SpiroSphere ECG Instructions for Use ® Feature Value Classi cation according to 60601-1 - Protection type against electric shock Device with internal power supply - Protection level against electric shock Type CF Electromagnetic compatibility (EMC) according to 60601-1-2 - Noise suppression...
Page 132: Item Numbers Of Disposables And Accessories
SpiroSphere ECG Instructions for Use ® Item Numbers of Disposables and Accessories Use ERT accessories and spare parts only! 720254 Manual calibration syringe, 3 L 852353 Syringe Adapter D 28 mm, L 60 mm 892120 Plastic nose clip 892121 Nose clip pad "foam material", disposable, 100 pieces per pack 706000 ERT PT, incl.
Page 133 SpiroSphere ECG Instructions for Use ® Index Indications for Use 2 Basic Conditions 65 Information on ECG Recording 61 Batteries 66 Isoelectric Segments 65 Bluetooth® Wireless Communication 126 Limb ECG 63 Charge Level Indicator 66 Chest ECG 62 Connectors 51...
Page 134 SpiroSphere ECG Instructions for Use ® For your notes: Page 134/136 Version 02.02 • 04AUG2022...
Page 135 SpiroSphere ECG Instructions for Use ® Version 02.02 • 04AUG2022 Page 135/136...
Page 136 SpiroSphere ECG Instructions for Use ® © 2022 eResearchTechnology GmbH or one of its af liates. All rights reserved eResearchTechnology GmbH Sieboldstrasse 3 97230 Estenfeld, Germany +49 9305 720-9891 tel +49 9305 720-7891 fax Page 136/136 Version 02.02 • 04AUG2022...

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