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Instructions for Use SpiroSphere 781235 Version 00.16 SpiroSphere Instructions for Use 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
processes. eResearchTechnology GmbH Sieboldstrasse 3 97230 Estenfeld, Germany Tel:
Fax:
www.ert.com
+49 9305 720-9891
+49 9305 720-7891 2017 eResearchTechnology GmbH. All rights reserved. Indications for Use 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.
Federal U.S. law restricts this device to sale by or on the order of a physician. (Rx only) Page 2/84
SpiroSphere Instructions for Use Table of Contents Indications for Use ...........................................................................................................2 Notes on Safety in this Instruction Manual ......................................................................4 Declaration of Conformity ................................................................................................4 Device Description...........................................................................................................5 Unpacking and Starting Operation ..................................................................................5 The SpiroSphere ............................................................................................................6 Start-Up ...........................................................................................................................7 Troubleshooting ...............................................................................................................9 LED Status SpiroSphere .................................................................................................9 LED Status SpiroSphere Sensor .....................................................................................9 Sensor insert .................................................................................................................10 Setup ..........................................................................................................................11 The Home Screen .........................................................................................................13 Sensor Check ...............................................................................................................14 Calibration Check ..........................................................................................................14 Linearity Check ..............................................................................................................16 Add Patient ....................................................................................................................17 Search Patient ...............................................................................................................19 Actions ..........................................................................................................................21 Preparing a Measurement .............................................................................................22 Perform a Forced Spirometry Measurement .................................................................23 Perform a Slow Spirometry Measurement.....................................................................28 Dosing ..........................................................................................................................31 Perform a Post Spirometry Measurement .....................................................................32 Adhoc Test .....................................................................................................................34 Perform an Adhoc Test ..................................................................................................34 Assign Adhoc Test now ..................................................................................................35 Assign Adhoc Test later .................................................................................................36 Show, Edit, Delete and Print Tests ................................................................................37 Print Recorded Results..................................................................................................40 Settings and Tools .........................................................................................................41 User Management .........................................................................................................54 Update ..........................................................................................................................69 About Device .................................................................................................................69 Restore Default Settings................................................................................................69 Factory reset..................................................................................................................69 Cleaning/Hygiene ..........................................................................................................70 General Safety Precautions...........................................................................................72 Graphical Symbols ........................................................................................................77 Notes on EMC according to EN60601-1-2 ..................................................................80 Technical Data ...............................................................................................................81 Item Numbers of Disposables and Accessories ............................................................83
Page 3/84 SpiroSphere Instructions for Use Notes on Safety in this Instruction Manual Following the ANSI (American National Standards Institute) recommendations for safety notes,
Degree of Danger Injury to persons Damages to property Meaning of Indicator X X X
(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:
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 4/84
SpiroSphere Instructions for Use Device Description The 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.
Unpacking and Starting Operation SpiroSphere is delivered with the following accessories*:
1 Main Unit 1 1 4 2 Nose clips and Pads 1 SpiroSphere Sensor Power Supply ERT PT with Mouthpiece Instruction manual
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.
* Depending on the type of equipment either included in the delivery or available as an option
Page 5/84 SpiroSphere Instructions for Use The SpiroSphere Main Unit:
Front view:
Power On/Off SpiroSphere Sensor Main Unit Fingerprint Sensor LCD touch display Speaker USB Rear view:
Charging Cradle LAN Power USB SpiroSphere Sensor:
LED Status Indicator ERT PT with Mouthpiece Power On/Off Page 6/84
SpiroSphere Instructions for Use Power supply:
Mains adapter Start-Up 1. Connect the SpiroSphere to a power source complying with local regulations. LAN 2. Put the SpiroSphere Sensor into the slot of the main unit as shown below. Power Supply Connection 3. Use the Power On switch located at the front of the main unit to switch on the SpiroSphere Main Unit. The operating status of the device is indicated via an LED on the main unit and on the SpiroSphere Sensor.
Page 7/84 SpiroSphere Instructions for Use
Power On" switch located at the back side of the SpiroSphere Sensor. 5. Ensure an ERT PT is inserted into the SpiroSphere Sensor. ERT PT with mouthpiece 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.
The maximum temperature of the SpiroSphere Sensor Unit can get up to 47C. Spirometry should only be performed by patients who can cooperate in the performance. Shut down 1. 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.
to operate the disconnection of the device from the mains supply. Page 8/84
SpiroSphere Instructions for Use Troubleshooting LED Status SpiroSphere Blue LED On Blue LED Off Blue LED Pulse Main Unit powered on Main Unit powered off Main Unit Standby To do:
N/A N/A N/A Orange LED On Orange LED Off Orange LED blinking Charging Not charging/ charging complete Low battery Connect Main Unit to a power socket LED Status SpiroSphere Sensor Only the highest priority LED at a time is turned on (LED priority: Orange - Blue). Charging in cradle No charging/ charging complete in cradle Low battery Orange LED On Orange LED Off Orange LED blinking slowly Orange LED blinking fast Blue LED blinking slowly Blue LED Off SpiroSphere Sensor is actively transferring data to the Main Unit Device in sleep mode Blue LED blinking fast Device powered on and paired with Main Unit Put the SpiroSphere Sensor into the cradle of the Main Unit Indicates an error in the SpiroSphere Sensor Put the device into the charging dock or press the Power On switch Error Messages
Page 9/84 SpiroSphere Instructions for Use Sensor insert 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 10/84
SpiroSphere Instructions for Use Setup
Enter the Global Password and press <OK>. (The preset global password is "691982".) The System Setup wizard starts automatically. Follow the system setup steps (step 1 - 6) and enter or select the appropriate settings. Tap on
<Next 1. Language Settings Select the appropriate language
Next>. 2. Date & Time Settings Select the appropriate settings
Next>.
Page 11/84 SpiroSphere Instructions for Use 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.
Next>. 4. Ethernet Settings Choose the appropriate settings
Next>. (Refer to chapter "Communication".) 5. WiFi Settings Choose the appropriate settings
Next>. (Refer to chapter "Communication".) 6. User Management Settings Choose the appropriate settings
Next>. Complete the initial setup of the device by tapping on <Yes>. Page 12/84
The Home Screen After the SpiroSphere has been set up, upon powering on the device the following screen appears:
SpiroSphere Instructions for Use 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 Search Patient Sensor Check Adhoc Test Settings & Tools Enter patient data for a new patient into your patient directory and start a test.
patient from the list to perform a test or to edit his/her data. Perform a volume or linearity check. Immediately perform a test without entering patient data or searching for a
Change settings.
Page 13/84 SpiroSphere Instructions for Use Sensor Check The ERT PTs included with the delivery are pre-calibrated as part of manufacture.
Tap <Sensor Check> to perform a sensor check. The sensor check consists of a calibration check as well as a linearity check. Tapping on the "i"- symbol will display information on the respectively selected check type. Calibration 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. Page 14/84
The calibration check With each syringe stroke, the volume accuracy should be within 3 %. SpiroSphere Instructions for Use High Ex Mid Ex Low Ex Low In Mid In High In 3 %
is not relevant and will be discarded. There should be one pump stroke in each of the
1 syringe stroke = pump twice, i.e. from impact to impact. Screen display after a total of three syringe strokes:
better than 3 %
X worse than 3 %
End the calibration check by tapping on <Save>.
Page 15/84 SpiroSphere Instructions for Use Linearity Check In order to perform a linearity check, tap on <Linearity Check>. Proceed as described in the "Calibration Check" section.
With each syringe stroke, the volume accuracy should be within 3 %.
is not relevant and will be discarded. Three pump strokes are required in each of the
1 syringe stroke = pump twice, i.e. from impact to impact. Screen display after a total of 9 syringe strokes:
better than 3 %
X worse than 3 %
End the linearity check by tapping on <Save>. Page 16/84
SpiroSphere Instructions for Use Add Patient
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" button on the Home Screen. The following screen appears:
Return to the Home Screen
instructions on entering Touchscreen Keyboard Hide Keyboard Enter
<Enter The following data must be entered:
Last Name:
First Name: Date of Birth:
Enter the Patient's last name
Select appropriate Day, Month and Year of Birth and continue by tapping on
<Return>.
Page 17/84 SpiroSphere Instructions for Use Age:
Gender:
Height:
Weight:
Ethnicity:
The Patient's age will be calculated automatically from the entered date of birth Select appropriate gender Enter the Patient's height Enter the Patient's weight Select the appropriate ethnicity Additionally, there is an option to enter:
Technician:
Physician:
Set A Name 1:
Set A Name 2:
Enter the Technician's name Enter the Physician's name As soon as all required patient data is entered, tap on <Save> to save the patient to your patient directory. Screen display after patient data input:
If you want to discard all data just entered, tap on <Clear Form>. All
Patient data Available Actions (Type), and list of tests already performed (Previous Tests) Page 18/84
SpiroSphere 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. Tap on the "Search Patient" button on the Home Screen to open the list of all patient data saved in the database. The following screen appears:
List of all patients data of a new Patient can be entered Display all tested patients Display all Patients tested today Display all Patients tested yesterday Display all Patients tested this week Display all Patients tested this month
is entered, all patients whose last names start with "S" are displayed.
Page 19/84 SpiroSphere Instructions for Use
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"
section shows the actions already performed for the
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. Page 20/84
Each patient can be completely deleted from the patient directory by tapping
<Delete>. SpiroSphere Instructions for Use 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 Spirometry (Flow/Volume loop) pre bronchospasmolysis Forced Spirometry (Flow/Volume loop) post bronchospasmolysis Slow Spirometry pre bronchospasmolysis Slow Spirometry post bronchospasmolysis Input Medication, Medication time and Technican Forced Pre Spirometry Forced Post Spirometry Slow Pre Spirometry Slow Post Spirometry Dosing
Page 21/84 SpiroSphere Instructions for Use Preparing a 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. The measurement is started by tapping on <Start>. The "Ambient Conditions" window appears:
The patient must not interact with the SpiroSphere Main Unit. Current room temperature (C) Current relative humidity (%) Current barometric pressure (hPa) 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. 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!
Page 22/84
SpiroSphere Instructions for Use
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. 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 2C or if relative humidity changed by more than 10%. Tap on <Continue> to apply the ambient data entered. Perform a Forced Spirometry Measurement Make the proper preparations according to ATS/ERS guidance. Please note: During the whole examination the patient must stay on the mouthpiece.
1 ) until a steady tidal breathing is shown. From tidal
2 ). 1 2 to TLC
Page 23/84 SpiroSphere Instructions for Use Screen display:
4 FVCin 3 6 s FEV1/FVC Screen display:
Tapping on the "i"-symbol will display information on the measurement procedure. Without interruption, the patient should immediately exhale as fast and as much (FEV1) and as
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
4 ). Tap <Evaluate 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. Flow-Volume curve Volume-Time tracing Page 24/84
SpiroSphere Instructions for Use The upper left part of the chart section shows the recording of the
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
Pred Best
= Predicted value
= Best value of all valid efforts.
%Pred = Best value in % of predicted values
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
If necessary, it is possible to terminate the test prematurely. In this case, a warning message is displayed. Start the next effort by tapping on <Start Effort>. Screen display after three efforts:
The "Best" column displays the best value out of all valid efforts.
on the Settings selected
(see: >Settings Spirometry >Forced Spirometry >Measurement). Scroll down to display further parameters
(if applicable)
* Literature:
MR Miller et al. Series ATS/ERS Task Force: Standardisation of Lung Function Testing, Standardisation
Page 25/84 SpiroSphere Instructions for Use Change View:
tiffaneau curve:
Screen display volume-time 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:
= no acceptability errors
= minor errors present
= major errors present Tap on the curve you want to be displayed. Individual parameter Repeatability
= Parameter repeatability criteria not met
= Parameter repeatability criteria met Overall Repeatability
= Not enough effort performed
= Enough efforts, but one or more repeatability criteria are not met
= Enough efforts and all repeatability criteria are met Page 26/84
SpiroSphere Instructions for Use Deactivate/reactivate efforts
can be deactivated. The system can also automatically deactivate efforts as a result of system detected ATS/ERS acceptability errors. Behaviour 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 trial An 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. End and save the test by tapping on <Finish>.
Page 27/84 SpiroSphere Instructions for Use Perform a Slow Spirometry Measurement Make the proper preparations according to ATS/ERS guidance. 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. 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!
1 Performance of an "ERV Maneuver":
Tidal breathing should be continued for a longer period of time
1 ). A stable breathing baseline is absolutely required to determine the lung volumes ERV and IC correctly. Tidal breathing Tapping on the "i"-symbol will display information on the measurement procedure. The two columns displayed show how constantly the patient is
dFRC = variation of the breathing baseline The 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. Page 28/84
2 ) followed by
3 ). Then, continue to breathe normally. SpiroSphere Instructions for Use 2 6 s ERV 3 VCin ERV/VCin 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. Tap on <Evaluate
Page 29/84 SpiroSphere Instructions for Use
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
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. If necessary, it is possible to terminate the test prematurely. In this case, a warning
Tap on <Start Effort> to start the next maneuver. Screen display after two efforts:
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 value Best = Best values from all efforts
%Pred = Best value in % of predicted values Scroll down to display further parameters
(if applicable) The "Best" column displays the best value out of all valid efforts.
(see: >Settings Spirometry >Slow Spirometry> Measurement) Page 30/84
SpiroSphere Instructions for Use Dosing 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 Medication time: Enter the time the Medication was given, hh:mm Technician:
Enter the Technician name Tap on <Save> to save the dosing to your patient directory.
Page 31/84 SpiroSphere Instructions for Use Perform a Post Spirometry Measurement The Flow-Volume curve shows the immediate bronchospasmolytic effect. The expiratory portion of the Flow-
forced expiratory volume after 1 sec (FEV1) as well as forced vital capacity (FVC) changes. Screen display after the "Pre Measurement":
Screen display after the "Post Measurement":
Post Measurement (purple) Pre Measurement (green) Page 32/84
Report:
SpiroSphere Instructions for Use
Page 33/84 SpiroSphere 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. 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 Test Tap on the "Adhoc Test 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:
Page 34/84
Assign Adhoc Test now Tap on <Yes>. The "Patient Directory" is displayed:
SpiroSphere Instructions for Use Tap on <Add> and enter the respective patient data (see chapter "Add Patient" for details). Following window appears:
Finish by tapping <OK>.
Page 35/84 SpiroSphere 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". Tap on <Add> to enter the appropriate patient data. Page 36/84
Show, Edit, Delete and Print Tests
SpiroSphere Instructions for Use Tap on <Show> to display the results of the selected test on the screen:
Page 37/84 SpiroSphere 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> will irrevocably delete the selected test!
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". Page 38/84
SpiroSphere Instructions for Use The selected patient including all measurements performed with the respective patient can be deleted by tapping on <Delete Patient>:
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> will irrevocably delete all tests assigned to the selected patient!
Page 39/84 SpiroSphere Instructions for Use Print Recorded Results As soon as a measurement is completed, the results can be printed by means of a connected USB*1 address*2 or saved to an USB stick. Preset: send PDF to an e-mail address (see >Setting Report & Printing) Tap on the Printer icon.
Best Effort Report a report displaying the best effort is created All Effort Report a report displaying all efforts is created Screen Capture Report a screen capture report is created Tap on <Return> to create the report. The "Print Result" window appears:
Tap on <OK> to send the report to
SpiroSphere Report: BestEffortReport_20160815_155247+0200.zip
*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"
Page 40/84
Settings and Tools The following includes a short description of settings which are not required for daily routine work. SpiroSphere Instructions for Use Tap on the "Settings & Tools" button on the Home Screen. The following will appear:
General Tap on "General"
Timezone Date & Time
ON/OFF 24h/12h YYYY.MM.DD DD.MM.YYYY DD-MMM-YYYY MM/DD/YYYY select actual Country select timezone City ON 24h set actual Time 2016.08.16 16.08.2016 DD-MM-YYYY 16-AUG-2016 08/16/2018 set actual Date
Page 41/84 SpiroSphere Instructions for Use Regional Sound Power Management Setting options:
English (US), German Preset:
English (US) cm. in kg. lb Setting options:
select select select select select select select select select cm kg Preset:
50%
Preset:
100%
100%
5 min 2 min 10 min 5 min 20 min 20 min
Page 42/84
Spirometry Settings Tap on "Spirometry Settings"
SpiroSphere Instructions for Use Spirometry Settings - Sensor Sensor Connection Active:
Not paired:
Battery:
The SpiroSphere Sensor is connected to the SpiroSphere via Bluetooth The SpiroSphere Sensor is not connected to the SpiroSphere Indicates the battery status of the SpiroSphere Sensor
Page 43/84 SpiroSphere Instructions for Use Spirometry Settings - General Predicted Values Module GLI 2012 Age range 3-95 years NHANES III 8-80 years Setting options:
None GLI 2012 NHANES III ECCS/Zapletal Knudson/Crapo Extrapolate Limits from Author No calculation outside limits Preset:
GLI 2012 Limits from Author Height range Differentiation acc. to Race no limitation 110-200 cm Ethnicity African-Descent Mexican-American all other groups African-Descent 0.87 for volume (18 - ) African-Descent 0.88 for volume all other groups ECCS/Zapletal Knudson/Grapo 5-17 years (Zapletal) 18-70 years (ECCS 93) 6-90 years 107-182 cm
(for Zapletal only) no limitation 1 For an age between 19 and 25, the calculation is based on the age of 25 Page 44/84
Sensor Check SpiroSphere Instructions for Use Setting options:
1, 2, 3 1, 2, 3, 4 2, 3, 4, 5, 6, 7, 8 ON, OFF
Ambient Conditions Unit Groups Setting options:
%
C, F hPa, mmHg Setting options:
mL, L mL, L L/s, mL/s, L/min L/s, mL/s, L/min L/min s, ms s, ms 1, %
L*L/s, mL*L/s Preset:
3 1 3 ON
Preset:
%
C hPa Preset:
L mL L/s L/s L/min s ms
%
L*L/s
Page 45/84 SpiroSphere Instructions for Use Decimals Setting options:
0, 1, 2, 3, 4 0, 1, 2, 3, 4 0, 1, 2, 3, 4 0, 1, 2, 3, 4 0, 1, 2, 3, 4 0, 1, 2, 3, 4 0, 1, 2, 3, 4 0, 1, 2, 3, 4 0, 1, 2, 3, 4 Preset:
2 0 2 0 0 0 2 0 2 Example: Preset 0: Preset 1: Preset 2:
FVC [L] 5 5,10 5,1 Spirometry Settings - Forced Spirometry Measurement Scroll down to display further settings
(if applicable) Page 46/84
SpiroSphere Instructions for Use Diagram Scaling Adult Diagram Scaling Child FVC as FEV2 FVC as FEV3 FVC as FEV6 Expiratory Back Extrapolation Inspiratory Back Extrapolation
Preset:
Automatic
OFF OFF OFF Setting options:
Automatic 16 L/s, 12 L/s, 8 L/s , 4 L/s If Automatic
ON, OFF ON, OFF ON, OFF If ON is selected, the value for the respective parameter is used as the FVC value. Setting options:
Always, Never Why 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. Preset:
Always correct incorrect Example: 4.6 liters Example: 3.8 liters Volume Start of expiration calculated by extrapolation Criterion 5% of FVC Expiration curve Time Why 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.
Page 47/84 SpiroSphere Instructions for Use FEF calculation Base FIF calculation Base Best Expiration Best Inspiration Setting options:
individual FVC VC max If individual FVC is selected, the FEF or the FIF values will be calculated based on FVC. Preset:
individual FVC Preset:
FEV1 + FVC Preset:
FVCin + PIF Setting options:
FEV1 + FVC FEV1 FVC FVC + FERV1 + 1/3*PEF FEV0.5 + FVC FEV0.5 Setting options:
FVCin + PIF FVCin + 0.1*PIF FVCin + FIV1 FVCin FIV1 Use best EX If several breathing maneuvers are performed within one test cycle, the software determines the best breathing maneuver within this trial according to preset criteria. Summary default View Setting options:
Flow/Volume Tiffenau Spirogram Preset:
Flow/Volume If Flow/Volume volume curve. If "Tiffeneau" is selected, the tiffenau curve will be displayed. Page 48/84
SpiroSphere Instructions for Use Display Inspiratory Preset:
ON Setting options:
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. Inspiratory Position Setting options:
TLC, RV Preset:
TLC The inspiratory and expiratory phase of the Flow-Volume curve can be referred to TLC or RV. TLC RV Display Predicted Curve Setting options:
ON, OFF Preset:
ON If activated (ON), a predicted curve will be displayed in the diagram as reference. Pred
Page 49/84 SpiroSphere Instructions for Use Spirometry Settings - Forced Spirometry Quality Feedback Setting options:
ON, OFF ON, OFF ON, OFF Error OFF Warning
Preset:
ON Error As the quality of a spirometry measurement strongly depends on the patient's
Quality Feedback documented in an "Example" report:
ATS error codes ABG means: errors A, B, G are present Page 50/84
Spirometry Settings - Slow Spirometry Measurement SpiroSphere Instructions for Use Setting options:
Automatic, 12, 9, 6, 4 L Automatic, 12, 9, 6, 4 L VCin, VCex, VCmax, IC, ERV ERV VC-, IC VC-Maneuver Preset:
Automatic Automatic VCmax ERV VC-Maneuver Quality Feedback Setting options:
Error OFF Warning
Preset:
Error Quality Feedback documented in an "Example" report:
ATS error codes N means:
the criteria N are not met
Page 51/84 SpiroSphere 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 FVC MMEF FVCin 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. 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. Forced Spirometry - Printed Parameters
"see above"
Page 52/84
Slow Spirometry - Displayed Parameters SpiroSphere Instructions for Use The "Shown Parameters" column displays the parameters shown in the result screen of the slow spirometry measurement. Preset:
VCin IC VCmax VT BF 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. 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. Slow Spirometry - Printed Parameters
"see above"
Page 53/84 SpiroSphere Instructions for Use 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
From "Settings" select
"User Management"
Tap the switch to activate User Management The following screen appears:
Enter the Global Password (691982) and tap <OK>. Page 54/84
The following screen appears:
SpiroSphere Instructions for Use Options for role type:
Administator User Support
system access. Patients New patient Search patient View patient details Change patient demographics View measurements Perform measurements Print reports Sensor Check Calibration Check Linearity Check Calibration CheckLog Linearity CheckLog Tools Create backup View system info Administrator User Support X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X
Page 55/84 SpiroSphere Instructions for Use System Administration Add or change user Deactivate/activate user Recover Change date and time settings Update software X X X X X X X X X X X X X X Select <YES> to register
Tap <Next
Save.) The following screen appears:
Page 56/84
SpiroSphere Instructions for Use
Page 57/84 SpiroSphere Instructions for Use
Save>. The following screen appears:
Tap <Yes the respective user. Page 58/84
SpiroSphere Instructions for Use You can login via entry of Username and Password.
User Directory When User Management is active, additional items appear in the Settings screen:
Select "User Directory"
The User Directory is displayed:
Page 59/84 SpiroSphere Instructions for Use Add User It 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
Change Password
Access to the User details, and Change password function is available To set a new password, tap <Change Password>. The following screen appears:
Make the appropriate entries and tap <Save> to save the new password. Page 60/84
Edit User To edit the currently selected user, tap <User Details appears:
SpiroSphere Instructions for Use Make the appropriate changes and tap <Next registration (see above).
Save.) Deactivate User /Reset Password An Administrator is able to activate/ deactivate a user and to reset the password (with a temporary
Tap <Deactivate User> to deactivate the selected user.
Page 61/84 SpiroSphere 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 current user. Make the appropriate entries and tap <Save> to save the Security Question. Page 62/84
SpiroSphere 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 Home Screen. If Perform Backup is selected, the message
"Please ensure a Backup USB Stick is Inserted" appears. Backup Insert USB stick Tap on Start Backup and save it to the USB stick!
Page 63/84 SpiroSphere Instructions for Use 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. Page 64/84
Communication SpiroSphere Instructions for Use Tap on "Communication"
Settings.
Network Requirements WiFi
Tap on the desired WiFi network. Tap <Connect> to initiate the connection.
Page 65/84 SpiroSphere 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. Page 66/84
SpiroSphere Instructions for Use Report & Printing SpiroSphere allows for reports to be printed with an external printer. In addition,
recipient. Tap on "Report & Printing"
Printer Setting options:
Printer, PDF via Email, PDF via USB ON, OFF see below see below Color, Black & White A4, Letter Send test page to Default Printer Preset:
PDF via Email OFF Color A4 Email 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".
Page 67/84 SpiroSphere Instructions for Use Reports Email Print Job Setting options:
Input Customer Name Input Customer Address Best Effort Report All Efforts Report Preset:
Best Effort Report Input Username Input Password Input Email Address Input Server Name Input Port Input SSL Print jobs state Page 68/84
SpiroSphere Instructions for Use 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. Update List of available updates About Device Restore Default Settings Factory reset A detailed description of this tool is not part of this Instructions for Use.
Page 69/84 SpiroSphere Instructions for Use Cleaning/Hygiene 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
Always be sure to disconnect the devices/systems from the mains power before cleaning or disinfecting. 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. How often should contaminated parts be exchanged?
Dispose after every patient Reuse may lead to patient infections.
Dispose nose clips after every patient Reuse may lead to patient infections. 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. Wiping disinfection Surface Cleaning and Disinfection The 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. Page 70/84
SpiroSphere Instructions for Use 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
parts. Protein residue on these parts might prevent an effective disinfection. ERT recommends the following disinfectants:
Precleaning and Disinfection:
Product mikrozidsensitive wipes CaviWipes Manufacturer Schuelke & Mayr GmbH Concentration/Reaction time 1 minute 1 minute Metrex
procedure with a second wipe for disinfection. Let the surface dry. 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. 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.
Disposal of single use items / damaged reusable items Take 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.
Page 71/84 SpiroSphere Instructions for Use General Safety Precautions The Instructions for Use is regarded as part of the instrument, and should always be kept on hand. The 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. Deviation from Intended Use Any 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/
ERT only guarantees for the safety, reliability and functionality of the instrument if
personnel authorized for these tasks by ERT.
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.
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
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. Page 72/84
SpiroSphere Instructions for Use 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.
the respective EN standards (e.g. EN 60950 or EN 60601-1). Everybody who connects additional equipment to the signal input part or signal
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.
Medical 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
- 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 Interference The 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
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 devices 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
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
reduction of the device's performance.
Page 73/84 SpiroSphere Instructions for Use Ambient Conditions The medical device must not be operated in rooms with the presence of
with oxygen or nitrous oxide. The medical device must be operated in rooms
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 Operation Temperature 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 units 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.
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
physician must reassess all measurements. An interpretation by the medical
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. Contraindications According 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 Maneuvers Acute, life threatening diseases of every description, e.g.
Page 74/84
SpiroSphere Instructions for Use
Relative contraindications for Forced Maneuvers
post-operatively)
surgeon)
origin Cleaning and Hygiene Prior 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. Biocompatibility Component Mouth piece Housing parts of the sensor unit and the main unit PT-tube Material Styrolution PS 454N HIPS Biocompatibility of the material has
Cycoloy CX2244ME Biocompatibility of the material has
Styrolution PS 454N HIPS
Page 75/84 SpiroSphere Instructions for Use Maintenance No 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 broken An unattended child should not get into contact with disposables, accessories and packing material as well as cleaning and disinfection substances. Recurrent Test Medical 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. Recycling Adhere 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. Page 76/84
SpiroSphere Instructions for Use The typeplate can be found at the rear side of the Main Unit. The typeplate on the SpiroSphere sensor is positioned at the left side. Graphical Symbols Alternating current Attention!
ON/OFF (device connected to/disconnected from the power supply system) Follow the instructions for Use!
Year of Production Manufacturer Applied part of Type BF Single use Disposal of electronic devices in compliance with WEEE Barometric pressure limits Rx only CAUTION:
FEDERAL U.S. LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. Packaging can be recycled Temperature limit Serial number Reference number IP20 IP21
eResearchTechnology GmbH corresponds to the international standard of ISO 13485. Possible source of interference
Page 77/84 SpiroSphere Instructions for Use 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, USA This product is based in part on Evas, Copyright 2000 - 2005 by Carsten Haitzler and various contributors, and on the work of the FreeType team. The safety precautions and operational procedures indicated in this chapter refer to Germany. Different regulations and standards may apply to other countries. Safety Precautions for Lithium Ion Rechargeable Batteries The 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!
- Do not dismantle or manipulate the battery.
be used any longer!
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 78/84
SpiroSphere Instructions for Use USA 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:
SpiroSphere - Sensor Unit:
FCC-ID: 2AAUFSPS001 FCC-ID: 2AAUFSPS002 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. Le prsent appareil est conforme aux CNR dIndustrie Canada applicables aux appareils radio exempts de licence. Lexploitation est autorise aux deux conditions suivantes : (1) lappareil ne doit pas produire de brouillage, et (2) lutilisateur de lappareil doit accepter tout brouillage radiolectrique subi, mme si le brouillage est susceptible den compromettre le fonctionnement. SpiroSphere - Main Unit:
SpiroSphere - Sensor Unit:
IC: 11335A-SPS001 IC: 11335A-SPS002 Transmission Frequency Frequency Range Band 1922 to 1978 MHz UMTS B1 1852 to 1908 MHz UMTS B2 826 to 847 MHz UMTS B5 832 to 838 MHz UMTS B6 882 to 913 MHz UMTS B8 832.4 to 842.6 MHz UMTS B19 GSM 850 824 to 849 MHz E-GSM 900 880 to 915 MHz DCS 1800 PCS 1900 1710 to 1785 MHz 1850 to 1910 MHz Maximum Output Power 23 dBm (+/- 2dBm) Class 3bis 23 dBm (+/- 2dBm) Class 3bis 23 dBm (+/- 2 dBm) Class 3bis 23 dBm (+/- 2 dBm) Class 3bis 23 dBm (+/- 2 dBm) Class 3bis 23 dBm (+/- 2 dBm) Class 3bis 2 Watts GSM, GPRS and EDGE 2 Watts GSM, GPRS and EDGE 1 Watt GSM, GPRS and EDGE 1 Watt GSM, GPRS and EDGE Gain
-1.74 dBi
-1.1 dBi
-3.31 dBi
-1.1dBi ERT complies with EMC guidelines according to EN60601-1-2. ERT can provide further information on EMC properties on request.
Page 79/84 SpiroSphere Instructions for Use 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.
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 RF emissions CISPR 11 Electrostatic discharge (ESD) IEC 61000-4-2 Radiated RF IEC 61000-4-3 Compliance level Group 1 Class B 8 kV indirect contact 15 kV direct air direct contact not possible 10 V/m from 80 MHz to 2700 MHz applied to 4 devices orientations each with vertical and horizontal antenna polarisation Electrical fast transient/burst IEC 61000-4-4 2 kV for power supply lines 1 kV for input/output lines Surge IEC 61000-4-5 Conducted RF IEC 61000-4-6 Voltage dips IEC 61000-4-11 Short interruptions and voltage variations IEC 61000-4-11 0.5 kV differential mode 1 kV differential mode 3 V(rms) from 150 kHz to 80 MHz 6 V(rms) in ISM bands 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 Hz tested at 100 and 240 V power supply input lines
< 5% @ 250 cycles and 50 Hz
< 5% @ 300 cycles and 60 Hz Page 80/84
SpiroSphere Instructions for Use Technical Data Dimension Weight Screen Display Medical Power Supply Frequency Battery 31.5 x 19.5 cm x 7.5 (L x W x H ) 1.5 kg 16.2 x 12.2 cm Model: GTM91099-3009-4.0-T2 Input: 100 - 240 Vac, 50/60 Hz, 1.5 A Output: 5 V, 6 A Cable length: 1200 mm 50 - 60 Hz Main Unit Built-in rechargeable lithium-ion battery 3.7 V, 5000 mAh. Battery will last under standard operating conditions for about 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. Full charging: 2 h Cycle life: 70% of rated capacity after 500 cycles Class II Internally powered IP42 IP21 IP20 Power Supply SpiroSphere Sensor continuous Protection class Mode of operation Moisture protection Power Supply Applied parts Application Interface Measuring Principle Operating Ambient Main unit SpiroSphere Sensor ERT PT, SpiroSphere Sensor Measuring Pulmonary Function USB Bluetooth WiFi Ethernet 3G high-quality pneumotach Temperature:
Relative humidity:
Barometric pressure: 700 to 1070 hPa Data transfer Data transfer Data transfer Data Transfer Data transfer
+10 C to +35 C 15 % to 90 %
Type BF
Page 81/84 SpiroSphere Instructions for Use Transport/Storage Ambient unit
-10 C to +50 C 0 % to 90 %
Temperature:
Relative humidity:
Barometric pressure: 600 to 1200 hPa Barometric pressure: 500 to 1100 hPa Measuring range Accuracy 2.5 hPa at 700 - 1060 hPa Technical Data Flow Sensor 0.1 to 16 L/s Measuring range: PEF:
Resolution:
Accuracy:
Resistance Spirometer FEV1 and FVC: 0.1 to 8 L PEF:
< 5 mL/s FEV1 and FVC: 1 mL PEF:
FEV1 and FVC: 0.1 to 8 L:
max. 135 Pa/L/s at 14 L/s 0.1 to 16 L/s: 10% of reading or 0.3 L/s 3% of reading or 0.050 L Instantaneous Flow 0.1 14 L/s: +/- 5% or 0.2 L/s The expected operational lifetime of the SpiroSphere is 7 years. Page 82/84
Item Numbers of Disposables and Accessories SpiroSphere Instructions for Use Use ERT accessories and spare parts only!
720254 852740 892120 892121 706000 706002 706002 706003 Manual calibration syringe, 3 L Syringe Adapter D 28 mm, L 60 mm Plastic nose clip Nose clip pad "foam material", disposable, 100 pieces per pack ERT PT, incl. mouthpiece ERT PT, incl. mouthpiece (box of 10) ERT PT, incl. mouthpiece (box of 10) ERT PT, incl. mouthpiece (box of 50) eResearchTechnology GmbH Sieboldstrasse 3 97230 Estenfeld, Germany Tel. +49 9305 720-9891 Fax +49 9305 720-7891 CustomerCare@ert.com
Page 83/84
All rights reserved eResearchTechnology GmbH Sieboldstrasse 3 97230 Estenfeld, Germany
+49 9305 720-9891
+49 9305 720-7891 tel fax
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2017-05-30 | 2402 ~ 2480 | DSS - Part 15 Spread Spectrum Transmitter | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2017-05-30
|
||||
1 | Applicant's complete, legal business name |
eResearchTechnology GmbH
|
||||
1 | FCC Registration Number (FRN) |
0022909717
|
||||
1 | Physical Address |
Sieboldstrasse 3
|
||||
1 |
Estenfeld, N/A 97230
|
|||||
1 |
Germany
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
j******@eurofins.de
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
2AAUF
|
||||
1 | Equipment Product Code |
SPS002
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
J****** K******
|
||||
1 | Title |
Director, Quality Management
|
||||
1 | Telephone Number |
0049 ******** Extension:
|
||||
1 | Fax Number |
0049 ********
|
||||
1 |
j******@cert.com
|
|||||
app s | Technical Contact | |||||
1 | Firm Name |
eResearchTechnology GmbH
|
||||
1 | Name |
B**** M********
|
||||
1 | Physical Address |
Sieboldstrasse
|
||||
1 |
Estenfeld, 97230
|
|||||
1 |
Germany
|
|||||
1 | Telephone Number |
+49 (********
|
||||
1 |
B******@ert.com
|
|||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DSS - Part 15 Spread Spectrum Transmitter | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | SpiroSphere is a diagnostic compact device to measure inspiratory and expiratory lung function parameters. | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Output power listed is conducted. SAR compliance for held to face operation is based on a separation distance of 0 cm between the unit and the face of the user. End-users must be informed of the held to face operating requirements for satisfying RF exposure compliance. The highest reported SAR value for mouth and body-worn accessory is 0.038 W/kg. | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
Eurofins Product Service GmbH
|
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1 | Name |
J**** K****
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1 | Telephone Number |
49-33********
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1 | Fax Number |
49-33********
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1 |
j******@eurofins.de
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Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
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Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402.00000000 | 2480.00000000 | 0.0150000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC