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ERT SpiroSphere Instructions For Use Manual Download Page 129

SpiroSphere

®

 ECG Instructions for Use

Page 129/136

Version 02.02 • 04AUG2022

Technical Data Flow Sensor

Measuring Range: 

PEF: 

0.1 to 16 L/s 

 

 

 

 

FEV1 and FVC:  0.1 to 8 L

Resolution: 

PEF: 

< 5 mL/s

 

FEV1 and FVC:  1 mL

Accuracy:

 

PEF:  

0.1 to 16 L/s:   ± 10% of reading or ± 0.3 L/s

 

FEV1 and FVC:  0.1 to 8 L:  

± 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.

Transport/Storage

 

Temperature:  

-20 °C to +50 °C

 

Relative Humidity:  

15 % to 90 %

 

Barometric Pressure:  600 to 1200 hPa

Ambient unit 

 

 

Measuring range  Accuracy

 

Barometric pressure:  500 to 1100 hPa 

± 2.5 hPa at 700 - 1060 hPa

Summary of Contents for SpiroSphere

Page 1: ...781239 Version 02 02 Instructions for Use SpiroSphere ECG ...

Page 2: ... minimum age for ECG application is 4 years It can be used by physicians in the of ce or hospital Indications for Use According to STANDARDIZATION OF SPIROMETRY 2019 UPDATE American Journal of Respiratory and Critical Care Medicine October 2019 performing lung function tests can be physically demand for a minority of patients The forced expiratory maneuver used in spirometry increases intrathoraci...

Page 3: ...Due to increases in sinus and middle ear pressures Sinus surgery or middle ear surgery or infection within 1 week Due to increases in intrathoracic and intraabdominal pressure Presence of pneumothorax Thoracic surgery within 4 weeks Abdominal surgery within 4 weeks Late term pregnancy Infection control issues Active or suspected transmissible respiratory or systemic infection including tuberculosi...

Page 4: ...atient 25 Actions 27 Preparing a Spirometry Measurement 28 Perform a Forced Spirometry Measurement 29 Perform a Slow Spirometry Measurement 34 Medication Dosing Record 37 Perform a Post Spirometry Measurement 38 Adhoc Test 40 Perform an Adhoc Test 40 Assign Adhoc Test now 41 Assign Adhoc Test later 42 Show Edit Delete and Print Tests 43 Print Recorded Results 46 Settings and Tools 47 Resting ECG 6...

Page 5: ...ns 105 General Safety Precautions 109 Safety Precautions ECG 114 General Cautions and Warnings 114 Operation Cautions and Warnings 115 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 130 Item Numbers of Disposables and Ac...

Page 6: ...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 X...

Page 7: ...f electronic devices in compliance with WEEE IP classi cation according to IEC60529 Radio symbol non ionizing radiation Manufacturer Date of manufacturing CE conformity symbol Medical Device Directive with code number of Noti ed Body Follow the Instructions for Use Federal U S Law restricts this device to sale by or on the order of a physician Attention General warning sign acc to ISO 7010 W001 On...

Page 8: ...d Moreover it is possible to transfer data via USB WiFi optional 3G module and Ethernet Unpacking and Starting Operation SpiroSphere is delivered with the following accessories 1 Main Unit 1 SpiroSphere Sensor 1 Power Supply with country adapters 4 ERT PT with Mouthpiece 2 Nose clips and Pads 1 Instruction manual Optional 1 ECG Unit With the option ECG electrocardiographic diagnoses can be made Fo...

Page 9: ...piroSphere Sensor LCD touch display Fingerprint Sensor Power On Off Power USB Speaker USB LAN Power On Off LED Status Indicator ERT PT with Mouthpiece SpiroSphere Sensor Charging Cradle Front view Rear view The SpiroSphere must not be exposed to direct sunlight nor positioned immediately near heating elements ...

Page 10: ...ated at the front of the main unit to switch on the SpiroSphere Main Unit LAN Power Supply Connection 2 Put the SpiroSphere Sensor into the slot of the main unit as shown below Power supply The operating status of the device is indicated via an LED on the main unit and on the SpiroSphere Sensor Please refer LED Status SpiroSphere and LED Status SpiroSphere Sensor on page 9 Mains adapter ...

Page 11: ...ligned the rail with the sensor holes of the PT tube with the grooved edge of the SpiroSphere Sensor as below when inserting the ERT PT into the SpiroSphere Sensor The maximum surface temperature of the SpiroSphere Sensor Unit can get up to 47 C during charging Spirometry should only be performed by patients who can cooperate in the performance Shut down 1 To power off the SpiroSphere Main Unit pr...

Page 12: ...he power button on the SpiroSphere Sensor for more than 8 seconds go to Spirometry Settings Sensor and try connecting to the SpiroSphere Sensor Blue LED On SpiroSphere Sensor is actively transferring data to the Main Unit Blue LED Off Device in sleep mode Device may be off or battery might be discharged Put the device into the charging dock or press the Power On switch Blue LED blinking slowly Dev...

Page 13: ...he cradle and insert again SpiroSphere Sensor might be fully charged or off Try to identify the SpiroSphere Sensor in the Spirometry Settings Place the SpiroSphere Sensor again in the charging cradle SpiroSphere Sensor can t be paired SpiroSphere Sensor is powered off Switch on SpiroSphere Sensor see above SpiroSphere Sensor is not in the pairing mode Remove the SpiroSphere Sensor from the chargin...

Page 14: ...y pressing the power button for min 3 seconds No Flow detect Check if ERT PT is inserted correctly Press the power button of the SpiroSphere Sensor for more than 8 seconds to power off Then restart by pressing the power button for more than 3 seconds SpiroSphere Sensor is not charging Check if the power supply is connected to the SpiroSphere Main Unit The SpiroSphere Sensor will only be charged if...

Page 15: ...care that you have aligned the rail with the sensor holes of the PT tube with the grooved edge of the SpiroSphere Sensor as below when inserting the ERT PT into the SpiroSphere Sensor The ERT PT should be inserted fully without force Remove the ERT PT in the direction of the arrow rail with sensor holes ...

Page 16: ...sword is 691982 The System Setup wizard starts automatically 1 Language Settings Select the appropriate language and con rm with Next Refer to chapter Settings Tools Regional 2 Date Time Settings Select the appropriate settings and con rm with Next Refer to chapter Settings Tools Timezone Date Time Follow the system setup steps step 1 6 and enter or select the appropriate settings Tap on Next to c...

Page 17: ...re with and select Pair from the dropdown menu Con rm with Next Refer to chapter Settings Tools Spirometry Settings Sensor 4 Ethernet Settings Choose the appropriate settings and con rm with Next Refer to chapter Communication 5 WiFi Settings Choose the appropriate settings and con rm with Next Refer to chapter Communication Note that pairing is only possible for 90 seconds after the SpiroSphere S...

Page 18: ...rator will then be able to create additional accounts for individuals authorized to work with the SpiroSphere Choose the appropriate settings and con rm with Next 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 Too...

Page 19: ...tings and Tools by tapping on the respective button Add Patient Enter patient data for a new patient into your patient directory and start a test Search Patient Search for a speci c patient in your patient directory Select a speci c patient from the list to perform a test or to edit his her data Sensor Check Perform a volume or linearity check Adhoc Test Immediately perform a test without entering...

Page 20: ...o the 3 L calibration syringe via an adapter as shown In order to perform a calibration check tap on Calibration Check Tapping on the i symbol will display information on the respectively selected check type Tap Sensor Check to perform a sensor check Sensor Check The ERT PTs included with the delivery are pre calibrated as part of manufacture A sensor check can be performed to con rm accurate meas...

Page 21: ...Mid Ex Low Ex Low In Mid In High In 3 End the calibration check by tapping on Save better than 3 X worse than 3 Screen display after a total of three syringe strokes It is important to pump without interruption from impact to impact The rst pump stroke is not relevant and will be discarded There should be one pump stroke in each of the following ow ranges low mid and high range 1 syringe stroke pu...

Page 22: ...on 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 With each syringe stroke the volume accuracy should be within 3 5 Linearity Check It is important to pump without interruption from impact to impact The rst pump stroke is not relevant and will be discarded Three pump strokes are required...

Page 23: ...rm with Enter The cursor automatically jumps to the next entry eld Add Patient The following data must be entered Identi er Enter the Patient Identi er Last Name Enter the Patient s last name First Name Enter the Patient s rst name Date of Birth Select appropriate Day Month and Year of Birth and continue by tapping on Return Before measuring a patient for the rst time the patient s personal data h...

Page 24: ...priate ethnicity Additionally there is an option to enter Technician Enter the Technician s name Physician Enter the Physician s name Set A Name 1 Set A Name 2 As soon as all required patient data is entered tap on Save to save the patient to your patient directory If you want to discard all data just entered tap on Clear Form All entry fields will be cleared Screen display after patient data input...

Page 25: ...Patients tested this week Display all Patients tested this month Search for speci c Patients by entering his her last name or ID Entering the rst letter or the rst character of the patient s ID is suf cient as well If e g S is entered all patients whose last names start with S are displayed Search Patient The following screen appears List of all patients When a patient whose data is already stored...

Page 26: ... The Previous Actions section shows the actions already performed for the speci c patient Tap on Edit to display the patient s demographic information If incorrect patient data was entered or if the patient data need to be updated e g due to weight or height change in children the respective data can be edited and will be used for future tests In the Actions section all conductable actions are lis...

Page 27: ...etry Forced Spirometry Flow Volume loop pre bronchospasmolysis Forced POST Spirometry Forced Spirometry Flow Volume loop post bronchospasmolysis Slow PRE Spirometry Slow Spirometry pre bronchospasmolysis Slow POST Spirometry Slow Spirometry post bronchospasmolysis Tapping on Yes will irrevocably delete the selected patient including all saved measurements performed for that patient A Warning appea...

Page 28: ...th mouthpiece is attached in the SpiroSphere Sensor The current ambient conditions are to be entered manually In this case the ambient data should be updated if the room temperature changed by more than 2 C or if relative humidity changed by more than 10 The ATP BTPS correction factors for inspiratory and expiratory ows and volumes will be determined from the ambient data Therefore ambient data mu...

Page 29: ...ol will display information on the measurement procedure 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 tee...

Page 30: ...ure 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 gure 4 6 s 6 s FEV1 FVC FVCin 3 4 Screen display Tap Evaluate to end the rst 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 se...

Page 31: ...ws 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 rst effort Pred Predicted value Best Best value of all valid efforts Pred Best value in of predicted values Screen display after three efforts The Best column displays the best value out of all valid efforts De nition of the best effort depen...

Page 32: ...neau curve Screen display volume time curve Change View Curves superimposed Tap on the curve you want to be displayed Print Report Return to Patient Details Return to Home Screen 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 ...

Page 33: ...aviour can be con gured in Settings 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 agai...

Page 34: ...ired to determine the lung volumes ERV and IC correctly Tapping on the i symbol will display information on the measurement procedure Perform a Slow Spirometry 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 adjus...

Page 35: ...mally ERV 6 s 6 s 2 VCin 3 Tap on Evaluate to end the rst effort 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...

Page 36: ...splay after the rst effort Screen display after two efforts Scroll down to display further parameters if applicable The lower section of the screen displays the predicted values calculated from the patient data and the actual values measured during the test Pred Predicted value Best Best values from all efforts Pred Best value in of predicted values The Best column displays the best value out of a...

Page 37: ...Medication time and the Technician name Tap on Enter Dosing Tap Dosing The following data can be entered Medication Enter the Medication e g Albuterol 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 Medication Dosing Record ...

Page 38: ... 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 Screen display after the Post Measurement Pre Measurement green Post Measurement purple ...

Page 39: ...SpiroSphere ECG Instructions for Use Page 39 136 Version 02 02 04AUG2022 Pre Post Report ...

Page 40: ...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 eld on the Home Screen 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 describ...

Page 41: ...e Page 41 136 Version 02 02 04AUG2022 Tap on Yes The Patient Directory is displayed Assign Adhoc Test now Tap on Add and enter the respective patient data see chapter Add Patient for details Following window appears Finish by tapping OK ...

Page 42: ...04AUG2022 Assign Adhoc Test later Tap on No Tap on Add to enter the appropriate patient data The patient which is not registered yet will appear as Adhoc Patient in the Patient Directory In order to assign a patient to the Adhoc test performed tap on Adhoc Patient ...

Page 43: ... Instructions for Use Page 43 136 Version 02 02 04AUG2022 Select a completed test The following y out menu appears Tap on Show to display the results of the selected test on the screen Show Edit Delete and Print Tests ...

Page 44: ...eight or height e g in children has changed in the meantime by tapping on Edit The selected test can be deleted with Delete Tap on Print to print the selected test or send a PDF report to a designated e mail address For more detailed information see chapter Print Recorded Results Tapping on Yes will irrevocably delete the selected test ...

Page 45: ...rformed with the respective patient can be deleted by tapping on Delete Tap on Delete All Tests to delete all measurements performed with the selected patient Tapping on Yes will irrevocably delete the selected patient and all respective tests Tapping on Yes will irrevocably delete all tests assigned to the selected patient ...

Page 46: ...he network 3 See chapter Settings and Tools Report Printing Tap on the Printer icon Tap on the Report Selection eld Print Recorded Results Tap on Return to create the report The Print Result window appears Tap on OK to send the report to the prede ned e mail address Best Effort Report a report displaying the best effort is created All Effort Report a report displaying all efforts is created Screen...

Page 47: ...work Tap on the Settings Tools button on the Home Screen The following will appear Timezone Date Time 2SWLRQV H QLWLRQ KRRVH 3UHVHW select actual Country select timezone City ON OFF ON 24h 12h 24h set actual Time YYYY MM DD 2016 08 16 DD MM YYYY 16 08 2016DD MM YYYY DD MMM YYYY 16 AUG 2016 MM DD YYYY 08 16 2018 set actual Date General Tap on General Settings and Tools ...

Page 48: ...g options Preset English US German English US cm in cm kg lb kg Sound Setting options Preset select 50 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 49: ...ction 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 To make the SpiroSphere Sensor visible for pairing ensure it is powered on and then remove and reinsert the SpiroSphere Sensor unit to the cradle ...

Page 50: ...2 04AUG2022 Select Pair to pair a new 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 unit Select Unpair to unpair the SpiroSphere Sensor ...

Page 51: ...an Asian American is 0 88 of Caucasian per MESA for FEV1 FVC ECCS Zapletal 5 17 years Zapletal 18 70 years ECCS 93 107 182 cm for Zapletal only Caucasian Oriental Hong Kong Chinese 1 0 of Caucasian Orientals Japanese Americans FEV1 0 89 of Caucasian FVC 1 0 of Caucasian Polynesians 0 9 of Caucasians North Indians Pakistanis 0 9 of Caucasians African Descent 0 87 of Caucasians Chinese Female FEV1 0...

Page 52: ...eset 1 2 3 3 1 2 3 4 1 2 3 4 5 6 7 8 3 ON OFF ON OFF Con rm Enforce Con rm OFF Con rm Enforce Con rm Ambient Conditions Setting options Preset C F C hPa mmHg hPa Unit Groups Setting options Preset mL L L mL L mL L s mL s L min L s L s mL s L min L s L min L min s ms s s ms ms 1 L L s L L s Hz 1 min 1 min ...

Page 53: ...L 0 0 Decimals of Flow L Sec 0 1 2 3 2 Decimals of Flow mL Sec 0 0 Decimals of Flow L min 0 1 0 Decimals of Volume per Minute L min 0 1 0 Decimals of Time s 0 1 2 3 2 Decimals of Time msec 0 0 Decimals of Ratios 1 0 1 2 3 2 Measurement Spirometry Settings Forced Spirometry Example Preset 0 Preset 1 Preset 2 FVC L 5 5 1 5 10 Scroll down to display further settings if applicable ...

Page 54: ...ck Extrapolation Inspiratory Back Extrapolation Setting options Preset Always Never Always correct incorrect Example 4 6 liters Example 3 8 liters 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 ...

Page 55: ...he system determines the best breathing maneuver within this trial according to preset criteria Best Expiration Setting options Preset FEV1 FVC FEV1 FVC FEV1 FVC FVC FERV1 1 3 PEF FEV0 5 FVC FEV0 5 Best Inspiration Setting options Preset FVCin PIF FVCin PIF FVCin 0 1 PIF FVCin FIV1 FVCin FIV1 Use best EX Summary default View Setting options Preset Flow Volume Flow Volume Tiffenau Spirogram If Flow...

Page 56: ...ns the inspiratory portion of the curve will not be displayed The setting can be changed during the measurement Inspiratory Position Setting options Preset TLC RV 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 Preset ON OFF ON If activated ON a predicted curve will be displayed in the diagram as referenc...

Page 57: ...mation Warning Error OFF Warning Con rmation Error Error OFF Warning Con rmation Error Error OFF Warning Con rmation Error Quality Feedback documented in an Example report ABG means errors A B G are present ATS error codes As the quality of a spirometry measurement strongly depends on the patient s cooperation the criteria de ned by the ATS must be met If the respective criteria are not met they w...

Page 58: ...c Automatic 12 9 6 4 L Automatic VCin VCex VCmax IC ERV VCmax ERV VC IC VC Maneuver ERV VC Maneuver Measurement Quality Feedback Quality Feedback documented in an Example report N means the criteria N are not met ATS error codes Setting options Preset Error OFF Warning Con rmation Warning Error OFF Warning Con rmation Warning Error OFF Warning Con rmation Error ...

Page 59: ...asurement Preset FEV1 FEV1 FVC FVC PEF MMEF FVCin Parameter Selection 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 cha...

Page 60: ...rameters which can be selected to be shown during a measurement Slow Spirometry Printed Parameters 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...

Page 61: ... electrical activity but is not a measure for cardiac pumping capacity muscle strength SpiroSphere ECG allows recording of a 12 lead resting ECG measurement The Waveform Willem Einthoven 1860 1927 Professor of Physiology and Winner of the 1924 Nobel Prize developed the ECG Standard Leads I II and III which are named after their inventor Einthoven named the prominent waves alphabetically P Q R S T ...

Page 62: ...h site should be suf cient TIP Electrodes should be stored in an air tight container Electrodes will dry out if not stored properly which will cause loss of adhesion and conductivity Please note the storage conditions indicated on the electrode packaging Correct electrode placement is important for acquiring a successful ECG recording Chest ECG V1 Fourth intercostal space at the right sternal bord...

Page 63: ...r line V5 Anterior axillary line at same horizontal level as V4 V6 Mid axillary line on same horizontal level as V4 and V5 LA Left wrist RA Right wrist RL Right ankle LL Left ankle 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 indivi...

Page 64: ... Goldberger I II III Six unipolar chest leads V1 V2 V3 V4 V5 V6 according to Wilson V1 V2 V3 V4 V5 V6 In contrast to the limb leads the chest leads have to be positioned precisely The lead positions are internationally standardized V1 V2 V3 V4 V5 V6 V1 4th intercostal space right sternal border V2 4th intercostal space left sternal border V3 midway between V2 and V4 V4 5th intercostal space left m...

Page 65: ...ecrease the device can be damaged or electric shock to the operator or other persons occur Preparing for the Measurement 1 Attach electrodes Procedure Clean the subject s skin with a skin sensitive agent to remove probable fatty residues Make sure that the skin is dry before applying the electrodes Only the supplied disposable electrodes are to be used Remove protecting foil and attach the electro...

Page 66: ...ubleshooting Guide Do not insert or change batteries while a patient is attached to the ECG device Dispose of used batteries in accordance with the regulations of your country Using a battery other than recommended by manufacturer may shorten the device runtime of the ECG device and may affect the accuracy of the battery status indication Performing an ECG Recording SpiroSphere ECG allows the reco...

Page 67: ...essing the power button The LED will turn blue indicating the ECG unit is powered on If the battery is low the LED will blink Select Next to continue A screen displaying the correct placement of the electrodes for the ECG recording will appear Select Next The system will illuminate the electrodes in a xed sequence ...

Page 68: ...th 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 If a contact is poor the respective electrode will blink on the screen If an electrode contact is indicated as poor please check the respective contact ...

Page 69: ...splayed on the screen The system will also check for possible pacemaker presence as well as any quality issues If detected a message box will appear and an icon will display 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 d...

Page 70: ...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 using a ruler It is possible to print with Gain 10mm mV or 5mm mV Speed 25mm s or 50mm s depending on the con gured on scree...

Page 71: ...V Scaling Line gap no reference value 1mV 1mV 1mV 1mV 1mV 1mV 1mV 1mV 1mV 1mV 1mV 1mV 1mV 1mV 1mV 1mV Line gap no reference value Line gap no reference value Line gap no reference value Line gap no reference value Line gap no reference value Line gap no reference value Line gap no reference value ...

Page 72: ...ording The ECG Result screen will display If the quality of the recorded data is not suf cient a new ECG recording should be started prior to pressing Repeat The full 10 seconds of any lead can be displayed by touching the respective lead required to be shown in the example Lead II Note The printed report will always show the full 10 seconds of Lead II independent of that selected in the Online vi...

Page 73: ...ge 73 136 Version 02 02 04AUG2022 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 ...

Page 74: ... considered as quasi standard for ECG recording and interpretation 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 ECG interpretation st...

Page 75: ...ring an ECG measurement They 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 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 Enables or disables printing of the ECG computeris...

Page 76: ...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 The number of parameters printed is not limited The ECG Unit will turn itself off after 10 minutes if it is not used Connecting an ECG Unit Start the device by brief pressing the ON button The LED lights steady blue when the device is ready ...

Page 77: ...k has a limited range The distance between the ECG unit and the receiving display device can therefore impact the quality of the Bluetooth connection Keep it as short as possible and free of objects between them If the Bluetooth transmission fails for more than 10 seconds the latest ECG data are erased and therefore lost for the recording The separation of the point to point Bluetooth connection f...

Page 78: ...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 Tap ON the switch to activate User Management The following screen appears Enter the Global Password 691982 and tap OK User Management ...

Page 79: ...g screen appears Enter the details for the user for rst user of the system this must be Administrator role Options for role type Administator User Support Select whether or wish to use your ngerprint reader for access to the system Enter all the required information to create your user ...

Page 80: ...ftware X X X Patients Administrator User Support New patient X X Search patient X X X View patient details X X X Change patient demographics X X View measurements X X X Perform measurements X X Print reports X X X Sensor Check Calibration Check X X X Linearity Check X X X Calibration CheckLog X X X Linearity CheckLog X X X Tools Create backup X X X View system info X X X Overview who has which use...

Page 81: ... 02 04AUG2022 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 Register ngerprints ...

Page 82: ... for Use Page 82 136 Version 02 02 04AUG2022 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 83: ...re ECG Instructions for Use Page 83 136 Version 02 02 04AUG2022 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 ...

Page 84: ...n 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 When User Management is active additional items appear in the Settings screen The User Directory is displayed User Directory Select User Directory ...

Page 85: ...ls 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 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: ...hanges and tap Next to move to the ngerprint registration see above If you choose not to register ngerprints this button is labelled Save An Administrator is able to activate deactivate a user and to reset the password with a temporary password for another user from the y out menu in the User Directory Edit User Deactivate User Reset Password Tap Deactivate User to deactivate the selected user ...

Page 87: ...rity Question and Answer can be de ned for the current user To reset the password for another user tap Reset Password The following screen appears The user will be required to change their password upon their login Change Security Question Make the appropriate entries and tap Save to save the Security Question ...

Page 88: ... the No backup performed eld on the Home Screen If Perform Backup is selected the message Please ensure a Backup USB Stick is Inserted appears Tap on Start Backup to create a backup le and save it to the USB stick Insert USB stick A backup of all saved patient and test data should be performed and saved to a USB Stick on a regular basis ...

Page 89: ...89 136 Version 02 02 04AUG2022 Recover If Perform Recover is selected the message Please ensure USB Stick for Recover is Inserted appears Tap on All Data to reload all data into the patient directory of your SpiroSphere Insert Backup USB stick ...

Page 90: ...on Network Requirements WiFi 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 Tap on the desired WiFi network Tap Connect to initiate the connection The following y out menu appears ...

Page 91: ...structions for Use Page 91 136 Version 02 02 04AUG2022 Enter the password as applicable and tap Connect Ethernet If DHCP is set on Off then you can manually enter the appropriate settings Choose the appropriate settings ...

Page 92: ...22 3G only applicable for optional 3G module Enter the appropriate Access Point Name and the Service Number 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 ...

Page 93: ... A more detailed description of the possible con guration settings in the Settings Tools menu can be found in the chapter Settings Tools Communication in this manual The following information describes the network settings and behavior of the SpiroSphere system How is SpiroSphere con gured Linux 32bit No Third Party Application can be installed No Access to operating system No Access to an open we...

Page 94: ... and the con guration of the electronic report functionality can be found in the section Report Printing Safety hints The integration of the SpiroSphere to an IT network that includes other devices can incorporate risks to patient operator or other persons The user operator who integrates the SpiroSphere to the network is responsible to analyze rate and handle those risk accordingly eg according I...

Page 95: ...he person the reports should be sent to Zip File Password Set the password the recipient is required to enter in order to open the zip folder See chapter Print Recorded Results SpiroSphere allows for reports to be printed with an external printer In addition 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 maile...

Page 96: ... 04AUG2022 Reports Setting options Preset Input Customer Name Input Customer Address Best Effort Report Best Effort Report All Efforts Report Email Print Job Print jobs state Input Username Input Password Input Email Address Input Server Name Input Port Input SSL ...

Page 97: ...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 Con guration of the Electronic Report Functionality Update Tap on Search for Update The device will search for updates on the connect...

Page 98: ...A detailed description of this tool is not part of this Instructions for Use About Device Restore Default Settings Factory Reset You can view system information under the About Device section The system settings can be restored to the defaults using Restore Default Settings ...

Page 99: ...e 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 reusin...

Page 100: ... while the devices are in operation Avoid Àuid eg detergent getting in contact with the connector inside of the guiding tube of the sensor unit 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 Ple...

Page 101: ...rculosis it is necessary to dispose of the single patient use items in special designated containers In addition please note country speci c disposal regulations 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 A...

Page 102: ...the ECG Unit Surface Clean the ECG unit only when switched off Be certain that no liquids penetrate into the device Wipe the housing with a soft moist cloth Use Incidin Foam or an equivalent means for disinfection such as Lysol wipes Follow the instructions regarding the use and exposure time of the disinfectant Never submerge the device into disinfectant or other liquids This might result in devi...

Page 103: ...ain 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 The separation of the point to point Bluetooth connection from another network e g intranet internet is under the responsibility...

Page 104: ...ces There is already a Bluetooth pairing with another device Put the device into pairing mode For this press the button after power on until the blue LED ashes This indicates that the former pairing is removed and the device is visible in the Bluetooth vicinity No or fragmentary ECG data is transferred Radio communication is interrupted Reduce distance to receiving unit or remove a possibly existi...

Page 105: ...ment of returns before reshipment Irrespective of whether or not a contamination risk is known products which had direct or indirect contact with biological working substances e g blood secre tions or other body uids or with highly active pharmaceuticals e g gloves of the clinical or surgical staff should be regarded as potentially dangerous to health According to the regulation on biological subs...

Page 106: ...be defective deposits and adhesions should be removed carefully without damaging or altering the product if possible For this refer to the notes on the preparation of products Products which have been contaminated by highly active pharmaceuticals have to be cleaned appropriately with tap water 3 Disinfection Sterilization After cleaning the products have to be disinfected and or sterilized only if...

Page 107: ...gulations on the transportation of dangerous goods and may be transported by a forwarding agent or a parcel service For this purpose use the accompanying shipping documents of the forwarding agent carrier containing the corresponding valid transportation regulations e g GGVSE Road and Railway Dangerous Goods Regulation The product is then dispatched to the address indicated by the manufacturer Add...

Page 108: ...luids so that it is hygienically safe the enclosed medical product had contact with blood or other body fluids during its use The product has been cleaned and decontaminated as follows Disinfection by wiping all accessible surfaces with Disinfectant Concentration Reaction time Other procedure please indicate Steam sterilization 3 minutes at 134 C or 15 minutes at 121 C the enclosed medical product...

Page 109: ...he operator user is liable for his her modi cation of the medical product ERT only guarantees for the safety reliability and functionality of the instrument if installation extension modi cations and repairs are exclusively carried out by personnel authorized for these tasks by ERT the room in which the equipment is operated complies with the country speci c installation standard the unit can be p...

Page 110: ...ce electric or magnetic interference elds may falsify the result of measurements or make taking measurements impossible Due to this the vicinity of power lines is to be avoided as well Existing environmental interferences may cause deviations of the measurement values without impairing the device s function Therefore it is recommended to keep a distance of about 2 meters from possible error source...

Page 111: ...r compliance of the unit s own data with those of the local power supply system mains voltage and mains frequency before actually connecting the unit Connect only if all data comply Inspect the mains connection cable plug and receptacle for visible damages prior to establishing the connection Damaged cables or plugs must be replaced immediately Installation and assembly of the device must be done ...

Page 112: ... 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 ...

Page 113: ...pened 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 vi...

Page 114: ...he medical device is not suitable for use in aircraft or moving vehicles User must comply with the instructions given in this manual for avoiding infections and bacterial contaminations Repairs must only be performed by the manufacturer or by factory trained personnel Carry out a visual control of device cables and the other equipment accessories before each use Do not use the device if obvious ex...

Page 115: ...ight result It is not possible to operate the medical device in combination with HF devices e g surgical units When monitoring critical patients an alternative medical device must be kept available at all times in case of a device breakdown Avoid tensional load on the cables Only use biocompatible and FDA or CE certi ed electrodes as applicable with the medical device Comply with the instructions ...

Page 116: ...t in an increased electromagnetic emission or decreased electromagnetic immunity of the medical device and result in improper operation The medical device must not be operated in potentially explosive atmosphere Check the settings of the signal strength before each use When using the medical device it is necessary to place the patient under constant monitoring The medical device must not be used o...

Page 117: ...itions for storage and transport that are listed in the chapter Technical Data Take care in arranging subject and ECG electrode cables to avoid risk of subject entanglement or strangulation No adverse effects are known for the ECG ampli er itself However electrodes or electrode gel can lead to skin irritation on a transient basis In rare cases an allergic reaction has been observed to certain kind...

Page 118: ...d part of Type BF Single use Disposal of electronic devices in compliance with WEEE Packaging can be recycled Temperature limit Unique Device Identi er Medical Device CAUTION FEDERAL U S LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN Serial number Reference number Protection against intrusion of solids 12 5mm diameter no protection against ingress of liquids Protection against...

Page 119: ...s 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 Protect the battery against re Do not dismantle or manipulate the battery Do not replace the battery Improper replacement can lead to re excessive heat or explosion The uid in the ba...

Page 120: ...ot cause harmful interference and 2 this device must accept any interference received including that may cause undesired operation SpiroSphere Main Unit FCC ID 2AAUFSPS001 for optional 3G module included 2AAUFSPS003 for optional 3G module excluded SpiroSphere Sensor Unit FCC ID 2AAUFSPS002 FCC Notice Declaration of Conformity Information This equipment has been tested and found to comply with the ...

Page 121: ...6 MHz 23 dBm 2 dBm Class 3bis GSM 850 824 to 849 MHz 2 Watts GSM GPRS and EDGE E GSM 900 880 to 915 MHz 2 Watts GSM GPRS and EDGE DCS 1800 1710 to 1785 MHz 1 Watt GSM GPRS and EDGE 1 1dBi PCS 1900 1850 to 1910 MHz 1 Watt GSM GPRS and EDGE 3G optional Frequency Band and Transmittet power Frequency Band Transmission Frequency Range Maximum Output Power 2400 MHz BT 2402 to 2480 MHz 12 dBm Bluetooth F...

Page 122: ... 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 The essential performance of the device is the acquisition of spirometry and ECG signals and display on the Main Unit Electromagnetic irradiation can influence the device essential perfo...

Page 123: ... in a stacked form as this may result in faulty operation 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 Portable RF communications equipment including peripherals such as antenna cables and external...

Page 124: ...es buildings used for domestic purposes Guidance and Manufacturerµs Declaration Electromagnetic Immunity 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 Immunity Test Electromagnetic Environment Electrostatic discharge ESD IEC 61000 4 2 8 kV in...

Page 125: ...acturer s Declaration Electromagnetic Immunity 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 Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Electrostatic Discharge ESD IEC 61000 4 2 8 kV contact 2 kV 4kV 8kV air 8 kV contact 2 kV 4kV 8k...

Page 126: ...0 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulation b 217 Hz 2 0 3 28 1845 1970 2450 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse modulation b 217 Hz 2 0 3 28 5240 5100 5800 WLAN 802 11 a n Pulse modulation b 217 Hz 0 2 0 3 9 5500 5785 NOTE If necessary to achieve the immunity test level the distance between the transmitting antenna and the ECG unit ...

Page 127: ... pursuant to Part 15 of the FCC rules These limits are designed to provide reasonable protection against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions it may cause harmful interference to radio communications However there is no guarantee that interference wil...

Page 128: ...eable 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 Protection Class Power Supply Class II SpiroSphere Sensor Internally powered Mode of Operation Continuous Moisture Protection Power Supply IP42 Main Unit IP21 SpiroSphere Sensor IP20 Applied ...

Page 129: ...0 of reading or 0 3 L s FEV1 and FVC 0 1 to 8 L 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 Transport Storage Temperature 20 C to 50 C Relative Humidity 15 to 90 Barometric Pressure 600 to 1200 hPa Ambient unit Measuring range Accuracy Barometric pressure 500 to 110...

Page 130: ...Pa 600 to 1200 hPa Humidity operation storage transport 5 95 RH not condensing Power supply 1x AA rechargeable battery Runtime 5h with AA battery 8h with rechargeable battery 2850mAh Current consumption at 1 5 V Operation Idle 230 mA 185 mA Data transmission wireless online with radio standard Bluetooth Protocol SPP Bluetooth Bluetooth module Panasonic PAN 1322 SPP Bluetooth standard V2 1 EDR clas...

Page 131: ...at sampling rate of 500Hz Filter bandpass 0 05 Hz 150 Hz no line lter 50Hz 60Hz Electrodes Standard ECG electrodes Connection of the electrodes 4 mm snap gilded Shelf life 1 year for device Product life The product life is 5 years Radio transmission Approved in accordance to RED directive transmitter module marked by CE manufactured by Panasonic incorporated to OEM product Application ECG Recordin...

Page 132: ...stic nose clip 892121 Nose clip pad foam material disposable 100 pieces per pack 706000 ERT PT incl mouthpiece 706002 ERT PT incl mouthpiece box of 10 706003 ERT PT incl mouthpiece box of 50 892104 Disposable Mouthpiece Snorkel pack of 30 992951 ECG Electrodes Extra Small 25 per pack 992950 ECG Electrodes Small 50 per pack 992946 ECG Electrodes Medium 25 per pack Use ERT accessories and spare part...

Page 133: ...ecording 61 66 ECG Results 72 ECG Settings 75 Electromagnetic Emission and Immunity 121 G General Cautions 114 Graphical Symbols 7 H Hygiene 102 I Indications for Use 2 Information on ECG Recording 61 Isoelectric Segments 65 L Limb ECG 63 M Mouthpiece 102 Muscle tremor interference 51 Q QRS Complex 65 R Rechargeable Batteries 66 Recycling 113 Resting ECG 61 Return of Goods 105 S Safety Precautions...

Page 134: ...SpiroSphere ECG Instructions for Use Page 134 136 Version 02 02 04AUG2022 For your notes ...

Page 135: ...SpiroSphere ECG Instructions for Use Page 135 136 Version 02 02 04AUG2022 ...

Page 136: ...s for Use Page 136 136 Version 02 02 04AUG2022 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 ...

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