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Instructions for Use SpiroSphere ECG 781239 Version 02.02 SpiroSphere ECG 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 thereof by any means, including printing, photo static duplication, microlms, or any other processes. eResearchTechnology GmbH Sieboldstrasse 3 97230 Estenfeld, Germany Tel:
Fax:
+49 9305 720-9891
+49 9305 720-7891 www.ert.com 2020 eResearchTechnology GmbH. All rights reserved. Indications for Use The SpiroSphere is a compact device to measure inspiratory and expiratory lung function parameters in adults and children aged 4 years and older. With the option ECG electrocardiographic diagnoses can be made. For this purpose a 12-channel surface electrocardiogram can be measured and recorded. Automatic interpretation of the ECG is not possible for pediatric subjects with an age below 16 years and for pacemaker subjects. It is not intended for intra-cardial use. The minimum age for ECG application is 4 years. It can be used by physicians in the ofce or hospital. Contraindications 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 intrathoracic, intraabdominal, and intracranial pressures. Potential risks of spirometry are primarily related to maximal pressures generated in the thorax and their impact on abdominal and thoracic organs, venous return and systemic blood pressure, and expansion of the chest wall and lung. The physical effort required can increase myocardial demand. Caution must be used for patients with medical conditions that could be adversely affected by these physiological consequences:
Due to increases in myocardial demand or changes in blood pressure Acute myocardial infarction within 1 week Systemic hypotension or severe hypertension Signicant atrial/ventricular arrhythmia Noncompensated heart failure Uncontrolled pulmonary hypertension Acute cor pulmonale Clinically unstable pulmonary embolism History of syncope related to forced expiration/cough Page 2/136 Version 02.02 04AUG2022 SpiroSphere ECG Instructions for Use Due to increases in intracranial/intraocular pressure Cerebral aneurysm Brain surgery within 4 weeks Recent concussion with continuing symptoms Eye surgery within 1 week Due to increases in sinus and middle ear pressures 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 tuberculosis Physical conditions predisposing to transmission of infections, such as hemoptysis, signicant secretions, or oral lesions or oral bleeding Spirometry should be discontinued if the patient experiences pain during the maneuver. Relative contraindications do not preclude spirometry but should be considered when ordering spirometry. The decision to conduct spirometry is to be determined by the ordering healthcare professional on the basis of their evaluation of the risks and benets of spirometry for the particular patient. Potential contraindications should be included in the request form for spirometry. LIMITATION:
The ECG unit is not suitable to be used with HF surgery devices. The ECG unit is not intended for intracranial use. The ECG unit is not intended for use in an EMS environment (Emergency Medical Services Environment). The ECG unit is not intended for use in home healthcare environments. The ECG unit is intended for indoor use only. Any non-observance of the procedure described in this Instructions for Use
(such as preparation for the measurement, operation, desinfection, accessories and replacement of parts etc.) results in a deviation from the intended use. Version 02.02 04AUG2022 Page 3/136 SpiroSphere ECG Instructions for Use Table of Contents Indications for Use ............................................................................................................................ 2 Contraindications .............................................................................................................................. 2 Notes on Safety in this Instruction Manual ....................................................................................... 6 Declaration of Conformity ................................................................................................................. 6 Graphical Symbols on the ECG amplier ......................................................................................... 7 Device Description............................................................................................................................ 8 Unpacking and Starting Operation ................................................................................................... 8 The SpiroSphere ............................................................................................................................. 9 Start-Up .......................................................................................................................................... 10 Shut down....................................................................................................................................... 11 LED Status SpiroSphere .......................................................................................................... 12 LED Status SpiroSphere Sensor .............................................................................................. 12 Troubleshooting .............................................................................................................................. 13 Sensor Insert and Remove ............................................................................................................. 15 Setup .............................................................................................................................................. 16 The Home Screen .......................................................................................................................... 19 Sensor Check ................................................................................................................................ 20 Calibration Check ........................................................................................................................... 20 Linearity Check ............................................................................................................................... 22 Add Patient ..................................................................................................................................... 23 Search Patient ................................................................................................................................ 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................................................................................................................................... 61 Information on ECG Recording ................................................................................................ 61 Performing an ECG Recording ................................................................................................ 66 ECG Results ............................................................................................................................ 72 ECG Evaluation ........................................................................................................................ 74 ECG Settings ........................................................................................................................... 75 Connecting an ECG Unit .......................................................................................................... 76 User Management .......................................................................................................................... 78 Backup & Recover ................................................................................................................... 88 Communication ........................................................................................................................ 90 Local IT Guide for Ethernet (LAN), WI-FI (WLAN) or optional 3G (Mobile Network) ............... 93 Report & Printing ...................................................................................................................... 95 Update ..................................................................................................................................... 97 About Device ............................................................................................................................ 98 Restore Default Settings .......................................................................................................... 98 Factory Reset ........................................................................................................................... 98 Page 4/136 Version 02.02 04AUG2022 SpiroSphere ECG Instructions for Use Cleaning/Hygiene Spirometry ......................................................................................................... 99 Hygiene ECG................................................................................................................................ 102 Functional Check ECG ................................................................................................................. 103 Troubleshooting Guide ECG ........................................................................................................ 103 Return of Goods in Medical Institutions ........................................................................................ 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 Accessories ........................................................................... 132 Version 02.02 04AUG2022 Page 5/136 SpiroSphere ECG Instructions for Use Notes on Safety in this Instruction Manual Following the ANSI (American National Standards Institute) recommendations for safety notes, specic passages of this instruction manual are clearly marked as safety notes. Degree of Danger Injury to persons Damages to property Meaning of Indicator 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.
(X) 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 6/136 Version 02.02 04AUG2022 SpiroSphere ECG Instructions for Use Graphical Symbols on the ECG amplier Symbol Description Applied Part of type CF, Debrillation-proof (ECG unit cable variant) Disposal of electronic devices in compliance with WEEE IP classication according to IEC60529 Radio symbol, non-ionizing radiation Manufacturer Date of manufacturing CE conformity symbol (Medical Device Directive) with code number of Notied 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 button Version 02.02 04AUG2022 Page 7/136 SpiroSphere ECG 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 aged 4 years and older. 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, optional 3G module and Ethernet. With the option ECG electrocardiographic diagnoses can be made. For this purpose a 12-channel surface electrocardiogram can be measured and recorded. Automatic interpretation of the ECG is not possible for pediatric subjects with an age below 16 years and for pacemaker ubjects. It is not intended for intra-cardial use. The minimum age for ECG application is 4 years. The SpiroSphere is intended to be used in a professional healthcare facility environment. Unpacking and Starting Operation SpiroSphere is delivered with the following accessories*:
1 Main Unit 1 1 SpiroSphere Sensor Power Supply with country adapters ERT PT with Mouthpiece Nose clips and Pads Instruction manual 4 2 1 Optional:
1 ECG Unit 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 8/136 Version 02.02 04AUG2022 The SpiroSphere SpiroSphere ECG Instructions for Use Main Unit:
Front view:
Power On/Off SpiroSphere Sensor Main Unit Fingerprint Sensor Rear view:
Charging Cradle LAN Power USB SpiroSphere Sensor:
LCD touch display Speaker USB LED Status Indicator ERT PT with Mouthpiece Power On/Off The SpiroSphere must not be exposed to direct sunlight nor positioned immediately near heating elements. Version 02.02 04AUG2022 Page 9/136 SpiroSphere ECG Instructions for Use Power supply:
Mains adapter Start-Up 1. Connect the SpiroSphere to a power 2. Put the SpiroSphere source complying with local regulations. LAN 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. Please refer "LED Status SpiroSphere and "LED Status SpiroSphere Sensor" on page 9. Page 10/136 Version 02.02 04AUG2022 SpiroSphere ECG Instructions for Use 4. Prior to the rst usage, switch on the SpiroSphere Sensor by pressing the "Power On" switch located at the back side of the SpiroSphere Sensor for at least 3 seconds. 5. Ensure an ERT PT is inserted correctly into the SpiroSphere Sensor (refer to Chapter "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. ERT PT with mouthpiece rail with sensor holes ERT PT is only for single use. Do not reuse the ERT PT due to risk of cross contamination. Do not remove the mouthpiece from the ERT PT. Only use the ERT PT with connected mouthpiece. Prior to the rst use, make sure that the SpiroSphere Sensor is fully charged. The maximum surface temperature of the SpiroSphere Sensor Unit can get up to 47C 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, press the "Power" button located at the front of the main unit. Disconnect the main unit from the power source (please note that this will prevent the battery from charging). 2. Power off the SpiroSphere Sensor by pressing the "Power" button located near the LEDs of the SpiroSphere Sensor. Do not position the Power Supply and the SpiroSphere so that it is difcult to operate the disconnection of the device from the mains supply. Version 02.02 04AUG2022 Page 11/136 SpiroSphere ECG Instructions for Use LED Status SpiroSphere Blue LED On Main Unit powered on Blue LED Off Main Unit powered off Blue LED Pulse Main Unit Standby Orange LED On Charging Orange LED Off Not charging/ charging complete To do:
N/A N/A N/A Orange LED blinking Low battery Connect Main Unit to a mains supply LED Status SpiroSphere Sensor Orange LED On Charging in cradle Orange LED Off No charging/ charging complete in cradle Low battery Orange LED blinking slowly Orange LED blinking fast Blue LED On SpiroSphere Sensor is actively transferring data to the Main Unit Blue LED Off Device in sleep mode Blue LED blinking slowly 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. The user has the following options:
- restart the SpiroSphere Sensor by pressing the power button on the SpiroSphere Sensor for more than 8 seconds
- go to "Spirometry Settings" >
"Sensor" and try connecting to the SpiroSphere Sensor Device may be off or battery might be discharged. Put the device into the charging dock or press the Power On switch Only the highest priority LED at a time is turned on (LED priority: Orange - Blue). Page 12/136 Version 02.02 04AUG2022 SpiroSphere ECG Instructions for Use Troubleshooting Problem Troubleshooting SpiroSphere Main Unit does not start SpiroSphere Main Unit is not switched on. Try to switch on with the power button (press the button for at least 3 seconds). Power supply is not connected and the battery discharged. Connect the power supply and let the SpiroSphere Main Unit charge for a few minutes. SpiroSphere Main Unit is in standby mode. Use the touch screen or power button to wake up. SpiroSphere Sensor does not start SpiroSphere Sensor is not switched on. Press the power button for at least 3 seconds to switch the SpiroSphere Sensor on. SpiroSphere Main Unit LED is blinking orange SpiroSphere Sensor orange LED is blinking slowly SpiroSphere Sensor LED is off while in the charging cradle Battery is discharged. Place the SpiroSphere Sensor in the charging cradle for at least 10 minutes, then try again. Battery is discharged. Connect power supply immediately. Battery is discharged. Place SpiroSphere Sensor in charging cradle of the SpiroSphere Main Unit. SpiroSphere Sensor is in sleep mode. Remove from the 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) Connection to the SpiroSphere Sensor is not possible Calibration Check or Linearity Check not successful SpiroSphere Main Unit is not responding SpiroSphere Sensor is not in the pairing mode. Remove the SpiroSphere Sensor from the charging cradle if already inserted and then insert the SpiroSphere Sensor in the charging cradle. SpiroSphere Sensor is now in pairing mode for 90 seconds. SpiroSphere Sensor is off. Power on SpiroSphere Sensor (see above). SpiroSphere Sensor is out of range. Check that the SpiroSphere Sensor is in the range (10m in the line of sight). Check if the calibration pump has the correct volume setting. Check if ERT PT is inserted correctly. ERT PT has been used replace by a new ERT PT Touch the Home icon (top left). Restart the SpiroSphere Main Unit by pressing the Power button for 3 seconds Shutdown Menu use restart. Press the power button for more than 8 seconds to switch off the SpiroSphere Main Unit. Then restart by pressing the power button for min 3 seconds. Version 02.02 04AUG2022 Page 13/136 SpiroSphere ECG Instructions for Use Problem Troubleshooting SpiroSphere Sensor orange LED is blinking fast
(error in SpiroSphere Sensor) Finger prints not recognized Press the power button of the SpiroSphere Sensor for more than 8 seconds to switch off the SpiroSphere Sensor. Then restart by pressing the power button for min. 3 seconds. Try to identify the SpiroSphere Sensor in the Spirometry Settings. Clean and dry the ngerprint sensor Restart the SpiroSphere Main Unit Touch Screen not reacting on touch Press the power button for more than 8 seconds to power off the SpiroSphere Main Unit. Then restart by 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 the power supply is connected. Check if the SpiroSphere sensor is inserted correctly in the cradle. SpiroSphere Sensor might be fully discharged; place it in the cradle and wait a few minutes then try to power on the SpiroSphere Sensor by pressing the power button for more than 3 seconds. SpiroSphere Main Unit is not charging Check if the power supply is connected to mains supply. Check if power supply is connected to the SpiroSphere Main Unit. Page 14/136 Version 02.02 04AUG2022 SpiroSphere ECG Instructions for Use Sensor Insert and Remove Take care that you have aligned the rail with the sensor holes of the PT tube with the grooved edge of the SpiroSphere Sensor (as below) when inserting the ERT PT into the SpiroSphere Sensor:
rail with sensor holes The ERT PT should be inserted fully without force. Remove the ERT PT in the direction of the arrow. Version 02.02 04AUG2022 Page 15/136 SpiroSphere ECG Instructions for Use Setup Prior to the rst use, a system setup needs to be performed. After switching on the SpiroSphere for the rst time, following screen appears:
Enter the Global Password and press <OK>. (The preset global password is "691982".) The System Setup wizard starts automatically. Follow the system setup steps (step 1 - 6) and enter or select the appropriate settings. Tap on
<Next> to conrm the respective settings and to continue with the next step. 1. Language Settings Select the appropriate language and conrm with <Next>.
(Refer to chapter "Settings &
Tools >Regional") 2. Date & Time Settings Select the appropriate settings and conrm with <Next>.
(Refer to chapter "Settings &
Tools >Timezone Date & Time") Page 16/136 Version 02.02 04AUG2022 SpiroSphere ECG Instructions for Use 3. Sensor Settings Place the SpiroSphere Sensor in the cradle, and 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. Conrm with <Next>.
(Refer to chapter "Settings &
Tools >Spirometry Settings -
Sensor") Note that pairing is only possible for 90 seconds after the SpiroSphere Sensor is placed in the cradle. 4. Ethernet Settings Choose the appropriate settings and conrm with <Next>. (Refer to chapter "Communication".) 5. WiFi Settings Choose the appropriate settings and conrm with <Next>. (Refer to chapter "Communication".) Version 02.02 04AUG2022 Page 17/136 SpiroSphere ECG Instructions for Use 6. User Management Settings 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. Choose the appropriate settings and conrm 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 & Tools". Page 18/136 Version 02.02 04AUG2022 The Home Screen After the SpiroSphere has been set up, upon powering on the device the following screen appears:
SpiroSphere ECG 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 Enter patient data for a new patient into your patient directory and start a test. Search for a specic patient in your patient directory. Select a specic patient from the list to perform a test or to edit his/her data. Sensor Check Perform a volume or linearity check. Adhoc Test Immediately perform a test without entering patient data or searching for a specic patient rst. Settings & Tools Change settings. Version 02.02 04AUG2022 Page 19/136 SpiroSphere ECG Instructions for Use Sensor Check The ERT PTs included with the delivery are pre-calibrated as part of manufacture. A sensor check can be performed to conrm accurate measurement data. Tap <Sensor Check> to perform a sensor check. The sensor check consists of a calibration check as well as a linearity check. Following screen appears:
Tapping on the "i"- symbol will display information on the respectively selected check type. Calibration Check Ensure a new ERT PT (with mouthpiece removed) is connected to the 3 L calibration syringe via an adapter (as shown). In order to perform a calibration check, tap on <Calibration Check>. An automatic zero adjustment is performed. Page 20/136 Version 02.02 04AUG2022 The calibration check is used to check the volume accuracy within 3 different ow ranges. With each syringe stroke, the volume accuracy should be within 3 %. SpiroSphere ECG Instructions for Use High Ex Mid Ex Low Ex Low In Mid In High In 3 %
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 = 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>. Version 02.02 04AUG2022 Page 21/136 SpiroSphere ECG Instructions for Use Linearity Check In order to perform a linearity check, tap on <Linearity Check>. Proceed as described in the "Calibration Check" section. During a linearity check, volume accuracy at different ows is tested. Three syringe strokes at a low, three at a mid-range ow and three at a high ow are required. With each syringe stroke, the volume accuracy should be within 3.5 %. 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 in each of the following ow levels; low, mid and high range. 1 syringe stroke = pump twice, i.e. from impact to impact. Screen display after a total of 9 syringe strokes:
better than 3.5 %
X worse than 3.5 %
End the linearity check by tapping on <Save>. Page 22/136 Version 02.02 04AUG2022 SpiroSphere ECG Instructions for Use Add Patient Before measuring a patient for the rst time, the patient's personal data has to be entered. Predicted values are calculated from patient data, so verify that the entered data are correct. Incorrect patient data produces incorrect predicted values!
To add a new patient to your patient directory, tap on the "Add Patient" button on the Home Screen. The following screen appears:
Return to the Home Screen Entry elds with instructions on entering Touchscreen Keyboard Hide Keyboard Enter Enter the appropriate patient data using the touchscreen keyboard and conrm with
<Enter>. The cursor automatically jumps to the next entry eld. The following data must be entered:
Identier:
Enter the Patient Identier 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>. Version 02.02 04AUG2022 Page 23/136 SpiroSphere ECG Instructions for Use Age:
Gender:
Height:
Weight:
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 Ethnicity:
Select the appropriate 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. Screen display after patient data input:
If you want to discard all data just entered, tap on <Clear Form>. All entry elds will be cleared. Patient data Available Actions (Type), and list of tests already performed (Previous Tests) Page 24/136 Version 02.02 04AUG2022 SpiroSphere ECG Instructions for Use Search Patient When a patient whose data is already stored in the database comes for another visit, you can reload his/her data from the patient directory. You do not have to enter the data again. 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 Search for specic Patients by entering his/her last name or ID. Entering the
rst letter or the rst character of the patient's ID is sufcient as well: If e.g. "S"
is entered, all patients whose last names start with "S" are displayed. Version 02.02 04AUG2022 Page 25/136 SpiroSphere ECG Instructions for Use If a listed patient is selected, the following y-out menu appears:
Tap on <Start> to display the patient's personal data on the left. In the "Actions"section, all conductable actions are listed. The "Previous Actions"
section shows the actions already performed for the specic 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. Page 26/136 Version 02.02 04AUG2022 SpiroSphere ECG Instructions for Use Each patient can be completely deleted from the patient directory by tapping
<Delete>. A "Warning" appears:
Tapping on "Yes" will irrevocably delete the selected patient including all saved measurements performed for that patient!
Actions SpiroSphere is capable of performing different types of measurements. The different options are displayed on the screen. Forced PRE Spirometry 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 Version 02.02 04AUG2022 Page 27/136 SpiroSphere ECG Instructions for Use Preparing a Spirometry Measurement Please observe the instructions for hygiene of your system. Verify that a new ERT PT with mouthpiece is attached in the SpiroSphere Sensor. Select a measurement
(e.g. <Forced PRE Spirometry>) via tapping. The measurement is started by tapping on <Start>. The "Ambient Conditions" window appears:
Current room temperature (C) Current relative humidity (%) Current barometric pressure (hPa) 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%. The ATP-BTPS correction factors for inspiratory and expiratory ows and volumes will be 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. Tap on <Continue> to apply the ambient data entered. Make the proper preparations according to ATS/ERS guidance. Page 28/136 Version 02.02 04AUG2022 SpiroSphere ECG Instructions for Use Perform a Forced Spirometry Measurement When the test is started, an automatic zero adjustment of the sensor unit is performed. Hold the SpiroSphere Sensor still and wait for the zero adjustment to be completed before approaching the mouthpiece. As soon as the zero adjustment is completed, the patient should close his/her nose with the nose-clip, take the mouthpiece between his/her teeth and seal his/her lips tightly around the mouthpiece. Check the correct position of the mouthpiece! For safety reasons, testing should be preferably done in the sitting position, using a chair with arms and without wheels. Please note: During the whole examination the patient must stay on the mouthpiece. The patient breathes normally (gure 1 ) until a steady tidal breathing is shown. From tidal breathing, the patient is instructed to inhale as deeply as possible (inhale to TLC - gure 2 ). 1 2 to TLC Screen display:
Tapping on the "i"-symbol will display information on the measurement procedure. Version 02.02 04AUG2022 Page 29/136 SpiroSphere ECG Instructions for Use Without interruption, the patient should immediately exhale as fast and as much (FEV1) and as long (FVC) as possible (gure 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 ). 4 FVCin 3 6 s6 s FEV1/FVC Screen display:
Flow-Volume curve Volume-Time tracing 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. Tap <Evaluate> to end the rst effort. Page 30/136 Version 02.02 04AUG2022 Screen display after the rst effort:
SpiroSphere ECG Instructions for Use The upper left part of the chart section shows the recording of the
ow-volume loop. The upper right part shows the volume-time tracing. The lower section of the screen displays the predicted values calculated from the patient data and the actual values measured from
rst effort. Pred Best
= Predicted value
= Best value of all valid efforts.
%Pred = Best value in % of predicted values The uality of the owvolume loop depends on the patients cooperation. 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
150 mL. For FVC 1 L a difference of 100 mL is valid*. 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. Denition of the best effort depends on the Settings selected
(see: >Settings Spirometry >Forced Spirometry >Measurement).
* Literature:
MR Miller et al. Series ATS/ERS Task Force: Standardisation of Lung Function Testing, Standardisation of Spirometry, Eur Respir J 2005; 319-338. Copyright ERS Journals Ltd. 2005 Scroll down to display further parameters
(if applicable) Version 02.02 04AUG2022 Page 31/136 SpiroSphere ECG Instructions for Use Change View:
Screen display ow-volume and 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 32/136 Version 02.02 04AUG2022 SpiroSphere ECG Instructions for Use Deactivate/reactivate efforts If several efforts were performed, individual efforts (e.g. efforts with insufcient patient cooperation) can be deactivated. The system can also automatically deactivate efforts as a result of system detected ATS/ERS acceptability errors. Behaviour can be congured 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 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>. Version 02.02 04AUG2022 Page 33/136 SpiroSphere ECG Instructions for Use Perform a Slow Spirometry Measurement When the test is started, an automatic zero adjustment of the sensor unit is performed. Hold the SpiroSphere Sensor still and wait for the zero adjustment to be completed before approaching the mouthpiece. As soon as the zero adjustment is completed, the patient should close his/her nose with the nose-clip, take the mouthpiece between his/her teeth and seal his/her lips tightly around the mouthpiece. Check the correct position of the mouthpiece! For safety reasons, testing should be preferably done in the sitting position, using a chair with arms and without wheels. Make the proper preparations according to ATS/ERS guidance. 1 Performance of an "ERV Maneuver":
Tidal breathing should be continued for a longer period of time
(gure 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 breathing over the last ve breathing cycles. dVT = variation (coefcient of variation) of the tidal volume 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 34/136 Version 02.02 04AUG2022 The patient should exhale slowly (see "Note" below) and completely (ERV - gure 2 ) followed by a slow and complete inhalation (VCin - gure 3 ). Then, continue to breathe normally. SpiroSphere ECG Instructions for Use 2 6 s6 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> to end the rst effort. Version 02.02 04AUG2022 Page 35/136 SpiroSphere ECG Instructions for Use Screen display after the rst effort:
The upper section of the chart section shows the recording of the volume-time curve. The lower section of the screen displays the predicted values calculated from the patient data and the actual values measured from
rst effort. 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. Denition of the best effort = highest VCmax.
(see: >Settings Spirometry >Slow Spirometry> Measurement) Page 36/136 Version 02.02 04AUG2022 SpiroSphere ECG Instructions for Use Medication Dosing Record Before the post-measurement is started you can input Medication, the Medication time and the Technician name. Tap <Dosing>. Tap on <Enter Dosing>
The following data can be entered:
Medication:
Enter the Medication, e. g. Albuterol/Salbutamol 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. Version 02.02 04AUG2022 Page 37/136 SpiroSphere ECG Instructions for Use Perform a Post Spirometry Measurement The Flow-Volume curve shows the immediate bronchospasmolytic effect. The expiratory portion of the Flow-
Volume curve and consequently, maximal peak ow (PEF), forced expiratory volume after 1 sec (FEV1) as well as forced vital capacity (FVC) changes. Screen display after the "Pre Measurement":
Screen display after the "Post Measurement":
Post Measurement (purple) Pre Measurement (green) Page 38/136 Version 02.02 04AUG2022 PrePost Report:
SpiroSphere ECG Instructions for Use Version 02.02 04AUG2022 Page 39/136 SpiroSphere ECG Instructions for Use Adhoc Test With the Adhoc Test application it is possible to perform a Spirometry measurement without having to register the patient beforehand. For example: An Adhoc test can be performed if a prompt measurement of a patient is urgently required (e.g. 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. Please select the measurement mode.
"Slow" or "Forced" spirometry:
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 40/136 Version 02.02 04AUG2022 SpiroSphere ECG Instructions for Use Assign Adhoc Test now Tap on <Yes>. The "Patient Directory" is displayed:
Tap on <Add> and enter the respective patient data (see chapter "Add Patient" for details). Following window appears:
Finish by tapping <OK>. Version 02.02 04AUG2022 Page 41/136 SpiroSphere ECG Instructions for Use Assign Adhoc Test later Tap on <No>. The patient which is not registered yet will appear as "Adhoc Patient" in the "Patient Directory". In order to assign a patient to the Adhoc test performed, tap on "Adhoc Patient". Tap on <Add> to enter the appropriate patient data. Page 42/136 Version 02.02 04AUG2022 Show, Edit, Delete and Print Tests Select a completed test. The following y-out menu appears:
SpiroSphere ECG Instructions for Use Tap on <Show> to display the results of the selected test on the screen:
Version 02.02 04AUG2022 Page 43/136 SpiroSphere ECG Instructions for Use Existing patient data can be edited (if e.g. the patient's body weight or height
(e.g. in children) has changed in the meantime) by tapping on <Edit>. The selected test can be deleted with <Delete>:
Tapping on <Yes> 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 44/136 Version 02.02 04AUG2022 SpiroSphere ECG Instructions for Use The selected patient including all measurements performed with the respective patient can be deleted by tapping on <Delete>:
Tapping on <Yes> will irrevocably delete the selected patient and all respective tests!
Tap on <Delete All Tests> to delete all measurements performed with the selected patient:
Tapping on <Yes> will irrevocably delete all tests assigned to the selected patient!
Version 02.02 04AUG2022 Page 45/136 SpiroSphere ECG 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 printer. It is also possible to create a PDF le which can be sent to a predened e-mail 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. Tap on the Report Selection eld. 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 the predened e-mail address. The report will be sent to the email address dened on your SpiroSphere. The report label will include the date and identication number. The le will be password protected as dened. 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 46/136 Version 02.02 04AUG2022 Settings and Tools The following includes a short description of settings which are not required for daily routine work. SpiroSphere ECG Instructions for Use Tap on the "Settings & Tools" button on the Home Screen. The following will appear:
General Tap on "General"
Timezone Date & Time
select actual Country select timezone City ON/OFF 24h/12h ON 24h set actual Time YYYY.MM.DD 2016.08.16 DD.MM.YYYY 16.08.2016 DD-MM-YYYY DD-MMM-YYYY 16-AUG-2016 MM/DD/YYYY 08/16/2018 set actual Date Version 02.02 04AUG2022 Page 47/136 SpiroSphere ECG Instructions for Use Regional Sound Power Management Setting options:
Preset:
English (US), German English (US) cm. in kg. lb cm kg Setting options:
select Preset:
50%
select select select select select select select select Preset:
100%
100%
5 min 2 min 10 min 5 min 20 min 20 min These settings inuence the battery life of the SpiroSphere. Page 48/136 Version 02.02 04AUG2022 Spirometry Settings Tap on "Spirometry Settings"
SpiroSphere ECG Instructions for Use Spirometry Settings - Sensor Sensor Connection 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. Active:
The SpiroSphere Sensor is connected to the SpiroSphere via Bluetooth Not paired:
The SpiroSphere Sensor is not connected to the SpiroSphere Battery:
Indicates the battery status of the SpiroSphere Sensor Version 02.02 04AUG2022 Page 49/136 SpiroSphere ECG Instructions for Use Select "Pair" to pair a new SpiroSphere Sensor Select "Unpair" to unpair the SpiroSphere Sensor Select "Activate" to make this SpiroSphere Sensor the active sensor for measurements Select "Identify" to trigger an LED response on active SpiroSphere Sensor unit Page 50/136 Version 02.02 04AUG2022 Spirometry Settings - General Predicted Values SpiroSphere ECG Instructions for Use Preset:
GLI 2012 Setting options:
None GLI 2012 NHANES III ECCS/Zapletal Knudson/Crapo Extrapolate Limits from Author Limits from Author No calculation outside limits Module GLI 2012 Age range Height range Differentiation acc. to Race 3-95 years no limitation Caucasian African American North East Asian South East Asian Other/mixed NHANES III 8-80 years 110-200 cm Caucasian ECCS/Zapletal 5-17 years
(Zapletal) 18-70 years
(ECCS 93) 107-182 cm
(for Zapletal only) African American Mexican American Asian-American is 0.88 of Caucasian (per MESA for FEV1, FVC) 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 0.93 of Caucasians, FVC = 1.0 of Caucasians Chinese (Male) = FEV1 0.95 of Caucasians, FVC = 0.94 of Caucasians Knudson/Crapo 6-90 years no limitation Caucasian African-Descent =
0.88 of Caucasian (for FEV1 & FVC) 1 For an age between 19 and 25, the calculation is based on the age of 25 Version 02.02 04AUG2022 Page 51/136 SpiroSphere ECG Instructions for Use Sensor Check Ambient Conditions Unit Groups Setting options:
Preset:
1, 2, 3 1, 2, 3, 4 2, 3, 4, 5, 6, 7, 8 ON, OFF 3 1 3 ON OFF, Conrm, Enforce OFF, Conrm, Enforce Conrm Conrm Setting options:
Preset:
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 Hz, 1/min
C hPa Preset:
L mL L/s L/s L/min s ms
L*L/s 1/min Page 52/136 Version 02.02 04AUG2022 Decimals SpiroSphere ECG Instructions for Use Possible Setting Options for Decimals:
Preset:
Decimals of Volume [L] - 0, 1, 2, 3 Decimals of Volume [mL] - 0 Decimals of Flow [L/Sec] - 0, 1, 2, 3 Decimals of Flow [mL/Sec] - 0 Decimals of Flow [L/min] - 0, 1 Decimals of Volume per Minute [L/min] - 0, 1 Decimals of Time [s] - 0, 1, 2, 3 Decimals of Time [msec] - 0 Decimals of Ratios [1] - 0, 1, 2, 3 2 0 2 0 0 0 2 0 2 Example: Preset 0: Preset 1: Preset 2:
FVC [L]
5.10 5.1 5 Spirometry Settings - Forced Spirometry Measurement Scroll down to display further settings
(if applicable) Version 02.02 04AUG2022 Page 53/136 SpiroSphere ECG Instructions for Use Diagram Scaling Adult Diagram Scaling Child Setting options:
Automatic 16 L/s, 12 L/s, 8 L/s , 4 L/s Preset:
Automatic If Automatic is selected and the breathing ow is greater or less than the preset ow axis, this axis will be rescaled automatically. FVC as FEV2 FVC as FEV3 FVC as FEV6
ON, OFF ON, OFF ON, OFF
OFF OFF OFF Expiratory Back Extrapolation Inspiratory Back Extrapolation If is selected, the value for the respective parameter is used as the FVC value. Setting options:
Always, Never Preset:
Always 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. 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 system determines the correct start of inspiration. Page 54/136 Version 02.02 04AUG2022 SpiroSphere ECG Instructions for Use FEF calculation Base FIF calculation Base Setting options:
individual FVC VC max Preset:
individual FVC If individual FVC is selected, the FEF or the FIF values will be calculated based on FVC. Best Expiration Best Inspiration 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 system determines the best breathing maneuver within this trial according to preset criteria. Summary default View Flow/Volume Setting options:
Preset:
Flow/Volume Tiffenau Spirogram If Flow/Volume is selected, the result screen will display the ow-
volume curve. If "Tiffeneau" is selected, the tiffenau curve will be displayed. Version 02.02 04AUG2022 Page 55/136 SpiroSphere ECG Instructions for Use Display Inspiratory ON, OFF Setting options:
Preset:
ON 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 TLC, RV Setting options:
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 56/136 Version 02.02 04AUG2022 SpiroSphere ECG Instructions for Use Spirometry Settings - Forced Spirometry Quality Feedback Setting options:
ON, OFF ON, OFF ON, OFF Preset:
ON Error Error, OFF, Warning, Conrmation Error, OFF, Warning, Conrmation Warning Error, OFF, Warning, Conrmation Warning Error, OFF, Warning, Conrmation Error, OFF, Warning, Conrmation Error, OFF, Warning, Conrmation Error Error Error As the quality of a spirometry measurement strongly depends on the patient's cooperation, the criteria dened by the ATS must be met. If the respective criteria are not met, they will be displayed in the results screen and nally documented in the report. Quality Feedback documented in an "Example" report:
ATS error codes ABG means: errors A, B, G are present Version 02.02 04AUG2022 Page 57/136 SpiroSphere ECG Instructions for Use Spirometry Settings - Slow Spirometry Measurement Quality Feedback 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 Setting options:
Preset:
Error, OFF, Warning, Conrmation Warning Error, OFF, Warning, Conrmation Warning Error, OFF, Warning, Conrmation Error Quality Feedback documented in an "Example" report:
ATS error codes N means:
the criteria N are not met Page 58/136 Version 02.02 04AUG2022 Parameter Selection Forced Spirometry - Displayed Parameters SpiroSphere ECG Instructions for Use The"Shown Parameters" column displays the parameters shown in the result screen of the forced spirometry measurement. Preset:
FEV1 FEV1/FVC FVC PEF 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 The"Shown Parameters" column displays shown the printed parameters of the forced spirometry measurement:
Preset:
FEV1 FEV1/FVC FVC PEF FEF25-75 FVCin Version 02.02 04AUG2022 Page 59/136 SpiroSphere ECG Instructions for Use Slow Spirometry - Displayed Parameters The "Shown Parameters" column displays the parameters shown in the result screen of the slow spirometry measurement. Preset:
ERV 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 The"Shown Parameters" column displays shown the printed parameters of the slow spirometry measurement:
Preset:
VCin IC VCmax VT BF Page 60/136 Version 02.02 04AUG2022 Resting ECG SpiroSphere ECG Instructions for Use SpiroSphere ECG allows recording of a 12-lead resting ECG measurement. Information on ECG Recording An electrocardiogram (ECG) is a graphic recording of the changes occurring in the electrical potentials (millivolt changes) at dened sites on the skin. The continuously changing electrical elds are the result of depolarization and polarization of the heart and are distributed in the body without any delay. The electrical elds are caused by the cardiac cells, which are electrically polarized. The ECG is a graphic recording of cardiac electrical activity but is not a measure for cardiac pumping capacity (muscle strength). 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 and U. The at amplitudes P, T and U are called waves, Q, R and S are called peaks. The P-wave represents the wave of depolarization that spreads from the atrium. The Q, R and S peaks, also referred to as QRS-complex, represent the wave of depolarization from the ventricle. The T-wave represents the repolarizations of the ventricle. The U-wave is undened. Version 02.02 04AUG2022 Page 61/136 SpiroSphere ECG Instructions for Use ECG Leads To minimize artifacts, the skin of the dened lead positions has to be prepared thoroughly. Preparing the subects skin:
1. Identify the (10) electrode sites on the torso by referring to the picture and description below. 2. Remove any hair from the electrode site using a razor. 3. Wipe oils from the electrode sites with an alcohol prep pad. 4. Remove any dead skin from the electrode sites with an abrasive cleaner. Two to three moderate rubs at each site should be sufcient. 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 V2 V3 V4 V5 V6 LA RA RL LL Fourth intercostal space at the right sternal border Fourth intercostal space at the left sternal border Midway between V2 and V4 Fifth intercostal space at the left of the midclavicular line Anterior axillary line at same horizontal level as V4 Mid-axillary line on same horizontal level as V4 and V5 Left wrist Right wrist Right ankle Left ankle Page 62/136 Version 02.02 04AUG2022 Limb ECG SpiroSphere ECG Instructions for Use V1 V2 V3 V4 V5 V6 LA RA RL LL Fourth intercostal space at the right sternal border Fourth intercostal space at the left sternal border Midway between V2 and V4 Fifth intercostal space at the left of the midclavicular line Anterior axillary line at same horizontal level as V4 Mid-axillary line on same horizontal level as V4 and V5 Left wrist Right wrist Right ankle 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 individual electrode and a group of combined electrodes and recorded by SpiroSphere ECG. Version 02.02 04AUG2022 Page 63/136 SpiroSphere ECG Instructions for Use The different measurement setups are commonly referred to as leads. For a standard 12-lead ECG, four electrodes are placed at the limbs and six at the chest. The 12 leads are:
Three bipolar limb leads: I, II and III (according to Einthoven) I II III Three unipolar limb leads: aVR, aVL and aVF (according to 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. MCLL VAXL MAXL =
mid-axillary line 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 mid-clavicular line V5: between V4 and V6, left anterior axillary line V6:
level with V4, left mid-axillary line Lateral view of lead positions Page 64/136 Version 02.02 04AUG2022 SpiroSphere ECG Instructions for Use Treatment of Isoelectric Segments within the QRS-Complex The wave of depolarization is a spatial entity, which means that the onset of a wave will not be evident in all leads at the same time. Isoeletric sections starting at QRS onset of a complex are treated as part of the subsequent signicant wave. Similarly, the isoelectric sections at the end of the QRS-complex are incorporated into the preceding signicant wave. Basic Conditions for ECG Recording For high-quality ECG recording, certain criteria have to be met:
Mentally prepare the subject for the examination in order to eliminate pain and consequently tachycardia and muscle tremor.
Ambient temperature should be at least 23 C to avoid shivering; make sure that the subject is lying comfortably on a suitable couch or bed and eliminate all sources of noise.
Check the condition of your equipment to ensure proper signal sampling.
Make sure that the chest electrodes are positioned according to international standards and pay attention to polarity of the limb and chest electrode cables.
The subject should try to avoid movement during the measurement because this can lead to motion artifacts. Only use original electrode cables delivered by ERT. If the wrong cable is used the debrillation energy delivered to the patient can decrease, 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 electrode to the skin. 2. Connect the ECG unit electrode cables with the electrodes.
Adhesive electrodes are for single use only.
Comply with the instructions for use of the elctrodes used.
The electrodes must only be applied to intact skin.
Do not use electrodes that have exceeded their expiration date or have dried electrode gel. Version 02.02 04AUG2022 Page 65/136 SpiroSphere ECG Instructions for Use Insertion of Batteries/Rechargeable Batteries, Charge Level Indicator To chage the battery, open the battery compartment cover and insert the battery or rechargeable battery matching the polarity indicated in the battery compartment. Close the battery compartment cover. To determine if the battery needs replacement, see "Troubleshooting 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 recording of a 12-lead resting ECG measurement. Add a <New Patient>, or <Select a Patient> from the "Search Patient" option. Scroll the list of Actions down to the action "ECG" within the Patient Details screen:
Page 66/136 Version 02.02 04AUG2022 Power on the ECG unit by pressing the power button. The LED will turn blue indicating the ECG unit is powered on. If the battery is low, the LED will blink. SpiroSphere ECG Instructions for Use Power button 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. Version 02.02 04AUG2022 Page 67/136 SpiroSphere ECG Instructions for Use The electrodes can be visually checked (running lights), starting with V1 and end with LL. Look for the e shape to conrm correct lead placement. Press <Next>. Prior to the ECG recording, an Impedance Check will be performed to conrm 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 68/136 Version 02.02 04AUG2022 SpiroSphere ECG Instructions for Use
Adhesive electrodes are for single use only.
Comply with the instructions for use of the elctrodes used.
The electrodes must only be applied to intact skin.
Do not use electrodes that have exceeded their expiration date or have dried electrode gel. Correct the contact issue (if necessary) and press <Next> to start the ECG recording. The ECG will begin to record. The recorded ECG waveforms are displayed 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:
Version 02.02 04AUG2022 Page 69/136 SpiroSphere ECG Instructions for Use Pacemaker Quality issue Scaling and Filter You can adjust the view of the online recording by changing the settings for Gain and Speed. You can also apply lters to the view. Note: The on-screen scaling has been adapted to t the aspect ratio of the display. It should not be used for direct on-screen measurement (e.g. using a ruler). Gain:
5mm/mV, 10mm/mV Speed: 25mm/sec, 50mm/sec Filter:
No Filter, Line Filter, Muscle Filter, All Filter It is possible to print with:
Gain: 10mm/mV or 5mm/mV Speed: 25mm/s or 50mm/s
(depending on the congured on-screen display). Page 70/136 Version 02.02 04AUG2022 10 mm/mV Scaling SpiroSphere ECG Instructions for Use 5 mm/mV Scaling 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 Line gap no reference value Version 02.02 04AUG2022 Page 71/136 SpiroSphere ECG Instructions for Use ECG Results After 10 seconds the <Evaluate> button will become available to allow you to end your recording. Inspect the recording quality of the signals. If the signals are free of drift and noise, press <Evaluate> to end the recording. The ECG Result screen will display:
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 view or Results screen. If the quality of the recorded data is not sufcient, a new ECG recording should be started prior to pressing <Repeat>. The previously recorded data will be deleted and the ECG recording re-started. Page 72/136 Version 02.02 04AUG2022 SpiroSphere ECG Instructions for Use If you are happy with the recording select <Finish> to save the ECG. The ECG can be printed by selecting the <Print> icon. You can also print your ECG afterwards from the Patient Details screen, via the
y-out menu:
Version 02.02 04AUG2022 Page 73/136 SpiroSphere ECG Instructions for Use ECG Evaluation The printed report will show the 12-lead ECG tracing, as well as information pertaining to the patient details, system calculated Interval Duration Measurements, Interpretation. These are provided as a guide only. Final clinical decision lies with the Physician. It is possible to print with: Gain: 10mm/mV or 5mm/mV | Speed: 25mm/s or 50mm/s (depending on the congured on-screen display). Interpretation according to HES SpiroSphere with ECG provides the Hannover ECG System HES, which has been developed together with leading cardiologists all over the world. Today, the HES algorithm is 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 qualied physician has to reassess all SpiroSphere ECG measurements. An interpretation by SpiroSphere with ECG is only signicant when considered together with other clinical ndings. ECG interpretation statements made by SpiroSphere with ECG represent partial qualitative and quantitative information on the subjects cardiovascular condition and no therapy or drugs can be administered solely on the interpretation statements. Page 74/136 Version 02.02 04AUG2022 ECG Settings Settings for ECG can be found under ECG Settings:
SpiroSphere ECG Instructions for Use ECG Displayed 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 computerised interpretation Up to seven (7) parameters can be selected for display during 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 Version 02.02 04AUG2022 Page 75/136 SpiroSphere ECG Instructions for Use ECG Printed Parameters:
This congures the parameters that will be displayed on the printed ECG Report. The parameters can be added or removed in this section, by either double tapping or dragging across the respective parameter to either Not active (not shown), or Shown Parameters. The number of parameters printed is not limited. Connecting an ECG Unit Start the device by brief pressing the <ON> button. The LED lights steady blue when the device is ready. The ECG Unit will turn itself off after 10 minutes if it is not used. Page 76/136 Version 02.02 04AUG2022 Select ECG Unit connection from the ECG Settings menu. SpiroSphere ECG Instructions for Use 1. On your ECG Unit press and hold the power button until the blue LED blinks fast. This will take approximately 20 seconds. 2. After further few seconds, the ECG unit will be listed in the above screen. 3. Select the ECG unit you wish to pair, and push Pair from the y out menu:
4. The ECG unit will then change to state Active and is ready to use.
The Bluetooth radio link 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 from another network (e.g. intranet, internet) is the responsibility of the operator. If the point-to-point Bluetooth connection is not active for more than 10 minutes, the connection will be terminated. Any ECG data not already transmitted from the ECG unit will be lost after 10 seconds (see above). Version 02.02 04AUG2022 Page 77/136 SpiroSphere ECG 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
ngerprints in order to utilise the ngerprint reader for system access. From "Settings" select
"User Management"
Tap "ON" the switch to activate User Management The following screen appears:
Enter the Global Password (691982) and tap <OK>. Page 78/136 Version 02.02 04AUG2022 The following screen appears:
SpiroSphere ECG Instructions for Use Select whether or wish to use your ngerprint reader for access to the system Enter all the required information to create your user:
Options for role type:
Administator User Support Enter the details for the user (for rst user of the system this must be Administrator role). Version 02.02 04AUG2022 Page 79/136 SpiroSphere ECG Instructions for Use Overview who has which user rights:
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 System Administration Add or change user Deactivate/activate user Recover Change date and time settings Update software 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 X X X X X X X X X X X X X Page 80/136 Version 02.02 04AUG2022 Register ngerprints:
SpiroSphere ECG Instructions for Use 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. Version 02.02 04AUG2022 Page 81/136 SpiroSphere ECG Instructions for Use Place your nger on and off the ngerprint reader as per on-screen instructions (approx. 5 times) in order to register your ngerprint. If the nger is not placed correctly, feedback is provided:
Page 82/136 Version 02.02 04AUG2022 You may register as many ngers as you like. SpiroSphere ECG Instructions for Use When nished tap <Save>. The following screen appears:
Tap <Yes> to save the ngerprints of the respective user. Version 02.02 04AUG2022 Page 83/136 SpiroSphere ECG Instructions for Use After saving the rst user, you will be sent to the Login page:
You can login via entry of Username and Password. If you registered your ngerprint, you can use the ngerprint reader. Two touches are required (the
rst touch identies the user, the second veries the user). User Directory When User Management is active, additional items appear in the Settings screen:
Select "User Directory"
The User Directory is displayed:
Page 84/136 Version 02.02 04AUG2022 SpiroSphere ECG Instructions for Use Add User It is possible to add another new user from the User Directory. To add a new user, tap <Add User>. Make the appropriate entries and, if desired, register ngerprints (see above). Change Password Tapping the currently logged in user in the directory will open a y out menu:
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. Version 02.02 04AUG2022 Page 85/136 SpiroSphere ECG Instructions for Use Edit User To edit the currently selected user, tap <User Details> in the y out menu. The following screen appears:
Make the appropriate changes and tap <Next> to move to the ngerprint registration (see above).
(If you choose not to register ngerprints this button is labelled Save.) Deactivate User /Reset Password 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. Tap <Deactivate User> to deactivate the selected user. Page 86/136 Version 02.02 04AUG2022 To reset the password for another user, tap <Reset Password>. The following screen appears:
SpiroSphere ECG Instructions for Use The user will be required to change their password upon their login. Change Security Question From "User Management Settings" a Security Question and Answer can be dened for the current user. Make the appropriate entries and tap <Save> to save the Security Question. Version 02.02 04AUG2022 Page 87/136 SpiroSphere ECG Instructions for Use Backup & Recover A backup of all saved patient- and test data should be performed and saved to a USB-
Stick on a regular basis. Tap on "Backup & Recover". Alternatively, tap on the "No backup performed" eld on the 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 to create a backup le and save it to the USB stick!
Page 88/136 Version 02.02 04AUG2022 SpiroSphere ECG 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. Version 02.02 04AUG2022 Page 89/136 SpiroSphere ECG Instructions for Use Communication Tap on "Communication"
It is possible to congure the Communication settings from the Communication menu within Settings. Select the Communication method to open the respective conguration settings. Network Requirements WiFi The following y-out menu appears:
Tap on the desired WiFi network. Tap <Connect> to initiate the connection. Page 90/136 Version 02.02 04AUG2022 SpiroSphere ECG Instructions for Use Enter the password as applicable and tap <Connect>. Ethernet Choose the appropriate settings. If DHCP is set on "Off", then you can manually enter the appropriate settings. Version 02.02 04AUG2022 Page 91/136 SpiroSphere ECG Instructions for Use You can check the status of the connection by selecting "Check the network connection". Upon conrmation of a successful connection, following message box is displayed:
3G (only applicable for optional 3G module) Enter the appropriate Access Point Name and the Service Number. Page 92/136 Version 02.02 04AUG2022 SpiroSphere ECG Instructions for Use Local IT Guide for Ethernet (LAN), WI-FI (WLAN) or optional 3G (Mobile Network) The SpiroSphere system offers data transfer functionality via Ethernet (LAN), Wi-Fi (WLAN) or optional 3G (Mobile Network) which requires access to the Internet. 3G is only applicable for the optional 3G module. Since the SpiroSphere system would for Ethernet (LAN) or WIFI (WLAN) be part of your local network, this guide explains how the system behaves and needs to be congured. SpiroSphere is compliant to HIPAA regulations. There is no direct access to the operating system. Where User Management is enabled the responsible user of the data has to be able to control the access to the system. How to congure Ethernet, WiFi Access or optional 3G (Mobile Network) In the "Settings & Tools" menu of the SpiroSphere system in the sub menu "Communication"
Ethernet (LAN), Wi-Fi (WLAN) (or 3G Mobile Network) can be congured. The MAC addresses and IP addresses are visible within the "Settings & Tools" / "About Device" Information Screen. A check connection function helps to verify the network setup. A more detailed description of the possible conguration 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 congured?
Linux (32bit) No Third Party Application can be installed No Access to operating system No Access to an open web browser (no surng) No Access to Bootloader No Network Registration (DNS) Firewall Activated (iptables), blocking all incoming trafc (except ping, ssh, DNS and DHCP, SMTP, FTP), preventing outgoing trafc except from authorized applications. Connected Media (USB) are checked against checksums before any content is accepted. No content form a USB stick is executed. Which endpoints are accessed?
Data Transfer Check DNS (Local) DHCP (Local) Ping (localhost) Ping (ERT) FTP (Local) Normal Operation DNS (Local) DHCP (Local) Ping (ERT) FTP (Local) SMTP (Local) How the system behaves?
The network interfaces are only used when data needs to be transmitted. Ideal Network Setup?
To satisfy common local network policies, a virtual or physically separated network with outgoing internet access is recommended. SpiroSphere does not require this separation. How is the system updated?
Software components of the SpiroSphere system are made available by ERT. Version 02.02 04AUG2022 Page 93/136 SpiroSphere ECG Instructions for Use Can the SpiroSphere system run without network access?
Yes. Alternatively, the data can be uploaded using a USB stick on a local Internet PC. Specication of network connection The SpiroSphere can be connected to an IT network in order to send a pdf report to a designated email address. In order to use this functionality, the SpiroSphere must be connected to an IT-
network with TCP/IP connectivity via Ethernet, WLAN (or optional 3G) with routing to the Internet. The conguration of the necessary network settings is described in the "Settings and Tools" menu in the sub menu "Communication". Add description and the conguration 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 IEC 80001-1). The following changes in the IT-network might lead to new risks and therefore it might be necessary that the user needs to reevaluate the analysis:
Change of the infrastructure Integration of additional devices to the network Removal of device from the network Update of devices connected to the IT-network Upgrade of devices connected to the IT-network If you have technical questions or require further assistance please feel free to contact our customer care. Page 94/136 Version 02.02 04AUG2022 SpiroSphere ECG Instructions for Use Report & Printing SpiroSphere allows for reports to be printed with an external printer. In addition, SpiroSphere will allow the user to generate reports as a PDF-le which can be transferred to an external device (i.e. via a USB stick), or e-mailed to a specied recipient. Printer Tap on "Report & Printing"
Setting options:
Preset:
Printer, PDF via Email, PDF via USB ON, OFF see below see below PDF via Email OFF Color, Black & White A4, Letter Color A4 Send test page to Default Printer 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".
*ZIP is an archive le format that supports lossless data compression. https://en.wikipedia.org/wiki/Zip_(le_format) Version 02.02 04AUG2022 Page 95/136 SpiroSphere ECG Instructions for Use Reports Setting options:
Preset:
Input Customer Name Input Customer Address Best Effort Report All Efforts Report Best Effort Report Email Print Job Input Username Input Password Input Email Address Input Server Name Input Port Input SSL Print jobs state Page 96/136 Version 02.02 04AUG2022 SpiroSphere ECG Instructions for Use Conguration of the Electronic Report Functionality In order to send a pdf report the SMTP server conguration, the user name and password of an active Email Account and the destination Email address of the receiver must be set up in the Settings and Tools menu in the sub menu Report & Printing. The SpiroSphere will send the Email with the attached pdf report to the destination address by using the congured SMTP server. The pdf report is secured by a user congurable 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. Update The SpiroSphere is continuously improved and expanded. Necessary updates are stored on a USB stick. Procedure: Insert the USB stick with the software update in one of the two USB slots. USB Stick List of available updates 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. Version 02.02 04AUG2022 Page 97/136 SpiroSphere ECG Instructions for Use About Device You can view system information under the About Device section. Restore Default Settings The system settings can be restored to the defaults using Restore Default Settings Factory Reset A detailed description of this tool is not part of this Instructions for Use. Page 98/136 Version 02.02 04AUG2022 SpiroSphere ECG Instructions for Use Cleaning/Hygiene Spirometry 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 be transported through the respiratory ow and may affect the next test subject. 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!
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?
SingleUse ERT PT with mouthpiece Dispose after every patient Reuse may lead to patient infections. Singlepatientuse Nose clip Dispose nose clips after every patient Reuse may lead to patient infections. Disposable mouthpiece snorkel Dispose mouthpiece snorkel after every patient Reuse may lead to patient infections. Disposable mouthpiece is to be used in combination with the tube portion of the ERT PT. ERT PT and mouthpiece are parts for single use only. These parts must be disposed after each single use. If reused, infection may occur. 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. Version 02.02 04AUG2022 Page 99/136 SpiroSphere ECG Instructions for Use Surface Cleaning and Disinfection Wiping 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. If the patient's history shows a dangerous infectious disease
(e.g. tuberculosis), all parts which had been in direct or indirect contact with the patients must be disinfected. Do not clean or disinfect the Main Unit or the SpiroSphere Sensor while the devices are in operation. Precleaning and Disinfection A thorough pretreatment/cleaning is a precondition for an efcient disinfection of contaminated parts. Protein residue on these parts might prevent an effective disinfection. ERT recommends the following disinfectants:
Precleaning and Disinfection:
Product Manufacturer Concentration/Reaction time mikrozidsensitive wipes CaviWipes Schuelke & Mayr GmbH Metrex 1 minute 1 minute Procedure: Use the rst cleaning wipe to cover all surfaces with the detergent. Repeat the procedure with a second wipe for disinfection. Let the surface dry. Avoid uid (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. 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. Page 100/136 Version 02.02 04AUG2022 SpiroSphere ECG Instructions for Use 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. Avoid contaminated uids (e.g. blood) to get into the SpiroSphere Sensor. In case of ingress of contaminated uids, do not use the SpiroSphere Sensor anymore. 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. In addition, please note country-specic disposal regulations. Version 02.02 04AUG2022 Page 101/136 SpiroSphere ECG Instructions for Use Hygiene ECG How often should contaminated parts be exchanged?
ECG electrodes are for single use only;
dispose after each subject ECG electrodes 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. Should any of these parts be recycled and misused intentionally, ERT seeks no responsibility nor can be made liable for the consequences arising from reusing these parts. The ECG unit and the electrode cables can be disinfected with a surface disinfectant (e.g. Incidin Foam or Lysol wipes), which is to be applied with a non-fuzzy, damp cloth. Cleaning and Disinfection of 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 device damage and/or consequently danger to the patient or operators. Cleaning and Disinfection of the Cables Wipe the cables with a soft, moist cloth to clean the device. Only use mild detergent in order to avoid damage. Pay attention not to pull too hard on the cables while doing this. Under no circumstances should the cables be submerged into liquids. For disinfection, wipe the cables with a cloth saturated with Incidin Foam or an equivalent means for disinfection such as Lysol wipes. Follow the instructions regarding the use and exposure time of the disinfectant. Lysol is a registered trademark of the Reckitt Benckiser company. Page 102/136 Version 02.02 04AUG2022 SpiroSphere ECG Instructions for Use Functional Check ECG At each power-on, the medical device carries out an integrated self test. By means of this test the correct functionality of the following components is ensured:
Voltage supply Memory Bluetooth module ADC for pacemaker detection ADC for ECG An error condition in the Bluetooth connection is indicated by a quick double ashing of the blue LED. Error conditions of all other components are transmitted via the Bluetooth interface to the host PC. Conduct a visual inspection of the medical device before each use. In case you should discover external damage at the device or the cables or in case the integrated self test fails, do not continue to operate the device. Contact the manufacturer Corscience or a specialist distributor authorized by Corscience to have the device repaired. Troubleshooting Guide ECG LED Status Chart LED code (blue) System status Possibility of intervention Blue LED blinks slowly (1Hz) Bluetooth connection active
Blue LED slow double blink Battery almost empty Replace battery Blue LED blinks fast (3Hz) Bluetooth pairing active Blue LED on (solid) Ready for operation Blue LED quick double blink Start-up error, connection impossible ECG unit can be paired from the according Settings menu Start measurement in order to establish connection Replace battery, retry connection. If continuous failure contact ERT Customer Care
The distance between the ECG unit and the SpiroSphere main unit impacts the quality of the Bluetooth connection. Keep it as short as possible and free of objects between both, e.g. furniture. If Bluetooth transmission fails for more than 10 seconds, the old ECG data are dismissed by the device and therefore lost for the recording.
The separation of the point-to-point Bluetooth connection from another network (e.g. intranet, internet) is under the responsibility of the operator. In case the point-to-point Bluetooth connection is not served for more than 10 minutes the connection is terminated. The not yet transferred ECG data from ECG unit will be lost after 10 seconds (see above). Version 02.02 04AUG2022 Page 103/136 SpiroSphere ECG Instructions for Use Malfunction Cause of the Malfunction Removal of the Malfunction The ECG unit cannot be switched on. Battery discharged below minimum power requirements. Change battery for either a new or
(re)charged one. The ECG unit is not visible to the receiving Bluetooth devices. There is already a Bluetooth pairing with another device. No or fragmentary ECG data is transferred. Radio communication is interrupted. Check polarity of the inserted energy source. 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. Reduce distance to receiving unit or remove a possibly existing obstacle. Device detects no ECG signal. Check ECG cable application and restart the device. Remove and insert battery before restart if normal restart leads to the same malfunction. Page 104/136 Version 02.02 04AUG2022 SpiroSphere ECG Instructions for Use Return of Goods in Medical Institutions Recommendations for action -
for all staff members having contact with potentially contaminated returns. Returns or returned goods are all products returned to the producer or the supplier, irrespective of whether or not they have been used, e.g. due to complaints, repair or maintenance. Those products might have had contact with biological substances or highly active pharmaceuticals (e.g. cytostatics, radioactive medicines) and could be contaminated by them. If in doubt, the goods to be returned should be treated as contaminated products. Due to infectious agents, pathogens or pharmaceuticals, contaminated goods pose a potential hygienic risk for all persons having contact with the returns. This leaet provides guidance on minimizing the potential hygienic risk when handling returned goods. Among other things, this information is based on the legal standards of the Biostoff-
Verordnung (= Biological Substances Regulation) and the Employment Protection Act (both valid in Germany). A more detailed reference list of applicable rules and regulations can be obtained from the BVMed (info@bvmed.de). In order to protect your and our employees who handle contaminated parts and to optimally examine such parts, you should consider the following:
1. Assessment 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 substances, substances of risk group 3 can cause severe illness in humans and pose a serious risk to staff members (e.g. tuberculosis or hepatitis). Substances of risk group 4 cause severe illness in humans and pose a serious risk to staff members (e.g. Ebola or smallpox). Regarding national and international regulations for the transport of potentially infectious substances (ADR, IATA-DGR), the risk groups 2 (e.g. staphylococcus aureus) and 3 dened by the Biological Substances Regulation are classied as Transport Category B. Products which are potentially contaminated by biological working substances of risk group 4 according to the regulation on biological substances as well as products which are potentially contaminated by pharmaceuticals posing a serious risk to health (e.g. X-ray contrast agents and cytostatics) must not be returned to the producer. Version 02.02 04AUG2022 Page 105/136 SpiroSphere ECG Instructions for Use The following applies to products that are potentially contaminated by biological working substan-
ces of risk group 3 and 2 according to the regulation on biological substances and that are thus classied as Transport Category B:
Please contact ERT before returning the goods and observe the regulations for the transport of dangerous goods. 2. Cleaning If the products had contact with biological working substances (for example blood or other body
uids), they have to be cleaned and disinfected in a combined cleaning and disinfection procedu-
re, unless a differing agreement has been made with ERT. As a rule, the products also have to be cleaned in order to minimize adhesions and bacterial contamination. Unless body uids, tissue or contrast agents etc. have caused the product to 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. If in doubt, contact ERT for guidance on further actions!
3. Disinfection/Sterilization After cleaning, the products have to be disinfected and/or sterilized (only if permitted for this medical product) in order to avoid harm to your and our employees. If in doubt or in case of suspected material incompatibility, please consult ERT. 4. Packaging To avoid any contamination, the cleaned and disinfected product has to be packed as follows:
a) Put it into a sealable primary packing. Parts with sharp edges need to be packed particularly safe. b) Put the primary packing in a waterproof secondary packing (if possible use hard packing material). c) Pack the secondary packing with a neutral packing material. For Packaging and labeling of noncontaminated products: see point 6. Page 106/136 Version 02.02 04AUG2022 SpiroSphere ECG Instructions for Use 5. Labeling If a concrete risk of infection (e.g. HIV, Hepatitis B or C) is known to be present, this risk has to be noted on the packing of the returned goods and/or in the accompanying documents. For Packaging and labeling of noncontaminated products: see point 6. 6. Packaging and labeling of noncontaminated products If the procedures described under point 2 and 3 are not applied, the contaminated product has to be returned in a combined packing complying with the packaging instruction P 650 ADR after contacting ERT, if necessary. Proceed as follows:
a) Put the product into a liquid-tight, sealable packing (e.g. tearproof plastic bag)
(primary packing) b) Put the primary packing into a (if possible, liquid-tight) protective packing (secon-
dary packing); for liquid materials insert an adequate amount of absorbing material between the primary and the secondary packing. c) Pack the secondary packing with an additional outer packaging (padded envelope or cardboard box). d) Label the outer packaging with the corresponding UN no. 3373 for diagnostic or clinical samples and add the note:
Biologischer Stoff, Kategorie B/Biological Substance, Category B 7. Dispatch Please note that non-decontaminated returns with suspected pathogens of risk group 3 are excluded from mailing. Diagnostic or clinical samples of UN no. 3373 which have been packed ac-
cording to packing instruction P 650 are not subject to any further regulations 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. Address:
eResearchTechnology GmbH Sieboldstrasse 3 97230 Estenfeld, Germany Tel: +49 9305 720-9891 www.ert.com Version 02.02 04AUG2022 Page 107/136 SpiroSphere ECG Instructions for Use
This certificate must be attached to ANY product complaint, ANY return of medical products and accessories, ANY repair order and ANY return of studies. Name of product:
REF (ERT item no.):
LOT (batch no.):
It is herewith confirmed by signature that (please mark appropriate box):
the enclosed medical product had no contact with blood or other body fluids so that it is hygienically safe.
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 could not be decontaminated. Reason:
Send returns to the following address:
Sender's signature and address:
Abteilung Wareneingang Sieboldstrasse 3 97230 Estenfeld Germany Page 108/136 Version 02.02 04AUG2022 General Safety Precautions SpiroSphere ECG Instructions for Use 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 and MDR (EU) 2017/745. 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/
user is liable for his/her modication of the medical product. ERT only guarantees for the safety, reliability and functionality of the instrument if
installation, extension, modications, 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-specic 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. Patient Safety according to EN 6611 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 subject environment must be dened. The subject has to keep a distance of at least 1.5 m from all open interfaces and connectors of the SpiroSphere Main Unit to avoid any contact with electrical voltage. The physician/operator must not touch any voltage-carrying parts (e.g. USB Plug, Ethernet Plug) and the subject at the same time. Version 02.02 04AUG2022 Page 109/136 SpiroSphere ECG 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. Accessory equipment connected to the interfaces must be certied according to the respective EN standards (e.g. EN 60950 or EN 60601-1). Everybody who connects additional equipment to the signal input part or signal output part congures a medical system, and is therefore responsible that 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. Use of MultiPlug Sockets Do not connect the medical device/system to 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 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 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 specied or provided by the device's manufacturer can result in increased 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 and cables specied by the manufacturer. Non-observance may lead to a reduction of the device's performance. For further information see chapter Electromagnetic Emission and Immunity and Notes on EMC. Page 110/136 Version 02.02 04AUG2022 SpiroSphere ECG Instructions for Use Ambient Conditions The medical device must not be operated in rooms with the presence of
ammable anaesthetic mixture with air or ammable anaesthetic mixture with oxygen or nitrous oxide. The medical device must be operated in rooms where only non-conductive pollution occurs; however, occasional temporary 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. After the rst setup or if the setup has been changed (e.g. exchanging of the SpiroSphere Sensor), a function test (e.g. calibration check) has to be performed. The Main Unit must be placed outside the patient environment during measurement. Medical Supervision During the measurement the patient must not be unattended. A qualied physician must reassess all measurements. An interpretation by the medical device is signicant only when considered together with other clinical ndings. 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. Version 02.02 04AUG2022 Page 111/136 SpiroSphere ECG Instructions for Use 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 Material Styrolution PS 454N HIPS Cycoloy CX2244ME PT-tube Styrolution PS 454N HIPS Page 112/136 Version 02.02 04AUG2022 SpiroSphere ECG 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. Further safety-related checks in accordance with IEC 62353 have to be performed every 3 years by an authorized technician. These safety-related checks include the measuring of leakage current and insulation resistance and the visual checks as performed on a daily basis. 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. If you recognize or experience any serious incident that has occurred in relation to the device, you should report this to the manufacturer and the competent authority of your country. Version 02.02 04AUG2022 Page 113/136 SpiroSphere ECG Instructions for Use Safety Precautions ECG Read these instructions for use carefully. They are part of the device and must be available at all times. Do only use the device for the intended purpose described in this document (see chapter Indications for Use). If you recognize or experience any serious incident that has occurred in relation to the device, you should report this to the manufacturer and the competent authority of your country. For your own safety as well as for the safety of your patients and according to the requirements of the FDA and Medical Devices Act, please observe the following:
General Cautions and Warnings CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. The medical device is only to be used by people who can guarantee proper operation based on their training or their knowledge, e. g. as a result of a training. Any claim to guarantee and liability expires if other than the equipment recommended in this instruction for use or original spare parts are used. Functional failure or non-biocom-patibility can result, if other than original or recommended parts and equipment is used. The 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 external damage or a failure of the self test is identied. Comply with the environmental conditions described in the technical data. Only use biocompatible and FDA or CE-certied electrodes, as applicable, with the medical device. Comply with the instructions for use of the applied electrodes at all times. Do not submerge the medical device into liquids, pour or splash it with liquids deliberately or expose it to rain. Should liquids penetrate into the device, do not operate it before a check of the customer support has been carried out. Do a functional check regularly. The medical device, other than the battery compartment, must only to be opened by factory authorized personnel. Opening the device by an unauthorized person will void all warranties. The manufacturer is not liable for the function of the medical device if the device is improperly maintained by the owner or the operator or if it is operated in a way that does not correspond with the intended use according to these instructions of use. Page 114/136 Version 02.02 04AUG2022 SpiroSphere ECG Instructions for Use The signals emitted by the measuring device do not comply with the alarmstandard for medical electrical devices, DIN EN 60601-1-8. All parts of the medical device, including the equipment, which come into contact with the patient when operating the device in accordance to the regulations, meet the applicable biocompatibility standards. Packaging material can pose a risk of suffocation. Keep it inaccessible for children or dispose of it in accordance with the regulations. Operation Cautions and Warnings The medical device, especially the electrodes and cables, must only be used on healthy and intact skin. Do not make any changes to the electrodes or the device during operation. That might result in incorrect measurements. The device is not suitable for heart leads. When using a debrillator the electrodes of ECG and debrillator must not come into contact. If a debrillator is used, pay attention that no one has contact with the patient. Burns or other injuries might 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-certied electrodes, as applicable, with the medical device. Comply with the instructions for use of the applied electrodes at all times. Assure that the electrodes are correctly applied. Incorrectly applied electrodes can adulterate the ECG and result in misinterpretations. The skin at the application positions of the electrodes has to be clean and dry. Moisture can result in signal distortion. If using an inammable skin cleansing agents, the skin must be dried completely as a means of precaution. Conductive parts of the electrodes have to be kept away from other combustible parts. Electric Shock from Unconnected Electrodes: As soon as at least one electrode or peripheral sensor is attached to a person, make sure that none of the other electrodes or peripheral sensors come into contact with any conductive material that might provide a return path to ground. Version 02.02 04AUG2022 Page 115/136 SpiroSphere ECG Instructions for Use Motion artefacts adulterate the measurements. They might result in an incorrect interpretation by the operator and, as a consequence, lead to a wrong or delayed therapy. When wearing other electronic devices, e. g. pacemakers, other implanted or body-
worn devices, errors or mutual interaction might possibly occur. Pacemaker patients have to be monitored separately. Magnetic and electric elds can inuence the function of the device. Keep a safe distance between the medical device and devices emitting HF radiation (e. g. mobile phones) as otherwise failures might occur (see chapter Technical Data). Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the medical device including cables. Otherwise, degradation of the performance of this equipment could result. Note that when using the device the electromagnetic radiation emitted might inuence other electric devices in the vicinity. Use of accessories, transducers and cables other than those specied or provided by the manufacturer could result 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 on children < 20 kg, infants and new-born. The medical device must not be used unattended on children younger than 4 years and disturbed patients. There is a danger of an aspiration of the electrodes. When operating heat therapy devices nearby disruptions from the radio transmission might arise. When wearing pacemakers, errors in the determination of the heart rate might possibly occur. A short circuits of the battery circuit can overheat the medical device. If the device feels warm, put it down immediately and remove the battery of energy. Do not use the medical device until it has been serviced by a factory trained represetative. Assure that the Bluetooth monitor which receives the measured data is paired to only the medical device to prevent loss of monitoring. ECG cables may wrapp around patients neck during sleep. So do not sleep with the device attached or x the ECG cable close to the body. Do not change the battery while the medical device is connected to a patient. Page 116/136 Version 02.02 04AUG2022 SpiroSphere ECG Instructions for Use Do not touch the device during shock release!
Do not use or store the device in dusty, wet or dirty environments. Make sure to always keep the environment conditions for storage and transport that are listed in the chapter Technical Data. 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 amplier 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 kinds of conductive electrode pastes. Version 02.02 04AUG2022 Page 117/136 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. Typeplate including optional 3G module SpiroSphere ECG Instructions for Use Graphical Symbols Applied Part of type CF, Debrillation-proof
(ECG unit cable variant) 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 Packaging can be recycled Temperature limit Unique Device Identier Medical Device UDI MD Rx only CAUTION:
FEDERAL U.S. LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. SN REF IP20 IP21 Serial number Reference number Protection against intrusion of solids 12,5mm diameter; no protection against ingress of liquids Protection against intrusion of solids 12,5mm diameter; protection against dripping water CE sign with code number of the Notied Body. The certied quality management system of eResearchTechnology GmbH corresponds to the international standard of ISO 13485. Possible source of interference Page 118/136 Version 02.02 04AUG2022 SpiroSphere ECG 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!
- 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 battery is toxic and ammable - leaky batteries or batteries with dents must not be used any longer!
- Do not come in contact with the uid in the battery. If the uid comes in contact with your skin, immediately rinse the affected part with water and contact a doctor!
- To charge the SpiroSphere Sensor, use only the Main Unit Cradle and observe the instructions in the manual!
- To charge the Main Unit, use only the provided power supply. Version 02.02 04AUG2022 Page 119/136 SpiroSphere ECG 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:
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 limits for a Class B digital device, 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 will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. Any changes or modications not expressly approved by ERT could void the user's authority to operate the equipment. Canada This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. 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:
IC: 11335A-SPS001 (for optional 3G module included) 11335A-SPS003 (MOD MU-SPS003) (for optional 3G module excluded) SpiroSphere - Sensor Unit:
IC: 11335A-SPS002 Exposure to radio frequency energy. The radiated output power of this device meets the limits of FCC/IC radio frequency exposure limits. This device should be operated with a minimum separation distance of 20 cm (8 inches) between the equipment and a persons body. Page 120/136 Version 02.02 04AUG2022 SpiroSphere ECG Instructions for Use Frequency Band and Transmittet power:
3G (optional):
Frequency Band Transmission Frequency Range Maximum Output Power Gain UMTS B1 1922 to 1978 MHz 23 dBm (+/- 2dBm) Class 3bis UMTS B2 1852 to 1908 MHz 23 dBm (+/- 2dBm) Class 3bis UMTS B5 826 to 847 MHz 23 dBm (+/- 2 dBm) Class 3bis UMTS B6 832 to 838 MHz 23 dBm (+/- 2 dBm) Class 3bis UMTS B8 882 to 913 MHz 23 dBm (+/- 2 dBm) Class 3bis UMTS B19 832.4 to 842.6 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
-1.74 dBi
-1.1 dBi
-3.31 dBi DCS 1800 1710 to 1785 MHz 1 Watt GSM, GPRS and EDGE PCS 1900 1850 to 1910 MHz 1 Watt GSM, GPRS and EDGE
-1.1dBi Bluetooth:
Frequency Band Transmission Frequency Range Maximum Output Power 2400 MHz (BT) 2402 to 2480 MHz 12 dBm WiFi:
Frequency Band Transmission Frequency Range Maximum Output Power 2400 MHz (WiFi) 2412 to 2484 MHz 19 dBm Wireless Charging:
Frequency Band Transmission Frequency Range Maximum Output Power Qi (wireless charger) 112 to 205 kHz 37 dBm Version 02.02 04AUG2022 Page 121/136 SpiroSphere ECG Instructions for Use Electromagnetic Emission and Immunity SpiroSphere ECG Medical electrical equipment is subject to special precautions regarding electromagnetic compatibility (EMC). User must follow the EMC installation instructions and only use the device in the intended environment during operation. The SpiroSphere meets the regulations according to EN60601-1-2 regarding the interference radiated and received. For more information, refer to the EMC tables of the instructions for use of your device/system. The SpiroSphere is intended to be used in professional healthcare facility environment like doctors ofce 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 performance by the following:
The maximum error (drift, uncertainty) of Flow measurements might be up to +/- 20ml/s Electromagnetic irradiation can influence the ECG device essential performance by the following:
The measurement signal might be inuenced but will recover for use within 10s after the source of disturbance disappeared. Page 122/136 Version 02.02 04AUG2022 SpiroSphere ECG Instructions for Use Electromagnetic Interference and Wrong Diagnosis
The device must not be installed and used in the vicinity of high-
frequency devices, X-ray equipment, motors or transformers with high installed power ratings since electric or magnetic interference elds may falsify the measurement.
Do not perform measurements with the device directly next to other equipment or in combination with other devices 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 antennas) should be used no closer than 30 cm (12 inches) to any part of the medical device, including cables specied by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
Use of accessories, cables etc. other than those specied or provided by the manufacturer could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
Changes or modications to the SpiroSphere may result in increased electromagnetic emissions or decreased electromagnetic immunity in relation to EMC performance.
Devices that are connected to the SpiroSphere can also cause radiated interference. Therefore, you must follow the regulatory and safety related notes of the respective device manufacturer.
Strong electromagnetic elds can disturb the measurement signal. Cellular phones, x-ray machines, thermal radio frequency treatment equipment, diathermy, electrocautery, and RFID, etc. produce strong electromagnetic elds. Make sure to keep devices that produce electromagnetic elds away from the SpiroSphere device.
Make sure that the recommended distances to radio wave emitters are met. If the measurement signal is lost or degraded due to electromagnetic disturbances, you need to relocate the device and repeat the measurement. Version 02.02 04AUG2022 Page 123/136 SpiroSphere ECG Instructions for Use The use of accessories not recommended by ERT may result in an increased electromagentic radiation or a reduced interference immunity of the SpiroSphere. SpiroSphere Guidance and Manufacturers Declaration Electromagnetic Emissions The SpiroSphere is suitable for use in all establishments including domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. EMC Basic Standard Compliance Electromagnetic Environment Guidance RF emissions CISPR 11 Group 1 RF emissions CISPR 11 Class B 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 unit is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-
voltage power supply network that supplies buildings used for domestic purposes. Guidance and Manufacturers 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 indirect contact 15 kV direct air 8 kV direct contact Radiated RF IEC 61000-4-3 3 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 1 kV differential mode 2 kV common 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 Short interruptions and voltage variations IEC 61000-4-11 tested at 100 and 240 V power supply input lines
< 5% @ 250 cycles and 50 Hz
< 5% @ 300 cycles and 60 Hz Page 124/136 Version 02.02 04AUG2022 SpiroSphere ECG Instructions for Use ECG amplier Guidance and Manufacturers Declaration Electromagnetic Emissions The ECG unit is intended for use in the electromagnetic environment specied below. The customer or the user of the ECG unit should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment Guidance RF Emissions CISPR 11 Group 1 RF Emissions CISPR 11 Class B The ECG unit uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The ECG unit is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Guidance and Manufacturers Declaration Electromagnetic Immunity The ECG unit is intended for use in the electromagnetic environment specied 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 Radiated, Radiofrequency, Electromagnetic Field Immunity IEC 61000-4-3 8 kV contact 8 kV contact 2 kV, 4kV, 8kV air 2 kV, 4kV, 8kV air 3 V/m 80 to 2700 MHz 80% AM at 1 kHz 3 V/m 80 to 2700 MHz 80% AM at 1 kHz Power Frequency Magnetic Field IEC 61000-4-8 30 A/m
(50/60Hz) 30 A/m
(50/60Hz) Floors should be wood, concrete or ceramic tile. If oors are covered with synthetic material, the relative humidity should be at least 30%. Portable and mobile RF communications equipment must be used no closer to any part of the ECG unit, including cables, than the recommend separation distance shown earlier Power frequency magnetic elds should be at levels characteristic of a typical commercial or hospital environment. Version 02.02 04AUG2022 Page 125/136 SpiroSphere ECG Instructions for Use Test Specications for Immunity to RF Wireless Communications Equipment Test frequency
(MHz) Band a) Service a) Modulation b)
(MHz) 385 380 - 390 TETRA 400 450 430 - 470 GMRS 460;
FRS 460 704 - 787 LTE Band 13, 17 800 - 960 GSM 800/900;
1700 -
1990 2400 -
2570 TETRA 800;
iDEN 820;
CDMA 850; LTE Band 5 GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3, 4, 25;
UMTS Bluetooth;
WLAN 802.11 b/g/n;
RFID 2450; LTE Band 7 5100 -
5800 WLAN 802.11 a/n 710 745 780 810 870 930 1720 1845 1970 2450 5240 5500 5785 Pulse modulation b) 18 Hz FM c) 5 kHz deviation 1 kHz sine Pulse modulation b) 217 Hz Pulse modulation b) 18 Hz Pulse modulation b) 217 Hz Pulse modulation b) 217 Hz Pulse modulation b) 217 Hz Maximum power
(W) 1.8 2 Distance
(m) 0.3 0.3 Immunity test level
(V/m) 27 28 0.2 0.3 9 2 2 2 0.3 28 0.3 28 0.3 28 0.2 0.3 9 NOTE: If necessary to achieve the immunity test level, the distance between the transmitting antenna and the ECG unit may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3. a) For some services, only the uplink frequencies are included. b) The carrier shall be modulated using a 50 % duty cycle square wave signal. c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case. Page 126/136 Version 02.02 04AUG2022 SpiroSphere ECG Instructions for Use Bluetooth Wireless Communication Bluetooth is a wireless technology standard for exchanging data over short distances from xed and mobile devices and building personal area networks (PANs). IEEE standardized Bluetooth as IEEE 802.15.1. The maximum output power the Bluetooth radio is 2.5mW. The typical range of operation is approximately 30 feet (10 meters). Bluetooth is used to pair the ECG unit with its data collection devices and transfer test data between them. Bluetooth links use encryption algorithms that are widely considered acceptably strong. The strength of Bluetooth security relies primarily on the length and randomness of the passkey used for Bluetooth pairing, during which devices mutually authenticate each other. The encryption procedure enables encryption of the data sent over the air-interface to prevent unintended eavesdropping. COR12 CS10785 Assembled from tested components Complete system not tested Corscience GmbH Hartmannstr. 65 91052 Erlangen Germany
+49 9131 977986-0 FCC ID: T7VPAN10 This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interferences, and (2) this device must accept any interference received, including interferences that may cause undesired operation. FCC Notice "Declaration of Conformity Information"
This equipment has been tested and found to comply with the limits for a Class B digital device, 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 will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. Bluetooth is a registered trademark of Bluetooth SIG, Inc. 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. IC: 216Q-PAN10 Version 02.02 04AUG2022 Page 127/136 SpiroSphere ECG Instructions for Use Technical Data Spirometry Dimension 31.5 x 19.5 x 7.5 cm (L x W x H ) Weight 1.5 kg Screen Display 16.2 x 12.2 cm Medical Model: GTM91099-3009-4.0-T2 Power Supply Input: 100 - 240 Vac, 50 - 60 Hz, 1.5 A Output: 5 V, 6 A Cable length: 1200 mm Battery 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 Protection Class Power Supply Class II SpiroSphere Sensor Internally powered Mode of Operation Continuous Moisture Protection Power Supply Main Unit IP42 IP21 SpiroSphere Sensor IP20 Applied Parts ERT PT, SpiroSphere Sensor Type BF Application Measuring Pulmonary Function Interface USB Bluetooth WiFi Ethernet 3G (optional) Data Transfer Data Transfer Data Tansfer Data Transfer Data Transfer Measuring Principle High-Quality Pneumotach Operating Ambient Temperature:
+10 C to +35 C Relative Humidity:
15 % to 90 %
Barometric Pressure: 700 to 1070 hPa Page 128/136 Version 02.02 04AUG2022 SpiroSphere ECG Instructions for Use 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 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 Instantaneous Flow max. 135 Pa/L/s at 14 L/s 0.1 14 L/s: +/- 5% or 0.2 L/s The expected operational lifetime of the SpiroSphere is 7 years. Version 02.02 04AUG2022 Page 129/136 SpiroSphere ECG Instructions for Use Technical Data ECG Feature Product class according to 93/42/
EWG (MDD) Value IIa Dimensions W x H x D in cm 8,0 x 9,3 x 2,1 (3.3 x 3.7 x 0.8 in) Weight, incl. cable / without cable 200 g (0.4 lbs) / 81 g (without battery) Temperature range Operation Temperature range Storage (without batteries) Air pressure range Operation Air pressure range Storage (without batteries) Humidity (operation, storage, transport) Power supply Runtime T = 10 to 37 C T = -20 to 50 C 70 to 1060 hPa 600 to 1200 hPa 5 95% RH (not condensing) 1x AA (rechargeable) battery
> 5h with AA battery
> 8h with rechargeable battery (2850mAh) Current consumption at 1,5 V 230 mA / 185 mA
- Operation / Idle Data transmission wireless, online with radio standard Bluetooth Protocol:
SPP. Bluetooth Bluetooth module Panasonic PAN-1322-SPP Bluetooth standard V2.1 + EDR, class 2 device Output power 2.5 dBm, max. 4.5 dBm Frequency range 2400 - 2483.5 MHz FCC identier IC identier T7VPAN10 216Q-PAN10 Bluetooth QD ID B021246 Buffer memory for a 10-second ECG Memory ECG unit manufactured by:
Corscience GmbH Hartmannstr. 65 91052 Erlangen Germany Page 130/136 Version 02.02 04AUG2022 SpiroSphere ECG Instructions for Use Feature Value Classication according to 60601-1
- Protection type against electric shock Device with internal power supply
- Protection level against electric shock Type CF Electromagnetic compatibility (EMC) according to 60601-1-2
- Noise suppression
- Immunity EN 55011 EN 61000-4 parts 2, 3, 6, 8 Protection level against access to hazardous parts and ingress of solid objects IP20 Variants 12-channel EU cable; 12-channel US cable, 12-channel connector Accuracy of the ECG signal 1,94V/bit resolution (at sampling rate of 500Hz) Filter Electrodes Connection of the electrodes Shelf life Product life Radio transmission bandpass 0,05 Hz 150 Hz no line lter (50Hz / 60Hz) Standard ECG electrodes 4 mm snap, gilded 1 year for device The product life is 5 years. Approved in accordance to RED directive transmitter module marked by CE, manufactured by Panasonic incorporated to OEM product. Application ECG leads Bandwidth ECG Recording acc. to Einthoven, Wilson, Goldberger 0 - 150 Hz digital Sampling rate per channel 500 Hz Pacemaker detection 4000 Hz sampling rate HR and pacemaker detection in ECG unit Resolution Power supply 1.94 V/bit ECG, 15 bit 1 x AA battery Connection to electrodes 4 mm snap connector, gold-plated Moisture protection Electrode cable length IP20 0.44 m / 0.81 m Version 02.02 04AUG2022 Page 131/136 SpiroSphere ECG Instructions for Use Item Numbers of Disposables and Accessories Use ERT accessories and spare parts only!
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 50) Disposable Mouthpiece Snorkel (pack of 30) ECG Electrodes - Extra Small, 25 per pack ECG Electrodes - Small, 50 per pack ECG Electrodes - Medium, 25 per pack 720254 852353 892120 892121 706000 706002 706003 892104 992951 992950 992946 Page 132/136 Version 02.02 04AUG2022 SpiroSphere ECG Instructions for Use Index B I Basic Conditions 65 Batteries 66 Bluetooth Wireless Communication 126 Indications for Use 2 Information on ECG Recording 61 Isoelectric Segments 65 C Charge Level Indicator 66 Chest ECG 62 Connectors 51 Contraindications 2 D Declaration of Conformity 7 Device Description 61 E ECG Evaluation 72, 74 ECG Leads 62 ECG Recording 61, 66 ECG Results 72 ECG Settings 75 Electromagnetic Emission and Immunity 121 G General Cautions 114 Graphical Symbols 7 H Hygiene 102 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 114 Scaling and Filter 70, 71 Sensor Connection 61 T Technical Data 129 Troubleshooting 103 W Warnings 114, 115 Waveform 61 Version 02.02 04AUG2022 Page 133/136 SpiroSphere ECG Instructions for Use For your notes:
Page 134/136 Version 02.02 04AUG2022 SpiroSphere ECG Instructions for Use Version 02.02 04AUG2022 Page 135/136 SpiroSphere ECG Instructions for Use 2022 eResearchTechnology GmbH or one of its afliates. All rights reserved eResearchTechnology GmbH Sieboldstrasse 3 97230 Estenfeld, Germany
+49 9305 720-9891
+49 9305 720-7891 tel fax Page 136/136 Version 02.02 04AUG2022
1 2 3 | AutLet | Cover Letter(s) | 190.55 KiB | October 04 2022 |
Federal Communications Commission Authorization and Evaluation Division Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 7/11/2022 To whom it may concern:
We, the undersigned, hereby authorize Eurofins Product Service GmbH to act on our behalf in all matters relating to applications for equipment authorization FCC ID: 2AAUFSPS003 including the signing of all documents related to these matters. Any and all acts carried out by Eurofins Product Service GmbH on our behalf shall have the same effect as acts of our own. We also hereby certify that no party to this application is subject to a denial of benefits, including FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862. Sincerely, Signature Juergen Kasprowitsch Senior Director Quality Management/ Regulatory Affairs eResearchTechnology GmbH Sieboldstrae 3 97230 Estenfeld, Germany
1 2 3 | ConReq | Cover Letter(s) | 88.67 KiB | October 04 2022 |
Federal Communications Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 7/11/2022 Request for Permanent Confidentiality Company name: eResearchTechnology GmbH FCC ID: 2AAUFSPS003 FCC Part 15 Certification Ladies and Gentlemen, In accordance with CFR 47 0.457 and CFR 47 0.459 eResearchTechnology GmbH hereby requests confidentiality of following attachments:
(1) schematic diagrams,
(2) detailed block diagrams,
(3) detailed operational descriptions,
(4) parts lists. These documents contain detailed system and equipment description and related information about the product which eResearchTechnology GmbH considers to be proprietary, confidential and a custom design and otherwise would not release to the general public. Since the design is a basis from which future technological products will evolve, eResearchTechnology GmbH considers that this information would be of benefit to its competitors and that the disclosure of the information in these documents would give competitors an unfair advantage in the market. Sincerely, Signature Juergen Kasprowitsch Senior Director Quality Management/ Regulatory Affairs eResearch Technology GmbH Sieboldstr. 3 97230 Estenfeld, Germany
1 2 3 | NewIDStatement | Cover Letter(s) | 192.56 KiB | October 04 2022 |
Date: 2022-07-11 Federal Communication Commission Authorization and Evaluation Division Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 Statement of re-use of original test results of approved radio modules according to KDB 996369 D02 Module Q and A v01 Q1(a) Reference of new FCC ID application:
Applicant: ERESEARCH TECHNOLOGY GMBH FCC ID:
2AAUFSPS003 We, the undersigned, hereby declare that our radio device hosts the following approved radio module(s) Grantee: TEXAS INSTRUMENTS INC. Type of Module: SINGLE MODULAR BT / WLAN MODULE FCC ID:
Z64-WL18SBMOD Report Reference FR3N2752-01A (BT BR), FR3N2752-01B (BLE), FR3N2752-01C (W-LAN) The module(s) is/are installed according to the installation instructions of the module manufacturer(s) without modification. The original module test report(s) accurately represent all conducted measured test results under the new conditions. All radiated measurements according to the applicable radio standard(s), the rf-exposure and simultaneous transmission evaluation are performed and reported for the entire host. Sincerely, Signature Juergen Kasprowitsch Senior Director Quality Management/ Regulatory Affairs eResearchTechnology GmbH
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2022-10-04 | 2422 ~ 2452 | DTS - Digital Transmission System | Original Equipment |
2 | 0.112 ~ 0.3 | 8CC - Part 18 Consumer Device | ||
3 | 2402 ~ 2480 | DSS - Part 15 Spread Spectrum Transmitter |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 2 3 | Effective |
2022-10-04
|
||||
1 2 3 | Applicant's complete, legal business name |
eResearchTechnology GmbH
|
||||
1 2 3 | FCC Registration Number (FRN) |
0022909717
|
||||
1 2 3 | Physical Address |
Sieboldstrasse 3
|
||||
1 2 3 |
Estenfeld, N/A
|
|||||
1 2 3 |
Germany
|
|||||
app s | TCB Information | |||||
1 2 3 | TCB Application Email Address |
j******@eurofins.de
|
||||
1 2 3 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
1 2 3 |
A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices
|
|||||
app s | FCC ID | |||||
1 2 3 | Grantee Code |
2AAUF
|
||||
1 2 3 | Equipment Product Code |
SPS003
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 2 3 | Name |
J**** K********
|
||||
1 2 3 | Title |
Director, Quality Management
|
||||
1 2 3 | Telephone Number |
0049 ******** Extension:
|
||||
1 2 3 | Fax Number |
0049 ********
|
||||
1 2 3 |
j******@cert.com
|
|||||
app s | Technical Contact | |||||
1 2 3 | Firm Name |
eResearchTechnology GmbH
|
||||
1 2 3 | Name |
B**** M********
|
||||
1 2 3 | Physical Address |
Sieboldstrasse 3
|
||||
1 2 3 |
Estenfeld, 97230
|
|||||
1 2 3 |
Germany
|
|||||
1 2 3 | Telephone Number |
+49 9********
|
||||
1 2 3 |
+49 9********
|
|||||
1 2 3 |
B******@ert.com
|
|||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 2 3 | 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 2 3 | 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 2 3 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 2 3 | Equipment Class | DTS - Digital Transmission System | ||||
1 2 3 | 8CC - Part 18 Consumer Device | |||||
1 2 3 | DSS - Part 15 Spread Spectrum Transmitter | |||||
1 2 3 | 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 2 3 | SpiroSphere is a diagnostic compact device to measure inspiratory and expiratory lung function parameters. | |||||
1 2 3 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 2 3 | Modular Equipment Type | Does not apply | ||||
1 2 3 | Purpose / Application is for | Original Equipment | ||||
1 2 3 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | Yes | ||||
1 2 3 | 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 2 3 | Grant Comments | Output power listed is conducted. This device has a 20 MHz and 40 MHz bandwidth mode. The antenna(s) used for this transmitter must be installed to provide a separation distance of at least 20 cm from all persons and must not be co-located or operating in conjunction with any other antenna or transmitter, except in accordance with FCC multi-transmitter product procedures. End-users and installers must be provided with antenna installation instructions and transmitter operating conditions for satisfying RF exposure compliance. | ||||
1 2 3 | Output power listed is conducted. The antenna(s) used for this transmitter must be installed to provide a separation distance of at least 20 cm from all persons and must not be co-located or operating in conjunction with any other antenna or transmitter, except in accordance with FCC multi-transmitter product procedures. End-users and installers must be provided with antenna installation instructions and transmitter operating conditions for satisfying RF exposure compliance. | |||||
1 2 3 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 2 3 | 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 2 3 | Firm Name |
Eurofins Product Service GmbH
|
||||
1 2 3 | Name |
J****** K********
|
||||
1 2 3 | Telephone Number |
49-33********
|
||||
1 2 3 | Fax Number |
49-33********
|
||||
1 2 3 |
j******@eurofins.de
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | CC MO | 2402 | 2480 | 0.01 | |||||||||||||||||||||||||||||||||||
1 | 2 | 15C | CC MO | 2412 | 2462 | 0.2438 | |||||||||||||||||||||||||||||||||||
1 | 3 | 15C | CC MO | 2422 | 2452 | 0.1052 | |||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
2 | 1 | 18 | 0.11200000 | 0.30000000 | |||||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
3 | 1 | 15C | CC | 2402.00000000 | 2480.00000000 | 0.0173000 |
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