Instructions for Use SpiroSphere® ECG 781239 Version 02.
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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
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 ..
SpiroSphere® ECG Instructions for Use Cleaning/Hygiene Spirometry ......................................................................................................... 99 Hygiene ECG................................................................................................................................ 102 Functional Check ECG ................................................................................................................. 103 Troubleshooting Guide ECG ...........................
SpiroSphere® ECG Instructions for Use Notes on Safety in this Instruction Manual Following the ANSI (American National Standards Institute) recommendations for safety notes, speci c passages of this instruction manual are clearly marked as safety notes. Degree of Danger Injury to persons Damages to property Meaning of Indicator X DANGER indicates an immediate hazardous situation, which, if not avoided, may result in serious injury or death. Limited to extremely dangerous situations.
SpiroSphere® ECG Instructions for Use Graphical Symbols on the ECG ampli er Symbol Description Applied Part of type CF, De brillation-proof (ECG unit cable variant) Disposal of electronic devices in compliance with WEEE IP classi cation according to IEC60529 Radio symbol, non-ionizing radiation Manufacturer Date of manufacturing CE conformity symbol (Medical Device Directive) with code number of Noti ed Body. Follow the Instructions for Use Federal U.S.
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.
SpiroSphere® ECG Instructions for Use The SpiroSphere Main Unit: Power On/Off Front view: SpiroSphere Sensor Fingerprint Sensor Main Unit LCD touch display Rear view: Speaker Charging Cradle LAN Power USB USB SpiroSphere Sensor: LED Status Indicator ERT PT with Mouthpiece Power On/Off The SpiroSphere must not be exposed to direct sunlight nor positioned immediately near heating elements. Version 02.
SpiroSphere® ECG Instructions for Use Power supply: Mains adapter Start-Up 1. Connect the SpiroSphere to a power source complying with local regulations. LAN 2. Put the SpiroSphere Sensor into the slot of the main unit as shown below. Power Supply Connection 3. Use the Power On switch located at the front of the main unit to switch on the SpiroSphere Main Unit. The operating status of the device is indicated via an LED on the main unit and on the SpiroSphere Sensor.
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.
SpiroSphere® ECG Instructions for Use LED Status SpiroSphere To do: Blue LED On Main Unit powered on N/A Blue LED Off Main Unit powered off N/A Blue LED Pulse Main Unit Standby N/A Orange LED On Charging Orange LED Off Not charging/ charging complete 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 Orange LED blinking slowly Low battery Orange LED
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® ECG Instructions for Use Problem Troubleshooting SpiroSphere Sensor orange LED is blinking fast Press the power button of the SpiroSphere Sensor for more than 8 seconds to switch off the SpiroSphere Sensor. (error in SpiroSphere Sensor) Then restart by pressing the power button for min. 3 seconds. Try to identify the SpiroSphere Sensor in the Spirometry Settings.
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.
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 . (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 to con rm the respective settings and to continue with the next step. 1.
SpiroSphere® ECG Instructions for Use 3. Sensor Settings Place the SpiroSphere Sensor in the cradle, and tap on to scan for available sensors. Tap on the sensor you want to pair the SpiroSphere with and select from the dropdown menu. Con rm with . (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.
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 con rm with . (Refer to chapter "User Management"). Complete the initial setup of the device by tapping on .
SpiroSphere® ECG Instructions for Use The Home Screen After the SpiroSphere has been set up, upon powering on the device the following screen appears: Here, you can select the submenus "Add Patient", "Search Patient", "Sensor Check", "Adhoc Test" as well as "Settings and Tools" by tapping on the respective button. Add Patient Enter patient data for a new patient into your patient directory and start a test. Search Patient Search for a speci c patient in your patient directory.
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 con rm accurate measurement data. Tap to perform a sensor check. The sensor check consists of a calibration check as well as a linearity check. Tapping on the "i"- symbol will display information on the respectively selected check type.
SpiroSphere® ECG Instructions for Use The calibration check is used to check the volume accuracy within 3 different ow ranges. With each syringe stroke, the volume accuracy should be within ± 3 %. High Ex Mid Ex Low Ex 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.
SpiroSphere® ECG Instructions for Use Linearity Check In order to perform a linearity check, tap on . 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.
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.
SpiroSphere® ECG Instructions for Use Age: The Patient's age will be calculated automatically from the entered date of birth Gender: Select appropriate gender Height: Enter the Patient's height Weight: Enter the Patient's weight Ethnicity: Select the appropriate ethnicity Additionally, there is an option to enter: 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 to save the
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.
SpiroSphere® ECG Instructions for Use If a listed patient is selected, the following y-out menu appears: Tap on 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 speci c patient. Tap on to display the patient's demographic information. If incorrect patient data was entered or if the patient data need to be updated (e.g.
SpiroSphere® ECG Instructions for Use Each patient can be completely deleted from the patient directory by tapping . 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.
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. ) via tapping. The measurement is started by tapping on .
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.
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 ). 3 6s 4 FVCin FEV1/FVC Screen display: End of Test criteria is displayed as dynamic icon (time of exhalation and plateau).
SpiroSphere® ECG Instructions for Use Screen display after the rst effort: The upper left part of the chart section shows the recording of the ow-volume loop. The upper right part shows the volume-time tracing. The lower section of the screen displays the predicted values calculated from the patient data and the actual values measured from rst effort. Pred = Predicted value Best = Best value of all valid efforts.
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 Tap on the curve you want to be displayed.
SpiroSphere® ECG Instructions for Use Deactivate/reactivate efforts If several efforts were performed, individual efforts (e.g. efforts with insuf cient patient cooperation) can be deactivated. The system can also automatically deactivate efforts as a result of system detected ATS/ERS acceptability errors. Behaviour can be con gured in Settings. Procedure: Mark the effort to be deactivated (in our example Effort 4). Following window appears: Tap on .
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.
SpiroSphere® ECG Instructions for Use 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. 3 2 6s VCin ERV 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.
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.
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 . Tap on 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 to save the dosing to your patient directory. Version 02.
SpiroSphere® ECG Instructions for Use Perform a Post Spirometry Measurement The Flow-Volume curve shows the immediate bronchospasmolytic effect. The expiratory portion of the FlowVolume 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.
SpiroSphere® ECG Instructions for Use Pre Post Report: Version 02.
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.
SpiroSphere® ECG Instructions for Use Assign Adhoc Test now Tap on . The "Patient Directory" is displayed: Tap on and enter the respective patient data (see chapter "Add Patient" for details). Following window appears: Finish by tapping . Version 02.
SpiroSphere® ECG Instructions for Use Assign Adhoc Test later Tap on . 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 to enter the appropriate patient data. Page 42/136 Version 02.
SpiroSphere® ECG Instructions for Use Show, Edit, Delete and Print Tests Select a completed test. The following y-out menu appears: Tap on to display the results of the selected test on the screen: Version 02.
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 . The selected test can be deleted with : Tapping on will irrevocably delete the selected test! Tap on 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.
SpiroSphere® ECG Instructions for Use The selected patient including all measurements performed with the respective patient can be deleted by tapping on : Tapping on will irrevocably delete the selected patient and all respective tests! Tap on to delete all measurements performed with the selected patient: Tapping on will irrevocably delete all tests assigned to the selected patient! Version 02.
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 prede ned 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.
SpiroSphere® ECG Instructions for Use Settings and Tools The following includes a short description of settings which are not required for daily routine work. Tap on the "Settings & Tools" button on the Home Screen. The following will appear: General Tap on "General" Timezone Date & Time 2SWLRQV 'H¿QLWLRQ &KRRVH 3UHVHW select actual Country select timezone City ON/OFF ON 24h/12h 24h set actual Time YYYY.MM.DD 2016.08.16 DD.MM.YYYY 16.08.
SpiroSphere® ECG Instructions for Use Regional Setting options: Preset: English (US), German English (US) cm. in cm kg. lb kg Setting options: Preset: select 50% Sound Power Management Preset: select 100% select 100% select 5 min select 2 min select 10 min select 5 min select 20 min select 20 min These settings in uence the battery life of the SpiroSphere. Page 48/136 Version 02.
SpiroSphere® ECG Instructions for Use Spirometry Settings Tap on "Spirometry Settings" 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.
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.
SpiroSphere® ECG Instructions for Use Spirometry Settings - General Predicted Values Setting options: Preset: None GLI 2012 GLI 2012 NHANES III ECCS/Zapletal Knudson/Crapo Extrapolate Limits from Author Limits from Author No calculation outside limits Module Age range Height range Differentiation acc.
SpiroSphere® ECG Instructions for Use Sensor Check Setting options: Preset: 1, 2, 3 3 1, 2, 3, 4 1 2, 3, 4, 5, 6, 7, 8 3 ON, OFF ON OFF, Con rm, Enforce Con rm OFF, Con rm, Enforce Con rm Setting options: Preset: % °C, °F hPa, mmHg % °C hPa Setting options: Preset: 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 L mL L/s L/s L/min s ms % L*L/s 1/min Ambient Conditions Unit Groups Page 52/136 Version 02.
SpiroSphere® ECG Instructions for Use Decimals Possible Setting Options for Decimals: Preset: Decimals of Volume [L] - 0, 1, 2, 3 2 Decimals of Volume [mL] - 0 0 Decimals of Flow [L/Sec] - 0, 1, 2, 3 2 Decimals of Flow [mL/Sec] - 0 0 Decimals of Flow [L/min] - 0, 1 0 Decimals of Volume per Minute [L/min] - 0, 1 0 Decimals of Time [s] - 0, 1, 2, 3 2 Decimals of Time [msec] - 0 0 Decimals of Ratios [1] - 0, 1, 2, 3 2 Example: Preset 0: FVC [L] 5 Preset 1: 5.1 Preset 2: 5.
SpiroSphere® ECG Instructions for Use Diagram Scaling Adult Diagram Scaling Child Setting options: Preset: Automatic Automatic 16 L/s, 12 L/s, 8 L/s , 4 L/s If “Automatic“ is selected and the breathing ow is greater or less than the preset ow axis, this axis will be rescaled automatically. &KRRVH FVC as FEV2 FVC as FEV3 FVC as FEV6 3UHVHW ON, OFF OFF ON, OFF OFF ON, OFF OFF If ““ is selected, the value for the respective parameter is used as the FVC value.
SpiroSphere® ECG Instructions for Use FEF calculation Base FIF calculation Base Setting options: Preset: individual FVC individual FVC VC max If “individual FVC“ is selected, the FEF or the FIF values will be calculated based on FVC. Best Expiration Setting options: Preset: FEV1 + FVC FEV1 + FVC FEV1 FVC FVC + FERV1 + 1/3*PEF FEV0.5 + FVC FEV0.5 Best Inspiration Setting options: Preset: FVCin + PIF FVCin + PIF FVCin + 0.
SpiroSphere® ECG Instructions for Use Display Inspiratory Setting options: Preset: ON, OFF 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 Setting options: Preset: TLC, RV TLC The inspiratory and expiratory phase of the Flow-Volume curve can be referred to TLC or RV.
SpiroSphere® ECG Instructions for Use Spirometry Settings - Forced Spirometry Quality Feedback Setting options: Preset: ON, OFF ON ON, OFF ON, OFF Error, OFF, Warning, Con Error, OFF, Warning, Con Error, OFF, Warning, Con Error, OFF, Warning, Con Error, OFF, Warning, Con Error, OFF, Warning, Con rmation rmation rmation rmation rmation rmation Error Warning Warning Error Error Error As the quality of a spirometry measurement strongly depends on the patient's cooperation, the criteria de ned by the A
SpiroSphere® ECG Instructions for Use Spirometry Settings - Slow Spirometry Measurement Setting options: Preset: Automatic, 12, 9, 6, 4 L Automatic Automatic, 12, 9, 6, 4 L Automatic VCin, VCex, VCmax, IC, ERV VCmax ERV VC-, IC VC-Maneuver ERV VCManeuver Quality Feedback Setting options: Preset: Error, OFF, Warning, Con rmation Error, OFF, Warning, Con rmation Error, OFF, Warning, Con rmation Warning Warning Error Quality Feedback documented in an "Example" report: ATS error codes Page 58
SpiroSphere® ECG Instructions for Use Parameter Selection Forced Spirometry - Displayed Parameters The"Shown Parameters" column displays the parameters shown in the result screen of the forced spirometry measurement. Preset: FEV1 FEV1/FVC 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.
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 Scroll down to display further parameters (if applicable) VT BF The "Not active parameters" column displays all parameters which can be selected to be shown during a measurement.
SpiroSphere® ECG Instructions for Use Resting ECG SpiroSphere ECG allows recording of a 12-lead resting ECG measurement. Information on ECG Recording An electrocardiogram (ECG) is a graphic recording of the changes occurring in the electrical potentials (millivolt changes) at de ned sites on the skin. The continuously changing electrical elds are the result of depolarization and polarization of the heart and are distributed in the body without any delay.
SpiroSphere® ECG Instructions for Use ECG Leads To minimize artifacts, the skin of the de ned lead positions has to be prepared thoroughly. Preparing the subMectµs 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.
SpiroSphere® ECG Instructions for Use Limb ECG V1 Fourth intercostal space at the right sternal border V2 Fourth intercostal space at the left sternal border V3 Midway between V2 and V4 V4 Fifth intercostal space at the left of the midclavicular line V5 Anterior axillary line at same horizontal level as V4 V6 Mid-axillary line on same horizontal level as V4 and V5 LA Left wrist RA Right wrist RL Right ankle LL Left ankle When connecting the electrodes to the ECG unit, the tiny and fast
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.
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 signi cant wave. Similarly, the isoelectric sections at the end of the QRS-complex are incorporated into the preceding signi cant wave.
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.
SpiroSphere® ECG Instructions for Use Power on the ECG unit by pressing the power button. The LED will turn blue indicating the ECG unit is powered on. If the battery is low, the LED will blink. Power button Select to continue. A screen displaying the correct placement of the electrodes for the ECG recording will appear. Select . The system will illuminate the electrodes in a xed sequence. Version 02.
SpiroSphere® ECG Instructions for Use The electrodes can be visually checked (“running lights”), starting with “V1” and end with “LL”. Look for the “e” shape to con rm correct lead placement. Press . Prior to the ECG recording, an Impedance Check will be performed to con rm good contact with the skin. If a contact is poor, the respective electrode will blink on the screen: If an electrode contact is indicated as poor, please check the respective contact. Page 68/136 Version 02.
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 to start the ECG recording. The ECG will begin to record.
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).
SpiroSphere® ECG Instructions for Use 10 mm/mV Scaling Line gap no reference value 1mV 1mV Line gap no reference value 1mV 1mV Line gap no reference value 1mV 1mV Line gap no reference value 1mV 1mV 5 mm/mV Scaling Line gap no reference value 1mV 1mV Line gap no reference value 1mV 1mV Line gap no reference value 1mV 1mV Line gap no reference value 1mV Version 02.
SpiroSphere® ECG Instructions for Use ECG Results After 10 seconds the 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 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.
SpiroSphere® ECG Instructions for Use If you are happy with the recording select to save the ECG. The ECG can be printed by selecting the icon. You can also print your ECG afterwards from the Patient Details screen, via the y-out menu: Version 02.
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 con gured on-screen display).
SpiroSphere® ECG Instructions for Use ECG Settings Settings for ECG can be found under “ECG Settings”: ECG Unit connection: Activate, Pair or Unpair an ECG Unit Pacemaker detection: ON/OFF: Enables or disable check for Possible Pacemaker Textual interpretation: ON/OFF: Enables or disables printing of the ECG computerised interpretation ECG Displayed Parameters: Up to seven (7) parameters can be selected for display during an ECG measurement.
SpiroSphere® ECG Instructions for Use ECG Printed Parameters: This con gures the parameters that will be displayed on the printed ECG Report. The parameters can be added or removed in this section, by either double tapping or dragging across the respective parameter to either Not active (not shown), or Shown Parameters. The number of parameters printed is not limited. Connecting an ECG Unit Start the device by brief pressing the button. The LED lights steady blue when the device is ready.
SpiroSphere® ECG Instructions for Use Select “ECG Unit connection” from the ECG Settings menu. 1. On your ECG Unit press and hold the power button until the blue LED blinks fast. This will take approximately 20 seconds. 2. After further few seconds, the ECG unit will be listed in the above screen. 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.
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.
SpiroSphere® ECG Instructions for Use The following screen appears: Select whether or wish to use your ngerprint reader for access to the system Enter all the required information to create your user: Options for role type: Administator User Support Enter the details for the user (for rst user of the system this must be Administrator role). Version 02.
SpiroSphere® ECG Instructions for Use Overview who has which user rights: Patients Administrator User Support New patient X X Search patient X X X View patient details X X X Change patient demographics X X View measurements X X Perform measurements X X Print reports X X X Calibration Check X X X Linearity Check X X X Calibration CheckLog X X X Linearity CheckLog X X X Create backup X X X View system info X X X X Sensor Check Tools System Administrati
SpiroSphere® ECG Instructions for Use Register ¿ngerprints: Select to register ngerprints. Tap 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.
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.
SpiroSphere® ECG Instructions for Use You may register as many ngers as you like. When nished tap . The following screen appears: Tap to save the ngerprints of the respective user. Version 02.
SpiroSphere® ECG Instructions for Use After saving the rst user, you will be sent to the Login page: You can login via entry of Username and Password. If you registered your ngerprint, you can use the ngerprint reader. Two touches are required (the rst touch identi es the user, the second veri es the user). 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.
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 . 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 .
SpiroSphere® ECG Instructions for Use Edit User To edit the currently selected user, tap in the y out menu. The following screen appears: Make the appropriate changes and tap to move to the ngerprint registration (see above). (If you choose not to register ngerprints this button is labelled “Save”.
SpiroSphere® ECG Instructions for Use To reset the password for another user, tap . The following screen appears: The user will be required to change their password upon their login. Change Security Question From "User Management Settings" a Security Question and Answer can be de ned for the current user. Make the appropriate entries and tap to save the Security Question. Version 02.
SpiroSphere® ECG Instructions for Use Backup & Recover A backup of all saved patient- and test data should be performed and saved to a USBStick 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.
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.
SpiroSphere® ECG Instructions for Use Communication Tap on "Communication" It is possible to con gure the Communication settings from the Communication menu within Settings. Select the Communication method to open the respective con guration settings. Network Requirements WiFi Tap on the desired WiFi network. The following y-out menu appears: Tap to initiate the connection. Page 90/136 Version 02.
SpiroSphere® ECG Instructions for Use Enter the password as applicable and tap . Ethernet Choose the appropriate settings. If DHCP is set on "Off", then you can manually enter the appropriate settings. Version 02.
SpiroSphere® ECG Instructions for Use You can check the status of the connection by selecting "Check the network connection". Upon con rmation of a successful connection, following message box is displayed: 3G (only applicable for optional 3G module) Enter the appropriate Access Point Name and the Service Number. Page 92/136 Version 02.
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 con gured.
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. Speci¿cation of network connection The SpiroSphere can be connected to an IT network in order to send a pdf report to a designated email address. In order to use this functionality, the SpiroSphere must be connected to an ITnetwork with TCP/IP connectivity via Ethernet, WLAN (or optional 3G) with routing to the Internet.
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 speci ed recipient.
SpiroSphere® ECG Instructions for Use Reports Setting options: Preset: Input Customer Name Input Customer Address Best Effort Report Best Effort Report All Efforts Report Email Input Username Input Password Input Email Address Input Server Name Input Port Input SSL Print Job Print jobs state Page 96/136 Version 02.
SpiroSphere® ECG Instructions for Use Con guration of the Electronic Report Functionality In order to send a pdf report the SMTP server con guration, 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 con gured SMTP server.
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.
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.
SpiroSphere® ECG Instructions for Use Surface Cleaning and Disinfection The surface disinfection of the Main unit and other contaminated surfaces, such as the SpiroSphere Sensor, must be performed on a regular basis (e.g. Main Unit daily). Wiping disinfection 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.
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 Àuids (e.g. blood) to get into the SpiroSphere Sensor. In case of ingress of contaminated Àuids, do not use the SpiroSphere Sensor anymore.
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.
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.
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. Check polarity of the inserted energy source. The ECG unit is not visible to the receiving Bluetooth devices. There is already a Bluetooth pairing with another device. Put the device into pairing mode.
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.
SpiroSphere® ECG Instructions for Use The following applies to products that are potentially contaminated by biological working substances of risk group 3 and 2 according to the regulation on biological substances and that are thus classi ed as Transport Category B: Please contact ERT before returning the goods and observe the regulations for the transport of dangerous goods. 2.
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 non contaminated products“: see point 6. 6.
SpiroSphere® ECG Instructions for Use 'IVXMJMGEXI SJ ,]KMIRI 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.
SpiroSphere® ECG Instructions for Use General Safety Precautions The Instructions for Use is regarded as part of the instrument, and should always be kept on hand. The Instructions for Use describes the present state of the device/system, including software and accessories, with regard to the fundamental requirements of the MDD 93/42/EEC and MDR (EU) 2017/745. Exact adherence to the instructions issued is a prerequisite for perfect and intended functioning of ERT instruments.
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 certi ed according to the respective EN standards (e.g. EN 60950 or EN 60601-1).
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.
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 crosscontamination of the next patient.
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.
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.
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.
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 bodyworn devices, errors or mutual interaction might possibly occur. Pacemaker patients have to be monitored separately. Magnetic and electric elds can in uence the function of the device.
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 ampli er itself.
SpiroSphere® ECG Instructions for Use Graphical Symbols Applied Part of type CF, De brillation-proof (ECG unit cable variant) 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.
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.
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® 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 -1.74 dBi UMTS B2 1852 to 1908 MHz 23 dBm (+/- 2dBm) Class 3bis -1.1 dBi 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.
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.
SpiroSphere® ECG Instructions for Use Electromagnetic Interference and Wrong Diagnosis The device must not be installed and used in the vicinity of highfrequency 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.
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 Manufacturerµs 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.
SpiroSphere® ECG Instructions for Use ECG ampli¿er Guidance and Manufacturer¶s Declaration ± Electromagnetic Emissions The ECG unit is intended for use in the electromagnetic environment speci ed below. The customer or the user of the ECG unit should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment ± Guidance RF Emissions CISPR 11 Group 1 The ECG unit uses RF energy only for its internal function.
SpiroSphere® ECG Instructions for Use Test Speci¿cations for Immunity to RF Wireless Communications Equipment Maximum power (W) Distance Immunity test level (m) (V/m) Pulse modulation b) 18 Hz 1.8 0.3 27 GMRS 460; FRS 460 FM c) ± 5 kHz deviation 1 kHz sine 2 0.3 28 704 - 787 LTE Band 13, 17 Pulse modulation b) 217 Hz 0.2 0.3 9 800 - 960 GSM 800/900; TETRA 800; iDEN 820; CDMA 850; LTE Band 5 Pulse modulation b) 18 Hz 2 0.
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.
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.
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 Barometric pressure: 500 to 1100 hPa Accuracy ± 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: FEV1 and FVC: 0.1 to 8 L: Resistance Spirometer max.
SpiroSphere® ECG Instructions for Use Technical Data ECG Feature Value Product class according to 93/42/ EWG (MDD) 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.
SpiroSphere® ECG Instructions for Use Feature Value Classi cation according to 60601-1 - Protection type against electric shock Device with internal power supply - Protection level against electric shock Type CF Electromagnetic compatibility (EMC) according to 60601-1-2 - Noise suppression EN 55011 - Immunity 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 A
SpiroSphere® ECG Instructions for Use Item Numbers of Disposables and Accessories Use ERT accessories and spare parts only! 720254 Manual calibration syringe, 3 L 852353 Syringe Adapter D 28 mm, L 60 mm 892120 Plastic nose clip 892121 Nose clip pad "foam material", disposable, 100 pieces per pack 706000 ERT PT, incl. mouthpiece 706002 ERT PT, incl. mouthpiece (box of 10) 706003 ERT PT, incl.
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 L Charge Level Indicator 66 Chest ECG 62 Connectors 51 Contraindications 2 Limb ECG 63 D M Mouthpiece 102 Muscle tremor interference 51 Declaration of Conformity 7 Device Description 61 Q E R ECG Evaluation 72, 74 ECG Leads 62 ECG Recording 61, 66 ECG Results 72 ECG Settings 75 Electromagnetic Emi
SpiroSphere® ECG Instructions for Use For your notes: Page 134/136 Version 02.
SpiroSphere® ECG Instructions for Use Version 02.
SpiroSphere® ECG Instructions for Use © 2022 eResearchTechnology GmbH or one of its af liates. All rights reserved eResearchTechnology GmbH Sieboldstrasse 3 97230 Estenfeld, Germany +49 9305 720-9891 tel +49 9305 720-7891 fax Page 136/136 Version 02.
