eResearchTechnology SPS001 SpiroSphere is a diagnostic compact device to measure inspiratory and expiratory lung function parameters User Manual

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Document Description	2AAUFSPS001 UserMan
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Date Submitted	2017-05-30 00:00:00
Date Available	2017-05-30 00:00:00
Creation Date	2017-05-30 11:30:59
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Instructions for Use
SpiroSphereÂŽ
781235
Version 00.16
SpiroSphereÂŽ 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
WKHUHRIE\DQ\PHDQVLQFOXGLQJSULQWLQJSKRWRVWDWLFGXSOLFDWLRQPLFURÂżOPVRUDQ\RWKHU
processes.
eResearchTechnology GmbH
Sieboldstrasse 3
97230 Estenfeld, Germany
Tel:
+49 9305 720-9891
Fax:
+49 9305 720-7891
www.ert.com
Š 2017 eResearchTechnology GmbH. All rights reserved.
Indications for Use
The SpiroSphere is a diagnostic compact device to measure inspiratory and expiratory lung
function parameters in adults and children. In addition the SpiroSphere can collect, store and
transfer vital data from other external devices.
,WFDQEHXVHGE\SK\VLFLDQVLQWKHRIÂżFHRUKRVSLWDODQGLQRFFXSDWLRQDOPHGLFLQH
Federal U.S. law restricts this device to sale by or on the order of a
physician. (Rx only)
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SpiroSphereÂŽ Instructions for Use
Table of Contents
Indications for Use ...........................................................................................................2
Notes on Safety in this Instruction Manual ......................................................................4
Declaration of Conformity ................................................................................................4
Device Description...........................................................................................................5
Unpacking and Starting Operation ..................................................................................5
The SpiroSphere ............................................................................................................6
Start-Up ...........................................................................................................................7
Troubleshooting ...............................................................................................................9
LED Status SpiroSphere .................................................................................................9
LED Status SpiroSphere Sensor .....................................................................................9
Sensor insert .................................................................................................................10
Setup .......................................................................................................................... 11
The Home Screen .........................................................................................................13
Sensor Check ...............................................................................................................14
Calibration Check ..........................................................................................................14
Linearity Check ..............................................................................................................16
Add Patient ....................................................................................................................17
Search Patient ...............................................................................................................19
Actions ..........................................................................................................................21
Preparing a Measurement .............................................................................................22
Perform a Forced Spirometry Measurement .................................................................23
Perform a Slow Spirometry Measurement.....................................................................28
Dosing ..........................................................................................................................31
Perform a Post Spirometry Measurement .....................................................................32
Adhoc Test .....................................................................................................................34
Perform an Adhoc Test ..................................................................................................34
Assign Adhoc Test now..................................................................................................35
Assign Adhoc Test later .................................................................................................36
Show, Edit, Delete and Print Tests ................................................................................37
Print Recorded Results..................................................................................................40
Settings and Tools .........................................................................................................41
User Management .........................................................................................................54
Update ..........................................................................................................................69
About Device .................................................................................................................69
Restore Default Settings................................................................................................69
Factory reset..................................................................................................................69
Cleaning/Hygiene ..........................................................................................................70
General Safety Precautions...........................................................................................72
Graphical Symbols ........................................................................................................77
Notes on EMC according to EN60601-1-2 ..................................................................80
Technical Data ...............................................................................................................81
Item Numbers of Disposables and Accessories ............................................................83
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SpiroSphereÂŽ Instructions for Use
Notes on Safety in this Instruction Manual
Following the ANSI (American National Standards Institute) recommendations for safety notes,
VSHFLÂżFSDVVDJHVRIWKLVLQVWUXFWLRQPDQXDODUHFOHDUO\PDUNHGDVVDIHW\QRWHV
Degree of
Danger
Injury
to
persons
Damages
to
property
Meaning of Indicator
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.
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SpiroSphereÂŽ Instructions for Use
Device Description
The SpiroSphere is a compact spirometry device. Its Sensor Unit is battery-powered. The Main
Unit can be powered by battery or power supply. The SpiroSphere is used to measure inspiratory
and expiratory lung function parameters in adults and children. The measured data is saved into
the device and can be read out at any time.
The disposable easy-to-exchange, high-quality pneumotach guarantees a high degree of patient
safety and provides precise recording results.
The Main Unit is equipped with a graphical LCD touch display, providing a state of the art solution
for selection of menu functions and the navigation throughout the menu.
The SpiroSphere Sensor is paired via Bluetooth with the Main Unit.
A printer can be connected with the SpiroSphere and all needed data can be printed. Moreover, it
is possible to transfer data via USB, WiFi, 3G and Ethernet.
7KHGHYLFHFDQEHXVHGE\SK\VLFLDQVLQWKHRIÂżFHRUKRVSLWDODVZHOODVLQRFFXSDWLRQDOPHGLFLQH
Unpacking and Starting Operation
SpiroSphere is delivered with the
following accessories*:
Main Unit
SpiroSphere Sensor
Power Supply
ERT PT with Mouthpiece
Nose clips and Pads
Instruction manual
7KH5HWXUQRI*RRGVLQ0HGLFDO,QVWLWXWLRQ&HUWLÂżFDWHRI+\JLHQHLVSURYLGHGDVDVHSDUDWH
GRFXPHQWÀ\HU
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
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SpiroSphereÂŽ Instructions for Use
The SpiroSphere
Main Unit:
Front view:
Power On/Off
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
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Power On/Off
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SpiroSphereÂŽ 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.
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SpiroSphereÂŽ Instructions for Use
 3ULRUWRWKHÂżUVWXVDJHVZLWFKRQWKH6SLUR6SKHUH6HQVRUE\SUHVVLQJWKHPower On" switch
located at the back side of the SpiroSphere Sensor.
5. Ensure an ERT PT is inserted into the SpiroSphere Sensor.
ERT PT with mouthpiece
ERT PT is only for single use. Do not reuse the ERT PT due to risk of cross
contamination.
Do not remove the mouthpiece from the ERT PT. Only use the ERT PT with
connected mouthpiece.
3ULRUWRWKHÂżUVWXVHPDNHVXUHWKDWWKH6SLUR6SKHUH6HQVRULVIXOO\FKDUJHG
The maximum temperature of the SpiroSphere Sensor Unit can get up to
47°C.
Spirometry should only be performed by patients who can cooperate in the performance.
Shut down
1. To switch off the SpiroSphere Main Unit, press the Power On/Off switch located
at the front of the main unit. Disconnect the main unit from the power source.
2. Switch on the SpiroSphere Sensor by pressing the "Power Off" switch located
at the back side of the SpiroSphere Sensor. Disconnect the SpiroSphere Sensor
from the main unit.
'RQRWSRVLWLRQWKH3RZHU6XSSO\DQGWKH6SLUR6SKHUHVRWKDWLWLVGLIÂżFXOW
to operate the disconnection of the device from the mains supply.
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SpiroSphereÂŽ Instructions for Use
Troubleshooting
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
power socket
LED Status SpiroSphere Sensor
Only the highest priority LED at a time is turned on (LED priority: Orange - Blue).
Orange LED On
Charging in cradle
Orange LED Off
No charging/ charging complete
in cradle
Orange LED
blinking slowly
Low battery
Orange LED
blinking fast
Put the SpiroSphere Sensor
into the cradle of the Main Unit
Indicates an error in the
SpiroSphere Sensor
Blue LED blinking
slowly
SpiroSphere Sensor is actively
transferring data to the Main Unit
Blue LED Off
Device in sleep mode
Blue LED blinking
fast
Device powered on and paired
with Main Unit
Put the device into the
charging dock or press the
Power On switch
Error Messages
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SpiroSphereÂŽ Instructions for Use
Sensor insert
Take care that you have aligned the rail with the sensor holes of the PT tube with the grooved
edge of the SpiroSphere Sensor (as below) when inserting the ERT PT into the SpiroSphere
Sensor:
rail with sensor holes
The ERT PT should be inserted fully without force.
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SpiroSphereÂŽ Instructions for Use
Setup
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$IWHUVZLWFKLQJRQWKH6SLUR6SKHUHIRUWKHÂżUVWWLPHIROORZLQJVFUHHQDSSHDUV
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
.
2. Date & Time Settings
Select the appropriate settings
DQGFRQÂżUPZLWKNext>.
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SpiroSphereÂŽ Instructions for Use
3. Sensor Settings
Tap on  to scan for
available sensors. Tap on the
sensor you want to pair the
SpiroSphere with and select
 from the dropdown menu.
&RQÂżUPZLWKNext>.
4. Ethernet Settings
Choose the appropriate settings
DQGFRQÂżUPZLWKNext>. (Refer
to chapter "Communication".)
5. WiFi Settings
Choose the appropriate settings
DQGFRQÂżUPZLWKNext>. (Refer
to chapter "Communication".)
6. User Management Settings
Choose the appropriate settings
DQGFRQÂżUPZLWKNext>.
Complete the initial setup of the device by tapping
on .
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SpiroSphereÂŽ 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
6HDUFKIRUDVSHFLÂżFSDWLHQWLQ\RXUSDWLHQWGLUHFWRU\6HOHFWDVSHFLÂżF
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
VSHFLÂżFSDWLHQWÂżUVW
Settings & Tools
Change settings.
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SpiroSphereÂŽ Instructions for Use
Sensor Check
The ERT PTs included with the delivery are pre-calibrated as part of manufacture.
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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.
Calibration Check
In order to perform a calibration check, tap on .
Following screen appears:
Ensure a new ERT PT (with mouthpiece removed) is connected to the 3 L calibration syringe via
an adapter (as shown).
Proceed by tapping . A zero adjustment of the connected SpiroSphere
Sensor will be performed automatically.
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SpiroSphereÂŽ Instructions for Use
The calibration checkLVXVHGWRFKHFNWKHYROXPHDFFXUDF\ZLWKLQGLIIHUHQWÀRZUDQJHV
With each syringe stroke, the volume accuracy should be within Âą 3 %.
High Ex
Mid Ex
Low Ex
Low In
Mid In
High In
Âą3%
,WLVLPSRUWDQWWRSXPSZLWKRXWLQWHUUXSWLRQIURPLPSDFWWRLPSDFW7KHÂżUVWSXPSVWURNH
is not relevant and will be discarded. There should be one pump stroke in each of the
IROORZLQJÀRZUDQJHVORZPLGDQGKLJKUDQJH
1 syringe stroke = pump twice, i.e. from impact to impact.
Screen display after a total of three syringe strokes:
better than Âą 3 %
X worse than Âą 3 %
End the calibration check by tapping on .
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SpiroSphereÂŽ Instructions for Use
Linearity Check
In order to perform a linearity check, tap on .
Proceed as described in the "Calibration Check" section.
'XULQJDOLQHDULW\FKHFNYROXPHDFFXUDF\DWGLIIHUHQWÀRZVLVWHVWHG7KUHHV\ULQJHVWURNHVDWD
ORZWKUHHDWDPLGUDQJHÀRZDQGWKUHHDWDKLJKÀRZDUHUHTXLUHG
With each syringe stroke, the volume accuracy should be within Âą 3 %.
,WLVLPSRUWDQWWRSXPSZLWKRXWLQWHUUXSWLRQIURPLPSDFWWRLPSDFW7KHÂżUVWSXPSVWURNH
is not relevant and will be discarded. Three pump strokes are required in each of the
IROORZLQJÀRZOHYHOVORZPLGDQGKLJKUDQJH
1 syringe stroke = pump twice, i.e. from impact to impact.
Screen display after a total of 9 syringe strokes:
better than Âą 3 %
X worse than Âą 3 %
End the linearity check by tapping on .
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SpiroSphereÂŽ Instructions for Use
Add Patient
%HIRUHPHDVXULQJDSDWLHQWIRUWKHÂżUVWWLPHWKHSDWLHQW VSHUVRQDOGDWDKDVWREH
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
(QWU\ÂżHOGVZLWK
instructions on
entering
Touchscreen
Keyboard
Hide Keyboard
Enter
(QWHUWKHDSSURSULDWHSDWLHQWGDWDXVLQJWKHWRXFKVFUHHQNH\ERDUGDQGFRQÂżUPZLWK
.
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SpiroSphereÂŽ 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 patient to your patient
directory.
If you want to discard all data just
entered, tap on . All
ENTRYžlELDSžWILLžBEžCLEAREDž
Screen display after patient data input:
Patient data
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Available Actions (Type), and list of
tests already performed (Previous
Tests)
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SpiroSphereÂŽ 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
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ÂżUVWOHWWHURUWKHÂżUVWFKDUDFWHURIWKHSDWLHQW V,'LVVXIÂżFLHQWDVZHOO,IHJ6
is entered, all patients whose last names start with "S" are displayed.
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SpiroSphereÂŽ Instructions for Use
,IDOLVWHGSDWLHQWLVVHOHFWHGWKHIROORZLQJÀ\RXWPHQXDSSHDUV
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
VSHFLÂżFSDWLHQW
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. due to
weight or height change in children), the respective data can be edited and will
be used for future tests.
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SpiroSphereÂŽ 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.
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
Dosing
Input Medication, Medication time and Technican
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SpiroSphereÂŽ Instructions for Use
Preparing a Measurement
Please observe the instructions for hygiene of your
system. Verify that a new ERT PT with mouthpiece is
attached in the SpiroSphere Sensor.
Select a measurement
(e.g. )
via tapping.
The measurement is started by tapping on .
The "Ambient Conditions" window appears:
The patient must not interact with the SpiroSphere Main Unit.
Current room temperature (°C)
Current relative humidity (%)
Current barometric pressure (hPa)
When the test is started, an automatic zero adjustment of the connected ERT PT is
performed. Hold the SpiroSphere Sensor still and wait for the zero adjustment to be
completed before approaching the mouthpiece.
As soon as the zero adjustment is completed, the patient should close his/her nose with
the nose-clip, take the mouthpiece between his/her teeth and seal his/her lips tightly
around the mouthpiece. Check the correct position of the mouthpiece!
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SpiroSphereÂŽ Instructions for Use
7KH$73%736FRUUHFWLRQIDFWRUVIRULQVSLUDWRU\DQGH[SLUDWRU\ÀRZVDQGYROXPHVZLOOEH
determined from the ambient data. Therefore, ambient data must be updated at regular
intervals. Incorrect or imprecise ambient data will result in incorrect measurement results.
The SpiroSphere must not be exposed to direct sunlight nor positioned immediately near heating
elements.
The current ambient conditions are to be entered manually. In this case, the ambient data should
be updated if the room temperature changed by more than 2°C or if relative humidity changed by
more than 10%.
Tap on  to apply the ambient data entered.
Perform a Forced Spirometry Measurement
Make the proper preparations according to ATS/ERS guidance.
Please note: During the whole examination the patient must stay on the mouthpiece.
7KHSDWLHQWEUHDWKHVQRUPDOO\ ÂżJXUH 1 ) until a steady tidal breathing is shown. From tidal
EUHDWKLQJWKHSDWLHQWLVLQVWUXFWHGWRLQKDOHDVGHHSO\DVSRVVLEOH LQKDOHWR7/&ÂżJXUH 2 ).
to TLC
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SpiroSphereÂŽ Instructions for Use
Screen display:
Tapping on the "i"-symbol will
display information on the
measurement procedure.
6s
FVCin
FEV1/FVC
Screen display:
Without interruption, the patient
should immediately exhale as
fast and as much (FEV1) and as
ORQJ )9& DVSRVVLEOH ÂżJXUH
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
ÂżJXUH 4 ).
Tap .
Screen display after three efforts:
The "Best" column displays the
best value out of all valid efforts.
'HÂżQLWLRQRIWKHEHVWHIIRUWGHSHQGV
on the Settings selected
(see: >Settings Spirometry >Forced
Spirometry >Measurement).
Scroll down to display further parameters
(if applicable)
Literature:
MR Miller et al. Series “ATS/ERS Task Force: Standardisation of Lung Function Testing“,
StandardisationRI6SLURPHWU\(XU5HVSLU-&RS\ULJKW‹(56-RXUQDOV/WG
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SpiroSphereÂŽ Instructions for Use
Change View:
6FUHHQGLVSOD\ÀRZYROXPHDQG
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.
= minor errors present
= major errors present
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
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SpiroSphereÂŽ Instructions for Use
Deactivate/reactivate efforts
,IVHYHUDOHIIRUWVZHUHSHUIRUPHGLQGLYLGXDOHIIRUWV HJHIIRUWVZLWKLQVXIÂżFLHQWSDWLHQWFRRSHUDWLRQ 
can be deactivated. The system can also automatically deactivate efforts as a result of system
detected ATS/ERS acceptability errors. Behaviour FDQEHFRQÂżJXUHGLQ6HWWLQJV
Procedure:
Mark the effort to be deactivated (in our example Effort 4). Following window appears:
Tap on . Tapping on  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 .
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SpiroSphereÂŽ Instructions for Use
Perform a Slow Spirometry Measurement
Make the proper preparations according to ATS/ERS guidance.
When the test is started, an automatic zero adjustment of the connected ERT PT is
performed. Hold the SpiroSphere Sensor still and wait for the zero adjustment to be
completed before approaching the mouthpiece.
As soon as the zero adjustment is completed, the patient should close his/her nose with
the nose-clip, take the mouthpiece between his/her teeth and seal his/her lips tightly
around the mouthpiece. Check the correct position of the mouthpiece!
Performance of an "ERV Maneuver":
Tidal breathing should be continued for a longer period of time
ÂżJXUH 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
EUHDWKLQJRYHUWKHODVWÂżYHEUHDWKLQJF\FOHV
G97 YDULDWLRQ FRHIÂżFLHQWRIYDULDWLRQ RIWKHWLGDOYROXPH
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.
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SpiroSphereÂŽ Instructions for Use
7KHSDWLHQWVKRXOGH[KDOHVORZO\ VHH1RWHEHORZ DQGFRPSOHWHO\ (59ÂżJXUH 2 ) followed by
DVORZDQGFRPSOHWHLQKDODWLRQ 9&LQÂżJXUH 3 ). Then, continue to breathe normally.
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. 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  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.
'HÂżQLWLRQRIWKHEHVWHIIRUW KLJKHVW9&PD[
(see: >Settings Spirometry >Slow Spirometry> Measurement)
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SpiroSphereÂŽ Instructions for Use
Dosing
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.
9HUVLRQ‡0$<
Page 31/84
SpiroSphereÂŽ Instructions for Use
Perform a Post Spirometry Measurement
The Flow-Volume curve shows the immediate
bronchospasmolytic effect. The expiratory portion of the Flow9ROXPHFXUYHDQGFRQVHTXHQWO\PD[LPDOSHDNÀRZ 3() 
forced expiratory volume after 1 sec (FEV1) as well as forced
vital capacity (FVC) changes.
Screen display after the "Pre Measurement":
Screen display after the "Post Measurement":
Post Measurement (purple)
Pre Measurement (green)
Page 32/84
9HUVLRQ‡0$<
SpiroSphereÂŽ Instructions for Use
3UH3RVW Report:
9HUVLRQ‡0$<
Page 33/84
SpiroSphereÂŽ Instructions for Use
Adhoc Test
With the Adhoc Test application it is possible to perform a Spirometry measurement without
having to register the patient beforehand.
For example: An Adhoc test can be performed if a prompt measurement of a patient is urgently
required (e.g. in an emergency situation).
It is possible to assign the measurements performed to a patient after the measurement has been
completed or at some point later.
Perform an Adhoc Test
Tap on the "Adhoc TestÂżHOGRQWKH+RPH6FUHHQ
The "Ambient Conditions" window appears and zeroing occurs:
Tap on  to apply the ambient data entered and perform three
successive "Forced Spirometry" maneuvers as described. Once the test is
completed, the following window appears:
Page 34/84
9HUVLRQ‡0$<
SpiroSphereÂŽ 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 .
9HUVLRQ‡0$<
Page 35/84
SpiroSphereÂŽ Instructions for Use
Assign Adhoc Test later
Tap on .
The patient which is not registered yet will appear as "Adhoc Patient" in the "Patient Directory".
In order to assign a patient to the Adhoc test performed, tap on "Adhoc Patient".
Tap on  to enter the appropriate patient data.
Page 36/84
9HUVLRQ‡0$<
SpiroSphereÂŽ Instructions for Use
Show, Edit, Delete and Print Tests
6HOHFWDFRPSOHWHGWHVW7KHIROORZLQJÀ\RXWPHQXDSSHDUV
Tap on  to display the results of the selected test on the screen:
9HUVLRQ‡0$<
Page 37/84
SpiroSphereÂŽ Instructions for Use
Existing patient data can be edited (if e.g. the patient's body weight or height
(e.g. in children) has changed in the meantime) by tapping on .
The selected test can be deleted with :
Tapping on  will irrevocably delete the selected test!
Tap on  to print the selected test or send a PDF-report to a designated
e-mail address.
For more detailed information, see chapter "Print Recorded Results".
Page 38/84
9HUVLRQ‡0$<
SpiroSphereÂŽ 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!
9HUVLRQ‡0$<
Page 39/84
SpiroSphereÂŽ Instructions for Use
Print Recorded Results
As soon as a measurement is completed, the results can be printed by means of a connected
USB*1 SULQWHU,WLVDOVRSRVVLEOHWRFUHDWHD3')ÂżOHZKLFKFDQEHVHQWWRDSUHGHÂżQHGHPDLO
address*2 or saved to an USB stick.
Preset: send PDF to an e-mail address (see >Setting Report & Printing)
Tap on the Printer icon.
7DSRQWKH5HSRUW6HOHFWLRQÂżHOG
Best Effort Report
a report displaying the best effort is
created
All Effort Report
a report displaying all efforts is
created
Screen Capture Report
a screen capture report is created
Tap on  to create the report. The "Print Result" window appears:
Tap on  to send the report to
WKHSUHGHÂżQHGHPDLODGGUHVV
7KHUHSRUWZLOOEHVHQWWRWKHHPDLODGGUHVVGHÂżQHGRQ\RXU6SLUR6SKHUH7KHUHSRUW
ODEHOZLOOLQFOXGHWKHGDWHDQGLGHQWLÂżFDWLRQQXPEHU7KHÂżOHZLOOEHSDVVZRUGSURWHFWHG
DVGHÂżQHG
SpiroSphere Report: BestEffortReport_20160815_155247+0200.zip
*1
*2
*3
For this option, an USB printer needs to be connected to the SpiroSphere
For this option, the SpiroSphere needs to be connected to the network
See chapter "Settings and Tools > Report & Printing"
Page 40/84
9HUVLRQ‡0$<
SpiroSphereÂŽ 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
'HÂżQLWLRQ &KRRVH3UHVHW
select actual Country
select timezone City
ON/OFF
ON
24h/12h
24h
YYYY.MM.DD
2016.08.16
set actual Time
DD.MM.YYYY
16.08.2016 DD-MM-YYYY
DD-MMM-YYYY
16-AUG-2016
MM/DD/YYYY
08/16/2018
set actual Date
9HUVLRQ‡0$<
Page 41/84
SpiroSphereÂŽ Instructions for Use
Regional
Setting options:
Preset:
English (US), German
English (US)
cm. in
cm
kg. lb
kg
Setting options:
Preset:
select
50%
select
100%
select
100%
select
5 min
select
2 min
select
10 min
select
5 min
select
20 min
select
20 min
Sound
Power Management
Preset:
7KHVHVHWWLQJVLQÀXHQFHWKHEDWWHU\OLIHRIWKH6SLUR6SKHUH
Page 42/84
9HUVLRQ‡0$<
SpiroSphereÂŽ Instructions for Use
Spirometry Settings
Tap on "Spirometry Settings"
Spirometry Settings - Sensor
Sensor Connection
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
9HUVLRQ‡0$<
Page 43/84
SpiroSphereÂŽ Instructions for Use
Spirometry Settings - General
Predicted Values
Setting options:
Preset:
None
GLI 2012
GLI 2012
NHANES III
ECCS/Zapletal
Knudson/Crapo
Extrapolate
Limits from Author
Limits from Author
No calculation outside limits
Module
Age range
Height range
Differentiation acc. to Race
GLI 2012
3-95 years
no limitation
Ethnicity
NHANES III
8-80 years
110-200 cm
African-Descent
Mexican-American
all other groups
ECCS/Zapletal
5-17 years (Zapletal)
18-70 years (ECCS
93)
107-182 cm
(for Zapletal only)
African-Descent
0.87 for volume (18 - ’)
Knudson/Grapo
6-90 years
no limitation
African-Descent
0.88 for volume
all other groups
For an age between 19 and 25, the calculation is based on the age of 25
Page 44/84
9HUVLRQ‡0$<
SpiroSphereÂŽ Instructions for Use
Sensor Check
Setting options:
Preset:
1, 2, 3
1, 2, 3, 4
2, 3, 4, 5, 6, 7, 8
ON, OFF
ON
2))&RQÂżUP(QIRUFH
&RQÂżUP
2))&RQÂżUP(QIRUFH
&RQÂżUP
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, mL*L/s
mL
L/s
L/s
L/min
ms
L*L/s
Ambient Conditions
Unit Groups
9HUVLRQ‡0$<
Page 45/84
SpiroSphereÂŽ Instructions for Use
Decimals
Setting options:
Preset:
0, 1, 2, 3, 4
0, 1, 2, 3, 4
0, 1, 2, 3, 4
0, 1, 2, 3, 4
0, 1, 2, 3, 4
0, 1, 2, 3, 4
0, 1, 2, 3, 4
0, 1, 2, 3, 4
0, 1, 2, 3, 4
Example: Preset 0: Preset 1: Preset 2:
FVC [L] 5
5,1
5,10
Spirometry Settings - Forced Spirometry
Measurement
Scroll down to display further settings
(if applicable)
Page 46/84
9HUVLRQ‡0$<
SpiroSphereÂŽ 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 “Automatic³LVVHOHFWHGDQGWKHEUHDWKLQJÀRZLVJUHDWHURUOHVV
WKDQWKHSUHVHWÀRZD[LVWKLVD[LVZLOOEHUHVFDOHGDXWRPDWLFDOO\
&KRRVH
FVC as FEV2
FVC as FEV3
FVC as FEV6
3UHVHW
ON, OFF
OFF
ON, OFF
OFF
ON, OFF
OFF
If “ON“ is selected, the value for the respective parameter is used as
the FVC value.
Setting options:
Preset:
Expiratory Back
Extrapolation
Always, Never
Always
Inspiratory Back
Extrapolation
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 computer determines the correct start of
inspiration.
9HUVLRQ‡0$<
Page 47/84
SpiroSphereÂŽ Instructions for Use
FEF calculation Base
FIF calculation Base
Setting options:
Preset:
individual FVC
individual FVC
VC max
If “individual FVC“ is selected, the FEF or the FIF values will be
calculated based on FVC.
Best Expiration
Setting options:
Preset:
FEV1 + FVC
FEV1 + FVC
FEV1
FVC
FVC + FERV1 + 1/3*PEF
FEV0.5 + FVC
FEV0.5
Best Inspiration
Setting options:
Preset:
FVCin + PIF
FVCin + PIF
FVCin + 0.1*PIF
FVCin + FIV1
FVCin
FIV1
Use best EX
If several breathing maneuvers are performed within one test cycle,
the software determines the best breathing maneuver within this trial
according to preset criteria.
Summary default View
Setting options:
Preset:
Flow/Volume
Flow/Volume
Tiffenau
Spirogram
If “Flow/Volume³LVVHOHFWHGWKHUHVXOWVFUHHQZLOOGLVSOD\WKHÀRZ
volume curve. If "Tiffeneau" is selected, the tiffenau curve will be
displayed.
Page 48/84
9HUVLRQ‡0$<
SpiroSphereÂŽ 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.
TLC
Display Predicted
Curve
RV
Setting options:
Preset:
ON, OFF
ON
If activated (ON), a predicted curve will be displayed in the diagram as
reference.
Pred
9HUVLRQ‡0$<
Page 49/84
SpiroSphereÂŽ Instructions for Use
Spirometry Settings - Forced Spirometry
Quality Feedback
Setting options:
Preset:
ON, OFF
ON
ON, OFF
ON, OFF
Error
Error
OFF
Warning
&RQÂżUPDWLRQ
As the quality of a spirometry measurement strongly depends on the patient's
FRRSHUDWLRQWKHFULWHULDGHÂżQHGE\WKH$76PXVWEHPHW,IWKHUHVSHFWLYHFULWHULDDUHQRW
PHWWKH\ZLOOEHGLVSOD\HGLQWKHUHVXOWVVFUHHQDQGÂżQDOO\GRFXPHQWHGLQWKHUHSRUW
Quality Feedback documented in an "Example" report:
ATS error codes
Page 50/84
ABG means:
errors A, B, G are
present
9HUVLRQ‡0$<
SpiroSphereÂŽ Instructions for Use
Spirometry Settings - Slow Spirometry
Measurement
Setting options:
Preset:
Automatic, 12, 9, 6, 4 L
Automatic
Automatic, 12, 9, 6, 4 L
Automatic
VCin, VCex, VCmax, IC, ERV
VCmax
ERV VC-, IC VC-Maneuver
ERV VC-Maneuver
Quality Feedback
Setting options:
Preset:
Error
Error
OFF
Warning
&RQÂżUPDWLRQ
Quality Feedback documented in an "Example" report:
ATS error codes
9HUVLRQ‡0$<
N means: the criteria N are not met
Page 51/84
SpiroSphereÂŽ Instructions for Use
Parameter Selection
Forced Spirometry - Displayed Parameters
The"Shown Parameters" column
displays the parameters shown in the
result screen of the forced spirometry
measurement.
Preset:
FEV1
FEV1/FVC
FVC
MMEF
Scroll down to display further parameters
(if applicable)
FVCin
The"Not active parameters" column displays all parameters which
can be selected to be shown during a measurement.
Add a parameter to the "Shown Parameters" column:
Double-tap on the required parameter in the "Not active parameters" column. The parameter will
immediately be added to the "Shown Parameter" list.
Remove a parameter from the "Shown Parameters" column:
Double-tap on the parameter you want to delete.
Tap on  in order to undo the recent changes.
Forced Spirometry - Printed Parameters
"see above"
Page 52/84
9HUVLRQ‡0$<
SpiroSphereÂŽ Instructions for Use
Slow Spirometry - Displayed Parameters
The "Shown Parameters" column
displays the parameters shown in the
result screen of the slow spirometry
measurement.
Preset:
VCin
IC
VCmax
VT
Scroll down to display further parameters
(if applicable)
BF
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  in order to undo the recent changes.
Slow Spirometry - Printed Parameters
"see above"
9HUVLRQ‡0$<
Page 53/84
SpiroSphereÂŽ Instructions for Use
User Management
This tool enables an authorized person to create an Administrator account. The newly
created administrator will then be able to create additional accounts for individuals
authorized to work with the SpiroSphere. Additionally, it is possible to register your
ÂżQJHUSULQWVLQRUGHUWRXWLOLVHWKHÂżQJHUSULQWUHDGHUIRUV\VWHPDFFHVV
From "Settings" select
"User Management"
Tap the switch to activate
User Management
The following screen appears:
Enter the Global Password (“691982”) and tap .
Page 54/84
9HUVLRQ‡0$<
SpiroSphereÂŽ Instructions for Use
The following screen appears:
Options for role type:
Administator
User
Support
(QWHUWKHGHWDLOVIRUWKHXVHU IRUÂżUVWXVHUWKLVPXVWEH$GPLQLVWUDWRUUROH 
2SWLRQDOO\\RXFDQFKRRVHWRUHJLVWHU\RXUÂżQJHUSULQWVLQRUGHUWRXWLOLVHWKHÂżQJHUSULQWUHDGHUIRU
system access.
Patients
Administrator
User
Support
New patient
Search patient
View patient details
Change patient
demographics
View measurements
Perform measurements
Print reports
Calibration Check
Linearity Check
Calibration CheckLog
Linearity CheckLog
Create backup
View system info
Sensor Check
Tools
9HUVLRQ‡0$<
Page 55/84
SpiroSphereÂŽ Instructions for Use
System Administration
Add or change user
Deactivate/activate user
Recover
Change date and time
settings
Update software
Select  to register
ÂżQJHUSULQWV
Tap .
The following screen appears:
Tap . Make the appropriate entries and, if
GHVLUHGUHJLVWHUÂżQJHUSULQWV VHHDERYH 
Change Password
7DSSLQJWKHFXUUHQWO\ORJJHGLQXVHULQWKHGLUHFWRU\ZLOORSHQDÀ\RXWPHQX
Access to the User details, and
Change password function is
available
To set a new password, tap . The following screen appears:
Make the appropriate entries and tap  to save the new password.
Page 60/84
9HUVLRQ‡0$<
SpiroSphereÂŽ Instructions for Use
Edit User
To edit the currently selected user, tap  to
deactivate the selected user.
9HUVLRQ‡0$<
Page 61/84
SpiroSphereÂŽ 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 SettingsD6HFXULW\4XHVWLRQDQG$QVZHUFDQEHGHÂżQHGIRUWKH
current user.
Make the appropriate entries and tap  to save the Security Question.
Page 62/84
9HUVLRQ‡0$<
SpiroSphereÂŽ 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 performedÂżHOGRQWKH
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 Backup³WRFUHDWHDEDFNXS¿OH
and save it to the USB stick!
9HUVLRQ‡0$<
Page 63/84
SpiroSphereÂŽ Instructions for Use
If “Perform Recover“ is selected, the
message "Please ensure USB Stick for
Recover is Inserted" appears.
Recover
Insert Backup USB stick
Tap on “All Data“ to reload all data into the
patient directory of your SpiroSphere.
Page 64/84
9HUVLRQ‡0$<
SpiroSphereÂŽ Instructions for Use
Communication
Tap on "Communication"
,WLVSRVVLEOHWRFRQÂżJXUHWKH&RPPXQLFDWLRQVHWWLQJVIURPWKH&RPPXQLFDWLRQPHQXZLWKLQ
Settings.
6HOHFWWKH&RPPXQLFDWLRQPHWKRGWRRSHQWKHUHVSHFWLYHFRQÂżJXUDWLRQVHWWLQJV
Network Requirements
WiFi
Tap on the desired WiFi network.
7KHIROORZLQJÀ\RXWPHQXDSSHDUV
Tap  to initiate the
connection.
9HUVLRQ‡0$<
Page 65/84
SpiroSphereÂŽ Instructions for Use
Enter the password as applicable and tap .
Ethernet
Choose the appropriate settings.
If DHCP is set on "Off", then
you can manually enter the
appropriate settings.
Page 66/84
9HUVLRQ‡0$<
SpiroSphereÂŽ Instructions for Use
Report & Printing
SpiroSphere allows for reports to be printed with an external printer. In addition,
6SLUR6SKHUHZLOODOORZWKHXVHUWRJHQHUDWHUHSRUWVDVD3')ÂżOHZKLFKFDQEH
WUDQVIHUUHGWRDQH[WHUQDOGHYLFH LHYLDD86%VWLFN RUHPDLOHGWRDVSHFLÂżHG
recipient.
Tap on "Report & Printing"
Printer
Setting options:
Preset:
Printer, PDF via Email,
PDF via USB
PDF via Email
ON, OFF
OFF
see below
see below
Color, Black & White
Color
A4, Letter
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".
9HUVLRQ‡0$<
Page 67/84
SpiroSphereÂŽ Instructions for Use
Reports
Setting options:
Preset:
Input Customer Name
Input Customer Address
Best Effort Report
Best Effort Report
All Efforts Report
Email
Input Username
Input Password
Input Email Address
Input Server Name
Input Port
Input SSL
Print Job
Print jobs state
Page 68/84
9HUVLRQ‡0$<
SpiroSphereÂŽ Instructions for Use
Update
Tap on . The device will
search for updates on the
connected USB stick.
Tap on  to
begin the update process.
List of available updates
About Device
Restore Default Settings
Factory reset
A detailed description of this tool is not part of this Instructions for Use.
9HUVLRQ‡0$<
Page 69/84
SpiroSphereÂŽ Instructions for Use
Cleaning/Hygiene
In the course of lung function testing, certain parts of the equipment can be contaminated by
germs, which creates the risk that these germs can be transferred to the next test subject.
For cross-contamination to occur, the test subject would need to be in direct contact with the
contaminated object or transport media such as droplets or aerosols. Contaminated aerosols may
EHWUDQVSRUWHGWKURXJKWKHUHVSLUDWRU\ÀRZDQGPD\DIIHFWWKHQH[WWHVWVXEMHFW
Always be sure to disconnect the devices/systems from the mains power before cleaning
or disinfecting.
The possible risk of infection can only be avoided if all of the contaminated parts are
thoroughly disinfected!
Hygiene Regulations:
In case of normal contamination all single-use items can be disposed of with the regular
waste. In case of dangerous infectious diseases (e.g. tuberculosis, blood...) single-use
items must be disposed of through hazardous waste.
How often should contaminated parts be exchanged?
6LQJOH8VH(5737ZLWKPRXWKSLHFH
Dispose after every patient
Reuse may lead to patient infections.
6LQJOHSDWLHQWXVH1RVHFOLS
Dispose nose clips after every patient
Reuse may lead to patient infections.
ERT PT and mouthpiece are parts for single use only. These parts must be
disposed after each single use. If reused, infection may occur.
Reprocessing may deteriorate the part, resulting in reduced stability and
leakage through micro cracks or releasing micro particles that could be inhaled.
Should any of these parts be recycled and misused intentionally, ERT takes no
responsibility nor can be made liable for the consequences arising from reusing
these parts.
Wiping
disinfection
Surface Cleaning and Disinfection
The surface disinfection of the Main unit and other
contaminated surfaces, such as the SpiroSphere Sensor,
must be performed on a regular basis (e.g. Main Unit daily).
If there has been direct contact with the skin or if the
case history/diagnosis of the patient requires it, a surface
disinfection has to be performed directly after the application.
Page 70/84
9HUVLRQ‡0$<
SpiroSphereÂŽ Instructions for Use
If the patient's history shows a dangerous infectious disease
(e.g. tuberculosis), all parts which had been in direct or indirect contact
with the patients must be disinfected.
Do not clean or disinfect the Main Unit or the SpiroSphere Sensor while
the devices are in operation.
Precleaning and Disinfection
$WKRURXJKSUHWUHDWPHQWFOHDQLQJLVDSUHFRQGLWLRQIRUDQHIÂżFLHQWGLVLQIHFWLRQRIFRQWDPLQDWHG
parts. Protein residue on these parts might prevent an effective disinfection.
ERT recommends the following disinfectants:
Precleaning and Disinfection:
Product
Manufacturer
Concentration/Reaction time
mikrozidÂŽsensitive
wipes
CaviWipes
Schuelke & Mayr GmbH
1 minute
Metrex
1 minute
3URFHGXUH8VHWKHÂżUVWFOHDQLQJZLSHWRFRYHUDOOVXUIDFHVZLWKWKHGHWHUJHQW5HSHDWWKH
procedure with a second wipe for disinfection. Let the surface dry.
Protein residue on parts which are to be disinfected prevents effective disinfection.
Therefore all protein residue must be removed prior to disinfection. In case of persistent
residues please use an appropriate tool (e.g. soft brush) to remove the residues.
Please observe the instructions with regard to concentration and reaction time!
If a different substance is used, please follow the manufacturer's instructions.
The use of detergents and disinfectants which have not been recommended by the
manufacturer might damage the products.
The manufacturer's information on the cleaning of accessories provided separately
must be observed!
With suspected tuberculosis or other resistant germs, the use of an appropriate
disinfectant (CaviWipes, Reaction time >3 minutes) is required.
$YRLGFRQWDPLQDWHGÀXLGV HJEORRG WRJHWLQWRWKH6HQVRU8QLW,QFDVHRI
LQJUHVVRIFRQWDPLQDWHGÀXLGVGRQRWXVHWKH6HQVRU8QLW
Disposal of single use items / damaged reusable items
Take precautions to avoid contaminating yourself (e.g. use gloves). All single patient use items
can be disposed of as domestic waste if there is a normal degree of contamination. In case of
dangerous infectious diseases (e.g. tuberculosis) it is necessary to dispose of the single patient
use items in special designated containers.
,QDGGLWLRQSOHDVHQRWHFRXQWU\VSHFLÂżFGLVSRVDOUHJXODWLRQV.
9HUVLRQ‡0$<
Page 71/84
SpiroSphereÂŽ Instructions for Use
General Safety Precautions
The Instructions for Use is regarded as part of the instrument, and should always be kept
on hand.
The Instructions for Use describes the present state of the device/system,
including software and accessories, with regard to the fundamental requirements of the
MDD 93/42/EEC.
Exact adherence to the instructions issued is a prerequisite for perfect and intended
functioning of ERT instruments.
Deviation from Intended Use
Any non-observance of the procedures (such as preparation for a measurement
and methods, disinfection procedures, use of accessories and replacement
parts etc.) described in the Instructions for Use results in a deviation from
intended use.
In case of a deviation from intended use, the operator/user has to supply proof
of meeting all corresponding fundamental requirements.
The operator/user is responsible for performing the conformity assessment
correctly and is also completely liable for defective products - i.e. the operator/
XVHULVOLDEOHIRUKLVKHUPRGLÂżFDWLRQRIWKHPHGLFDOSURGXFW
ERT only guarantees for the safety, reliability and functionality of the instrument if

LQVWDOODWLRQH[WHQVLRQPRGLÂżFDWLRQVDQGUHSDLUVDUHH[FOXVLYHO\FDUULHGRXWE\
personnel authorized for these tasks by ERT.

WKHURRPLQZKLFKWKHHTXLSPHQWLVRSHUDWHGFRPSOLHVZLWKWKHFRXQWU\VSHFLÂżF
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.
3DWLHQW6DIHW\DFFRUGLQJWR(1
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
VXEMHFWHQYLURQPHQWPXVWEHGHÂżQHG7KHVXEMHFWKDVWRNHHSDGLVWDQFHRIDWOHDVWPIURPDOO
open interfaces and connectors of the SpiroSphere Main Unit to avoid any contact with electrical
voltage.
The physician/operator must not touch any voltage-carrying parts (e.g. USB Plug, Ethernet Plug)
and the subject at the same time.
Page 72/84
9HUVLRQ‡0$<
SpiroSphereÂŽ 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.
$FFHVVRU\HTXLSPHQWFRQQHFWHGWRWKHLQWHUIDFHVPXVWEHFHUWLÂżHGDFFRUGLQJWR
the respective EN standards (e.g. EN 60950 or EN 60601-1).
Everybody who connects additional equipment to the signal input part or signal
RXWSXWSDUWFRQÂżJXUHVDPHGLFDOV\VWHPDQGLVWKHUHIRUHUHVSRQVLEOHWKDW
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.
8VHRI0XOWL3OXJ6RFNHWV
Medical devices/systems must only be connected to multi-plug sockets if all
regulatory requirements are met.
- Additional mobile multi-plug sockets must not be connected to power
sockets of medical devices/systems.
- Mobile multi-plug sockets of medical devices/systems must not be placed
RQWKHÀRRU
- Equipment (for example vacuum cleaner, radio, etc.) and devices which are
not part of the medical device/system must not be connected to the multiplug 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
RUPDJQHWLFLQWHUIHUHQFHÂżHOGVPD\IDOVLI\WKHUHVXOWRIPHDVXUHPHQWVRUPDNH
taking measurements impossible. Due to this, the vicinity of power lines is to be
avoided as well. Existing environmental interferences may cause deviations of
the measurement values without impairing the device’s function. Therefore, it is
recommended to keep a distance of about 2 meters from possible error 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
VSHFLÂżHGRUSURYLGHGE\WKHGHYLFH VPDQXIDFWXUHUFDQUHVXOWLQLQFUHDVHG
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
DQGFDEOHVVSHFLÂżHGE\WKHPDQXIDFWXUHU1RQREVHUYDQFHPD\OHDGWRD
reduction of the device's performance.
9HUVLRQ‡0$<
Page 73/84
SpiroSphereÂŽ Instructions for Use
Ambient Conditions
The medical device must not be operated in rooms with the presence of
ÀDPPDEOHDQDHVWKHWLFPL[WXUHZLWKDLURUÀDPPDEOHDQDHVWKHWLFPL[WXUH
with oxygen or nitrous oxide. The medical device must be operated in rooms
ZKHUHRQO\QRQFRQGXFWLYHSROOXWLRQRFFXUVKRZHYHURFFDVLRQDOWHPSRUDU\
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 unit’s
own data with those of the local power supply system (mains voltage and mains
frequency) before actually connecting the unit.
Connect only if all data comply!
Inspect the mains connection cable, plug, and receptacle for visible damages
prior to establishing the connection. Damaged cables or plugs must be replaced
immediately. Installation and assembly of the device must be done only in
compliance with this Instructions for Use.
$IWHUWKHÂżUVWVHWXSRULIWKHVHWXSKDVEHHQFKDQJHG HJH[FKDQJLQJRIWKH
SpiroSphere Sensor), a function test (e.g. calibration check) has to be performed.
The Main Unit must be placed outside the patient environment during
measurement.
Medical Supervision
'XULQJWKHPHDVXUHPHQWWKHSDWLHQWPXVWQRWEHXQDWWHQGHG$TXDOLÂżHG
physician must reassess all measurements. An interpretation by the medical
GHYLFHLVVLJQLÂżFDQWRQO\ZKHQFRQVLGHUHGWRJHWKHUZLWKRWKHUFOLQLFDOÂżQGLQJV
The performance of the spirometer can be affected by the patient spitting or
coughing into the spirometer during expiration or by extremes of temperature,
humidity and altitude.
Contraindications
According to ‘‘ATS/ERS TASK FORCE: STANDARDISATION OF LUNG
FUNCTION TESTING’’ (ERS Journals Ltd 2005) performing lung function tests
can be physically demanding for a minority of patients. It is recommended that
patients should not be tested within 1 month of a myocardial infarction. In rare
cases spirometry testing can lead to syncope due to extensive exhalation.
In the S2 guideline "Spirometry" (German Airway League, German Respiratory
Society and German Society of Occupational and Environmental Medicine,
2015), contraindications of spirometry are divided into absolute and relative
contraindications:
Absolute contraindications for Forced Maneuvers
Acute, life threatening diseases of every description, e.g.
‡ $FXWH0\RFDUGLDO,QIDUFWLRQ
‡ $FXWH)XOPLQDQW3XOPRQDU\(PEROLVP
Page 74/84
9HUVLRQ‡0$<
SpiroSphereÂŽ Instructions for Use
‡ /DUJH$VFHQGLQJ$RUWLF$QHXU\VP
‡ 7HQVLRQ3QHXPRWKRUD[
Relative contraindications for Forced Maneuvers
‡ 0DVVLYH3QHXPRWKRUD[ ZLWKLQWKH¿UVWZHHNV
‡ $EGRPLQDORU7KRUDFLF6XUJHU\ GHSHQGLQJRQWKH¿QGLQJVWRZHHNV
post-operatively)
‡ 6XUJHU\RIWKH(\HV%UDLQRU(DUV YDULDEOHFRQVXOWDWLRQZLWKWKH
surgeon)
‡ 6SHFLDOFDUHPXVWEHWDNHQZKHQGHDOLQJZLWK+HPRSW\VLVRIXQNQRZQ
origin
Cleaning and Hygiene
Prior to every application, all parts which come in contact with the patient and
which are intended for reuse must be cleaned or disinfected (unless otherwise
instructed).
Prior to taking measurements of a patient, his/her medical history is to be
checked in order to avoid a contamination of the device and a resulting crosscontamination of the next patient.
While performing a calibration check, a new disposable Pneumotach must be
used to prevent cross-contamination between the calibration syringe and the
parts. This will prevent contamination of the syringe and allow for its reuse.
Always be sure to disconnect the devices/systems from the mains power before
cleaning or disinfecting. The Main Unit corresponds to protection class IP21, the
SpiroSphere Sensor to class IP20.
The device may not be soaked in liquid of any kind. Liquid inside the device/
system may lead to harm of the user and can destroy the device.
The device can be cleaned with a damp (but not soaked) cloth, which does not
produce lint. More detailed information can be found under “Hygiene“ in this
Instructions for Use.
Detergents and chemicals required for cleaning and disinfection must always be
stored in specially marked containers to prevent any accidental improper use.
Biocompatibility
Component
Material
Mouth piece
Styrolution PS 454N HIPS
Biocompatibility of the material has
EHHQFRQÂżUPHG
Housing parts of the sensor unit and
the main unit
PT-tube
9HUVLRQ‡0$<
Cycoloy CX2244ME
Biocompatibility of the material has
EHHQFRQÂżUPHG
Styrolution PS 454N HIPS
Page 75/84
SpiroSphereÂŽ Instructions for Use
Maintenance
No part of the medical device may be replaced by the customer.
Use only ERT approved accessories and spare parts for this medical device.
If applied parts (e.g. SpiroSphere Sensor) have been exposed to extreme
mechanical stress, a function test (e.g. volume calibration check) has to be
performed. If function is lost, the defective part is to be replaced. Damaged
parts, e.g. frayed plugs, receptacles, a damaged handle, and defective cables
should be replaced immediately by an authorized specialist or engineers from
ERT Customer Care. The device must not be opened. If it is opened without
authorization the guarantee entitlement expires. ERT Customer Care is always
at your disposal with help and assistance in case of problems.
Before turning on the device/system you should always check whether the
power cable, power plug, outlet and power input of the device are free from
defects.
Before turning on the device/ system the following issues have to be checked
visually on a daily basis:
- the display glass is undamaged
- the unit has not been mechanically stressed in the extreme (e.g. damage
to the housing, the cable is made defective by running over it with a heavy
object or dragging it)
- no liquid got inside the unit
- the SpiroSphere Sensor is not damaged
- cables and/or multiple connectors are not defective
- coverings are not broken
An unattended child should not get into contact with disposables, accessories
and packing material as well as cleaning and disinfection substances.
Recurrent Test
Medical Electrical equipment needs a recurrent testing after repair of the
equipment according to IEC 62353.
The calibration syringe itself has to be calibrated at regular intervals as
determined by the manufacturer and as indicated on the syringe. The calibration
syringe must be checked for an accuracy of Âą 12 mL.
Recycling
Adhere to the national law of the country when disposing the medical device
and its accessories.
Improper disposal of the device and/or its accessories can result in serious
environmental hazards.
Page 76/84
9HUVLRQ‡0$<
SpiroSphereÂŽ Instructions for Use
Graphical Symbols
Alternating current
Attention!
ON/OFF (device connected to/disconnected from the
power supply system)
The typeplate can be found
at the rear side of the Main
Unit.
The typeplate on the
SpiroSphere sensor is
positioned at the left side.
Follow the instructions for Use!
Year of Production
Manufacturer
Applied part of Type BF
Single use
Disposal of electronic devices in compliance with WEEE
Barometric pressure limits
Rx only
CAUTION:
FEDERAL U.S. LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A
PHYSICIAN.
Packaging can be recycled
Temperature limit
Serial number
Reference number
IP20
3URWHFWLRQDJDLQVWLQWUXVLRQRIVROLGV•PPGLDPHWHUQRSURWHFWLRQDJDLQVWLQJUHVVRIOLTXLGV
IP21
3URWHFWLRQDJDLQVWLQWUXVLRQRIVROLGV•PPGLDPHWHUSURWHFWLRQDJDLQVWFRQGHQVDWLRQ
&(VLJQZLWKFRGHQXPEHURIWKH1RWLÂżHG%RG\
7KHFHUWLÂżHGTXDOLW\PDQDJHPHQWV\VWHPRIeResearchTechnology GmbH corresponds to the
international standard of ISO 13485.
Possible source of interference
9HUVLRQ‡0$<
Page 77/84
SpiroSphereÂŽ 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, CopyrightŠ 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!
 3URWHFWWKHEDWWHU\DJDLQVWÂżUH
- Do not dismantle or manipulate the battery.
 'RQRWUHSODFHWKHEDWWHU\,PSURSHUUHSODFHPHQWFDQOHDGWRÂżUHH[FHVVLYHKHDWRUH[SORVLRQ
 7KHÀXLGLQWKHEDWWHU\LVWR[LFDQGÀDPPDEOHOHDN\EDWWHULHVRUEDWWHULHVZLWKGHQWVPXVWQRW
be used any longer!
 'RQRWFRPHLQFRQWDFWZLWKWKHÀXLGLQWKHEDWWHU\,IWKHÀXLGFRPHVLQFRQWDFWZLWK\RXUVNLQ
immediately rinse the affected part with water and contact a doctor!
- To charge the SpiroSphere Sensor, use only the Main Unit Cradle and observe the instructions
in the manual!
- To charge the Main Unit, use only the provided power supply.
Page 78/84
9HUVLRQ‡0$<
SpiroSphereÂŽ Instructions for Use
USA
“This device complies with Part 15 of the FCC Rules. Operation is subjected to the following two
conditions: (1) this device may not cause harmful interference, and (2) this device must accept any
interference received, including that may cause undesired operation.“
SpiroSphere - Main Unit:
FCC-ID: 2AAUFSPS001
SpiroSphere - Sensor Unit:
FCC-ID: 2AAUFSPS002
Canada
This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject
to the following two conditions: (1) this device may not cause interference, and (2) this device must
accept any interference, including interference that may cause undesired operation of the device.
Le présent appareil est conforme aux CNR d’Industrie Canada applicables aux appareils radio
exempts de licence. L’exploitation est autorisée aux deux conditions suivantes : (1) l’appareil
ne doit pas produire de brouillage, et (2) l’utilisateur de l’appareil doit accepter tout brouillage
radioélectrique subi, même si le brouillage est susceptible d’en compromettre le fonctionnement.
SpiroSphere - Main Unit:
IC: 11335A-SPS001
SpiroSphere - Sensor Unit:
IC: 11335A-SPS002
Frequency
Band
Transmission Frequency
Range
Maximum Output Power
Gain
UMTS B1
1922 to 1978 MHz
23 dBm (+/- 2dBm) Class 3bis
-1.74 dBi
UMTS B2
1852 to 1908 MHz
23 dBm (+/- 2dBm) Class 3bis
-1.1 dBi
UMTS B5
826 to 847 MHz
23 dBm (+/- 2 dBm) Class 3bis
UMTS B6
832 to 838 MHz
23 dBm (+/- 2 dBm) Class 3bis
UMTS B8
882 to 913 MHz
23 dBm (+/- 2 dBm) Class 3bis
UMTS B19
832.4 to 842.6 MHz
23 dBm (+/- 2 dBm) Class 3bis
GSM 850
824 to 849 MHz
2 Watts GSM, GPRS and EDGE
E-GSM 900
880 to 915 MHz
2 Watts GSM, GPRS and EDGE
DCS 1800
1710 to 1785 MHz
1 Watt GSM, GPRS and EDGE
PCS 1900
1850 to 1910 MHz
1 Watt GSM, GPRS and EDGE
-3.31 dBi
-1.1dBi
ERT complies with EMC guidelines according to EN60601-1-2.
ERT can provide further information on EMC properties on request.
9HUVLRQ‡0$<
Page 79/84
SpiroSphereÂŽ Instructions for Use
Notes on EMC according to EN60601-1-2
The use of accessories not recommended by ERT may result in an increased electromagentic
radiation or a reduced interference immunity of the SpiroSphere.
*XLGDQFHDQG0DQXIDFWXUHUÂľV'HFODUDWLRQÂą(OHFWURPDJQHWLF(PLVVLRQVDQG,PPXQLW\
The SpiroSphere uses RF energy for internal function. Therefore, its RF emissions are very low
and are not likely to cause any interference to nearby electronic equipment. The SpiroSphere
is suitable for use in all establishments including domestic and those directly connected to the
public low-voltage power supply network that supplies buildings used for domestic purposes.
IEC 60601 directive
Compliance level
RF emissions CISPR 11
Group 1 Class B
Electrostatic discharge (ESD)
IEC 61000-4-2
Âą 8 kV indirect contact
Âą 15 kV direct air
direct contact not possible
Radiated RF
IEC 61000-4-3
10 V/m from 80 MHz to 2700 MHz applied to
4 devices orientations each with vertical and
horizontal antenna polarisation
Electrical fast transient/burst
IEC 61000-4-4
Âą 2 kV for power supply lines
Âą 1 kV for input/output lines
Surge
IEC 61000-4-5
0.5 kV differential mode
1 kV differential mode
Conducted RF
IEC 61000-4-6
3 V(rms) from 150 kHz to 80 MHz
6 V(rms) in ISM bands
Voltage dips
IEC 61000-4-11
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 80/84
9HUVLRQ‡0$<
SpiroSphereÂŽ Instructions for Use
Technical Data
Dimension
31.5 x 19.5 cm x 7.5 (L x W x H )
Weight
1.5 kg
Screen Display
16.2 x 12.2 cm
Medical
Model: GTM91099-3009-4.0-T2
Power Supply
Input: 100 - 240 Vac, 50/60 Hz, 1.5 A
Output: 5 V, 6 A
Cable length: 1200 mm
Frequency
50 - 60 Hz
Battery
Main Unit
Built-in rechargeable lithium-ion battery 3.7 V,
5000 mAh. Battery will last under standard
operating conditions for about 3 h.
Full charging: 2 h
Cycle life: 70% of rated capacity after 350 cycles
SpiroSphere Sensor Built-in rechargeable lithium-ion battery 3.7 V,
640 mAh. Battery will last under standard
operating conditions for about 3 days in standby
and 2.5 h operation.
Full charging: 2 h
Cycle life: 70% of rated capacity after 500 cycles
Protection class
Power Supply
Class II
SpiroSphere Sensor Internally powered
Mode of operation
Moisture protection
continuous
Power Supply
IP42
Main unit
IP21
SpiroSphere Sensor IP20
Applied parts
ERT PT, SpiroSphere Sensor
Application
Measuring Pulmonary Function
Interface
Measuring Principle
Operating Ambient
USB
Data transfer
Bluetooth
Data transfer
WiFi
Data transfer
Ethernet
Data Transfer
3G
Data transfer
Type BF
high-quality pneumotach
Temperature:
+10 °C to +35 °C
Relative humidity:
15 % to 90 %
Barometric pressure: 700 to 1070 hPa
9HUVLRQ‡0$<
Page 81/84
SpiroSphereÂŽ Instructions for Use
Transport/Storage
Temperature:
-10 °C to +50 °C
Relative humidity:
0 % to 90 %
Barometric pressure: 600 to 1200 hPa
Ambient unit
Measuring range
Barometric pressure: 500 to 1100 hPa
Accuracy
Âą 2.5 hPa at 700 - 1060 hPa
Technical Data Flow Sensor
Measuring range: PEF:
0.1 to Âą 16 L/s
FEV1 and FVC: 0.1 to 8 L
Resolution:
PEF:
Accuracy:
PEF:
< 5 mL/s
FEV1 and FVC: 1 mL
0.1 to 16 L/s:
FEV1 and FVC: 0.1 to 8 L:
Resistance
Spirometer
max. 135 Pa/L/s at 14 L/s
Instantaneous
Flow
0.1 – 14 L/s: +/- 5% or 0.2 L/s
Âą 10% of reading or Âą 0.3 L/s
Âą 3% of reading or Âą 0.050 L
The expected operational lifetime of the SpiroSphere is 7 years.
Page 82/84
9HUVLRQ‡0$<
SpiroSphereÂŽ Instructions for Use
Item Numbers of Disposables and Accessories
Use ERT accessories and spare parts only!
720254
Manual calibration syringe, 3 L
852740
Syringe Adapter D 28 mm, L 60 mm
892120
Plastic nose clip
892121
Nose clip pad "foam material", disposable,
100 pieces per pack
706000
ERT PT, incl. mouthpiece
706002
ERT PT, incl. mouthpiece (box of 10)
706002
ERT PT, incl. mouthpiece (box of 10)
706003
ERT PT, incl. mouthpiece (box of 50)
eResearchTechnology GmbH
Sieboldstrasse 3
97230 Estenfeld, Germany
Tel. +49 9305 720-9891
Fax +49 9305 720-7891
CustomerCare@ert.com
9HUVLRQ‡0$<
Page 83/84
‹H5HVHDUFK7HFKQRORJ\*PE+RURQHRILWVDI¿OLDWHV
All rights reserved
eResearchTechnology GmbH
Sieboldstrasse 3
97230 Estenfeld, Germany
+49 9305 720-9891 tel
+49 9305 720-7891 fax

---

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Rendition Class                 : proof:pdf
History Action                  : created, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved
History Instance ID             : xmp.iid:93846FB1D314E111A2C6842E6BE7BE36, xmp.iid:94846FB1D314E111A2C6842E6BE7BE36, xmp.iid:95846FB1D314E111A2C6842E6BE7BE36, xmp.iid:96846FB1D314E111A2C6842E6BE7BE36, xmp.iid:97846FB1D314E111A2C6842E6BE7BE36, xmp.iid:98846FB1D314E111A2C6842E6BE7BE36, xmp.iid:99846FB1D314E111A2C6842E6BE7BE36, xmp.iid:9A846FB1D314E111A2C6842E6BE7BE36, xmp.iid:9C846FB1D314E111A2C6842E6BE7BE36, xmp.iid:4E72B31AD114E111BD10C29E5587B8CE, xmp.iid:8A5F4A10F214E111BD10C29E5587B8CE, xmp.iid:8C5F4A10F214E111BD10C29E5587B8CE, xmp.iid:8D5F4A10F214E111BD10C29E5587B8CE, xmp.iid:8E5F4A10F214E111BD10C29E5587B8CE, xmp.iid:8F5F4A10F214E111BD10C29E5587B8CE, xmp.iid:B8E154686916E11198A6FDBF08B35CFF, xmp.iid:B9E154686916E11198A6FDBF08B35CFF, xmp.iid:0C9740808716E11198A6FDBF08B35CFF, xmp.iid:0D9740808716E11198A6FDBF08B35CFF, xmp.iid:0E9740808716E11198A6FDBF08B35CFF, xmp.iid:149740808716E11198A6FDBF08B35CFF, xmp.iid:159740808716E11198A6FDBF08B35CFF, xmp.iid:169740808716E11198A6FDBF08B35CFF, xmp.iid:949D87839A16E11198A6FDBF08B35CFF, xmp.iid:959D87839A16E11198A6FDBF08B35CFF, xmp.iid:969D87839A16E11198A6FDBF08B35CFF, xmp.iid:979D87839A16E11198A6FDBF08B35CFF, xmp.iid:989D87839A16E11198A6FDBF08B35CFF, xmp.iid:999D87839A16E11198A6FDBF08B35CFF, xmp.iid:9A9D87839A16E11198A6FDBF08B35CFF, xmp.iid:9B9D87839A16E11198A6FDBF08B35CFF, xmp.iid:9C9D87839A16E11198A6FDBF08B35CFF, xmp.iid:BF45A118A316E11198A6FDBF08B35CFF, xmp.iid:C045A118A316E11198A6FDBF08B35CFF, xmp.iid:10DF97FA2C17E111ADF1940397EE4DB4, xmp.iid:11DF97FA2C17E111ADF1940397EE4DB4, xmp.iid:12DF97FA2C17E111ADF1940397EE4DB4, xmp.iid:13DF97FA2C17E111ADF1940397EE4DB4, xmp.iid:14DF97FA2C17E111ADF1940397EE4DB4, xmp.iid:186126A0BA27E1119CD1EF2B8336DC2C, xmp.iid:196126A0BA27E1119CD1EF2B8336DC2C, xmp.iid:1A6126A0BA27E1119CD1EF2B8336DC2C, xmp.iid:62D27EC64C40E1119C91FAA54300DE11, xmp.iid:63D27EC64C40E1119C91FAA54300DE11, xmp.iid:64D27EC64C40E1119C91FAA54300DE11, xmp.iid:A141A8AEA766E111A8C2FE5E8026C11D, 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History When                    : 2011:11:22 07:32:04+01:00, 2011:11:22 07:34:09+01:00, 2011:11:22 07:34:09+01:00, 2011:11:22 07:40:36+01:00, 2011:11:22 07:46:28+01:00, 2011:11:22 07:47:29+01:00, 2011:11:22 07:47:29+01:00, 2011:11:22 07:49:01+01:00, 2011:11:22 07:55:28+01:00, 2011:11:22 10:32:21+01:00, 2011:11:22 11:09:28+01:00, 2011:11:22 12:12:37+01:00, 2011:11:22 14:11:19+01:00, 2011:11:22 15:39:10+01:00, 2011:11:22 15:54:45+01:00, 2011:11:24 10:12:09+01:00, 2011:11:24 10:36:53+01:00, 2011:11:24 11:31:42+01:00, 2011:11:24 11:57:16+01:00, 2011:11:24 12:31:17+01:00, 2011:11:24 13:45:50+01:00, 2011:11:24 13:46:34+01:00, 2011:11:24 13:47:13+01:00, 2011:11:24 13:47:48+01:00, 2011:11:24 13:57:15+01:00, 2011:11:24 14:02:35+01:00, 2011:11:24 14:06:50+01:00, 2011:11:24 14:09:13+01:00, 2011:11:24 14:11:54+01:00, 2011:11:24 14:12:41+01:00, 2011:11:24 14:13:49+01:00, 2011:11:24 14:13:49+01:00, 2011:11:24 15:59:18+01:00, 2011:11:24 16:00:28+01:00, 2011:11:25 07:16:14+01:00, 2011:11:25 08:09:23+01:00, 2011:11:25 08:36:02+01:00, 2011:11:25 08:36:37+01:00, 2011:11:25 08:36:37+01:00, 2011:12:16 09:26:48+01:00, 2011:12:16 09:26:50+01:00, 2011:12:16 09:41:36+01:00, 2012:01:16 15:28:30+01:00, 2012:01:16 15:32:11+01:00, 2012:01:16 15:33:07+01:00, 2012:03:05 11:22:13+01:00, 2012:03:05 11:22:14+01:00, 2012:03:05 11:40:52+01:00, 2012:03:05 13:54:33+01:00, 2012:03:05 14:04:54+01:00, 2012:03:05 14:16+01:00, 2012:03:05 14:18:02+01:00, 2012:03:05 14:19:32+01:00, 2012:03:05 14:29:51+01:00, 2012:03:05 14:32:17+01:00, 2012:03:05 14:32:33+01:00, 2012:03:05 14:32:33+01:00, 2012:03:05 14:46:15+01:00, 2012:03:05 14:49:48+01:00, 2012:03:05 14:55:10+01:00, 2012:03:05 15:02:50+01:00, 2012:03:05 15:03+01:00, 2012:03:05 15:03+01:00, 2012:05:04 07:26:23+02:00, 2012:05:04 07:31:54+02:00, 2012:05:04 07:31:54+02:00, 2012:05:04 07:39:52+02:00, 2012:05:30 11:34:17+02:00, 2012:05:30 11:43:54+02:00, 2012:05:30 11:44:10+02:00, 2012:05:30 11:44:11+02:00, 2012:05:30 11:59:14+02:00, 2012:05:30 11:59:14+02:00, 2012:05:31 13:58:53+02:00, 2012:05:31 14:01:29+02:00, 2012:06:01 11:50:45+02:00, 2012:06:01 12:03:29+02:00, 2012:06:12 07:03:14+02:00, 2012:06:12 07:04:39+02:00, 2012:06:12 07:13:43+02:00, 2012:06:12 07:13:43+02:00, 2012:06:12 07:18:19+02:00, 2013:02:04 10:22:10+01:00, 2013:02:04 10:28:31+01:00, 2013:02:04 10:30:44+01:00, 2013:02:04 10:34:12+01:00, 2013:02:04 10:40:41+01:00, 2013:02:04 10:40:41+01:00, 2013:07:29 15:44:27+02:00, 2013:07:29 15:45:02+02:00, 2013:07:29 15:54:16+02:00, 2013:07:29 16:25:31+02:00, 2013:07:30 07:29:16+02:00, 2013:07:30 07:37:05+02:00, 2013:07:30 07:37:05+02:00, 2013:07:30 07:47:10+02:00, 2013:07:30 08:06:28+02:00, 2013:07:30 08:06:28+02:00, 2013:07:30 08:21:42+02:00, 2013:07:30 08:22:35+02:00, 2013:07:30 08:22:35+02:00, 2013:07:30 08:41:25+02:00, 2013:07:30 08:41:25+02:00, 2013:07:30 08:51:51+02:00, 2013:07:30 08:58:29+02:00, 2013:07:30 09:01:05+02:00, 2013:07:30 09:01:51+02:00, 2013:07:30 09:05:47+02:00, 2013:07:30 09:05:47+02:00, 2013:07:31 15:08:18+02:00, 2013:09:23 15:42:25+02:00, 2013:09:23 15:48:49+02:00, 2013:09:23 15:51:57+02:00, 2014:10:08 15:14:05+02:00, 2014:10:08 15:14:05+02:00, 2014:10:08 16:00:15+02:00, 2014:10:09 07:32:19+02:00, 2014:10:09 07:34:27+02:00, 2014:10:09 07:34:27+02:00, 2014:10:09 07:42:21+02:00, 2014:10:09 07:59:44+02:00, 2014:10:09 07:59:54+02:00, 2014:10:09 07:59:54+02:00, 2014:10:16 15:57:11+02:00, 2014:10:17 10:51:31+02:00, 2014:10:27 10:24:43+01:00, 2014:10:27 10:30:27+01:00, 2014:11:12 08:01:42+01:00, 2015:03:06 11:23:50+01:00, 2015:05:05 14:33:42+02:00, 2016:08:03 12:02:32+02:00, 2016:08:04 13:36:31+02:00, 2016:08:04 14:07:46+02:00, 2016:08:04 14:40:53+02:00, 2016:08:04 15:03:03+02:00, 2016:08:04 16:38:32+02:00, 2016:08:04 17:01:29+02:00, 2016:08:05 07:07:43+02:00, 2016:08:05 07:18:08+02:00, 2016:08:05 07:28:11+02:00, 2016:08:05 07:37:29+02:00, 2016:08:05 10:50:16+02:00, 2016:08:05 11:33:57+02:00, 2016:08:05 12:47:36+02:00, 2016:08:08 07:11:10+02:00, 2016:08:08 12:03:55+02:00, 2016:08:08 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16:31:32+02:00, 2016:08:11 16:32:38+02:00, 2016:08:11 16:33:32+02:00, 2016:08:12 11:32:49+02:00, 2016:08:16 07:11:58+02:00, 2016:08:16 07:15:18+02:00, 2016:08:16 13:43:51+02:00, 2016:08:16 14:43:48+02:00, 2016:08:16 15:32:16+02:00, 2016:08:16 15:53:13+02:00, 2016:08:16 15:55:01+02:00, 2016:08:17 08:36:02+02:00, 2016:08:17 09:11:36+02:00, 2016:08:17 09:57:28+02:00, 2016:08:17 10:50:51+02:00, 2016:08:17 11:00:55+02:00, 2016:08:17 11:11:05+02:00, 2016:08:17 11:33:56+02:00, 2016:08:17 12:00:44+02:00, 2016:08:17 12:33:52+02:00, 2016:08:17 15:05:23+02:00, 2016:08:17 15:21:46+02:00, 2016:08:17 15:33:01+02:00, 2016:08:17 16:04:56+02:00, 2016:08:17 16:22:21+02:00, 2016:08:18 08:15:39+02:00, 2016:08:18 10:03:33+02:00, 2016:08:18 10:48:21+02:00, 2016:08:18 11:09:15+02:00, 2016:08:18 12:07:32+02:00, 2016:08:18 12:56:22+02:00, 2016:08:18 13:09:21+02:00, 2016:08:18 13:33:57+02:00, 2016:08:18 14:04:53+02:00, 2016:08:18 14:07:54+02:00, 2016:08:18 14:15:16+02:00, 2016:08:18 14:16:37+02:00, 2016:08:18 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Format                          : application/pdf
Title                           : untitled
Producer                        : Acrobat Distiller 11.0 (Windows)
Trapped                         : False
Page Count                      : 84

EXIF Metadata provided by EXIF.tools