GEB 0205 Custo Spiro Mobile Spirometry V04 DK 1651 en 001 LEN

Operating Manual
Spirometry
with custo spiro mobile and custo diagnostic
Operating characteristics:
custo diagnostic V04 and higher

for Windows®
GEB 0205 – DK 1651

28.04.2017
Operating Manual
Spirometry
with custo spiro mobile and custo diagnostic
© 2017 custo med GmbH

This Operating Manual may not be copied in its entirety or in part, duplicated in any
form or by any means or translated into another language without the prior written
consent of custo med GmbH.
The manufacturer reserves the right to change the information in this Operating
Manual without prior notice. The current version can be downloaded from our web-
site: www.customed.de, under SUPPORT, Manuals.
Manufacturer's contact details:

custo med GmbH
Maria-Merian-Str. 6
85521 Ottobrunn
Germany
Phone: +49 (0) 89 710 98 - 00

Fax: +49 (0) 89 710 98 - 10
Email: info@customed.de
Internet: www.customed.de
Table of contents
01 Introduction
01.1 Symbols on the devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
01.2 Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
01.3 Symbols used in this Operating Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
02 Safety instructions
02.1 General notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
02.2 Safety installations and safe working . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
02.3 Maintenance (regular safety checks) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
02.4 Disclaimer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
02.5 Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
03 Description of device, basic instructions for initial operation

03.1 Part names, components for spirometry measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
03.2 Operating the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
03.3 custo diagnostic - basic program structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
03.4 Connecting and configuring the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
03.5 Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
04 Hygiene
04.1 Cleaning and disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
04.2 Recommended cleaning agents and disinfectants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
04.3 custo spiro protect bacterial and viral filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
05 Carrying out an examination

05.1 Instructions for preparing the patient and measurement . . . . . . . . . . . . . . . . . . . . . . . 24
05.2 First work steps in custo diagnostic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
05.3 Settings for the reference measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
05.4 Overview of the measurement interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
05.5 Reference measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
05.6 Sequential measurements: Spasmolysis and provocation . . . . . . . . . . . . . . . . . . . . . . . 30
05.6.1 Call sequential measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
05.6.2 Perform spasmolysis test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
05.6.3 Perform provocation test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
05.7 Report and COPD report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
05.8 Plausibility check of a series of measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
05.9 Printing the measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
4 Spirometry with custo spiro mobile and custo diagnostic | GEB 0205 – DK 1651 | Version 001 – 28.04.2017 | custo med GmbH
06 Working with the evaluation
06.1 Opening the evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
06.2 Structure of the evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
06.3 Reference and spasmolysis evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
06.4 Overview of provocation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
06.5 Further evaluation pages
06.5.1 Process control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
06.5.2 Comparison. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
06.5.3 Trend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
06.6 Confirming the evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
06.7 Ending the evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
06.8 Archiving evaluations (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
07 Settings, measured values and predicted values

07.1 Settings for the spirometry
07.1.1 Settings for the printout of a spirometry measurement. . . . . . . . . . . . . . 44
07.1.2 Set the parameters for the spirometry measurement . . . . . . . . . . . . . . . . . 45
07.1.3 Procedures and functions for the spirometry measurement . . . . . . . . 46
07.2 Error messages and remedies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
07.3 Abbreviations of spirometry measured values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
07.4 Calculation tables for predicted values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
08 Product information
08.1 Technical data and system requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
08.2 Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
08.3 Manufacturer declaration regarding EMC
(Electromagnetic Compatibility) according to IEC 60601-1-2:2007 . . . . . . . . . 62
08.4 EC Declaration of Conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
08.5 Shutdown, storage and transport. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
08.6 Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
08.7 Keyboard navigation and shortcuts in custo diagnostic . . . . . . . . . . . . . . . . . . . . . . . . . 67
Spirometry with custo spiro mobile and custo diagnostic | GEB 0205 – DK 1651 | Version 001 – 28.04.2017 | custo med GmbH 5
01 Introduction
01.1 Symbols on the devices

custo spiro mobile spirometry device
Manufacturer:
custo med GmbH, Maria-Merian-Str. 6, 85521 Ottobrunn, Germany
CE mark
A review of the operating manual is recommended
Protection class classification of medical electrical

equipment according to IEC 60601-1 (Type BF)
Separate collection of electrical and electronic equipment,

do not dispose with domestic waste
custo spiro mobile Measuring head
Manufacturer:
custo med GmbH, Maria-Merian-Str. 6, 85521 Ottobrunn, Germany
Operating manual must be observed and followed

(particularly cleaning and disinfection)
custo spiro protect bacterial and viral filter
Single-use items
Accompanying documents must be observed.
CE mark
01.2 Intended use
custo spiro mobile is a spirometry device designed for measuring and evaluating a
patient’s spirometry.
custo spiro mobile is perfectly safe for patients with a pacemaker. The operator has
to decide himself/herself whether to use custo spiro mobile for a patient in certain
situations (e.g., in the case of disabilities).
The system is intended for use by trained specialist staff or physicians in clinics and
medical practices.
01.3 Symbols used in this Operating Manual

This Operating Manual uses the following symbols to indicate important information,
comments and tips:
ACTIONS THAT ARE PROHIBITED

or not allowed under any circumstances!
WARNING
used to indicate situations which, if not avoided, may result in personal injury and
property damage
NOTE
provides important information which must be observed
TIP
contains practical information to assist you with your work
Words highlighted in colour indicate buttons or click paths Words highlighted

for the corresponding program point, e.g. Examination, Spirometry in colour..
02.1 General notes

Strict compliance with the safety instructions protects against personal injury and
property damage during device operation. This operating manual is designed to
accompany the product and must be kept ready to hand close to the device.
As either the operator or user of this device you should have read and understood
this operating manual, in particular the safety instructions.
Laws and regulations applicable to the product

This system is designed in accordance with Medical Device Directive 93/42/EEC,
Class IIa, and meets the requirements of protection class I or II (depending on the
power supply unit used; custo spiro mobile meets the requirements of protection
class II), type BF according to IEC 60601-1.
Other devices which are part of the system must meet the requirements of the
Standard for Information Technology Equipment (IEC 60950) or the Standard for
Electrical Medical Devices (IEC 60601-1).
The electrical installations in the rooms in which the system is used must meet the
requirements of the applicable safety standards.
For users outside the Federal Republic of Germany, the respective national accident
prevention measures, regulations and requirements apply.
02.2 Safety installations and safe working

custo spiro mobile must only be used in a technically perfect condition. Regularly
carry out a visual inspection of the device and the cables. Only use accessories
approved by custo med.
Installation of the system
Portable socket outlets must not be laid on the ground.
Portable multiple socket outlets which are supplied with the system are to be used
only for supplying devices which are part of the system. Additional portable mul-
tiple socket outlets, lines and other equipment, which are not part of the system,
must not be connected to the system.
When using a multiple socket outlet, the maximum permitted load is 3200 VA.
Sockets which are not used in the delivered system (portable multiple socket out-
lets) must be provided with covers.
Ambient conditions, handling
For the installation and operation of the device, the EMC notes (electromagnetic
compatibility) in this operating manual must be observed. See Chapter 08.3 Manu-
facturer's Declaration regarding EMC... .
custo spiro mobile is not suitable for use in rooms or areas with a risk of explosion.
Strong electromagnetic sources in the vicinity of custo spiro mobile can lead to
errors in the recording. custo spiro mobile must not be located, stored or operated in
the vicinity of x-ray equipment, diathermy devices and magnetic resonance imaging
equipment (MRI). Other electrical devices such as mobile phones or radio transceiv-
ers may impair the quality of the recording.
If custo spiro mobile is transported at temperatures below the freezing point, the
device may only be put into operation after it has reached ambient room tempera-
ture. Observe the operating conditions
To ensure precise measuring results, the environmental data in custo diagnostic

must be adapted to local conditions (air humidity, temperature, etc.). Otherwise this
may falsify the measurement data obtained.
The device must be protected from moisture, dust or dirt, and against mechanical
impacts, such as damage due to dropping or shipping damage (in particular, the
handhold of the device which contains the electronic measuring equipment).
Patient safety
Safety distances of devices to the patient
1.5 m
2.5 m 2.5 m
1.5 m 1.5 m
1.5 m 1.5 m 1.5 m
Without medical protective devices, for example medical protector, the PC and all
the non-medical devices connected to the system (e.g. the monitor and printer)
must be set up and used at a distance of at least 1.5 m to the patient unit (see the
orange area in the figure) as leakage currents can occur.
Non-medical devices and the patient must not be touched at the same time during
the examination.
During routine maintenance work to non-medical devices connected to the system

the patient must not be touched (risk of electric shock).
All unconfirmed reports produced by the system must be considered as suggestions

only. For diagnosis and therapy purposes it is essential that the results are checked
and assessed by a qualified physician.
custo spiro mobile USB cable
Do not bend the USB cable. Do not step on the USB cable.
Only roll up the USB cable loosely and let it hang freely during operation.
Always remove the USB cable from the PC by pulling on the connector.
custo spiro protect bacterial and viral filter
Only use bacterial and viral filters approved by custo med,

such as custo spiro protect.
Unsuitable filters may falsify the measurement data obtained.
custo spiro protect is a single-use article. Make sure that it is disposed of after each
examination in a safe and environmentally responsible manner.
Hygiene
For cleaning and disinfection observe the legal requirements and the current state
of technology.
Use only cleaning agents and disinfectants recommended by custo med for cleaning
and disinfection. Clean and disinfect your device in accordance with the specifica-
tions given in chapter 04 Hygiene.
System and data security
The device must only be used with the supplied custo med software
(custo diagnostic).
As the operator you are responsible for ensuring regular data backups (patient
databases, evaluations, etc.) and system backups. We recommend that you backup
the data at the latest before new installations, updates and far-reaching system
configurations.
custo diagnostic new installations, updates and system configurations may only be
performed by your authorised custo med dealer.
Only change data generated in custo diagnostic within custo diagnostic itself and
not in your surgery IT system or your hospital information system (HIS).
custo med does not accept any responsibility for any changes to data in your
surgery IT system or your HIS which were made after the export from custo
diagnostic.
To ensure the safe operation of custo diagnostic, deactivate the screensaver and
energy management options on your PC.
Set up your operating system in such a way to prevent the PC from being switched
off either accidentally or automatically during the examination (standby mode/
idle mode).
custo connect
When you use custo connect to integrate additional medical devices in the custo
med system, for automatic PDF printouts from the connected medical device, check
whether the PDF file belongs to the current patient. Do not trigger any PDF print-
outs in other programs during the PDF printout in the connected medical device.
When you use custo connect to integrate additional medical devices in the custo
med system, on starting the connected medical device check whether the patient
name was taken over correctly.
Data management in custo diagnostic: Assign evaluation (allocate evaluation)
If an examination was conducted with incorrect patient data, the evaluation can
be subsequently allocated to the correct patient. Make sure that the evaluation
is definitely allocated to the correct patient. An incorrect allocation can lead to a
misdiagnosis. Please note that data which has already been exported to an external
system (e.g. surgery IT system) cannot be changed.
custo diagnostic is preset with the Assign evaluation function deactivated; however
it can be reactivated via user rights if necessary. Only the Supervisor can configure
the user rights. If the Assign evaluation function is activated, it can be found in the
evaluation search or in open evaluations in the Options menu.
We recommend configuring user rights in custo diagnostic so that only authorised

persons can execute the Assign evaluation function.
02.3 Maintenance (regular safety checks)

The operator is responsible for maintenance. The operator must ensure that the
device is checked for proper condition at the latest every two years. The functiona-
lity and the state of accessories must be checked at regular intervals. If damaged
and / or heavily soiled, the complete system must no longer be used.
All interventions in the existing system, changes to system components, enhance-

ments as well as internal cleaning and repairs may only be performed by your
authorised custo med dealer or by custo med.
Technical safety check

After each system or device repair, modification or conversion, a technical safety
check must be performed by your authorised custo med dealer.
Technical measurement check

No technical measurement check is prescribed for custo spiro mobile. custo med
recommends that you carry out a technical measurement check every two years.
02.4 Disclaimer
The manufacturer is not responsible for improper operation, failure to comply with
the safety instructions and non-observation of specifications due to negligence.
custo med will only assume responsibility for the safety and reliability of the device
when all changes, enhancements, repairs and other work to the device or system
have been performed by an authorised custo med dealer or custo med and the
operating manual has been observed during device operation.
02.5 Warranty
Our product philosophy is committed to providing you with faultless products which
meet your expectations. Should you have reason to complain we aim to rectify any
defects immediately or provide a replacement delivery.
This does not include damage that can be attributed to usual wear and tear, im-
proper use, unauthorised modification of parts and the use of violent force.
After the expiration of the warranty period only use original spare parts and acces-
sories from custo med. This is the only way to ensure safe and proper operation of
your device.
03.1 Part names, components for spirometry measurement
custo spiro mobile

Spirometry device with USB cable
Measuring head with ceramic filter
Mouthpiece
Consumables
custo spiro protect
bacterial and viral filter
Nose clip (not shown)
Accessories
Calibration pump (2l or 3l)
Connecting piece
(between mouthpiece and pump)
03.2 Operating the device
Function indicator
The LED on the handhold of the device lights up when
custo spiro mobile is connected to the PC. The device
is ready for operation.
Function indicator:
Lights up if
custo spiro mobile
is operational.
USB cable,
connection to the PC
Using the bacterial and viral filters

custo spiro protect bacterial and viral filters are fitted
to the mouthpiece before conducting measurements. A
filter may only be used for a single patient and it must
be disposed of in a safe and environmentally responsi-
ble manner after the examination.
Disassembling and assembling the device

To disassemble custo spiro mobile, press firmly on the
release key and detach the measuring head upwards.
Pull the mouthpiece from the measuring head.
When assembling, make sure that the measuring head

and handhold engage.
03.3 custo diagnostic – basic program structure

The program is divided into three areas – User, Patient and Examination. This struc-
ture ensures that you can always recognize who (which user) is carrying out what
type of examination with whom (which patient). The main menus of each area can
be reached by clicking on User, Patient or Examination.
In the User main menu the users of the system can be created and managed. The
user administration can be used to allocate user rights and control user-specific
settings, e.g. the creation of a separate patient database for each user.
The Patient main menu is used for patient management.

Its most important functions include Search for Patient, New Patient and Search
Evaluation.
The Examination main menu lists all of the examination types which are possible
with custo diagnostic. The modules which you do not own are deactivated – this can
be recognised by the light grey font.
This menu is also linked to the Settings area. This area is for making cross-program,
examination-related and user-specific settings.
03.4 Connecting and configuring the device
Requirement:
custo diagnostic is installed on your PC and ready for operation.
The custo med devices and components may only be connected to the PC af-
ter custo diagnostic has been installed. The required device drivers are installed
using the custo diagnostic standard setup or via targeted selection during the custo
diagnostic setup.
Connect custo spiro mobile to the PC. The driver is installed

automatically. Wait until the installation is complete.
Start custo diagnostic. Open the page Examination, Spirometry,
Settings, Connection, Spirometry device
Activate the spiro mobile option
If you use custo spiro protect bacterial and viral filters,
activate the spiro protect option
Enter the code of the custo spiro protect bacterial and viral filters .
The five-digit code is located on the packaging of the filter (see line Cat. No.).
Click on Save to apply your entries.
Click on End to close the settings.
03.5 Calibration
Calibration intervals
Before using the device for the first time, a calibration must be carried out.
In the event of mechanical impacts, immediately perform a calibration in order to

check the function and precision of the spirometry device.
If the spirometry device is used in combination with custo spiro protect bacterial
and viral filters, daily calibration is not required.
The use of custo spiro protect bacterial and viral filters reduces the need for clean-
ing and disinfection and, as a result, the formation of deposits in the measuring
head. Deposits on the measuring head may result in faulty measurement results.
If you suspect that there has been a drop in the quality of your measuring
results (e.g. all measured values are significantly above the target values), carry out a
calibration.
If you own a calibrated calibration pump, you can carry out the calibration yourself.
Otherwise please contact your authorised custo med dealer. Calibration pumps are
available as accessories.
Instructions for performing calibration
Using a non-calibrated device will falsify the measurement data obtained. To ensure
correct results, a calibration is essential.
Calibration is to be performed without bacterial and viral filters.
Only use calibrated calibration pumps.
The best results can be achieved by using 2l or 3l pumps. One litre pumps may result
in inaccuracies.
For calibration make sure to specify the correct pump volume. An incorrect pump
volume will result in an incorrect calibration and falsify the measurement data
obtained.
Make sure that custo spiro mobile
is inserted vertically in the calibration pump!
Start calibration
Connect custo spiro mobile to the PC. Put all com-
ponents together as illustrated. Start custo diagnostic
and select Examination, Spirometry, Calibration.
Specify the volume of your pump and enter your

name in the performed by field. Click on Start Cali-
bration .
Follow the system instructions.
The instructions are displayed at the bottom right in

the white window .
Operating the calibration pump

After the start, pump rapidly from end stop to end stop.
If your speed is not optimal, the system will give you
precise instructions.
End
As soon as the exact pump volume has been measured,
the calibration process is automatically ended.
Documenting calibrations
The last calibrations are displayed in the "Documenta-
tion of last calibration" area with the date, pump, and
the person who performed it .
04 Hygiene
04.1 Cleaning and disinfection

Procedure and frequency for cleaning and disinfection depend on the risk of infec-
tion and whether custo spiro protect bacterial and viral filters are being used.
IF IT IS OPERATED WITHOUT CUSTO SPIRO PROTECT, custo spiro mobile and

all of its components must be completely disinfected after each examination (also
inside). In case of contagious patients, safe and proper disposal of the consumables
must be ensured as described in Chapter 04.3.
IF IT IS OPERATED WITHOUT CUSTO SPIRO PROTECT, custo spiro mobile and all
of its components must be completely disinfected after each examination, but only
externally. Pay attention to the following:
In case of contagious patients where air-borne transmission may occur:

custo spiro mobile and all its parts that come into contact with the patient dur-
ing the examination must be externally disinfected. For this, the device and all other
parts are sprayed and wiped with a surface disinfectant.
Discard the custo spiro protect bacterial and viral filters and the nose clips as
described in Chapter 04.3.
For all other patients where an air-borne transmission is not suspected:

custo spiro mobile and all of its parts (including nose clips), should be wiped
with a damp cloth and mild cleaning agent.
The custo spiro protect viral and bacterial filters are discarded in the normal
waste (domestic waste in a medical practice).
Irrespective of the cleaning and disinfection after each patient, we recommend

a thorough weekly cleaning and disinfection of all device parts.
Important instructions for performing calibration
Use only cleaning agents and disinfectants recommended by custo med. Unsuitable
agents may damage the device.
Follow the manufacturer's instructions (e.g., regarding dosage and contact times).
The handhold of the device must not be immersed in liquid.
The measuring head is suitable for cleaning in an ultrasonic bath.
It is not necessary that the measuring head is completely dry after cleaning. The
measurement results are not influenced by humidity in the measuring head.
Disassembling custo spiro mobile for cleaning and disinfection
Remove the measuring head from the handhold .
To do this, press the release button and pull
the measuring head toward the top.
Make sure that the sealing ring is not damaged.
Pull the mouthpiece from the measuring head .
If possible, immediately clean or disinfect after use. This avoids impurities from
drying on.
Disinfection
When the device is disassembled, immerse the measuring head and the mouthpiece FREQUENCY
in a disinfection bath or spray the inside and outside of the measuring head and OF THE
mouthpiece with a disinfectant until the surfaces are completely moistened. Con- DISINFECTION
sider the manufacturer’s specifications regarding dosage and contact times of the
applied disinfectant.
with
Rub the handhold of the device with a disinfectant. No moisture may be allowed to custo spiro protect
enter the handhold. Once per week
After the contact time has elapsed, rinse the measuring head and mouthpiece
thoroughly with water, shake the water out of the measuring head and wipe down without
the surfaces with a single-use cloth. custo spiro protect
after each
Reassemble the device – the unlocking button must engage when mounting the examination
measuring head.
04 Hygiene
Cleaning the Equipment

Only a damp cloth with a mild detergent (commercial plastic cleaner) may be used
to clean all plastic surfaces, if necessary. Do not use acidic cleaning solutions.
Cleaning the nose clips

Rinse the nose clip with tap water after each examination and, if necessary, spray
on a disinfectant.
TIP: Several measuring heads for use without bacterial and viral filter
To ensure smooth processing and a maximum level of hygiene, we recommend that

you keep several measuring heads and mouthpieces in stock if no bacterial and viral
filter is used. The differences between the measuring heads are so minimal (< 1.5%)
that it is not necessary to make a new calibration for each measuring head.
04.2 Recommended cleaning agents and disinfectants

Disinfectants:
All alcohol-based disinfectants approved for medical use

(e.g. propanol, ethanol).
04.3 custo spiro protect bacterial and viral filter
When using custo spiro protect bacterial and viral filters, the necessity to clean and
disinfect the spirometry device is minimised but not entirely eliminated.
custo spiro protect bacterial and viral filters are optimally adapted to custo spiro
mobile and do not have any effect on the measurement data obtained.
A filter may only be used for a single patient and it must be disposed of properly
and in a safe manner after the examination.
Disposal of custo spiro protect bacterial and viral filters
According to the Waste Catalogue Ordinance (WCO), contaminated bacterial and

viral filters (and nose clips) are wastes whose collection and disposal is subject
to special requirements to prevent infection, and are assigned to the waste code
WC 18 01 03.
The disposal method also depends on the amount of contaminated waste.
In clinics and medical practices, which focus on treating patients with the cor-
responding diseases (e.g., actively treat tuberculosis, not just sporadically), the filter
and the nose clips must be discarded in an extra container (tear-resistant, marked
with the "biohazard symbol").
Please note the German Protection against Infection law (Article 17 IfSG: Objects
tainted with reportable pathogens).
Generally, this requirement also applies in the case of small quantities of con-
taminated waste. However, disinfection of individual parts (any disinfectant, re-
gardless of the part) is possible. You can then discard the filter and nose clips with
normal waste (domestic waste in a medical practice).
See the Directive on the proper disposal of waste from health care facilities.
05.1 Instructions for preparing the patient and measurement

custo spiro mobile
Check to make sure that custo spiro mobile is connected to the PC.
The device is ready for operation when the LED on the handhold is illuminated.
Fit a new custo spiro protect bacterial and viral filter.
Patient
During the measurement the patient should sit upright (or stand).
The patient must place the spirometry device in their mouth as follows:
The patient's teeth are on the mouthpiece and the tongue is under the
mouthpiece. The mouthpiece must be held firmly between the patient's lips.
During the measurement no air must be allowed to escape from corners
of the mouth.
Explain the breathing manoeuvre to the patient in advance and

vocally encourage the patient to cooperate during the measurement.
Use short, simple instructions: such as INHALE - AGAIN - AGAIN - EXHALE...
Precise instructions contribute to significantly improving the quality of
the measurement.
Put the nose clips on the patient immediately before the measurement.
Performing a breathing manoeuvre
The patient must start by taking a few quiet breaths.
During the last quiet breath before the breathing manoeuvre the patient
must exhale as forcefully as possible (signal tone and system indication).
Next the patient must inhale as deeply as possible,
holding his/her breath (max. 1 second), if necessary.
and then exhaling again as forcefully as possible.
After the last breath, the device is set down.
The software workflows are described on the following pages.
05.2 First work steps in custo diagnostic
Note on the procedure
The steps necessary to carry out and evaluate spiro-
metry measurements in custo diagnostic are shown
without a surgery IT system or HIS connection.
Program start, calling the spirometry

Start custo diagnostic and log in with your user name
and password if required.
Click on:
Examination , Spirometry , Measurement .
Selecting the patient

Select a patient for the examination. Enter the
patient's name or the first letter of their name into the
input fields of the patient search screen .
Select the patient from the list below the input fields
and confirm your selection by clicking on the Select
Patient button. You can also select the patient by
double clicking on the corresponding name.
The settings for the reference measurement are

displayed.
New patient
If the patient does not yet exist in your database, click
on the New Patient button. Enter the patient data.
The fields marked with an asterisk are mandatory.
For a spirometry measurement, you also have to enter

the gender, height, weight and ethnic origin. This in-
formation is used later to determine the predicted
values.
Save the details to enter the patient in your database.
Afterwards the settings for the reference measurement

are displayed.
05.3 Settings for the reference measurement

Predicted values
The standard setting for adults is ECCS (European Coal
and Steel Community) and for children Zapletal. If the
patient data deviate from the range of validity of the
preset predicted value table, the system will propose a
suitable predicted value table. The information on the
selected predicted value table is stated in the footer .
(For information on changing the preset predicted values
see chapter 07.1.2 Set parameters for the spirometry
measurement).
If no suitable predicted value table is available, “none”

is displayed in the “Predicted” field. In this case, select
a predicted value table from the menu. The determined
reference values are displayed in brackets during the
measurement and may be incomplete.
Smoking habit
Select the corresponding entry from the menu. The
smoking habit information is included on the printout
in the “Report” area.
Type of measurement
The first measurement taken from a patient is always
a reference measurement. The type of measurement
can only be changed with sequential measurements
(spasmolysis or provocation).
Drugs and dosage (optional)

Here you can specify which medication was adminis-
tered to the patient. To be able to use this function,
you need to have saved a medication selection list in
custo diagnostic. To do this, select Examination, Spiro-
metry, Settings, Diagnostic, Drugs.
Enter the medicine in the text field in the “Drugs” area
and click on Add . The procedure is identical in the
“Dosage” area. Save your input.
Measurement with custo spiro protect

To obtain precise measurements, indicate if you are
using bacterial and viral filters.
Environmental data
Set the environmental data correctly (weather station,
Internet). Confirm your input.
05.4 Overview of the measurement interface
Starting or stopping the measurement 1)The software feature

"Tilt sensor" is part of custo vit
Settings for the measurement (change predicted values, animation on/off) professional and is not included in
the standard product.
Miniature views of the performed measurements If the tilt sensor is not used, this area
of the screen remains empty during
NEW: Indicator to check the posture of the patient during the first measurement. Afterwards,
miniature views of the measure-
the measurement, if you work with the tilt sensor software feature 1) ments that were already carried out
are displayed.
Operating instructions on how to perform the breathing manoeuvre
Flow volume curve, predicted value curve (grey)
Tabular display of the target and patient values
Time-volume curve in real-time display
Stop Measurement, close measurement interface
Optional: Spirometry measurement with animation for children

You can enable the animation under Options. Description: Schnaufi the Dragon tries 2) Under Options,
Settings Animation you can define
to spit fire and light a candle. The patient helps Schnaufi with his/her breathing the exhalation level (PEF) as of
which the candle is lit. The lower the
when he is lighting the candle 2). percentage, the easier it is to light
the candle. Click on Confirm to apply
The animation should be shown on a separate screen for the patient. In order to set the changes.
up an additional screen, open the page Examination, Spirometry, Settings, General,
General and, in the "Animation" area, select the option Own window . Save your
input.
05.5 Reference measurement

Start measurement, standard process
Put the nose clips on the patient and click on Start .
Next, the patient places the mouthpiece of the device
into his/her mouth and begins breathing normally. The
mouthpiece must be held firmly between the patient's
lips. Provide clear instructions on how to perform
the breathing manoeuvre. The maximum recording
time is two minutes. Remove the device from the pa-
tient after the breathing manoeuvre.
To cancel a current measurement, e.g., for incorrect
handling of the device or faulty performance of the
breathing manoeuvre, click the Stop button.
Performed measurements are displayed at the bottom

left of the screen in the form of miniature views . The
most recent measurement is displayed in the coordi-
nate system . Other measurements can be displayed
by clicking on the corresponding miniature views in
the coordinate system.
Additional feature Tilt Sensor

The tilt sensor is displayed after pressing the Start but-
ton. This feature is used to check the posture of the
patient during the measurement. An upright posture
improves the quality of the measurement and allows a
more precise identification of the measured values, in
particular, FEV1.
As soon as the patient has the spirometry testing de-

vice in their mouth, make sure that the arrows of the
tilt sensor are in the middle, green area of the display.
If the Patient leans too far to the front or rear, the
arrows move into the red or yellow area, which may
affect the measurement.
The miniature views of the measurements that have
been carried out have a green, yellow or red back-
ground, in order to obtain information about the
patient's posture during the measurement.
Green: upright posture (-10° to +10°)

Yellow: tilted too far back
Red: tilted too far forward
Repeat measurement
Click on Repeat, in order to start another reference
measurement.
Up to six repetitions are possible. If further repetitions
of the measurements are required (and six miniature
views already exist), measurements will need to be de-
leted first. Click on the measurement that you would
like to delete with the left mouse button. Next, open
the context menu with a right-click and then click on
Delete measurement .
Set best measurement

The best measurement in a series of measurements is
marked in bold font, in the same colour as the curve .
This measurement is shown later when opening the
evaluation.
To set a different measurement as the best measure-
ment, click with the left mouse button on the minia-
ture view of the desired measurement. Open the con-
text menu with a right-click and then click on Best
measurement .
The best measurement is determined based on the
FEV1 value (default settings). The determination of the
best measurement can also be made based on the IVC
or FVC value. The value is set on the page Examina-
tion, Spirometry, Settings, Diagnostic, Parameter in the
"Identification best value" area.
TIP on starting a sequential measurement

If another measurement (spasmolysis or provocation)
should be performed after the reference measurement,
click on the button Post Test in the measurement in-
terface. A sequential measurement can also be started
later via the spirometry main menu. The work steps
"Start measurement", "Repeat" and "Best measure-
ment" function exactly as described here for sequential
measurements.
End and close measurement

Click on End (bottom right) to close the measurement.
Confirm the End dialogue in order to finally close
the measurement interface.
05.6 Sequential measurements:

Spasmolysis and provocation
Spasmolysis and provocation are referred to as post

test in custo diagnostic. These types of measurement
can only be performed after a reference measurement.
05.6.1 Call sequential measurement

Start the sequential measurement via the spirometry
main menu by clicking on Examination, Spirometry,
Post Test .
A list will open including all patients for whom a refer-

ence measurement was already carried out on the cur-
rent day (spirometry group). Select the patient from
the list and confirm your selection with Select Patient
or double-click on the patient name.
Note on the spirometry group

A patient is deleted from the spirometry group if a
sequential measurement has been saved, if a new
measurement has been generated (via Examination,
Spirometry, Measurement) or on the next day.
TIP on starting a sequential measurement

A sequential measurement can also be started directly
in the reference measurement belonging to a patient
via the Post Test button.
Sequential measurement settings

Define the settings for the sequential measurement.
Check and, if necessary, change the data. Select the
type of measurement – spasmolysis or provocation .
You can only enter data for "Medication" if a medica-

tion list has been created in the settings for spirometry.
You can also carry out a sequential measurement with-

out indicating the medicine administered. Click on
Confirm to continue.
05.6.2 Perform spasmolysis test
Put the nose clips on the patient and click on Start.
Next, the patient places the mouthpiece of the de-
vice into his/her mouth and begins breathing normally.
Provide clear instructions on how to perform the
breathing manoeuvre. The maximum recording time is
two minutes. Remove the device from the patient after
the breathing manoeuvre.
If necessary, Repeat the measurement. The measure-
ments are displayed at the bottom left of the screen in
the form of miniature views .
The results of the spasmolysis (orange) are shown to-
gether with the results of the reference measurement
(blue) for direct comparison .
To close the measurement interface, click End (bottom
right).
05.6.3 Perform provocation test

Up to a maximum of eight provocation measurements
follow a dilatation measurement and up to eight con-
trol measurements. The setting options and control
elements of a provocation test correspond to those
of a reference measurement. After you called up the
sequential measurement, selected a patient and made
the settings, the measurement can be started.
Put the nose clips on the patient and click on Start.
Next, the patient places the mouthpiece of the de-
vice into his/her mouth and begins breathing normally.
Provide clear instructions on how to perform the
breathing manoeuvre. The maximum recording time is
two minutes. Remove the device from the patient after
the breathing manoeuvre.
The next measurement of the series of measurements
is triggered by the Post Test button.
Marking of measurement types

Reference measurement . . . . . . . . . . . . . . . . blue
Provocation measurement . . . . . . . . . . . green
Dilatation measurement . . orange-brown
Control measurement . . . . . . orange-brown
To close the measurement interface, click End

(bottom right).
05.7 Report and COPD report

Unconfirmed report
Open the context menu by right-clicking on the
measurement interface. In the context menu, select
Report .
If the Unconfirmed report option is selected in the sys-
tem settings, the unconfirmed report dialogue already
contains an automatic report of the system. This op-
tion is enabled by default and can be disabled under
Spirometry, Settings, Diagnostic, Report. You can mod-
ify and complement the text in the unconfirmed report
dialogue. In order to save your input, click on Confirm.
The unconfirmed report is closed with Cancel, without
changes taking effect.
If you save your information with Confirm, the un-
confirmed report becomes a report. Consequently, the
evaluation is confirmed. If the evaluation should not
to be classified as confirmed at this point, you can re-
set the report status when ending the measurement in
the End dialogue.
All unconfirmed reports produced by the system

must only be considered as suggestions. For diag-
nosis and therapy purposes it is essential that the
results are checked and assessed by a qualified
physician.
COPD Report
(Chronic Obstructive Pulmonary Disease)
In addition to the unconfirmed report, custo diagnostic
creates an automatic COPD report after a measure-
ment has been carried out. To open the COPD report,
right-click on the measurement interface and select
Report COPD in the context menu. The COPD report
is displayed in the unconfirmed report dialogue . The
Confirm button transfers the COPD report to the
standard report text and saves it.
custo diagnostic can be configured in such a way that
the COPD report is automatically integrated in the
standard report. For this open the page Examination,
Spirometry, Settings, Diagnostic, Report and enable
the COPD option in the „Report“ area. Specify whether
the COPD report should be integrated into the stan-
dard report after a reference measurement or after a
spasmolysis. Save your input.
05.8 Plausibility check of a series of measurements
If you carry out a series of measurements in which the quality of the patient’s coop-
eration and the plausibility of the measured results have to be proven, use "Process
Control" function (Options, Process Control).
Strong deviations between the measurement curves show that the patient has
not cooperated correctly. For a meaningful comparison, you need at least three
measurements of a type of measurement.
05.9 Printing the measurement

Print with standard settings: In the measurement interface, click on the Print 1) The system settings for the
print pages of a spirometry
button1) at the bottom of the screen). measurement are available in custo
diagnostic on the page Examination,
Spirometry, Settings, Print, Content.
On the page Examination,
Print with temporarily changed print settings: If you do not want to print with Spirometry, Settings, Print, Printer in
the “Print process control” area you
the system settings, you can select Options, Print... and carry out your print settings set the pages that will be printed
when you press on the Print button.
there. Changes in this print menu only affect the current print. Start printing by
clicking on the Print button.
With the Job Manager The print orders will be collected in the Job Manager
from where they can be printed collectively at a later point in time. In order to store
print jobs in the Job Manager, open the page Options, Print... and click on Print
Task . The existing print jobs are started on the page Examination, Task using the
Start button.
06.1 Opening the evaluation

custo diagnostic offers different options to open an evaluation, e.g. via the evaluation
search or the main menu of the respective examination (spirometry in this case).
Opening an evaluation via the evaluation search
Using the right mouse button click on the Patient button. This opens the evalu-
ation search.
In the Examinations area, enter what type of evaluation you are searching for, e.g.
Spirometry . In the Properties area you can define more search criteria.
If you set the confirmed preference to No, you will receive a list of all the evaluations
which have not yet been confirmed – a type of to-do list.
To start the search, click on Search Evaluation or activate Search automatically

option . This option triggers an automatic search in your database whenever the
search criteria are changed.
The right part of the screen displays a list of all the evaluations which correspond
to the activated search criteria. To open the desired evaluation, select it from the
list and click on the Show Evaluation button or double-click on the evaluation.
Reference between If you want to use the same search criteria for the next search, activate the Save
End dialogue and search Selection option.
screen
In order to make
proper use of the search
screen, the correct
examination status must
be defined in the End
dialogue when closing an
examination.
Example: An
examination can only
be found in the search
screen with the
preference “confirmed:
No” when the evaluation
status “Confirmed” is NOT
selected
in the End dialogue.
Opening an evaluation via the examination main menu
Open the spirometry main menu via Examination, Spirometry, and then click on
Show Evaluation .
The patient search screen appears. In this screen select the patient whose evalu-
ation you want to open. Enter the patient’s name or the first letter of their name
into the input fields of the patient search screen . Select the patient from the list
below the input fields and confirm your selection by clicking the Select Patient
button. You can also select the patient by double-clicking on the corresponding
name.
A list containing all the evaluations of the patient is then displayed. Select the
desired evaluation from the list and open it by double-clicking on it or via the
Show Evaluation button .
06.2 Structure of the evaluation
Overview Reference & spasmolysis Trend Overview of provocation

with best measurement of each type, all patient’s Tabular overview
each with measurement curve and evaluations in bar with reference, provocation and
measured values chart format dilatation measurements
Process control Comparison Individual

Overview each with of current and further measurement
max. three reference evaluation. Display of measurement
and spasmolysis selected in the overview
measurements incl. with measurement
measurement tables and curve and measured
measurement curves Overlaying values table.
for superimposition the measurement curves
(direct comparison) from the comparison
evaluations
Resistance
Shows the resistance
graphics under the
measurement curves
06.3 Reference and spasmolysis evaluation
Flow volume curve with predicted value curve (grey background) 1) The Miller Quadrant shows
the results of the spirometry
Predicted values measurement in a coordinate system.
The four fields of the coordinate
Measurement table with patient's target values and measured values; system are labelled with "Normal",
"Obstruction", "Restriction",
when you click on the column heading, the corresponding "Obstruction & Restriction".
flow volume curve is displayed or hidden On the x-axis the FEV1%VC value
obtained is entered in comparison to
Bar chart with tidal volume the target value in per cent,
on the y-axis the FVC value obtained
Volume time curve is entered in comparison to the
target value in per cent.
Environmental data input before the measurement The intersection of these values
will be marked with a cross in the
coordinate system. The label of the
field provides information about the
Additional evaluation pages, program control patient's report.
Comparison between patient's current and other evaluations The crosses are the colour of the
type of measurement (blue for the
Comparison of individual measurements from a series of measurements reference measurement, orange for
spasmolysis).
(plausibility check)
Options menu:
Print Menu, export of the evaluation (e.g., Excel, PDF, e-mail),
changing the predicted value table, overview of medication,
Miller Quadrant 1), Lung age
Print with standard settings
End evaluation
06.4 Overview of provocation
Display of measured values

Graphic representation of all measurements of the series of measurements
with display of the selected measured value, here IVC
Measured value buttons for graphical display of additional measurement values
Measured value table
Registered environmental data
Open the single view, program control

Button for selecting a measurement for the single view
Opening the selected measurement
Comparison between patient's current and other evaluations

Options menu:
Print Menu, export of the evaluation (e.g., Excel, PDF, e-mail),
changing the predicted value table, overview of medication, Lung age
Print with standard settings
End evaluation
06.5 Further evaluation pages
06.5.1 Process control
The Process control option is used to compare a series of reference and/or spasmo-
lysis measurements in order to check the quality of the patient’s cooperation as well
as the plausibility of the results.
It is a precondition that the measurements have been made in direct succession. By

clicking on the miniature views of the curves the measurements can be super-
imposed. By clicking on the miniature again, the superimposition is disabled again.
Strong deviations between the measurement curves show that the patient has not
cooperated correctly.
06.5.2 Comparison
With the Compare function the current evaluation can be compared to another
evaluation of the patient. The comparison can also be called in the spirometry main
menu with Show Comparison.
When you click on Overlap the measurement curves of both evaluations are
superimposed. The Evaluation button leads back to the single view of the
evaluation.
The comparative measurement can also be displayed as an individual measurement.

For this, click on the line above the measurement curve and then on Evaluation .
Using the arrow buttons you will see lists of all available evaluations for the
patient. To open one of those evaluations select the desired evaluation and click on
Evaluation .
06.5.3 Trend
This view mode is opened with the Show Trend button in the spirometry main
menu. The trend view serves to display developments over a longer period of time.
All measurements of a patient are summarised as a bar chart with a measurement
table on an overview page. Further measurements can be shown with the scrollbar
under the bar charts.
The trend view also considers the results of already deleted and archived measure-
ments. These measurements can no longer be shown in the single view. In order to
display a measurement from the trend view, select the desired measurement by
clicking the line with the date of creation . Then click on Evaluation . With the
Trend button you can return from the single view to the trend view.
06.6 Confirming the evaluation

The report is opened by right-clicking on the evalu-
ation interface. In the context menu, select Report.
Enter your data in the white text field . If the “Add

report” option is enabled in the system settings, an
automatic report is already present in the text field.
When you click on Confirm your input is saved and
the evaluation gets the “Confirmed” status (see “End
dialogue”).
In the event that your report text is not yet complete

but should be saved nevertheless, without reaching
“Confirmed” status, reset the evaluation “Confirmed”
status in the End dialogue.
Text modules for writing reports

On the page Examination, Spirometry, Settings, Diag-
nostic, Report text modules for writing a report can be
created . A total of four groups with up to eight
text modules can be stored. The text modules are
called in the “Report dialogue” using keyboard com-
mands (F5 to F12).
A text module can be created from normal text as

well as variables. When you use a text module in the
“Report dialogue”, the actual value from the evalua-
tion is used instead of a variable and automatically
inserted in the report text. The structure of a variable is
@VARIABLE (e.g. PEF reference measurement @PEF_R).
The Shortcuts for export values button provides you
with a list containing all the available variables.
If the report modules should be shown in the “Report

dialogue”, make sure that the Enable option is ac-
tivated. Alternatively, the text modules can be shown
in the “Report dialogue” via the Show modules button.
There is also the option of entering a text or a user-

defined report text (also as normal text and variables),
which will be automatically shown in each report .
The predefined text can be changed later in the “Report
dialogue”.
Save your input.
06.7 Ending the evaluation
Click on the End button in the evaluation (in the bot-
tom right of the screen). The end dialogue is opened.
The status of the evaluation is set here . Setting
properties (e.g., confirmed/not confirmed) makes it
easier to find evaluations in the evaluation search.
Evaluation confirmed
A confirmed evaluation can be reset to "Not confirmed"
by deselecting the "Confirmed" option, for example, if
reporting has not yet been completed.
Printed
Indicates if the evaluation has been printed.
Locked
After reporting has been completed by an authorised
person, set the status of the evaluation to "Locked".
Afterwards, the evaluation can still be viewed, but no
longer changed.
Close the examination with Confirm .
06.8 Archiving evaluations (optional)

Archiving is not the same as making a backup (copy). It
refers to moving your evaluations from one storage lo-
cation to another. Take adequate measures to backup
data within your archive at regular intervals in order
to avoid data loss.
Archiving is used to save recordings on a long-term

basis. During archiving, the evaluations are moved to
a directory on your hard disc, which you can then save
on a data carrier (CD, DVD, etc.).
The archiving functions can be found under Patient,

Edit Database.
07.1 Settings for the spirometry

07.1.1 Settings for the printing a spirometry measurement
On the page Examination, Spirometry, Settings, Print, Printer you define which print
pages will be printed when using the Print button. In "Print process control" area,
select the option Current page, Pre-set pages (= default, see configuration below) or
Total printout PA (professional association). On this page you can select the printer
for spirometry printouts.
If the option Pre-set pages is selected:

You will find the settings for the print pages on the page Examination, Spirometry,
Settings, Print, Content . The content of the printout can be selected in the "Print-
out" area .
1) The settings in the "Measured If Summary is defined as the print page (contains measured value table, flow
value presentation" area (d) relate
to the measured value table and the volume diagram, volume time diagram, and report), further settings for the contents
flow volume curve.
The described changes of the Summary can be made in the "Measured value presentation" area 1):
(e) and (f) can also be applied to
other print pages, which also include In the "Measured value selection" area you can select up to eight other
a measured value table and flow
volume curve. This applies to, for measured values for the measured value table instead of the standard values. The
example, the options Process control
and Total printout PA (Summary measured values IVC, FVC and FEV1 are fixed.
occupational medicine).
The Draw curve option causes the predicted value curve to be shown in the
coordinate system when printing.
Save your input.
The work steps shown represent how default print settings are made. The default
print settings automatically apply to all other print types (print job via the Job Man-
ager, PDF export). In order to change the print settings for further print types, select
the desired print type in the "Type" area , such as print job, and select the content
of the print pages as described above. Save your input.
07.1.2 Set parameters for the spirometry measurement
Various parameters for the measurement are set under Examination, Spirometry,
Settings, Diagnostic, Parameter , such as the predicted value table, validity range,
measured value display, etc.
Predicted value table and range of validity

Define which predicted value table should be proposed by default for children and
adults . If you enable the Also out of selected range option under "Validity", the
predicted value table will also be proposed if the patient data do not match the
range of validity of the predicted value table.
Show measured values

For a spirometry, nine measured values are shown on the screen. The values IVC,
FVC and FEV1 are fixed. The remaining six values can be configured individually.
Configure the desired values in the selection list in the “Measured values presenta-
tion” area . To select other values, deactivate the values which have already been
selected.
Determining the best measurement

You can define which measured value serves as the basis for the determination of
the best measurement of a series of measurements. Select IVC, FVC or FEV1 in the
“Indication best value” area.
ATS display on screen

For ATS-compliant display of the flow volume curve in custo diagnostic select the
Show flow-volume chart by ATS (2:1) option . Save your input.
07.1.3 Procedures and functions for the spirometry measurement

These settings can be found on the page Examination, Spirometry, Settings, General,
General.
Measurement units for the environmental data
In the "Units for environmental data" area you can change the units. The pre-set
units are °Celsius, Pascal and meter.
Animation for children (Schnaufi the Dragon)
In the “Animation” area you can define whether the animation should be inte-
grated in the measurement window or run on an extra screen and for which age
groups the animation should start automatically
Measurement only expiratory
If this option is enabled, the patient only has to exhale forcefully once into the
device for the spirometry measurement.
Save your input.
07.2 Error messages and remedies

Error message: Spirometry device not ready for use
Disconnect the USB plug of the spirometry device from the PC and reconnect custo
spiro mobile after a few seconds. Confirm the error message. The device is ready for
operation when the LED on the handhold is illuminated. Afterwards you can con-
tinue with the spirometry. If the system still does not recognise your device, custo
diagnostic must be restarted.
Error message: Breathing manoeuvre could not be detected
If the patient’s respiration is too weak or incorrect, custo diagnostic might not be
able to recognise the breathing manoeuvre when the measurement is carried out.
Without a breathing manoeuvre the system cannot create an evaluation. Confirm
the error message. Repeat the measurement, give the patient clear breathing in-
structions and follow the system specifications as to breathing.
Important: The patient may only breathe into the device after you have clicked
on the Start button!
07.3 Abbreviations of spirometry measured values
Abbreviation Unit Description

IVC l Inspiratory vital capacity
IRC l Inspiratory reserve capacity
ERC l Expiratory reserve capacity
TV l Breath volume (Tidal Volume)
BF l/min Respiration rate at rest (Breathing Frequency)
tl s Average time of inspiration at rest
tE s Average time of expiration at rest
VTtl l/s Average inspiratory flow at rest
FVC l Forced vital capacity
FEV1%VC % Relative second capacity of vital capacity in per cent
PEF l/s Peak expiratory flow
MEF25%FVC l/s Forced expiratory flow at 25% of FVC
FEF25%FVC l/s = MEF75%FVC
FEF25-75% l/s Average forced expiratory flow between 25% and 75% of FVC
FEF75-85% l/s Average forced expiratory flow between 25% and 85% of FVC
FIF25-75% l/s Average forced inspiratory flow between 25% and 75% of FVC
PIF l/s Peak inspiratory flow
MIF25%FVC l/s Forced inspiratory flow at 25% of FVC
FEV0.5 l 0.5 second capacity (forced expiratory volume in 0.5 seconds)
FEV0.75 l Relative 0.75 second capacity (forced expiratory volume in 0.75 seconds)
FEV1 l Absolute second capacity
FEV1.5 l Relative 1.5 second capacity (forced expiratory volume in 1.5 seconds)
FEV2 l 2 second capacity (forced expiratory volume in 2 seconds)
FEV0.5/VC % Relative 0.5 second capacity of VC in per cent
FEV2/VC % Relative 2 second capacity of VC in per cent
AFEV l2/s Area of the flow-volume curve
Abbreviation Unit Description

FIT100 s Forced inspiratory time for the total FVC
FET100 s Forced expiratory time for the total FVC
FET25-75 s Forced expiratory time between 25 and 75% of FVC
FET95%FVC s Forced expiratory time at 95% of FVC
FIV0.5 l 0.5 second capacity (forced inspiratory volume in 0.5 seconds)
FIV1 l Second capacity (forced inspiratory volume in 1 second)
FIV2 l 2 second capacity (forced inspiratory volume in 2 seconds)
FIV3 l 3 second capacity (forced inspiratory volume in 3 seconds)
FIV0.5/VC % Relative 0.5 second capacity of VC (inspirat.) in per cent
FIV1%VC % Relative second capacity of VC (inspirat.) in per cent
FIV2/VC % Relative 2 second capacity of VC (inspirat.) in per cent
FIV3/VC % Relative 3 second capacity of VC (inspirat.) in per cent
OBQ Obstruction rate
Phi ° Phase angle (4 Hz, 8 Hz, 16 Hz)
VCmax l Maximum vital capacity, inspiratory or expiratory
MVV l Maximum random ventilation
07.4 Calculation tables for predicted values
Multicèntrico di Barcelona . . . . . . . . . . . . . . . . . . . . . . .Page 49 Ulmer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Page 53

Polgar79 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Page 50 Baur . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Page 53
Polgar71 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Page 50 ECCS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Page 53
Crapo . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Page 50 Hankinson . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Page 54
Morris . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Page 51 HSU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Page 58
Austrian reference values . . . . . . . . . . . . . . . . . . . . . . . . .Page 51 Schindl . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Page 58
Cherniak . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Page 51 ECCS-Children/Quanjer . . . . . . . . . . . . . . . . . . . . . . . . . . . .Page 58
Knudson . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Page 52 Zapletal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Page 59
The predicted values tables define their validity ranges according to age, size, weight,
ethnic origin etc. In accordance with the patient's data, a suitable predicted value
table for the measurement is assigned to the patient.
Abbreviations in the calculation tables

A = Age
H = Height
G = Weight
B = Broca index; B = Weight : (Height - 100)
Fi = Fat index = H : 3√W
Multicèntrico di Barcelona Boys Girls

H = 85 – 180 cm | A = 6 – 20 years H = 85 – 180 cm | A = 6 – 20 years
FVC [l] 0.02800 * H + 0.03451 * G + 0.05728 * A - 3.21 0.03049 * H + 0.02220 * G + 0.03550 * A - 3.04
FEV1 [l] 0.02483 * H + 0.02266 * G + 0.07148 * A - 2.91 0.02866 * H + 0.01713 * G + 0.02955 * A - 2.87
MVV [l] (0.02483 * H + 0.02266 * G + 0.07148 * A - 2.91) * 37.5 (0.02866 * H + 0.01713 * G + 0.02955 * A - 2.87) * 37.5
FEF25-75% [l/s] 0.038 * H + 0.140 * A - 4.33 0.046 * H + 0.051 * A - 4.30
PEF [l/s] 0.075 * H + 0.275 * A - 9.08 0.073 * H + 0.134 * A - 7.57
MEF25%FVC [l/s] 0.024 * H + 0.066 * A - 2.61 0.027 * H + 0.032 * A - 2.68
MEF50%FVC [l/s] 0.017 * H + 0.157 * A + 0.029 * G - 2.17 0.046 * H + 0.067 * A - 4.17
FEV1%VC [%] -0.1902 * A + 85.58 -0.224 * A - 0.1126 * G + 94.88
Men Women
H = 150 – 200 cm | A = > 20 years H = 150 – 200 cm | A = > 20 years
FVC [l] 0.0678 * H - 0.0147 * A - 6.05 0.0454 * H - 0.0221 * A - 2.83
FEV1 [l] 0.0499 * H - 0.0211 * A - 3.84 0.0317 * H - 0.0250 * A - 1.23
MVV [l] (0.0499 * H - 0.0211 * A - 3.84) * 37.5 (0.0317 * H - 0.0250 * A - 1.23) * 37.5
FEF25-75% [l/s] 0.0392 * H - 0.0430 * A - 1.16 0.0230 * H - 0.0456 * A - 1.11
PEF [l/s] 0.0945 * H - 0.0209 * A - 5.77 0.0448 * H - 0.0304 * A - 0.35
MEF25%FVC [l/s] 0.0190 * H - 0.0356 * A - 0.14 0.02 * H - 0.031 * A - 0.0062 * G - 0.21
MEF50%FVC [l/s] 0.0517 * H - 0.0397 * A - 2.40 0.0242 * H - 0.0418 * A - 1.62
FEV1%VC [%] -0.1902 * A + 85.58 -0.224 * A - 0.1126 * G + 94.88
Polgar79 Boys Girls

Men Women
FVC [l] 2.12 * 0.000001 * H2.81 2.34 * 0.000001 * H2.78
IVC [l] 2.12 * 0.000001 * H2.81 2.34 * 0.000001 * H2.78
FEF25-75% [l/s] (219.66 + 2.72 * H) : 60 (219.66 + 2.72 * H) : 60
PEF [l/s] (467.96 + 5.59 * H) : 60 (376.51 + 4.85 * H) : 60
Polgar71 Boys Girls

Men Women
2.67
FVC [l] 4.4 * 0.000001 * H 3.3 * 0.000001 * H2.72
2.67
IVC [l] 4.4 * 0.000001 * H 3.3 * 0.000001 * H2.72
FEV1 [l] 2.1 * 0.000001 * H2.8 2.1 * 0.000001 * H2.8
MVV [l] 99.507 + 1.276 * H 99.507 + 1.276 * H
FEF25-75% [l/s] (207.7 + 2.621 * H) : 60 (207.7 + 2.621 * H) : 60
PEF [l/s] (425.5714 + 5.2428 * H) : 60 (-425.5714 + 5.2428 * H) : 60
PIF [l/s] 5.26 + 0.06 * H 5.26 + 0.06 * H
Crapo Men Women

FVC [l] 6.00 * H - 0.0214 * A - 4.650 4.91 * H - 0.0216 * A - 3.590
IVC [l] 6.00 * H - 0.0214 * A - 4.650 4.91 * H - 0.0216 * A - 3.590
FEV0.5 [l] 3.27 * H - 0.0152 * A - 1.914 2.38 * H - 0.0185 * A - 0.809
FEV1 [l] 4.14 * H - 0.0244 * A - 2.190 3.42 * H - 0.0255 * A - 1.578
MVV [l] (4.14 * H - 0.0244 * A - 2.190) * 37.5 (3.42 * H - 0.0255 * A - 1.578) * 37.5
FEV3 [l] 5.35 * H - 0.0271 * A - 3.512 4.42 * H - 0.0257 * A - 2.745
FEV1%VC [%] 13.0 * H - 0.152 * A + 110.49 20.20 * H - 0.252 * A + 126.58
FEV3/VC [%] 6.27 * H - 0.145 * A + 112.09 9.37 * H - 0.163 * A + 118.16
FEF25-75% [l/s] 2.04 * H - 0.038 * A + 2.133 1.54 * H - 0.046 * A + 2.683
Morris Men Women
FVC [l] 5.83 * H - 0.025 * A - 4.241 4.52 * H - 0.024 * A - 2.852
IVC [l] 5.83 * H - 0.025 * A - 4.241 4.52 * H - 0.024 * A - 2.852
FEV1 [l] 3.62 * H - 0.032 * A - 1.260 3.50 * H - 0.025 * A - 1.932
MVV [l] 3.62 * H - 0.032 * A 1.260 * 37.5 3.50 * H - 0.025 * A - 1.932 * 37.5
FEV1%VC [%] 107.12 - 12.28 * H - 0.2422 * A 88.70 - 2.67 * H - 0.1815 * A
FEF25-75% [l/s] 1.85 * H - 0.045 * A + 2.513 2.36 * H - 0.030 * A + 0.551
Austrian reference values1) Men Women

H = 1,44 – 2,00 m | A = 18 – 90 years H = 1,40 – 1,90 m | A = 16 – 90 years
FVC [l] -11.606 + 8.172H - 0.0339A * H + 1.2869 In(A) -10.815 + 6.640H - 0.0408A * H + 1.7293 In(A)
FEV1 [l] -8.125 + 6.212H - 0.0300A * H + 0.9770 In(A) -6.995 + 5.174 - 0.0314A * H + 1.0251 In(A)
2 2
PEF [l/s] (1.798 + 2.311 In(H) + 0.0159A - 0.000248A ) (1.832 + 1.838 In(H) + 0.0078A - 0.000172A2)2
2 2
MEF75%FVC [l/s] (1.581 + 1.854 In(H) + 0.0213A - 0.000283A ) (1.779 + 1.421 In(H) + 0.0096A - 0.000179A2)2
MEF50%FVC [l/s] (1.490 + 1.290 In(H) + 0.0125A - 0.000218A2)2 (1.561 + 1.177 In(H) + 0.0045A - 0.000140A2)2
2 2
MEF25%FVC [l/s] (1.314 + 0.898 In(H) - 0.0083A - 0.000026A ) (1.372 + 0.938 In(H) - 0.0152A + 0.000036A2)2
FEV1%VC [%] 101.99 - 1.191H2 - 3.962 In(A) 118.993 - 3.0320H2 - 6.9053 In(A)
Boys Girls
H = 1.09 – 1.96 m | A = 5 – 17.99 years H = 1.10 – 1.82 m | A = 5 – 15.99 years
FVC [l] exp(-1.142 + 1.259H + 0.004070A √W) exp(-3.842 + 4.1632 √H + 0.1341 √A - 1.614Fi)
FEV1 [l] exp(-1.178 + 1.221H + 0.003841A √W) exp(-3.877 + 3.9808 √H + 0.1485 √A - 1.322Fi)
PEF [l/s] exp(-0.214 + 0.921H + 0.0467A + 0.0020W) exp(0.411 + 1.793 In(H) + 0.4251 In(A) - 0.910 Fi)
MEF75%FVC [l/s] exp(-0.077 + 0.770H + 0.0373A + 0.0025W) exp(0.455 + 1.616 In(H) + 0.3738 In(A) - 0.861Fi)
MEF50%FVC [l/s] exp(-0.522 + 0.843H + 0.0300A + 0.0035W) exp(0.256 + 1.643 In(H) + 0.3481 In(A) - 1.089Fi)
MEF25%FVC [l/s] exp(-1.576 + 1.166H + 0.0219A + 0.0021W) exp(-0.772 + 2.002 In(H) + 0.3063 In(A) - 0.409Fi)
FEV1%VC [%] (101.99 - 1.191H2 - 3.962In(A)) 92
Cherniak2) Men Women

FVC [ml] 47.6 * H - 14 * A - 3180 30.7 * H - 15 * A - 1310
FEV1 [ml] 35.9 * H - 23 * A - 1510 23.7 * H - 19 * A - 0190
MVV [ml] (35.9 * H - 23 * A - 1510) * 37.5 (23.7 * H - 19 * A - 0190) * 37.5
PEF [ml/s] 57.6 * H - 24 * A + 0230 35.9 * H - 18 * A + 1130
MEF75%FVC [ml/s] 35.6 * H - 20 * A + 2730 27.1 * H - 19 * A + 2150
MEF50%FVC [ml/s] 25.7 * H - 30 * A + 2400 24.5 * H - 23 * A + 1430
MEF25%FVC [ml/s] 14.1 * H - 41 * A + 1610 09.2 * H - 35 * A +2220
Boys Girls
FVC [ml] 40.53 * H + 51.34 * A - 3655 27.86 * H + 90.96 * A - 2554
Knudson3) Men Women

FVC [ml] 65 * H - 29 * A - 5460 37 * H - 22 * A - 1770
FEV1 [ml] 52 * H - 27 * A - 4200 27 * H - 21 * A - 790
MVV [ml] (52 * H - 27 * A - 4200) * 37.5 (27 * H - 21 * A - 790) * 37.5
FEV1%VC [%] 0.087 * H - 0.14 * A + 103.64 0.111 * H - 0.109 * A + 107.38
PEF [ml/s] 94 * H - 35 * A - 5993 49 * H - 25 * A - 735
MEF75%FVC [ml/s] 88 * H - 35 * A - 5620 43 * H - 25 * A - 130
MEF50%FVC [ml/s] 69 * H - 15 * A - 5400 35 * H - 13 * A - 440
MEF25%FVC [ml/s] 44 * H - 12 * A - 4140 -14 * A + 3040
Boys Girls
FVC [ml] 59.0 * H - 73.9 * A - 6887 41.6 * H + 69.9 * A - 4447
FEV1 [ml] 51.9 * H - 6118 35.1 * H + 6.94 * A - 3762
MVV [ml] (51.9 * H - 6118) * 37.5 (35.1 * H + 6.94 * A - 3762) * 37.5
FEV1%VC [%] -0.0813 * H + 100.439 -0.1909 * H + 0.6655 * A + 109.97
PEF [ml/s] 78.0 * H + 166 * A - 8060 49.0 * H + 157 * A - 3916
MEF75%FVC [ml/s] 70.0 * H + 147 * A - 7054 44.0 * H + 144 * A - 3365
MEF50%FVC [ml/s] 54.3 * H + 115 * A - 6385 28.8 * H + 111 * A - 2304
MEF25%FVC [ml/s] 39.7 * H - 5.7 * A - 4242 24.3 * H + 292.3 * A - 7.5 * A2 - 4400.9
Boys Girls
FVC [ml] 40.9 * H - 3376 43.0 * H - 3749
FEV1 [ml] 34.0 * H - 2814 33.6 * H - 2758
MVV [ml] (34.0 * H - 2814) * 37.5 (33.6 * H - 2758) * 37.5
FEV1%VC [%] 0.0813 * H + 100.439 -0.1909 * H + 0.6655 * A + 109.97
PEF [ml/s] 78.0 * H + 166 * A - 8060 49.9 * H + 157 * A - 3916
MEF75%FVC [ml/s] 70.0 * H + 147 * A - 7054 44.0 * H + 144 * A - 3365
MEF50%FVC [ml/s] 37.8 * H + 2545 184.6 * A + 736
MEF25%FVC [ml/s] 17.1 * H - 1014.9 10.9 * H - 165.7
Ulmer4) Men Women
G = 40 – 170 kg G = 40 – 170 kg
IVC [ml] 82.243 * H - 20.4 * A - 8420.5 - 69.8 * B 56.695 * H - 19.4 * A - 5096 - 69.7 * B
IRC [ml] 47.291 * H - 11.3 * A - 6632 + 1297.3 * B 35.751 * H - 6.4 * A - 4241.4 - 1016.1 * B
ERC [ml] 41.995 * H - 7.8 * A - 3523.8 - 1875 * B 12.126 * H - 14.4 * A + 136 - 624.6 * B
FVC [ml] 77.576 * H - 21.7 * A - 7769.5 - 151.3 * B 52.467 * H - 19.9 * A - 4412.3 - 400.4 * B
FEV1 [ml] 53.212 * H - 26.1 * A - 4234 - 71.8 * B 23.939 * H - 20.7 * A - 641.6 - 209 * B
MVV [ml] (53.212 * H - 26.1 * A - 4234 - 71.8 * B) * 37.5 (23.939 * H - 20.7 * A - 641.6 - 209 * B) * 37.5
PEF [ml/s] 66.067 * H - 20.8 * A - 2981.3 - 1249.3 * B 55.175 * H - 31.4 * A - 1683.4 - 115.1 * B
MEF50%FVC [ml/s] 30.584 * H - 44 * A + 672.3 + 668.5 * B 26.181 * H - 22.4 * A + 2618.1 + 124 * B
MEF25%FVC [ml/s] 25.108 * H - 39 * A - 1254.2 + 697.4 * B 20.129 * H - 35.2 * A - 438.6 + 593.6 * B
Baur5) Men Women

H = 1,55 – 1,95 m | A = 18 – 70 years H = 1,45 – 1,80 m | A = 18 – 70 years
FVC [l] 6.00 * H - 0.0214 * A - 4.650 4.91 * H - 0.0216 * A - 3.590
FEV1 [l] 4.14 * H - 0.0244 * A - 2.190 3.42 * H - 0.0255 * A - 1.578
MVV [l] (4.14 * H - 0.0244 * A - 2.190) * 37.5 (3.42 * H - 0.0255 * A - 1.578) * 37.5
PEF [l/s] 6.14 * H - 0.043 * A + 0.15 5.50 * H - 0.030 * A - 1.11
MEF75%FVC [l/s] 5.46 * H - 0.029 * A - 0.47 3.22 * H - 0.025 * A + 1.60
MEF50%FVC [l/s] 3.79 * H - 0.031 * A - 0.35 2.45 * H - 0.025 * A + 1.16
MEF25%FVC [l/s] 2.61 * H - 0.026 * A - 1.34 1.05 * H - 0.025 * A + 1.11
ECCS6) Men Women

IVC [ml] 61.03 * H - 28 * A - 4654 46.64 * H - 26 * A - 3284
FVC [ml] 57.57 * H - 26 * A - 4345 44.26 * H - 26 * A - 2887
FEV1 [ml] 43.01 * H - 29 * A - 2492 39.53 * H - 25 * A - 2604
MVV [ml] (43.01 * H - 29 * A - 2492) * 37.5 (39.53 * H - 25 * A - 2604) * 37.5
FEV1%VC [%] 87.21 * H - 0.179 * A 89.10 * H - 0.192 * A
PEF [ml/s] 61.46 * H - 43 * A + 154 55.01 * H - 30 * A + -1106
MEF75%FVC [ml/s] 54.59 * H - 29 * A - 470 32.18 * H - 25 * A + 1596
MEF50%FVC [ml/s] 37.94 * H - 31 * A - 352 24.50 * H - 25 * A + 1156
MEF25%FVC [ml/s] 26.05 * H - 26 * A - 1336 10.50 * H - 25 * A + 1107
FEF25-75% [ml/s] 19.4 * H - 43.0 * A + 2700.0 12.5 * H - 34.0 * A + 2920.0
Hankinson Boys
Caucasian/Asiatic
H = 75 – 180 cm | A = 4 – 19 years
FEV1%VC [%] 88.066 + (-0.2066 * A)
FEV1 [l] 0.7453 + (-0.04106 * A) + (0.004477 * A * A) + (0.00014098 * H * H)
MVV [l] (0.7453 + (-0.04106 * A) + (0.004477 * A * A) + (0.00014098 * H * H)) * 37.5
FEV6 [l] -0.3119 + (-0.18612 * A) + (0.009717 * A * A) + (0.00018188 * H * H)
FVC [l] -0.2584 + (-0.20415 * A) + (0.010133 * A * A) + (0.00018642 * H * H)
IVC [l] -0.2584 + (-0.20415 * A) + (0.010133 * A * A) + (0.00018642 * H * H)
PEF [l/s] -0.5962 + (-0.12357 * A) + (0.013135 * A * A) + (0.00024962 * H * H)
FEF25-75% [l/s] -1.0863 + (0.13939 * A) + ( 0.00010345 * H * H)
Afro-American
H = 75 – 180 cm | A = 4 – 19 years
FEV1%VC [%] 89.239 + (-0.1828 * A)
FEV1 [l] -0.7048 + (-0.05711 * A) + (0.004316 * A * A) + (0.00013194 * H * H)
MVV [l] ((-0.7048 + (-0.05711 * A) + (0.004316 * A * A) + (0.00013194 * H * H)) * 37.5
FEV6 [l] -0.5525 + (-0.14107 * A) + (0.007241 * A * A) + (0.00016429 * H * H)
FVC [l] -0.4971 + (-0.15497 * A) + (0.007701 * A * A) + (0.00016643 * H * H)
IVC [l] -0.4971 + (-0.15497 * A) + (0.007701 * A * A) + (0.00016643 * H * H)
PEF [l/s] -0,2684 + (-0.28016 * A) + (0.018202 * A * A) + (0.00027333 * H * H)
FEF25-75% [l/s] -1.1627 + ( 0.12314 * A) + (0.00010461 * H * H)
Latin-American
H = 75 – 180 cm | A = 4 – 19 years
FEV1%VC [%] 90.024 + (-0.2186 * A)
FEV1 [l] -0.8218 + (-0.04248 * A) + (0.004291 * A * A) + (0.00015104 * H * H)
MVV [l] (-0.8218 + (-0.04248 * A) + (0.004291 * A * A) + (0.00015104 * H * H)) * 37.5
FEV6 [l] -0.6646 + (-0.11270 * A) + (0.007306 * A * A) + (0.00017840 * H * H)
FVC [l] -0.7571 + (-0.09520 * A) + (0.006619 * A * A) + (0.00017823 * H * H)
IVC [l] -0.7571 + (-0.09520 * A) + (0.006619 * A * A) + (0.00017823 * H * H)
PEF [l/s] -0.9537 + (-0.19602 * A) + (0.014497 * A * A) + (0.00030243 * H * H)
FEF25-75% [l/s] -1.3592 + (0.10529 * A) + (0.00014473 * H * H)
Hankinson Girls
Caucasian/Asiatic
H = 75 – 180 cm | A = 4 – 17 years
FEV1%VC [%] 90.809 + (-0.2125 * A)
FEV1 [l] -0.8710 + (0.06537 * A) + (0.00011496 * H * H)
MVV [l] (-0.8710 + (0.06537 * A) + (0.00011496 * H * H)) * 37.5
FEV6 [l] -1.1925 + (0.06544 * A) + (0.00014395 * H * H)
FVC [l] -1.2082 + (0.05916 * A) + (0.00014815 * H * H)
IVC [l] -1.2082 + (0.05916 * A) + (0.00014815 * H * H)
PEF [l/s] -3.6181 + (0.60644 * A) + (-0.016846 * A * A) + (0.00018623 * H * H)
FEF25-75% [l/s] -2.5284 + (0.52490 * A) + (-0.015309 * A * A) + (0.00006982 * H * H)
Afro-American
H = 75 – 180 cm | A = 4 – 17 years
FEV1%VC [%] 91.655 + (-0.2039 * A)
FEV1 [l] -0.9630 + (0.05799 * A) + (0.00010846 * H * H)
MVV [l] ((-0.9630 + (0.05799 * A) + (0.00010846 * H * H)) * 37.5
FEV6 [l] 0.6370 + (-0.04243 * A) + (0.003508 * A * A) + (0.00013497 * H * H)
FVC [l] -0.6166+(-0.04687 * A) + (0.003602 * A * A) + (0.00013606 * H * H)
IVC [l] -0.6166+(-0.04687 * A) + (0.003602 * A * A) + (0.00013606 * H * H)
PEF [l/s] -1.2398 + (0.16375*A) + (0.00019746 * H * H)
FEF25-75% [l/s] -2.5379 + (0.43755 * A) + (-0.012154 * A * A) + (0.00008572 * H * H)
Latin-American
H = 75 – 180 cm | A = 4 – 17 years
FEV1%VC [%] 92.360 + (-0.2248 * A)
FEV1 [l] -0.9641 + (0.06490 * A) + (0.00012154 * H * H)
MVV [l] ((-0.9641 + (0.06490 * A) + (0.00012154 * H * H)) * 37.5
FEV6 [l] -1.2410 + ( 0.07625 * A) + (0.00014106 * H * H)
FVC [l] -1.2507 + ( 0.07501 * A) + (0.00014246 * H * H)
IVC [l] -1.2507 + ( 0.07501 * A) + (0.00014246 * H * H)
PEF [l/s] -3.2549 + ( 0.47495 * A) + (-0.013193 * A * A) + (0.00022203 * H * H)
FEF25-75% [l/s] -2.1825 + ( 0.42451 * A) + (-0.012415 * A * A) + (0.00009610 * H * H)
Hankinson Men
Caucasian/Asiatic
H = 150 – 200 cm | A = 20 – 120 years
FEV1%VC [%] 88.066 + (-0.2066 * A)
FEV1 [l] 0.5536 + (-0.01303 * A) + (-0.000172 * A * A) + (0.00014098 * H * H)
MVV [l] (0.5536 + (-0.01303 * A) + (-0.000172 * A * A) + (0.00014098 * H * H)) * 37.5
FEV6 [l] 0.1102+(-0.00842 * A) + (-0.000223 * A * A) + (0.00018188 * H * H)
FVC [l] -0.1933 + (0.00064 * A) + (-0.000269 * A * A) + (0.00018642 * H * H)
IVC [l] -0.1933 + (0.00064 * A) + (-0.000269 * A * A) + (0.00018642 * H * H)
PEF [l/s] 1.0523 + ( 0.08272 * A) + (-0.001301 * A * A) + (0.00024962 * H * H)
FEF25-75% [l/s] 2.7006 + (-0.04995 * A) + (0.00010345 * H * H)
Afro-American
H = 150 – 200 cm | A = 20 – 120 years
FEV1%VC [%] 89.239 + (-0.1828 * A)
FEV1 [l] 0.3411 + (-0.02309 * A) + ( 0.00013194 * H * H)
MVV [l] (0.3411 + (-0.02309 * A) + (0.00013194 * H * H)) * 37.5
FEV6 [l] -0.0547 + (-0.02114 * A) + (0.00016429 * H * H)
FVC [l] -0.1517 + (-0.01821 * A) + (0.00016643 * H * H)
IVC [l] -0.1517 + (-0.01821 * A) + (0.00016643 * H * H)
PEF [l/s] 2.2257 + (-0.04082 * A) + (0.00027333 * H * H)
FEF25-75% [l/s] 2.1477 + (-0.04238 * A) + (0.00010461 * H * H)
Latin American
H = 150 – 200 cm | A = 20 – 120 years
FEV1%VC [%] 90.024 + (-0.2186 * A)
FEV1 [l] 0.6306 + (-0.02928 * A) + (0.00015104 * H * H)
MVV [l] (0.6306 + (-0.02928 * A) + (0.00015104 * H * H)) * 37.5
FEV6 [l] 0.5757 + (-0.02860 * A) + (0.00017840 * H * H)
FVC [l] 0.2376 + (-0.00891 * A) + (-0.000182 * A * A) + (0.00017823 * H * H)
IVC [l] 0.2376 + (-0.00891 * A) + (-0.000182 * A * A) + (0.00017823 * H * H)
PEF [l/s] 0.0870 + (0.06580 * A) + (-0.001195 * A * A) + (0.00030243 * H * H)
FEF25-75% [l/s] 1.7503 + (-0.05018 * A) + (0.00014473 * H * H)
Hankinson Women
Caucasian/Asian
H = 140 – 200 cm | A = 18 – 120 years
FEV1%VC [%] 90.809 + (-0.2125 * A)
FEV1 [l] 0.4333 + (-0.00361 * A) + (-0.000194 * A * A) + (0.00011496 * H * H)
MVV [l] (0.4333 + (-0.00361 * A) + (-0.000194 * A * A) + (0.00011496 * H * H)) * 37.5
FEV6 [l] -0.1373 + (0.01317 * A) + (-0.000352 * A * A) + (0.00014395 * H * H)
FVC [l] -0.3560 + (0.01870 * A) + (-0.000382 * A * A) + (0.00014815 * H * H)
IVC [l] -0.3560 + (0.01870 * A) + (-0.000382 * A * A) + (0.00014815 * H * H)
PEF [l/s] 0.9267 + (0.06929 * A) + (-0.001031 * A * A) + (0.00018623 * H * H)
FEF25-75% [l/s] 2.3670 + (-0.01904 * A) + (-0.000200 * A * A) + (0.00006982 * H * H)
Afro-American
H = 140 – 200 cm | A = 18 – 120 years
FEV1%VC [%] 91.655 + (-0.2039 * A)
FEV1 [l] 0.3433 + (-0.01283 * A) + (-0.000097 * A * A) + (0.00010846 * H * H)
MVV [l] (0.3433 + (-0.01283 * A) + (-0.000097 * A * A) + (0.00010846 * H * H)) * 37.5
FEV6 [l] -0.1981 + (0.00047 * A) + (-0.000230 * A * A) + (0.00013497 * H * H)
FVC [l] -0.3039 + (0.00536 * A) + (-0.000265 * A * A) + (0.00013606 * H * H)
IVC [l] -0.3039 + (0.00536 * A) + (-0.000265 * A * A) + (0.00013606 * H * H)
PEF [l/s] 1.3597 + (0.03458 * A) + (-0.000847 * A * A) + (0.00019746 * H * H)
FEF25-75% [l/s] 2.0828 + (-0.03793 * A) + (0.00008572 * H * H)
Latin-American
H = 140 – 200 cm | A = 18 – 120 years
FEV1%VC [%] 92.360 + (-0.2248 * A)
FEV1 [l] 0.4529 + (-0.01178 * A) + (-0.000113 * A * A) + (0.00012154 * H * H)
MVV [l] (0.4529 + (-0.01178 * A) + (-0.000113 * A * A) + (0.00012154 * H * H)) * 37.5
FEV6 [l] 0.2033 + (0.00020 * A) + (-0.000232 * A * A) + (0.00014106 * H * H)
FVC [l] 0.1210 + (0.00307 * A) + (-0.000237 * A * A) + (0.00014246 * H * H)
IVC [l] 0.1210 + (0.00307 * A) + (-0.000237 * A * A) + (0.00014246 * H * H)
PEF [l/s] 0.2401 + (0.06174 * A) + (-0.001023 * A * A) + (0.00022203 * H * H)
FEF25-75% [l/s] 1.7456 + (-0.01195 * A) + (-0.000291 * A * A) + (0.00009610 * H * H)
Polgar71 Boys Girls

FVC [l] (3.58 : 10000) * H3.18 : 1000 (2.57 : 1000) * H2.78 : 1000
IVC [l] (3.58 : 10000) * H3.18 : 1000 (2.57 : 1000) * H2.78 : 1000
3.00
FEV1 [l] (7.74 : 10000) * H : 1000 (3.79 : 1000) * H2.68 : 1000
MVV [l] (7.74 : 10000) * H3.00 : 1000 * 37.5 (3.79 : 1000) * H2.68 : 1000 * 37.5
2.79
PEF [l/s] ((3,35 : 10000) * H ) : 60 ((2.58 : 1000) * H2.37) : 60
FEF25-75% [l/s] ((7.98 : 10000) * H2.46) : 60 ((3.79 : 1000) * H2.16) : 60
Schindl7) Boys Girls

FVC [ml] 49.2 * H + 118.2 * A - 6006.0 41.7 * H + 91.3 * A - 4660.6
FEV1 [ml] 41.9 * H + 79.0 * A 4674.4 41.9 * H + 70.6 * A - 4176.1
PEF [ml/s] 76.8 * H + 224.2 * A - 8381.5 62.1 * H + 176.3 * A - 5623.2
MEF75%FVC [ml/s] 56.2 * H + 175.4 * A - 5530.3 46.5 * H + 154.7 * A - 3627.9
MEF50%FVC [ml/s] 41.5 * H + 109.5 * A - 3988.0 48.3 * H + 115.6 * A - 4896.6
MEF25%FVC [ml/s] 30.3 * H + 39.0 * A - 3059.9 38.8 * H + 51.4 * A - 4331.9
ECCS children/Quanjer Boys Girls

FVC [l] H2.7 0.95 * H2.7
IVC [l] H2.7 0.95 * H2.7
2.7
FEV1 [l] 0.84 * H 0.81 * H2.7
MVV [l] 0.84 * H2.7 * 37.5 0.81 * H2.7 * 37.5
FEV1%VC [%] 84 84
PEF [l/s] 8.2 * H - 6.8 6.7 * H - 5.3
FEF50%FVC [l/s] 5.6 * H - 4.4 4.6 * H - 3.3
MEF50%FVC [l/s] 5.6 * H - 4.4 4.6 * H - 3.3
Zapletal8) Boys Girls
logVC [ml] -2.5768 + 2.7799 log(H) -2.2970 + 2.6361 log(H)
logIRC [ml] -2.79590 + 2.73794 log(H) -2.69813 + 2.67126 log(H)
logERC [ml] -3.81064 + 3.12550 log(H) -2.74262 + 2.61668 log(H)
logVT [ml] -1.3956 + 1.8643 log(H) -1.3956 + 1.843 log(H)
logFVC [ml] -2.9239 + 2.9360 log(H) -2.7040 + 2.8181 log(H)
logFEV1 [ml] -2.86521 + 2.87294 log(H) -2.60565 + 2.74136 log(H)
FEV1%VC [%] 90.6043 - 0.04104 * H 90.6043 - 0.0410 * H
logPEF [l/s] -4.37221 + 2.34275 log(H) -4.37221 + 2.34275 log(H)
logMEF75%FVC [l/s] -4.01648 + 2.1541 log(H) -4.01648 + 2.15414 log(H)
MVV [ml] -1.9178 + 3.0388 log(H) -1.9178 + 3.0388 log(H)
1) Austrian reference values – sources

- Lecture Notes SPIROMETRY of The Austrian Society for Pneumology
Created by the members of the working group for clinical respiratory physiology, standardisation and evaluation
2) Cherniak – sources
- PH. H. Quanjer et al.: "Lung Volumes and Forced Ventilatory Flows" Report Working Party, Standardization of Lung Function Tests,
European Community of Steel and Coal; The European Respiratory Journal 1993, Volume 6, Supplement 16, 5 - 40;
- "Standardization of Lung Function Tests in Paediatrics" The European Respiratory Journal, Volume 2, Supplement 4, March 1989, ISBN 87-16-14801-0;
- R.M. Cherniak, M.B. Raber: "Normal standards of ventilatory function..." Am. Rev. Respir. Dis. 1972;
- R.M. Cherniak: "Ventilatory function in normal children" Canad. Med. Assoc. 1962;
3) Knudson – sources
- R. J. Knudson, M.D. Lebowitz, R.C. Slatin: "Normal standards variability, and effects of age" AM. Rev. Respir. Dis. 1983;
4) Ulmer – sources
- W.T. Ulmer et al.: "Lungenfunktion: Physiologie und Pathophysiologie" [Pulmonary function: Physiology and Pathophysiology]
Methodology, 2nd Edition, Thieme Stuttgart, 1983;
- W.T. Ulmer, G. Reichel, D. Nolte, M.S. Islam: "Die Lungenfunktion" [The Pulmonary Function] 3rd Edition, Thieme-Verlag Stuttgart, 1983;
5) Baur – sources
- X. Baur: "Lungenfunktionsprüfung und Allergiediagnostik" [Pulmonary function test and allergy diagnostic]
Dustri-Verlag, Dr. Karl Feistle, 1998, ISBN 3-87185-270-8;
6) ECCS – sources
- W. Schmidt: "Angewandte Lungenfunktions-Prüfung" [Applied Lung Function Testing] 3rd Edition, 1987, Dustri-Verlag, ISBN 3-87185-130-2;
- G. J. Tammeling, PH. H. Quanjer: "Physiologie der Atmung" Thomae;
- H. Löllgen: "Kardiopulmonale Funktionsdiagnostik" [Cardiopulmonary Functional Diagnostics] CIBA-GEIGY GmbH;
7) Schindl – sources
- R. Schindl, K. Aigner: "Atemfunktionsscreening und Sollwertebezug bei Kindern und Jugendlichen"
[Respiratory Screening and Reference Values for Children and Adolescents];
8) Zapletal – sources
- A. Zapletal., M. Samánek, T. Paul: "Lung Function in Children and Adolescents" Progress in Respiration Research, Volume 22, Kager-Verlag, ISBN 3-8055-4495-2;
08.1 Technical data and system requirements

Technical data
Measuring sensor Differential pressure gauge with laminar element
Display of measured values BTPS (Body Temperature Pressure Saturated)
Measuring range ± 14 l/s
Resolution 12 bit
Accuracy ATS standard, ISO 23747
Linearity < 5%
Air resistance < 35 kPa / l/s at 14 l/s
Power supply via USB (Universal Serial Bus)
Operating conditions Temperature +10°C ... +40°C
Air humidity 10 ... 95 % rH
Air pressure 700 ... 1060 hPa
Transport and storage Temperature -20°C ... +45°C
Conditions Air humidity 10 ... 95 % rH
Air pressure 700 ... 1060 hPa
Dimensions Size 140 * 150 * 45 mm (L * B * H)
Weight approx. 330 g
Classification Protection class II
Class IIa
Type BF
IEC 60601-1
Bacterial and viral filters Single Use
Filter Class H13 (HEPA, 99.95 %)
Manufactured according to IEC 1822-1
Tested according to IEC ISO 10933-1
System requirements
Operating system Windows XP (x64)
Windows Vista (x64)
Windows 7 (x64)
Windows Server 2003 (x64)
Windows Server 2008 (x64)
Windows Server 2008 R2
Older versions are not supported.
PC The PC hardware must meet the minimum requirements
of the operating system being used.
custo diagnostic requires additional RAM (256 MB).
Ensure that there is sufficient free hard disk space
for the custo diagnostic evaluations.
File sizes of the evaluations Holter ECG: approx. 15 MB (max 60 MB)
ABPM: approx. 1 MB (max 2 MB)
Holter ABPM: approx. 20 MB (max 25MB)
Resting ECG: approx. 200 KB (for approx. 10 seconds of ECG)
Stress ECG: approx. 6 MB (for approx. 20 seconds of ECG)
CPET: see Stress ECG
Spirometry: approx. 50 KB (max. 256 KB)
Rehab: approx. 6 MB (for approx. 45 minutes of training)
Hardware & ports DVD or CD ROM drive
USB port
Monitors If animation for children is used,
a second screen should be used for the animation
08.2 Support
If you have any questions or problems which are not dealt with here, please do not
hesitate to contact your authorised custo med dealer. A list of the authorised custo
med dealers can be found in the Internet under www.customed.de, in the category
Contact, Dealers.
You can also contact custo med GmbH directly at any time. We will be pleased to
provide you with information about your authorised custo med dealer or contact
your authorised custo med dealer and forward your queries.
08.3 Manufacturer declaration regarding EMC (Electromagnetic Compatibility)

according to IEC 60601-1-2:2007
Lengths of the USB cable: 3 m
Manufacturer’s Declaration – electromagnetic emissions

The custo spiro mobile spirometry device is designed for operation in the electromagnetic environment stated
below. The customer or user of custo spiro mobile should make sure that it is used in such an environment.
Emission Measurements Compliance Electromagnetic Environment - Guidelines
HF emissions according to CISPR11 Group 1 custo spiro mobile uses HF energy only for its internal
function. Its level of HF emission is therefore very low
and is unlikely to be sufficient to interfere with other
electronic devices.
HF emissions according to CISPR11 Class B custo spiro mobile is suitable for use in all establishments,
including domestic establishments and those directly
Harmonics according to IEC61000-3-2 Not applicable connected to the public low voltage power supply net-
work that supplies buildings used for domestic purposes.
Voltage fluctuations/flickers according to IEC61000-3-3 Not applicable
Manufacturer’s Declaration – electromagnetic immunity

Immunity Tests IEC 60601 Test Level Compliance Level Electromagnetic Environment - Guidelines
Electrostatic ± 6 kV contact discharge ± 6 kV contact discharge Floors should be made of wood or concrete or be equipped
discharge (ESD) ± 8 kV air discharge ± 8 kV air discharge with ceramic tiles. If the floor is provided with synthetic
according to IEC 61000-4-2 material, the relative air humidity must be at least 30 %.
Fast transient electric ± 2 kV for net wires Not applicable The quality of the supply voltage should correspond to
interference factors/bursts ± 1 kV for input and the one of a typical business or clinical environment.
according to IEC 61000-4-4 output wires
Surges ± 1 kV push-pull voltage Not applicable The quality of the supply voltage should correspond to
according to IEC 61000-4-5 ± 2 kV push-push voltage the one of a typical business or clinical environment.
Voltage drops, < 5 % UT for 0.5 period Not applicable The quality of the supply voltage should correspond to
short-time interruptions (> 95 % drop) the one of a typical business or clinical environment.
and fluctuations If the user of custo spiro mobile requires continued func-
in the supply voltage 40 % UT for 5 periods tion, even if interruptions in the energy supply occur, it
according to (60 % drop) is recommended to supply custo spiro mobile from an
IEC 61000-4-11 interruption-free power supply.
70 % UT for 25 periods
(30 % drop)
< 5 % UT for 5 s
(> 95 % drop))
Magnetic field with 3 A/m 10 A/m Magnetic fields with net frequency should correspond to
supply frequency the typical values, as they can be found in the business
(50/60 Hz) and clinical environment.
according to IEC 61000-4-8
COMMENT: UT is the alternating supply voltage prior to application of test levels
Manufacturer’s Declaration – electromagnetic immunity
Immunity Tests IEC 60601 Test Level Compliance Level Electromagnetic Environment - Guidelines
Portable and mobile radio sets should not be used at a

closer distance to the device including the leads than the
recommended protective distance which is determined
according to the equation of transmitting frequency.
Recommended protective distance:

d = (3.5/U1) √P
Conducted HF transients 3 Veffective value U1 = 3Veffective value
according to IEC 61000-4-6 150 KHz to 80 Mhz

d = (3.5/E1) √P 80 MHz to 800 MHz
d = (7/E1) √P 800 MHz to 2.5 GHz

Radiated HF transients 3 V/m E1 = 3 V/m
with P as the nominal power of the transmitter in watt
according to IEC 61000-4-3 80 MHz to 2.5 GHz (W) according to the indications of the transmitter man-
ufacturer and d as the recommended protective distance
in meters (m).
According to an examination on-site a) the field strength

of stationary radio transmitters should be inferior to the
compliance level b) with regard to all frequencies.
In the vicinity of devices carrying the following symbol,

interferences are possible:
COMMENT 1:
With 80 MHz and 800 MHz the higher frequency range is valid.
COMMENT 2:
These guidelines may not apply in every case. The propagation of electromagnetic variables is influenced by ab-
sorptions and reflections of buildings, objects and people.
a) The field strength of stationary transmitters, such as, for example, base stations of mobile phones and mobile
transmitting stations, amateur radio stations, AM and FM broadcasting as well as television networks cannot
be exactly predetermined theoretically. In order to determine the electromagnetic environment regarding the
stationary transmitters, a study of the location should be considered. If the measured field strength exceeds the
above-mentioned compliance levels at the location where the device is used, the device should be watched in
order to prove the intended functions. If unusual performance characteristics are observed, it may be necessary
to take additional measures, such as, for example, reorienting or relocating the device.
b) Over the frequency range from 150 kHz to 80 MHz the field strength should be inferior to 10 V/m.
Recommended protective distances between portable

and mobile HF telecommunication devices and custo spiro mobile
custo spiro mobile is designed for the operation in an electromagnetic environment in which the HF transients
can be controlled. The user can help avoid electromagnetic interferences by maintaining the minimum distance
between portable and mobile HF telecommunication devices (transmitters) and the device – depending on the
initial performance of the communication device – as indicated below.
Protective distance depending on the transmitting frequency in m
Nominal power 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
of the transmitter
W d= (3.5/U1) √P d= (3.5/E1) √P d= (7/E1) √P
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.17 1.17 2.33
10 3.69 3.69 7.38
100 11.67 11.67 23.33
For transmitters whose maximum nominal power is not indicated in the above table, the recommended protec-
tive distance d can be determined in meters (m), using the equation affiliated with the corresponding column.
P is the maximum nominal power of the transmitter in watt (W) according to the indications of the manufacturer
of the transmitter.
COMMENT 1:
With 80 MHz and 800 MHz the higher frequency range is valid.
COMMENT 2:
These guidelines may not apply in every case. The propagation of electromagnetic variables is influenced by
absorptions and reflections of buildings, objects and people.
08.4 EC Declaration of Conformity
08.5 Shutdown, storage and transport

Putting out of operation and storage
Clean and disinfect custo spiro mobile and its components before putting it out of
operation.
Make sure that the storage location is dust-free, dry and away from direct sunlight.
After a long period of non-operation, custo spiro mobile may only be used again if
a technical safety check has been carried out by your authorised custo med dealer.
Transport
Clean and disinfect custo spiro mobile and its components before transport.
Use the original packaging for transport. This is a sensitive piece of electronic
equipment. If the original packaging is not available, pack the device so that it is
protected against impact, moisture and dust.
The device must comply with the operating conditions when it is put into operation
again, e.g. operating temperature (see 08.1 Technical Data...).
Ambient conditions for storage and transport
Temperature: -20° ... +45°C

Air humidity: 10 ... 95% rH
Air pressure: 700 ... 1060 hPa
08.6 Disposal
The device and all its components must be disposed of in a proper manner in
compliance with applicable regulations (that is, in accordance with the valid laws
governing waste electrical and electronic equipment). The device must not be
disposed of as normal domestic waste.
The original packaging is recyclable

(cardboard/waste paper).
08.7 Keyboard navigation and shortcuts in custo diagnostic
Use the quick links in the main navigation, the keyboard navigation and the key-
board shortcuts to enable fast and convenient working.
Quick links in the main navigation
LEFT-CLICK RIGHT-CLICK
User master data Evaluation search
Call last patient Call last patient
Examination main menu Evaluation last displayed
LEFT-CLICK RIGHT-CLICK
User master data All the patient's evaluations
Patient master data Evaluation last displayed
Menu of the current examination of this examination
Keyboard navigation
When you press the Alt key, the initial letters of all the buttons on a screen page
are underlined. Pressing an initial letter in combination with the Alt key triggers the
corresponding button.
Generally accepted keyboard shortcuts
Esc End, Cancel
Confirm, continue
Ctrl I Program Information
Ctrl H User main menu
Ctrl P Patient main menu
Ctrl U Examination main menu
Ctrl S Patient master data of the selected patient
Ctrl A All examinations of the selected patient
Ctrl G List of recently opened evaluations

(same as clicking on the arrow button at top right)
Ctrl F List of recently opened evaluations
Ctrl L Evaluation search
Ctrl W Waiting room list
Ctrl Q Device list
Ctrl M Switching to Metasoft
Ctrl F1 Create system report, service e-mail
Generally accepted keyboard shortcuts for open evaluations
Ctrl N Report dialogue
Ctrl K Medication input dialogue
Ctrl R Call comparison1)
Ctrl T Call trend1)
Ctrl D Call print1)
Ctrl E Call settings1)
Ctrl O Call Options menu1)
1) Keyboard shortcuts will only work if the corresponding button is available on the screen page.
Notes
Manufacturer's contact details:
custo med GmbH
Maria-Merian-Str. 6
85521 Ottobrunn
Germany
Phone: +49 (0) 89 710 98 - 00

Fax: +49 (0) 89 710 98 - 10
Email: info@customed.de
Internet: www.customed.de

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Operating Manual

custo diagnostic V04 and higher

GEB 0205 – DK 1651

© 2017 custo med GmbH

Manufacturer's contact details:

Phone: +49 (0) 89 710 98 - 00

03 Description of device, basic instructions for initial operation

05 Carrying out an examination

07 Settings, measured values and predicted values

01.1 Symbols on the devices

A review of the operating manual is recommended

Protection class classification of medical electrical

Separate collection of electrical and electronic equipment,

custo spiro mobile Measuring head

Operating manual must be observed and followed

custo spiro protect bacterial and viral filter

Accompanying documents must be observed.

01.3 Symbols used in this Operating Manual

ACTIONS THAT ARE PROHIBITED

Words highlighted in colour indicate buttons or click paths Words highlighted

02.1 General notes

Laws and regulations applicable to the product

02.2 Safety installations and safe working

Installation of the system

Portable socket outlets must not be laid on the ground.

To ensure precise measuring results, the environmental data in custo diagnostic

Safety distances of devices to the patient

1.5 m 1.5 m 1.5 m

During routine maintenance work to non-medical devices connected to the system

All unconfirmed reports produced by the system must be considered as suggestions

custo spiro mobile USB cable

custo spiro protect bacterial and viral filter

Only use bacterial and viral filters approved by custo med,

Unsuitable filters may falsify the measurement data obtained.

System and data security

Data management in custo diagnostic: Assign evaluation (allocate evaluation)

We recommend configuring user rights in custo diagnostic so that only authorised

02.3 Maintenance (regular safety checks)

All interventions in the existing system, changes to system components, enhance-

Technical safety check

Technical measurement check

03.1 Part names, components for spirometry measurement

custo spiro mobile

Using the bacterial and viral filters

Disassembling and assembling the device

When assembling, make sure that the measuring head

03.3 custo diagnostic – basic program structure

The Patient main menu is used for patient management.

Connect custo spiro mobile to the PC. The driver is installed

In the event of mechanical impacts, immediately perform a calibration in order to

Instructions for performing calibration

Calibration is to be performed without bacterial and viral filters.

Only use calibrated calibration pumps.

Specify the volume of your pump and enter your

Follow the system instructions.

The instructions are displayed at the bottom right in

Operating the calibration pump

04.1 Cleaning and disinfection

IF IT IS OPERATED WITHOUT CUSTO SPIRO PROTECT, custo spiro mobile and

In case of contagious patients where air-borne transmission may occur:

For all other patients where an air-borne transmission is not suspected:

Irrespective of the cleaning and disinfection after each patient, we recommend

Important instructions for performing calibration

The handhold of the device must not be immersed in liquid.