Custo Med Custo spiro mobile User manual

Operating Manual
Spirometry
custo spiro mobile
custo diagnostic 5.8
CMA 0025 ∙ DK 2139 ∙ Version 1∙2022/10/25

CMA
0025 ∙ DK 2139 ∙ Version 001 ∙ 2022/10/25 ∙ www.customed.de
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© 2022 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 website:
www.customed.de
.

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Table of Contents
1Safety ..................................................................................................5
1.1 General notes.......................................................................................................5
1.1.1 Symbols used in this Operating Manual............................................ 5
1.1.2 Laws and regulations applicable to the product.............................6
1.1.3 Disclaimer .................................................................................................7
1.1.4 Warranty.................................................................................................... 7
1.1.5 Support .....................................................................................................7
1.2 Safety installations and safe working ............................................................8
1.2.1 Putting into operation, setup...............................................................8
1.2.2 Ambient conditions, handling of the devices...................................8
1.2.3 Patient safety ...........................................................................................9
1.2.4 System and data security....................................................................11
1.2.5 Information on EMC (Electromagnetic Compatibility).................13
1.2.6 Maintenance (regular safety checks)................................................13
1.3 Safety instructions for spirometry.................................................................14
1.4 Residual risks spirometry................................................................................15
2Hardware...........................................................................................16
2.1 Intended use ......................................................................................................16
2.2 Symbols on the devices and packaging......................................................18
2.3 Technical data and system requirements...................................................19
2.4 Putting out of operation, storage, transport, disposal.............................22
2.5 Components for the recording ......................................................................23
2.6 Device operation...............................................................................................24
2.6.1 Function display....................................................................................24
2.6.2 Using the bacterial and viral filters ...................................................25
2.6.3 Disassembling and assembling the device.....................................26
2.6.4 Notes on calibration.............................................................................27
2.7 Procedure of an examination.........................................................................28
3Software............................................................................................29
3.1 custo diagnostic program structure.............................................................29
3.2 custo spiro mobile connection to the PC....................................................30
3.3 Calibrating custo spiro mobile ......................................................................31
3.4 Performing the spirometry measurement ..................................................32
3.4.1 Reference measurement.....................................................................32
3.4.2 Follow-up measurements: Spasmolysis and provocation..........40
3.4.3 Unconfirmed report..............................................................................42
3.4.4 Printing the measurement..................................................................44
3.5 Opening evaluations........................................................................................45
3.5.1 Opening an evaluation via the evaluation search.........................45
3.5.2 Opening an evaluation via the evaluation main menu ................47
3.6 Evaluation structure.........................................................................................48
3.7 Navigation in the evaluation ..........................................................................50
3.8 Diagnostic terms in the evaluation...............................................................51
3.9 Evaluation of the reference and spasmolysis measurement .................53
3.10 Evaluation of a provocation measurement series ....................................54
3.11 Further screens of an evaluation...................................................................55

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3.12 Confirming the evaluation..............................................................................60
3.13 Optional: Reporting with approval process................................................61
3.14 Ending the evaluation......................................................................................62
3.15 Settings for spirometry....................................................................................63
3.16 Error messages and solutions........................................................................68
4Hygiene .............................................................................................69
4.1 Important notes ................................................................................................69
4.2 Hygienic reprocessing......................................................................................70
4.2.1 Procedure and frequency of cleaning and disinfection...............70
4.2.2 Disassembling the device for cleaning and disinfection..............71
4.2.3 Wipe disinfection, after each examination......................................72
4.2.4 Instrument disinfection, weekly or after 100 Examinations........73
4.3 Recommended cleaning agents and disinfectants ..................................74
4.4 Disposal of contaminated consumables.....................................................75
5Appendix ...........................................................................................76
5.1 Abbreviations of the spirometry measured values...................................76
5.2 Calculation tables for predicted values.......................................................78
5.3 Keyboard navigation and shortcuts .............................................................90
5.4 Manufacturer’s declaration regarding EMC ................................................92
5.5 EC Declaration of Conformity ........................................................................94
5.6 Product components and accessories ........................................................95
5.7 List of Figures.....................................................................................................96

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1Safety
1.1 General notes
1.1.1 Symbols used in this Operating Manual
Safety warning symbol, in case of dangerous situations with
high and medium risk level, which may result in personal
injuries
IMPORTANT:
absolutely necessary working steps
INFORMATION:
for the correct and safe use of the system.
TIP:
contains practical information to assist you with your work
custo
Words highlighted in colour indicate buttons or click paths to
the corresponding program point, e.g.:
Examination, Settings

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1.1.2 Laws and regulations applicable to the product
INFORMATION:
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 the Operating Manual, in particular the safety instructions.
Should serious incidents occur in connection with a custo med product, they
must be reported by the user and/or patient to the manufacturer and the
competent authority of the Member State in which the user and/or patient is
established.
custo med devices are designed in accordance with the Medical Device
Directive 93/42/EEC and Medical Devices Regulation (MDR 2017/745), class IIa
and meet the requirements of protection class I or II, depending on the power
supply unit used or they are devices with an internal power supply, type BF or
CF 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 62368) 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.

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1.1.3 Disclaimer
The manufacturer will not be held liable for improper operation, non-
compliance with safety instructions and negligently skipped instructions.
custo med only assumes responsibility for the safety and reliability of the device
if all changes, enhancements, repairs and other work on the device or system
have been performed by an authorised custo med distributor or custo med and
the Operating Manual has been observed during device operation.
1.1.4 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,
improper use, unauthorised modification of parts and the use of violent force.
After the warranty period has expired, only use original spare parts and
accessories supplied by custo med. Only this will ensure the safe and problem-
free operation of your device.
1.1.5 Support
If you have any questions or problems which are not dealt with here, please do
not hesitate to contact your authorised custo med distributor. A list of
authorised custo med distributor can be found on the Internet at:
www.customed.de, under Contact, Distributors.
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 distributor or
contact your authorised custo med distributor and forward your queries.

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1.2 Safety installations and safe working
1.2.1 Putting into operation, setup
custo med systems must only be used in a technically perfect condition.
Regularly carry out a visual inspection of the devices and their associated
components. Only use accessories approved by custo med. The use of
accessories other than those specified may result in increased emissions or
decreased immunity.
A PC with peripherals is required to operate the custo med devices. For
assembly it is recommended to use portable multiple socket outlets approved
by custo med, e.g. medical protector. The following must be noted:
→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 multiple 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.
→Slots which are not used in the delivered system (portable multiple socket
outlets) must be provided with covers.
1.2.2 Ambient conditions, handling of the devices
Emissions
The custo med devices/systems are not suitable for use in rooms or areas with a
risk of explosion.
For installation and operation of the devices/systems, the EMC
(electromagnetic compatibility) instructions in the Operating Manual must be
observed.
Strong electromagnetic sources in the immediate vicinity of the custo med
device/system may result in recording errors. The custo med device/system
must not be stored or used in the vicinity of X-ray equipment, diathermy units or
magnetic resonance devices (MRT). Other electrical devices such as mobile
phones or radio transceivers may impair the quality of the recording.
Other devices may interfere with the custo med devices/systems, even if the
other devices comply with the applicable emissions requirements according to
CISPR.
Mechanical impact
No modifications may be made to the custo med devices/systems. Contact your
authorised custo med distributor for repairs.
custo med devices for outpatient use (recorder, transmitter) must be protected
from heat, moisture, dust and dirt. The devices may not function properly if they
come into contact with liquid.
It is not permitted to wear the devices in a swimming pool, in the sauna,
bathtub, shower or similar wet rooms. Do not submerge the custo med devices.
The custo med devices must be protected from mechanical impact, such as
falls or transport damage. Avoid heavy mechanical loads.

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Rechargeable batteries
Some custo med devices contain an integrated lithium polymer battery
(permanently installed in the housing). Any mechanical stress which is beyond
the intended use must be avoided. Do not use force to open the devices.
Some custo med devices contain a lithium-ion battery or other batteries that
can be removed. Remove the rechargeable battery when the device is not in
use. Do not expose the rechargeable battery to extreme temperatures, fire and
moisture. Do not immerse in liquids. Observe the operating and storage
conditions. Do not subject the rechargeable battery to strong shocks or drop it.
The rechargeable battery must not be disassembled, modified or short
circuited. Only use the supplied charger to charge the rechargeable batteries.
Do not remove battery compartment covers or other covers during use.
USB cable
Some custo med devices have a USB cable. This cable must not be kinked. Do
not step on the USB cable, only roll up the cable loosely and allow it to hang
freely during operation. Always hold the USB cable by the plug in order to
disconnect it from the PC.
Memory cards
Some custo med devices contain memory cards. custo med recommends that
you leave the supplied memory cards (if present) in the respective recorders to
ensure that they cannot get lost and to prevent dirt from entering the opening.
Do not insert or remove memory cards unless the device is switched off. The
supplied memory cards are only intended for the respective device. Do not use
the card to store any other data.
Only use the original memory card. Additional memory cards are available as
accessories.
Use the supplied memory card case to send in defective memory cards. If using
multiple recorders and/or memory cards, be careful not to confuse them.
1.2.3 Patient safety
Fig. 1: Safety distances at the patient area
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.
During examination or routine maintenance, do not touch non-medical
equipment and the patient at the same time (risk of electric shock). Make sure

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that the electrode contacts do not come into contact with other conductive
parts.
All results achieved by automatic analysis and the resulting 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.

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1.2.4 System and data security
IMPORTANT: Patient data must be handled in accordance with the legal
requirements of the respective country (this includes the General Data
Protection Regulation (GDPR)). custo diagnostic offers functions to help you
meet these requirements (e.g., user administration, password assignment).
Manufacturer’s note for users/customers for the integration of
programmable electronic medical systems (PEMS) into existing IT
networks
The custo med products and systems are programmable electronic medical
systems (PEMS). The integration of custo med products into an IT network that
includes other devices can lead to risks for patients, operators or third parties
that were not previously known. The responsible organisation should identify,
analyse, evaluate and control these risks. Subsequent changes to the IT
network can lead to new risks, and therefore require additional analysis.
Changes to the IT network include the following: Changes to the IT network
configuration, connecting additional items to the IT network, removing items
from the IT network, updates/upgrades of devices that are connected to the IT
network.
custo diagnostic
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 distributor.
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 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 printouts in other programs during the PDF printout in the connected
medical device.
If you use custo connect to integrate additional medical devices in the custo
med system, on starting the connected medical device check whether the
patient’s name was taken over correctly.

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Allocation of case and job numbers
If case or job numbers are manually entered into the system or they are
changed in the system, there is a risk of confusing patients and subsequent
misdiagnosis if an incorrect entry is made by a user. Always make sure that case
or job numbers are entered correctly!
Scanning or manually entering patient, case or job numbers does not relieve
the user of the obligation to check the patient to be physically treated.
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. Incorrect allocation can lead to
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 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.

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1.2.5 Information on EMC (Electromagnetic Compatibility)
The use of other accessories, other converters and leads than those indicated,
except for the converters and leads sold by custo med as spare parts for inner
components, can lead to increased electromagnetic emissions or to a reduced
electromagnetic immunity of the system. For connecting the device to other
equipment, only specially screened cables supplied by custo med must be
used.
1.2.6 Maintenance (regular safety checks)
The operator is responsible for maintenance.
Observe the legal regulations for checking electrical systems and equipment
(e.g., Regulation 3 “Accident Prevention Regulation” of the German Social
Accident Insurance (DGUV) in the Federal Republic of Germany).
The functionality and the state of accessories must be checked at regular
intervals. If damaged or heavily soiled, the complete system must no longer be
used.
After each system or device repair, modification or conversion, your authorised
custo med distributor must perform a safety and conformity assessment.

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1.3 Safety instructions for spirometry
If custo spiro mobile is transported at temperatures below freezing point, the
device must only be put into operation when it has reached ambient room
temperature. 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.
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.

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1.4 Residual risks spirometry
CAUTION
Cross
-contamination and falsification of measured values due to soiling in
the filter
→
Dispose of the custo spiro protect bacterial and viral filters after each
examination. Do not reuse!
CAUTION
Risk of contamination from used bacterial and viral filters
→
A custo spiro protect bacterial and viral filter may only be used for one
patient.
→
Dispose of the custo spiro protect bacterial and viral filter safely and
properly after the examination.

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2Hardware
2.1 Intended use
custo spiro mobile is a pulmonary function testing device designed for
measuring and evaluating a patient's pulmonary function. custo spiro mobile
measures respiratory flow rates and lung volumes and displays them
graphically in the software interface. The type and status of a lung disease can
be diagnosed on the basis of the derived measured values. The quality of the
evaluation depends largely on the patient's cooperation.
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 disablement). The system is intended for
use by trained specialist staff or physicians in clinics and medical practices.
Indications spirometry1)
Diagnosis
→To evaluate symptoms, signs, or abnormal laboratory test results
→To measure the physiologic effect of disease or disorder
→To screen individuals at risk of having pulmonary disease
→To assess preoperative risk
→To assess prognosis
Monitoring
→To assess response to therapeutic intervention
→To monitor disease progression
→To monitor patients for exacerbations of disease and recovery from
exacerbations
→To monitor persons for adverse effects of exposure to injurious agents
→To monitor for adverse reactions to medications with known pulmonary
toxicity
Disability/impairment evaluations
→To assess patients as part of a rehabilitation program
→To assess risks as part of an insurance evaluation
→To assess individuals for legal reasons
Other
→Research and clinical studies
→Epidemiological surveys
→Derivation of reference equations
→Preemployment and lung health monitoring for at-risk occupations
→To assess health status before beginning at-risk physical activities
1) Brian L. Graham et al.
Standardization of Spirometry
2019 Update, An Official
American Thoracic Society and
European Respiratory Society,
Technical Statement

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Relative contraindications spirometry1)
Due to increased myocardial stress or changes in blood pressure
→Acute myocardial infarction within one week
→Systemic hypotension or severe hypertension
→Significant atrial/ventricular arrhythmia
→Non-compensated heart failure
→Uncontrolled pulmonary hypertension
→Acute cor pulmonale
→Clinically unstable pulmonary embolism
→History of syncope related to forced expiration/cough
Due to increases in intracranial/intraocular pressure
→Cerebral aneurysm
→Brain surgery within four weeks
→Recent concussion with continuing symptoms
→Eye surgery within one week
Due to increases in sinus and middle ear pressures
→Sinus or middle ear surgery or infection within one week
Due to increases in intrathoracic and intraabdominal pressure
→Presence of pneumothorax
→Thoracic surgery within four weeks
→Abdominal surgery within four weeks
→Late-term pregnancy
Infection control issues
→Active or suspected transmissible respiratory or systemic infection,
including tuberculosis. Physical conditions predisposing to transmission of
infections, such as hemoptysis, significant secretions, or oral lesions or oral
bleeding.
Spirometry should be discontinued if the patient experiences pain during the
manoeuvre. Relative contraindications do not preclude spirometry but should
be considered when ordering spirometry. The decision to conduct spirometry is
determined by the ordering healthcare professional on the basis of their
evaluation of the risks and benefits of spirometry for the particular patient.
Potential contraindications should be included in the request form for
spirometry.

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2.2 Symbols on the devices and packaging
Manufacturer: custo med GmbH, Maria-Merian-Str. 6,
85521 Ottobrunn, Germany
Order number/designation
Lot designation
Serial number
Unique Device Identifier
Medical device
Date of manufacture (YYYY-MM, e.g., 2022-01)
CE mark
CE mark
Follow the Operating Manual!
Safety class classification of medical electrical equipment
according to DIN EN 60601-1 (Type BF)
Single-use article, do not reuse
Separate collection of electrical and electronic equipment, do not
dispose with domestic waste.

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2.3 Technical data and system requirements
custo spiro mobile
Measuring sensor
Differential pressure gauge with laminar element
Display of measured
values
BTPS (Body Temperature Pressure Saturated)
Measurement range
according to ISO 23747
1.00l/s
– 14.5 l/s
(peak expiratory flow)
Measurement range
according to ISO 26782
0l
– 8l
(time forced expired volume)
Error of measurement
according to ISO 23747
±3%
(peak expiratory flow)
Error of measurement
according to ISO 26782
3% or ±0,05l
(time forced expired volume)
Linearity
according to ISO 23747
1%
(peak expiratory flow)
Linearity
according to ISO 26782
3%
(time forced expired volume)
Repeatability
according to ISO 26782
0.02l
(time forced expired volume)
Flow resistance
according to ISO 23747
Maximum value: 0.21 kPa/l/s at 14.5 l/s
(peak expiratory flow)
Flow resistance
according to ISO 26782
Maximum value: 0.17 kPa/l/s at 7.0
l/s
Average value: 0.14 kPa/l/s
(time forced expired volume)
Frequency response
Maximum value 9%
Time zero
Time zero is determined by the back
-extrapolation
method
Resting breathing detection
> 300 ml
End of measurement detection
< 150 ml/sec for 5 sec
Resolution
12 Bit
Power supply
USB (Universal Serial Bus),
Standard USB port on the PC
Dimensions
140 * 150 * 45 mm (L * B * H)
Weight
approx. 330 g
Operating conditions
Temperature +10°C ... +40°C
Humidity 10 ... 95 % rH
Air pressure 700 ... 1060 hPa
Transport and storage conditions
Temperature
-20°C ... +45°C
Humidity 10 ... 95 % rH
Air pressure 700 ... 1060 hPa
Only for storage in a medical environment, under
consideration of the conditions mentioned here.
Classification
Protection class I
I
Type BF
Class IIa
Applied standards
DIN EN ISO 13485, DIN EN ISO 14971, DIN EN 1041,
DIN
EN ISO 15223-1, DIN EN 60601-1, DIN EN 60601-1-2,
DIN
IEC 60601-1-6, DIN EN 62304, DIN EN 62366-1,
DIN
EN ISO 10993-1, DIN EN ISO 26782, DIN EN ISO 23747,
DIN
EN ISO 10993-10, ISO 10993-5

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General system requirements
Operating system
The custo diagnostic software is only suitable for
installation on Microsoft Windows systems.
custo diagnostic 5 is a client/server combination. The
custo diagnostic 5 ser
ver can only run on 64-bit systems.
For proper operation it is necessary to use the operating
system/software combinations tested and approved by
custo med for the respective custo diagnostic version
(also custo diagnostic server and client for custo
diagn
ostic 5). These can be obtained from the authorised
custo med dealer or directly from custo med.
PC
The PC’s hardware must be compatible with Intel
products and fulfil the minimum requirements for the
operating system used.
Provide additional RAM (1
GB) for custo diagnostic. Ensure
that there is sufficient free space on the hard disk for the
custo diagnostic evaluations.
The PC must meet the requirements of the safety
standard DIN EN 62368 for information technology
equipment.
File sizes of the
evaluations
Holter: approx. 15 MB (max. 60 MB)
ABPM: approx. 128 KB (max. 512 KB)
Holter
-ABPM: approx. 20 MB (max. 25 MB)
Resting ECG: approx. 200 KB (for an ECG of approx. 10
sec.)
Stress ECG: approx. 6 MB (for an ECG of approx. 20 min.)
CPET: refer to st
ress ECG
Spirometry: approx. 50 KB (max. 256 KB)
Rehab: approx. 6 MB (for approx. 45 min. of exercise)
Hardware & ports
DVD or CD
-ROM drive
USB connection
For
Spirometry with custo spiro
mobile:
If working with the option animation for children, use a
second screen to display the animation.