Vyaire MicroLab User manual

MicroLab
Operating Manual – English
Operating Manual – USA
Manuel d‘utilisation – Français
Betriebshandbuch – Deutsch
Manual de funcionamiento – Español
Manual de Operação – Português
Gebruiksaanwijzing – Nederlands

Contents
I. Introduction - English .............................................. 11
Contraindications .................................................................12
Warnings and Cautions..........................................................12
Overview.............................................................................14
Indication for Use .................................................................15
Getting Started ....................................................................16
Calibration Check (Verication)...............................................26
Customisation......................................................................28
Administration Mode .............................................................30
Paper Loading ......................................................................31
Switching Off .......................................................................32
Charging Procedure ..............................................................32
PC connection using SPCS .....................................................33
Looking after your Spirometer................................................34
Product Lifetime ...................................................................34
Disinfection with Perasafe ......................................................34
Cleaning Instructions ............................................................35
Servicing.............................................................................37
Trouble Shooting Information .................................................38
Safety Designation per IEC 60601-1 .......................................40
Electromagnetic Compatibility (EMC) to IEC 60601-1-2..............42
Symbols..............................................................................47
Specication of the MicroLab..................................................48
Spirometry Measurements .....................................................49
Consumables/ Accessories .....................................................52
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II. Introduction – English - USA.................................... 58
Contraindications .................................................................59
Warnings and Cautions..........................................................59
Overview.............................................................................61
Indication for Use .................................................................62
Getting Started ....................................................................63
Calibration Check (Verication)...............................................73
Customization......................................................................75
Administration Mode .............................................................77
Paper Loading ......................................................................78
Switching Off .......................................................................79
Charging Procedure ..............................................................79
PC connection using SPCS .....................................................80
Looking after your Spirometer................................................81
Product Lifetime ...................................................................81
Disinfection with Perasafe ......................................................81
Cleaning Instructions ............................................................82
Servicing.............................................................................84
Trouble Shooting Information .................................................85
Safety Designation per IEC 60601-1 .......................................87
Electromagnetic Compatibility (EMC)
to IEC 60601-1-2 .................................................................89
Symbols..............................................................................94
Specication of the MicroLab..................................................95
Spirometry Measurements:....................................................96
Consumables/ Accessories .....................................................99
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III. Introduction - Français .......................................... 104
Contre-indications .............................................................105
Avertissements et mises en garde.........................................105
Présentation ......................................................................107
Indications d’utilisation........................................................108
Démarrage ........................................................................109
Vérication de l’étalonnage ..................................................119
Personnalisation .................................................................121
Mode d’Administration.........................................................123
Chargement du Papier.........................................................124
Mise hors tension ...............................................................125
Procédure de chargement de la batterie.................................125
Connexion au PC à l’aide de SPCS.........................................126
Prendre soin du MicroLab.....................................................127
Durée de vie du produit.......................................................127
Décontamination avec Perasafe ............................................127
Instructions de nettoyage ....................................................128
Entretien...........................................................................131
Diagnostic des pannes.........................................................131
Certicat de sécurité selon la norme CEI 60601-1 ...................134
Compatibilité électromagnétique (CEM) à la norme IEC 60601-1-2.
136
Symbols............................................................................141
Spécications du MicroLab ...................................................142
Mesures de spirométrie ......................................................143
Consommables/Accessoires .................................................146
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IV. Einführung - Deutsch ............................................. 151
Gegenanzeigen .................................................................152
Warn- und Vorsichtshinweise................................................152
Übersicht...........................................................................154
Zweckbestimmung..............................................................155
Startanleitung....................................................................156
Kalibrationsprüfung.............................................................166
Individuelle Konguration ....................................................168
Verwaltungsmodus .............................................................170
Papier einlegen ..................................................................171
Ausschalten .......................................................................172
Akku laden ........................................................................172
Anschluss an einen PC mit SPCS Software..............................173
Pege des MicroLab ............................................................174
Produktlebensdauer ............................................................174
Desinfektion mit Perasafe ....................................................174
Reinigungsanleitung............................................................175
Wartung............................................................................178
Informationen zur Fehlerbehebung .......................................178
Sicherheitsbezeichnung gemäß IEC 60601-1 ..........................181
Elektromagnetische Verträglichkeit (EMV) gemäß IEC60601-1-2 ....
183
Symbole............................................................................188
Spezikationen des MicroLab................................................189
Spirometrie-Messungen: .....................................................190
Verbrauchsartikel/Zubehör...................................................193
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V. Introducción - Español........................................... 198
Contraindicaciones ............................................................199
Advertencias y precauciones ................................................199
General.............................................................................201
Instrucciones de uso ...........................................................202
Cómo comenzar .................................................................203
Vericar la calibración .........................................................213
Personalización ..................................................................215
Modo Administración...........................................................217
Carga de papel...................................................................218
Apagado............................................................................219
Procedimiento de Carga de Baterías ......................................219
Conexión a PC utilizando SPCS .............................................220
Recuerde en su Espirómetro.................................................221
Duración del producto .........................................................221
Desinfección con Perasafe....................................................221
Instrucciones de limpieza ....................................................222
Servicio.............................................................................225
Información de solución de problemas ..................................225
Designación de seguridad conforme a IEC 60601-1 .................228
Compatibilidad electromagnética (CEM) con IEC60601-1-2.......230
Símbolos ...........................................................................235
Especicaciones del MicroLab ...............................................236
Espirometría mediciones......................................................237
Consumibles/Accesorios ......................................................240
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VI. Introdução - Português.......................................... 245
Contraindicações ...............................................................246
Avisos e Cuidados...............................................................246
Visão Geral........................................................................248
Indicações de Utilização ......................................................249
Iniciando...........................................................................250
Vericação da Calibração .....................................................260
Conguração......................................................................262
Modo Administração............................................................264
Colocação de Papel .............................................................265
Desligar ............................................................................266
Procedimento de Carga .......................................................266
Conexão do PC com o SPCS .................................................267
Cuidados com o Espirômetro................................................268
Vida útil do produto ............................................................268
Desinfeção com Perasafe .....................................................268
Instruções de Limpeza ........................................................269
Manutenção.......................................................................272
Informações sobre Resolução de Problemas ..........................272
Designação de Segurança de acordo com IEC 60601-1 ............275
Compatibilidade Eletromagnética (CEM) de acordo com IEC 60601-
1-2...................................................................................277
Símbolos ...........................................................................282
Especicações do MicroLab ..................................................283
Medidas da Espirometria: ....................................................284
Consumíveis/Acessórios ......................................................287
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VII. Inleiding - Nederlands ........................................... 292
Contra-indicaties ...............................................................293
Waarschuwingsberichten .....................................................293
Overzicht ..........................................................................295
Indicatie voor gebruik .........................................................296
Starten .............................................................................297
Kalibratiecontrole ...............................................................307
Aanpassen aan de wensen van de klant.................................309
Administratie-modus...........................................................311
Papierinvoer ......................................................................312
Uitschakelen ......................................................................313
Laadprocedure ...................................................................313
PC-aansluiting met behulp van SPCS.....................................314
Onderhoud van uw spirometer .............................................315
Productlevensduur..............................................................315
Desinfecteren met Perasafe..................................................315
Reinigingsinstructies ...........................................................316
Service .............................................................................319
Problemen oplossen ..........................................................319
Veiligheidsaanduiding volgens IEC 60601-1............................322
Elektromagnetische compatibiliteit (EMC) volgens IEC 60601-1-2 ..
324
Symbolen..........................................................................329
Specicatie van de MicroLab ................................................330
Spirometrie Afmetingen.......................................................331
Verbruiksartikelen/accessoires..............................................334
9

10

MicroLab
Operating manual
I. Introduction - English
The MicroLab is mains/battery operated portable spirometer with the
unique combination of ease of use and sophistication. Ease of use is
assured through the use of context sensitive help screens, accessed
at a touch of a button, that explain every MicroLab feature.
The MicroLab uses the Vyaire Digital Volume Transducer, an
extremely stable form of volume transducer, which measures
expired air directly at B.T.P.S (Body Temperature and Pressure
with Saturated water vapour) thus avoiding the inaccuracies of
temperature corrections. The transducer is insensitive to the effects
of condensation and temperature and avoids the need for individual
calibration prior to performing a test.
Test results may be uploaded to a PC using the optional Spirometry
PC Software (SPCS) and patient details may be downloaded to the
MicroLab.
Stored data may be printed to the integral thermal printer or to an
external HP printer using the USB cable supplied.
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Contraindications
It is recommended that patients should not be tested within 1
month of a myocardial infarction.
Conditions where suboptimal spirometry are likely:
• chest or abdominal pain
• oral or facial pain exacerbated by a mouthpiece
• stress incontinence
• dementia or confusional state
Ref: ATS/ERS Task Force: Standardisation of Lung Function
Testing. General considerations for lung function testing.
M. Miller et al. Eur Resp J 2005:26. 153-161
Warnings and Cautions
The following terms are used as follows in this manual
CAUTION: Possibility of injury or serious damage
WARNING: conditions or practices that could result in personal
injury
Note: Important information for avoiding damage to the
instrument or facilitating operation of the instrument.
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Note: Patients below 4 years of age may struggle to perform
spirometry correctly and reproducibly.
Note: The device should only be used by trained and qualied
personnel.
13
CAUTION: Read the manual before use
WARNING: The instrument is not suitable for use in the
presence of explosive or ammable gases, ammable
anaesthetic mixtures or in oxygen rich environments.
CAUTION: Mouthpieces are single patient use. If used on more
than one patient there is a risk of cross-infection. Repeat use
may degrade materials and lead to an incorrect measurement.”
CAUTION: Pulmonary lters are single patient use. If used
on more than one patient there is a risk of cross-infection.
Repeat use may increase air resistance and lead to an incorrect
measurement.”
PLEASE NOTE: The product and the battery you have
purchased should not be disposed of as unsorted waste.
Please utilise your local WEEE collection facilities for the
disposal of this product.
PLEASE NOTE: Degree of protection against Ingress of Water is
IPX0
WARNING: To avoid risk of electric shock, this equipment must
only be connected to a supply mains with protective earth
WARNING: Do not connect devices that are not specied as
part of the system.

Overview
When the unit is turned on for the rst
time the system customise menu is
displayed. Touch the name of the
required region with the stylus stored on
the left hand side of the unit and then
touch ‘Finish’. This will set the regional
defaults including language, if available.
If this screen is not displayed then touch
the ‘Customise’ icon on the main menu
followed by the ‘System’ icon.
The MicroLab uses a touch screen with
icons representing each function available.
A stylus, housed in the left hand side of the
unit, is provided for icon screen activation.
Touch the displayed time to adjust time
and date. Touch the toolbox icon to adjust
volume and brightness.
Unused icons may be disabled by touching
the blue background and selecting from
the list displayed.
Four levels of battery charge are indicated
by the segmented battery icon. When
this icon turns red the battery is nearly
exhausted and the batteries must be
charged – see Charging Procedure.
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The complete functionality is described on
the help screen.
This is obtained by pressing the help
button (?).
Help text exists for every screen viewed
during the operation of the MicroLab.
You are recommended to make full use of
the extensive Help screens provided.
Indication for Use
The MicroLab spirometer is intended, for prescription use only, to
measure the maximal volume and ow of air that can be moved in
and out of a patient’s lungs and for pulse oximetry measurements.
The system is intended for use with paediatric (4 to 17 years)
and adult (18 to 99 years) patients in hospitals, physician ofces,
laboratories and occupational health testing environments.
The optional Nonin IPOD®Integrated Pulse Oximetry Device is
designed to measure pulse rate and oxygen saturation in adult
patients. The sensor is designed for use on the ngers of patients
weighing more than 30 kilograms, where the nger tissue is
between 5 and 21 millimeters.
Note: Pulse Oximetry is an optional measurement mode. Therefore
the sensor for pulse oximetry measurements is not part of the
standard MicroLab package and needs to be purchased separately.
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Getting Started
When performing a spirometry test the
recommended workow is to enter the
patient’s details, or retrieve them from
memory, perform the required test and
then print and save the results.
Please ensure that the turbine
transducer, is plugged in to either of the
rst two sockets on the right hand side of
the instrument.
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Touch the ‘Patients’ icon to enter the
patient database.
The required patient may be selected
from the stored patient list.
If the patient details have not been
previously stored then touch Add to enter
the new patient’s details. The patient
details may also be downloaded from the
optional SPCS software.
Once selected, the patient’s name will
appear at the bottom of the screen.
Use the help button to obtain further
information.
To add a patient to the database use the
on screen keyboard to type a unique
patient ID and then touch the enter key.
You will then be prompted for Last Name,
First Name, Sex, Ethnic Origin, Height,
Weight, date of Birth and Factor.
A factor can be applied when testing
individuals of other ethnic origins who
would not normally be tested against
the countries set of predicted values eg
ECCS predicted values are used but Non
Caucasian individuals tested. The factor
alters the predicted value set on volume
indices by the percentage applied.
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The following factors are recommended when using ECCS normal
values:
Hong Kong Chinese 100%
Japanese American 89%
Polynesians 90%
North Indians and Pakistanis 90%
South Indians and those of African descent 87%
Ref: Lung Volumes and Forced Ventilatory Flows. P.H.Quanjer et al.
Eur Respir J, 1993, 6, Suppl. 16p5-40
Once all the patient details are added the
patient is added to the database and the
main menu is displayed with the patient
name displayed at the bottom of the
screen.
From the main menu select the required
test, by touching the icon with the stylus.
If the displayed patient is not required for
testing then touch the patients name and
options to change or remove the current
patient will become available.
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If Relaxed Spirometry is selected then
a volume/time graph will be displayed.
Note that the unit may be customised to
perform a relaxed Vital Capacity with tidal
breathing or from a single expiration or
single inspiration.
When a manoeuvre has been obtained
touch ‘Results’ to view the indices, ‘Again’
to repeat the manoeuvre, ‘Reject’ to
delete the manoeuvre or ‘Done’ to end
the test.
All the active indices are displayed for
any of the manoeuvres selected together
with an option to review the volume/
time curves. The active indices listed can
be changed by using the customisation
option.
Select ‘Done’ to proceed to the Spirometry
Main Menu.
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From this menu the results of the test
may be viewed, saved, or printed and
notes may be added.
It is also possible to proceed to a forced
baseline spirometry test, or a post
medication relaxed spirometry test.
Select ‘Exit’ when all the required
functions have been used.
If forced spirometry is selected the default
graph will be displayed. This may be
changed by touching the arrows at the top
of the screen. Flow/Volume, Volume/time
or child incentive default displays may be
selected using the customise option from
the main menu.
When the spirometry manoeuvre has
been completed options to repeat the
test, reject the test, and view results will
be available.
At the end of the test options to view
results, save results, print results, and
to add notes will be available from the
spirometry main menu.
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