Care Fusion Micro I User manual

Micro I
Diagnostic
Spirometer
Operating Manual – English
Operating Manual – CareFusion USA
Mode d’emploi - Français
edienungsanleitung - Deutsch
Manual de funcionamiento – Español
Manual de Instruções do - Português
Gebruikshandleiding – Nederlands

1
Contents
I. Introduction – English .......................................................9
Package contents.............................................................10
Contraindications, Warnings and Cautions...........................11
Intended Use...................................................................12
Environment....................................................................12
Getting Started................................................................12
Configuration ..................................................................13
Micro I PC Software..........................................................14
Operation .......................................................................18
Main Menu Overview ........................................................18
Quick Exam.....................................................................19
Exam with Predicted values...............................................21
Post D Exam..................................................................24
NLHEP Mode....................................................................24
NLHEP Quality Checks ......................................................25
NLHEP QC Grades ............................................................26
NLHEP Interpretation........................................................26
Switching Off...................................................................27
Maintenance....................................................................27
attery Management ........................................................27
attery Replacement ........................................................28
Calibration Check.............................................................30
Cleaning the Transducer ...................................................31
Servicing ........................................................................31
Trouble Shooting Information ............................................32
Electromagnetic Compatibility (EMC)..................................32
Safety Designation per IEC60601-1....................................33
Symbols .........................................................................34
Specification of the Micro I ................................................36
Accessories .....................................................................37
Customer Contact Information......................................... 212

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Contents
II. Introduction – CareFusion USA........................................38
Package contents.............................................................39
Contraindications, Warnings and Cautions...........................40
Intended Use...................................................................41
Environment....................................................................41
Getting Started................................................................41
Configuration ..................................................................42
Micro I PC Software..........................................................43
Operation .......................................................................47
Main Menu Overview ........................................................47
Quick Exam.....................................................................48
Exam with Predicted values...............................................50
Post D Exam..................................................................53
NLHEP Mode....................................................................53
NLHEP Quality Checks ......................................................54
NLHEP QC Grades ............................................................55
NLHEP Interpretation........................................................55
Switching Off...................................................................56
Maintenance....................................................................56
attery Management ........................................................56
attery Replacement ........................................................57
Calibration Check.............................................................59
Cleaning the Transducer ...................................................60
Servicing ........................................................................60
Trouble Shooting Information ............................................61
Electromagnetic Compatibility (EMC)..................................61
Safety Designation per IEC60601-1....................................62
Symbols .........................................................................63
Specification of the Micro I ................................................65
Accessories .....................................................................66
Customer Contact Information......................................... 212

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Table des matières
III. Introduction - Français....................................................67
Contenu de l'emballage ....................................................68
Contre-indications, avertissements et mises en garde ..........69
Utilisation .......................................................................70
Conditions d'utilisation......................................................70
Première utilisation ..........................................................70
Configuration ..................................................................71
Logiciel Micro I PC Software ..............................................72
Fonctionnement...............................................................76
Présentation du menu principal..........................................76
Examen rapide ................................................................77
Examen à l'aide de valeurs prédites ...................................79
Examen Post D ..............................................................82
Mode NLHEP....................................................................82
Contrôles qualité NLHEP ...................................................83
Niveaux de qualité NLHEP .................................................84
Interprétation NLHEP........................................................84
Mise hors tension.............................................................85
Entretien.........................................................................85
Entretien de la batterie.....................................................85
Remplacement de la batterie.............................................86
Contrôle de l'étalonnage ...................................................88
Nettoyage du transducteur................................................89
Réparation ......................................................................89
Dépannage .....................................................................90
Compatibilité électromagnétique (CEM) ..............................90
Classification selon la norme CEI 60601-1...........................91
Symboles........................................................................92
Caractéristiques du Micro I................................................94
Accessoires .....................................................................95
Coordonnées du service client ......................................... 212

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Inhalt
IV. Einführung – Deutsch......................................................96
Packungsinhalt ................................................................97
Kontraindikationen, Warn- und Vorsichtshinweise ................98
Verwendungszweck..........................................................99
Umgebungsbedingungen...................................................99
Inbetriebnahme ...............................................................99
Konfiguration ................................................................ 100
Micro I PC Software........................................................ 101
etrieb ......................................................................... 105
Übersicht Hauptmenü ..................................................... 105
Schnelluntersuchung ...................................................... 106
Untersuchung mit Prognosewerten................................... 108
Untersuchung nach ronchodilatator ................................ 111
NLHEP-Modus................................................................ 111
NLHEP-Qualitätsprüfungen (QC)....................................... 112
NLHEP QC-Stufen........................................................... 113
NLHEP-Interpretation ..................................................... 113
Ausschalten des Gerätes................................................. 114
Instandhaltung .............................................................. 114
atteriemanagement...................................................... 114
atterieaustausch .......................................................... 115
Kalibrationsprüfung........................................................ 117
Reinigen des Transducers ............................................... 118
Wartung ....................................................................... 118
Informationen zur Fehlerbehebung................................... 119
Elektromagnetische Verträglichkeit (EMV)......................... 119
Sicherheitsbestimmungen gemäß IEC60601-1................... 120
Symbole ....................................................................... 121
Spezifikationen des Micro I.............................................. 123
Zubehör........................................................................ 124
Kundendienst-Kontaktadressen........................................ 212

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Contenido
V. Introducción - Español .................................................. 125
Contenido del envase ..................................................... 126
Contraindicaciones, advertencias y precauciones................ 127
Uso indicado.................................................................. 128
Entorno ........................................................................ 128
Para comenzar............................................................... 128
Configuración ................................................................ 129
Micro I PC Software........................................................ 130
Funcionamiento ............................................................. 134
Descripción general del menú principal ............................. 134
Examen rápido .............................................................. 135
Examen con valores previstos.......................................... 137
Examen Post D ............................................................ 140
Modo NLHEP.................................................................. 140
Revisiones de calidad del NLHEP ...................................... 141
Niveles de CC del NLHEP................................................. 142
Interpretación del NLHEP ................................................ 142
Desconexión.................................................................. 143
Mantenimiento............................................................... 143
Gestión de la batería ...................................................... 143
Cambio de la batería ...................................................... 144
Comprobación de la calibración........................................ 146
Limpieza del transductor................................................. 147
Reparaciones................................................................. 147
Información sobre resolución de problemas....................... 148
Compatibilidad electromagnética (CE) .............................. 148
Designación de seguridad según IEC60601-1 .................... 149
Símbolos....................................................................... 150
Especificaciones del Micro I ............................................. 152
Accesorios..................................................................... 153
Información de contacto para el cliente ............................ 212

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Índice
VI. Introdução - ortuguês ................................................. 154
Conteúdo da Embalagem ................................................ 155
Contra-indicações, Avisos e Cuidados ............................... 156
Utilização Prevista.......................................................... 157
Ambiente ...................................................................... 157
Primeira Utilização ......................................................... 157
Configuração ................................................................. 158
Micro I PC Software........................................................ 159
Funcionamento.............................................................. 163
Descrição Geral do Menu Principal.................................... 163
Exame Rápido ............................................................... 164
Exame com Valores Previstos .......................................... 166
Exame Pós- D............................................................... 169
Modo NLHEP.................................................................. 169
Controlos de Qualidade NLHEP......................................... 170
Grau de CQ do NLHEP..................................................... 171
Interpretação NLHEP ...................................................... 171
Desligar........................................................................ 172
Manutenção .................................................................. 172
Manutenção das Pilhas.................................................... 172
Substituição das Pilhas ................................................... 173
Teste de Calibração........................................................ 175
Limpeza do Transdutor ................................................... 176
Assistência técnica ......................................................... 176
Informações sobre Resolução de Problemas ...................... 177
Compatibilidade Electromagnética (CEM) .......................... 177
Designação de Segurança segundo a norma IEC60601-1 .... 178
Símbolos....................................................................... 179
Especificações do Micro I ................................................ 181
Acessórios..................................................................... 182
Informação de Apoio ao Cliente ....................................... 212

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Inhoud
VII. Inleiding - Nederlands .................................................. 183
Inhoud van de verpakking............................................... 184
Contra-indicaties, Waarschuwingen en aandachtspunten..... 185
eoogd gebruik ............................................................. 186
Gebruiksomgeving ......................................................... 186
Aan de slag ................................................................... 186
Configuratie .................................................................. 187
Micro I pc-software ........................................................ 188
ediening...................................................................... 192
Overzicht hoofdmenu ..................................................... 192
Snel onderzoek.............................................................. 193
Onderzoek met voorspelde waarden................................. 195
Postbronchodilatoronderzoek........................................... 198
NLHEP-modus................................................................ 198
Kwaliteitscontroles NLHEP............................................... 199
Classificatie kwaliteitscontroles NLHEP.............................. 200
Interpretatie NLHEP ....................................................... 200
Uitschakelen.................................................................. 201
Onderhoud.................................................................... 201
atterijbeheer ............................................................... 201
atterij vervangen ......................................................... 202
Kalibratiecontrole........................................................... 204
De transducer reinigen ................................................... 205
Reparatie...................................................................... 205
Informatie over probleemoplossing .................................. 206
Elektromagnetische compatibiliteit (EMC) ......................... 206
Veiligheidsaanduiding volgens IEC60601-126 .................... 207
Symbolen ..................................................................... 208
Specificatie van de Micro I .............................................. 210
Hulpstukken.................................................................. 211
Contactinformatie voor klanten........................................ 212

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9
Micro I
Diagnostic
Spirometer
Operating Manual – English

9
I. Introduction
The Micro I is a compact, rechargeable battery operated and fully
portable diagnostic spirometer. It is accurate to the requirements of
the ATS/ERS TASK FORCE: STANDARDISATION OF LUNG FUNCTION
TESTING 2005. Its ergonomic and user-friendly design allows
diagnostic spirometry measurements, including predicted values and
automatic interpretation, to be made quickly and simply.
The Micro I features include:
oMeasures FEV1, FVC(FEV6), FEV1/FVC, FEV1/FEV6, PEF,
FEF25, FEF75, and FEF 25-75
oFully configurable using software supplied
oECCS, Asian or NHANES III predicted values
oVariation from norm as percentage or Z-score
oNLHEP, NICE, or the ATS/ERS interpretation
oSpirometry manoeuvre quality checks
oPost bronchodilator comparison
oNLHEP compliant mode
The spirometer uses the CareFusion Digital Volume Transducer, an
extremely stable form of volume transducer, which measures
expired air directly at .T.P.S ( ody Temperature and Pressure with
Saturated water vapour) thus avoiding the inaccuracies of
temperature corrections. This transducer is insensitive to the effects
of condensation and temperature and avoids the need for individual
calibration prior to performing a test.
CareFusion can supply spirometers to fulfil all your diagnostic and
monitoring spirometry needs. The Micro II spirometer is the sister
spirometer to the Micro I specifically designed for monitoring of
asthma and COPD either at home or in the work place.

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ackage Contents
The Micro I is packaged in a convenient carrying case and comes
complete with the following items (Fig.1):
1. Micro I spirometer
2. CareFusion Digital Volume Transducer together with
disposable cardboard mouthpieces and instruction manual.
3. Universal power supply (36-PSU1017 5VDC 1.2A)
4. Cardboard mouthpiece adapter
5. US /Charging cable
Fig 1

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Contraindications, Warnings and Cautions
Contraindications: As performing spirometry might be physically
demanding, it is contraindicated in patients with recent myocardial
infarction. Also extensive exhalation might lead to syncope.
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.
lease Note: Important information for avoiding damage to the
instrument or facilitating operation of the instrument.
CAUTION: Read the manual before use
WARNING: The instrument is not suitable for use in the presence of
explosive or flammable gases, flammable 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 filters are single patient use. If used on more
than one patient there is a risk of cross-infection. Repeat use may
also increase air resistance and lead to an incorrect measurement.
CAUTION: Do not allow the patient to handle the spirometer when
connected to either the power supply for charging or to a PC when
configuring the unit.
PLEASE NOTE: The product you have purchased should not
be disposed of as unsorted waste. Please utilise your local
WEEE collection facilities for the disposal of this product.

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Intended Use
The Micro I is used by clinicians and healthcare professionals for the
diagnosis of asthma and COPD in adults and children over the age of
3 years.
Environment
Please observe the following precautions:
•Avoid exposing the Micro I to direct sunlight.
•Avoid operating the spirometer in dusty conditions or near to
heating appliances or radiators.
•Do not keep the spirometer in a damp place or expose it to
extreme temperatures.
•Do not direct the transducer holder towards a strong light
source whilst operating the spirometer.
Getting Started
It is recommended that Micro I spirometer is fully charged before
use. The power supply is provided with separate UK, USA and
European plugs. Connect the required plug to the power supply and
plug in to a mains outlet. Connect the Micro I to the power supply
using the US /charging cable and the charging symbol will appear
on the screen.
Fully charge for a minimum of 5 hours when used for the first
time.
Remove the protective film from the display screen before use.

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Configuration
When the unit is first turned on it may be configured for your region.
This will set the language, height and weight units, date format and
predicted values set appropriate for your region. It will also
configure the indices to be displayed and whether percentage
predicted or Z-score is to be used to show variation from the norm.
However all of these settings may be customised using the PC
software supplied.
Turn the unit on by pressing the on/off button located at the top of
the device and the following will be displayed:
Use the up and down arrow keys to highlight the required country
and then press ‘Enter’ (↵). This procedure is only required when the
unit is first switched on and the selection will be stored for future
use.
It is recommended that the PC software be used to adjust these
settings, if required. Connect Micro I to the PC using the US cable
supplied. Run the software, and turn on the Micro I. The PC
software will detect that the Micro I is connected. Follow the on-
screen instructions to configure your unit.

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Micro I C Software
This software allows you to customise the settings on your Micro I
spirometer. Once successfully installed, comprehensive help is
available through the Help menu when using the application.
System Requirements
Micro I PC Software requires certain hardware and software
components in order to run properly.
C Requirements
An I M-compatible PC is required, with hardware that meets or
exceeds the following minimum requirements.
Processor: 800 MHz or above
RAM: 256 M
Free Disk Space: 50 M
Video: 800x600, 256 colours. It is recommended that a resolution of
at least 1280x1024 be used to enable the full benefits of the multi-
window interface.
At least one free US port. (An additional US port will be required
for US enabled spirometers)
Operating System Requirements
Micro I PC Software will run on the following operating systems:
Windows XP
Windows Vista 32bit
Windows Vista 64bit
Windows Server 2003
Windows Server 2008

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Installing Micro I C Software
efore you begin, please ensure your computer meets the minimum
system requirements and the user installing the software has
administrative user rights.
Close any other applications that are running.
Insert the installation CD into your CD-Rom drive.
The setup program should launch automatically, displaying the
welcome dialog box, click ‘Next’ to continue. If the setup program
does not launch automatically use Windows Explorer to manually
select the CD drive then open the file named Micro I PC
Software.exe.
The license agreement will be displayed. Please read the complete
document and ensure you understand fully before accepting the
terms of the license. Click ‘Next’ to continue.
The select destination location dialog will be displayed showing the
directory where the Micro I PC Software will be installed. The default
location is:
C:\Program Files\CareFusion\Micro I PC Software
To change this location select ‘ rowse’.
Click ‘Next’ to display the Select program manager group dialog.
This will be the location where the Micro I PC Software launch icon
will be placed under the Start Menu. Either a new location can be
entered or an existing location used.
Click ‘Next’ to display the installation options dialog containing the
following option:
Add Micro I PC Software icon to the desktop.
Click ‘Next’ to start copying the files to your system.
Once the files have finished copying to your system you will be
advised that the Micro I PC Software has been successfully installed

16
and that it would be advisable to restart your PC before using the
application. Click ‘Finish’ to complete the installation process.
Running Micro I C software
Connect your Micro I to a US port on the PC using the cable
provided. The Micro I will take power from the US port on the PC.
Please be advised that the Micro I requires a High Current US port,
and if connected to a Low Power US port the device will turn itself
off and fail to respond to any key presses until disconnected. Low
Power US ports are commonly found on keyboards and unpowered
US hubs and should not be used. Whilst connected to the PC the
Micro I will display:
Do not allow the patient to handle the spirometer during this
procedure.

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Run the Micro I PC software and the first screen will show:
From this screen you can either change the device settings or adjust
the Micro I internal clock. When the change settings options is used
the display will change to:
y selecting the ‘Custom’ option at the top of the screen all of the
Micro I features may be tailored to you specific requirements.