CareFusion Micro I Operating Manual
Micro I
Diagnostic
Spirometer
Operating Manual – English
Operating Manual – CareFusion USA
Mode d’emploi - Français
Bedienungsanleitung - Deutsch
Manual de funcionamiento – Español
Manual de Instruções - Português
Gebruikshandleiding – Nederlands
1
Contents .............................................................. 1
I Introduction ..................................................................... 9
Package Contents ........................................................... 10
Contraindications, Warnings and Cautions .......................... 11
Intended Use ................................................................. 13
Environment .................................................................. 13
Getting Started............................................................... 13
Configuration ................................................................. 14
Micro I PC Software......................................................... 15
Operation ...................................................................... 20
Main Menu Overview ....................................................... 20
Quick Exam.................................................................... 21
Exam with Predicted Values.............................................. 23
Post BD Exam ................................................................ 27
NLHEP Mode................................................................... 27
NLHEP Quality Checks ..................................................... 28
NLHEP QC Grades ........................................................... 29
NLHEP Interpretation....................................................... 29
Switching Off ................................................................. 30
Maintenance................................................................... 30
Battery Management ....................................................... 30
Battery Replacement ....................................................... 31
Calibration Check............................................................ 33
Cleaning Instructions....................................................... 34
Cleaning the Transducer .................................................. 35
Servicing ....................................................................... 35
Trouble Shooting Information ........................................... 36
Safety Designation per IEC 60601-1 .................................. 37
Electromagnetic Compatibility (EMC) to EN60601-1:2007 .... 39
Symbols ........................................................................ 44
Specifications of the Micro I.............................................. 46
Consumables & Accessories.............................................. 47
2
Contents .............................................................. 9
II. Introduction – CareFusion USA ......................................... 49
Package Contents ........................................................... 50
Contraindications, Warnings and Cautions .......................... 51
Intended Use ................................................................. 53
Environment .................................................................. 53
Getting Started............................................................... 53
Configuration ................................................................. 54
Micro I PC Software......................................................... 55
Operation ...................................................................... 60
Main Menu Overview ....................................................... 60
Quick Exam.................................................................... 61
Exam with Predicted Values.............................................. 63
Post BD Exam ................................................................ 67
NLHEP Mode................................................................... 67
NLHEP Quality Checks ..................................................... 68
NLHEP QC Grades ........................................................... 69
NLHEP Interpretation....................................................... 69
Switching Off ................................................................. 70
Maintenance................................................................... 70
Battery Management ....................................................... 70
Battery Replacement ....................................................... 71
Calibration Check............................................................ 73
Cleaning Instructions....................................................... 74
Cleaning the Transducer .................................................. 75
Servicing ....................................................................... 75
Trouble Shooting Information ........................................... 76
Safety Designation per IEC 60601-1 .................................. 77
Electromagnetic Compatibility (EMC) to EN60601-1:2007 .... 79
Symbols ........................................................................ 84
Specifications of the Micro I.............................................. 86
Consumables & Accessories.............................................. 87
3
Table des matières .......................................... 88
III. Introduction ................................................................... 89
Contenu de l'emballage.................................................... 90
Contre-indications, avertissements et mises en garde .......... 91
Utilisation prévue............................................................ 93
Conditions d'utilisation..................................................... 93
Première utilisation ......................................................... 93
Configuration ................................................................. 94
Logiciel Micro I PC Software.............................................. 95
Fonctionnement.............................................................100
Présentation du menu principal ........................................100
Examen rapide ..............................................................101
Examen à l'aide de valeurs prédites..................................103
Examen Post BD ............................................................107
Mode NLHEP..................................................................107
Contrôles qualité NLHEP..................................................108
Niveaux de qualité NLHEP ...............................................109
Interprétation NLHEP......................................................109
Mise hors tension...........................................................110
Entretien ......................................................................110
Entretien de la batterie ...................................................110
Remplacement de la batterie ...........................................111
Contrôle de l'étalonnage .................................................113
Instructions de nettoyage ...............................................114
Nettoyage du transducteur..............................................115
Réparation....................................................................115
Dépannage ...................................................................116
Classification selon la norme CEI 60601-1 .........................117
Compatibilité électromagnétique (CEM) à la norme
EN60601-1:2007 ...........................................................119
Symboles .....................................................................124
Caractéristiques du Micro I..............................................126
Consommables/Accessoires.............................................127
4
Inhalt .................................................................. 1
IV. Einführung....................................................................129
Packungsinhalt ..............................................................131
Kontraindikationen, Warn- und Vorsichtshinweise...............132
Verwendungszweck........................................................134
Umgebungsbedingungen.................................................134
Inbetriebnahme.............................................................134
Konfiguration ................................................................135
Micro I PC Software........................................................136
Betrieb.........................................................................141
Übersicht Hauptmenü .....................................................141
Schnelluntersuchung ......................................................142
Untersuchung mit Sollwerten...........................................144
Untersuchung nach Bronchodilatator.................................148
NLHEP-Modus................................................................148
NLHEP-Qualitätsprüfungen ..............................................149
NLHEP QC-Stufen...........................................................150
NLHEP-Interpretation .....................................................150
Ausschalten des Gerätes .................................................151
Instandhaltung ..............................................................151
Batteriemanagement......................................................151
Batterieaustausch ..........................................................152
Kalibrationsprüfung........................................................154
Reinigungsanleitung .......................................................155
Reinigen des Transducers................................................156
Wartung .......................................................................156
Informationen zur Fehlerbehebung...................................157
Sicherheitsbestimmungen gemäß IEC 60601-1...................158
Elektromagnetische Verträglichkeit (EMV) gemäß
EN60601-1:2007 ...........................................................160
Symbole.......................................................................165
Spezifikationen des Micro I..............................................167
Verbrauchsartikel/Zubehör..............................................168
5
Contenido ............................................................ 1
V. Introducción..................................................................170
Contenido del envase .....................................................171
Contraindicaciones, advertencias y precauciones ................172
Uso indicado .................................................................174
Entorno ........................................................................174
Para comenzar ..............................................................174
Configuración................................................................175
Micro I PC Software........................................................176
Funcionamiento .............................................................181
Descripción general del menú principal..............................181
Examen rápido ..............................................................182
Examen con valores previstos..........................................184
Examen Post BD ............................................................188
Modo NLHEP..................................................................188
Revisiones de calidad del NLHEP ......................................189
Niveles del CC del NLHEP ................................................190
Interpretación del NLHEP ................................................190
Desconexión .................................................................191
Mantenimiento ..............................................................191
Gestión de la batería ......................................................191
Cambio de la batería ......................................................192
Comprobación de calibración ...........................................194
Instrucciones de limpieza................................................195
Limpieza del transductor.................................................196
Reparaciones ................................................................196
Información sobre resolución de problemas .......................197
Designación de seguridad según IEC 60601-1 ....................198
Compatibilidad electromagnética (CEM) con
EN60601-1:2007 ...........................................................200
Símbolos ......................................................................205
Especificaciones del Micro I .............................................207
Consumibles/Accesorios..................................................208
6
Índice .................................................................. 1
VI. Introdução....................................................................210
Conteúdo da Embalagem ................................................211
Contra-indicações, Avisos e Cuidados................................212
Utilização Prevista..........................................................214
Ambiente......................................................................214
Primeira Utilização .........................................................214
Configuração.................................................................215
Micro I PC Software........................................................216
Funcionamento..............................................................221
Descrição Geral do Menu Principal ....................................221
Quick Exam (Exame Rápido)............................................222
Exame com Valores Previstos ..........................................224
Post BD Exam (Exame Pós-BD)........................................228
Modo NLHEP..................................................................228
Controlos de Qualidade NLHEP.........................................229
Grau de CQ do NLHEP.....................................................230
Interpretação NLHEP ......................................................230
Desligar........................................................................231
Manutenção ..................................................................231
Manutenção das Pilhas....................................................231
Substituição das Pilhas ...................................................232
Teste de Calibração........................................................234
Instruções de Limpeza....................................................235
Limpeza do Transdutor ...................................................235
Assistência técnica .........................................................236
Informações sobre Resolução de Problemas.......................237
Designação de Segurança segundo a norma IEC 60601-1 ....238
Compatibilidade Eletromagnética (CEM) de acordo com
EN60601-1:2007 ...........................................................240
Símbolos ......................................................................245
Especificações do Micro I.................................................247
Consumíveis/Acessórios..................................................248
7
Inhoud................................................................. 1
VII. Inleiding .......................................................................250
Inhoud van de verpakking...............................................251
Contra-indicaties, Waarschuwingen en aandachtspunten......252
Beoogd gebruik .............................................................254
Milieu...........................................................................254
Aan de slag...................................................................254
Configuratie ..................................................................255
Micro I PC Software........................................................256
Bediening .....................................................................261
Overzicht hoofdmenu .....................................................261
Snel onderzoek..............................................................262
Onderzoek met voorspelde waarden .................................264
Postbronchodilatoronderzoek...........................................268
NLHEP-modus ...............................................................268
Kwaliteitscontroles NLHEP ...............................................269
Classificatie kwaliteitscontroles NLHEP ..............................270
Interpretatie NLHEP .......................................................270
Uitschakelen .................................................................271
Onderhoud....................................................................271
Batterijbeheer ...............................................................271
Batterij vervangen .........................................................272
Calibration Check (kalibratiecontrole)................................274
Reinigingsinstructies.......................................................275
De transducer reinigen ...................................................276
Reparatie......................................................................276
Informatie over probleemoplossing...................................277
Veiligheidsaanduiding volgens IEC 60601-1 .......................278
Elektromagnetische compatibiliteit (EMC) volgens
EN60601-1:2007 ...........................................................280
Symbolen .....................................................................285
Specificatie van de Micro I...............................................287
Verbruiksartikelen/Accessoires.........................................288
8
Micro I
Diagnostic
Spirometer
Operating Manual – English
Contents
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:
o Measures FEV1, FVC(FEV6), FEV1/FVC, FEV1/FEV6, PEF,
FEF25, FEF75, and FEF 25-75
o Fully configurable using software supplied
o ECCS, Asian, NHANES III, or Quanjer-GLI (2012) predicted
values
o Variation from norm as percentage or Z-score
o NLHEP, NICE, or the ATS/ERS interpretation
o Spirometry manoeuvre quality checks
o Post bronchodilator comparison
o NLHEP compliant mode
o Upload of the last patient tested for report generation either
to be printed directly or saved as a PDF document and printed
or stored in the patient’s electronic medical records.
The spirometer uses the CareFusion 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. 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.
10
Package 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. USB/Charging cable
Fig 1
11
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.
Please 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.
WARNING: With any other use as described in cleaning
instructions, the Volume Transducer, Mouthpiece adaptor and the
Paediatric adapter have to be cleaned between patients.
WARNING: use of portable phones or other radio frequency (RF)
emitting equipment near the system may cause unexpected or
adverse operation.
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.
12
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.
WARNING: The user must not touch any voltage-carrying parts and
the patient at the same time.
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.
PLEASE NOTE: Degree of protection against Ingress of Water is
IPX0.
13
Intended Use
The Micro I Spirometer is intended to measure the maximal volume
and flow of air that can be moved out of a patient’s lungs. The system
is intended for use with Paediatric and adult patients over the age of 3
years in hospitals, physician offices, laboratories and occupational
health testing environments.
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
USB/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.
14
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 Zscore 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 USB 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.
15
Micro I PC Software
This software allows you to customise the settings on your Micro I
spirometer, and allows full spiormetry reports containing patient
demographics, indices and flow volume and volume time graphs to be
generated and saved as a PDF file or printed. 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.
PC Requirements
An IBM-compatible PC is required, with hardware that meets or
exceeds the following minimum requirements.
Processor: 800 MHz or above
RAM: 256 MB
Free Disk Space: 50 MB
Video: 800x600, 256 colours. It is recommended that a resolution of
at least 1280x1024 be used to enable the full benefits of the multiwindow interface.
At least one free USB port. (An additional USB port will be required
for USB enabled spirometers)
Operating System Requirements
Micro I PC Software will run on the following operating systems:
Windows XP 32 bit
Windows 7 32 bit
Windows 7 64 bit
16
Installing Micro I PC Software
Before 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 ‘Browse’.
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
17
and that it would be advisable to restart your PC before using the
application. Click ‘Finish’ to complete the installation process.
Running Micro I PC software
Connect your Micro I to a USB port on the PC using the cable
provided. The Micro I will take power from the USB port on the PC.
Please be advised that the Micro I requires a High Current USB port,
and if connected to a Low Power USB port the device will turn itself off
and fail to respond to any key presses until disconnected. Low Power
USB ports are commonly found on keyboards and unpowered USB
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.
18
The Micro I PC software will automatically be launched when a Micro I
unit is connected to the PC, the first screen will show:
From this screen you can enter an ID and the patient’s names to
generate a report. The Patient options allows the last results to be
uploaded from the Micro I and print preview of the report can be
viewed in preparation for printing or alternatively a PDF of the report
can be generated for saving to a specified location.
Please note: The patient ID can contain a maximum of 20 characters.
Please note: IF Quanjer-GLI (2012) predicted values are selected, the
number of indices will be limited to those of the published set, it is
also not possible on the printed report to have a predicted area on the
flow volume or volume time graphs if the GLI-2012 predicted values
have been chosen.
In the Actions section the user has the choice of two Options either
change the device settings or adjust the Micro I internal clock.
19
When the change settings option is used the display will change to:
By selecting the ‘Custom’ option at the top of the screen all of the
Micro I features may be tailored to you specific requirements.
20
Operation
The Micro I is designed to suit a range of applications from the very
simplest spirometry test where only a few indices are required to be
displayed to more complex operation where deviation from the norm,
bronchodilator response, and interpretation of results are required.
The main menu is displayed after the initial configuration and
subsequently when the unit is turned on:
Main Menu Overview
Quick Exam
Use this function to take an immediate spirometry measurement with
no predicted values or interpretation.
Exam with Predicted
This function requires the entry of the patient’s demographics so that
predicted values and interpretation may be calculated and displayed.
Post BD Exam
This function allows the post bronchodilator response to be measured.
The response is measured with respect to the previously measured
baseline obtained using either the Quick Exam or the Exam with
Predicted options. The last recorded baseline examination is
automatically stored when the unit is turned off and will be available
for a post bronchodilator comparison when the unit is turned on.
21
Last Results
This option is used to view the results of the last stored examination.
Settings
This option allows the user to adjust various settings including date,
time and language and to perform a calibration check.
Quick Exam
After selecting this option the display will change to:
The Micro I may be used directly with a MicroGuard filter or with a
disposable cardboard mouthpiece with the adapter supplied. Insert
mouthpiece or MicroGuard filter into the mouthpiece holder of the
spirometer.
Instruct the patient to inhale as deeply as possible, seal their lips
around the mouthpiece and exhale as hard and as fast as possible
until no more air can be exhaled.
22
The spirometry results for that blow are then displayed together with
the manoeuvre quality check based upon ATS/ERS guidelines:
Further indices, if configured, and the best results from a sequence of
blows may be displayed by pressing the down key.
Each manoeuvre is quality checked for a slow start, abrupt end, short
blow, poor effort or cough according to ATS/ERS 2005 guidelines.
Please note that the percentage of predicted value and the
interpretation are not available for the Quick Exam option.
Press Enter to display:
To repeat the test select Blow Again and press Enter.
23
Exam with Predicted Values
When this option is selected the following is displayed:
The date of the birth displayed will be the last patient tested, select
‘Yes’ to confirm the date of birth is correct or ‘No’ to enter the date of
birth of the patient to be tested.
If ‘No’ is selected then the screen will change to allow the correct date
of birth to be entered. Use the up and down keys to enter the date of
birth and press the enter key after each correct entry has been made.
If ‘Yes’ is selected and the date of birth is correct then the patient
details screen will be displayed.
24
The up and down keys should also be used to adjust the patient’s age
and then press enter. Repeat for gender, height and racial origin. If
a mistake is made then simply touch the back key to go back to the
previous entry. The racial origin selected applies a percentage drop
to the volumetric predicted values to be applied for the patient.
These ethnic corrections for ECCS are as follows:
Population Percentage drop
Caucasian 0
Non-Specified 0
Polynesian 10
Asian 10
Afro Caribbean 13
Press Enter when the required correction has been selected.
If NHANES III predicted values are used then the ethnic origin will be
used according to the NHANES III equations.
If Quanjer-GLI (2012) predicted values are used then the ethnic
origin will be used according to Quanjer-GLI (2012) equations.
Please note that the Micro I may be configured to accept height in
inches.
25
If a mistake is made then simply touch the back key to go back to the
previous entry.
When all the patient data has been entered the following screen will
be displayed and a spirometry test may be performed:
After performing a test the results are displayed:
Each manoeuvre is quality checked for a slow start, abrupt end, short
blow, poor effort or cough according to ATS/ERS 2005 guidelines. An
asterix ( * ) at the end of the line denotes a result below the lower
limit of normality.
If additional indices were chosen during configuration, press the down
arrow key to view these.
When a sequence of blows is recorded, the results and the quality
check refer to the current blow but the interpretation is based upon
the best result of the sequence.
26
Use the down arrow to see further indices, if configured, and the best
results from a sequence of blows:
At any time when the results are displayed another spirometer test
may be performed by touching the enter key. If the enter key is
touched accidently then simply press the back key to return to the
results screen.
The Micro I may be configured to display the Z score instead of the
percentage of predicted values where data from the predicted value
sets are available:
The Z score is the number of standard deviations that the results are
above (positive Z score) or below (negative Z score) the predicted
value.
27
Post BD Exam
Once satisfactory baseline tests have been recorded a post
bronchodilator examination may be performed by selecting the Post
BD Exam option from the main menu. When these tests are
performed the percentage of predicted value is replaced by the
percentage change from the best baseline result for each index:
Using the down key will display the other indices and the best results
as with the baseline blows.
NLHEP Mode
This mode of operation is obtained by selecting the USA (NLHEP)
option from the configuration menu when the unit is first turned on or
subsequently from the settings option on the main menu. In this
mode the functionality of the Micro I becomes fully compliant with the
National Lung Health Education Program requirements.
Only FEV1, FEV6 and the ratio, FEV1/FEV6, are displayed and stored,
quality checks are applied to every manoeuvre and a quality grading
score for the test session is displayed:
28
NLHEP Quality Checks
In order for the interpretation to be displayed a manoeuvre must pass
a set of enhanced quality checks. After the patient has performed a
poor quality manoeuvre, one of the three following messages will
appear:
Message Criteria Recommended action
Don’t
hesitate
Back-extrapolated volume
(BEV) greater than 150 ml
The patient should blast
out the air more quickly
and evenly and without
hesitation at the
beginning of the
manoeuvre
Blast out
faster
Time until peak flow
(PEFT) greater than 120
msec
The patient must exhale
more explosively at the
beginning of the
manoeuvre
Blow out
longer
Expiration time less than 6
seconds or volume
accumulation has not
dropped below 100 ml per
0.5 seconds
The patient stopped
exhaling too early. The
patient must exhale until
their lungs are completely
empty.
Once an acceptable manoeuvre has been performed, the following
consistency checks will also be applied to subsequent manoeuvres
Blast out
harder
Peak flow not
reproducible. The best
previous manoeuvres do
not match within 1.0 L/sec
indicating that the patient
is giving an inconsistent
effort.
The patient must give
their maximum effort for
each manoeuvre
Deeper
breath
FEV1 or FEV6 not
reproducible. Difference
with respect to best test
greater than 150 ml
The patient must inhale
until their lungs are
completely full before
each manoeuvre
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