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

29

When two manoeuvres fail either of the consistency checks, then the best individual results of the two are saved (FEV1, FEV6, and PEF individually).

When any of the above messages appear, instruct the patient on how to improve their manoeuvre and demonstrate the correct manoeuvre yourself.

NLHEP QC Grades

The quality of each session is graded according to the following criteria:

QC

Grade

Criteria

A at least two acceptable manoeuvres, with the

largest two FEV1’s matching better than 100mL and the largest two FEV6’s matching better than 100mL

B at least two acceptable manoeuvres, with the

largest two FEV1’s matching better than 150mL

C at least two acceptable manoeuvres, with the

largest two FEV1’s matching between 200ml and 150mL

D only one acceptable manoeuvre or two with the

largest two FEV1’s matching less than 200mL

F No acceptable manoeuvres

NLHEP Interpretation

The interpretation is performed on the best spirometry results and is based upon the predicted values for the forced expiratory ratio, FEV1/FEV6, and FEV1. If airways obstruction is detected the level of severity is reported in accordance with the NLHEP guidelines.

30

Switching Off

The unit is switched off by pressing the On/Off button.

The unit can disconnected from the mains by unplugging the charger from the mains socket or unplugging the USB cable.

Maintenance

Battery Management

The Micro I is powered by a rechargeable battery pack.

The battery voltage is monitored and a warning is displayed on switch on when the battery starts to become exhausted.

Battery Status Icons

Battery nearly exhausted. Recharge as soon as possible

to avoid running out of charge.

Battery fully charged.

The battery is not required to hold the internal memory and stored results will not be lost when the battery becomes exhausted.

To recharge the battery connect the Micro I to the charger provided and then plug the charger into a suitable wall socket ensuring that access to the charger is not restricted so that it may easily be removed.

The Micro I will display:

31

Do not allow the patient to handle the spirometer during this procedure.

The charging icon ( ) will display to indicate that the device is charging.

Once the charging icon has switched off (up to 5 hours) it will be replaced by the battery fully charged icon. (

) Remove the power adapter from the wall socket and from the base of the unit. Micro I is now ready for portable use.

Note: Micro I may be also charged from PC or laptop using the USB cable provided.

Battery Replacement

The lifetime of all rechargeable batteries is limited and the battery pack will need to be replaced after a few years, depending upon usage. As the battery nears the end of its life you will notice that fewer tests can be performed between charges.

For access to the battery the rear of the device requires careful removal.

Clips are moulded into the rear cover in the positions indicated and should be carefully prised undone in the sequence shown.

32

To aid this process clip 1 has a recess moulded into the device body to allow a small flat bladed screw driver to be carefully slid under the clip to release it.

Once released work the screw driver around to clips 2, 3 and 4.

Finally slide the cover off the bottom of the unit which in turn releases clips 5 and 6

Replace the battery paying particular attention to the orientation of the connector in its socket and of the battery itself in the case. Note the leads coming from the battery should exit from the upper face of the pack when installed.

Replace the rear cover by attaching the securing clips in the reverse order.

Dispose of the waste battery in line with EU Battery Regulations.

33

Calibration Check

The Micro I is calibrated to read in litres at body temperature, barometric pressure saturated with water vapour (BTPS).

The calibration should remain stable indefinitely, unless the transducer is physically damaged, and the unit should not require recalibration. However, to ensure the correct functioning of the unit we do recommend that a calibration check is performed after each patient or when the transducer was removed for cleaning.

To perform a calibration check select calibration check option from the setting menu and the display will show:

Connect a 3L syringe to the Micro I with the minimum of adapters and inject the syringe volume into the transducer evenly, without pausing. When complete the display will show:

The acceptable calibration accuracy is +/- 3.5%. If the calibration accuracy is outside of this range then the tick will be replaced by a cross. If this happens then check the syringe and the connections for leaks and repeat the check. If the Micro I is repeatedly outside the

34

calibration range then the unit will have to be returned to CareFusion for servicing.

Cleaning Instructions

With the use of a MicroGard Filter or One-way Safety Mouthpiece for each patient, cleaning for the components in the patients’ gas path is recommended once a month.

When using a paediatric/Adult disposable mouthpiece without a filter under the prerequisite that the patient was instructed only to exhale into the Micro I device, the following parts have to be cleaned once a day: Volume Transducer, Mouthpiece adaptor and paediatric adapter.

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

The Cleaning of the Transducer, Mouthpiece adaptor and Paediatric adapter is equal for all the components in the patient gas path and is described in the below section “Cleaning the Transducer”

35

Cleaning the Transducer

The transducer requires no routine maintenance or servicing.

To sterilise or clean the transducer it may be removed by means of the following procedure:

1 Remove the transducer by gently rotating the transducer anti-

clockwise and then pulling from the main body.

2 The transducer may now be immersed in warm soapy water

for routine cleaning or immersed in cold sterilising solutions e.g. Perasafe for a period not exceeding 10 minutes. (Alcohol and chloride solutions should be avoided.) After cleaning/sterilising, the transducer should be rinsed in distilled water and dried. Perasafe is available from CareFusion in convenient 81g plastic bottles, Cat No. 36-SSC5000A.

3 Re-assemble the transducer into the Micro I.

CAUTION: Do not attempt to wash or immerse the spirometer or accessories in water or cleaning fluid, as there are electronic components inside that will be permanently damaged.

Servicing

If your unit requires service or repair please see page 289 for contact details.

There are no user serviceable parts in the Micro I.

36

Trouble Shooting Information

Should you encounter problems operating your spirometer, please consult the table below:

Problem Possible

Cause

Solution

Micro I cannot be switched on

Batteries are flat

Recharge batteries

Every time you switch the instrument on the time is shown as 00:00

The internal battery of Micro I is defective

Contact your dealer.

Micro I is outside of % when conducting the calibration check

There are leaks in the syringe or connections

Check the syringe and connections for leaks

37

Safety Designation per IEC 60601-1

Type of protection against electrical shock

Class II

Degree of protection against electrical shock

Type B applied part

Supply connection 100-240 VAC, 50/60Hz Power Equipment Adapter and rechargeable

internal NiMH battery.

Battery life: Approximately 30 hours with

a fully charged new battery.

Degree of Electrical connection between equipment and Patient

Equipment designed as nonelectrical connection to the patient.

Degree of mobility Transportable Mode of operation Continuous

NOTE: When you connect other equipment to the unit, always make

sure that the whole combination complies with the international safety standard IEC 60601-1 for medical electrical systems. When connecting to a PC with the supplied USB lead then the PC must be EN 60601-1 / ANSI/AAMI ES60601-1:2005 compliant.

IMPORTANT: Only use the mains adapter supplied (36-PSU1017 5V DC 1.2A). The adapter contains a transformer. Do not cut off the adapter to replace it with another plug as this causes a hazardous situation.

• The adapter transforms the mains voltage (100-240 Volts) to a safe voltage (5V DC)

• Make sure the adapter does not get wet

• Do not use a damaged adapter

• Always unplug your Micro I before cleaning

WARNING: Do not connect devices that are not specified as part of the system.

WARNING: No modification of this equipment is allowed.

38

NOTE: If an MPSO (Multiple Portable Socket Outlet) is used with the system, the maximum permitted load should not be exceeded. Do not connect electrical equipment that has not been supplied as part of the system.

39

Electromagnetic Compatibility (EMC) to EN60601-1:2007

WARNING: use of portable phones or other radio frequency (RF)

emitting equipment near the system may cause unexpected or adverse operation.

The Micro I has been tested to EN60601-1-2:2007, regarding its ability to operate in an environment containing other electrical/electronic equipment (including other medical devices).

The purpose of this testing is to ensure that the Micro I is not likely to adversely affect the normal operation of other such equipment and that other such equipment is not likely to adversely affect the normal operation of the Micro I.

Despite the testing of the Micro I that has been undertaken, normal operation of the Micro I can be affected by other electrical/electronic equipment and portable and mobile RF communications equipment.

As the Micro I is medical equipment, special precautions are needed regarding EMC (electromagnetic compatibility).

It is important that the Micro I is configured and installed/put into service, in accordance with the instructions/guidance provided herein and is used only in the configuration as supplied.

Changes or modifications to the Micro I may result in increased emissions or decreased immunity of the Micro I in relation to EMC performance.

The Micro I should be used only with the accessories (USB cables, mains adapter and turbine transducer) supplied (which are referenced in the accessories section of this manual). None of the Micro I cables should be extended in length by the user.

If any cables are extended by the user or non approved accessories are used, this may result in an increased level of emissions or decreased level of immunity, in relation to the Micro I EMC. None of the Micro I accessories should be used with other devices, as this may result in an increased level of emissions or decreased level of immunity, in relation to the other devices’ EMC.

The Micro I has an essential performance – When verified with a 3 litre syringe the readings remain within a tolerance of +/-3.5%, and unit firmware must not cease operating. In the unlikely event of a Fast Transient / ESD event occurring, the device should be reset and located away from the source of interference.

WARNING: The Micro I should not be used adjacent to or stacked with other

equipment. If adjacent or stacked use with other equipment is necessary, the Micro I and the other equipment should be observed / monitored, to verify normal operation in the configuration in which it will be used.

40

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

The Micro I is intended for use in the electromagnetic environment specified below. The customer or the user of the Micro I should assure that it is used in such an environment

Emission Test Compliance Electromagnetic Environment –

Guidance

RF emissions CISPR11

Group 1

The Micro I uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR11

Class [B]

Harmonic Emissions IEC 61000-3-2

[Not Applicable]

Voltage fluctuations / flicker emissions IEC 61000-3-3

[Not applicable]

The Micro I is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purpose.

41

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

The Micro I is intended for use in the electromagnetic environment specified below. The customer or the user of the Micro I should assure that it is used in such an environment.

Immunity Test IEC 60601 test

level

Compliance Level

Electromagnetic Environment – Guidance

Electrostatic discharge (ESD) IEC 61000-4-2

+/- 6 kV contact

+/- 8 kV air

+/- 6 kV contact

+/- 8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at

least 30%. Electrical fast transient/burst IEC 61000-4-4

+/- 2 kV for power supply lines

+/- 1 kV for input/output lines

+/- 2 kV for power supply lines

[Not Applicable]

Mains power quality

should be that of a

typical commercial or

hospital environment.

Surge IEC 61000-4-5

+/- 1 kV line(s) to line (s)

+/- 2 kV line(s) to earth

+/- 1 kV line(s) to line (s)

[Not Applicable]

Mains power quality

should be that of a

typical commercial or

hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

< 5% UT (>95% dip in UT) for 0.5% cycle

40% UT (60% dip in UT) for 5 cycles

70% UT (30% dip in UT) for 25 cycles

< 5% UT (>95% dip in UT) for 5s

< 5% UT (>95% dip in UT) for 0.5% cycle

40% UT (60% dip in UT) for 5 cycles

70% UT (30% dip in UT) for 25 cycles

< 5% UT (>95% dip in UT) for 5s

Mains power quality

should be that of a

typical commercial or

hospital environment. If

the user of the Micro I

requires continued

operation during power

main interruptions, it is

recommended that the

Micro I be powered

from an uninterruptible

power supply or a

battery.

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

3 A/m

Power frequency

magnetic fields should

be at levels

characteristics of a

typical location in a

typical commercial or

hospital environment. NOTE UT is the a.c. mains voltage prior to application of the test level.

42

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

The Micro I is intended for use in the electromagnetic environment specified below. The customer or the user of the Micro I should assure that it is used in such an environment.

Immunity

Test

IEC 60601

test level

Compliance Level

Electromagnetic Environment – Guidance

Conducted RF IEC610004-6

Radiated RF IEC 610004-3

3 Vrms 150kHz to 80MHz

3 V/m 80MHz to

2.5GHz

3 V

3 V/m

Portable and mobile RF communications equipment should be used no closer to any part of the Micro 1, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

d = 1.2 x √P

d = 1.2 x √P 80MHz to 800MHz

d = 2.3 x √P 800MHz to 2.5GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).

Field strengths from a fixed RF transmitters as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. b

Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

43

a

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radio, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the model Micro 1 is used exceeds the applicable RF compliance level above, the model Micro 1 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orientating or relocating model Micro I.

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less

than 3 V/m

Recommended separation distances between portable and mobile RF communications equipment and the Micro I

The Micro I is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Micro I can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Micro 1 as recommended below, according to the maximum output power of the communications equipment.

Separation Distance in Meters (m) according to Frequency of Transmitter

Rated Maximum Output Power of Transmitter in Watts (W)

150 KHz to 80 MHz

d = 1.2 x √P

80 MHz to 800 MHz

d = 1.2 x √P

800 MHz to

2.5 GHz

d = 2.4 x √P

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73 1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in Watts (W) according to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures objects and people.

44

Symbols

Type B device

0086

In accordance with Directive 93/42/EEC

Disposal in compliance with WEEE

Consult the instructions for use

Caution: consult the accompanying documents

Date of manufacture

Manufacturer

Serial number

Federal U.S. law restricts this device to sale by or on the order of a physician. (Rx only)

Nationally Recognized Test Laboratory (NRTL) officially recognized by the American Occupational Safety and Health Administration (OSHA) for OSHA Electrical safety and compliance

45

Please Note: Information in this manual is subject to change without notice and does not represent commitment on the part of CareFusion UK 232 Ltd. The software may be used or copied only in accordance with the terms of that agreement. No part of this manual may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying and recording for any purpose without the written permission

of CareFusion UK 232 Ltd.

46

Specifications of the Micro I

Measurements:

Forced Expired Volume in 1 second (FEV1) Forced Expired Volume in 6 second (FEV6) Forced Vital Capacity (FVC) Forced Expiratory Ratio (FEV1/FEV6) Forced Expiratory Ratio (FEV1/FVC) Peak Expiratory Flow Rate (PEF), Mid Expiratory Flow (FEF25-75) Expiratory Flow at 75% of volume remaining (FEF75) Expiratory Flow at 25% of volume remaining (FEF25)

Display: 128 x 128 pixel graphic backlit

monochrome LCD

Transducer type: CareFusion Uni-Directional Digital

Volume

Accuracy: To the requirements of the

ATS/ERS TASK FORCE: STANDARDISATION OF LUNG FUNCTION TESTING 2005 (Eur Respir J 2005; 26: 319-338 Table 6)

Power supply: 2 X AA size NiMH rechargeable

cells

Battery life: Approximately 30 hours with a

fully charged new battery.

Operating current Less than 90mA Charging current Less than 500mA Dimensions: 162 X 61 X 30mm Weight: 152g Operating temperature: 10 to +35° C Operating humidity: 20% to 80% RH Storage & Transport

temperature:

-20 to +70° C

Storage& Transport humidity:

30% to 90% RH

Life time 5 years

47

Consumables & Accessories

Cat. No. Description

36-PSA1000 Adult Disposable Mouthpieces (500 per box) 36-SST1250 One-way Safety Mouthpieces (250 per box) 36-SST1000 One-way Safety Mouthpieces (500 per box) 36-MGF1025 Microgard Pulmonary Filter (25 per box) 36-MGF1100 Microgard Pulmonary Filter (100 per box) 36-PSA1200 Paediatric Disposable Mouthpieces (250 per box) 36-PSA1100 Paediatric Adaptor 36-SSC5000A PeraSafe Sterilising Powder 81g (to make up 5 litres of solution) 36-VOL2104 Nose Clips (pack of 5) 36-SM2125 3 Litre Calibration Syringe 36-MLD1621 Mouthpiece adaptor 36-BAT1043 Battery Pack (NiMH AA 2.4V, 1600mAh) 36-PSU1017 5V DC 1.2A (GlobTek WR9QA1200USBNR-G2267)

PLEASE NOTE: USE ONLY CAREFUSION ACCESSORIES

48

Micro I Diagnostic Spirometer

Operating Manual – CareFusion USA

Federal (USA) law restricts this device to sale by or on the

order of a physician or licensed practitioner.

CareFusion,

22745 Savi Ranch Parkway,

Yorba Linda

CA 92887-4668

USA

Contents

49

II. Introduction – CareFusion USA

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.

50

Package Contents

The Micro I is packaged in a convenient carrying case and comes complete with the following items (Fig.1):

6. Micro I spirometer

7. CareFusion Digital Volume Transducer together with disposable cardboard mouthpieces and instruction manual.

8. Universal power supply (36-PSU1017 5VDC 1.2A)

9. Cardboard mouthpiece adapter

10. USB/Charging cable

Fig 1

51

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.

52

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.

53

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.

54

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.

55

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

56

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

57

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.

58

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.

59

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.

60

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.

61

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.

62

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.

63

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.

64

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.

65

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.

66

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.

67

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:

68

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

69

When two manoeuvres fail either of the consistency checks, then the best individual results of the two are saved (FEV1, FEV6, and PEF individually).

When any of the above messages appear, instruct the patient on how to improve their manoeuvre and demonstrate the correct manoeuvre yourself.

NLHEP QC Grades

The quality of each session is graded according to the following criteria:

QC

Grade

Criteria

A at least two acceptable manoeuvres, with the

largest two FEV1’s matching better than 100mL and the largest two FEV6’s matching better than 100mL

B at least two acceptable manoeuvres, with the

largest two FEV1’s matching better than 150mL

C at least two acceptable manoeuvres, with the

largest two FEV1’s matching between 200ml and 150mL

D only one acceptable manoeuvre or two with the

largest two FEV1’s matching less than 200mL

F No acceptable manoeuvres

NLHEP Interpretation

The interpretation is performed on the best spirometry results and is based upon the predicted values for the forced expiratory ratio, FEV1/FEV6, and FEV1. If airways obstruction is detected the level of severity is reported in accordance with the NLHEP guidelines.

70

Switching Off

The unit is switched off by pressing the On/Off button.

The unit can disconnected from the mains by unplugging the charger from the mains socket or unplugging the USB cable.

Maintenance

Battery Management

The Micro I is powered by a rechargeable battery pack.

The battery voltage is monitored and a warning is displayed on switch on when the battery starts to become exhausted.

Battery Status Icons

Battery nearly exhausted. Recharge as soon as possible

to avoid running out of charge.

Battery fully charged.

The battery is not required to hold the internal memory and stored results will not be lost when the battery becomes exhausted.

To recharge the battery connect the Micro I to the charger provided and then plug the charger into a suitable wall socket ensuring that access to the charger is not restricted so that it may easily be removed.

The Micro I will display:

71

Do not allow the patient to handle the spirometer during this procedure.

The charging icon ( ) will display to indicate that the device is charging.

Once the charging icon has switched off (up to 5 hours) it will be replaced by the battery fully charged icon. (

) Remove the power adapter from the wall socket and from the base of the unit. Micro I is now ready for portable use.

Note: Micro I may be also charged from PC or laptop using the USB cable provided.

Battery Replacement

The lifetime of all rechargeable batteries is limited and the battery pack will need to be replaced after a few years, depending upon usage. As the battery nears the end of its life you will notice that fewer tests can be performed between charges.

For access to the battery the rear of the device requires careful removal.

Clips are moulded into the rear cover in the positions indicated and should be carefully prised undone in the sequence shown.

72

To aid this process clip 1 has a recess moulded into the device body to allow a small flat bladed screw driver to be carefully slid under the clip to release it.

Once released work the screw driver around to clips 2, 3 and 4.

Finally slide the cover off the bottom of the unit which in turn releases clips 5 and 6

Replace the battery paying particular attention to the orientation of the connector in its socket and of the battery itself in the case. Note the leads coming from the battery should exit from the upper face of the pack when installed.

Replace the rear cover by attaching the securing clips in the reverse order.

Dispose of the waste battery in line with EU Battery Regulations.

73

Calibration Check

The Micro I is calibrated to read in litres at body temperature, barometric pressure saturated with water vapour (BTPS).

The calibration should remain stable indefinitely, unless the transducer is physically damaged, and the unit should not require recalibration. However, to ensure the correct functioning of the unit we do recommend that a calibration check is performed after each patient or when the transducer was removed for cleaning.

To perform a calibration check select calibration check option from the setting menu and the display will show:

Connect a 3L syringe to the Micro I with the minimum of adapters and inject the syringe volume into the transducer evenly, without pausing. When complete the display will show:

The acceptable calibration accuracy is +/- 3.5%. If the calibration accuracy is outside of this range then the tick will be replaced by a cross. If this happens then check the syringe and the connections for leaks and repeat the check. If the Micro I is repeatedly outside the

74

calibration range then the unit will have to be returned to CareFusion for servicing.

Cleaning Instructions

With the use of a MicroGard Filter or One-way Safety Mouthpiece for each patient, cleaning for the components in the patients’ gas path is recommended once a month.

When using a paediatric/Adult disposable mouthpiece without a filter under the prerequisite that the patient was instructed only to exhale into the Micro I device, the following parts have to be cleaned once a day: Volume Transducer, Mouthpiece adaptor and paediatric adapter.

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

The Cleaning of the Transducer, Mouthpiece adaptor and Paediatric adapter is equal for all the components in the patient gas path and is described in the below section “Cleaning the Transducer”

75

Cleaning the Transducer

The transducer requires no routine maintenance or servicing.

To sterilise or clean the transducer it may be removed by means of the following procedure:

4 Remove the transducer by gently rotating the transducer anti-

clockwise and then pulling from the main body.

5 The transducer may now be immersed in warm soapy water

for routine cleaning or immersed in cold sterilising solutions e.g. Perasafe for a period not exceeding 10 minutes. (Alcohol and chloride solutions should be avoided.) After cleaning/sterilising, the transducer should be rinsed in distilled water and dried. Perasafe is available from CareFusion in convenient 81g plastic bottles, Cat No. 36-SSC5000A.

6 Re-assemble the transducer into the Micro I.

CAUTION: Do not attempt to wash or immerse the spirometer or accessories in water or cleaning fluid, as there are electronic components inside that will be permanently damaged.

Servicing

If your unit requires service or repair please see page 289 for contact details.

There are no user serviceable parts in the Micro I.

76

Trouble Shooting Information

Should you encounter problems operating your spirometer, please consult the table below:

Problem Possible

Cause

Solution

Micro I cannot be switched on

Batteries are flat

Recharge batteries

Every time you switch the instrument on the time is shown as 00:00

The internal battery of Micro I is defective

Contact your dealer.

Micro I is outside of % when conducting the calibration check

There are leaks in the syringe or connections

Check the syringe and connections for leaks

77

Safety Designation per IEC 60601-1

Type of protection against electrical shock

Class II

Degree of protection against electrical shock

Type B applied part

Supply connection 100-240 VAC, 50/60Hz Power Equipment Adapter and rechargeable

internal NiMH battery.

Battery life: Approximately 30 hours with

a fully charged new battery.

Degree of Electrical connection between equipment and Patient

Equipment designed as nonelectrical connection to the patient.

Degree of mobility Transportable Mode of operation Continuous

NOTE: When you connect other equipment to the unit, always make

sure that the whole combination complies with the international safety standard IEC 60601-1 for medical electrical systems. When connecting to a PC with the supplied USB lead then the PC must be EN 60601-1 / ANSI/AAMI ES60601-1:2005 compliant.

IMPORTANT: Only use the mains adapter supplied (36-PSU1017 5V DC 1.2A). The adapter contains a transformer. Do not cut off the adapter to replace it with another plug as this causes a hazardous situation.

• The adapter transforms the mains voltage (100-240 Volts) to a safe voltage (5V DC)

• Make sure the adapter does not get wet

• Do not use a damaged adapter

• Always unplug your Micro I before cleaning

WARNING: Do not connect devices that are not specified as part of the system.

WARNING: No modification of this equipment is allowed.

78

NOTE: If an MPSO (Multiple Portable Socket Outlet) is used with the system, the maximum permitted load should not be exceeded. Do not connect electrical equipment that has not been supplied as part of the system.

79