Care Fusion SpiroUSB User manual

SpiroUSB
Operating Manual –English
Operating Manual –English - USA
Manuel d'utilisation –Français
Betriebshandbuch –Deutsch
Manual de funcionamiento –Español
Manual de instruções – Português
Gebruiksaanwijzing –Nederlands
Handbok –Svenska
Manuale operativo –Italiano
Instrukcja obsługi – język polski
Руководство пользователя –русский язык
操作手册 –简体中文

1
Contents
I. Introduction - English................................................... 13
Package contents ...................................................................14
Contraindications ...................................................................15
Warnings and Cautions ...........................................................15
Indication for Use...................................................................16
Installing SPCS ......................................................................17
Installing SpiroUSB device driver..............................................17
Compatibility status................................................................17
Driver installation...................................................................17
Operation..............................................................................18
Looking after your SpiroUSB Spirometer....................................18
Calibration Check ...................................................................19
Cleaning Instructions ..............................................................20
External Surfaces of the Spirometer..........................................20
Cleaning accessories...............................................................20
Cleaning the Transducer..........................................................22
Servicing ..............................................................................23
Product Lifetime.....................................................................23
Trouble Shooting Information...................................................24
Safety Designation per IEC 60601-1 .........................................25
Electromagnetic Compatibility (EMC) to EN60601-1-2:2007..........27
Symbols ...............................................................................32
Specification of the SpiroUSB ...................................................33
Spirometry Measurements:......................................................34
Consumables/ Accessories.......................................................36
Customer contact information ..................................................38
II. Introduction –English - USA ........................................ 42
Package contents ...................................................................43

2
Contraindications ...................................................................43
Warnings and Cautions ...........................................................44
Indication for Use...................................................................45
Installing SPCS ......................................................................46
Installing SpiroUSB device driver..............................................46
Compatibility status................................................................46
Driver installation...................................................................46
Operation..............................................................................47
Looking after your SpiroUSB Spirometer....................................47
Calibration Check ...................................................................48
Cleaning Instructions ..............................................................49
External Surfaces of the Spirometer..........................................49
Cleaning accessories...............................................................49
Cleaning the Transducer..........................................................51
Servicing ..............................................................................52
Product Lifetime.....................................................................52
Trouble Shooting Information...................................................53
Safety Designation per IEC 60601-1 .........................................54
Electromagnetic Compatibility (EMC) to EN60601-1-2:2007..........56
Symbols ...............................................................................61
Specification of the SpiroUSB ...................................................62
Spirometry Measurements:......................................................63
Consumables/ Accessories.......................................................65
Customer contact information ..................................................67
III. Introduction - Français ................................................. 70
Contenu de l’emballage...........................................................71
Contre-indications ..................................................................72
Avertissements et mises en garde ............................................72
Indications d'utilisation ...........................................................74

3
Installation de SPCS ...............................................................75
Installation du pilote de l’appareil Spiro-USB ..............................75
État de compatibilité...............................................................75
Installation du pilote...............................................................75
Utilisation .............................................................................76
Entretien du spiromètre SpiroUSB.............................................77
Vérification de l'étalonnage......................................................77
Instructions de nettoyage........................................................79
Surfaces extérieures du spiromètre...........................................79
Accessoires de nettoyage ........................................................79
Nettoyage du capteur .............................................................81
Entretien...............................................................................82
Certificat de sécurité selon la norme CEI 60601-1 .......................84
Compatibilité électromagnétique (CEM) à la norme EN60601-1-
2:2007..............................................................................86
Symboles..............................................................................91
Caractéristiques du Spiro-USB..................................................92
Mesures de spirométrie :.........................................................93
Consommables / Accessoires Care Fusion ..................................95
Informations de contact clientèle ..............................................97
IV. Einführung - Deutsch.................................................. 101
Lieferumfang .......................................................................102
Gegenanzeigen ....................................................................103
Warn- und Vorsichtshinweise .................................................103
Zweckbestimmung ...............................................................105
Installieren der SPCS ............................................................105
Installieren des SpiroUSB-Gerätetreibers .................................105
Kompatibilitätsstatus ............................................................106
Treiberinstallation ................................................................106
Betrieb ...............................................................................106

4
Pflege des SpiroUSB-Spirometers ...........................................107
Kalibrationsprüfung ..............................................................108
Reinigungsanleitung .............................................................110
Außenoberflächen des Spirometers .........................................110
Reinigungszubehör ...............................................................110
Reinigen der Turbine.............................................................112
Wartung .............................................................................113
Produktlebensdauer..............................................................113
Informationen zur Fehlerbehebung .........................................114
Sicherheitsbezeichnung gemäß IEC 60601-1 ............................115
Elektromagnetische Verträglichkeit (EMV) gemäß......................117
EN60601-1-2:2007...............................................................117
Symbole .............................................................................123
Spezifikationen des SpiroUSB.................................................124
Spirometrie-Messungen: .......................................................125
Verbrauchsartikel/Zubehör ....................................................127
Kundenkontaktdaten.............................................................129
V. Introducción - Español................................................ 133
Contenido Del Paquete:.........................................................134
Contraindicaciones ...............................................................135
Advertencias y precauciones ..................................................135
Instrucciones de uso.............................................................137
Instalación del SPCS.............................................................138
Instalación del driver de dispositivos SpiroUSB .........................138
Estado de compatibilidad.......................................................138
Instalación del driver ............................................................138
Funcionamiento ...................................................................139
Cuidado del espirómetro SpiroUSB..........................................140
Verificación de la calibración ..................................................140

5
Instrucciones de limpieza ......................................................142
Superficies externas del espirómetro.......................................142
Accesorios de limpieza ..........................................................142
Limpieza del transductor .......................................................144
Servicio ..............................................................................145
Información de solución de problemas.....................................146
Designación de seguridad conforme a IEC 60601-1 ...................147
Compatibilidad electromagnética (CEM) de acuerdo con EN60601-1-
2:2007............................................................................149
Símbolos.............................................................................154
Especificaciones del SpiroUSB ................................................155
Mediciones de espirometría: ..................................................156
Consumibles/Accesorios ........................................................158
Información de contacto del cliente.........................................160
VI. Introdução - Português .............................................. 164
Conteúdo da embalagem.......................................................165
Contraindicações..................................................................166
Avisos e Cuidados ................................................................166
Indicações de Utilização ........................................................168
Instalação do SPCS ..............................................................169
Instalação do controlador do SpiroUSB ....................................169
Estado de compatibilidade .....................................................169
Instalação do controlador ......................................................169
Funcionamento ....................................................................170
Cuidados com o Espirômetro SpiroUSB ....................................171
Verificação da Calibração.......................................................171
Instruções de Limpeza ..........................................................173
Superfícies Externas do Espirômetro .......................................173
Acessórios de limpeza ...........................................................173
Limpeza do transdutor ..........................................................175

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Manutenção.........................................................................176
Informações sobre Resolução de Problemas .............................177
Designação de Segurança de acordo com o IEC 60601-1............178
Compatibilidade Eletromagnética (CEM) de acordo o com EN60601-
1-2:2007.........................................................................180
Símbolos.............................................................................185
Especificações do SpiroUSB ...................................................186
Medidas da Espirometria: ......................................................187
Consumíveis/Acessórios ........................................................189
Informações do cliente para contato .......................................191
VII. Inleiding - Nederlands ................................................ 195
Inhoud verpakking ...............................................................196
Contra-indicaties..................................................................197
Waarschuwingsberichten .......................................................197
Indicatie voor gebruik ...........................................................199
Installeren van SPCS ............................................................200
Installeren van het SpiroUSB-stuurprogramma .........................200
Compatibiliteitsstatus ...........................................................200
Installatie van het stuurprogramma ........................................200
Bediening............................................................................201
Onderhoud van uw SpiroUSB spirometer .................................202
Kalibratiecontrole .................................................................202
Reinigingsinstructies .............................................................204
Externe oppervlakken van de spirometer .................................204
Reinigingsaccessoires ...........................................................204
Reinigen van de transducer ...................................................206
Service ...............................................................................207
Informatie over problemen oplossen .......................................208
Veiligheidsaanduiding volgens IEC 60601-1..............................209

7
Elektromagnetische compatibiliteit (EMC) volgens EN60601-1-
2:2007............................................................................211
Symbolen ...........................................................................217
Specificaties van de SpiroUSB ................................................218
Spirometrie Afmetingen: .......................................................219
Verbruiksartikelen / accessoires .............................................221
Contactinformatie voor klanten ..............................................223
VIII. Inledning –Svenska............................................. 226
Innehållet i kartongen...........................................................227
Kontraindikationer................................................................228
Varningar och försiktighet .....................................................228
Användningsområde .............................................................230
Installation av SPCS .............................................................231
Installation av drivrutin för SpiroUSB-enheten ..........................231
Kompatibilitetsstatus ............................................................231
Installation av drivrutin.........................................................231
Användning .........................................................................232
Skötsel av SpiroUSB-spirometern ...........................................232
Kalibreringskontroll ..............................................................233
Rengöringsanvisningar..........................................................235
Spirometerns utvändiga ytor..................................................235
Rengöringstillbehör...............................................................235
Rengöra omvandlaren...........................................................237
Service ...............................................................................238
Felsökning...........................................................................239
Säkerhetsbeteckning enligt IEC 60601-1 .................................240
Elektromagnetisk kompatibilitet (EMC) med EN60601-1-2:2007..242
Symboler ............................................................................247
SpiroUSB-enhetens specifikationer..........................................248
Spirometri –måttenheter:.....................................................249

8
Produkter/Tillbehör...............................................................251
Kundtjänstinformation ..........................................................253
IX. Introduzione - Italiano ............................................... 257
Contenuto della confezione ....................................................258
Controindicazioni..................................................................259
Avvertenze e precauzioni.......................................................259
Istruzioni per l'uso................................................................261
Installazione di SPCS ............................................................262
Installazione del device driver per SpiroUSB.............................262
Stato di compatibilità............................................................262
Installazione del driver..........................................................262
Funzionamento ....................................................................263
Cura dello spirometro SpiroUSB..............................................264
Verifica calibrazione..............................................................264
Istruzioni per la pulizia..........................................................266
Superfici esterne dello spirometro...........................................266
Accessori per la pulizia..........................................................266
Pulizia del trasduttore ...........................................................268
Assistenza tecnica ................................................................269
Prescrizioni per la sicurezza secondo la direttiva IEC 60601-1 .....271
Compatibilità elettromagnetica (EMC) in conformità con la norma
EN60601-1-2:2007 ...........................................................273
Simboli ...............................................................................278
Specifiche dello SpiroUSB ......................................................279
Misurazioni spirometria .........................................................280
Consumabili / Accessori ........................................................282
Informazioni di contatto per i clienti ........................................284
X. Wprowadzenie —język polski..................................... 288
Zawartość zestawu...............................................................289

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Przeciwwskazania.................................................................290
Ostrzeżenia i przestrogi.........................................................290
Wskazania dotyczące zastosowania.........................................292
Instalowanie programu SPCS .................................................293
Instalowanie sterownika urządzenia SpiroUSB ..........................293
Stan zgodności ....................................................................293
Instalacja sterownika............................................................293
Obsługa ..............................................................................294
Konserwacja spirometru SpiroUSB ..........................................295
Kontrola kalibracyjna ............................................................296
Instrukcje dotyczące czyszczenia............................................298
Powierzchnie zewnętrzne spirometru.......................................298
Akcesoria do czyszczenia.......................................................298
Mycie i dezynfekcja przetwornika............................................300
Serwis ................................................................................301
Rozwiązywanie problemów ....................................................302
Oznaczenia bezpieczeństwa zgodnie z normą IEC 60601-1 .........303
Zgodność elektromagnetyczna (EMC) zgodnie z normą EN60601-1-
2:2007............................................................................305
Symbole .............................................................................310
Parametry techniczne urządzenia SpiroUSB..............................311
Parametry mierzone: ............................................................312
Materiały eksploatacyjne/akcesoria .........................................314
Informacje kontaktowe .........................................................316
XI. Введение (русский язык).......................................... 319
Комплект поставки..............................................................320
Противопоказания ..............................................................321
Предупреждения и меры предосторожности ..........................321
Показания к применению.....................................................323
Установка SPCS ..................................................................324

10
Установка драйвера устройства SpiroUSB ..............................324
Совместимость ....................................................................324
Установка драйвера ............................................................324
Работа................................................................................325
Уход за вашим спирометром SpiroUSB ...................................326
Проверка калибровки..........................................................326
Инструкции по очистке........................................................328
Внешняя поверхность спирометра ........................................328
Очистка дополнительных принадлежностей...........................328
Очистка датчика .................................................................330
Сервис ...............................................................................331
Информация о поиске и устранении неисправностей..............332
Описание безопасности по IEC 60601-1 ................................333
Электромагнитная совместимость (EMC) по EN60601-1-2:2007 335
Символы ............................................................................341
Спецификации SpiroUSB ......................................................342
Спирометрия, измерения .....................................................343
Расходный материал/дополнительные принадлежности..........346
Контактная информация для клиентов ..................................348
XII. 简介- 简体中文............................................................... 351
包装内容 ..............................................................................352
禁忌证 .................................................................................353
警告和小心 ...........................................................................353
使用说明 ..............................................................................354
安装 SPCS ...........................................................................355
安装 SpiroUSB 设备的驱动程序..................................................355
兼容性 .................................................................................355
驱动程序安装.........................................................................355
操作....................................................................................356

11
妥善照管 SpiroUSB 肺量计 .......................................................356
校准检查 ..............................................................................357
清洁说明 ..............................................................................358
肺量计的外表面 ......................................................................358
清洁配件 ..............................................................................358
清洁传感器 ...........................................................................359
维修....................................................................................360
故障排除信息.........................................................................361
根据 IEC 60601-1 的安全指示...................................................362
符合 EN60601-1:2007 的电磁兼容性 (EMC) ................................363
符号....................................................................................367
SpiroUSB 的规格 ...................................................................368
肺量计衡量标准： ...................................................................369
消耗品/配件 ..........................................................................371
客户联系信息.........................................................................373

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13
SpiroUSB
Operating manual
I. Introduction - English
The SpiroUSB is a PC connected spirometer dedicated to work with
the comprehensive Spirometry PC Software (SPCS).
SPCS is a fully Windows™ compatible spirometry system that
interfaces seamlessly with the SpiroUSB providing many display
options and includes powerful reporting and database facilities.
SPCS has many advanced features including display of real time
respiratory traces, predicted values, patient database, and the
ability to carry out pre and post bronchodilator and post steroid
testing.
The SpiroUSB 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.

14
2
1
Package contents
The SpiroUSB is packaged in a sturdy carrying case containing this
manual and the following items (Fig.1):
1. Carefusion Digital Volume Transducer
2. SpiroUSB transducer housing.
Together with SPCS, extension cable, disposable cardboard
mouthpieces and nose clip.
2
1

15
Contraindications
Acute disorders affecting test performance (e.g Vomiting ,
nausea, vertigo)
Recent eye surgery (increases in intraocular pressure during
spirometry)
Oral or facial pain exacerbated by a mouthpiece
recent myocardial infarction
post- operative thoracic surgery patients
hyperventilation syndrome
Note: Extensive exhalation might lead to syncope
Warnings and Cautions
The following terms are used as follows in this manual
CAUTION: Possibility of injury or serious damage
WARNING: conditions or practices that could result in personal
injury
Note: Important information for avoiding damage to the instrument
or facilitating operation of the instrument.
Note: Patients below the age of 4 may struggle to perform
spirometry correctly and reproducibly
Note: The device should only be used by trained and qualified
personnel.

16
CAUTION: Read the manual before use
WARNING: The instrument is not suitable for use in the presence
of explosive or flammable gases, flammable anaesthetic mixtures or
in oxygen rich environments.
CAUTION: Mouthpieces are single patient use. If used on more than
one patient there is a risk of cross-infection. Repeat use may
degrade materials and lead to an incorrect measurement.”
CAUTION: Pulmonary filters are single patient use. If used on more
than one patient there is a risk of cross-infection. Repeat use may
increase air resistance and lead to an incorrect measurement.”
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
WARNING: To avoid risk of electric shock, this equipment must
only be connected to a supply mains with protective earth
CAUTION: When you connect the SpiroUSB to other equipment,
always make sure that the whole combination complies with the
international safety standard IEC 60601-1 for medical electrical
systems. During measurements, connect the SpiroUSB only to
printers and computers that comply with IEC 60601-1 / ANSI/AAMI
ES60601-1:2005 / CAN/CSA-C22.2 No. 60601-1:14.
Indication for Use
The SpiroUSB spirometer is intended, for prescription use only, to
measure the maximal volume and flow of air that can be moved in
and out of a patient's lungs. The system is intended for use with
paediatric (4 to 17 years) and adult (18 to 99 years) patients in
hospitals, physician offices, laboratories and occupational health
testing environments.

17
Installing SPCS
SPCS is supplied on CD ROM with your SpiroUSB. Install SPCS
according to the instructions in the SPCS quick start guide.
Installing SpiroUSB device driver
The driver enables CareFusion Ltd USB devices to work with USB
enabled PC software on Windows based machines.
Compatibility status
There are two versions of the USB driver. The driver used depends
on the Operating System you are using. There is a driver for
Windows 32 bit Operating Systems and for 64 bit.
The following operating systems are supported:
Windows 7 32 & 64 bit Operating Systems
Windows 8 32 & 64 bit Operating Systems
The driver will not be supported under older Windows Operating
Systems.
Driver installation
If software is installed that provides support for USB, the drivers
may be pre-installed, allowing automatic installation of the drivers
when the device is connected to the USB port. If the device does not
install automatically, download the driver and install the device
manually. The driver can be downloaded from the following
homepage:
www.carefusion.co.uk/our-products/respiratory-care/cardio-
pulmonary-diagnostics/pulmonary-function-
testing/spirometers/spirometry-software-and-firmware-downloads

18
Operation
Simply connect the SpiroUSB to a spare USB port on your PC with
the supplied SPCS installed. SPCS will automatically detect that the
SpiroUSB has been connected to a USB port and will run, ready for
you to start your spirometry session. There is no need to remove
the SpiroUSB between sessions.
Please note that with certain PC configurations, even if a compatible
operating system is being used, SPCS may not be launched
automatically when the SpiroUSB is plugged in. In this case SPCS
may be run in the usual way using the Windows on-screen Start
button.
The SpiroUSB transducer is supplied with a two-meter cable. If this
length is insufficient then a remote USB hub should be used.
Remote USB hubs are readily available from computer accessory
suppliers. For some recent computers the USB signal will work over
a longer distance using an extension cable. An extension cable has
been supplied for your convenience, if required. If communication
problems are encountered using the extension cable, then a remote
USB hub must be used.
Note: Keep the PC and Monitor out of reach of the patient at all
times.
Looking after your SpiroUSB Spirometer
Please observe the following precautions:
Avoid exposing the SpiroUSB to direct sunlight during use.
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
extremes of temperature.
Do not direct the transducer holder towards a strong light source
whilst operating the spirometer.