ndd Medical Technologies
EasyOne-CS Operators Manual Rev B
Operators Manual
310 Pages
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2030434-002 Rev. B
Seite 42
15 Literatur [1] [2] [3] [4] [5] [6] [7] [8] [9] [10] [11] [12] [13]
American Thoracic Society. Standardization of Spirometry: 1994 Update, Nov. 11,1994. Am J Resp Crit Care Med 1995; 152:1107-1136. Occupational Health and Safety Administration (OSHA), Pulmonary Function Standards for Cotton Dust, 29 CFR: 1910.1043 Appendix D. Social Security Administration Disability (SSD) Guidelines, CFR404: Appendix 1 to Subpart P. Ferguson GT, Enright PL, Buist AS, et al. Office spirometry for lung health assessment in adults: A consensus statement from the National Lung Health Education Program. Chest 2000; 117:1146-1161. ATS Pulmonary Function Laboratory Management and Procedure Manual, American Thoracic Society, New York, NY 10019. Enright PL, Hyatt RE. Office Spirometry. Lea & Febiger, Philadelphia, 1987. Hyatt, RE, Scanlon PD, Nakamura M. Interpretation of Pulmonary Function Tests – A Practical Guide. Lippincott – Raven, Philadelphia, 1997. American Thoracic Society. Lung Function Testing: Selection of Reference Values and Interpretative Strategies, Am Rev Respir Dis 1991; 144:1202-1218. Morris JF, Temple W. Short Report: Spirometric „Lung Age“ Estimation for Motivating Smoking Cessation, Preventive Medicine 14. 655-662 (1985). Polgar, Promadhat, Pulmonary Function Testing in Children: Techniques and Standards. W.B. Saunders Co., Philadelphia, 1971. M.R. Miller, R. Crapo, J. Hankinson, et al. ATS/ERS Task Force: Standardization of Lung Function Testing. Numbers 1 to 5. Eur Respir J 2005; 26: 153-161, 319-338, 511-522, 720-735, 948-968. Global Strategy For The Diagnosis, Management, And Prevention Of Chronic Obstructive Pulmonary Disease, Executive Summary, Updated 2003 (GOLD) Hardie et.al., "Risk of over-diagnosis of COPD in asymptomatic elderly never-smokers" Eur Respir J2002;20: 1117-1122
16 Zubehör 2030434-001 2030434-002 2030431-003 2030431-005 2030431-006 2030431-007 2030431-008 2030431-009 2030431-010 73700008
Bitte beachten:
Kurzgebrauchsanweisung EasyOne-CS (GER, ENG, FRE, ITA, SPA, BRA) Gebrauchsanweisung EasyOne-CS (GER, ENG, FRE, ITA, SPA, BRA) Screen-Connector (USB Verbindung zum PC) CD EasyWare V2.9.4 spirette Standard 50 Stück Box spirette Standard 200 Stück Box Nasenklammern, 25 Stück Nasenklammer-Pads, 100 Stück Kalibrationspumpe mit Kalibrationsadapter Alkaline Batterie (2 Stück erforderlich)
Für größtmögliche Patientensicherheit und Störfreiheit sowie zur Einhaltung der angegebenen Messgenauigkeit empfehlen wir ausschießlich das über GE Medical Systems zu beziehende Originalzubehör. Das Verwenden von Fremdzubehör liegt in der Verantwortung des Anwenders.
2030434-002 Rev.B
Seite 47
CH
o
o o o
o
FVC
FVC
o o CH o
o
FVC
FVC
o
unused
o
o o
o
FVC
FVC
o o
o
o
FVC
FVC
o
o
unused
o
o
o
FVC
FVC
o o
o
FVC
FVC
o
o
o
o
o
FVC
FVC
o
o
o o o o o CH o
o
FVC
IVC
o
o
o
o
o o o o o CH
VC
VC
o
o
o
o
o
o
o
FVC
FVC
o
o
ER
o
FVC
FVC
o
o
o
o
FVC
o
o
FEV1 /VC
o
VC
VC
o
o
o
o
VC
VC
o
o
o
VC
VC
o
o
o
FVC
FVC
o
1993
ER
Zapletal
1977
ZA
Forche (Austria)
1988
FO
145..195 (145..210) 115..180 (93..210) 110..200 (110..210)
Sapaldia (Swiss)
1996
SA
18..70 (18..90) 6..17 (4..17) 7..76 (7..90) 18..60 (18..90)
Roca (Spain)
1982
BA
Hedenström + ZA
1985 1986
HE
Gulsvik + ZA
1985
GU
Berglund + ZA
1963
BE
o
o
o
o o
CH
o
o o o
o
o
PEF
FEF75
o
unused
o 76 FEV1 o /FVC
-
FEF25-75
FEF50
FEF25
FEV1/FVC%
FEV1/FEV6%
FEV1
FEV3/FVC%
VC
FEV6
FIVC
FEV3
FVC
o
FEV1/IVC%
Lung Age
PEF
FEF25-75
o
o
FVC
ERS (ECCS / EGKS)
o
o
o
-
o o o
o
o
o o o o o o
o o
o
FVC
FVC
o o
o o
o o
unused
o
o
o
FVC
IVC
unused
o
o
VC
VC
o o o
unused
o
o
o
FVC
FVC
o o
ER ER ER ER ER
FVC
o o
o o o o o
…
unused
o
o
FVC
6..70
110-200 (110..210)
>0
o
o
o
FVC
FVC
o
FEV1 /FVC
20..70 (18..90) 20..70 (18..90) 20..70 (18..90)
150..195 (150..210) 150..190 (150..210) 154..191 (154..210)
female: 45..94
o
o
o
FVC
o o
FEV1 /VC
unused
o
o
VC
VC
o o o
unused
o
o
VC
VC
o o o
120..190 (90..220) 145..195 (90..220)
unused
VC
VC
o o
unused
o
FVC
FVC
o o
o o
JR
FVC
o
FVC
unused
90..220
o
FVC
o o
o
136..182 (90..220)
6..90
o
o
o
o
20..78 (20..)
18..92 (18..)
o
o
o
o
PE
A4
o
o
unused
1992
6..90
o
CH
Pereira
A3
o
FVC
o
unused
A2
FVC
FVC
o o
FVC
100..200
Asia 3
FVC
o
FVC
15..79
Asia 2
o
o
o
o
FVC
CH
6..90
o
o o o
o CH 76 o CH
o
FVC
1972
115..180 (90..220) 115..180 (90..220) 115..180 (90..220) 115..180 (90..220)
o
o
Cherniak
6..90
o
o
4..17
A1
FVC
o
PO
Asia 1
FVC
unused
DO
GO
o
o
unused
1971
1995
o
o
o o
Polgar
Gore, Crockett
FVC
FVC
Dockery (Harvard)
HI
FVC
FVC
6..18
1989
o
o
HS
Hibbert
o
o
1993
8..19 (6..19) 18..78 (18..)
CH
o
1979
JRS 2001
o
unused
Hsu
2001
o
o 76
7..20 (4..20)
Asia 4
FEF75
20..90
o
FEF50
MO
o o
Lower Limit of Normal of Parameter
FEF25
1971 (1976)
FVC
FEV1/FEV6%
CR
Morris
FVC
FEV3/FVC%
Crapo
o
FEV6
8..85 15..91
o o o
FEV3
KN
1981
o
FEV1/VC%
1976
unused
FEV1/FVC%
Knudson_76
6..85
FEV1
KN
VC
Knudson_83
1983 (1976)
FIVC
110..195 (110..210) 107..183/19 6 110..200 (110..210) 146..195 (146..210) 142..203 (142..210) 110..195 (93..210) 115..185 (115..210) 109..170 (90..210)
FVC
8..80 (6..90)
1999
Caucasian African Mexican Asian Other
NH
NHANES III
Weight Range [kg]
Build In
Height Range [cm]
Parameter
MVV
North America Latin America Europe Europe Scandinavia Australia
Age Range [years]
Publ. Year
Reference
Asia
Abbrev.
Ethnic
o
o
o
o
o
o
o
o
ER
ER
ER
ER
o
o
o
o
o
o
o
o
o o o o CH o
o o o
o o
o o o o
unused
o
VC
VC
o o o
o o o o o
unused
o
VC
VC
o o o
o o o o o
unused
o
VC
VC
o o o
o o o o
unused
o
VC
VC
o o o
o o o o
unused
o
o
FVC
o o o
o o o o
o
o
o o
o
o
o
o o
o
Australien Asien
Skandinavien
Europa
Südamerika
Nordamerika
2030434-002 Rev.B
Seite 48
Referenz
Index
NHANES III (Hankinson)
/REF_P01/
John L. Hankinson, John R. Odencrantz, and Kathleen B. Fedan. Spirometric Reference Values from a Sample of the General U.S. Population. Am J Respir Crit Care Med, Vol 159, p 179-187, 1999
Knudson_83
/REF_P02/
Knudson, Ronald J, Michael Lebowitz, Holberg Catherine J., Benjamin Burrows. Changes in the Normal Maximal Expiratory Flow-Volume Curve with Aging. American Review of Respiratory Disease, Volume 127, p. 725-734, 1983.
Knudson_76
/REF_P03/
Knudson, Ronald J, Ronald Slatin, Michael Lebowitz, Benjamin Burrows. The maximal Expiratory Flow-Volume Curve. American Review of Respiratory Disease, Volume 113, p. 587-600, 1976
Crapo
/REF_P04/
Crapo RO, Morris AH, Gardner RM. Reference spirometric values using techniques and equipment that meets ATS recommendations. Am Rev Respir Dis Volume 123, p.659-664, 1981.
/REF_P05/
Morris, James F., Koski, Arthur, Lavon Johnson. Spirometric Standards for Healthy Non-Smoking Adults. American Review of Respiratory Disease, Volume 10-3, p. 57-67, 1971
Morris
/REF_P19/
Publikation
Morris, J.F. West J. Med (1976) 125:110-118
Hsu
/REF_P06/
Hsu KHK, Bartholomew PH, Thompson V, Hsieh GSJ. Ventilatory Functions of Normal children and Young Adults- Mexican- American, White, Black. I. Spirometry. J Pediatr Volume 95, p. 14-23, 1979.
Dockery (Harvard)
/REF_P07/
Dockery, D.W. et al., Distribution of Forced Vital Capacity and Forced Expiratory Volume in One Second in Children 6 to 11 Years of Age, American Rev. of Respiratory Disease. Volume 128, p. 405-412, 1983.
Polgar
/REF_P20/
Polgar, Promadhat, Pulmonary Function Testing in Children: Techniques and Standards. W.B. Saunders Co., Philadelphia, 1971
Cherniak
/REF_P08/
Cherniak, R.M., and Raber M.B. Normal Standards for Ventilatory Function using an Automated Wedge Spirometer. American Review of Respiratory Disease. Volume 106, p.38-46, 1972
Pereira
/REF_P09/
Carlos Alberto de Castro Pereira, Sueli da Penha Barreto, João Geraldo Simõnes, Francisco W.L. Pereira, José Gerson Gerstler, Joge Nakatani. Valores de referência para a espirometria em uma amostra da populacao brasileira adulta, Jornal de Pneumologia 18(1):10-22, maco de 1992
ERS (ECCS, EGKS)
/REF_P10/
P.H. Quanjer. Lung Volumes and Forced Ventilatory Flows. Eur Respir J, Vol 6, Suppl 16, p. 5-40, 1993
Zapletal
/REF_P11/
A. Zapletal, T. Paul, M. Samanek. Die Bedeutung heutiger Methoden der Lungenfunktionsdiagnostik zur Feststellung einer Obstruktion der Atemwege bei Kindern und Jugendlichen. Z. Erkrank. Atm.-Org., Volume 149, 343-371, 1977.
Austria (Forche)
/REF_P12/
G. Forche, K. Harnoncourt, E. Stadlober. Neue spirometrische Bezugswerte für Kinder, Jugendliche und Erwachsene. Öst. Ärzteztg. 43, 15-16, 1988.
Sapaldia
/REF_P13/
SAPALDIA team, O Brändli, CH. Schindler, N. Künzli, R. Keller, A.P. Perruchoud. Lung function in healthy never smoking adults: reference values and lower limits of normal of a Swiss population. Thorax 1996; 51:277-283
Spain (Roca)
/REF_P14/
J. Roca et al. spirometric reference values for a Mediterranean population. Bull Eur Physiopathol Respir, 18:101-102, 1982.
Hedenström
/REF_P15/
H. Hedenström, P. Malmberg, K. Agarwal. Reference values for lung Function tests in females. Bull. Eur. Physiopathol. Respir. 21, p. 551-557, 1985. H. Hedenström, P. Malmberg, H.V. Fridriksson. Reference values for lung function tests in men. Upsala J. Med. Sci., 91:299-310, 1986
Gulsvik
/REF_P16/
A. Gulsvik. Spirometri (Korrespondanser). Tidsskr Nor Loegeforen nr. 31, 105:2240-2, 1985.
Berglund
/REF_P17/
E. Berglund, G. Birath, J. Bjure, G. Grimby, I. Kjellmer, L. Sandqvist, B. Söderholm. Spirometric Studies in Normal Subjects. Acta Medica Scandinavica, Vol. 173, fasc. 2, p. 185-206, 1963.
Hibbert
/REF_P18/
Marienne E. Hibbert, M App SCI, Anna Lannigan, RN, Louis I. Landau, MD, Peter D. Phelan, MD. Lung Function Values From a Longitudinal Study of Healthy Children Adolescents, Pediatric Pulmonology 7:101-109 (1989)
Gore, Crockett
/REF_P19/
C.J. Gore, A.J. Crockett, D.G. Pederson, M.L. Booth, A. Bauman, N. Owen. Spirometric standards for healthy adult lifetime nonsmokers in Australia. Eur Respir J., 1995, 8, 773-782
JRS2001
/REF_P20/
日本人のスパイログラムと動脈血液ガス分圧基準値 日本呼吸器学会肺生理専門委員会２００１年４月
2030434-002 Rev.B
Seite 51
ndd Medizintechnik AG Technoparkstrasse 1, CH-8005 Zürich, Schweiz Tel +41 (44) 445 25 30, Fax +41 (44) 445 25 31, E-Mail [email protected]
Declaration of Conformity Manufacturer:
ndd Medizintechnik AG
Address:
Technoparkstrasse 1 CH-8005 Zürich, Switzerland
declares under its sole responsibility, that the product Product designation: Spirometer Product name:
EasyOne-CS
EasyOne has been classified as Class IIa and is in conformity with the essential requirements and provisions of Council Directive 93/42 EEC, is in conformity with the following standards transposing harmonized standards: EN 1041:1998 EN ISO 14971:2000 and A1 : 2003 EN 50103:1995 EN 60601-1: 1990 and A1 :1993 and A2 : 1995 EN 60601-1-1: 2001 EN 60601-1-2: 2001 EN 60601-1-4: 1996 and A1: 1999 is subject to the procedure set out in ISO 9001, ISO 13485, EN 46001 and in Annex 2 of Directive 93/42/EEC under the supervision of Notified Body Number 0120, SGS Yarsley International Certification Services Ltd., 217-221 London Road, Camberley, Surrey, GU15 3EY.
Zurich, March 4th, 2005
2030434-002 Rev. B
Page 1
Contents 1
Introduction... 3
2
Warning Information ... 3
3
Intended use... 4
4 4.1 4.2 4.3 4.4 4.4.1 4.4.2 4.4.3 4.4.4 4.4.5
Instrument installation ... 4 Setting up the device...4 Operation of the keys ...6 Setting region, language, date, time, altitude (above sea level) and printer type ...6 Installing the PC software ...7 Installation of the EasyWare PC software ...7 Installing the Screen-Connector (driver installation)...9 Installing EasyWare in a network ...9 Installing the CardioSoftTM PC software ...10 Configuring CardioSoftTM...10
5 5.1 5.2 5.2.1 5.2.2 5.2.3 5.3 5.3.1 5.3.2 5.3.3 5.3.4 5.3.5 5.3.6 5.4
Conducting a spirometry test ... 11 Preparations ...11 Conducting a spirometry test in CardioSoftTM ...11 Measuring the forced vital capacity (FVC)...12 Conducting a 'Post' test...14 Displaying a detailed procedure report ...14 Performing a spirometry test directly with EasyOne ...15 Measuring the forced vital capacity (FVC)...15 Adding a spirometry maneuver ...17 Conducting a 'Post' test...17 Saving and retrieving measurements directly in EasyOne...17 Quick Test ...17 Editing patient data...18 Conducting a spirometry test with EasyWare and EasyOne...18
6 6.1 6.2 6.3 6.4 6.5 6.6 6.7 6.8 6.9 6.10
Further explanation of the spirometry tests ... 18 Test type 'FVC (Expiration)' ...19 Test type ‘FVL (Inspiration and Expiration)' ...19 Test type 'Slow VC' ...19 Test type 'MVV'...20 Test type 'OSHA Cotton Dust'...20 Test type 'Disability' ...20 'Post' test...20 Quality messages...20 Interpretation of results...21 Definition of the parameters ...21
7 7.1 7.2 7.3 7.4 7.5 7.6 7.7 7.8 7.9 7.10 7.11 7.12 7.13 7.14 7.15 7.16 7.17 7.18
EasyWare PC software... 22 EasyWare’s main window ...22 PC database...23 Displaying patient data ...23 Entry of patient data ...23 Deleting records...23 Test result preview ...24 Online test ...25 Pediatric animation ...25 Trend display ...25 Searching for records ...26 Printing a test...26 Exporting records ...26 Importing records...27 Selecting the EasyOne instrument for the database view ...27 Device status ...27 Device Configuration ...27 Program Preferences ...27 Language Selection ...27
2030434-002 Rev. B
Page 2
8 8.1 8.2 8.3 8.4
Device Configuration... 28 Operating modes 'Diagnostic', 'Frontline' and ‘NLHEP.’ ...28 Test Settings ...28 System Configuration ...29 Print Settings ...30
9 9.1 9.2 9.3
Quality messages and quality grades ... 31 Quality messages...31 Quality Grades ...31 Best Test Selection...32
10 10.1 10.2
System Interpretation ... 33 NLHEP System Interpretation ...33 GOLD/Hardie System Interpretation...34
11 11.1 11.2
Predicted Values... 35 Predicted Values for Adults ...35 Predicted Values for Children ...35
12
Hygiene and instrument maintenance... 36
13
Calibration Check... 36
14
Troubleshooting Tips ... 37
15
Bibliography... 39
16
Accessories ... 39
17 17.1 17.2
Appendix A: Specifications... 40 EasyOne-CS Model 2001 Spirometer ...40 EasyOne-CS Model 2010 Screen-Connector ...40
18
Appendix B: Text file export format... 41
19
Appendix C: Predicted Normals ... 43
20
Appendix D: Electromagnetic Compatibility (EMC)... 46
Version history Version 2030434-002 Ver. A 2030434-002 Rev.B
Description First edition for EasyOne-CS Revised pages: 2, 3, 4, 40, 41, 43 (ECO087884), updated pictures
Date 27 Sept. 2006 7 November 2007
Target reader group This Operator Manual is intended for specialist medical staff with practical knowledge of medical workflow and applications and familiar with the terminology required for conducting these procedures. The information in this document may be amended at any time and without prior notice. Copyright© 2007 by ndd Medizintechnik AG, Switzerland. All rights reserved EasyOne and the spirette are protected by one or more of the following patents: EP 0597060, EP 0653919, US 5419326, US 5503151, US 5645071 and US5647370. CardioSoftTM and CASETM are brands of GE Medical Systems Information Technologies GmbH, a company of the General Electric Company, trading under the name of GE Healthcare.
2030434-002 Rev. B
Page 3
1 Introduction Thank you for choosing the EasyOne Spirometer. With EasyOne you have chosen a high quality spirometer that minimizes the need for maintenance due to its unique ultrasound technology. EasyOne does not need calibration and remains consistently accurate over years. The spirette™ breathing tube assures perfectly hygienic conditions for every patient at low cost even if the spirometer is frequently used. The EasyOne-CS Spirometer contains the Screen-Connector and the related EasyWare PC software, in addition to the CardioSoftTM software used for patient data management. The measurement curves can be displayed in real time on the PC monitor with the EasyOne-CS Screen-Connector.
2 Warning Information The following terms are used as follows in this document:
Caution:
Possibility of injury or serious damage
Please note:
Important information for avoiding damage to the instrument or facilitating operation of the instrument
Please note the following information on safe operation of the EasyOne-CS spirometer: Important. Note the Operator’s Manual. Application part, Type BF. The product described in this Operator’s Manual may not be disposed of as regular, non-separated domestic waste but must be disposed of separately. Please contact an authorized representative of the manufacturer to obtain information on disposal of your unit. Catalogue number. Serial number. E marked per the Medical Device Directive 93/42/EEC of the European Union. The notified body is SGS Yarsley International Certification Services Ltd.
CSA International classification mark.
Manufacturer’s identification. Date of manufacture.The number found under this symbol is the date of manufacture in the YYYY-MM format. Caution:
The instrument is not suitable for use in the presence of explosive or flammable gases.
Caution:
Connect only computers complying with Standard IEC 60950-1 or IEC 60601-1.
2030434-002 Rev. B
Page 4
Caution:
For AA batteries, do not attempt to charge, connect improperly, or dispose of in fire as there is possibility of leakage or explosion. Follow manufacturer’s recommendation for proper disposal.
Caution:
Calibration and servicing may be carried out only by GE (General Electric) or ndd staff. Do not open the device.
Caution:
Pulmonary function tests require maximum effort on the part of the patient and may lead to sensations of dizziness or giddiness.
Please note:
The unit may be calibrated only by GE Medical Systems Information Technologies After-Sales Servicing Department. Do not open the device.
Please note:
Please use only long-life batteries (alkaline batteries). Rechargeable batteries may not be used. Remove the batteries from the battery compartment if you do not intend to use the device for long periods. Ensure that the battery compartment cover is properly closed since patient safety may depend on this.
Manufacturer: ndd Medizintechnik AG Technoparkstrasse 1, CH-8005 Zurich, Switzerland Tel.: +41 44 445 29 70 Fax: +41 44 445 25 31 Web: www.ndd.ch Distributor: GE Medical Systems Information Technologies, Inc. 8200 West Tower Avenue, Milwaukee, WI 53223 USA Tel.: +1 414 355 5000 +800 558 5120 (USA only) Fax: +1 414 355 3790
3 Intended use The EasyOne-CS is designed for conducting simple spirometric measurements on adults and children over the age of 4 by general practitioners, specialists, in occupational medicine and in hospitals. The EasyOne-CS spirometer is used together with the spirette™ respiratory tube in order to conduct slow and forced spirometric maneuvers and MVV tests.
4 Instrument installation 4.1 Setting up the device The EasyOne Spirometer is supplied with Screen-Connector (USB connection to PC), two alkaline AA batteries, four spirettes, one nose clip, ten nose clip pads, one CD-ROM containing the EasyWare PC software and one CD-ROM containing the CardioSoftTM software.
2030434-002 Rev. B
Page 5
Install the two AA alkaline batteries (included) in the compartment on the rear of the spirometer, taking care to match the polarity marking on the batteries with the markings inside the battery compartment. Caution:
Do not attempt to charge or burn the AA batteries used in the instrument. Please follow the manufacturer's instructions on battery disposal.
Please note:
Please use only long-life batteries (alkaline batteries). Rechargeable batteries may not be used. Remove the batteries from the battery compartment if you do not intend to use the device for long periods. Ensure that the battery compartment cover is properly closed since patient safety may depend on this.
Please note:
A low battery message will alert you when battery power falls below 10%. Data saved in memory is not lost when battery power is low, or when batteries are removed.
Install the spirette™ as shown. Be sure to orient the spirette™ so that the arrow on the spirette™ lines up with the arrow on the spirometer.
Caution:
Connect only computers complying with Standard IEC 60950-1 or IEC 60601-1.
2030434-002 Rev. B
Page 6
4.2 Operation of the keys (ON/OFF)
This switches EasyOne-CS on or off. Press and hold the key (for at least 2 sec.) until you hear an audible signal.
(ENTER)
This confirms data entry or the selection and moves you to the next entry field.
(<)
Deletes last character, scrolls to the left or up.
(>)
Scrolls to the right or down
(0,ESC)
Press the key briefly in order to enter (0), keep the key pressed longer (at least 1 sec.) in order to return to the previous field with (ESC) or abort the operation, press the key briefly twice in order to enter a blank (the key function operates only if letters can be entered).
(2,abc), etc.
Press the key briefly in order to enter the digit "2", press the key briefly in order to enter "A" (the key function operates only if letters can be entered), press the key briefly twice in order to enter "B" (the key function operates only if letters can be entered), if you press the same key quickly several times consecutively, you will scroll first to the upper-case letters, then to the number and then to the lower-case letters, umlauts and special characters can be found on key (1).
Please note:
The escape key (Esc-0) is particularly helpful and important in unit navigation. The escape function requires the key to be pressed and held momentarily. Escape is useful for moving to previous menus, items, or fields, and escaping a spirometry test. Pressing this key rapidly in fields where letters are possible, such as patient name and report header, allows the entry of a blank space or a zero.
4.3 Setting region, language, date, time, altitude (above sea level) and printer type Press the (ON/OFF) key for at least 2 seconds in order to switch on the instrument. The instrument switches off automatically if no key is pressed for 15 minutes. You will see a world map on the display when you switch the instrument on for the first time:
Choose your region (North America, South America, Europe, Asia, Africa or Australia) using the arrow keys < > and confirm your entry with ENTER. You are then prompted to choose your language and to set the date, time, contrast, altitude above sea level and the approximate relative humidity at the instrument’s location. This data is not preset. Note that the region can be selected only once. You must use the “Device Configuration / Reset Device” menu to choose a new region. The spirometer is delivered with the pre-set default settings. Please refer to Chapter 8 of this User Manual for the procedure for changing the settings. Adapting the settings to your needs allows you to get the most out of your EasyOne-CS instrument.
2030434-002 Rev. B
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After the above-specified settings have been entered for the first time, all settings apart from the region, can be changed at any time using the DEVICE CONFIGURATION menu item in the main menu. Alternatively, you can change the settings using the PC software.
4.4 Installing the PC software The minimum requirements for installing the PC software are as follows: Operating system: Microsoft Windows 2000 (min. SP4), XP Home and Professional (min. SP2) Processor: Pentium ≥1.6 GHz Screen resolution: SVGA 1024 x 768 Hard disk memory: 4 GB (depending on number of procedures), 300 MB free RAM: 256 MB Internet Explorer: Microsoft Internet Explorer 6.0 or higher (Please refer to the corresponding manual for detailed information for CardioSoftTM)
4.4.1 Installation of the EasyWare PC software You will require Administrator privileges to install the software. Proceed as follows: • • •
Do not yet connect the Screen-Connector to the PC. You will require Administrator privileges on the PC in order to install the software. Quit all programs and insert the EasyWare CD into your CD ROM drive. The installation routine should start automatically within 30 seconds of inserting the CD. If the installation routine does not start automatically, switch to directory ‘Setup’ on the CD-ROM and run the Setup.exe program. You will then see the following window:
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Click on "Next >".
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Enter the user name under "User Name" and enter a name for your organization under "Organization". In the bottom part of the window, you can still select whether this application is to be installed for all users ("Anyone who uses this computer") or for you only ("Only for me"). Now click on "Next >".
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Click on "Next >" to confirm the displayed installation path. If you wish to change the displayed installation path, you can do this by clicking on "Change…"
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Confirm the summarized installation information by clicking on "Install".
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Click on "Finish".
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Macromedia Flash Player must be installed on your system in order to display the pediatric animation. Confirm installation by clicking on “Yes”. Your computer may need to be restarted during this installation procedure under certain circumstances.
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Confirm completion of installation by clicking on "OK". Remove the CD from the drive.
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An EasyWare icon will have been installed on your desktop after installation. Launch EasyWare. When EasyWare is launched for the first time, you are prompted to choose the language and enter the software serial number. Enter the software serial number that is provided on the CD-ROM sleeve and then quit EasyWare.
4.4.2 Installing the Screen-Connector (driver installation) The corresponding driver must be installed in order to install the Screen-Connector. After installation of the EasyWare PC software is complete, connect the Screen-Connector USB connector to a free USB port on your PC. Caution:
Do not touch the contacts of the Screen-Connector.
Proceed as follows under Windows XP: • • • •
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Message 'Found New Hardware' is displayed. The 'Found New Hardware Wizard’ is displayed. When prompted whether to make a connection to Windows Update answer “No, not this time”. Click on ‘Continue’. Choose “Install the software automatically (Recommended)”. Click on 'Continue'. You will see the following message after the driver has been found on the system:
Accept the proposed driver and choose "Continue Anyway". Complete driver installation by choosing “Finish” in the last dialog box. You will now also see a message indicating that the software is ready to use.
Under Windows 2000: Connect the Screen-Connector to a USB port on your PC. Hardware detection is started automatically and the driver is installed. No user entries are necessary.
4.4.3 Installing EasyWare in a network • •
Install EasyWare on each PC on which you wish to use EasyWare and set the following configuration. You will require Administrator privileges to install the software. During installation, choose the option for allowing all users to use the software. After installation, you will need to start the software once with Administrator privileges. Now enter the software serial number and define the location of the database using Properties in the File menu:
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Enter the complete path and name of the database under ‘Database path and name’. You can also search for an existing database with the ‘Search’ button. If you do not yet have a database, enter "EasyWare.mdb" for instance as the name of the database. After EasyWare has been installed correctly, you can access an EasyWare database from different PCs at the same time. If you have several EasyOne devices, you can also synchronize several EasyOne devices with the same database at the same time.
Please note: EasyWare is not intended for installation on a CASETM system. This is why procedures recorded in the network with EasyOne can be displayed only as a summary and not as a detailed report on a CASETM system.
4.4.4 Installing the CardioSoftTM PC software You will require Administrator privileges to install the program. 1. Switch on your computer and monitor. Quit all programs (including programs running in the background). 2. Insert the CardioSoftTM CD in the CD-ROM drive. If the installation routine is not started automatically, follow instructions 3 to 5. 3. Click on Start -> Run. 4. Enter the following at the command prompt: X:Disk1Setup (X = Name of CD-ROM drive, e.g. "E" or "D"). 5. Click on OK. 6. Follow the instructions on screen. 7. Confirm the two proposed directories with Continue. 8. Enter the serial number (see CD-ROM). CardioSoftTM is now installed on your computer. 9. Restart Windows. Please note: You will require at least Version V6.5 of CardioSoftTM for operation with EasyWare. The CD-ROM contains the User Manual for CardioSoftTM.
4.4.5 Configuring CardioSoftTM You must set the following configuration in order to use CardioSoftTM together with the EasyWare software: Choose 'System Configuration' and then the 'Devices' tab. Make the following settings: • •
Path to external program: enter the installation path of EasyWare at this point. Use the button to the right of the entry field for this. Normally, it will be C:Programsndd MedizintechnikEasyWareEasyWare.exe. Enter the text ‘Spirometry' under 'Procedure Name for External Program'.
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Please note: Do not check the 'Use External Program for Spirometry Devices' checkbox. •
Automatic PDF-Export can be activated in CardioSoft as follows: − Select dialog "System Configuration" and click "Export…" − Enter the name of your PDF printer driver. − Select check box "Generate automatic file name" o Select the patient and/or test information to be included in the file name that the system will generate automatically. − Select check box "Export after each examination: PDF".
Please note: The PDF-Export Directory depends on the settings of the corresponding printer driver.
5 Conducting a spirometry test Caution:
If operating with the Screen-Connector, always connect EasyOne to the ScreenConnector first before connecting the Screen-Connector to the PC. When disconnecting, always disconnect the USB connector from the PC first before disconnecting the Screen-Connector from EasyOne.
5.1 Preparations Prepare for testing by having the patient loosen tight clothing, remove dentures, and relax. The patient may sit or stand. If standing you may want to perform testing in an area free of sharp table or counter edges, or have a chair handy as there is a slight possibility that the patient could faint during the strenuous spirometry maneuver. Explain that the purpose of the test is to determine how much air a person’s lungs can hold and how quickly that air can be expelled with a forceful, maximal effort. Since the spirometry test requires active participation by the patient it is very important to demonstrate the maneuver for the patient. Emphasize the essential elements of the test: • • • •
filling lungs completely sealing lips around the spirette™ so that there are no leaks, taking care not to block its opening with teeth or tongue or bite down excessively blasting out as hard and fast as possible continue blowing out until the lungs are completely empty
If you are new to spirometry, you should practice testing yourself and others prior to testing patients. You will learn to recognize a poor effort by observing the patient and/or interpreting the Quality Messages displayed by the spirometer after each effort. After a poor effort you must explain what went wrong. Develop enthusiastic coaching techniques to use during the maneuver to maximize your chances of getting quality results with a minimum number of efforts. Caution:
Pulmonary function tests require maximum effort on the part of the patient and may lead to sensations of dizziness or giddiness.
5.2 Conducting a spirometry test in CardioSoftTM This Chapter describes the procedure for conducting a spirometry test with CardioSoftTM, the EasyWare spirometry software and EasyOne-CS. Launch CardioSoftTM. In CardioSoftTM, choose a new patient. Select 'Spirometry (external program)' as the type of procedure and click on the 'Select' button. The following dialog box is displayed if EasyOne is not yet switched on or connected to the PC via the Screen-Connector.
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Follow the instructions and click on 'OK'. You will now see a window with the patient data that has been imported directly from CardioSoftTM:
If the patient information is incomplete (missing date of birth for instance) or if the patient data lies outside of the permitted range1, you will see a corresponding error message. If necessary, you can add the ethnic group, asthma status and smoker status to the patient data. Confirm the window with OK. You will see the following display:
5.2.1 Measuring the forced vital capacity (FVC) • • • •
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Insert a spirette™ into the instrument. When doing this, please ensure that the arrow on the spirette™ is lined up with the arrow on the instrument. Use the arrow keys to choose the test type, in this case FVC, and confirm your selection with (ENTER). Press ENTER when the patient is ready. You will now hear the sensor buzz. The instrument prompts you to avoid flow in the spirette™ while it is setting the baseline. It is necessary to block off the spirette™ at one end in order to ensure that the baseline is set precisely. An audible signal sounds when the baseline is set. You will see the prompt "Blast out…" on the screen. Hand the instrument to the patient and ask the patient to breath in deeply first, then to insert the spirette™ correctly into his or her mouth, to exhale as firmly and quickly as possible and to
Permitted ranges: age 4 to 120, height 60 to 250 cm, weight 0 to 250 kg.
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continue exhaling until all the air has been exhaled. The illustration below shows EasyOne in use (but not using the Screen-Connector).
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The flow volume and the volume-time curve are displayed online on screen during the test. Alternatively, a pediatric animation can be used for FVC tests (see Chapter 7.8). The complete flow-volume and volume-time curves are displayed at the end of the spirometry maneuver at the left on screen, and the measured values are shown at the right. An assessment of the measurement and information on how to continue are shown in red beneath the graph with the measured values.
In order to assess the pulmonary function of the patient, it is necessary to obtain acceptable test quality. The test quality depends on co-operation of the patient and this, in turn, depends on the quality of the physician's instructions. Consequently, EasyOne incorporates an automatic quality control function with prompts to facilitate the physician's job of providing the patient with good instructions. After each maneuver, a message on the screen will inform you as to whether the maneuver was acceptable or not. If not, the message will guide you on how to coach the patient to do better (please see Chapter 6.8 for details): Only one of the above prompts is shown after a maneuver. As soon as you see message "Session complete…", you need not conduct further maneuvers. If, even after repeated attempts, it is not possible to obtain an adequate number of good maneuvers, you should take a break, de-
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pending on how the patient feels or stop measurement. The results are saved even if the measurement is aborted. Now conduct the next test by pressing the (ENTER) key on the EasyOne. Comments can be entered even during the test by entering a reviewer name in the text box at the bottom left. At least three acceptable spirometry maneuvers must have been performed for a complete spirometry measurement. If this is the case, you will see message "Session Complete! Great Job!". A quality grade from A to F is displayed at the end of the test. It provides information on the overall quality of the test. Please refer to 9.2for further information on the quality grades. You can quit or cancel the test at any time by clicking on "Close". Clicking on "Print / Close" ends the test, after which the results are printed out directly. After you click on "Close", the data is synchronized between EasyOne and PC. Please wait a moment until this has been done. The following is then displayed on screen:
The following spirometry tests can be conducted with EasyOne-CS: FVC (expiration), FVL (Inspiration and Expiration), Pre/Post Tests, SVC test and MVV. A detailed description of the test types can be found in Chapter 5.4. The procedure for performing the other test types is equivalent to that for conducting an FVC test.
5.2.2 Conducting a 'Post' test In order to conduct a 'Post' test, choose a patient who has already undergone a spirometry test that day in CardioSoftTM. Proceed in precisely the same way as described in the preceding chapter. After choosing the patient, you will then see a window prompting you to specify whether you wish to conduct a 'Post' test or a normal ('Pre') test with this patient. If you answer this prompt with 'Yes', the data of the 'Pre' test will already be shown in the online Test window. Now conduct the 'Post' test on the patient. If several 'Pre' tests have already been conducted on the same day on a patient, you can choose to what test a 'Post' test is to be added if conducting a 'Post' test. See Chapter 6.5 for explanatory information on 'Post' test and more detailed information.
5.2.3 Displaying a detailed procedure report Please proceed as follows to display a detailed spirometry procedure report in CardioSoftTM. Choose the procedure on a patient in CardioSoftTM. Click on the ‘View’ button. A summary of the external procedure is displayed. Click on the ‘Detailed Report’ button to view a detailed report. You will see the following display:
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You now have the following options: •
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Print: Choose the ‘Print’ button on the report display to print out the detailed procedure report. EasyOne offers a number of print options, see Chapter 8.4. The selection of the printer is taken directly from CardioSoftTM. If this is not possible, the Windows default printer is used. The header lines on the printout are also taken from CardioSoftTM. Choose “System Configuration” for this in CardioSoftTM and enter your data in “Institution Name and Address”. Add Comments: Additional fields for adding comments to the record are shown below the curve display. Enter the name of the reviewer and enter the comments in the large field beneath. After you close with OK, the comments are transferred to CardioSoftTM. The comments are also shown on the printout. Delete procedure: Proceed as follows in order to delete a procedure: you will see a ‘Delete’ button in the display of the test results at the bottom right. Click on this button and, after you confirm a prompt asking whether you really wish to delete, the test is deleted both from the EasyWare database and from the CardioSoftTM database (after a prompt asking you whether you do really wish to delete). Quit: Clicking on this button closes the detailed test view and returns you to CardioSoftTM.
5.3 Performing a spirometry test directly with EasyOne This Chapter describes the procedure for conducting a spirometry test if using only EasyOne, i.e. EasyOne is not connected to a USB port of the PC via the Screen-Connector. The tests conducted in this way cannot be exported to the CardioSoftTM database.
5.3.1 Measuring the forced vital capacity (FVC) • • • •
Insert a spirette™ into the instrument. When doing this, please ensure that the arrow on the spirette™ is lined up with the arrow on the instrument. Choose “Perform Test” in the main menu and then NEW. Confirm with ENTER. The instrument will now allow you to enter the patient data. Enter the corresponding patient data line by line. Use the keys as described in Chapter 0. Confirm with ENTER each time. Enter the patient data. You then move to the TEST menu. Choose the “FVC-forced Ex test“ and confirm with (ENTER).
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Once again briefly prepare the patient for the test. When the patient is ready, press ENTER. You will now hear the sensor buzzing. The instrument now prompts you to avoid air flow in the spirette™ since it is setting the baseline. It is advisable to block off the spirette™ on one end in order to ensure that the baseline is set precisely even if the room is draughty. An audible signal will sound when the baseline has been set. You will see prompt "Blast out" on the screen. Hand the instrument to the patient. Ask the patient to breathe in deeply, insert the spirette™ correctly into his or her mouth. Now ask the patient to exhale as firmly and as quickly as possible, and continue exhaling until all air has been exhaled.
The flow-volume curve, the measured values for FEV1 and FVC and the variability of these measured values are displayed after the end of the spirometry maneuver. Confirm this display with (ENTER). The next display is used to assess the quality of the measurement. In order to be able to assess the lung function of the patient, it is necessary to achieve a result with acceptable test quality. The test quality depends on the cooperation of the patient and this, in turn, depends on the quality of the instructions given by the examiner. Consequently, EasyOne-CS features automatic quality control with prompts to make it easier for the examiner to give good instructions to the patient. After each spirometry maneuver, a message is displayed on screen, providing information on whether the spirometry maneuver was acceptable and, if it was not, what should be done better. You can find details in Chapter 9.1. You can now conduct the next test (CONTINUE), view the data of this test (DATA) and cancel the test (CANCEL) by pressing the arrow keys and (ENTER). At least three acceptable spirometry maneuvers must be performed for a complete spirometry measurement. Message “Session Complete! Great Job!” is then displayed. A quality grade from A to F is displayed at the end of the test. It provides information on the overall quality of the test. Please refer to Chapter 9.1 for further information on the quality grades. If, even after repeated attempts, it is not possible to obtain an adequate number of good maneuvers, you should take a break, depending on how the patient feels or stop measurement. Even after a break, the measurement is stored and can be printed out under “Print results” in the main menu. You also have the option of adding tests subsequently. Please also read Chapter 5.3.2 for more on this. You can view the result on screen (DAT) with the arrow keys. In order to print the result, click on the PRINT button and press (ENTER). Connect the instrument to the PC for this purpose. The report is then printed out.
The following spirometry tests can be conducted with EasyOne-CS: FVC (Expiration), FVL (Inspiration and Expiration), Pre/Post Tests, SVC test and MVV. A detailed description of the test types can be found in Chapter 5.4. The procedure for conducting the other test types is equivalent to that for conducting an FVC test.