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Cosmed SpirHOMEter User Manual Download Page 1

Cosmed does not assume the liability for interpretation mistakes of this
documentation or for casual or consequential damages in connection with the
provision, representation or use of this documentation.
No parts of this manual may be reproduced or transmitted in any form without
the express permission of COSMED Srl.
COSMED Software can be installed only in one device.
Excel is a registered trademark of Microsoft Corporation.
DBIII is a registered trademark of Bordland International Inc.
Lotus 123 is a registered trademark of Lotus Development Corporation .

SpirHOMEter User manual, V Edition
10/2004

Copyright © 1999 COSMED
Copyright © 2003 COSMED

COSMED Srl - Italy
http://www.cosmed.it
Part N. C02046-02-91

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Summary of Contents for SpirHOMEter

Page 1: ...transmitted in any form without the express permission of COSMED Srl COSMED Software can be installed only in one device Excel is a registered trademark of Microsoft Corporation DBIII is a registered trademark of Bordland International Inc Lotus 123 is a registered trademark of Lotus Development Corporation SpirHOMEter User manual V Edition 10 2004 Copyright 1999 COSMED Copyright 2003 COSMED COSME...

Page 2: ...13 Medical Device Directive CE mark 13 Keynotes 14 Typographic keynotes 14 Graphic keynotes 14 Before starting 15 Checking the packing contents 15 SpirHOMEter standard packaging 15 Kit software SpirHOMEter standard packaging 15 Warranty registration 16 Register the product via software 16 How to contact COSMED 16 Complain feedback and suggestions 16 PC configuration required 17 Technical features ...

Page 3: ...t up patient data 26 Set up the device 27 Software installation 28 Installing the software 28 Run the software 28 PC port configuration 28 Software main features 29 Display 29 Tool bar 29 Show hide the toolbar 29 Dialog windows 29 Use of the keyboard 29 Use of the mouse 29 Scroll bars 30 On line help 30 Software version 30 Calibration 31 Turbine calibration 32 Database Management 33 Settings 34 Gr...

Page 4: ...lete the archive 41 Backup and restore 41 Backup 41 Restore 42 Spirometry 43 Setting spirometry options 44 Spirometry 44 Automatic Interpretation 44 Quality control 45 Parameters manager 45 Predicted values manager 46 Predicteds set 46 Set the current predicted 47 Formula definition 47 Page set up 48 Spirometry tests 50 Tips for correct use of the device 50 Keyboard 50 Drugs 50 Recording the sever...

Page 5: ...he turbine 62 Suggested disinfection solutions 62 Inspections 62 Replace the batteries 63 Appendix 65 Service Warranty 66 Warranty and limitation of liability 66 Return goods policy for warranty or non warranty repair 67 Repair Service Policy 67 Privacy Information 69 Personal data treatment and purposes 69 How your personal data are treated 69 The consent is optional but 69 Holder of the treatmen...

Page 6: ...6 SpirHOMEter User Manual ...

Page 7: ...Getting started ...

Page 8: ...on respect of the hereunder reported precautions and instructions Warnings The device the program algorithms and the presentation of measured data have been developed according to the specifications of ATS American Thoracic Society and ERS European Respiratory Society Other international references have been followed when these were not available All bibliography references are reported in Appendi...

Page 9: ...or users and equipment 3 Before powering the system check the power cables and the plugs Damaged electrical parts must be replaced immediately by authorised personnel 4 Cleaning residue particulates and other contaminates including pieces of torn or broken components in the breathing circuit pose a safety risk to the patient during testing procedures Aspiration of contaminates can potentially be l...

Page 10: ...emission displays 10 It is necessary to make the PC connected to the SpirHOMEter compliant with EN 60601 1 by means of an isolation transformer 11 Graphical symbols used in accordance to present specifications are described here below Equipment type B EN60601 1 Danger high temperature OFF ON Protective earth ground Alternating current ...

Page 11: ...mation Absolute contraindications Post operating state from thoracic surgery Severe instability of the airways such as a destructive bronchial emphysema Bronchial non specific marked hypersensitivity Serious problems for the gas exchange total or partial respiratory insufficiency Relative contraindications spontaneous post pneumothorax state arterial venous aneurysm strong arterial hypertension pr...

Page 12: ...ir oxygen or nitrogen protoxide If not otherwise stated in the shipping documents Cosmed equipment have been conceived for operating under normal environmental temperatures and conditions IEC 601 1 1988 EN 60 601 1 1990 Temperature range 10 C 50 F and 40 C 104 F Relative humidity range 20 to 80 Atmospheric Pressure range 700 to 1060 mBar Avoid to use it in presence of noxious fumes or dusty enviro...

Page 13: ...0 ordinary equipment unprotected against water penetration Non sterile device Device not suitable in the presence of flammable anaesthetics Continuous functioning equipment EMC SpirHOMEter meets the EMC Directive 89 336 EN 60601 1 2 EN 55011 Class B emission IEC 1000 4 2 IEC 1000 4 3 IEC 1000 4 4 Quality Assurance UNI EN ISO 9001 2000 Registration n 387 A Cermet Medical Device Directive CE mark MD...

Page 14: ...e the typographic keynotes used in the manual Style Description Bold indicates a control or a key to be pressed Italic indicates a messages shown by the firmware Graphic keynotes These are the graphic keynotes used in the manual Illustration Description shows the button to click in the software to activate the related feature ...

Page 15: ...ms listed below In case of missing or damaged parts please contact your nearest COSMED technical assistance SpirHOMEter standard packaging Code Qty Description C00486 01 05 1 SpirHOMEter unit C00033 01 05 1 Turbine A 662 100 001 1 Nose clips C00063 01 20 2 Conic mouthpiece C00066 01 10 1 Carrying case A 410 110 001 4 AAA battery 1 5 V C00067 02 94 1 Registration card C01999 02 DC 1 Conformity decl...

Page 16: ...software it is possible to fill in an electronic form with the customer information 1 To run the software double click on the icon Registration or select Registration from menu 2 Type the requested information and click Send to send the form via e mail to COSMED How to contact COSMED For any information you may need please contact the manufacturer directly at the following address COSMED S r l Via...

Page 17: ...onfiguration required Pentium 133 MHz Windows 95 98 XP 16 Mb RAM 3 5 drive VGA SVGA monitor Serial Port RS 232 available Any Mouse and Printer compatible with the MS Windows operative system PC conform to European Directive 89 336 EMC ...

Page 18: ...al turbine Flow Range 0 03 20 l s Volume Range 12 l Accuracy 3 or 50 ml Resistance 12 l s 0 7 cmH2O l sec Memory 120 tests Display LCD 2 lines x 16 char Keyboard 4 multi function keys Serial port RS232C Power supply 4 AAA 1 5V batteries Dimensions 175 x 35 x 35 mm Weight 120g ...

Page 19: ...Measurements ...

Page 20: ... Flow 25 of the FVC Vmax50 l sec Expiratory Flow 50 of the FVC Vmax75 l sec Expiratory Flow 75 of the FVC FEF25 75 l sec Mid exp flow between 25 75 FVC FET100 sec Forced expiratory time FEV2 l Forced Expiratory Volume in 2 sec FEV3 l Forced Expiratory Volume in 3 sec FEV2 FVC FEV2 as a percentage of FVC FEV3 FVC FEV3 as a percentage of FVC FEV1 VC Tiffenau index FEF50 75 l sec Mid exp flow between...

Page 21: ...Installation ...

Page 22: ... the device 4 Close the battery compartment It is suggested to replace the batteries only if you have the new ones The SpirHOMEter without batteries retains the stored data only few minutes Note If you don t use the SpirHOMEter for a long time remove the batteries being careful to save on the PC the tests in the unit memory Install the turbine Remove the transparent wrapping and insert the turbine...

Page 23: ...n the device Set the on off switch to I Note If the switch is already set to I but the display doesn t show anything turn off and then turn on the device The SpirHOMEter if not used turn off itself automatically after about one minute ...

Page 24: ...rs they represent on the keyboard 0 1 2 and 3 respectively Access to Control Menu 1 Hold the key 3 down and at the same time switch on the device by setting the on off switch to I 2 Release the key 3 and the display panel will display a menu different from that accessible by the patient 2 Calib 3 Config 1 Trans 0 Cancel By pressing the respective keys it is possible to 0 delete all the data stored...

Page 25: ... will appear on the display of the device MEMORY EMPTY Press any key Transmit data to the PC This function is described in the chapter Database management Calibrate the flowmeter This function is described in the chapter Calibration Set up date and time In order to set up the date and the time 1 Access the control menu 2 Press the key 3 to enter in configuration 3 Press the key 3 date Date Time 05...

Page 26: ...At the end of the entry set up the character 7 Confirm with the key 0 Set up patient data This function allows the user to set up the ID code and the best PEF of the patient It is very important setting up correctly the ID code of the patient this code is used to refer the test data transmitted to the PC through serial or modem connection to the proper patient card To set up the patient data 1 Acc...

Page 27: ...e SpirHOMEter is left without power for a relatively long period of time when turned on it displays the following message Setup the memory Note When this message appears any data stored in the device are lost Delete the stored data as already described ...

Page 28: ...ver the program will advise you with a message indicating that the installation has been successfully completed click on End Notice The software is copy protected Install the software from the original disk Run the software 1 In the Windows Start menu open the Program Group in which the software was installed 2 Click the SpirHOMEter icon PC port configuration The first time the software is used it...

Page 29: ...g function is shown in a label Show hide the toolbar Select Toolbar from Options menu in order to show or hide the toolbar Dialog windows The typical operating environment of Microsoft Windows is the Dialog box This window is provided with a series of fields in which input the information Use of the keyboard To move the cursor among fields press the Tab key until you reach the desired field Press ...

Page 30: ...des of the scroll fields On line help COSMED Help is a complete on line reference tool that you can use at any time Help is especially useful when you need information quickly or when the user manual is not available Help contains a description of each command and dialog box and explains many procedures for accomplishing common tasks To get the Help on line press the F1 key Software version To kno...

Page 31: ...Calibration ...

Page 32: ... appear 2 New K 128 1 Standard 0 Esc 3 To cancel the operation press the key 0 4 To restore the factory settings press the key 1 5 To carry out a new calibration connect the calibration syringe to the turbine and press the key 2 6 Perform 2 or 3 complete inspirations expirations and wait for a message similar to the following one Pred Meas Corr 3 00 3 32 9 7 Pred represents the real syringe volume...

Page 33: ...Database Management ...

Page 34: ... appearance 1 Select the desired colours of the curves 5 curves max can be overlapped on the same graph 2 Enable or disable the Grid option 3 Enable or disable the Show Info Test option Serial port You must select the serial port RS 232 that will be used to connect the SpirHOMEter with the PC To select the serial port click on the proper COM button the selected port must be different from the mous...

Page 35: ...Card and Test card where it is possible to store the information about patients and visits Besides the standard information it is possible to customise some fields user free fields entering and labelling measurements coming from other devices The customisable free fields are 3 fields in the Patient Card Patient s information 3 fields in the Visit Card information about the visits 3 fields 2 numeri...

Page 36: ...each patient there is only one Patient Card which is created the first time the Patient performs a test To move within the database use the following buttons Move to the first patient in the archive Move to the previous patient in the archive Move to the next patient in the archive Move to the last patient in the archive Find a patient in the archive Enter a new patient in the archive Delete curre...

Page 37: ...next visit in the archive Move to the last visit in the archive Find a visit in the archive Enter a new visit card in the archive Delete current visit card from the archive Edit the current visit card Test Card It contains all the information about the test To move within the database use the following buttons Delete current test from the archive Edit the current test Import export a Tests card Th...

Page 38: ...ne either by typing the desired text in the field Diagnosis of the Visit Card or more quickly retrieving from the diagnosis database the desired one If you want to insert modify or delete a diagnosis from the database select Database Diagnosis from the File menu ...

Page 39: ...nsmission 5 Press another time the key 1 to select the transmission towards PC 6 Confirm pressing the Receive button on PC 7 Start data transmission from the spirometer by pressing any key A solid bar on the PC display will highlight the state of data acquisition from the SpirHOMEter Note Be sure that the program is correctly configured to acquire data through the serial port COM1 or COM2 as previ...

Page 40: ...t the test you want to link in the top area of the window Move to the first test to link Move to the previous test to link Move to the next test to link Move to the last test to link Delete current test View a preview of the report 3 Select the correspondent Patient in the bottom area of the window Find a patient in the archive by the Archive Navigator Id Find a patient in the archive with the sam...

Page 41: ... Reorganise the archive 1 Select Reorganize archive from the File menu 2 Wait for the end of the operation before performing any other function Delete the archive 1 Select Initialize Archive from the File menu 2 Wait for the end of the operation before performing any other function Backup and restore It is strongly recommended to backup files a warning message will be displayed monthly This functi...

Page 42: ...timate of the number of floppy you need in order to back up the archives Press OK Restore 1 Select Restore archive from the File menu 2 On the Restore dialog box specify the drive source and press OK a dialog box will appear indicating all data of the backup processed ...

Page 43: ...Spirometry ...

Page 44: ... selection of reference values and interpretative strategies A R R D 144 1991 1202 1218 The automatic diagnosis is calculated at the end of the FVC if the automatic diagnosis option is enabled the patient s anthropometric data allow the calculation of the LLN Lower Limit of Normal range at least one FVC test has been performed To enable disable the automatic diagnosis 1 Click on Enable Automatic I...

Page 45: ...er The program allows to calculate a huge number of parameters it is advisable in order to simplify the analysis of the results to view to print and to sort the desired parameters only Select the menu item Options Parameters View Move the parameters to view into the Selected parameters list Print Move the parameters to print into the Selected parameters list Sort Drag the parameter up or down with...

Page 46: ...edicteds start since this age To enter a new set of predicteds click on the New button The field Name must be filled and must be unique To stop without saving click on the Cancel button To save the set click on the Save button To delete a set of predicteds click on the Delete button If a set is deleted also the associated formulae are deleted It is possible to generate a new set of predicteds with...

Page 47: ...udson83 Knudson83 ITS white ITS white ITS black ITS black LAM LAM MC Barcelona MC Barcelona Nhanes III Nhanes III Select the desired choice in the group Predicted Formula definition This form allows the user to manage the formulae associated to a set of predicteds Select the set of predicteds from the list Predicteds set To insert a new parameter click on the New button The parameter formulae can ...

Page 48: ...ge Setup from the File menu Header All the printouts carried out by the program are preceded by 3 rows of customisable header usually they contain the name and the address of the Hospital using the spirometer Data Patient and visit information are printed below the header These data are reported on 3 columns and 5 rows the user may configure the disposition change and eventually cancel the fields ...

Page 49: ... file name Defines the automatic name to be asssigned to the pdf file if the report will be printed in this format In the example it has been set to create a filename composed by date of the test followed by last name and first name ...

Page 50: ...e of ease we shall refer to the SpirHOMEter keys with the numbers they represent on the keyboard Key 0 Key 1 Key 2 Key 3 Drugs In order to analyze the state of the lung function also as a function of the treatment being received it is possible to record the time at which the drug is taken The SpirHOMEter records the date and the time at which one or more drugs up to a maximum of 4 are taken After ...

Page 51: ...ediately after this the symptoms DYSPNEA MUCUS and WHEEZING will appear in order Repeat the operations described for COUGH When this phase has been completed the following message will appears Carry out test no 1 Performing the test The Forced Vital Capacity FVC test can also be performed by taking a few normal breaths before step 4 breathing in fully For hygienic reasons we strongly recommend the...

Page 52: ...est is complete carry out the second and then a third if the device requires it Note If the tests are not carried out correctly the following error message will appear and in this case the test session must be repeated Test finished incorrectly ...

Page 53: ... Volume graph F5 view Volume Time graph F6 view data of the test F7 If you need more than one visualisation meantime use the New Window function from the Window menu If you need to display a list of visits Select Visits list from the File menu Type the name of the Company and or the time interval desired or simply confirm for the complete list Tests of the current patient If a current patient has ...

Page 54: ... patient Select the test you want view the trend following the instructions on the window 3 In the lower part of the window select the parameters to graph For each trend graph you can choose if it will be graphed a measured parameter and its predicted value or two different measured parameters 4 Press OK to confirm A window will appear divided into two sections in the upper section you can see the...

Page 55: ...out when the patient had taken the drugs below the graphs for each time it is shown the severity of the symptoms You can choose to view in the lower part of the window the trend graphs or the measured values from the View menu ...

Page 56: ...C Post the patient data the notes the diagnosis and the test results Otherwise the report will contain two pages the first with the patient data the graphs and the diagnosis and the second one with the measured parameters according to the ATS recommendations Select the desired options FVC graph Prints the F V and V t curves for the best FVC test One page no ATS Prints data and graphs on the first ...

Page 57: ... a customizable filename format It is possible to define the created filename format selecting File Page Set up see Page set up Export data With this function you can export the test data in 4 different formats txt ASCII xls Microsoft Excel wk1 Lotus 123 xpo Cosmed Export a test 1 Select Export tests from the File menu 2 Select the test to export from the list box and press OK 3 Type the name and ...

Page 58: ...58 SpirHOMEter User Manual ...

Page 59: ...System maintenance ...

Page 60: ...patient safety In fact aspiration of residue particles and contaminated agents are life threatening In this handbook we strongly recommend you to follow the rules worked out by ATS and ERS see Lung Volume Equipment and Infection Control ERS ATS WORKSHOP REPORT SERIES European Respiratory Journal 1997 10 1928 1932 which are summarised as follows Accessible internal as well as external surfaces of e...

Page 61: ...rol vol 24 N 4 pp 313 342 August 1996 http www apic org pdf gddisinf pdf As disinfecting solution it is suggested Sodium hypochlorite 0 5 5000 ppm prepared fresh for use within 24 hours Sodium hypochlorite 1 10000 ppm prepared fresh for use within 30 days The first solution can be easily prepared by adding 1 part household bleach sodium hypochlorite 5 25 to 9 parts water the second one by adding 1...

Page 62: ...spections to be carried out in order to assure a proper electrical and mechanical safety level in the years These inspections are highly recommended after a rough use of the equipment or after a period of storage in unfavourable environmental conditions Referring to the electrical safety it is important to check the conditions of insulation materials of cables plugs and any other visible part by m...

Page 63: ...teries ready 2 The on off switch must be set to 0 3 Remove the cover of the battery compartment 4 Remove the old batteries 5 Insert the new ones as indicated on the back of the device 6 Close the battery compartment by sliding the cover along the slots Note Do not replace the battery if you don t have the new ones ready If the SpirHOMEter is left without batteries it retains stored data only for f...

Page 64: ...64 SpirHOMEter User Manual ...

Page 65: ...Appendix ...

Page 66: ...tured by a third party COSMED shall make available for the Buyer s benefit only those warranties which COSMED has received from the third party manufacturer s COSMED hereby specifically disclaims any and all warranties and or liabilities arising from defect s and or damage s to and or caused by products manufactured by third party manufacturers Buyer must obtain written authorisation from COSMED p...

Page 67: ...nd Packing List outside the package 3 Goods returned must be shipped with freight and insurance charges prepaid Collect shipments will not be accepted 4 The following list of goods are not eligible for return unless proven defective Special order items Expendable products Goods held over 30 days from COSMED s invoice date Used goods not in original shipping containers Goods which have been altered...

Page 68: ...ollowing address COSMED S r l Via dei Piani di Monte Savello 37 P O Box 3 00040 Pavona di Albano Rome Italy tel 39 06 9315492 fax 39 06 9314580 E mail customersupport cosmed it For USA customers only please contact COSMED USA Inc 2758 North Paulina Chicago IL 60614 USA Phone 1 773 528 8113 Fax 1 773 528 8116 email usa sales cosmed it To ensure that you receive efficient technical assistance please...

Page 69: ...l profile c in order to use your commercial profile for own marketing and advertising purposes d for accounting purposes including e mailing of commercial invoices e for providing your information to selected business partners also abroad in order to supply the service How your personal data are treated Your personal data will be stored in electronic format and protected at the best from destructi...

Page 70: ... personal data and their communication in intelligible form b obtain updating correction or integration of your data deletion or transformation in anonymous form of your personal data c deny your consent to the treatment of your personal data These rights can be exercised directly requesting in writing to the holder of the treatment ...

Page 71: ...with at least 6 seconds of collected volume Accumulation time the maximum time allowed for volume accumulation during the VC manoeuvre should be at least 30 seconds and at least 15 seconds during the FVC The spirometer should be store at least 8 FVC maneuvres FEV1 should be calculated by using the back extrapolation method to detect the start of the test extrapolated volume must not be higher then...

Page 72: ...ilatory capacity in Chinese subjects in Hong Kong Lam Kwok Kwong Pang Shing et Al Annals of Human Biology 1982 vol 9 No 5 459 472 Multicéntrico de Barcelona Spirometric reference values from a Mediterranean population J Roca J Sanchis A Agusti Vidal F Segarra D Navajas R Rodriguez Roisin P Casan S Sans Bull Eur Physiopathol Respir 1986 22 217 224 Nhanes III Spirometric reference values from a samp...

Page 73: ...eder JA Andreoni S Castelo Filho A Nery LE Reference values for lung function tests I Static Volumes Brazilian Journal Medical and Biological Research 1999 32 703 17 Neder JA Andreoni S Lerario MC Nery LE Reference values for lung function tests II Maximal respiratory pressures and voluntary ventilation Braz J Med Biol Res 1999 32 719 27 DLCO Standardized Lung Function Testing Official Statement o...

Page 74: ...ip to determinants of respiratory function Bull Eur Physiopathol Resp 23 435 439 Automatic diagnosis algorithm Reference Lung Function Testing selection of reference values and interpretative strategies A R R D 144 1991 1202 1218 LLN Pred 0 674 SD ATS 50 percentile LLN Pred 1 647 SD ERS 95 percentile LLN Pred 0 8 80 Pred Message interpretation Criterion Normal Spirometry FVC and FEV1 FVC LLN Obstr...

Page 75: ...PEFT 120 msec Avoid coughing 50 drop in the flow in first second Blow out longer FET100 6 sec Blow out more air flow 0 2l s within 20 ml of FVC Blow out harder dPEF 10 Take a deeper breath dFVC 200ml and 5 best FVC Blow out faster dFEV1 200ml and 5 FEV1 That was a good test No errors FVC reproducible diff 2 max FVC within 0 2 l FEV1 reproducible diff 2 max FEV1 within 0 2 l PEF reproducible diff 2...

Page 76: ...ory Society The European Respiratory Journal Volume 6 Supplement 16 March Standardization of Spirometry 1987 Update American Review of Respiratory Disease Vol 136 1285 1289 1987 Lung function J E Cotes Blackwell scientific publications Guidelines for Clinical Exercises Testing Laboratories I L Pina G J Balady P Hanson A J Labovitz D W Madonna J Myers American Heart Association 1995 91 912 Office s...

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