Table of Contents
Advertisement
Quick Links
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
Advertisement
Table of Contents
Subscribe to Our Youtube Channel
Related Manuals for Cosmed SpirHOMEter
Summary of Contents for Cosmed SpirHOMEter
- 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.
-
Page 2: Table Of Contents
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.......... - Page 3 Install/replace batteries................. 22 Install the turbine.................. 22 Turn on the device................23 Set-up the SpirHOMEter ............24 The keyboard..................24 Access to Control Menu ............... 24 Delete stored data ................. 25 Transmit data to the PC ................ 25 Calibrate the flowmeter ................ 25 Set-up date and time ................
- Page 4 Tips for correct use of the device............50 Keyboard ....................50 Drugs ....................50 Recording the severity of symptoms............. 51 Performing the test................51 Viewing results..............53 Tests of the current patient ............. 53 Delete a test ..................53 4 - SpirHOMEter User Manual...
- Page 5 View a trend ..................54 Printing results...............56 Printing Reports..................56 Printing the active window..............56 Printing a series of reports..............57 Electronic reports (*.pdf)..............57 Export data ................... 57 Export a test ................... 57 System maintenance System maintenance..............60 Cleaning and disinfection ..............60 Preparing the disinfecting solution..........
- Page 6 6 - SpirHOMEter User Manual...
-
Page 7: Getting Started
Getting started... -
Page 8: Important Notices
Important notices Intended use SpirHOMEter is an electrical medical device designed to perform pulmonary function tests. It is to be used by physicians or by trained personnel on a physician responsibility. Caution: Federal law restricts this device to sale by or on the order of a physician. - Page 9 7. Keep the device away from heat and flame source, flammable or inflammable liquids or gases and explosive atmospheres. 8. In accordance with their intended use SpirHOMEter is not to be handled together with other medical devices unless it is clearly declared by the manufacturer itself.
- Page 10 9. It is recommended to use a computer with electromagnetic compatibility CE marking and with low radiation 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...
-
Page 11: Contraindication
Contraindication The physical strain to execute the respiratory manoeuvre is contraindicated in case of some symptoms or pathology. The following list is not complete and must be considered as a piece of mere information. Absolute contraindications • Post-operating state from thoracic surgery •... -
Page 12: Environmental Condition Of Use
Due to this the vicinity of power lines is to be avoided as well. Cosmed equipment are not AP not APG devices (according to EN 60601-1): they are not suitable for use in presence of flammable anaesthetic mixtures with air, oxygen or nitrogen protoxide. -
Page 13: Safety And Conformity
• Device not suitable in the presence of flammable anaesthetics; • Continuous functioning equipment; 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) MDD 93/42/EEC (Notified Body 0476). -
Page 14: Keynotes
“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. 14 - SpirHOMEter User Manual... -
Page 15: Before Starting
The first purchase will be of two packages:one containing the software, the other one the SpirHOMEter. Make sure that the packing boxes contain the items listed below. In case of missing or damaged parts, please contact your nearest COSMED technical assistance. -
Page 16: Warranty Registration
Warranty registration Before using the system, please take a moment to fill in the registration form and the warranty and return them to COSMED, by doing this you are eligible to the customers assistance service. For further information, please refer to the enclosed registration and warranty form. -
Page 17: Pc Configuration Required
PC configuration 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. -
Page 18: Technical Features
< 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 18 - SpirHOMEter User Manual... -
Page 19: Measurements
Measurements... -
Page 20: Measured Parameters
FiVC Inspiratory Forced Vital Capacity FiF25-75% l/sec Forced mid-inspiratory flow FiV1 l/sec Forced Inspiratory Volume in 1 sec l/sec Peak Inspiratory Flow VEXT Extrapolated Volume (back extrapolation) PEFT msec Time to PEF (10% - 90%) 20 - SpirHOMEter User Manual... -
Page 21: Installation
Installation... -
Page 22: Prepare The Spirhometer
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. -
Page 23: Turn On The Device
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. Chapter 3 - Installation - 23... -
Page 24: Set-Up The Spirhometer
Deletion Transmission Calibration Configuration For the sake of ease, we shall refer to the SpirHOMEter keys with the numbers 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. -
Page 25: Delete Stored Data
Delete stored data Before the SpirHOMEter is delivered to the patient, it must be reprogrammed to free up the memory, used during the last session. 1. Access the control menu 2. Press the key 0 (deletion). The following message will... -
Page 26: Modem Option
To set up the ID code of the patient, press the key 2 and then modify the ciphers by means of the keys 2 (increase) or 1 (decrease), moving by means of the key 3. Confirm with the key 0. 26 - SpirHOMEter User Manual... -
Page 27: Set-Up The Device
Set-up the device When the 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: Software Installation
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 is necessary to configure the communication port with the PC (USB, COM1, COM2,…). -
Page 29: Software Main Features
Software main features Display The program may contain several windows. The active window is highlighted with a different colour of the caption. Some functions of the program are "active window" sensitive (Print, right key of the mouse). Tool bar Many of the functions that may be selected from the menu can be activated more rapidly by clicking with the mouse on the corresponding icon in the tool bar. -
Page 30: Scroll Bars
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. -
Page 31: Calibration
Calibration... -
Page 32: Turbine Calibration
Turbine calibration The SpirHOMEter is calibrated by COSMED. ATS recommends a daily calibration of the turbine. However if it is correctly maintained, turbine retains its precision for longer periods. We advice to calibrate the turbine daily to detect malfunctioning. The check must be carried out... -
Page 33: Database Management
Database Management... -
Page 34: Settings
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 mouse one). -
Page 35: Units Of Measurements
Units of measurements It is possible to configure the units of measurements, weight and height, for printing and viewing. To select the units of measurement click on cm/Kg or in/lb according to the desired format. Using extra fields The Patient’s database is organised in 3 different cards (Patient card, Visit Card and Test card.) where it is possible to store the information about patients and visits. -
Page 36: Patient's Database
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 current patient from the archive Edit the current patient card 36 - SpirHOMEter User Manual... -
Page 37: Visit Card
1. Select the patient. 2. Choose the tests to be exported and press the key by side. All data will be imported/exported in the XPO file format (Cosmed proprietary). Diagnosis Database The program allows to manage a diagnosis database, whose records are composed by a diagnosis ID code and a string of text. - Page 38 “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. 38 - SpirHOMEter User Manual...
-
Page 39: Transmit Data To The Pc
At the end of the data transmission, if reception has taken place correctly, the program will open a window to link the tests to the patient (see later). The SpirHOMEter display will show the following message: Check data rec’d... -
Page 40: Link The Test To A Patient In The Archive
Find a patient in the archive by the Archive Navigator Find a patient in the archive with the same ID Code of the current test to link. Link Link the current test to the current patient. 40 - SpirHOMEter User Manual... -
Page 41: Archive Maintenance
Archive maintenance The software allows to manage files selecting Archive from the File menu. It is advisable to perform the archive reorganisation every month, in order to free space on the hard disk and/or to correct possible errors present within the database. It is possible also that your have no more hard disk space. -
Page 42: Restore
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. 42 - SpirHOMEter User Manual... -
Page 43: Spirometry
Spirometry... -
Page 44: Setting Spirometry Options
Configure from the Option menu. Spirometry Automatic Interpretation The SpirHOMEter has the function of interpreting each test performed by a patient visualising an automatic diagnosis. The algorithm has been calculated basing on “Lung Function Testing: selection of reference values and interpretative strategies, A.R.R.D. -
Page 45: Quality Control
Quality control The SpirHOMEter allows a quality test control. The calculation has been carried out referring to “Spirometry in the Lung Health Study: Methods and Quality Control, A.R.R.D. 1991; 143:1215- 1223”. The messages concerning the quality control are shown at the end of the test. -
Page 46: Predicted Values Manager
Copy... button and specify a new Name. To import a set of predicteds click on the Import... button and select a file of Predicteds files type. To export a set of predicteds click on the Export... button. 46 - SpirHOMEter User Manual... -
Page 47: Set The Current Predicted
In the list Set current predicteds choose the current predicteds for printing and viewing. Set the current predicted The SpirHOMEter allows to calculate the predicted values according to the following configurable sets: Adults Paediatrics ERS 93 Zapletal Knudson83 Knudson83 ITS white... -
Page 48: Page Set-Up
Margins Configures the print margins from the borders of the paper. The unit of measure is decided in Units of measurements. Footer Configures information at the bottom of the page. 48 - SpirHOMEter User Manual... - Page 49 Printed 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>...
-
Page 50: Spirometry Tests
Keyboard For the sake of ease, we shall refer to the SpirHOMEter keys with the numbers they represent on the keyboard: Key 0. Key 1. -
Page 51: Recording The Severity Of Symptoms
Press 0 to indicate that the drug was not taken, otherwise press 1, 2 or 3 to confirm. When the stage has been completed, the following message is displayed: Carry out test ? Press 0 to terminate the session, press 1, 2 or 3 to perform the test. - Page 52 When the first test 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 52 - SpirHOMEter User Manual...
-
Page 53: Viewing Results
Viewing results All the visualisation functions refer to the test carried out by the Current Patient, whose name is indicated on the left-side of the status bar. To view tests results: 1. Select the Patients from the File menu 2. Select the patient corresponding to the test you want to view. 3. -
Page 54: View A Trend
A window will appear, divided into two sections: in the upper section you can see the measured parameters of all the tests, in the lower part, the trend graphs. On the graphs will be pointed 54 - SpirHOMEter User Manual... - 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. Chapter 6 - Spirometry - 55...
-
Page 56: Printing Results
(title bar highlighted) is one of the following objects: • Any kind of Graph. • Numeric data • List of visit To print the active window select Print Active window from File menu. 56 - SpirHOMEter User Manual... -
Page 57: Printing A Series Of Reports
Save as allows you to configure the separators for character based files. With the *.xpo Cosmed file format it is possible to import data from another Quark archive. Press OK to confirm. 4. Select the folder for the export and type the file name. Press OK to confirm. - Page 58 58 - SpirHOMEter User Manual...
-
Page 59: System Maintenance
System maintenance... -
Page 60: System Maintenance
(to be required to the manufacturer). All materials used in the construction of the SpirHOMEter are non toxic and pose no safety risk to the patient or operator. -
Page 61: Preparing The Disinfecting Solution
During the disinfection: • do not use alcohol or other liquids containing gluteraldehyde on the exterior surfaces of the equipment. Actually they can damage polycarbonates plastics and may produce unhealthy substances. • do not use abrasive powders or glass cleaners containing alcohol or ammonia on the plexiglas components of the equipment •... -
Page 62: Precautions During The Cleaning Of The Turbine
(it can be useful to shake slightly the turbine in order to note any anomalous movement). Check if there are any torn or broken components in the breathing circuits: remember that they can create safety risk to patients during tests. 62 - SpirHOMEter User Manual... -
Page 63: Replace The Batteries
Note: Do not replace the BATTERIES battery if you don’t have the The SpirHOMEter uses 4 AAA-size 1,5 Volt vatteries. new ones ready. If the 1. Check that you have the new batteries ready. SpirHOMEter is 2. The on-off switch must be set to 0. - Page 64 64 - SpirHOMEter User Manual...
-
Page 65: Appendix
Appendix... -
Page 66: Service - Warranty
Service - Warranty Warranty and limitation of liability COSMED provides a one (1) year limited warranty from the date of the original sale of COSMED products. All COSMED products are guaranteed to be free from defect upon shipment. COSMED’s liability for products covered by this warranty is... -
Page 67: Return Goods Policy For Warranty Or Non Warranty Repair
COSMED, its agents or employees in connection with Buyer’s order or use of the product(s) furnished hereunder. - Page 68 • All the goods returned to COSMED without the customs papers will not be accepted. For European Community members: Pro-Forma invoice complete with: • Number • Description of the goods • Quantity • Serial Number • Value in € •...
-
Page 69: Privacy Information
If you deny the consent, we regret we cannot supply the service. Holder of the treatment The holder of the treatment is Cosmed Srl, Via dei Piani di Monte Savello 37, Pavona di Albano Laziale (RM). The responsible of the personal data treatment is indicated in the documentation stored by Cosmed Srl itself. -
Page 70: Customer Rights
These rights can be exercised directly requesting in writing to the holder of the treatment. 70 - SpirHOMEter User Manual... -
Page 71: Ats 94 Recommendations
ATS 94 recommendations Reference: “Standardization of Spirometry: 1994 Update” “American J. Respiratory Critical Care Medicine”, Vol. 152, 1107-1136; 1995. ATS recommendations Volume range: 8l (BTPS) Flow range: ±14 l/sec Volume accuracy: ±3% or < 50ml Flow accuracy: ±5% or < 200ml/sec Flowmeter resistance: <1.5 cmH2O da 0 a 14 l/sec Reproducibility: the 2 largest of 3 acceptable FEV1 and FVC... -
Page 72: Predicted Values
Doutoramento do Dr. Carlos Alberto de Castro Pereira. (Boehringer). Gutierrez (Chile) Gutierrez et Al. Reference values for Chile population Knudson, Morris and Bass The maximal Expiratory Flow-Volume curve: Knudson et al. ARRD Vol. 123, p. 659-664, 1981 72 - SpirHOMEter User Manual... - Page 73 Spirometric Standard for healthy non-smoking adults: ARRD Vol. 10-3, p. 57-67, 1971 Pereira (Brazil) Pereira CAC; Barreto SP; Simões JG; Pereira FWL; Gerstler JG; Nakatani J. Valores de Referência para Espirometria em uma amostra da população brasileira adulta. Jornal de Pneumologia 1992;...
-
Page 74: Automatic Diagnosis (Algorithm)
FVC<LLN and %Pred FVC>=70 Restrictive abn.: moderate % Pred FVC < 70 and >= 60 Restrictive abn.: mod. severe % Pred FVC < 60 and >= 50 Restrictive abn.: severe % Pred FVC < 50 and >= 34 74 - SpirHOMEter User Manual... -
Page 75: Quality Control Messages
Restrictive abn.: very severe % Pred FVC < 34 Quality Control Messages Reference: Spirometry in the Lung Health Study: Methods and Quality Control, ARRD 1991; 143:1215-1223. Message Criterion Start faster VEXT >5% of the FVC and >150ml Blast out harder PEFT >120 msec Avoid coughing 50% drop in the flow in first second... -
Page 76: References
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 spirometry”, R.E. Hyatt - P.L. Enright, Lea & Febiger 76 - SpirHOMEter User Manual...
Need help?
Do you have a question about the SpirHOMEter and is the answer not in the manual?
Questions and answers