User`s Manual Part Number 603719.C
Contents
1. PiKoNET Lung Health Management Software Users Manual www nspirehealth com User s Manual Part Number 603719 C Information in this manual is subject to change without notice and does not represent a commitment on the part of nSpire Health Inc The software described in this document is furnished under a license agreement The software may be used or copied only in accordance with the terms of the agreement It is against the law to copy the software on any medium except as specifically allowed in the license or nondisclosure agreement No part of this manual may be reproduced or transmitted in any form or by any means electronic or mechanical including photocopying and recording for any purpose without the express written permission of nSpire Health Inc Copyright 2008 nSpire Health Inc This symbol indicates that this device provides a certain level of protection against electric shock because the patient applied part is floating This symbol indicates that the user must read and understand all instructions and warnings prior to use This symbol indicates that this class IIA equipment complies with the Medical Devices Directive of the European Economics Community 0086 This symbol indicates that the associated jack is for a Universal Serial Bus connection j All rights reserved Reproduction adaptation or translation without prior written permission is prohibited except as al2. L min E Unit purchased on 8 28 04 600 600 400 200 0 8 12 2004 8 23 2004 9 3 2004 9 14 2004 9 25 2004 10 6 2004 10 17 2004 10 28 2004 11 8 2004 Show Serial Date Time of PEF FEV1 FEV1 Q Factor Comments C0064109 10 9 2004 12 15 PM Sa ee ee ee C0064109 9 13 20048 15AM a EE 224L witnessed patient do a short blow C0064109 9 7 2004 7 45 AM 383 L min 72 227L C0064109 3 7 20046 304M ul C0064109 8431 2004 4 45 PM 347 L min 64 182L C0064109 8 31 2004 445 PM fume mx 238L C0064109 8 31 2004 4 30 PM 305 L min VUL C0064109 8730 2004 3 45 AM 373 L min DUO EK 4 C Documents and Settings rich My DocumentsY PiKoNET Data PiKoNET Data PND Figure 8 Main Screen Notes on the Main Viewing Screen 1 If the patient is issued multiple PiKo units by double clicking on its serial number you can type in a comment related to that PiKo unit 22 2 Acomment specific to any measurement can be added by clicking in the box to the right of the measurements labeled Comments These comments will appear on the printed report 3 To create an Adobe Acrobat copy of the report which can easily be emailed click on the Acrobat icon on the toolbar 4 Ifan appears in the Q Factor column it means that when the patient blew into the PiKo device there was a technical error This could include a Blowing less than one complete second duration b A weak effo
3. file you want to create and save Use standard Windows navigation to store the file in the desired location or you can also type the full path of a file for example CAMy Documents WDrugStudy PND PiKoNET Pro Only Open keyboard shortcut Ctrl O or aw icon Enables you to type the name of the file you want to open To quickly find a file you ve previously opened click the file name in the drop down list if available If you are searching for a file you can use asterisks as wildcards For example you can type to see a list of all files You can also type the full path of a file for example C My Documents DrugStudy PND If you are saving a file you cannot use a question mark or an asterisk in the file name If you use a question mark or asterisk and click Save the file will not be saved and the dialog box will not close PiKoNET Pro Only Export This choice will be unavailable button will be dimmed if there is no current patient selected The export feature enables you to export any individual patient s data to one of three file types e PDF Creates an Adobe Acrobat Portable Document of the entire patient report e TXT Creates a Tab Delimited Text File useful for importing into word processing documents see Figure 1 9 e CSV Creates a Comma Separated Values text file suitable for importing easily into Excel or other spreadsheets databases and statistical analysis programs see
4. of this database as containing data from a specific study coming from this specific site For example a pharmaceutical company sponsored study will be provided a program that allows collection of multiple databases from all their participating study sites This program uses the information in this Study Properties dialog box to ensure that this data is part of their study The user can enter the Site ID the Study Code and any relevant comments all usually provided by the study sponsor PiKoNET Pro Only Change Password This choice will be unavailable button will be dimmed if a current patient is not selected This optional function is used to provide password protection for this particular database If using multiple databases this prevents accidentally using the wrong database and allows access to the database by only the authorized personnel To create a password the first time leave the Old Password line blank but enter a password in the New Password line and retype it into the Confirm Password field 11 Print keyboard shortcut Ctrl P Opens a standard Windows Print dialog box to send the report to your printer Print Preview Provides an on screen preview of the report that would normally go directly to the printer Exit keyboard shortcut Alt F4 Closes the PiKoNET program 5 1 2 Edit Menu Patient keyboard shortcut Cirl E or ag icon Opens a dialog box to edit the demographics of the currently
5. your PiKo unit PiKo Settings PiKo Model n zl Reference zm se Zone 1 2 zee20 Zone 3 Zee Elevation Sealevel ox Progress Figure 4 PiKo Programming Screen PiKoNET Pro Only Program This opens a dialog box providing instructions for programming the PiKo settings To program simply place the PiKo device in the cradle and with this window open press the Download button After a brief delay the data will begin downloading shown by the progress bar After a few seconds the current settings in the PiKo for Model Reference Parameter either the default PEF or FEV1 or FEV6 if previously changed the Reference Value the Zone breakpoints for the on device and on screen Green Yellow Red zone and the Elevation correction factor are displayed To change any of these settings simply fill in the fields and then press the 16 Program button and then press the button on the PiKo device All the new settings will then be quickly uploaded to the PiKo If there is no value in the Reference field on the patient entry screen this will be updated during the programming sequence Preferences This opens a dialog box providing a variety of settings for the PIKoNET program Application Settings User Preferences 1 Number of days of displayed data changes the number of days back from today s date to show on the graph and tabular charts 2 Height and weight units to chan
6. 0 or higher MDAC version 2 6 or higher or JET version 4 0 or higher 3 During the installation please read and accept the terms of the license agreements On one screen it will ask to choose between Just me and Everyone It is recommended to choose Everyone to ensure that all users can gain access to this program 2 1 USB Cradle Driver Installation 1 If you are using the USB version of the PiKo interface cradle for downloading data from the PiKo device keep the CD in the drive after you have completed the above installation Plug the USB PiKo Cradle into any available USB port on the computer The computer will automatically search for and load the appropriate USB driver If for any reason the driver fails to load follow standard Windows procedure for manual installation of the drivers which can be found in the following folder C Program Files nSpire Health PiKoNET Prolific 3 Starting the Program From the Windows Start Menu choose PiKoNET Client or click on the appropriate shortcut icon After a brief display of an opening screen the main program window is displayed If using a USB interface cradle be sure to set the USB port to be the default port by choosing Tools gt Preferences gt Applications Settings tab gt Communications Port Name set to USB 4 Using the Built in Help System On most screens to get help with any item click the field in which you ne
7. Figure 2 Show Serial Date Time E PEF FEV1 Q Factorf True gt C0064109 10 9 2004 12 15 PM 489 L min 2 86 L 1 C0064 109 9 13 2004 8 15 AM 447 L min 2 24 L True gt 4 True gt C0064109 9 7 2004 7 45 AM 389 L min 2 27 L 1 True gt C0064109 9 7 2004 6 30 AM 242 L min 1 50 L q True C0064109 8 31 2004 4 45 PM 347 L min 1 82 L q Figure 1 Example of Tab Separated Text TXT Export Format Show Serial Date Time PEF FEV1 Q Factor Comments TRUE C0064109 10 9 2004 12 15 489 L min 2 86 L TRUE C0064109 9 13 2004 8 15 447 L min 2 24 L TRUE C0064109 9 7 2004 7 45 389 L min 2 27 L TRUE C0064109 9 7 2004 6 30 242 L min 1 50 L Figure 2 Example of Comma Separated Values Properties This choice will be unavailable button will be dimmed if a current patient is not selected This function lets you view the File name and location of the current database its file size and when it was created It also lets you add comments to the properties to provide reminders of the purpose of this specific database The Repair 10 button can be used to attempt to repair problems in searching the file or viewing data within the file PiKoNET Pro Only Study Properties This choice will be unavailable button will be dimmed if a current patient is not selected This optional function is used for drug and other research studies to provide identification
8. ed help and then press F1 You also can click the in the upper right corner of the window and move the cursor to the field you need help with and click again A help text paragraph is displayed 5 Creating a New Database PiKoNET Pro Only Since the PiKoNET Professional software can support multiple databases e g one for research use and another for clinical use a default database does not open the first time the program is run To create a new database choose File New In the resulting window enter any desired name for the new database in the File 7 Name field The extension for all PIKONET database files is PND and they are by default stored in the following folder C My Documents PiKoNET Data Each time the program is restarted the last database used will be automatically accessed PiKoNET Personal Only Since the PiKoNET Personal software only uses one database it is created and opened automatically Note By default the database is stored in the Documents or My Documents folder depending on the Windows Version of the logged in user Other Users may not be able to access the database To allow all users to access the database locate the new database in a folder located outside of My Documents for Windows XP or 2000 or Users Documents for Windows Vista 5 1 Menu Descriptions 5 1 1 File Menu PiKoNET Pro Only New keyboard shortcut Ctrl N or L icon Enables you to type the name of a
9. ge patient entry units from inches and pounds in Ibs to centimeters and kilograms cm kg 3 Font enables changing of both on screen and report font Application Settings Communication Settings 1 Communications port name the pull down pick list enables the choice of all serial COM ports and the USB port This choice should match the port used by the cradle This can be verified using Windows Hardware Device Manager under Ports If this shows Prolific USB to Serial Comm COMX simply choose USB 17 2 Polling this is the number of seconds between looks at the cradle to see if the data download button has been pressed 3 Timeout this is the number of seconds that the software will wait for you to press the download button on the PiKo before it will abort the download Parameter Settings this enables you to choose which parameters you would like to view on the graph or tabular chart For example if you have a PiKo 1 you can disable viewing of the FEV6 parameter since the PiKo 1 device does not produce the FEV6 measurement Refer to Figure 5 PiKoNET Pro Application Settings Application Settings Parameter Settings Graph Settings Diumal Variation Select the parameters you would like displayed in the data grid You may select up to a maximum of 4 parameters IV PEF L min FEV6 L PEF of Reference FEV6 of Reference IV FEV1 L FEVI FEVB X IV FEV1 X of Reference FEVI FEV6 of Refe
10. lowed under the copyright laws PiKoNET is a trademark of nSpire Health Inc All other brand and product names mentioned in this document are trademarks and or registered trademarks of their respective holders PiKo Net Manual 662217 Part Number 603719 Rev C PiKo Net Manual 662117 Table of Contents T Introduction ee ede id tees aa ada 4 1 1 Requirements euer 4 1 1 1 Operating System unnneensnnennnnnnnnnnnnnnnnnnnnnnnn nenn 4 1 1 2 Hardware rer hs c a ee Ast 5 1 1 3 NT T0 4 CEDERE 5 2 Software Installation eesssesssseeenee 5 2 1 USB Cradle Driver Installation seseseessssse 6 3 Starting the Program te teet ida 7 4 Using the Built in Help System sess 7 5 Creating a New Database sss 7 5 1 Menu Descriptions eeeeenn eme 8 5 1 1 Elle MenU scii tH ERE E a CERT ale 8 5 1 2 eB mr 12 5 1 3 VIeWMOenU s ode tte cet eee gens 13 5 1 4 Tools Ment sonurin ii 14 5 2 Understanding the Main Screen Items 22 1 Introduction Thank you for purchasing this quality product from nSpire Health the exclusive provider of PiKo lung home health monitoring worldwide For more details on our company and its offerings please refer to our website www nspirehealth com NOTE NOTE This manual covers both the PiKoNET Personal and PiKoNET Professional ver
11. pdate to Section 5 PiKo Personal Use section to note that the database is stored in the Documents or My Documents folder depending on the Windows version Updates to reflect online help file as well as new company address 24
12. rence Figure 5 Parameters Settings Tab 18 Graph Settings refer to Figure 6 PiKoNET Pro Application Settings Application Settings Parameter Settings Graph Settings Diurnal Variation Zone 1 Color Zone 2 Color Zone 3 Z Color Zone 4 Z Color FEV1 Scale PEF Scale FEVB Scale FEV1 FEVB Cancel Figure 6 Graph Settings Tab 1 Zone Percentage and Colors the colors and percentage break points for each zone shown on screen can be changed if desired 19 2 Scales the scale shown for each parameter can be changed to better match the particular patient s data set 20 Diurnal Variation the percent difference between any specific days best AM value versus its best PM value is called Diurnal Variation The percentage at which to define this as abnormal is configurable by the user as is the scale and colors used to define normal and abnormal PiKoNET Pro Application Settings Application Settings Parameter Settings Graph Settings Diumal Variation Abnormal diurnal variation Diurnal variation graph scale 3 Normal diurnal variation color Abnormal diurnal variation color Figure 7 Diurnal Tab Settings 21 5 2 Understanding the Main Screen liems WI PiKoNET Pro ROSE051955 Rosenthal Rich File Edit View Tools Help la A uB P 2 amp EL ERES ER EE ER ER EG BF FiKo 1 C0064109 PEF
13. rt with a slow start producing a low peak flow c A trumpeted blow producing an impossibly high peak flow over 150 of the reference value d Avery low abnormal blow of less than 3096 of the reference value 5 When a Q Factor is present the PiKONET software will not show that data in the graph To override this choice click the check box in the Show column 23 nSpire Health Division www nspirehealth com Manufactured by nSpire Health Inc 1830 Lefthand Circle Longmont Colorado 80501 USA General Information 1 800 574 7374 1 303 666 5555 Fax 1 800 574 7373 1 303 666 5588 Support 1 800 635 3200 Email sales nspirehealth com Authorized Representative nSpire Health Ltd Unit 10 Harforde Court John Tate Road Hertford SG13 7NW U K Tel 44 0 1992 526 300 Fax 444 0 1992 526 320 Email info nspirehealth com nSpire Health GmbH Managing Director Alfred Albert Schlimpfhofer Strasse 14 D 97723 Oberthulba Germany Tel 449 097 36 8181 0 Fax 49 097 36 8181 20 Email vertieb nspirehealth com Revision History Version Revision Release Date Description 1 B January 2005 Implemented this revision history Updated document formatting added numbered headings table of contents figure captions etc 2 A October 2007 Updated content to reflect current feature sets and company identification C March 2008 U
14. selected patient New Patient keyboard shortcut Ctrl A Provides an empty dialog box for entry of a new patient Clicking the down arrow next to the patient search button and choosing New Patient can also access this function PiKoNET Personal Only NOTE There is a limit of 10 patients in the PiKoNET Personal version This accommodates the use of one copy of the software in a large family 12 Find Patient keyboard shortcut Ctrl F or d icon Opens a dialog box to search for a patient by any combination of Patient ID Last Name First Name or Middle Name After a successfully completed search click on the patient from the Search Results area and choose Select 5 1 3 View Menu per I ee All Data shown as AM PM icon The graph and data table will display data from both AM and PM the time before 1200 or after 1200 hours measurements AM Data Shown as AM icon The graph and data table will display data only from AM measurements PM Data shown as PM icon The graph and data table will display data only from PM measurements Diurnal Variation shown as DV icon The graph and data table will display diurnal variation the change from morning to night data from any pair of both AM and PM tests 13 from the same day without any quality indicator DV is presented as change for PEF FEV1 FEV6 and FEV1 FEV6 at Graph PEF shown as PEF icon The graph will display PEF
15. sions of the product Please refer to the following paragraph tags for issues specific only to the referred product PiKoNET Personal Only or PiKoNET Pro Only It also covers the presentation of FEV6 values available only on the PiKo 6 device Please ignore these references if your device is a PiKo 1 If using the USB version of the PiKo interface cradle for downloading data from the PiKo device DO NOT plug the cradle into the USB port until after the software has been installed 1 1 Requirements 1 1 1 Operating System Windows 2000 Service Pac 3 or higher Windows XP or Windows Vista Installation requires that the user be logged in as an administrator 4 1 1 2 Hardware Hardware should include minimum Pentium III 600 MHz 64MB RAM 500MB free disk space 1 1 3 Networks This is a single computer based product however if the computer is part of a network installation requires that the user be logged in as an administrator 2 Software Installation 1 Insert installation CD in the computer s CD drive After a short delay for loading the installation program should automatically start If it does not choose Start Run click the Browse button navigate to the CD drive and double click on the SETUP icon 2 Follow the on screen instructions to complete the installation If the computer does not have any of the following support files they will be automatically installed NET Framework version 2
16. values only Graph FEV1 shown as FEV1 icon The graph will display FEV1 values only Graph FEV6 shown as FEV6 icon The graph will display FEV6 values only Graph FEV1 FEV6 Ratio shown as FEV1 FEV6 icon The graph will display FEV1 FEV6 ratio only 5 1 4 Tools Menu Download keyboard shortcut F5 or 76 icon This opens a dialog box providing instructions for downloading data from the PiKo To download simply place the PiKo device in the cradle and with this window open press the button on the PiKo device After a brief delay the data will begin downloading shown by the progress bar This should take a few seconds to complete After the data is downloaded the Do you wish to clear the data from the PiKo Y N question is displayed This is your opportunity 14 to erase data from the PiKo memory that has already been downloaded However it is not necessary since the PIKONET software will not accidentally download duplicate data PiKoNET Pro Dowload PiKo Data 1 Turn your PiKo unit on by pushing the unit button once 2 Push the unit button once again to initiate the download 3 Place your PiKo unit on it s cradle 4 Once download completes this window will close Searching 11 7 2004 3 33 05 PM Cancel Figure 3 Download PiKo Data Screen 15 PiKoNET Pro PiKo Programming Instructions 1 Download current settings from your PiKo unit 2 Adjust your settings 3 Program
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