Spirometrics PC Classic Classic, Classic Plus spirometer User's Manual
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PC Classic/Classic Plus User’s Manual
PC CLASSIC / PC CLASSIC PLUS
USER’S MANUAL
Copyright 2003, 2004
Spirometrics Medical Equipment Company
PO Box 680
22 Shaker Road
Gray, ME 04039 USA
http://www.spirometrics.com
IMPORTANT!
Please send in the attached card to activate your warranty.
Rev. 06, February 2004
PC Classic/Classic Plus User’s Manual
Table of Contents
Specifications..........................................i
Models................................................................................ i
General ..............................................................................ii
Electrical............................................................................ iii
Operating .......................................................................... iii
Environmental ................................................................... iii
Chapter 1: Introduction..........................1
1.1 Welcome ..................................................................... 1
1.2 Product Differences: PC Classic vs. PC Classic Plus .. 1
1.3 Warranty ..................................................................... 2
Chapter 2: Safety....................................5
2.1 Intended Use............................................................... 5
2.2 Warnings and Precautions .......................................... 5
2.3 Disposal ...................................................................... 7
2.4 Symbols and Definitions .............................................. 7
Chapter 3: Equipment Preparation .......9
3.1 Preparing for Installation.............................................. 9
3.1.1 Inventory...........................................................................9
3.1.2 Connecting the Classic Sensor ......................................10
3.2 Software Installation .................................................. 11
3.2.1 Initial Setup Wizard ........................................................12
3.2.2 Welcome Window ..........................................................12
3.2.3 Sensor Found Window...................................................13
3.2.4 Address Window ............................................................14
3.2.5 Ambient Conditions Window ..........................................15
3.2.6 Access Codes Window ..................................................16
3.2.7 Attaching the 3-Liter Syringe ..........................................18
3.2.8 Performance Verification Routine (
PC Classic only
)......19
3.2.9 Calibration (
PC Classic Plus only
)..................................23
Chapter 4: Test Preparation ................31
4.1 Processing Patient Data ............................................ 31
4.1.1 Entering a New Patient...................................................31
4.1.2 Retrieving and Modifying Patient Information.................38
PC Classic/Classic Plus User’s Manual
4.1.3 Deleting Patient Information ...........................................40
Chapter 5: Testing................................42
5.1 Optional Pre-Test Training (
PC Classic Plus Only
).... 42
5.2 FVC Test ................................................................... 45
5.2.1 Warning Messages ........................................................52
5.3 VC Test ..................................................................... 52
5.4 Post-Bronchodilator Testing (
PC Classic Plus Only
).. 56
5.4.1 Method 1: .......................................................................56
5.4.2 Method 2: .......................................................................59
5.5 MVV Test (
PC Classic Plus Only
).............................. 61
5.5.1 View or Delete Test ........................................................66
5.6 Summary Report ....................................................... 67
5.7 Trend Analysis........................................................... 72
Chapter 6: Special Features ................77
6.1 Customization............................................................ 77
6.1.1 Software Customization .................................................77
6.1.2 Data Options ..................................................................79
6.1.3 Report Setup ..................................................................81
6.1.4 Report Options ...............................................................83
6.1.5 Methacholine Challenge Options ...................................84
6.1.6 Licensing ........................................................................86
6.1.7 General Customization Buttons......................................87
6.2 Performance Verification & Calibration ...................... 87
6.2.1 Performance Verification Routine (
PC Classic only
)......88
6.3 Calibration (
PC Classic Plus Only
) ............................ 91
6.3.1 Calibration Routine.........................................................91
6.4 Printer Selection ........................................................ 96
Chapter 7: Data Management..............99
7.1 Protecting Patient Data.............................................. 99
7.2 Exporting and Importing Files.................................. 101
7.2.1 Exporting Files..............................................................101
7.2.2 Importing Files..............................................................102
7.3 Batch Reports.......................................................... 103
7.4 Calibration Review and Maintenance....................... 104
7.5 Maintaining Users.................................................... 105
7.6 Network Option (
PC Classic Plus Only
)................... 107
Chapter 8: Care and Maintenance ....110
PC Classic/Classic Plus User’s Manual
8.1 Maintenance of the PC Classic Flow Sensor ........... 110
8.1.1 Removing the Easy Clean Core ...................................110
8.1.2 Cleaning the Easy Clean Core .....................................111
8.1.3 Installing the Easy Clean Core .....................................111
8.2 Service .................................................................... 113
Appendices ......................................... A-1
Definitions ......................................................................A-1
Normals Tables ..............................................................A-4
Diagnostic Interpretation.................................................A-9
Interpretation Table ............................................................. A-10
References...................................................................A-10
Standards and Guidelines: .................................................. A-10
Additional Resources: ......................................................... A-11
Spirometry Websites: .......................................................... A-12
Product List ..................................................................A-12
Accessories:........................................................................ A-12
Educational Products .......................................................... A-13
PC Classic/Classic Plus User’s Manual
S
PECIFICATIONS
M
ODELS
The PC Classic and the PC Classic Plus consist of a sensor handle and the Classic Windows
-based software. Together, these items make up the complete PC Classic system.
PC Classic:
Consists of the Classic sensor handle and
Classic software configured to measure and compute the following indices at minimum:
FVC, SVC, FEV
FEV
1
/FEV
6
FEF
FEF
50
50
, FEF
/FIF
75
1
, FEV
, PEF, FEF
, FEF
3
, FEV
25-75
6
, FEF
, FEV
75-85
1
/FVC,
, FEF
200-1200
, FIVC, PIF, FIF
50
, and ET.
25
,
50
,
PC Classic Plus: The PC Classic Plus adds PRE/POST to the standard PC Classic test capabilities and allows the clinician to purchase MVV and/or
Methacholine Challenge. It also allows addition of the network option.
NOTE!
The PC Classic can be upgraded to PC Classic Plus without the addition of new hardware.
The Classic software can be installed in any Windows
-based desktop or laptop computer that meets the minimum requirements described on the next page.
Feb-04 Specifications i
PC Classic/Classic Plus User’s Manual
G
ENERAL
Weight / Size
(sensor handle and cord only)
Computer hardware
requirements
(minimum)
Operating System
Hazardous /
Flammable
Environments
Mode of Operation
1.1 lbs. (0.5 kg)
8” h x 4” d x 2.8” w
•
90 MHz Pentium class processor
•
8 Mbytes RAM
•
7 Mbytes available hard disc space
•
Compliance to applicable electromagnetic compatibility standards
•
Compliance to applicable electrical safety standards
•
SVGA (800X600 screen resolution or better)
•
Windows compatible printer
•
Available serial port
Windows 95 or 98, Windows
NT Work Station 4.0, Windows
ME, Windows 2000
Professional and Windows XP.
1
EQUIPMENT not suitable for use in the presence of a
FLAMMABLE
ANAESTHETIC MIXTURE
WITH AIR or WITH OXYGEN
OR NITROUS OXIDE.
Rated for continuous operation
1
Windows 95/98, Windows NT Workstation 4.0, Windows ME,
Windows 2000 Professional and Windows XP Professional are registered trademarks of Microsoft Corporation, Redmond,
Washington.
Feb-04 Specifications ii
PC Classic/Classic Plus User’s Manual
E
LECTRICAL
Power
Serial Port
EMC
E
NVIRONMENTAL
Operating
Storage Temperature
Humidity
Derived from the RS-232 port.
RS-232C compliant
Compliant with Standard
60601-0, 1990 of the
Electromagnetic Compatibility
Directive
O
PERATING
Meets or exceeds Standards of Spirometry requirements, 1994 update, American Thoracic Society, Medical Section of the
American Lung Association.
Flow Ranges
-14.0 to 14.0 liters/second
17
°C (63°F) to 40°C (104°F)
0 – 80% Relative Humidity
-18
°C (0°F) to 50°C (122°F)
0 – 80% Relative Humidity
Feb-04 Specifications iii
PC Classic/Classic Plus User’s Manual
NOTES
Feb-04 Specifications iv
PC Classic/Classic Plus User’s Manual
Chapter 1:
I
NTRODUCTION
1.1 W
ELCOME
You have purchased a Spirometrics Medical Equipment
Company PC Classic/Classic Plus spirometer for Windows ™
2
.
The PC Classic/Classic Plus represents the newest technology in the medical equipment field. Its ease of operation and durability will provide years of service.
Spirometrics is committed to designing products that meet the highest standards of quality instrumentation for pulmonary function testing. We have designed the PC Classic/Classic Plus to take advantage of the latest developments in computers and software.
NOTE!
Federal law restricts this device to use by or on the order of a physician.
NOTE!
Before setting up, please complete the warranty card, enclosed at the end of this chapter, to ensure that your warranty rights are covered.
1.2 P
RODUCT
D
IFFERENCES
:
PC C
LASSIC VS
.
PC C
LASSIC
P
LUS
The
PC Classic is a monitoring device designed to be used in screening applications, e.g. early detection of Chronic
Obstructive Pulmonary Disease (COPD). Spirometry is the only test available on the PC Classic.
2
Windows™ is a registered trademark of Microsoft Corporation,
Redmond, Washington.
Feb-04 Chapter 1: Introduction
1
PC Classic/Classic Plus User’s Manual
The PC Classic Plus is a diagnostic device used in clinical applications, such as bronchodilator evaluation and provocation testing, that requires a very high standard of accuracy. The PC
Classic Plus contains routines for calibrating the spirometer that are not available on the PC Classic. These calibration routines meet the 1994 American Thoracic Society (ATS) recommendations. Also, networking is only available with the
PC Classic Plus.
The PC Classic can be upgraded to the Classic Plus at any time.
For more information about the upgrade call our toll-free number: 1-800-767-0004.
1.3 W
ARRANTY
The
PC Classic/Classic Plus is warranted for one year from delivery date as validated by the return of the warranty card or, if the warranty card is not returned, one year from the date of manufacture.
During the warranty period, any original parts and/or workmanship proven to be defective will be replaced or repaired at an authorized service center provided the equipment has been operated and maintained in accordance with the instructions contained in this manual. This warranty applies to the original user only and does not extend to any product or component that has been repaired or altered by anyone other than personnel authorized by Spirometrics. This warranty is in lieu of and excludes any warranty as to merchantability and all other warranties expressed or implied and do not cover consequential damages due to improper use or application of the product.
For the device warranty to be in effect, the warranty card packaged with this product must be returned to Spirometrics
Medical Equipment Company for warranty registration. Please
take this time to fill out the postage-paid warranty card. You may also register your warranty by calling 1-800-767-0004 or
Feb-04 Chapter 1: Introduction
2
PC Classic/Classic Plus User’s Manual
faxing the information to 207-657-4123. For software license and warranty information, refer to the first 2 pages of this manual.
NOTE!
Computers, printers, and products not manufactured by
Spirometrics are
not covered under the one-year warranty.
These products are covered under the manufacturers’ warranties, which may vary. Please consult the appropriate user’s manuals for further details.
Feb-04 Chapter 1: Introduction
3
PC Classic/Classic Plus User’s Manual
NOTES
Feb-04 Chapter 1: Introduction
4
PC Classic/Classic Plus User’s Manual
!
Chapter 2:
S
AFETY
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
2.1 I
NTENDED
U
SE
The PC Classic and PC Classic Plus spirometers are intended for use with adult and pediatric patients for the diagnosis and monitoring of pulmonary disorders. The company disclaims responsibility for all other uses, and the user agrees to assume liability for damages resulting from non-intended use or operator error by the user or user’s employees.
The PC Classic is not intended for use as a diagnostic instrument. Please upgrade to the PC Classic Plus for diagnostic capability.
The PC Classic is intended for use at a single facility or location.
If the instrument is to be used at a different location other than its original setup location, the Classic software must be uninstalled, then re-installed to insure proper operation.
2.2 W
ARNINGS AND
P
RECAUTIONS
The following warnings and precautions must be heeded at all times:
Use a genuine Spirometrics filter/mouthpiece (Spiro-Filter) to ensure proper accuracy, reduce the risk of patient crosscontamination and to protect the internal sensor element.
Replace the Spiro-Filter after each patient.
Feb-04 Chapter 2: Safety
5
PC Classic/Classic Plus User’s Manual
Clean the Easy Clean Core regularly to insure the long-term stability and accuracy of the instrument. Please refer to
Chapter 8: C
ARE AND
M
AINTENANCE
for proper cleaning procedures. Do not attempt to clean the unit with abrasives or solvents. Do not autoclave any portion of the unit.
Never immerse any component of the system in water or other liquids with the exception of the Easy Clean Core.
Use only a desktop or laptop PC that adheres to the specifications listed in the Specifications section of this document.
The PC Classic has a built-in operation verification feature to insure the operation of the system. Establishment of verification procedures and schedule are the responsibility of the user. The ATS 1994 spirometry recommendations and the
American Association for Respiratory Care (AARC) 1996
Spirometry Clinical Practice Guideline provide guidance.
The PC Classic Plus has built-in calibration capability. The
1994 ATS standard on spirometry recommends daily calibration of this instrument or more frequently as appropriate.
Accurate and effective use of the PC Classic and PC Classic
Plus depends on correct application of well established spirometry practices.
Do not operate the unit in a flammable or explosive atmosphere.
Insure that the Easy Clean Core is properly installed as described in Chapter 8: C
ARE AND
M
AINTENANCE
.
Do not drop the sensor handle. The PC Classic handle is a sensitive measurement device. Improper handling could affect the accuracy of its reported results.
Do not disassemble sensor handle. There are no userserviceable parts inside.
Feb-04 Chapter 2: Safety
6
PC Classic/Classic Plus User’s Manual
2.3 D
ISPOSAL
This instrument contains electronic circuitry and multiple plastics. Please dispose of properly at the end of useful life.
Computer recycling facilities are capable of recycling this instrument.
2.4 S
YMBOLS AND
D
EFINITIONS
Symbol Definition
Attention, consult accompanying documents
Dangerous voltage
Spirometrics Notation
The specific directions in this manual and on the PC
Classic handle must be observed.
The system must not be modified or serviced except by authorized personnel.
Class II Equipment
Type BF Equipment
Feb-04 Chapter 2: Safety
7
PC Classic/Classic Plus User’s Manual
NOTES
Feb-04 Chapter 2: Safety
8
PC Classic/Classic Plus User’s Manual
Chapter 3:
E
QUIPMENT
P
REPARATION
3.1 P
REPARING FOR
I
NSTALLATION
NOTE!
The PC Classic/Classic Plus is shipped in a box specifically designed to protect it during shipment. Keep the shipping box and packing materials in case you ever need to ship the unit for service or maintenance.
Common Windows tasks and uses should be familiar to the user before attempting to operate this program. Consult the
Microsoft
®
Windows™ user’s manual if this is not the case.
3
3.1.1 I
NVENTORY
After unpacking your new PC Classic/Classic Plus, check each item against the following list:
1 Handle Assembly for PC Classic/Classic Plus
1 Coiled Cable
1 9-pin Adapter
1 Program CD
1 User's Manual & Warranty Card
3
Windows™ and Microsoft
®
are registered trademarks of
Microsoft Corporation, Redmond, Washington.
Feb-04 Chapter 3: Equipment Preparation
9
PC Classic/Classic Plus User’s Manual
NOTE!
If anything is missing, immediately contact a Spirometrics inside sales representative:
•
Phone: 207-657-6700 or 1-800-767-0004.
•
E-mail: [email protected]
3.1.2 C
ONNECTING THE
C
LASSIC
S
ENSOR
To connect the Classic Sensor, do the following:
1.
Connect one end of the coiled cable to the outlet on the bottom of the Classic Sensor.
2.
Connect the other end of the coiled cable to the telephone type connector of the 9-pin adapter.
3.
Plug the 9 pin end of the adaptor into one of the serial ports
(COM1–COM4) on the back of the host computer.
HANDLE ASSEMBLY
TO COMPUTER SERIAL PORT
9 PIN ADAPTER
COILED CABLE
Figure 3-1:
Connection Diagram
.
Feb-04 Chapter 3: Equipment Preparation
10
PC Classic/Classic Plus User’s Manual
NOTE!
If a 25-pin adapter (PN 15111F) is needed to connect your sensor to a COM port on your computer, call Inside Sales
(207-657-6700 or 1-800-767-0004) to obtain one or buy a
DB9 to DB25 adapter from a local computer supply house.
The PC Classic/Classic Plus for Windows is automatically set to the proper COM port by the Startup Wizard. The COM port can also be manually set by accessing the
Customization option.
See Section 6.1 C
USTOMIZATION
, for details.
3.2 S
OFTWARE
I
NSTALLATION
If you purchased the computer from Spirometrics, the PC
Classic/Classic Plus software will be loaded and configured on your computer. If you already have a computer or purchase one from a source other than Spirometrics, you will need to install the software.
To load the software, insert the CD into the CD drive. The program should load automatically. If not, do the following:
1.
Click the START button.
2.
Select
RUN.
3.
Select, or enter,
<CD drive letter>:\setup.exe on the Open command line and click
OK.
4.
Follow the instructions in the PC Classic InstallShield
Wizard.
NOTE!
When asked to confirm or change the program Destination
Folder, Spirometrics recommends accepting the default destination. However if you wish to install this program software and data on a server or network location, please consult your network administrator.
Feb-04 Chapter 3: Equipment Preparation
11
PC Classic/Classic Plus User’s Manual
3.2.1 I
NITIAL
S
ETUP
W
IZARD
Run PC Classic for the first time by one of the following methods:
Double click on the newly created PC Classic shortcut icon on your desktop, or
Select Programs (All Programs), Spirometrics, PC Classic
v2.11, PC Classic under the Windows Start menu.
The PC Classic Wizard takes over to complete the installation.
The entire process takes only a couple of minutes.
The first five windows that you will see during installation serve three purposes:
•
They tell the user what is happening.
•
They verify that the sensor is properly connected.
•
They allow you to set the report heading and ambient condition default parameters.
3.2.2 W
ELCOME
W
INDOW
The first window is a welcome message. Read the message, then click Next or press the Enter key to proceed.
Feb-04 Chapter 3: Equipment Preparation
12
PC Classic/Classic Plus User’s Manual
Figure 3-2:
Welcome Window
.
3.2.3 S
ENSOR
F
OUND
W
INDOW
The second window informs you that the sensor has been properly connected. If the sensor is not connected properly, check the back of your PC or laptop to make sure that the connection is okay as described in 3.1.2 Connecting the Classic
Sensor. Follow the instructions in your PC owner’s manual to ensure that your serial communications port is enabled.
When ready, click
Next or press the Enter key to proceed.
Feb-04 Chapter 3: Equipment Preparation
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PC Classic/Classic Plus User’s Manual
Figure 3-3:
Sensor Found Window.
3.2.4 A
DDRESS
W
INDOW
The third window asks you to input the name of the practice, clinic, or hospital that will be using the spirometer. This information will appear on all hard copy reports. There are four lines available for inputting the information. If you wish to complete or change this information at any time, refer to section
6.1.3 Report Setup in this manual which describes the appropriate customization procedure.
When ready, click
Next to proceed.
Feb-04 Chapter 3: Equipment Preparation
14
PC Classic/Classic Plus User’s Manual
Figure 3-4:
Address Window
.
3.2.5 A
MBIENT
C
ONDITIONS
W
INDOW
The fourth window allows you to change the default ambient conditions. This data is used to calculate a correction factor called Body Temperature and Pressure Saturated (BTPS) that is applied to the lung volumes measured during patient testing.
Gas volumes are reduced as they are exhaled from a warm body into a cooler room. The BTPS adjusts the lung volumes measured during testing so that they more accurately resemble conditions in the body. Ambient conditions should be accurately recorded each day testing is performed. This data can also be changed at anytime by accessing the
Customization option. (See section 6.1.1 Software Customization.)
When ready, click
Next to proceed.
Feb-04 Chapter 3: Equipment Preparation
15
PC Classic/Classic Plus User’s Manual
Figure 3-5:
Ambient Conditions Window
.
3.2.6 A
CCESS
C
ODES
W
INDOW
Enter unique activation codes in the
Access Codes Window for the modules that you have purchased. You may have up to five license code entries. Please refer to the first page of this manual or your PC Classic software CD packaging for a list of license codes that you have purchased.
Feb-04 Chapter 3: Equipment Preparation
16
PC Classic/Classic Plus User’s Manual
Figure 3-6:
Access Codes Window
.
•
If you have purchased a PC Classic for screening only, enter only the first access code.
•
If you have purchased the PC Classic Plus, enter the first two access codes.
•
If you have purchased the Methacholine Challenge,
Maximum Voluntary Ventilation (MVV), or Network Data options, enter those access codes in addition to the first two codes.
After entering each code in its appropriate box, click the
Unlock button on the right. If the access code has been entered correctly, the lock icons will change from locked to unlocked. If at any time you choose to purchase additional license options, you may enter those license codes by accessing the
Customization option as described in section 6.1.6 Licensing.
When ready, click Next to proceed.
Feb-04 Chapter 3: Equipment Preparation
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PC Classic/Classic Plus User’s Manual
3.2.7 A
TTACHING THE
3-L
ITER
S
YRINGE
The next window to appear will depend upon whether you have purchased a PC Classic or a PC Classic Plus.
•
If you have the PC Classic, you will see the
Performance
Verification window.
•
If you have the PC Classic Plus, you will see the
Initial
Calibration window.
In both cases the 3-liter syringe should be connected to the sensor as shown.
ADAPTER SEAL
SPIRO-FILTER
CALIBRATION SYRINGE
FLOW SENSOR
Figure 3-7:
Flow Sensor and 3-Liter Syringe
.
To connect the 3-liter syringe to the flow sensor, do the following:
1.
Connect the adapter seal to the end of the 3-liter syringe.
2.
Connect the flow sensor mouthpiece firmly to the 3-liter syringe.
Feb-04 Chapter 3: Equipment Preparation
18
PC Classic/Classic Plus User’s Manual
Once the syringe is firmly connected, follow the installation routine for the software you have purchased, as described in the following sections.
3.2.8 P
ERFORMANCE
V
ERIFICATION
R
OUTINE
(
PC C
LASSIC ONLY
)
If you purchased the PC Classic, the Performance Verification window will open after the correct access codes have been entered.
Figure 3-8:
Performance Verification window
.
The following steps describe how to complete the performance verification sequence:
1.
Click the
Perform Verification button. The Prepare for
Product Verification window will appear.
Feb-04 Chapter 3: Equipment Preparation
19
PC Classic/Classic Plus User’s Manual
NOTE!
A 3 liter syringe is required to perform initial calibration for the PC Classic / Classic Plus system.
Figure 3-9:
Prepare for Performance Verification Window
.
2.
Read the instructions carefully.
3.
Pull the handle out to its farthest extent.
4.
Click
Go when ready to proceed.
5.
A dialog box will appear instructing you to verify that the syringe is ready. Click
Ready to continue.
Feb-04 Chapter 3: Equipment Preparation
20
PC Classic/Classic Plus User’s Manual
Figure 3-10:
Syringe Ready Dialog Box
.
6.
A full-screen display that shows the syringe injection will appear.
Figure 3-11:
Full-screen Display –Syringe Injection
.
7.
Wait for the “Inject Syringe” command to appear on the left.
8.
Push in the handle. Be sure to use a steady, continuous stroke in such a manner that the scroll bar remains between the “Min Flow” and “Max Flow” markers.
Feb-04 Chapter 3: Equipment Preparation
21
PC Classic/Classic Plus User’s Manual
9.
When done, immediately pull the handle back all the way to prepare for another injection.
10.
If your injection was too fast or too slow, you will be given the opportunity to repeat the injection. If several failed injection attempts are made, a dialog box will appear instructing you to “ Keep Trying”.
Figure 3-12:
Product Verification Dialog Box
.
11.
After your first successful injection a dialog box will appear indicating that one more injection is required to verify the calibration. Repeat steps 5 through 10, following the onscreen prompts until a
Performance Verification Results window appears reporting the measured volume. The measured result should be between 2.91 and 3.09.
Figure 3-13:
Performance Verification Results
.
12.
Upon completion of performance verification, the Finished window will appear. The system is ready for patient testing.
Feb-04 Chapter 3: Equipment Preparation
22
PC Classic/Classic Plus User’s Manual
Figure 3-14:
Finished Window
.
Additional performance verifications may be performed at any time by selecting the Performance Verification option on the program window. See section 6.2 Performance Verification.
3.2.9 C
ALIBRATION
(
PC C
LASSIC
P
LUS ONLY
)
If you purchased the PC Classic Plus, the
Initial Calibration window will open after the correct access codes have been entered.
Figure 3-15:
Initial Calibration Window
.
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The following steps describe how to complete the calibration sequence:
1.
Click the Perform Calibration button. The Calibration dialog box will appear. It displays the syringe volume, set to a default value of 3 liters.
NOTE!
A 3 liter syringe is required to perform initial calibration for the PC Classic / Classic Plus system.
Figure 3-16:
Calibration Dialog Box
.
2.
Click OK to proceed or Cancel to abort the calibration procedure.
3.
If you selected
OK, a second dialog box will appear with an instruction to “Hold SENSOR STEADY”.
Figure 3-17:
Hold Sensor Steady Dialog Box
.
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4.
Pull the handle out to its farthest extent.
5.
When ready, press
ENTER or click OK to proceed. A fullscreen display will appear.
Figure 3-18:
Full-screen Display – Syringe Injection
.
6.
Wait for the “Inject Syringe” command to appear on the left.
7.
Push in the handle. Be sure to use a steady, continuous stroke in such a manner that the scroll bar remains between the “Min Flow” and “Max Flow” markers.
8.
Upon successful injection, a
Verify Calibration dialog box will appear. If your injection was too fast or too slow, the appropriate dialog box will appear instructing you to repeat the injection.
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Figure 3-19:
Verify Calibration Dialog Box
.
9.
Pull the handle back out to its farthest extent. Click
OK to proceed.
10.
Repeat steps 6 through 7.
11.
Upon successful completion, a Flow Calibration Results window will appear, denoting that the calibration results are either “in agreement” or “not in agreement.” The measured
ATPS volume will be between
2.91 and 3.09. You may print a copy of the calibration results or proceed to other calibration options. Calibration results are also saved in a data file. Calibration should be repeated if the results are
“not in agreement”.
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Figure 3-20:
Flow Calibration Results
.
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Figure 3-21:
Calibrating Flow Sensor Dialog Box
.
12.
When ready to continue, click
OK. A final calibration dialog box appears, offering three options:
•
Click Done to proceed to patient testing.
•
Click
ReStart to repeat the calibration routine.
•
Click
ReCheck to verify the calibration over a wide range of flow rates. See Section 6.3 Calibration (PC
Classic Plus Only) for a review of the calibration and recheck procedures necessary to meet the 1994 ATS spirometry recommendations.
NOTE!
It is important to select the ReCheck option to verify the calibration over a wide range of flow rates. This option meets the ATS recommendations for calibration verification over a wide flow range. Proceed with this step as previously during the calibration routine. Each of three syringe injection routines must be completed separately by selecting
ReCheck.
•
Inject the syringe at a slow rate. (< 2 L/second)
•
Inject the syringe at a medium rate. (4 to 6 L/second)
•
Inject the syringe at a fast rate. (> 8 L/second)
The calibration window will appear after each injection. It should display “ in Agreement” at all three flows.
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13.
If Done is selected a Finished window will appear indicating that the calibration process is complete.
Figure 3-22:
Finished Window
.
Additional calibrations may be performed at any time by selecting the Calibration option on the program window. See section 6.3 Calibration (PC Classic Plus Only).
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NOTES
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Chapter 4:
T
EST
P
REPARATION
4.1 P
ROCESSING
P
ATIENT
D
ATA
Patient information must be entered into the software before testing. Patient data is always accessed via Browse Patient List window.
Figure 4-1:
Browse Patient List: (Test options will vary depending on whether you have the Classic or Classic Plus versions.)
The following sections describe how to enter, retrieve, modify, and delete patient data.
4.1.1 E
NTERING A
N
EW
P
ATIENT
From the
Browse Patient List window, select Add. The following window will appear:
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Figure 4-2:
Add a Patient: Patient Info
.
NOTE!
There are three ways of inputting and changing information in this software:
•
Use the Tab key to move sequentially through each field.
•
Use the
Enter key to move from one required field to the next.
•
Click the mouse to position the cursor in the desired field.
Enter patient information as follows:
ID#
Type the patient's identification number. This ID# may be any combination of letters and numbers but must be unique to each patient. The maximum number of characters is 20.
This field is
required.
First Name
Type the patient's first name.
This field is
required.
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Last Name
Type the patient's last name.
This field is
required.
Street
Type the patient's street address.
This field is
optional.
City
State/Prov
Type the state in which the patient lives.
This field is
optional.
Zip
Type the city in which the patient lives.
This field is
optional.
Type the patient's zip code.
This field is
optional.
Birthdate
Type the patient's birth date, in mm/dd/yyyy format.
This field is
required.
Location ID
Enter a location ID number in this field. Maximum number of digits is 12. This field may be used to identify a specific test site or piece of equipment and is
optional
. (It remains optional in network data.)
Ethnic Origin
Access the pull-down menu by clicking the button.
Highlight one of the following choices: Asian, Black,
Caucasian, Hispanic, and Non-Caucasian. After highlighting your selection, click the button.
This field is
required.
NOTE!
Selection of ethnic origin may impact the normal predicted results. Consult the Appendix to review the Normals Tables.
The default reference for spirometry is NHANESIII.
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Height
Enter the patient's measured height (without shoes) to the nearest one-half inch or centimeter: 40–89 is designated as inches; 90–250 is designated as centimeters.
This field is
required
Weight
Enter the patient's weight in pounds or kilograms.
(Units are set during customization. See Section 6.1
C
USTOMIZATION
for specifics.)
This field is
optional
, but weight may impact the interpretation of the results.
Gender
Select the appropriate field for the patient.
This field is
required.
Predicted normal values are generally based on age, height, and gender. Review all entries for accuracy.
Press ENTER or click the OK button to accept the entries. The patient's first Respiratory History tab will then be displayed.
Feb-04
Figure 4-3:
Add a Patient: Respiratory History Tab
.
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The Respiratory History tab contains default information. If the default entries are acceptable, press
Enter or click the OK button to accept them
.
If one or more of the default entries is not correct, you will have to enter information into the following fields:
Reason for Test
Access the pull-down menu by clicking the button.
Highlight one of the following choices:
screening,
asthma, COPD, lung fibrosis, pre-surgery or other.
Cigarettes Ever Smoked
The default setting is no (if the patient has never smoked). Select yes if the patient has smoked.
#
per day
Enter the number of cigarettes the patient smokes each day.
Years
Enter the number of years that the patient has smoked.
Then Quit
The default setting is
no (if the patient has not quit smoking or has never smoked). Select
yes if the patient has quit smoking
.
Years Quit
Enter the number of years since the patient stopped smoking. If the patient has not quit smoking, leave the default of
0 (zero).
Short of breath
The default setting is
no. If it is not accurate, access the pull-down menu by clicking the button. Highlight one of the following alternate choices:
on stairs,
walking, or at rest.
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Lung surgery
The default setting is
no. If it is not accurate, access the pull-down menu by clicking the button. Highlight one of the following alternate choices:
one lung
removed, lobectomy, biopsy, or other.
After verifying that the information is correct, press
Enter or click the OK button to accept the entries. The patient's Resp.
Hist. (cont.) tab will then be displayed.
Figure 4-4:
Add a Patient: Respiratory History (Continued) Tab
.
The
Resp. Hist. (cont.) tab contains default information. If the default entries are acceptable, press Enter or click the OK button to accept them .
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If one or more of the default entries is not correct, you will have to enter information into the following fields:
Pain while Breathing
The default setting is
no and is appropriate if the patient does not experience pain while breathing. Select yes if the patient experiences pain.
Cough [frequently]
The default setting is
no and is appropriate if the patient does not cough frequently. Select
yes if the patient coughs frequently.
[With Sputum]
The default setting is
no and is appropriate if the patient coughs without producing sputum. Select yes if the patient produces sputum while coughing.
Wheezing
The default setting is
no and is appropriate if the patient does not wheeze. Select
yes if the patient wheezes.
History of Heart Disease
The default setting is
no and is appropriate if the patient does not have a history of heart disease. Select
yes, or click on the word
yes, if the patient has a history of heart disease.
Abnormal Chest X-ray
The default setting is no and is appropriate if the patient has never had an abnormal chest x-ray. Select yes if the patient has had an abnormal chest x-ray.
The Notes tab contains a blank page to enter additional pre-test information. An example of information to include is medications, dose, frequency, time last taken, and delivery method. Information entered in the
Notes tab is NOT printed on the report summary, but continues to be available in the patient’s file.
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Figure 4-5:
Add a Patient: Notes Tab
.
After verifying that the information is correct, press ENTER or click the OK button to accept the entries.
The patient record has now been created. To begin testing, refer to Chapter 5: T
ESTING
, in this manual.
4.1.2 R
ETRIEVING AND
M
ODIFYING
P
ATIENT
I
NFORMATION
If you have tested a patient previously and the information is already stored in the system, you can access the patient’s data by entering his or her ID number, Last Name, or Location ID at the
Browse Patient List window.
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Figure 4-6:
Browse Patient List: (Test options will vary depending on whether you have the Classic or Classic Plus version.)
To locate a patient’s file, do one of the following:
•
To locate the patient by
ID#, click the by Patient ID tab.
Enter the first digit or letter of the patient ID# and use the scrollbar or the arrow keys to scroll through the patient listing.
•
To locate the patient by
Name, click the by Patient Name tab. Enter the first letter of the patient’s last name and use the scrollbar or the arrow keys to scroll through the patient listing.
•
To locate a patient by
Location ID, click the by Location ID tab. Enter the first digit or letter of the location and use the scrollbar or the arrow keys to scroll through the patient listing.
If you need to change patient information accessed through any of these methods, do the following:
1.
Highlight the specific patient.
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2.
Click Modify.
3.
Enter any necessary change(s) in each tab.
4.
After all changes are made, press Enter or click the OK button to save immediately.
The updated information will be stored as part of the patient’s record.
4.1.3 D
ELETING
P
ATIENT
I
NFORMATION
!
CAUTION: Deleting a patient from the system also deletes all associated records. This is not reversible.
To delete a patient from the system, do the following:
1.
Locate the patient you want to delete.
2.
Press the
Delete key, or click the Delete button. The following
Confirm Delete dialog box will appear:
Figure 4-7:
Confirm Delete Dialog Box
.
3.
Click the
OK button to delete the selected patient record.
Click the Cancel button or press the Esc key to abort the deletion of the patient record.
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NOTES
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Chapter 5:
T
ESTING
This chapter describes how to perform the various tests available to users of both the PC Classic and the PC Classic Plus.
After entering information for a new patient or selecting an existing patient, select the test to be preformed by clicking on the appropriate test button (
Pre-Test (for training), FVC Tests,
VC Tests, Post-Bronchodilator Tests, MVV Tests, or
Methacholine Challenge Tests). Each of these menu options is described in detail in this chapter. Options will vary depending upon available modules.
NOTE!
In its 1994 update to Standards of Spirometry, the American
Thoracic Society (ATS) recommends that a minimum of three acceptable Forced Vital Capacity (FVC) tests be performed. Acceptability criteria are defined in the 1994 update. After three acceptable trials are performed, at least two trials should meet the reproducibility criteria. The limits require the two highest acceptable FVC and FEV1 measurements to agree within 200 mLs. To help the clinician achieve this reproducibility target, we have included a short routine in the PC Classic Plus called Pre-
Test that can be done prior to the FVC tests.
5.1 O
PTIONAL
P
RE
-T
EST
T
RAINING
(
PC C
LASSIC
P
LUS
O
NLY
)
For the pre-test, the patient takes several deep breaths through the spirometer. The results are compared to the patient’s predicted inspiratory capacity (IC). This procedure provides two benefits: first, it maximizes and stabilizes the lungs’ resting position. This is important because many patients, particularly those with sedentary lifestyles, will exhibit some degree of
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atelectasis, i.e., collapsed alveoli. The pre-test will eliminate a source of variability and enhance the achievement of reproducible maneuvers. Second, the pre-test helps the patient acclimate to the surroundings, gain confidence in the clinician's instructions, perform the first half of the test with the spirometer, and contribute to an overall better testing experience.
To perform a Pre-Test, do the following:
1.
From the
Browse Patient List window, click the PRE-test button. The
PRE-Tests window will open.
Figure 5-1:
PRE-Tests Window
.
2.
Click the
Perform PRE-Test button. Initially, the HOLD
SENSOR STEADY box will appear. Click
OK. A fullscreen display will appear with a graduated scale and an arrow indicating the predicted Inspiratory Capacity (IC).
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Figure 5-2:
Full-screen Display – PRE Test
.
3.
Instruct the patient to place the sensor into his/her mouth, making sure to keep a tight seal.
4.
Ask the patient to breathe quietly and, when ready, instruct the patient to inhale maximally. The display will show a bar moving up as the patient inhales.
5.
After full inhalation is achieved, instruct the patient to exhale passively to the resting position.
6.
Click the
Detail button on each highlighted Test Number. A result window will appear showing the measured, predicted, percent predicted IC value and variance, in liters.
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Figure 5-3:
PRE Test Details Display
.
7.
Repeat the procedure until a maximal value for IC is achieved.
8.
Close the IC results window and return to the
PRE-Tests,
Browse Patient List window to begin FVC testing.
5.2 FVC T
EST
This Forced Vital Capacity (FVC) Test applies to both the PC
Classic and the PC Classic Plus programs. To perform an FVC test, do the following:
1.
Click the FVC Test button. The FVC Tests window will display the tests in descending order from the newest to the oldest.
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Figure 5-4:
FVC Tests Window
.
2.
Instruct the patient how to perform the FVC maneuver and demonstrate the procedure to the patient. Coach the patient to breathe in as deeply as possible, place the mouthpiece in their mouth with the tongue placed under the mouthpiece, blow out as hard and as fast as possible, and breathe in as deeply as possible. Explain that nose clips will also be used.
NOTE!
Insert a new Spiro-Filter on to the flow sensor if this is a new patient.
3.
Click the
Perform FVC button to open the FVC test mode window.
Feb-04
Figure 5-5:
Sensor Steady Warning
.
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4.
Hold the sensor steady in the testing position and click the
OK button or press the Enter key when ready.
NOTE!
Clicking the
Cancel button returns to the FVC Tests window.
NOTE!
The sensor’s zero-point is being established and is not ready until the Begin FVC message is displayed.
5.
Although a full loop (both inhalation and exhalation) is preferred and provides the most complete information, exhalation only can be obtained: a.
When performing the complete loop, after the patient has reached a one-second plateau on the exhalation effort, he/she must forcefully begin the inhalation until full inspiration is achieved. b.
If the full loop is not desired, the patient should continue to hold the sensor steady as the computer detects the end of the test. Moving the sensor may falsely record as patient effort.
6.
The flow volume loop graph will appear on-screen and testing may begin.
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Figure 5-6:
Sample Flow Volume Loop Graph
.
NOTE!
When the necessary predicted normal values are available in the selected normals table, the graphs will contain a predicted curve. See the section 6.1.1 Software
Customization and the Normals Tables section of the
Appendix for more information.
7.
Place nose clips on the patient and instruct in the following manner: a.
"Breathe in as deeply as possible; then place your mouth securely around the mouthpiece with your tongue under the mouthpiece."
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b.
"Blow out as hard and fast as possible until I ask you to breathe in as deeply as possible again. Your mouth will still be on the mouthpiece, when you breathe in deeply the second time. Even if it feels like you have all the air out of your lungs, keep squeezing the air out until I ask you to breathe in deeply."
NOTE!
If only the exhale maneuver is to be performed, the sensor must be held steady until the end of test is determined (the software will wait five [5] seconds from the beginning of the plateau for the beginning of the inhalation to begin). A short inhale will immediately trigger the end of test.
8.
Instruct the patient to begin the procedure whenever he or she is ready.
As the patient exhales, the effort is being displayed onscreen. This display is used as an incentive for the patient to blow as hard, fast, and completely as possible and as feedback to the clinician as to how well the test is being performed. It is important to observe a sharp immediate peak at the beginning of the test. (The FV Loop incentive graph is the default setting. Refer to Section 6.1.1
S
OFTWARE
C
USTOMIZATION
, to change the incentive display).
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9.
Once the patient has completed the maneuver, the following message window will appear on-screen:
Figure 5-7:
Test Results Tab
.
NOTE!
The results in the
Var column under the Test Results tab will appear as
n/a if only one test has been performed.
NOTE!
You may print the current test by clicking the
Print button,
Accept the test and return to the FVC Test window, or
Reject the test as unacceptable.
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10.
You may review all or any of the tabs prior to accepting, rejecting or printing the test. To do so, click on one of the following:
•
More Test Results displays additional indices.
•
FVC Graph displays the Flow-Volume Loop.
•
VT Graph displays the Volume-Time Graph.
11.
Click Accept to accept the test or Reject to reject the test just performed.
The effort was “acceptable” if the patient met all of the following criteria:
•
Started with a full inspiration to Total Lung Capacity
(TLC)
•
Exhaled with an immediate, fast start (back extrapolation less than 5% of the FVC or 150 mL, whichever is greater)
•
Exhaled with maximal effort (observed on the peak flow)
•
Continued smooth continuous exhalation for at least 6 seconds or until there is no change in volume for onesecond on the volume-time curve
•
No coughing in the first second
•
Inhaled maximally after the expiration
Errors are also displayed on the Test Results tab to assist in re-instructing the patient.
12.
Click Perform FVC to perform another FVC test.
13.
When testing is complete, click Close to return to the
Browse Patient List window. You may then:
•
Select a different type of test for the patient
•
Generate a summary report for the patient
•
Select a previous patient
•
Enter a new patient
•
Modify a patient's biographical information
•
Delete a patient's record.
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5.2.1 W
ARNING
M
ESSAGES
The following warning messages may appear:
•
Test Too Short – Expiratory Time < 6.0 Seconds displays if the patient exhales for less than six seconds.
•
Slow Start – Extrapolated Volume > 5% of FVC displays if the patient has a slow start to the test.
•
Early Termination – No Plateau in VT displays if a onesecond (1) plateau was not reached prior to the conclusion of the exhalation maneuver.
5.3 VC T
EST
This test applies to both the PC Classic as well as the PC Classic
Plus software. In patients with severe obstructive lung disease, the Forced Vital Capacity (FVC) may be reduced due to increased airway resistance or a loss of elastic recoil that results in early closure of the airways and gas trapping. Exhaling at much slower flow rates may allow the patient to more fully empty the lungs. A higher value for VC (Slow Vital Capacity) relative to the FVC may help rule out a combined obstructive/restrictive disorder, but static lung volumes must be measured for a definitive answer.
The difference between the FVC and VC measurements may estimate how much air is trapped in the lungs during a forced expiration.
To administer the test, perform the following steps:
NOTE!
Insert a new Spiro-Filter on to the flow sensor if this is a new patient.
1.
Click the VC Tests button. The VC Tests window will display the tests in descending order from the newest to the oldest.
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Figure 5-8:
VC Tests
.
2.
The patient should be instructed to breathe in as deeply and completely as possible and then blow all of the air out slowly and completely.
3.
Click the PerformVC button.
4.
When the sensor is in the testing position, click
OK.
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Figure 5-9:
Vital Capacity Test Graph
.
5.
When the message
Begin SlowVC... appears on-screen the zero-point has been established and the system is ready to begin the test.
6.
Place nose clips on the patient and instruct the patient to do the following: a.
"Breathe in as deeply as possible...place your mouth tightly around the mouthpiece with your tongue under the mouthpiece." b.
"Blow all of the air out of your lungs slowly until I ask you to stop."
7.
Once the maneuver is complete, the following window will appear:
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Figure 5-10:
Accept or Reject VC Test Window
.
Options on the Accept or Reject VC Test window are:
Test Results tab
This is the default window displayed after the test results are processed.
VT Graph tab
For review of the volume time curve created from the
VC. This is only viewable at the initial accept / reject window. Once the test has been accepted, and the details are recalled for viewing, the volume time curve is no longer available for the VC test.
Print:
Prints a page report with the test results.
Accept
This choice indicates that the test was acceptable and returns to the Browse the VC Tests File window.
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Reject
This choice indicates that the test was unacceptable.
The VC effort was "acceptable" if the patient:
• put forth a good effort
• inhaled completely
• exhaled completely and
• exhaled smoothly. (NO COUGHING!)
If you have completed testing this patient for VC, close the
VC
Tests window by either clicking the Close button or pressing the
Esc key. This will return you to the Browse Patient List window.
5.4 P
OST
-B
RONCHODILATOR
T
ESTING
(
PC C
LASSIC
P
LUS
O
NLY
)
If you would like to perform post-bronchodilator testing, there are two ways to enter post-bronchodilator testing mode.
NOTE!
The ATS and AARC have established recommendations for the administration of the bronchodilator and post-testing procedures.
5.4.1 M
ETHOD
1:
If you have performed FVC tests on a patient and you have not closed the
FVC Tests window for that patient, do the following from the
FVC Tests window:
1.
Click
Post Mode button. The following window will appear:
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Figure 5-11: Setting
Post Mode Window
.
2.
Click
Yes if all pre-bronchodilator testing is complete and to set the patient for Post Mode. A dialog box will appear instructing you to administer a bronchodilator. Click
OK to proceed. The
FVC Tests window will appear with a title bar that reads:
FVC Tests - (patient name) [Post-
Bronchodilator Testing]. The Post Mode button will now be grayed out.
NOTE!
Once Post Mode is set for a patient on a particular day, it is
NOT POSSIBLE to exit the post mode until the next day.
Feb-04
Figure 5-12: FVC Tests
Post Mode Window
.
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3.
Perform post mode FVC tests by clicking on the
Perform
FVC button.
4.
To view post mode test details, select the desired test and click on the Detail button. A FVC Test Details window will appear. If the test was performed in the postbronchodilator mode, a note at the bottom right of the detail window will indicate:
Post Mode Test. If the test was performed prior to entering the post-bronchodilator mode, there will be no message at the lower right area of the detail window.
Figure 5-13: Bronchodilator Test Results in Details Window.
NOTE!
The 1991 ATS recommendations for interpretation of spirometry discuss limits for an acceptable response.
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5.
To view a testing report close the FVC Tests window and click on the
Summary Results button in the Browse
Patient List window. Post-bronchodilator results appear in a separate column on the test report, and a percent change from pre-bronchodilator results is also given.
Figure 5-14: Bronchodilator Test Results in Summary Window.
5.4.2 M
ETHOD
2:
After administering a bronchodilator to a particular patient, you may wish to perform other tests on other patients. If you have returned to the
Browse Patient List window after performing
FVC tests and before you have entered the post mode by clicking on the
Post Mode button, you may enter the post bronchodilator testing mode by doing the following from the
Browse Patient List window:
1.
Highlight the patient's name.
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2.
Click the FVC Tests button.
3.
If you have already performed testing on this patient earlier in the day, you will be prompted to set post-bronchodilator mode, click
Yes if all pre-bronchodilator testing is complete.
If all pre-bronchodilator testing is not complete, click
No and complete pre-bronchodilator testing before proceeding to post-bronchodilator testing.
Figure 5-15:
Setting Post-bronchodilator Mode Window
.
NOTE!
Once Post Mode is set for a patient on a particular day, it is
NOT POSSIBLE to exit the post mode until the next day.
4.
You will not be prompted to administer a bronchodilator when using this method. Administer the bronchodilator if you have not already done so.
NOTE!
If you have not done testing on this patient earlier in the day and you click on the Post Mode button, you will see a dialog box instructing you to perform pre-bronchodilator testing.
Click OK to return to the FVC Tests window.
5.
Perform FVC tests according to steps 3 through 5 in section
5.4.1 Method 1: above.
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5.5 MVV T
EST
(
PC C
LASSIC
P
LUS
O
NLY
)
The Maximal Voluntary Ventilation (MVV) is a non-specific indicator of respiratory system dysfunction and provides information about the patient's overall breathing ability. The
MVV is sometimes performed in conjunction with and following FVC testing.
NOTE!
This test requires considerable effort and motivation on the part of the patient. It is fatiguing and patient effort dependent. It may induce gas trapping or bronchospasm. It is not recommended for routine screening procedures.
The MVV correlates well with a patient’s exercise capacity and is used as a predictor of the maximum ventilatory capacity.
To perform the MVV test, do the following:
1.
Explain the procedure to the patient so that he or she fully understands what will happen.
2.
Highlight the patient's name in the
Browse Patient List
window.
3.
Click the MVV Tests button.
NOTE!
Insert a new Spiro-Filter into the flow sensor for each new patient.
4.
Have the patient breathe in and out as hard and fast as possible for at least 12 seconds.
5.
From the
MVV Tests window, click the Perform MVV button.
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Figure 5-16:
MVV Tests Window
.
6.
When the
Hold SENSOR STEADY window appears click
OK.
7.
Place nose clips on the patient and instruct the patient in the following manner with: a.
"Place your mouth on the mouthpiece with your tongue under the mouthpiece." b.
"Breathe in and out as hard and fast as possible.
Continue this forced panting until I tell you to stop. It will be about 12 seconds."
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Figure 5-17:
MVV Graph Window
.
The curve moves up and down, displaying the volume breathed in and out as well as the respiratory rate. This display indicates the breathing pattern during the MVV maneuver.
8.
After the test is complete, the Accept or Reject MVV Test window appears.
An MVV test is “acceptable” if:
•
The patient put forth maximal effort
•
The test lasted a full 12 seconds or more
•
The patient did not cough or choke
•
The result is approximately 35 times the FEV1
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Figure 5-18:
Accept or Reject MVV Test Results Window
.
Options on the
MVV Tests window shown in Figure 5-16 are:
Perform MVV: enters MVV testing mode
Print: prints the numeric test results of the highlighted test when selected later
Detail:
displays the numeric results window
Delete: deletes the currently highlighted test from the data base. Confirmation is required.
9.
Click the Print & Accept button to accept and print the test.
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NOTE!
If the accepted test is not printed at this time, only the numeric test data, not the volume-time graph, will be available for printing later.
10.
Both window tabs may be clicked for review before making the
Accept or Reject determination. Once the test is rejected, the information for that test is no longer available.
11.
Click the Detail button to view the MVV Test Details window.
Figure 5-19:
MVV Test Detail Window
.
12.
Click the OK button to return to the MVV Tests window.
13.
If you have completed testing this patient, click Close to return to the
Browse Patient List window.
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5.5.1 V
IEW OR
D
ELETE
T
EST
To view or delete a test, do the following:
1.
Select the patient whose tests you wish to view or delete by highlighting his or her name in the
Browse Patient List
window.
2.
Select the type of test to view or delete by clicking the individual test button (
FVC Tests, Pre Test, Meth Chal.,
VC Tests, MVV Tests).
3.
To view a test, highlight the specific test, then click the
Detail button.
4.
To delete a test, highlight it in the desired test window, then click the Delete button.
Figure 5-20:
Confirm Delete Window
.
NOTE!
Completing the delete using this procedure will
permanently remove tests from the database.
A
Confirm Delete window will appear to make sure you truly want to delete the test. Click
OK to delete or click Cancel or the
Esc key to cancel the operation. These will bring you back to the previous window. Click the Close button or the Esc key to return to the previous window.
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5.6 S
UMMARY
R
EPORT
This option allows you to display the summary of the results, along with an interpretation, COPD risk indicator, and lung age estimation.
NOTE!
To learn more about customizing your report summary printing options, see sections 6.1.3 Report Setup and 6.1.4
Report Options.
To prepare a summary report, highlight the name of the patient for whom you want a summary and then click the
Summary
Results button from the Browse Patient List window. Options include:
Test Results tab
Displays the test results for testing that day for the individual selected.
More Test Results tab
Displays the second page of test results.
FVC Graph tab
Displays the flow volume loop graph.
VT Graph tab
Displays the volume time curve.
Print Summary
Formats and prints a summary report.
Comments
Allows the clinician to add text comments about this patient. The comments are only viewable from the patient summary window and will not be printed on the final report.
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Figure 5-21:
Summary Window
.
The following examples illustrate one-page and two-page printed summary reports.
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Spirometrics Medical Equipment Co
22 Shaker Road
Gray, ME 04039
207-657-6700
Patient: Johnny Doe
ID #:
Age:
Sex:
Race:
Smoke:
4516156
29
Male
Caucasian
Height: 72 inches
Weight: 0 lbs
0 cigarettes/day
Normals: Composite
Ambient Conditions: 760
Calibrated: 12/09/2002
Graph legend mm Hg at 72 F
Predicted Graph
Pre Test - Best Test is bold
Post Test - Best Test is bold
Pre FEV1 Mark
Post FEV1 Mark
Flow / Volume Loop
16
Summary Report
Best Test is #1 of 3 Tests
Best Post is #5 of 3 Tests
Index Unit
FVC
FEV1
FEV6
FEV3
FEV1/FVC
FEV1/FEV6
FEF.2-1.2
FEF25-75
FEF75-85
PEF
FEF25
FEF50
FEF75
FIVC
FIF50
FEF50/FIF50
PIF
MMET
FET
MVV VOL
Rate
VC
ATI: VC-FVC
Brths/m l l
% l/s s s l/m l/s l/s l/s l l/s l/s l/s l/s l/s
%
% l
l l
l
Meas
9.0
3.4
0.8
10.1
8.3
4.3
1.3
3.95
6.5
65.2
6.7
0.65
7.74
4.38
3.52
<<
4.32
4.09
80.4
81.5
Pred
5.84
4.75
5.76
5.49
82.1
83.3
8.5
4.7
1.5
10.2
n/a
5.9
n/a
5.84
n/a n/a n/a n/a n/a
187 n/a
5.8
105
71
53
100 n/a
72 n/a
68 n/a n/a n/a n/a n/a
0 n/a
0
3/18/2005
3/18/2005
%Pred Post
12:37PM
12:39PM
%Chng
75
74
75
74
4.52
3.49
4.35
4.07
77.2
80.2
8.7
2.8
0.5
9.4
8.4
3.8
1.0
4.40
7.4
50.7
7.7
0.80
9.40
3.2%
-0.9%
0.7%
-0.5%
-2.8%
-16.4%
-35.9%
-7.2%
1.4%
-10.8%
-23.1%
11.4%
13.3%
-22.2%
14.8%
23.1%
21.4%
<< Measured value less than 75% of predicted
12
Interpretation
8
4
0
-4
-8
-12
1 2
PC-Classic Plus
3 4 5 6
2.11d
7 8
Interpretation: Spirometric Results Appear Normal
Volume / Time Curve
8
6
4
2
0
0 1 2 3 4
12/30/2002 2:32PM
5 6 7
Page 1
8
Figure 5-22:
One-Page Summary Report
.
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Spirometrics Medical Equipment Co
22 Shaker Road
Gray, ME 04039
207-657-6700
Patient: Johnny Doe
ID #:
Age:
Sex:
4516156
29
Male
Race:
Height:
Caucasian
72 inches
Weight: 0 lbs
Smoke: 0 cigarettes/day
Normals: Composite
Ambient Conditions: 760
Calibrated: 12/09/2002
Interpretation mm Hg at 72 F
Interpretation:
Spirometric Results Appear Normal
Graph legend
Predicted Graph
Pre Test - Best Test is bold
Post Test - Best Test is bold
Pre FEV1 Mark
Post FEV1 Mark
Volume / Time Curve
8
6
4
2
Summary Report
Best Test is #1 of 3 Tests
Best Post is #5 of 3 Tests
Index Unit
FVC
FEV1
FEV6
FEV3
FEV1/FVC
FEV1/FEV6
FEF.2-1.2
FEF25-75
FEF75-85
PEF
FEF25
FEF50
FEF75
FIVC
FIF50
FEF50/FIF50
PIF
MMET
FET
MVV VOL
Rate
VC
ATI: VC-FVC
Brths/m l l
% l/s s s l/m l/s l/s l/s l l/s l/s l/s l/s l/s
%
%
l
l
l
l
Meas
4.38
3.52
<<
4.32
4.09
80.4
81.5
9.0
3.4
0.8
10.1
8.3
4.3
1.3
3.95
6.5
65.2
6.7
0.65
7.74
0
0
PC-Classic Plus
1 2
2.11d
3 4
Time -- Seconds
5
12/30/2002 2:26PM
6
Pred
5.84
4.75
5.76
5.49
82.1
83.3
8.5
4.7
1.5
10.2
n/a
5.9
n/a
5.84
n/a n/a n/a n/a n/a
187 n/a
5.8
105
71
53
100 n/a
72 n/a
68 n/a n/a n/a n/a n/a
0 n/a
0
3/18/2005 12:37PM
%Pred Post
%Chng
75
74
75
74
4.52
3.49
4.35
4.07
77.2
80.2
8.7
2.8
0.5
9.4
8.4
3.8
1.0
4.40
7.4
50.7
7.7
0.80
9.40
3.2%
-0.9%
0.7%
-0.5%
-2.8%
-16.4%
-35.9%
-7.2%
1.4%
-10.8%
-23.1%
11.4%
13.3%
-22.2%
14.8%
23.1%
21.4%
<< Measured value less than 75% of predicted
7 8
Page 1
Figure 5-23:
Two-Page Summary Report - Page 1
.
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Spirometrics Medical Equipment Co
22 Shaker Road
Gray, ME 04039
207-657-6700
Flow / Volume Loop
Summary Report
Johnny Doe
ID # 4516156
Test # 1
16
12
8
4
0
-4
-8
-12
Patient History
Cigarettes:
Short of Breath:
Pain while Breathing:
Cough Frequently: no no no no
1 2 3 4
Volume -- Liters
5 6 7 8
Wheezing: no
History of Heart Disease:
Abnormal X-Ray ever:
Lung Surgery: no no no
PC-Classic Plus 2.11d
12/30/2002 2:26PM
Page 2
Figure 5-24:
Two-Page Summary Report-Page 2
.
NOTE!
When the necessary predicted normal values are available in the selected normals table, the report graphs will contain a predicted curve. See the section 6.1.1 Software
Customization and the Normals Tables section of the
Appendix for more information.
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5.7 T
REND
A
NALYSIS
The Trend Analysis option, found in both the PC Classic and PC
Classic Plus versions, allows you to choose tests and plot the values over time. This allows you to view graphically the change in the patients’ lung function over time.
To prepare a trend analysis, do the following:
1.
Click the Trend button in the Browse Patient List window.
Alternatively, click File to access the pull down menu.
Click
Trend Analysis to display the Trend Analysis window.
Figure 5-25:
Trend Analysis Window
.
2.
You may compare individual tests or the best test results, from
All tests, Pre BD Only or Post BD Only
(Bronchodilator).
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3.
Make selections within the Which Kind of Trend Analysis and
Include Which Tests boxes and then highlight the tests from those displayed in the
Select area.
4.
Use the scrollbar, press the arrow keys or press the
PgUp or
PgDn keys to move within the available tests.
5.
Press the Space Bar or double click to tag tests for trending. Tests are tagged to be trended when the icon to the left is a . Up to twenty (20) tests maybe selected to trend.
6.
If you have selected a test that you wish to de-select, highlight it and press the
Space Bar or double click the test.
The test is not tagged for trending when the icon to the left is an .
7.
Five indices are trended: FVC, FEV1, FEV1/FVC, FEF 25-
75, and PEF. Click the
Trend button to display the Trend
Analysis window with its two (2) tabs:
The
Trend Data tab displays the numeric results, with each line showing the date the test was performed, the specific test number for that day, the respective indices, and a column indicating Pre or Post bronchodilator testing results.
A zero (0) indicates that it was Pre testing; a one (1) shows it as a Post test.
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Figure 5-26:
Trend Analysis: Trend Data Tab.
The
Trend Graph tab will open a graph window and display a plot of the indices.
Feb-04
Figure 5-27:
Trend Analysis: Trend Graph Tab
.
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To print a copy of the trend analysis, click the Print button. To return to the previous window click the
Done button, or press the
Esc key. The test number corresponds to date from the oldest to most recent record.
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NOTES
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Chapter 6:
S
PECIAL
F
EATURES
6.1 C
USTOMIZATION
Spirometrics designed the PC Classic and PC Classic Plus to be as flexible as possible, allowing users to customize it to meet their particular needs.
To customize your software settings, open the Customization window, by clicking on the
Customization option of the main menu.
6.1.1 S
OFTWARE
C
USTOMIZATION
The
Setup tab contains fields that allow you to customize your software. The following variables are included in this window:
Feb-04
Figure 6-1:
Customization - Setup
.
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COM Port setup (Flow Sensor)
To change the COM Port, highlight the number for
COM Port Flow sensor and enter the number of the
COM port to be used. Alternately, use the scrollbar, or press the up or down arrow keys on the keyboard, to arrive at the number you desire.
Predicteds
The default setting is Composite. To change it, access the pull-down menu by clicking the button. Scroll through the listed studies, highlight the author you want to use and click on it. The choices are:
Composite,
Crapo, ECCS, Hsu, Knudson-1983, Knudson-1976,
Lam, Morris, NHANES III, and Polgar. Refer to the
R
EFERENCES
section in the Appendix for selection guidance.
Extrapolation
The default setting is no, indicating that the predicted will not be extrapolated. By changing this field to
yes, the predicted will be reported even though the height or age range was not captured in the author’s study. The predicted will be identified as being extrapolated when displayed on-screen and in the report(s).
Calibration Settings (Syringe Volume)
The default setting is
3 liters. To change it, use the up and down arrows on the keyboard or highlight the existing number and enter the appropriate number.
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Gauge readings
Allows you to change the settings for air temperature and barometric pressure each day of testing. To do so, highlight the field and enter the appropriate number.
(Temperature values from 10 to 40 are recorded as ° C and those from 50 to 104 as °F. Barometric pressure values from 20 to 35 are recorded as inches Hg, and from 500 to 900 are recorded as mmHg). These values must be accurate for each individual tested.
FVC Incentive Display
The default setting is Flow Volume loop (
FVLoop).
The choices are: FVLoop (Flow-Volume Loop),
VTCurve (Volume-Time Curve), and Balloons.
Weight Units
The default setting is lbs (pounds). To change it, select
kgs (kilograms).
Gain Factor
This variable is set during calibration. It is only displayed on the
Setup window and cannot be changed.
6.1.2 D
ATA
O
PTIONS
The
Data Options tab allows customization of the security, backup and data location settings.
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Figure 6-2:
Customization - Data Options
.
Security
The program can be set to require a password for all individuals to access to the PC-Classic software and related patient data in order to ensure patient privacy protection. See section 7.5 Maintaining Users to develop a user list and set passwords prior to selecting
Require Password to access PC-Classic. Section 7.5 also has default password information.
Auto Backup
The default setting for automatic backup is for all data to be backed up when exiting the program. The interval between each backup may be selected from 1 to 30 days.
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Data Directory
The data directory is set to the default location during installation. This setting may be changed by selecting the
Change Dir button and entering the new data directory location. The Set to Default option resets the data path to the data subdirectory of the program directory. Both short and long filenames may be used.
6.1.3 R
EPORT
S
ETUP
Figure 6-3:
Customization - Report Setup
.
The Report Setup tab allows customization of the report printout.
Report Header: Allows four (4) lines of text to identify the facility performing the testing.
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FVC Test Report Option
The default setting is
Two page ATS (graph scaling meets ATS recommendations for hand measurements).
The other option is a
One page condensed report.
(Note: condensed graph scaling does not meet ATS recommendations, but is quick and will print both graphs on a single page).
Summary Report Options
The default is set to Two page ATS (graph scaling meets ATS recommendations for hand measurements).
As in the FVC Test Report Options, a single
One page
condensed report is also available. Up to 3 graphs may be included in the pre- and post-bronchodilator report. The graphs may be placed directly on top of each other or slightly offset.
Flow / Volume Loop
16
4
0
12
8
-4
-8
-12
1 2 3 4 5 6 7 8
PC-Classic Plus
2.11d
Figure 6-4:
Offset Graphs Example
.
When Offset Graphs is selected, the graphs will be offset 0.5 liters at Residual Volume (RV) in the summary report.
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NOTE!
Spirometrics recommends that at least 3 acceptable graphs should be available for review by the interpreting physician.
Variability Method
The default variability method is set to
Actual, which will display the absolute differences and will note the
FVC or FEV1 differences from the best to the second best test above 0.20 liters. (ATS 1994 method)
Optionally, the variability method may be set to
Percent, which will display percentage differences and will note FVC or FEV1 percent differences from the best to the second best test that are greater than five
(5%) percent. (ATS 1987 method)
6.1.4 R
EPORT
O
PTIONS
Feb-04
Figure 6-5:
Customization - Report Options
.
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The Report Options window allows you to customize whether listed indices or a list of information will appear on the individual and summary reports.
The window comprises the following fields:
Automatic Test Printout
The default setting is
no.
Weight on report
The default setting is
yes.
Diagnostic Interpretation
The default setting is no. See the Diagnostic
Interpretation section of the Appendix for more information.
COPD Risk
The default setting is no.
Respiratory History
The default setting is
yes.
Lung Age
The default setting is
no.
6.1.5 M
ETHACHOLINE
C
HALLENGE
O
PTIONS
!
WARNING: Methacholine is an inhaled agent that may cause the airways to constrict in susceptible patients. The 1999 ATS guidelines for methacholine and exercise testing should be followed. (See the R
EFERENCES
section in the Appendix.)
Users can customize the methacholine challenge settings at the
Challenge tab.
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Figure 6-6:
Customization - Methacholine Options
.
Breaths Per Concentration
The default setting is 5 breaths. Selection range is one
(1) to nine (9). To change the number, click on the number or press the
Tab key repeatedly to reach the field, delete the old value, and enter the new one.
Concentration
Concentration 1 is always a baseline diluent. The defaults for levels two (2) through eleven (11) are 0.031,
0.062, 0.125, 0.25, 0.50, 1, 2, 4, 8, 16 mg/ml/breath, respectively. These are consistent with the 1999 ATS recommendations for dosing protocols. To change any of the present values, click on the number or press the
Tab key repeatedly to reach the appropriate field, delete the old value, and enter the new value.
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Lower Limit of Normal
This is used in the interpretation statement. The default setting is 8.0 mg/ml. To change the number, click on the number or press the
Tab key repeatedly to reach the appropriate field, delete the old value, and enter the new value.
6.1.6 L
ICENSING
Figure 6-7: Customization -
Licensing
.
The
Licensing tab allows entry of a license code for each module purchased. Spirometrics has provided each of these codes with the equipment at the time of purchase or upgrade.
For a list of license codes provided when your system was originally purchased, see the first page of this manual or the PC
Classic CD packaging.
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Enter each code and click Unlock. Notice the padlock symbol turns green when a module is activated.
6.1.7 G
ENERAL
C
USTOMIZATION
B
UTTONS
The following buttons are located at the bottom of the
Customization window:
•
The
Print Customization button allows you to print a copy of the customization settings that you have just made, in case you share the equipment with others who might change the settings. The default system printer will be used.
NOTE!
We recommend that you make a copy of your customization settings and keep it with the user’s manual.
•
The OK button allows you to accept all changes that you have made.
•
The Cancel button allows you to cancel the changes that you have made and abort the customization session.
6.2 P
ERFORMANCE
V
ERIFICATION
&
C
ALIBRATION
We have included a routine called Performance Verification for PC Classic users and a Calibration routine for PC Classic
Plus users to test the long-term stability of the system.
Performance verification or calibration was completed as part of the installation process. These procedures can be repeated at any time to validate that the spirometer is working properly.
ATS standards require daily calibration. For more information on the calibration option and ATS requirements see section 6.3
Calibration (PC Classic Plus Only).
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ADAPTER SEAL
SPIRO-FILTER
CALIBRATION SYRINGE
FLOW SENSOR
Figure 6-8:
Flow Sensor and 3-Liter Syringe
.
To connect the 3-liter syringe to the flow sensor, do the following:
1.
Connect the adapter seal to the end of the 3-liter syringe.
2.
Connect the flow sensor mouthpiece firmly to the 3-liter syringe.
Once the syringe is firmly connected, follow the routine for the software you have purchased, described in the following sections.
6.2.1 P
ERFORMANCE
V
ERIFICATION
R
OUTINE
(
PC C
LASSIC ONLY
)
If you purchased the PC Classic, the
Performance Verification window can be accessed after installation and initial setup of the software at any time by clicking on the
Performance
Verification button.
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Figure 6-9:
Prepare for Product Verification Window
.
The following steps describe how to complete the performance verification sequence:
1.
Click the
Perform Verification button. The Prepare for
Product Verification window will appear.
2.
Read the instructions carefully.
3.
Click Go when ready to proceed. A full-screen display that shows the syringe injection will appear.
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Figure 6-10:
Full-screen Display – Syringe Injection
.
4.
Wait for the “ Inject Syringe” command to appear on the left.
5.
Pull the handle to its farthest extent.
6.
Push in the handle. Be sure to use a steady, continuous stroke in such a manner that the scroll bar remains between the “
Min Flow” and “Max Flow” markers.
7.
When done, immediately pull the handle back all the way.
The full-screen display will reappear.
8.
Repeat steps 4 through 6, following the on-screen prompts, until a window appears, reporting the measured results.
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Figure 6-11:
Performance Verification Results
.
9.
Click
OK to complete the verification procedure.
6.3 C
ALIBRATION
(
PC C
LASSIC
P
LUS
O
NLY
)
Calibrating your PC Classic Plus ensures accurate test results.
You should calibrate before you use it for the first time, and recalibrate it at routine intervals. Spirometrics recommends daily calibrations to insure that the spirometer is working properly.
NOTE!
For compliance with the American Thoracic Society’s 1994
Standards of Spirometry and good quality control procedures, it is recommended that the linearity of the flow sensing pneumotach be checked on a daily basis. This can be accomplished by injecting your syringe at three different flow rates during a follow-up injection. As an example, injecting a 3-liter syringe for 1, 3, and 6 seconds will create rates of 3 l/s, 1 l/s, and 0.5 l/s, respectively. See the following section for instructions.
6.3.1 C
ALIBRATION
R
OUTINE
The following steps describe how to complete the calibration sequence:
1.
Click the
Calibration button. The Calibration dialog box will appear. It displays the syringe volume.
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Figure 6-12:
Calibration Dialog Box
.
2.
Click
OK to proceed or Cancel to abort the calibration procedure.
NOTE!
To change the syringe volume, the user must access the
Customization option from the main menu and change the syringe volume. Syringe volumes from 1 to 9 liters may be entered. Using a syringe with volume different from the display value will result in calibration errors.
3.
If you selected
OK, a second dialog box will appear with an instruction to “
Hold SENSOR STEADY”.
Figure 6-13:
Hold Sensor Steady Dialog Box
.
4.
Pull the handle to its farthest extent.
5.
When ready, click OK to proceed. A full-screen display will appear.
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Figure 6-14:
Full-screen Display – Syringe Injection
.
6.
Wait for the “ Inject Syringe” command to appear on the left.
7.
Push in the handle. Be sure to use a steady, continuous stroke in such a manner that the scroll bar remains between the “ Min Flow” and “Max Flow” markers.
8.
Upon successful completion, a Verify Calibration dialog box will appear.
9.
Pull the handle back to its farthest extent. Click OK to proceed.
Feb-04
Figure 6-15:
Verify Calibration Dialog Box
.
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10.
Repeat steps 6 and 7.
11.
Upon successful completion, a
Flow Calibration Results window will appear, denoting that the calibration results are either “
in agreement” or “NOT in agreement”. At this point, the user can print a copy of the calibration results or proceed to other calibration options. Calibration records should be maintained for each day testing is performed.
Feb-04
Figure 6-16:
Flow Calibration Results
.
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12.
When ready to continue, click OK. A final calibration dialog box appears, offering three options:
•
Click Done to proceed to patient testing.
•
Click
ReStart to repeat the calibration routine.
•
Click ReCheck to verify the calibration over a wide range of flow rates.
Figure 6-17:
Calibrating Flow Sensor Dialog Box
.
NOTE!
It is important to select the ReCheck option to verify the calibration over a wide range of flow rates. This option meets the ATS recommendations for calibration verification over a wide flow range. Proceed with this step as previously during the calibration routine. Each of three syringe injections must be completed separately by selecting
ReCheck.
•
Inject the syringe at a slow rate. (< 2 L/second)
•
Inject the syringe at a medium rate. (4 to 6 L/second)
•
Inject the syringe at a fast rate. (> 8 L/second)
The calibration window will appear after each injection. It should display “ in Agreement” at all three flows.
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6.4 P
RINTER
S
ELECTION
The PC Classic/PC Classic Plus for Windows program uses the default printer selected under Print Manager or Control Panel. If your default printer does not supply satisfactory results, change your printer selection by doing the following: PC Classic/PC
Classic Plus only determines the Windows system default printer at program start-up. If you use Windows to change the system default printer, you will need to close and restart PC
Classic to update the printer selection.
1.
From the main menu, select the
File option.
2.
Click on Print Setup.
3.
Select the Specific Printer option.
Figure 6-18:
Print Setup
Window.
4.
Click the button to scroll through the printer choices.
5.
Highlight the printer that you want to use.
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6.
Click OK to save the selection to disk.
NOTE!
If the print driver supplied by the printer manufacturer gave results that were unacceptable, try installing a different driver from that family, then retry printing. For example, the
BJ-130 driver prints the lines darker on the graphs than does the native BJC-210 driver to the BJC-210 printer.
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Chapter 7:
D
ATA
M
ANAGEMENT
7.1 P
ROTECTING
P
ATIENT
D
ATA
It is recommended that the files located in the DATA directory be regularly backed up.
Figure 7-1:
File Options Window
.
To generate a
Backup/Restore from the main menu:
1.
Select
File.
2.
Highlight
Backup/Restore.
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3.
A dialog box will appear informing you that the PC Classic program needs to close in order to perform backup and restore procedures. Press the Enter key to proceed and PC
Classic will close automatically. The
PC Classic - Back Up
& Restore program will open.
Figure 7-2:
Backup & Restore Console
.
You may
BACKUP files, RESTORE files, or review the backup LOG FILE from this screen. Choose the appropriate options and follow the on-screen instructions in each subwindow to perform the desired operation.
4.
Click
BACKUP to back up patient data to floppy or to a directory of your choice.
5.
Click RESTORE to retrieve patient data from the backup files.
6.
Click
LOG FILE to review all backup and restore history.
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Upon exiting the PC Classic program, the following message will appear to allow automatic backup of files:
Figure 7-3:
Automatic Backup Window
.
Click Yes to backup files. PC Classic will close and the PC
Classic - Back Up & Restore program will open.
7.2 E
XPORTING AND
I
MPORTING
F
ILES
The following sections describe how to export and import files.
7.2.1 E
XPORTING
F
ILES
The PC Classic can export patient records to a file. To do so:
1.
From the main menu, select
File.
2.
Select
Export Data.
3.
Select Export File Format and specific fields to export.
The default is checked to Export All Fields. If the box is unchecked, specific fields may be selected to export. Fields selected are tagged with a green circle.
4.
Enter the dates, which start and end the period from which you wish to export data. (The default starts from 1/01/80, and ends with the current date, as read from the computer’s current settings.)
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Figure 7-4:
Export Data from PC Classic
.
5.
To proceed with exporting, click
Export. The file will be created and written to your computer’s hard drive. To abort exporting, click Close.
7.2.2 I
MPORTING
F
ILES
The PC Classic can also import patient records to a file. To do so:
1.
From the main menu, select File.
2.
Select
Import Data.
3.
Select
Import File Format.
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4.
To proceed with importing, click Import. To abort importing, click
Close.
Figure 7-5:
Import Data from PC Classic
.
7.3 B
ATCH
R
EPORTS
To generate batch reports from the main menu:
1.
Select Batch Reports.
2.
Click on the option that best suits your needs –
Patients by ID, Print Patients by Name, Print Patients by
Location ID, or Print the Customization.
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Figure 7-6:
Batch Reports Menu
.
7.4 C
ALIBRATION
R
EVIEW AND
M
AINTENANCE
1.
Select Browse Data.
2.
Click on All Calibrations. The Saved Calibrations window will appear.
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Figure 7-7:
Calibration Data Detail Review Window
.
Date and time are used to sort all calibration data. The data may be reviewed for trending and for evaluation of concerning results. The details of a single calibration can also be examined and printed from this window. The last date of calibration also prints on each patient report.
7.5 M
AINTAINING
U
SERS
A list of all system users as entered by a program administrator is maintained by the PC Classic/PC Classic Plus program. A valid username and password is required to run PC Classic/PC
Classic Plus software when the security option is selected in the
Data Options tab of the Customization window. See section
6.1.1 Software Customization.
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NOTE!
The user list contains the user name MASTER by default.
The default password for the MASTER user is master. The username and password are NOT uppercase or lowercase character sensitive. The MASTER password may be changed or the MASTER user may be deleted entirely if desired.
!
WARNING: Store password information in a safe, secure place. The procedure required to recover lost passwords may result in data loss.
The steps necessary to add, delete or modify user information are as follows:
1.
Select the Browse Data option in the main menu.
2.
Click on
Maintain Users and the User List window will appear.
Figure 7-8:
Maintain Users - User List Window
.
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3.
Click Insert to add a new user and password or click
Update to change a user record. The Adding a User’s
Record or Changing a User’s Record window will appear.
Figure 7-9:
Adding User Record Window
.
4.
Enter or modify the user’s information.
5.
Click the
Reset button to add or modify a password for the user.
6.
Click OK to continue and save the user entry or changes or
Cancel to abort. The current window will close and return to the
User List window.
7.
If desired, click on
Delete to permanently remove a user from the PC Classic user list.
7.6 N
ETWORK
O
PTION
(
PC C
LASSIC
P
LUS
O
NLY
)
The network option is only available on the PC Classic Plus.
The network code may be verified in the
Customization window in the
Licensing tab.
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Verify that the data directory path is set to your shared location as desired.
Figure 7-10:
Data Directory Path Setting
.
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Chapter 8:
C
ARE AND
M
AINTENANCE
8.1 M
AINTENANCE OF THE
PC C
LASSIC
F
LOW
S
ENSOR
You must disassemble the flow sensor to clean it. Refer to
Figure 8-1: Flow Sensor Disassembly. below to learn the names of the different parts of the flow sensor.
!
CAUTION: Do not use alcohol or attempt to autoclave any part of the PC Classic.
!
WARNING: To reduce the risk of cross contamination, you must replace the Spiro-Filter after each patient. It is also recommended that the sensor be cleaned after any testing.
Federal and state regulations for infection control must be followed.
!
WARNING: Always unplug the PC Classic before cleaning to avoid electric shock.
8.1.1 R
EMOVING THE
E
ASY
C
LEAN
C
ORE
To disassemble the Easy Clean Core, do the following:
1.
Unscrew the core by turning it counterclockwise.
2.
Continue to turn the core until the threads are disengaged from the handle assembly.
3.
Pull out the entire Easy Clean Core when it is no longer engaged with the sensor housing.
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!
CAUTION: DO NOT disassemble the Easy Clean Core. After removal from the sensor handle, it may be cleaned without further disassembly.
Easy Clean Core
Spiro-Filter
Handle Assembly
To disassemble the Flow sensor unscrew the core assembly counterclockwise
To assemble the Flow Sensor screw in the Core Element clockwise
Figure 8-1:
Flow Sensor Disassembly
.
8.1.2 C
LEANING THE
E
ASY
C
LEAN
C
ORE
To clean the flow sensor’s core element, do the following:
1.
Place the core element in cold sterilization fluid (a protein dissolving solution). Follow the sterilization fluid manufacturer's instructions for disinfecting and sterilizing the core.
2.
Be sure to rinse in water thoroughly and allow the core to dry completely before attempting to re-insert the Easy Clean
Core into the handle assembly.
8.1.3 I
NSTALLING THE
E
ASY
C
LEAN
C
ORE
To install the Easy Clean Core, insert the Easy Clean Core into the sensor assembly and tighten by turning until green marker aligns with the pin.
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Top Pin
Screw in Easy Clean Core until seated then tighten in the direction shown until the green band on the core is aligned with the top pin.
Figure 8-2:
Alignment of Easy Clean Core
.
The figure below shows how to assemble the flow sensor.
Spiro-Filter
Easy Clean Core
Screw the Core
Element from this side to assemble
Handle Assembly
Handle Assembly
(fully assembled)
Feb-04
Figure 8-3:
Flow Sensor Assembly
.
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8.2 S
ERVICE
If the instrument fails to work, do the following:
1.
Ensure that the power to the computer is on and that all connections are secure.
2.
Examine the unit for obvious loose, broken, or damaged components.
3.
Check that the Easy Clean Core is tightened properly. (See
Figure 8-2:
Alignment of Easy Clean Core
.)
4.
Check that the Easy Clean Core is not blocked.
5.
Check the computer communications port connection.
If the problem persists and the unit is within the warranty period, call Spirometrics at 800-767-0004. Otherwise, please contact
Spirometrics at 207-657-6700. Our repair personnel can handle many problems over the phone.
Please be prepared to provide the information listed on the following page.
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Product Model Number
(PC Classic)
Serial Number of Sensor
(located on the bottom of the handle)
Current hardware configuration including:
CPU:
Amount of RAM
Size of Hard Drive
Available Space on Hard Drive
Type of mouse installed
COM port
Current software configuration, including:
Operation system and version
Is this computer on a network?
Is the computer used for other purposes besides spirometry?
If possible, be prepared to work with the device and its program while on the phone with technical support.
If the problem persists, the unit must be returned to Spirometrics for repair.
NOTE!
•
You MUST call for an RGR number before returning your product for repair.
•
Only Spirometrics and its service representatives are authorized to service equipment.
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A
PPENDICES
D
EFINITIONS
Forced Vital Capacity (FVC) is a measure of the patient's expiratory vital capacity (the volume of air between a maximal inspiration and a maximal expiration). FVC indicates the greatest expired volume of air in a person’s lungs. Note, however, that this vital capacity is derived from a forced expiration and dynamic compression of the airways may occur. Therefore, it may be different from the vital capacity derived from a slow expiration in a VC test.
Forced Expiratory Volume at One Second (FEV
1
) is the volume of air exhaled in the first second of the FVC maneuver. It may be reduced in obstructive and restrictive processes. The decreased FEV
FEV
1
/ FEV
6
ratio and FEV
1
/
FVC ratio is needed to help determine the reason for the
1
. FEV
1 is derived from the volume-time curve by finding the volume expired on the Y-axis of the curve at exactly one second into the test. However, if the maneuver had a slow start the PC Classic Plus automatically uses the Back Extrapolation Technique to determine the start of the test. One second is measured relative to the extrapolated start of the test.
Forced Expiratory Volume at Three Seconds (FEV
3
similar to the FEV
1 into the test, rather than one-second.
) is
, but is measured at three seconds
Forced Expiratory Volume at Six Seconds (FEV
6
to the FEV
1 rather than one-second.
) is similar
, but is measured at six seconds into the test,
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PC Classic/Classic Plus User’s Manual
FEV
1
/FVC% is a ratio of FEV
1 to FVC. It is the FEV
1
divided by the FVC, then multiplied by 100 so that it can be expressed as a percentage. It is decreased in obstructive processes.
FEV
1
/ FEV
6
% is a ratio of FEV divided by the FEV
1 to FEV
6
. It is the FEV
1
6
, then multiplied by 100 so that it can be expressed as a percentage. FEV
6 is used as a
Forced Vital Capacity surrogate and is recommended by the National Lung Health Education Program (NLHEP).
It is decreased in obstructive processes.
Forced Mid-Expiratory Flow (FEF
25-75%
) is the average forced expiratory flow over the middle 50% of the FVC curve, between 25 percent and 75 percent of the FVC.
Peak Expiratory Flow (PEF) or maximal expiratory flow is the highest point on the flow-volume curve. PEF should be at the very beginning of the curve; if PEF is after the beginning, the PC Classic Plus uses the Back
Extrapolation Technique to determine the zero second point for the FEV
1
and FEV
3
calculations.
Forced Expiratory Flow (FEF
50
) is the forced expiratory flow after 50% of the FVC has been exhaled.
Forced Inspiratory Vital Capacity (FIVC) is a measure of the patient's inspiratory vital capacity (the volume of air between a maximal expiration and a maximal inspiration). It is derived from a forced inspiration.
Forced Inspiratory Flow (FIF
50
) is the forced inspiratory flow after 50% of the FIVC has been inhaled.
Ratio of FIF
50
to FEF
50
(FIF
50
/FEF
50
) is the Forced Expiratory
Flow at 50% as a percentage of the Forced Inspiratory
Flow at 50%, then multiplied by 100 to express the ratio as a percentage.
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PC Classic/Classic Plus User’s Manual
Peak Inspiratory Flow (PIF) is the maximum inspiratory flow anywhere on the inspiratory portion of the Flow-Volume
Loop (below the zero line). PIF is the lowest point on the inspiratory portion of the Flow-Volume Loop.
Expiratory Time (ET) is the elapsed time, expressed in seconds, from the beginning of the expiration until the expiration is completed.
Maximum Voluntary Ventilation (MVV) is the largest volume of air inhaled or exhaled over a timed period, typically
12 to 15 seconds, which is then extrapolated to one minute. The maneuver done to measure the MVV should imitate rapid breathing during strenuous exercise.
Vital Capacity (VC) is the largest volume of exhaled gas measured on a slow complete expiration after a maximal inspiration.
Air Trapping Index (ATI) is the difference between the FVC and the VC indices. It may reflect how much air becomes trapped in the lungs during a forced expiration.
Lung Age is an estimate of the age of the subject’s lungs based on spirometric measurements. The method used to estimate lung age is that described by Morris and
Temple (Preventive Medicine, pp. 655-662, 1985.)
COPD Index is a measure of the subject’s risk for developing
COPD. To determine the COPD Index, the Tecumseh
Index of Risk is calculated using the subject’s age, gender, current smoking habits, FEV
1
, and height according to the method described by Higgins and
Keller (Journal of Respiratory Diseases, January, 1983).
Back Extrapolation Technique is necessary for the FEV when a back extrapolation error occurs.
1
and the FEV timed. All flow related indices are affected
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PC Classic/Classic Plus User’s Manual
N
ORMALS
T
ABLES
The principal indication for spirometry testing is to determine whether a patient's pulmonary function is normal or abnormal.
A
predicted normal value for a spirometric test index is a prediction of the value a patient
should attain if his/her pulmonary function is normal. The predictions are based on extensive studies of a population, and were often done by leading pulmonologists. To obtain predicted values, the technologist must enter the height, age, gender, and ethnic background of the patient. The spirometric test indices from thousands of people of varying height, age, gender, and ethnicity were analyzed and compiled into an equation. Each normals table is named by the pulmonologist who led the study.
The PC Classic Plus has normals tables from the following seven studies. When customizing your spirometer, select the table that you want to use (See Section 6.1 C
USTOMIZATION
).
The selected normals table should match the population to be tested as closely as possible. Note the applicable indices and ranges for each study.
NOTE!
When the table selected in Customization contains the indices: FVC, PEF and FEF 25-75, a predicted curve will be generated and displayed during testing and on reports. See the section 6.1.1 Software Customization for more information.
Feb-04 Appendices A-
4
INDICES
FVC
FEV1
FEV6
FEV1/FVC
FEV1/FEV6
FEF 25-75
PEF
PC Classic/Classic Plus User’s Manual
SEX
FEMALE:
MALE:
NHANES III
AGE
Yrs: Min-max
HEIGHT cm: Min-max
8 – 80
8 - 80
No stated limitation
No stated limitation
HEIGHT in: Min-max
No stated limitation
No stated limitation
INDICES
FVC
FEV1
FEV1/FVC%
FEF 25-75
FEF 50
SEX
Knudson 1983
AGE
Yrs -Min-max
HEIGHT cm - Min-max
6 - 10 106.7 - 147.3
11 - 19 132.1 - 182.9
FEMALE:
20 - 69 147.3 - 180.3
MALE:
70 - 87
6 - 11
12 - 24
25 - 84
147.3 - 167.6
111.8 - 154.9
139.7 - 193.0
157.5 - 195.6
HEIGHT in - Min-max
42 - 58
52 - 72
58 - 71
58 - 66
44 - 61
55 - 76
62 - 77
Feb-04 Appendices A-
5
INDICES
FVC
FEV1
FEV3
FEV1/FVC%
FEF 25-75
PEF
PC Classic/Classic Plus User’s Manual
SEX
FEMALE:
MALE:
Knudson 1976
AGE
Yrs -Min-max
HEIGHT cm - Min-max
8 - 79
8 - 79
No stated limitation
No stated limitation
HEIGHT in - Min-max
No stated limitation
No stated limitation
INDICES:
FVC
FEV1
FEV3
FEV1/FVC%
FEF 25-75
MVV vol.
SEX
FEMALE
Crapo
AGE
Yrs - min-max
17-84
HEIGHT cm. min-max
146-178
MALE 15-91 157-194
HEIGHT in. min-max
57-71
61-77
Feb-04 Appendices A-
6
INDICES:
FVC
FEV1
FEF 25-75
MVV vol.
PC Classic/Classic Plus User’s Manual
SEX
FEMALE
MALE
Polgar
AGE
Yrs - min-max
6-18
6-18
HEIGHT cm. min-max
No stated
limitation
No stated
limitation
HEIGHT in. min-max
No stated
limitation
No stated
limitation
ECCS with Knudson 1983
Children (ages 18 - 24 are evaluated as age 25)
INDICES SEX
AGE
Yrs: Min-max
HEIGHT cm: Min-max
HEIGHT in: Min-max
FVC FEMALE: 25 - 90 145.0 - 180.0 56 - 72
FEV1 6 - 10 106.7 - 147.3 42 - 58
CHILDREN
(female)
FEV1/FVC% 11 - 17 132.1 - 182.9 52 - 72
FEF 25-75 MALE: 25 - 90 155.0 - 195.0 58 - 80
PEF 6 - 11 111.8 - 154.9 44 - 61
CHILDREN
(male)
FEF 50 12 - 17 139.7 - 193.0 55 - 76
FIVC
MVV vol.
VC
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PC Classic/Classic Plus User’s Manual
INDICES
FVC
FEV1
FEV1/FVC%
FEF 0.1 - 1.2
FEF 25-75
FEF 75-85
SEX
FEMALE:
MALE:
Morris
AGE
Yrs: Min-max
20 - 84
20 - 84
HEIGHT cm: Min-max
145.0 - 180.0
155.0 - 195.0
HEIGHT in: Min-max
56 - 72
58 - 80
HSU 1979 (Using Journal of Pediatrics 1979)
INDICES SEX
AGE
Yrs: Min-max
HEIGHT cm: Min-max
HEIGHT in: Min-max
FVC FEMALE: 7 - 20 111 - 180 43 - 71
FEV1 MALE: 7 - 20 111 - 190 43 - 75
FEF 25-75
PEF
LAM 1979 (Using Journal of Pediatrics 1979)
INDICES SEX
AGE
Yrs: Min-max
HEIGHT cm: Min-max
HEIGHT in: Min-max
FVC
FEV1
FEMALE:
MALE:
5 - 74
5 - 74
No stated limitation
No stated limitation
No stated limitation
No stated limitation
PEF
Feb-04 Appendices A-
8
PC Classic/Classic Plus User’s Manual
COMPOSITE
This is the Default normals selection. These normals provide predicted values for most indices.
INDICES
FVC
FEV1
FEF 50
FEV3
FEV6
FEF 25-75
FEF 75-85
PEF
FIVC
FIF 50
PIF
FEV1/FVC
FEF 2-1.2
MVV
VC
AUTHOR
NHANES III
NHANES III
Knudson 83
Crapo
NHANES III
NHANES III
Morris
NHANES III
NHANES III
No Predicted
No Predicted
NHANES III
Morris
35 X FEV1 from NHANES III
NHANES III
D
IAGNOSTIC
I
NTERPRETATION
The PC Classic can make simple diagnostic interpretations of the spirometric test data. The interpretation scheme is designed to distinguish normal from abnormal pulmonary function test results without making a diagnosis. Spirometry test data cannot stand by itself. It is important to coach patients to their maximal effort.
!
WARNING: Spirometry tests must be evaluated by a qualified physician. The interpretations printed by the PC Classic software are suggestive only and should not be considered conclusive.
Feb-04 Appendices A-
9
PC Classic/Classic Plus User’s Manual
The Summary Report, which is created by clicking on the
Summary Results button in the Browse Patient List window, contains a box where interpretation information can be written.
See section 5.6 Summary Report for more information. This box will also optionally contain a brief diagnostic summary generated by the PC Classic software. See section 6.1.4 Report
Options to enable or disable this option.
Interpretations are based entirely on two indices: FVC and
FEV1. The PC Classic uses the best of each of these indices from all test data for a particular patient.
I
NTERPRETATION
T
ABLE
The following table describes the interpretation scheme and corresponding diagnostic messages:
FVC
% of Predicted
FEV1 FEV1/FVC
Interpretive Message
< 75%
< 60%
≤≤≤≤ 75%
≥≥≥≥ 75%
Low FEV1 Suggests
Obstructive Disorder
Low FEV1 Suggests
Ventilatory Disorder
< 75%
< 60%
≥≥≥≥ 75%
< 75%
Low FVC Suggests
Restrictive Disorder
Low FVC Suggests
Ventilatory Disorder
In all other cases spirometric results appear normal
R
EFERENCES
S
TANDARDS AND
G
UIDELINES
:
American Thoracic Society Pulmonary Laboratory Management and Procedure Manual. New York: ATS; 1998. (Updated chapters are available each year.)
Feb-04 Appendices A-
10
PC Classic/Classic Plus User’s Manual
American Thoracic Society. Standardization of spirometry-1987 update. Am Rev Respir Dis 1987; 136:1039-1060.
Published concurrently in Respir Care 1987;32(11): 1039-
1060.
American Thoracic Society. Standardization of spirometry 1994 update. Am J Respir Crit Care Med 1995; 152 (3): 1107-
1136.
American Thoracic Society. Lung function testing: Selection of reference values and interpretative strategies. Am Rev
Respir Dis 1991; 144: 1202-1218.
American Thoracic Society. Guidelines for methacholine and exercise challenge-1999. Am J Respir Crit Care Med 2000;
161: 309-329.
American Association for Respiratory Care Clinical Practice
Guideline: Spirometry, 1996 update. Respir Care
1996;41:629-636.
American Association for Respiratory Care Clinical
Practice Guideline. Methacholine Challenge Testing: 2001
Revision and Update. Respir Care 2001; 46(5):523-530
National Committee for Clinical Laboratory Standards. HS-4,
Approved document. A Quality System Model for
Respiratory Care. Wayne, PA: NCCLS; 2002.
A
DDITIONAL
R
ESOURCES
:
Eaton T, Withy S, Garrett JE, Mercer J, Whitlock RML, Rea
HH. Spirometry in primary care practice: The importance of quality assurance and the impact of spirometry workshops. Chest 1999;116: 416-423.
Enright PL, Johnson LJ, Connett JE, Voelker H, Buist
AS. Spirometry in the Lung Health Study: methods and quality control. Am Rev Respir Dis 1991;143:1215-1223.
Feb-04 Appendices A-
11
PC Classic/Classic Plus User’s Manual
American College of Occupational an Environmental Medicine
Position Paper. Spirometry in the occupational setting.
ACOEM. 2000.
Ferguson GT, Enright PL, Buist AS, Higgins MW. Office
Spirometry for Lung Health Assessment in Adults: A
Consensus Statement From the National Lung Health
Education Program. Chest 2000 117: 1146-1161.
Wanger J, Irvin C. Office spirometry: equipment selection and training of staff in the private practice setting. Journal of
Asthma 1997; 34(2), 93-104.
S
PIROMETRY
W
EBSITES
:
American Thoracic Society www.thoraic.org
American Association for Respiratory Care www.aarc.org
National Lung Health Education Program www.nlhep.com
National Lung Health Education Program www.nlhep.com
Global Initiative for Chronic Obstructive Lung Disease: www.goldcopd.com
P
RODUCT
L
IST
A
CCESSORIES
:
Item# Description
2195 Spiro-Filter
2104 Nose Clips
20043 Pediatric Adapter
3014 Pediatric Mouthpiece
Packaging
Box of 100
Bag of 10
Bag of 1
Bag of 100
Feb-04 Appendices A-
12
PC Classic/Classic Plus User’s Manual
E
DUCATIONAL
P
RODUCTS
Item# Description
SP-061973 Spirometry: Producing Quality Test Results
CDROM
SP-040151 Diagnostic Training and Competence Manual:
Pulmonary and Noninvasive Cardiology
CD-ROM containing manual
SP-111680 Spirometry Quality: The Essentials
Printed Version
SP-081570 Spirometry Quality: The Essentials
CD-ROM Version
SP-101201 Spirometry: Test Quality Assessment Selecting
and Reporting Results
Video and Workbook
SP-070402 Additional Workbook for SP-101201
Feb-04 Appendices A-
13
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