Spirometrics FLOWMATE V PLUS User manual

FLOWMATE V PLUS USER’S MANUAL

Copyright 2000, 2004

P O Box 680, 22 Shaker Road

Gray, ME 04039 USA

http://www.spirometrics.com

REV 03

February 2004

Doc. #: 20003 Rev. 3

Spirometrics FLOWMATE V PLUS User Manual

FLOWMATE V PLUS USER’S MANUAL

Table of Contents

CHAPTER 1 1

Introduction

Warranty Card 3

1

CHAPTER 2 5

Intended Use 5
Warnings and Precautions 5
Setting Up 6

Loading Paper 6
Factory Settings 8
Customization Routine 10
Setting Time/Date 11

CHAPTER 3 12

Calibrating the Spirometer 12

CHAPTER 4 14

Operating the Flowmate V Plus 14
Summary of Operations 16

CHAPTER 5 17

Testing 17
Patient Preparation 17
Entering Patient Data 18
Forced Vital Capacity (FVC) Testing 20
Summary of FVC Test Results 22
Maximum Voluntary Ventilation (MVV) Testing 23
Vital Capacity (VC) Testing 25
Methacholine Challenge 27
Post-Bronchodilator Testing 30
Retrieving Test Results 31
Erasing a Test 32
Erase Procedure 32
Saving Patients to Diskette 33
Summary Reports 33

CHAPTER 6 35

Maintenance 35
Diagram Handle Assembly 36
Cleaning and Sanitizing 37
Troubleshooting 38
Calibration 40
Patient Storage 41

Page 2

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

CHAPTER 7 42

Specifications 42

Page 3

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

CHAPTER 1

INTRODUCTION

CONGRATULATIONS...on your purchase of a Spirometrics FLOWMATE V PLUS
spirometer. Built by the Spirometrics Medical Equipment Company of Maine, the
FLOWMATE V 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
FLOWMATE V PLUS to take advantage of new developments in computers and
software for years to come.

Please read this manual carefully before setting up and operating your new FLOWMATE
V PLUS.

STOP!

BEFORE SETTING UP, PLEASE COMPLETE THE ATTACHED WARRANTY
CARD ON PAGE THREE (3) TO ENSURE THAT YOUR WARRANTY RIGHTS
ARE COVERED.

Page 4

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

For the device warranty to be in effect, the attached warranty card must be returned to
Spirometrics Medical Equipment Co. for warranty registration. Please take this time to
fill out the enclosed postage paid warranty card. You may also register your warranty by
calling 800-767-0004 or faxing the information to 207-657-4123.

All Spirometrics spirometers are warranted to be free from defects in workmanship and
material for a period of TWELVE MONTHS from the date of purchase as validated by
the return of the warranty card. If the warranty card is not returned or otherwise
registered by phone, the TWELVE MONTH warranty begins from the date of
manufacture.

During the warranty period, any and all 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 the Operator’s Manual. This warranty applies to the original user only, is
not transferable, and does not extend to any product or component which 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 does not cover consequential damages due to
improper use or application of the product.

Page 5

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

This page set aside for the WARRANTY CARD insert.

Page 6

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

This page set aside for the WARRANTY CARD insert.

Page 7

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

CHAPTER 2

INTENDED USE

The FLOWMATE V PLUS spirometer is 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.

WARNINGS AND PRECAUTIONS

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 cross-contamination and to protect the

internal sensor element. Replace the Spiro-Filter after each patient.

!!!!

When the unit is not used for extended periods of time, set the printer lever in

the down position. If the printer is left for a long time with the printer head

engaged, the printer head may become deformed and print quality cannot be

guaranteed. See the LOADING PAPER section later in this chapter.

!!!!

Clean the EASY CLEAN cartridge regularly to insure the long-term stability

and accuracy of the instrument. Please refer to Chapter 6 MAINTENANCE

AND TROUBLESHOOTING 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 cartridge.

!!!!

The FLOWMATE V 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 FLOWMATE V 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 cartridge is properly installed as described in

Chapter 6 MAINTENANCE AND TROUBLESHOOTING.

!!!!

Do not drop the sensor handle. The FLOWMATE V PLUS handle is a sensitive

measurement device. Improper handling could affect the accuracy of its

reported results.

Page 8

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

SETTING UP

1. Remove FLOWMATE V PLUS from box and unwrap packing materials.
Check the list to make sure all items listed are in the box.
1 - FLOWMATE V PLUS
1 - Thermal paper roll
1 - Power cord
1 - Power supply
1 - Operator’s manual

2. Place FLOWMATE V PLUS on flat surface.

3. Take the five (5) pin DIN connector end of power supply cord and plug into
the power input of FLOWMATE V PLUS.

• Take the IEC320 connector end of power cord and plug into the power
supply.

• Plug AC cord into an outlet.

4. Insert disposable filter onto EASY CLEAN Cartridge.

LOADING PAPER

The FLOWMATE V PLUS is equipped with an internal thermal printer, and an external
parallel printer connection. Before using, the thermal paper will have to be loaded.

1. Cut the printer paper with a diagonal cut as shown at the end of this section.
Position the printer lever in the down position. This releases the printer platen
to ease the threading of paper into the printer.

2. Place paper roll into holder by pulling either of the spring-loaded clips.

3. Insert paper into the printer slot going in from the top. When the paper meets
with resistance against the paper roller, press the PAPER key on the keypad.
Pressing once and releasing will advance the paper one line at a time.
Pressing the PAPER key down and holding it for 4 seconds will initiate the
printer continuous feed mode until the PAPER key is released.
Note: The printer has an internal paper sensor located on the right hand

side. If when inserting the paper to thread the printer, paper does not cover

Page 9

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

the sensor, the printer will not advance when pressing the paper key. It will
beep to indicate that the paper is not detected. Please remove and try again.

4. Once the paper has begun to feed through the printer, create enough lead to
check the paper alignment through the printer by lining up the edges of the
paper through the printer with that to be fed into it from the back. Shift as
necessary to align.

5. Set paper release toggle to up position to engage printer platen onto the paper.

CAUTION: When the unit is not used for extended periods of time, set the

printer lever in the down position. If the printer is left for a long time with

the printer head engaged, the printer head may become deformed and print
quality cannot be guaranteed.

6. Press paper advance.

We suggest cutting the thermal paper roll on a diagonal and leave about an inch on the
right hand side to ease the paper detection and threading of paper into the printer:

Now your FLOWMATE V PLUS is ready to operate.

BEFORE SETTING UP, PLEASE COMPLETE THE ATTACHED WARRANTY
CARD ON PAGE THREE (3) TO ENSURE THAT YOUR WARRANTY RIGHTS
ARE COVERED.

Page 10

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

FACTORY SETTINGS

The FLOWMATE V PLUS comes ready to operate with settings already configured at
the factory. Upon initial start-up, the FLOWMATE V PLUS must be configured for the
language to use. Select the language for use by entering the number corresponding to the
language on the display. Selecting number 1 by pressing the 1 key will enable English as
the displayed language. To customize settings, see CUSTOMIZING YOUR
FLOWMATE V PLUS in the next section. The standard configuration chart listing the
default settings and options on the FLOWMATE V PLUS follows.

STANDARD CONFIGURATION CHART

Function Standard Configuration Options

1. Language Selection Selected by user on initial start-up

1. Select English Language

2. Seleccione el idioma Español

3. Wählen Sie Deutsche Sprache aus.

4. Selezionare la lingua italiana

5. Choisir langue française

2. Autoprint Test No Yes

3. Use Inspiratory Calibration No Yes

4. Selected Printer Internal Epson FX (9)

5. Time format (hr) 12 24

Spanish - Español

German - Deutsch

Italian - Italiano

French – Français

Epson LQ (24)

IBM Proprinter

IBM Pro X24

HP Laser Jet 2

DeskJet 4-ink

English

Epson Color

6. Date format American
(mm/dd/yy)

7. Use Location I.D. # No Yes

Page 11

European

(dd/mm/yy)

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

8.Enter Current Location I.D. # Blank (up to 16 digits)

9. Prompt daily for Loc. I.D. # No Yes

10. Report Format Short Expanded

11. Use ATS Hand Measure Yes No

12. Print Vol/Time Curve Yes No

13. Print Flow/Vol Loop Yes No

14. ATS flat 0.2L Variability Yes No (uses 5%

comparison)

15. Graph Best Test Curves Both VT Curve

FV Loop

None

16. Superimpose each effort on

No Yes

graph

17. Print diagnostic

Yes No

interpretations

18. Print COPD Risk Yes No

19. Print Lung Age Yes No

20. Selected Normals Composite Knud 76

Knud 83

Crapo

Morris

Hsu

ECCS

Lam

21. Height in (units) in. cm.

22. Record Patient Weight Yes No

23. Weight in (units) Lbs kgs

24. Extrapolate Predicted (if

outside range)

Page 12

No Yes

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

25. Inhalation Challenge

settings OK?

26. Print Out Settings No default YES or NO

Inhalations per concentration: 5
Methacholine concentration:
(#2) = .025mg
(#3) = .250
(#4) = 2.500
(#5) =10.00
(#6) =25.00
Lower limit of normal Default=08
Cum. Dose = ?

Custom options

NOTE: It is strongly suggested that you print out and keep handy a copy of your
customization settings.

CUSTOMIZATION ROUTINE

CUSTOMIZING SETTINGS:
To customize the settings of your FLOWMATE V PLUS, simply cycle through each
setting. To display the options for each setting, press the left or right ARROW keys. Press
ENTER or the DOWN arrow to move to the next setting without changing the previous
setting.

EXAMPLE
To change the setting under the “Graph Best Test Curves” from “Both” to “None”, follow
these steps:

1. From MAIN MENU, select 2 - CUSTOMIZATION

2. Press ENTER to cycle through settings until you reach “Graph Best Test
Curves”.

3. Press either left or right ARROW key until display shows “None”.

4. Press ENTER to change setting and to continue through subsequent settings.

Page 13

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

SETTING TIME/DATE

It is important to make sure the time and date are correct since test records will display
such information for each test. To set the time and/or date, perform the following steps:

1. From MAIN MENU select 4 - TIME/DATE.

2. Based on the time display format you selected during customization, screen
will display hour-minute-second values with cursor on HOUR.

3. Enter value from 01 to 12 (for 12 hour format or for 24 hour format, 01 to 24)
for hour, or use side ARROW keys to select appropriate setting.

4. Cursor automatically moves to MINUTES. Enter value from 00 to 59.

5. Cursor automatically moves to SECONDS. Enter value from 00 to 59 or press
the ENTER key to accept value that is there.

6. Cursor will drop down to the date field. Press the appropriate numbers on the
keypad, as when setting time.

7. When date is set, press ENTER.

8. Screen will prompt: “Accept time and date?” YES or NO.

9. If YES, you’ll go back to the MAIN MENU, if NO you’ll return to
TIME/DATE for modifications.

NOTE: To maintain the internal rechargeable battery’s ability to keep accurate date and
time, it must be charged from 20 – 24 hours during a thirty day cycle. The battery will
only charge when the FLOWMATE V PLUS is actually turned on.

Page 14

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

CHAPTER 3

CALIBRATING THE FLOWMATE V PLUS

CALIBRATING THE SPIROMETER

Calibrating the FLOWMATE V PLUS ensures accurate test results. The American
Thoracic Society (ATS) recommends daily calibration and at intervals throughout the day
when performing a large number of tests. When calibration is out of date, meaning that a
calibration has not been performed on the same day that testing is to take place, a
message will appear on the screen: “Calibration out of date.”
To calibrate your FLOWMATE V PLUS, first set up your calibration syringe in the
following manner:

• You will need a calibration syringe (part #2125) and a calibration syringe
adapter (part # 30-0015).

• Connect the adapter seal to the end of the calibration syringe.

• Connect the flow sensor and filter firmly to the calibration syringe.

The FLOWMATE V PLUS allows calibrations in both the inspiration and expiration
volumes. Each mode is a two step process, the first step gives the unit a reference, the
second checks the volume measured.

NOTE: The inspiratory calibration is an optional choice during CUSTOMIZATION. If
not selected, the expiratory calibration factor will be used for both.

To calibrate the spirometer, follow these steps:

1. From the MAIN MENU press 3 - Calibration.

2. Screen prompts: “Enter environmental conditions.” Or set to the average
where testing is to be conducted and scroll through.

• Air temperature in °F (50-104) or °C (10-40)

• Barometric Pressure in inches (20-35) or mmHg (500-900).

3. Select the calibration to perform:

1= Flow Sensor Expiratory
2=Flow Sensor Inspiratory

Page 15

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

4. Screen prompts: “What is the test syringe volume? (Enter volume: 1-9
liters)”

5. ENTER correct syringe volume, i.e., 3 liters

6. At Flow Sensor Calibration screen press ENTER when ready to inject.

7. Screen will display a sliding bar graph representing the air flow. Keep the
indicator within boundaries of target range.

HELPFUL HINT:
In keeping with the American Thoracic Society’s 1994 Standardization of Spirometry and

good quality control procedures, it is recommended that the linearity of the flow
sensing pneumotach should be checked on a weekly basis. This can quickly and
easily be accomplished by injecting your calibration syringe at three different flow
rates during a Follow-up Injection. As an example, taking a three liter syringe and
injecting it 1, 3, and 6 seconds would create flow rates of 3 l/s, 1 l/s, and 0.5 l/s
respectively. Answer YES to the question “Do You Want To Check Calibration
Again?”, and repeat for each subsequent follow-up injection desired to check. The
volumes measured at the flow rates used, should all be within the stated +/- tolerance
to be considered acceptable.

STOP!

DID YOU COMPLETE THE ATTACHED WARRANTY CARD TO ENSURE THAT
YOUR WARRANTY RIGHTS ARE COVERED? IF NOT, PLEASE DO SO NOW!

Page 16

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

CHAPTER 4

OPERATING THE FLOWMATE V PLUS

FLOWMATE V PLUS KEYPAD

CONTROL KEYS

PAPER From the MAIN MENU pressing this key advances paper one line

at a time.

ARROW KEYS Pressing the UP or DOWN arrow moves cursor appropriately.

Pressing the LEFT or RIGHT arrow selects and deselects options
when customizing, otherwise moves cursor in appropriate
direction.

SEND Pressing this key transmits unsaved data to diskette.

OUTPUT KEYS

These keys control the output of test results and summaries on the display and the printer.

DISPLAY From the MAIN MENU, pressing this key gives you a readout on

the memory remaining in the FLOWMATE V PLUS. In other
modes, pressing this key will change the display on screen.

PRINT From the MAIN MENU, pressing this key will give you six

choices:

1. All patients in memory.

2. All patients on disk.

3. A single patient.
Batch print: (0 of 32 in list)

4. Add patient to list

5. Remove patient from list.

6. Print List

Page 17

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

Pressing 1 will give you a printed readout on every patient in the

machine’s memory.

Pressing 2 will give you a printed readout on every patient on the

disk.

Pressing 3 will prompt the machine to ask you for specific

identification numbers of the subject of printed readout.

Pressing 4 will give you prompts to add a patient’s ID number to

the list.

Pressing 5 will give you prompts to delete a patient’s ID number

from the list.

Pressing 6 will print a Best Test Summary for all patients on the

list.

From the TEST MENU, pressing the PRINT key prints out a report of the
current test if viewing results of a specific test, or will prompt you to select
a test by number for that particular patient.

NOTE: If you selected AUTOPRINT during customization, each test result will
automatically be printed out at the conclusion of each test.

ERASE From the MAIN MENU, pressing the ERASE key will prompt the

following three choices:

1. Erase all patient records in memory? Are you sure? (Press YES
or NO). By pressing YES you will erase all patient records stored
in memory. Pressing NO will take you back to the MAIN MENU.

2. Erase some records in memory? This will call up on the screen
patient records in sequence and give you a choice of YES or NO
with each individual record.

To go back to MAIN MENU without erasing anything, press 0.

From the TEST MENU, pressing the ERASE key offers a selection

of tests on each particular patient to be erased. As a safety

Page 18

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

precaution, the FLOWMATE V PLUS will always ask you if you
are sure you would like to erase the data you have selected.

SUMMARY From the MAIN MENU, pressing the SUMMARY key will display

a listing of all patients in the machine’s memory. From within a
patient’s record, pressing the SUMMARY key will print out the
Best Test Summary.

NEXT KEYS

These two keys “schedule” the operation of the FLOWMATE V PLUS

PATIENT Pressing this key returns you to the MAIN MENU.

TEST Pressing this key offers the prompt: Which TEST would you like?

You may select one of four tests: FVC, MVV, VC, or Chal.

NOTE: Pressing the TEST key from the MAIN MENU will create a “J. Doe

#xxx” patient. See Chapter 5

SUMMARY OF OPERATIONS:

Follow these easy steps to operate the FLOWMATE V PLUS:

1. Turn power switch (on back of machine) to ON. (0=Off I=On)

• Upon power-up, the unit initially checks the integrity of the memory and the
program. Then the logo screen will appear showing the unit’s time and date
settings. If incorrect, update by following the procedures outlined in
CUSTOMIZATION, Chapter 2.

2. After cycling through the initial checks, screen will display MAIN MENU.

3. At the MAIN MENU screen, press the appropriate number on the key pad:

• 1 -- PATIENT.

• 2 -- CUSTOMIZATION

• 3 -- CALIBRATION

• 4 -- TIME/DATE

Page 19

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

CHAPTER 5

TESTING

Before testing a patient, the patient should be prepared by making him/her feel
comfortable and relaxed. This can be accomplished by explaining and demonstrating the
procedures to be undertaken. The following guidelines may be followed in preparing a
patient.

PATIENT PREPARATION

Explain

...A spirometer is used to assess lung function. The purpose of the
spirometry test to you (the patient): is to measure how hard and how
fast you can breathe and how much air is in your lungs. If properly
performed the test results can indicate the presence or absence of an
obstructive or restrictive lung disorder.

Direct

...the patient to:

•

Remove or loosen tight clothing such as tight collars or necktie.

•

Remove dentures (optional).

•

Stand in front of the spirometer. (Patient should not take the test

sitting down unless he/she can not stand).

•

Elevate chin and extend neck slightly.

•

Use a nose clip, if available. (Have the patient pinch his/her nose if

unavailable) See the FLOWMATE V PLUS Accessories.

Demonstrate

...the procedure yourself:

•

Take the deepest breath possible.

•

Place mouth and teeth tightly around the mouthpiece.

•

Do not block the opening with the tongue.

•

Then, blow out as hard and fast and completely as possible- getting

all the air out. If a loop is being tested, inhale deeply back through
the sensor.

•

Pull away from the mouthpiece and relax.

Instruct

...the patient firmly and enthusiastically: "Take a good deep breath. Pull it ALL in. Push
it all OUT!...Blow as hard as possible and then inhale back in... Good job!"

Page 20

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

ENTERING PATIENT DATA

Before beginning tests with a new patient, the FLOWMATE V PLUS will need some
information on the patient for predictions and easy test recall later. The data is stored in
memory and does not have to be re-entered before each subsequent test. However, you
can perform tests without filling out the patient data field, simply by pressing the TEST
key from the MAIN MENU. See NOTE following step 3.

To enter appropriate patient data, perform the following steps:

1. If needed, turn on FLOWMATE V PLUS by depressing the POWER switch at rear of
instrument.

2. From the MAIN MENU press 1.

3. The screen prompts: “Patient information (or press test) Enter I.D. number .” Enter
patient’s I.D.(identification) number, up to 16 digits, including periods and slashes. The
number can be the patient’s social security number or any other appropriate identification.
Be sure that each patient has his or her own number. Do not start a patient’s ID# with a
period.

NOTE: If you press the TEST key at this point, you will jump directly to the TEST
SELECTION MENU without having to enter patient data. If you do this the
FLOWMATE V PLUS will display and print test results for “J. Doe. xx.” Such test
results will not include predicteds, percent of predicteds, or interpretations, since there is
no patient data on which to base such results. In addition, the patient’s test results will
only be stored as “J. Doe xx” when you move on to the next patient. To reprint later,
batch print all must be selected. Individual “J. Doe’s” can not be recalled for additional
testing.

4. After entering an I.D. number and pressing ENTER, the FLOWMATE V PLUS will
search its base memory for that I.D. number.

• If it is found, the display will prompt: “Is this Post Bronchodilator testing?”
(YES or NO?). Answer NO unless you are performing Post Bronchodilator
testing (see directions at end of this chapter).

• If it is not found, the display will prompt: “Create new patient using I.D.
number?” If you press YES, the screen will change to the patient

questionnaire.

Page 21

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

• If NO, the display will prompt: “Load patient from diskette?” If patient
information is on diskette, you would utilize this option for recalling a
previously tested patient that has been stored on diskette.

NOTE: If you are unsure of which diskette patient is located, you will have an option to
check several diskettes.

5. Enter the age of the patient, up to 2 digits. The patient’s age must be between 1 and
99, press ENTER.

6. To enter the patient’s SEX, use the LEFT or RIGHT ARROW keys to choose Male or
Female. press ENTER.

7. To enter the patient’s RACE, use the LEFT or RIGHT ARROW to cycle through the
choices (caucasian, black, non-caucasian, asian, hispanic), then press ENTER.

8. To enter the patient’s HEIGHT in either centimeters or inches, enter the appropriate
numbers, then press ENTER.

9. To enter the patient’s weight in pounds or kilograms, enter the appropriate numbers,
then press ENTER.

10. The display will prompt: “cigarettes per day”. Enter the number of cigarettes per day
the patient smokes, then press ENTER.

11. Accept changes by pressing ENTER/YES if the changes are appropriate. If you need
to make further changes, press NO and the procedure will begin anew.

12. TEST MENU will then be displayed with the prompt: “Which test would you like?”
You are now ready to begin testing by selecting the test by number.

Page 22

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

FORCED VITAL CAPACITY (FVC) TEST

PROCEDURES
Before beginning the test, DEMONSTRATE the FVC maneuver so the patient has a clear

idea of what is expected of him/her.

1. INSERT new mouthpiece and filter into the flow sensor.

2. SELECT from the test choice menu by pressing NUMBER 1

3. INSTRUCT patient in the maneuver with the following suggestions:

• Take as deep a breath as you can and hold it.

• Put mouthpiece in your mouth, past your teeth, and form a tight seal with your

lips. Make sure your tongue is not blocking the mouthpiece.

• Now blast the air out as hard and fast as possible.

• Inhale as deeply and quickly as possible through the mouthpiece.

• Remove the mouthpiece.

4. While patient is performing the test, FLOWMATE V PLUS displays both the
Volume/Time Curve and the Flow/Volume Loop, allowing the patient to view a visual
display of the test results.

5. When flow has stopped there will be an audible “beep-beep-beep” and the screen
displays the message: “Was the Patient Effort Acceptable? (press YES or NO)”

6. Press YES or NO.

• If YES the unit computes, displays and stores the test results. If AUTOPRINT
option has been activated, the report is printed out.

• If NO, the unit abandons the test and the patient can try again until clinician is
satisfied with effort.

NOTE: Patient effort is acceptable if the patient:

• Started with the deepest possible inspiration

• Exhaled maximally with a good, fast start.

• Inhaled maximally after the expiration.

• Inhaled and exhaled smoothly, with no coughing.

The FLOWMATE V PLUS may display a message indicating the test was too short or
that the start was too slow, based on criteria established by the American Thoracic
Society. However, the unit will still store such a test.

Page 23

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

When a patient’s test is accepted, the FLOWMATE V PLUS displays the test result.

ILLUSTRATION

FVC TEST RESULTS SUMMARY page 1
Index Units Meas. Pred %Pred Var.
FVC L 5.52 5.67 97 2.3
FEV1 L 3.96 4.65 85 0.5
FEV1/FVC % 70.0 82.6 85 1.9
FEV25-75 L/S 2.6 4.8 55 7.6
PEF L/S 10.6 9.8 107 9.8

Forced Expiratory Time: 12.15 sec

Press DOWN to show page 2

Press DISPLAY to show graphs

To start another test, simply press TEST, then select test by number.

Page 24

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

SUMMARY OF FVC TEST RESULTS

FVC VOLUME-TIME CURVE (ILLUSTRATION)

The Volume vs. Time curve represents the volume of air through the mouthpiece over a
period of time. The left axis represents volume in liters at BTPS (Body Temperature,
standard Pressure, and Saturated with water vapor at these conditions). The bottom axis is
time in seconds.
The Volume-Time Curve shows two of the most important indices, Forced Vital Capacity
(FVC) and Forced Expiratory Volume at one second (FEV1) See Chapter 7 for a complete
listing of test indices.

The Flow Volume Loop represents flow along the y-axis and volume along the x-axis at
BTPS.

Page 25

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

MAXIMUM VOLUNTARY VENTILATION TEST (MVV)

PROCEDURES
Before beginning the test, DEMONSTRATE the MVV maneuver:

1. INSERT new mouthpiece and filter into the flow sensor.

2. SELECT from the test choice menu by pressing NUMBER 2

3. INSTRUCT patient in the maneuver with the following suggestions:

• Put mouthpiece in your mouth, past your teeth, and form a tight seal with your
lips. Make sure your tongue is not blocking the mouthpiece.

• Breathe through mouthpiece as rapidly and deeply as possible. This should
simulate breathing during hard exercise.

4. Press ENTER when patient’s breathing is deep and regular for at least 12 seconds.

The FLOWMATE V PLUS will display a graphic rendering of the patient’s breathing
pattern.

5. Encourage patient to make the graph move up and down as rapidly as possible.

6. After 12 seconds have elapsed, have the patient remove the mouthpiece and relax. The
unit will beep at the completion of a full exhalation after 12 seconds

Page 26

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

7.When flow has stopped screen prompts: “Was the Patient Effort Acceptable? (press
YES or NO)”

8. Press YES or NO.

• If YES the unit computes, displays and stores the test results. If AUTOPRINT
option has been activated, the report is printed out.

NOTE: If the MVV graph is not printed at the time the numeric values are displayed on
the screen, the graph will not be available later, but the MVV numeric values for up to
two tests may be recalled later.

• If NO, the unit abandons the test and the patient can try again until clinician is
satisfied with effort.

NOTE: Patient effort is acceptable if the patient:

• Made a maximum effort.

• Lasted a full 12 seconds.

• Did not cough.

FLOWMATE V PLUS displays results when patient test is accepted.

MVV TEST RESULTS SUMMARY

Index Units Meas. Pred %Pred Var.

MVV L 185 177 104 n/a
Rate Breaths/M 55 n/a n/a n/a

Press DISPLAY to show graph

NOTE: The MVV test can be exhausting to some patients, especially the elderly or ill.
Therefore, it should not be repeated without a rest period.

Press TEST to return to the TEST MENU.

Page 27

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

VITAL CAPACITY (VC) TEST PROCEDURES

Before beginning the test, DEMONSTRATE the VC maneuver so the patient has a clear
idea of what is expected of him/her.

1. INSERT new mouthpiece and filter into the flow sensor.

2. SELECT from the test choice menu by pressing NUMBER 3.

3. INSTRUCT patient in the maneuver with the following suggestions

• Take as deep a breath as possible and hold it.

• Put mouthpiece in your mouth, past your teeth, and form a tight seal with your

lips. Make sure your tongue is not blocking the mouthpiece.

• Exhale slowly, push every bit of air out of your lungs.

• Remove mouthpiece.

4. While exhaling, patient should look at the incentive display and try to move the bar as
far to the right as possible.
ILLUSTRATION

Page 28

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

5. When flow has stopped screen prompts: “Was the Patient Effort Acceptable? (press

YES or NO)”

6. Press YES or NO.

• If YES the unit computes, displays and stores the test results. If AUTOPRINT
option has been activated, the report is printed out.

• If NO, the unit abandons the test and the patient can try again until clinician is
satisfied with effort.

NOTE: Patient effort is acceptable if the patient:

• Made a maximum effort.

• Exhaled completely.

• Exhaled smoothly, without coughing.

FLOWMATE V PLUS displays results when patient test is accepted.

VC TEST RESULTS SUMMARY

Index Units Meas Pred %Pred Var

VC L 5.50 5.67 97 0.2

Press DISPLAY to show graph

Page 29

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

METHACHOLINE CHALLENGE

OVERVIEW

The methacholine challenge test determines airways reactivity. It is useful for diagnosing
"variant asthma" and to identify predictive factors in asthma patients.

•

Variant asthma: An intermittent asthma which may occur during exercise,

exposure to cold air, due to infections, or at night. The patient's baseline
spirometry might appear normal, and there isn't a significant response to a
bronchodilator, hence they appear to be non-asthmatic. A methacholine
challenge test will demonstrate an abnormally high airways reactivity in
patients with variant asthma.

•

Predictive Factors: The degree of airways reactivity may be correlated with

the severity of asthma symptoms and the duration or frequency of asthma
attacks.

The methacholine challenge test is performed by inhaling successively increasing doses
of methacholine, and measuring the change in FEV1 between each dosage level. The
FEV1 is an important indice in this test.

PROCEDURES

1. From the MAIN MENU press NUMBER 1 (PATIENT)

2. Enter the Patient ID number and other information as previously described.

3. At the TEST MENU Press NUMBER 4 (CHAL)

4. Administer 5 breaths of diluent, press ENTER when ready for FVC test.

NOTE: Diluent is a saline solution with no methacholine in it. It is a placebo which will
give a baseline spirometry reading. Once the diluent has been administered, and the
ENTER key is pressed, the normal FVC routine is entered. The FVC test is administered
as usual and all FVC and FEV1 indices are the same as the normal FVC testing except for
the test header.

Page 30

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

1. INSTRUCT THE PATIENT:

• Place noseclip on nose.

• Take as deep a breath as you can and hold it

• Put mouthpiece in your mouth, past your teeth, and form a tight seal with your

lips. Make sure your tongue is not blocking the mouthpiece.

• Now blast the air out as hard and fast as possible.

• Inhale as deeply and quickly as possible through the mouthpiece.

• Remove the mouthpiece.

2. Press TEST

• The FLOWMATE V PLUS will prompt: “Do you want to increase the
challenge dose? (YES, NO, or exhale for another FVC)”

NOTE: Several baseline FVC tests should be performed until the %VAR is less than 5%

or 0.2L, whichever variability method you have selected. Clinician/physician must
determine whether to repeat another baseline test or continue with the challenge.
They must also determine whether to continue another FVC for that dose, or
whether to increase the dosage.

3. Press ENTER

The FLOWMATE V PLUS selects the best test according to the normal best test criteria,
then checks to see if the FEV1 %Pred is less than 70%. If results show that the FEV1 is
less than 70%, the FLOWMATE V PLUS displays a warning:

LOW FEV1: CHALLENGE NOT RECOMMENDED!! Press CLEAR to stop; ENTER
for challenge test.

4. Press CLEAR to stop. The FLOWMATE V PLUS will revert back to the test
selection prompt, but the baseline test is saved.

5. Press ENTER to continue the methacholine test.

Page 31

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

Once ENTER is pressed, the normal FVC test routine remains the same, but the display
and report for the challenge test are different. The index of primary interest is the FEV1.
The display also has columns with BASE and %CHNG (for baseline readings)

Index Unit Meas. Base %Chng %Var
FEV1 L x.xx x.xx x.xx xxx

NOTE: The FVC tests should be continued for this dosage until the %VAR is less than
5% or 0.2L, whichever variability method you have selected. Both indices are displayed.

6. Press TEST to continue testing after test results are displayed. You will see the
following display:

Administer 5 breaths of xx.xx #x
Press ENTER when ready for FVC test

Perform the following procedures:

1. Administer five (5) breaths There are up to five sequences of methacholine,

labeled #2-6, and then one sequence (#7) of bronchodilator to open the airway
back to normal.

2. Perform the FVC maneuver with a new dosage, and continue with that dosage

until the VAR is within acceptable limits.

3. Administer Bronchodilator after a sequence of six tests have been performed

or the patient’s FEV1 has dropped 20%. Press ENTER and perform another
FVC test.

4. If the FEV1 has dropped 20% from baseline the FLOWMATE V PLUS will

display: “FEV

has dropped xx%, challenge complete. Press ENTER to

1

continue.” Press ENTER.

5. Screen will prompt: “Do you want to end challenge? (YES, NO, or exhale

for another)”

6. Press YES to end methacholine challenge test.

7. Administer the Bronchodilator.

Page 32

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

POST -BRONCHODILATOR TESTING

After giving the patient a series of baseline tests, you may want to administer a
bronchodilator and then retest the patient to measure the effects of it. The FLOWMATE
V PLUS calculates the differences in various Pre-BD and Post-BD indices. (BD=
BronchoDilator) Any test on the TEST MENU can be performed both pre and post-BD
by simply pressing PATIENT and following the postbronchodilator prompts.

1. From the MAIN MENU press NUMBER 1 -- PATIENT.

2. After re-entering the patient’s ID number, press ENTER.

3. Display will prompt: “Is this Post BD?”

4. Press YES for Post-BD testing.

5. Press NO if you want to continue Pre-BD testing

NOTE: Once you have flagged a patient as Post-BD, you can’t remove the category

unless you re-enter all the patient ID information, including a different ID number.

6. Press ENTER repeatedly to scroll through patient data until reaching the

TEST options, or press CLEAR from the top of the information screen if you
do not want to make changes in the current data.

7. Continue testing as usual. Post and Pre-BD testing procedures are similar. The

only difference is that the test results will be labeled Pre or Post-BD on the
Best Test Summary Report.

NOTE: In order to compare Post-BD with Pre-BD testing, the FLOWMATE V PLUS
must have the patient’s Pre-BD tests stored in memory. Therefore, take care not to erase
patient’s Pre-BD data.

Page 33

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

RETRIEVING TEST RESULTS

After each test is completed and accepted, the FLOWMATE V PLUS automatically
stores it in its memory. If you chose the Automatic Printout option during customization,
the results of each test will automatically be printed. You can recall test data for
displaying, printing, or erasing by following these steps:

1. From the MAIN MENU press 1 -- PATIENT

2. Enter patient ID number, then press ENTER

NOTE: If you are unable to remember the patient ID number, you may return to MAIN

MENU by pressing the PATIENT key, then press SUMMARY to see a listing of the
patient directory.

3. Press ENTER repeatedly to scroll through patient data until reaching the

TEST options, or press CLEAR from the top of information screen if you do
not want to make changes to the current data.

4. From the TEST MENU, press DISPLAY, then enter the test number of the test

you are seeking data on.

NOTE: Each test for a given patient is given a test number of two digits (01,02,03, etc.)

The number increased by one for each consecutive test on the patient, regardless of
the type of test or whether it is pre or post-bronchodilator. This is the number you
enter.

5. Use the DISPLAY key to scroll through the various test indices. The indices

appear in the same order they are printed on the test report.

6. Use the PRINT key from the MAIN MENU to print tests of all or some of the

patients. From the TEST MENU press PRINT to print out the current test
results.

Page 34

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

ERASING A TEST

Press ERASE

• From MAIN MENU to erase the tests of all or some of the patients

• From TEST MENU to erase the test data from a single patient.

NOTE: The FLOWMATE V PLUS will always confirm that you want to erase this data.

ERASE TEST PROCEDURE

1. From the TEST MENU, press ERASE.

2. Display will prompt: “Erase which test?”

3. Enter the number of the test you want to erase

4. FLOWMATE V PLUS will confirm. Press YES to erase, NO to cancel.

5. From within the test results display, pressing the ERASE key will erase that

particular test. Before erasing, the FLOWMATE V PLUS will ask for
confirmation. Press YES to erase, NO to cancel.

NOTE: Once you press the YES key and the test record is erased, there is no recovery
possible.

ERASE PATIENT FROM MEMORY

1. From the MAIN MENU, press ERASE.

2. Display will prompt: 1. All records in memory

2. Some records in memory

0. Nothing

3. Selecting one (1) will delete all the patient records in memory. Selecting two

(2) will allow the user to select specific patients to delete from the base
memory. Selecting zero (0) or pressing the CLEAR key makes no changes to
the base memory.

4. If one (1) or two (2) are selected, the FLOWMATE V PLUS will confirm.

Press YES to erase, NO to cancel.

Page 35

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

SAVING PATIENTS TO DISKETTE

1. From the MAIN MENU, press SEND. The diskette must be in the disk drive

before pressing the SEND key.

2. Display will indicate records are being saved by the displaying message

“Sending unsaved records to diskette”.

Pressing the send key while viewing a patient record, will send updated and
previously unsaved test information about that patient to the diskette.

SUMMARY REPORTS

From TEST MENU, pressing the SUMMARY key prints out a Best Test Summary
Report. Each report contains the following:

Report Header: Indicates the type of test, number of test (to recall from

memory), and date and time of test.
Index: Indicates the names of the various test indices.
Unit: Indicates that L=liters, L/M=liters per minute; and L/S=

liters per second.
Meas: Indicates the actual measured value for that index, in the

units indicated in the “UNIT” column.
Pred: Indicates the predicted value for the index, based on the

patient data. If you skipped the patient data to go directly to

testing, the FLOWMATE V PLUS prints “N/A” for “not

applicable.” It will also print “N/A” for indices not covered

by a respective set of normals.
%Pred: Compares the patient’s measured result to the predicted

normal result for that index, expressed as a percentage.
%Var or Var: Indicates the variability or reproducibility of the test index,

as compared to the best previous measured value for that

Page 36

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

index.This is reportable as a percentage or as absolute

variant. For the FVC and FEV1 test, this value must be less

than 5% or 0.20L for the test to be regarded as

reproducible. Continue testing until the %Var or Var is less

than 5% or 0.20L respectively.
Diff: Indicates the variability of test indices, expressed as

comparison in indices units, between Best Test Post-BD

effort to Best Test Pre-BD effort.
%Diff: Indicates the variability of test indices, expressed in

percentage difference, between Best Test Post-BD effort

and Best Test Pre-BD effort.

NOTE: The variability (%Var) does not appear on the first test taken since there are no
indices in memory to compare it to.

Page 37

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

CHAPTER 6

MAINTENANCE AND TROUBLESHOOTING

MAINTENANCE

The FLOWMATE V PLUS is designed to require a minimum of maintenance. The most
important regular maintenance routine is the cleaning of the flow sensor. To clean the
EASY CLEAN Cartridge, it must be unscrewed. Before beginning disassembling
procedures, please note the following points:

• Do not use alcohol on Flow Sensor or any other parts.

• To reduce the risk of cross contamination Spirometrics states that you replace

the Filter Mouthpiece Housing between patients. The EASY CLEAN
Cartridge’s recommended cleaning schedule when the 2195 Filter Mouthpiece
Housing is used, is monthly or every 60 patients, whichever comes first.

• When testing a patient with an active communicable disease, the EASY
CLEAN Cartridge should be cleaned before reuse even when the 2195 Filter
Mouthpiece Housing is used. This is especially important after you test any
patient with an active communicable disease.

• ALWAYS UNPLUG THE FLOWMATE V PLUS BEFORE CLEANING TO
AVOID ELECTRICAL SHOCK.

To disassemble the Flow Sensor, proceed with the following steps:

1. Remove filter system (disposable filter).

2. Hold Flow Sensor towards you as if about to test yourself, and grasp the
sensor core with your hand.

3. Turn counter clockwise to unscrew EASY CLEAN Cartridge from Flow
Sensor.

4. Pull out the EASY CLEAN Cartridge section from Flow Sensor when the
threads disengage.

Page 38

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

EASY CLEAN CARTRIDGE

HANDLE ASSEMBLY

To disassemble the Flow sensor unscrew the core assembly counterclockwise

To assemble the Flow Sensor screw in the Core Element clockwise

To clean the Flow Sensor, proceed with the following steps:

1. Clean the EASY CLEAN Cartridge element in cold sterilization fluid,
preferably a protein-dissolving solution. Follow the manufacturer’s
instructions, thoroughly rinse in water and allow to dry completely.

2. Once the core element is completely dry insert back into Flow Sensor.

3. Align threads of EASY CLEAN Cartridge to threads of Sensor handle and
screw clockwise.

4. Tighten until snug. DO NOT exert high torque in screwing together, or
internal alignment pins may be broken holding the sensor core in position. A
snug fit is all that is required.

5. Replace filter.

FILTER

Page 39

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

CLEANING AND SANITIZING

In addition to regular cleaning of the flow sensor as described above, the remaining parts
of the FLOWMATE V PLUS may become soiled and require occasional cleaning or
sanitizing.

1. ALWAYS UNPLUG THE FLOWMATE V PLUS BEFORE CLEANING TO
AVOID ELECTRICAL SHOCK.

2. The base unit and the handle assembly may be cleaned with a soft cloth
dampened with water or a mild disinfectant soap. Squeeze all excess water
from the cloth before wiping the unit. DO NOT allow any water to enter the
printer slot or any other opening on the unit.

3. External surfaces of the unit may be sanitized by gently wiping with a
disposable germicidal cloth such as a Sani-Cloth®.

4. DO NOT use abrasives or harsh chemical solutions to clean the unit.

5. The FLOWMATE V PLUS is not waterproof or autoclavable.

Spirometrics Medical Equipment Co. will make available on request circuit diagrams,
component part lists, and descriptions which will assist the USER’s appropriately
qualified technical personnel to repair those parts which are designated by the
manufacturer as repairable.

Page 40

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

TROUBLESHOOTING

If your FLOWMATE V PLUS is not operating properly, try the procedures outlined in
this section. If any problems persist, or seem too complex to solve immediately, technical
questions may be addressed by calling 207-657-6700, or by e-mail at
[email protected] or 800-767-0004.

IF PROBLEM

IS THIS....

No message on

display

Is power supply

Is there power to

Printer Not

Responding

message on

display

(External

Printer)

ASK THESE

QUESTIONS...

Is FLOWMATE
V PLUS plugged
into power
supply?

plugged in?

the outlet?

Is there sufficient
paper in unit?

Is the paper
release lever in
the up position?
Is the external
printer selected?

Is the external
printer ON and
ON LINE?
Is the appropriate
printer cable
(#3355) being
used?

Is printer still not
operating
correctly?

IF ANSWER IS

YES....

IF ANSWER IS

NO...

Continue Plug unit into

power supply

Continue Plug power

supply into

outlet.
Contact service
department

Check circuit

breaker or power

source.
Continue Insert roll of

#2128 thermal

paper into unit.

Contact Service
Dept.

Push paper

release lever into

the up position.
Continue Select the

external printer

from

Customization

Menu.
Continue Select ON LINE

on the printer

controls.
Continue Attach cable

#3355 to

FLOWMATE V

PLUS and

printer.
Contact Service
Department

Page 41

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

IF PROBLEM

IS THIS....

Paper advances,

but no print

shown

FLOWMATE V

PLUS does not

respond to

ASK THESE

QUESTIONS...

Are you using
#2128 thermal
paper?

Is paper release
lever in UP
position?
Is printer
operating
correctly?

Is the tubing
connected to
FLOWMATE V
PLUS?

IF ANSWER IS

YES....

IF ANSWER IS

NO...

Continue Insert roll of

#2128 thermal

paper into unit.

Continue Push paper

release lever into

the UP position.
Check paper

position and if

necessary

reinstall roll with

paper feeding

from back of roll.
Continue Connect tubing to

fittings on back

of unit.

testing

VOLUME

reported larger

or smaller than

expected

FLOWMATE V

PLUS does not

maintain

accurate Date

and or Time

Is the tubing
kinked between
base and
Flowsensor?
Does the unit
show acceptable
results when
performing
calibration
linearity check?
How long is the
unit turned on for
during the course
of a week?

Continue Un-kink tubing.

Failure to obtain

acceptable results

from the linearity

check, see section

on calibration.

The unit only

charges when the

unit is turned on,

and to maintain

the internal

battery’s charge it

must be run 20 –

24 hours a

month. That can

be broken up into

as little as 6 – 8

hours each week.

Page 42

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

Calibration:

This section contains possible solutions for calibration problems.

Problem Solution

Can not keep the calibration
puck within the tolerance
window in the calibration
routine.

When performing linearity
check at different flow rates,
the reported values exceed the
+/- tolerances.

The calibration graph will not
move within the tolerance
window of the calibration
routine and the sensor will not
detect flow.

Calibration of the Flow Sensor requires a steady even
injection from the calibration syringes.
Check the Following...

•

The proper reference value of the calibration

syringe is entered. ie., 3Liter value for a

3Liter Calibration Syringe.

•

The calibration syringe does not leak air.

•

The adapter seal for air leakage-make sure it

provides a tight seal around the syringe nozzle and
the filter system.

•

The filter system is snugly connected to Flow

Sensor.

•

The Easy Clean Cartridge snuggly screwed into the
outer core housing.

•

Is Core free from moisture buildup?

Check the Following...

•

The proper reference value of the calibration

syringe is entered. ie., 3Liter value for a

3Liter Calibration Syringe.

•

The calibration syringe does not leak air.

•

The adapter seal for air leakage-make sure it

provides a tight seal around the syringe nozzle and
the filter system.

•

The filter system is snugly connected to Flow

Sensor.

•

The Easy Clean Cartridge snuggly screwed into the
outer core housing.

•

Is Core free from moisture buildup?
Perform calibration linearity check to verify that any
changes have corrected the earlier problem.

Check that the core element is properly installed. This
requires complete insertion of the core element into
the handle assembly. Refer to the maintenance section
for assembly instruction.

Page 43

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

Patient Storage:

This section contains possible solutions to patient storage problems.

Problem Solution

FLOWMATE V PLUS will not
store more than 7 patients in
the base memory.

The FLOWMATE V PLUS will store 7 patients in its
base memory. If you need more storage you can save to
a diskette, by pressing the SEND key. See Chapter 4

When saving to diskette and
“Disk Error” message appears

Diskette may not be formatted correctly. The
FLOWMATE V PLUS requires that any diskette used
be formatted before using. Diskette must be a 1.44 MB,
not a 720 k. IBM-PC format. Is diskette write
protected?

Problem Solution

Can not recall a stored patient. Storage of patient data is automatic in the base

memory.
Patients are stored by patient ID, when patient data is
first entered. To determine what is stored in the
FLOWMATE V PLUS's memory:

•

Press the SUMMARY key at the Main MENU.

Make sure the spirometer is customized to the type

of printer being used. A list of patients stored by

ID number and age will be displayed. To print a

list, press the PRINT key.

• To search for patients on a disk, insert disk into

drive and select YES to the “List patients on a

diskette?” prompt.

NOTE: The patient storage memory will always discard the
earliest patient once the FLOWMATE V PLUS reaches the
maximum patient storage. Always print or erase patients in
storage or send the patient information to a floppy disk for
additional storage.

Page 44

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

CHAPTER 7

FLOWMATE V PLUS SPECIFICATIONS
PHYSICAL

Height 5.5” (14.0 cm)
Depth 9.0” (22.9 cm)
Width 11.375” (28.9 cm)
Weight 10.5 lbs. (4.8 kg)

POWER REQUIREMENTS
Voltage 100-240 VAC, 50-60Hz
Amperage 1.0A to 500 Milliamps (As supplied to the external power supply)
Wattage 45 Watts maximum

POWER CONNECTION
IEC standard three prong connector with ground. Permits wide

variety of international primary power connector cord sets.
Supplied with hospital grade plug USA and Canada.

The power supply cord serves as the MAINS (power) disconnect

for the power supply.

ENVIRONMENTAL
Temperature Operating Range 50°F to 104°F (10°C to 40°C)
Maximum storage temperature 158°F (70°C)

USER INTERFACE
Display 256 by 128 graphic LCD display
Keypad 26 key membrane switch keypad with tactile feedback.

PATIENT DATA
ID number Up to 16 digits including, periods (.), and slashes (/). Do not start

with either a period (.) or a slash (/) however.
Age 1 to 99
Sex Male, Female
Race Caucasian, Black, Non-Caucasian, Hispanic, Asian
Height Up to three digits, in inches or centimeters.
Weight Up to three digits (optional entry)
Customizable as lbs. or kgs.
Smoke 0-60 cigarettes per day.

TEST MANEUVERS
FVC Forced Vital Capacity
MVV Maximum Voluntary Ventilation
VC Vital Capacity (Otherwise known as Slow VC)
Challenge Methacholine Challenge

Page 45

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

INDICES CALCULATED

FVC maneuver

FVC Forced Vital Capacity
FEV1 1 second Forced Vital Capacity
FEV 3 *3 second Forced Vital Capacity
FEV1/FVC% % FEV1 Ratio
FEF25-75 Mid Expiratory Flow Rate
FEF75-85 *Late Expiratory Flow Rate
FEF200-1200 *Forced Expiratory Flow Rate between

200ml and 1200 ml

FEF50 *Forced Expiratory Flow Rate at 50% of

FVC
PEF Peak Expiratory Flow
FIVC *Forced Inspiratory Vital Capacity
FIF50 *Forced Inspiratory Flow at 50% of FVC
FEF50/FIF50 *Ratio of FEF50 to FIF50
PIF *Peak Inspiratory Flow
COPD **Risk Assessment
Lung Age **Lung Age Assessment based on FEV1

1

2

NOTE: FEV timing is based on back extrapolation
* - these indices appear on the expanded reports
** - these indices appear on the summary report

MVV maneuver
MVV volume Volume Expired per minute
MVV rate Breaths per minute
VC maneuver
VC Vital Capacity
ATI Air Trapping Index
Challenge
FVC Forced Vital Capacity
FEV1 1 Second Forced Vital Capacity
PD20 Provocative Dose

________________________________________________________________________

1

Higgins, Millicent W., M.D. and Keller, Jacob B., M.P.H., Estimating your patient’s risk

COPD, J Respir Dis 4(1):97-108, 1983.

2

Morris, James F., M.D. and Temple, William, Spirometric “Lung Age” Estimation for

Motivating Smoking Cessation, Preventive Medicine 14, 655-662,

1985.

Page 46

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

FLOW SENSOR

Maximum Flow Rate +/- 16 liters/second
Accuracy +/- 3%
Resolution 12 bit signed A/D
Sampling Rate 150Hz
Back Pressure 1.1 cmH20/L/s@14L/S

BTPS Calculated automatically based on user input for

environmental conditions.
Temperature 40° to 104°F
10° to 40°C
Barometric Pressure 20 to 35 inches of mercury
500 to 900 millimeters of mercury
Input values determines units automatically

BEST TEST DETERMINATIONS (pertains to FVC trials only)

FVC Largest regardless of test
FEV1 Largest regardless of test
Ratio Combination of Best FEV1/Best FVC
Flow Rates Taken from the trace with the greatest sum of FVC and

FEV1

Patient Effort Requires clinician to evaluate acceptable or unacceptable

patient effort. Discards tests the clinician deems as

unacceptable.

Variability Compares indices of current test with best test in memory.

Displays and prints variability as % or as absolute

difference (user selectable in customization). Variability

greater than 5% or 0.2L (depending on user selection) for

the FVC and/or the FEV1 is regarded as poor

reproducibility.

Expiratory Time If forced expiratory time is less than 6 seconds, a “TEST

TOO SHORT” message will be displayed.

Extrapolated Volume If extrapolated volume is greater than 5% of the FVC, and

or > 0.20 L a “SLOW START” message will be displayed.

Interpretations Obstruction, Restriction, or Ventilatory disorder.

Page 47

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

INPUT/OUTPUT COMMUNICATION PORTS

Graphic Output Printouts according to ATS scale specifications when user

selects option within customization (Scale Factors:

Volume is 10 mm/L, Flow is 5 mm/L/s, and Time is 20

mm/s).

Printer Options Internal thermal printer using 112mm wide thermal paper.

External printer with selectable print drivers within

customization.
Standard DB-25 Female IBM PC pin out to standard

centronic connection.

The use of ACCESSORY equipment not complying with the equivalent safety
requirements of this equipment may lead to a reduced level of safety of the resulting
system. Consideration relating to the choice shall include:

- use of the accessory in the PATIENT VICINITY

- evidence that the safety certification of the ACCESSORY has been
performed in accordance to the appropriate IEC 601-1-1 harmonized
standard.

Serial Port Currently no user defined function for the serial connection.

Patient Storage Internal minimum of 7 patients (variable depending on

number of FVC tests performed and saved)

External storage on 1.44 Mb formatted disk minimum 45

patients (variable depending on number of FVC tests
performed and saved)

FVC - 6 trials each patient
MVV - 6 trials each patient
VC - 6 trials each patient

Test Numbering Numbers each patient trial that is accepted consecutively

regardless of the type of test for recall later.

INSTRUMENT CALIBRATION

Syringe Selectable from 1 to 9 liters at ATPS. Daily calibration is

recommended on days testing is to be performed.
Calibration reports print out automatically if printer is
connected and is on-line.

Page 48

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

EQUIPMENT CLASSIFICATION

Class 1 Equipment
Class BF Applied Part
Ordinary Equipment – (enclosed equipment without protection against ingres of water.
Equipment not suitable for use in the presence of a FLAMMABLE ANAESTHETIC
mixture with air or with OXYGEN or NITROUS OXIDE.)

SAFETY COMPLIANCE

The FLOWMATE V PLUS has been evaluated and found to comply with the applicable
requirements of the Standard UL2601-1 ‘Medical Electrical Equipment, Part 1: General
Requirements for Safety’ 2nd Edition including Amendments 1 and 2, CAN/CSA C22.2
No. 601.1-M90, ‘Medical Electrical Equipment-Part 1: General Requirements for
Safety’, including C22.2 No. 601.1 S1-94 (IEC601-1, Amendment 1:1991) Supplement
No. 1-94 to CAN/CSA 22.2 No. 601.1-M90.

EMI COMPLIANCE STATEMENT

The FLOWMATE V PLUS has been tested to IEC 601-1-2 : 1993 and EN55011 : 1991
and found to comply with the criteria for laboratory equipment.

TRANSPORT AND TEMPORARY STORAGE

The FLOWMATE V PLUS has been packaged for transport and shipping for an ambient
temperature between -40ºC to 70ºC and a relative humidity range of less than 100% non­condensing. The shipping package should not get wet, as possible damage to the device
can occur.

EMBEDDED MICROPROCESSOR

The FLOWMATE V PLUS utilizes an Intel embedded microprocessor for control and
calculations.

Page 49

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

Markings used on Device and / or Power Supply:

Symbol Description

Direct Current

Type BF Equipment

Attention, consult ACCOMPANYING
DOCUMENTS

Alternating Current

Indoor Use

Off (power: disconnection from the
Mains)

On (power: connection to the Mains)

Protective earth ground

Safety Mark of Intertek Testing
Services NA Inc. to applicable
standards

Page 50

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

147.3

CHAPTER 8

NORMALS TABLES

One of the principal functions of a spirometer 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 he/she were "normal".
The predictions are based on extensive studies of a population done by leading
pulmonologists. To obtain predicted values the technician must enter the height, age, sex
and race. The spirometric test indices from thousands of people of different height, age,
sex and race were analyzed and compiled into an equation. Each normals table is named
by the pulmonologist who led the study.

NORMALS TABLES

The FLOWMATE V PLUS has normals tables from the following five studies stored in
memory. Select the table you want to use in Customizing the FLOWMATE V PLUS on
pg. 8. Note the applicable indices and ranges for each study.

Knudson 1983

INDICES

FVC

FEV1

FEV1/FVC 11 - 19 132.1 - 182.9 52 - 72

FEF 25-75 20 - 69 147.3 - 180.3 58 - 71

FEF 50 70 - 87 147.3 - 167.6 58 - 66

MALE:

12 - 24

25 - 84

SEX AGE

Yrs -Min-max

FEMALE: 6 - 10 106.7 -

6 - 11 111.8 - 154.9 44 - 61

HEIGHT
cm - Min-max

139.7 - 193.0 55 - 76

157.5 - 195.6 62 - 77

HEIGHT
in - Min-max

42 - 58

Page 51

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

Crapo

INDICES:

SEX AGE

Yrs - Min-max

HEIGHT
cm. Min-max

HEIGHT
in. Min-max

FVC

FEV1

FEV3

FEV1/FVC%

FEF 25-75%

MVV vol

FEMALE 17-84 146-178 57-71

MALE 15-91 157-194 61-77

ECCS with Knudson 1983 Children (ages 18 - 24 are evaluated as age 25)

INDICES

FVC

FEV1

FEV1/FVC

FEF 25-75

PEF

FEF 50

FIVC

MVV vol

VC

SEX AGE

Yrs, Min - max

FEMALE: 25 - 90 145.0 -

CHILDREN:
(female)
11 - 17 132.1 -

MALE: 25 - 90 155.0 -

CHILDREN:
(male)
12 - 17 139.7 -

6 - 10 106.7 -

6 - 11 111.8 -

HEIGHT
cm - Min-max

180.0

147.3

182.9

195.0

154.9

193.0

HEIGHT
in - Min-max

56 - 72

42 - 58

52 - 72

58 - 80

44 - 61

55 - 76

Page 52

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

Morris

INDICES

FVC

FEV1

FEV1/FVC

FEF .1 - 1.2

SEX AGE

yrs - Min-max

FEMALE: 20 - 84 145.0-180.0 56 - 72

MALE: 20 - 84 155.0-195.0 58 - 80

HEIGHT
cm - Min-max

HEIGHT
in - Min-max

FEF 25-75

FEF 75-85

HSU 1979 (Using Journal of Pediatrics 1979)

INDICES

FVC FEMALE: 7 - 20 111 - 180 43 - 71

FEV1

FEF 25-75

PEF

SEX AGE

yrs- Min-max

MALE: 7-20 111 - 190 43 - 75

HEIGHT
cm - Min-max

HEIGHT
in - Min-max

LAM 1982

INDICES

FVC FEMALE: 5 - 74 Height range

FEV1

PEF

SEX AGE

yrs- Min-max

MALE: 5 - 74 Height range

HEIGHT
cm - Min-max

not specified
in study.

not specified
in study.

HEIGHT
in - Min-max

Height range
not specified
in study.

Height range
not specified
in study.

Page 53

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

COMPOSITE

This is the Default normals selection. These normals provide predicted values for most
indices.

INDICES

FVC

FEV1

FEF 50

FEV3

FEF 25-75 Knudson 83

FEF 75-85 Morris

PEF ECCS

FIVC Knudson 83

FIF 50 No Predicted

PIF No Predicted

FEV1/FVC Knudson 83

FEF 2-1.2 Morris

MVV Vol Crapo

VC Knudson 83

AUTHOR

Knudson 83

Knudson 83

Knudson 83

Crapo

Page 54

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

ATPS and BTPS

BTPS: The air in the patient's lungs is said to be "BTPS conditions". BTPS is an
abbreviation for Body Temperature, Standard Pressure, and Saturated with water vapor.

ATPS: The air measured by the Flow Sensor is said to be at "ATPS conditions". ATPS
is an abbreviation for the Ambient Temperature, Standard Pressure, and Saturated with
water vapor.

AUTOMATIC EXPIRATORY BTPS CALCULATION: The air inside the patient's
lungs is at body temperature (98.6 degrees Fahrenheit or 37 degrees Centigrade). A
patient exhales into the Flow Sensor, the air cools. As the air cools, it contracts and
becomes a smaller volume than it was in the patient's lungs. The volume you want to
measure is the larger volume in the patient's lungs, not the smaller volume measured by
the Flow Sensor.

To calculate the volume of air in the patient's lungs, the FLOWMATE V PLUS
automatically multiplies the volume measured by the Flow Sensor. The correction factor
is based on temperature present in the testing room.

NOTES

NOTE: Barometric pressure must be entered in



Calibration Refer to Pg. 37

AUTOMATIC INSPIRATORY BTPS CALCULATIONS: The air that the patient
inspires through the Flow Sensor is at ambient temperature (the temperature of the
immediate surroundings). As the patient inhales through the Flow Sensor, the air heats
up in the lungs. As the air heats up it expands and becomes a larger volume than it was
before. The volume you want to measure is the larger volume in the patient's lungs, not
the smaller volume measured by the Flow Sensor.

To calculate the volume of air in the patient's lungs, the FLOWMATE V PLUS
automatically multiplies the volume measured by the Flow Sensor and the BTPS
correction factor. The inspiratory BTPS correction factor for the FLOWMATE V PLUS
is variable, based on the air temperature and average standard barometric pressure you
entered in the Calibration Routine.

Page 55

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

BTPS Correction Factors

The FLOWMATE V PLUS automatically corrects to give you BTPS readings. This chart
is included for reference purposes only. You calculate the BTPS correction factor by
determining the ambient temperature and locating the corresponding BTPS correction
factor on this table at 760mmHg barometric pressure.

AMBIENT

TEMPERATURE

(degrees)

CO FO

10 50.0 1.125
11 51.8 1.120
12 53.6 1.115
13 55.4 1.110
14 57.2 1.105
15 59.0 1.100
16 60.8 1.095
17 62.6 1.090
18 64.4 1.085
19 66.2 1.079
20 68.0 1.074
21 69.8 1.069
22 71.6 1.064
23 73.4 1.058
24 75.2 1.053
25 77.0 1.047
26 78.8 1.042
27 80.6 1.036
28 82.4 1.030
29 84.2 1.025
30 86.0 1.019
31 87.8 1.013
32 89.6 1.007
33 91.4 1.001
34 93.2 1.000
35 95.0 1.000
36 96.8 1.000
37 98.6 1.000
38 100.4 0.993
39 102.2 0.986
40 104.0 0.979

BTPS
EXPIRATORY
FACTOR

Page 56

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

Feet / Inches / Centimeters Conversion Chart

FEET INCHES CENTIMETERS FEET INCHES CENTIMETERS

3'0"

36"

3'1"

37"

3'2"

38"

3'3"

39"

3'4"

40"

3'5"

41"

3'6"

42"

3'7"

43"

3'8"

44"

3'9"

45"
3'10" 46"
3'11" 47"
4'0"

48"
4'1"

49"
4'2"

50"
4'3"

51"
4'4"

52"
4'5"

53"
4'6"

54"
4'7"

55"
4'8"

56"
4'9"

57"
4'10" 58"
4'11" 59"
5'0"

60"
5'1"

61"
5'2"

62"
5'3"

63"

92
94
97
99
102
105
107
110
112
115
117
120
122
125
127
130
132
135
138
140
143
145
148
150
153
155
158
160

5'4"

64"

5'5"

65"

5'6"

66"

5'7"

67"

5'8"

68"

5'9"

69"
5'10" 70"
5'11" 71"
6'0"

72"
6'1"

73"
6'2"

74"
6'3"

75"
6'4"

76"
6'5"

77"
6'6"

78"
6'7"

79"
6'8"

80"
6'9"

81"
6'10" 82"
6'11" 83"
7'0"

84"
7'1"

85"
7'2"

86"
7'3"

87"
7'4"

88"
7'5"

89"
7'6"

90"

163
165
168
171
173
176
178
181
183
186
188
191
193
196
198
201
204
206
209
211
214
216
219
221
224
226
229

-- -- --

Page 57

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

Pounds / Kilograms Conversion Chart

LBS KGS LBS KGS LBS KGS LBS KGS

50 23

51 23 101 46 151 69 201 91
52 24 102 46 152 69 202 92
53 24 103 47 153 70 203 92
54 25 104 47 154 70 204 93
55 25 105 48 155 70 205 93
56 25 106 48 156 71 206 94
57 26 107 49 157 71 207 94
58 26 108 49 158 72 208 95
59 27 109 50 159 72 209 95
60 27 110 50 160 73 210 95
61 28 111 50 161 73 211 96
62 28 112 51 162 74 212 96
63 29 113 51 163 74 213 97
64 29 114 52 164 75 214 97
65 30 115 52 165 75 215 98
66 30 116 53 166 75 216 98
67 30 117 53 167 76 217 99
68 31 118 54 168 76 218 99
69 31 119 54 169 77 219 100
70 32 120 55 170 77 220 100
71 32 121 55 171 78 221 100
72 33 122 55 172 78 222 101
73 33 123 56 173 79 223 101
74 34 124 56 174 79 224 102
75 34 125 57 175 80 225 102
76 35 126 57 176 80 226 103
77 35 127 58 177 80 227 103
78 35 128 58 178 81 228 104
79 36 129 59 179 81 229 104
80 36 130 59 180 82 230 105
81 37 131 60 181 82 231 105
82 37 132 60 182 83 232 105
83 38 133 60 183 83 233 106
84 38 134 61 184 84 234 106
85 39 135 61 185 84 235 107
86 39 136 62 186 85
87 40 137 62 187 85 237 108
88 40 138 63 188 85 238 108

89 40 139 63 189 86 239 109

90 41 140 64 190 86 240 109
91 41 141 64 191 87 241 110
92 42 142 65 192 87 242 110
93 42 143 65 193 88
94 43 144 65 194 88 244 111
95 43 145 66 195 89 245 111
96 44 146 66 196 89 246 112
97 44 147 67 197 90 247 112
98 45 148 67 198 90 248 113
99 45 149 68 199 90 249 113

100 45

150 68

200 91

236 107

243 110

Page 58

Doc. #: 20004 Rev. 03

Spirometrics FLOWMATE V PLUS User Manual

(Ault Inc. external power supply model SW154)

ACCESSORIES + REORDER INFORMATION

The following is a list of accessories and model numbers for the FLOWMATE V PLUS
Spirometry System.

Description

FLOWMATE V PLUS Spirometer
Nose Clips
(Pkg. of 100)
Filter, Disposable - Single Patient Use
(Box of 100)

3-Liter Calibration Syringe

Adapter Seal, Calibration Syringe
Spirometer, EASY CLEAN Cartridge
(FLOWMATE V PLUS)

Printer Cable
Spirometer, AC Adapter (16 VDC, 2.8A)

FLOWMATE V PLUS Operator's Manual

Call your local distributor for more information on FLOWMATE V PLUS Accessories.

Printers available through Spirometrics

Please contact Inside Sales for complete computer / printer options.

207-657-6700

or

800-767-0004

Fax [phone]

www.spirometrics.com

email [email protected]

Model #

4000

2104

2195

2125

30-0015

18225

3355

17002

4000M

Page 59

Doc. #: 20004 Rev. 03