Spirometrics FLOWMATE V PLUS User Manual

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FLOWMATE V PLUS USER'S MANUAL

P O Box 680, 22 Shaker Road

Gray, ME 04039 USA

http://www.spirometrics.com

REV 03

February 2004

Doc. #: 20003 Rev. 3

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Page 1 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...
Page 2: Table Of Contents
Spirometrics FLOWMATE V PLUS User Manual FLOWMATE V PLUS USER’S MANUAL Table of Contents CHAPTER 1 Introduction Warranty Card CHAPTER 2 Intended Use Warnings and Precautions Setting Up Loading Paper Factory Settings Customization Routine Setting Time/Date CHAPTER 3 Calibrating the Spirometer...
Page 3 Spirometrics FLOWMATE V PLUS User Manual CHAPTER 7 42 Specifications Page 3 Doc. #: 20004 Rev. 03...
Page 4: 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.
Page 5 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.
Page 6: Warranty Card
Spirometrics FLOWMATE V PLUS User Manual This page set aside for the WARRANTY CARD insert. Page 6 Doc. #: 20004 Rev. 03...
Page 7 Spirometrics FLOWMATE V PLUS User Manual This page set aside for the WARRANTY CARD insert. Page 7 Doc. #: 20004 Rev. 03...
Page 8: Intended Use
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 9: Setting Up
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.
Page 10 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 11: 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.
Page 12 Spirometrics FLOWMATE V PLUS User Manual 8.Enter Current Location I.D. # Blank (up to 16 digits) 9. Prompt daily for Loc. I.D. # 10. Report Format Short Expanded 11. Use ATS Hand Measure 12. Print Vol/Time Curve 13. Print Flow/Vol Loop 14.
Page 13: Customization Routine
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.
Page 14: Setting Time/Date
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...
Page 15: Calibrating The Spirometer
“Calibration out of date.” To calibrate your FLOWMATE V PLUS, first set up your calibration syringe in the following manner: •...
Page 16 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.
Page 17: Operating The Flowmate V Plus
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...
Page 18 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.
Page 19: Summary Of Operations
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.
Page 20: Testing
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. •...
Page 21: Entering Patient Data
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.
Page 22 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.
Page 23: Forced Vital Capacity (Fvc) Testing
• 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.
Page 24 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. 5.52 5.67 FEV1 3.96 4.65 FEV1/FVC 70.0 82.6...
Page 25: Summary Of Fvc Test Results
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).
Page 26: Maximum Voluntary Ventilation (Mvv) Testing
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.
Page 27 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.
Page 28: Vital Capacity (Vc) Testing
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.
Page 29 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...
Page 30: Methacholine Challenge
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, •...
Page 31 Press ENTER The FLOWMATE V PLUS selects the best test according to the normal best test criteria, then checks to see if the FEV %Pred is less than 70%. If results show that the FEV less than 70%, the FLOWMATE V PLUS displays a warning: LOW FEV1: CHALLENGE NOT RECOMMENDED!! Press CLEAR to stop;...
Page 32 FEV has dropped 20%. Press ENTER and perform another FVC test. 4. If the FEV has dropped 20% from baseline the FLOWMATE V PLUS will display: “FEV has dropped xx%, challenge complete. Press ENTER to continue.” Press ENTER.
Page 33: Post-Bronchodilator Testing
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 34: Retrieving Test Results
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.
Page 35: Erasing A Test
• 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.
Page 36: Saving Patients To Diskette
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.
Page 37 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.
Page 38: Maintenance
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: •...
Page 39: Diagram Handle Assembly
Spirometrics FLOWMATE V PLUS User Manual 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.
Page 40: Cleaning And Sanitizing
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.
Page 41: Troubleshooting
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 spiro@spirometrics.com or 800-767-0004.
Page 42 Spirometrics FLOWMATE V PLUS User Manual IF PROBLEM ASK THESE IF ANSWER IS IF ANSWER IS IS THIS..QUESTIONS... YES..NO... Paper advances, Are you using Continue Insert roll of #2128 thermal #2128 thermal but no print paper? paper into unit.
Page 43: Calibration
Spirometrics FLOWMATE V PLUS User Manual Calibration: This section contains possible solutions for calibration problems. Problem Solution Can not keep the calibration Calibration of the Flow Sensor requires a steady even puck within the tolerance injection from the calibration syringes.
Page 44: Patient Storage
This section contains possible solutions to patient storage problems. Problem Solution FLOWMATE V PLUS will not The FLOWMATE V PLUS will store 7 patients in its store more than 7 patients in base memory. If you need more storage you can save to the base memory.
Page 45 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)
Page 46 Spirometrics FLOWMATE V PLUS User Manual INDICES CALCULATED FVC maneuver 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...
Page 47 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°...
Page 48 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.
Page 49 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% non-...
Page 50 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)
Page 51 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.
Page 52 Spirometrics FLOWMATE V PLUS User Manual Crapo HEIGHT HEIGHT INDICES: Yrs - Min-max cm. Min-max in. Min-max FEMALE 17-84 146-178 57-71 FEV1 MALE 15-91 157-194 61-77 FEV3 FEV1/FVC% FEF 25-75% MVV vol ECCS with Knudson 1983 Children (ages 18 - 24 are evaluated as age 25)
Page 53 Spirometrics FLOWMATE V PLUS User Manual Morris HEIGHT HEIGHT INDICES yrs - Min-max cm - Min-max in - Min-max FEMALE: 20 - 84 145.0-180.0 56 - 72 FEV1 FEV1/FVC MALE: 20 - 84 155.0-195.0 58 - 80 FEF .1 - 1.2...
Page 54 Spirometrics FLOWMATE V PLUS User Manual COMPOSITE This is the Default normals selection. These normals provide predicted values for most indices. INDICES AUTHOR Knudson 83 FEV1 Knudson 83 FEF 50 Knudson 83 FEV3 Crapo FEF 25-75 Knudson 83 FEF 75-85...
Page 55 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.
Page 56 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.
Page 57 Spirometrics FLOWMATE V PLUS User Manual Feet / Inches / Centimeters Conversion Chart FEET INCHES CENTIMETERS FEET INCHES CENTIMETERS 3'0" 36" 5'4" 64" 3'1" 37" 5'5" 65" 3'2" 38" 5'6" 66" 3'3" 39" 5'7" 67" 3'4" 40" 5'8" 68" 3'5"...
Page 58 Spirometrics FLOWMATE V PLUS User Manual Pounds / Kilograms Conversion Chart LBS KGS LBS KGS LBS KGS LBS KGS 50 23 100 45 150 68 200 91 51 23 101 46 151 69 201 91 52 24 102 46 152 69...
Page 59 Spirometrics FLOWMATE V PLUS User Manual ACCESSORIES + REORDER INFORMATION The following is a list of accessories and model numbers for the FLOWMATE V PLUS Spirometry System. Description Model # FLOWMATE V PLUS Spirometer 4000 Nose Clips (Pkg. of 100)