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FLOWMATE III USER`S MANUAL

1. Press or gt Do you want to print Press ENTER Volume Time Curves 1 YES 2 NO Now 1 Volume Time Curve is included when printing report for individual FVC tests Press O or gt Do you want to print Press ENTER Flow Volume Loops 1 YES 2 NO Now 1 Flow Volume Loop is included when printing report for individual FV tests Press 0 0 0 0 gt Graph Best Test Curve s on Press ENTER Summary Both Includes chosen Best Test Curves on the Summary 2 VT Curve Report when printed 3 FV Loop 4 None Press O or gt Do you want to print COPD Press ENTER Risk 1 YES 2 NO Now 1 COPD Risk Chronic Obstructive Pulmonary Disease assessment to be printed on the Summary Report Press O or gt Do you want to print Lung Age Press ENTER 1 YES 2 NO Now 1 Lung Age calculation to be printed on the Summary Report Press YES or NO gt Inhalation Challenge defaults f okay Press YES or NO YES See default settings pgs 16 amp 17 NO May change the methacholine default values for each dosage If you answered NO to the prior question the Flowmate III will ask the following questions Answer each question accordingly and then press ENTER See Methacholine Challenge pg 38 e How many breaths per concentration enter number of inhalations Now 5 e What is methacholine concentration 2 enter dose in mg ml breath 00 025 e What is methacholine concentration 3 ent
2. 02 20 98 T oor proces CG User s Manual Rev 02 Page 2 MESCA mz mzc oc Spirometrics Flowmate III User s Manual Rev 02 SPECIFICATIONS PHYSICAL Height 2 25 inches 5 7 cm Depth 5 50 inches 14 0 cm Width 9 0 inches 22 9 cm Weight 2 Lbs 0 9 kg POWER REQUIREMENTS Battery amp AC Requires 6 1 2 volt AA NiCad batteries 500 mhr AC adapter is a UL 544 recognized 9 volts DC at 1 amp Power consumption is 200 Milliamps in operation Battery recharge time is 15 hrs which provides 4 5 hrs of continuous use under battery power Amperage 200 Milliamps in use Electrical Requirements Meets UL544 requirements AC Adapter provided Plugs into any standard 120 VAC 60 Hz ENVIRONMENTAL Temperature Operating range 50 F 104 F 10 C 40 C Max storage temperature 40 F 110 F 5 C 46 C USER INTERFACE Display 2 line by 40 character LCD display Keypad 20 key membrane switch with audible feedback PATIENT DATA Verification report is printed after entering all patient data ID number Up to 16 digits incl and Age Up to 3 digits Sex Male Female Race Caucasian Black Other Height Up to 3 digits 36 to 89 inches 90 to 250 centimeters automatically determines units of measurement Weight Up to 3 digits optional Selectable as Lbs or Kgs TEST Maneuvers FVC maneuver MVV maneuver VC maneuver Methacholine Challenge Inhalation Challenge Maneuver
3. 72 Spirometrics Flowmate III User s Manual Rev 02 INDICES CALCULATED FVC Maneuver FVC Forced Vital Capacity FEV1 Forced Expiratory Vol 1 sec FEV3 Forced Expiratory Vol 3 sec FEV1 FVC FEV1 Ratio FEF 25 75 Mid Expiratory Flow Rate FEF 75 85 Late Expiratory Flow Rate FEF 200 1200 Forced Expiratory Flow Rate in between 200ml 1200ml PEF Peak Expiratory Flow Rate FEF50 Forced Expiratory Flow Rate at 50 of FVC FIVC Forced Inspiratory Vital Capacity FIF50 Forced Inspiratory Flow at 50 of FIVC FEF50 FIF50 Ratio of FEF50 to FIF50 PIF Peak Inspiratory Flow COPD Chronic Obstructive Pulmonary Disease Risk Assessment These indices appear only on expanded reports FEV Timing FEV timings based on back extrapolation MVV Maneuver MVV volume Minute expired volume MVV rate Breaths per minute VC Maneuver VC Vital capacity ATI Air Trapping Index Max Volume 10 liters Max Flow Rate 16 liters sec Accuracy 3 of reading Resolution 1ml Sec LSB 12 Bit A D Sampling Rate 150 HZ Back Pressure Less than 1 5 cm H2O L S BTPS CONVERSION Calculated in real time User Input Temp 50 to 104 F 10 to 40C Automatically determines units User Input Pressure 20 35 inches of mercury 500 900 millimeters of mercury automatically determines units 73 Spirometrics VALIDITY DETERMINATION Best FVC Best FEV1 Best Ratio Best Flow Rates Patient Effort Variability Expir
4. E e FILTER HOUSING i e 3 HANDLE ASSEMBLY To disassemble the Flow sensor unscrew the Core Element counterclockwise To assemble the Flow Sensor screw in the Core Element clockwise 54 Spirometrics Flowmate III User s Manual Rev 02 Assembling the Flowmate Ill Flow Sensor 1 Insert the EASY CLEAN Cartridge back into the Sensor Assembly and turn clockwise to tighten 2 Insert the back of the Easy Clean Cartridge into the handle assembly towards the finger grips 3 Insert into sensor handle and turn clockwise to tighten Once the EASY CLEAN Cartridge has contacted the inner core housing outer face turn until snug about a 1 32 of a turn or roughly a quarter 1 4 of an inch Over tightening can damage the sensor handle alignment pins WARNING Do not disassemble core element The core element can be cleaned fully assembled Exholotion Flow A FILTER SYSTEM A M SENSOR CORE Screw the Core Element from this side to assemble e e wi HANDLE ASSEMBLY a Handle Assembly Fully assembled 55 Spirometrics Flowmate III User s Manual Rev 02 TROUBLESHOOTING If your Flowmate Ill is not operating properly try the following suggestions If any problems persist or seem too complex to solve immediately you can contact us at spi
5. Rev 02 NOTE Diluent is a saline solution with no methacholine in it It is a ET placebo which will give a baseline spirometry reading Once the diluent has been administered and the ENTER key pressed the normal FVC routine is entered The FVC test is conducted as usual and all FVC and FEV1 indicies are the same as the normal FVC testing with the exception of the test header Instruct the Patient SEE FVC TESTING SECTION pg 31 1 Place a noseclip on his her nose 2 Position the flow sensor mouthpiece in mouth past teeth and form a tight seal Make sure the tongue is not blocking the mouthpiece 3 Take as deep a breath as possible through the mouthpiece and hold it 4 Blast ALL the air out as hard and fast as possible 5 Inhale as deeply and quickly as possible through the mouthpiece 6 Remove the mouthpiece Press TEST cy Each time you would like to start a new test The Flowmate III will ask if you would like to increase the challenge dose 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 Nar is less than 5 You the technician physician must determine whether to repeat another baseline test or continue with the challenge Also whether to continue another FVC for that dose or whether to increase dosage NOT RECOMMENDED The Flowmate III selects the best test as per the normal best test Press CL
6. Manual Rev 02 FVC Testing Forced Vital Capacity Test FVC testing begins after the D Which test would you like test would you like patient data is entered The Flowmate III will automatically 1 FVC 3 Mvv 4 CHAL or Output Insert a new filter for each patient Press o gt Test No 01 FVC Exhale hard Then inhale Instruct the Patient to 1 Place a noseclip on his her nose 2 Take as deep a breath as possible through the mouth and hold it 3 Put the flow sensor mouthpiece in mouth past teeth and form a tight seal Make sure the tongue is not blocking the mouthpiece 4 Blast ALL the air out as hard and fast as possible 5 Inhale as deeply and quickly as possible through the mouthpiece 6 Remove the mouthpiece NOTE Flowmate Ill numbers each test consecutively 01 02 03 regardless of test type This lets you recall the test later See Retrieving Test Results p 41 The Flowmate Ill shows an incentive ES 123456 7 8 9 Lit bar graph of expiratory volume as the patient breathes into the mouthpiece The screen incentive will continue to encourage the patient until the unit senses no more airflow z Target Press YES or NO gt Was the patient effort Once the patient has performed an acceptable FVC effort the technician must determine if the effort is acceptable Press YES or NO 32 Spirometrics Flowmate III Answering YES The Flowmate IIl computes display
7. 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 I 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 y ADAPTER SEA SS Spirometrics ne p Y CALIBRATION SYRINGE FILTER SYSTEM 25 Spirometrics Press PATIENT This will bring you to the Main MENU Press e Enter correct syringe volume i e 3 liters Press ENTER Flowmate III will prompt you to inject the volume of air from the syringe Press ENTER Inject syringe Keep the calibration puck in the boundaries of the target range Injection is acceptable Inject syringe If injection is not acceptable the following message will appear Injection is OK A calibration report will print automatically if printer is connected Press YES or NO YES Inject syringe again to check calibration at different flow rates NO Will automatically display the Main MENU T Flowmate
8. enter number of test Be sure you want to erase the test gt gt Are you sure you want to Once you erase it there is no erase test NO xx press recovery YES or NO 44 Spirometrics Flowmate III User s Manual Rev 02 Summary Reports SUMMARY KEY Press to print a Best Test gt Summary Report of all the data in memory for that patient If this is used during the Methacholine Challenge it gives only the Methacholine Challenge Summary The following are possible summary reports e Pre Testing e Best Post BD Summary e Inhalation Challenge Report Header Each test report has a header that gives the type of test the Index Unt unit Meas Pred Pred NVar Diff Diff number of the test to recall test from memory and the date and time of the test This column indicates the names of the various test indices Read across the line to receive values for an index Indicates that L liters L M liters per minute and L S liters per second Indicates the actual measured value for that index in the units indicated in the UNT column Indicates the predicted value for the index based on the patient data age sex height and race If you skipped the patient data entry routine or the given patient is out of range for the selected predicted Normals table then the Flowmate III prints a N A not applicable in the appropriate columns Compares the patient s measu
9. important information for more efficient and convenient operation A ud 5 Spirometrics Flowmate III User s Manual Rev 02 INTRODUCTION TO THE Flowmate lll Features e Compact design and battery powered portability e Unit memory 5 patients optional memory card allows for additional 118 patients e Automatic calculation and optional test interpretations e Menu driven simplicity e Bacterial Viral filter e Compliance with ATS NIOSH and OSHA standards Please read this manual carefully before setting up and operating your new Flowmate III STOP BEFORE SETTING UP PLEASE COMPLETE THE ATTACHED WARRANTY CARD ON THE NEXT PAGE TO ENSURE THAT YOUR WARRANTY RIGHTS ARE COVERED 6 Spirometrics Flowmate III User s Manual Rev 02 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 207 657 6700 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 TWO YEARS 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 two year warranty begins from the date of manufacture During the warranty perio
10. 1 FVC FEF 2 1 2 7 63 Spirometrics Flowmate III User s Manual Rev 02 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 Ill automatically multiplies the volume measured by the Flow Sensor The correction factor is based on temperature present in the testing room NOTE Average Barometric pressure must be entered in Customization Pg 20 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 larg
11. 23 4 56789 Lit UUUUUUU E Instruct the Patient to look at the incentive display Try to make the bar move to the right as far as possible 36 Spirometrics Flowmate III User s Manual Rev 02 Press YES or NO gt Once the patient has performed a Was the patient effort Sud acceptable VC effort the technician must determine if the effort is Press YES or NO acceptable Answering YES The Flowmate III computes displays and stores the test results of the patient s effort and prints report if autoprint has been chosen in customization Answering NO The Flowmate III will abandon the test and the patient must try effort again NOTE Patient effort is acceptable if the patient e Made a maximum effort e Exhaled completely e Exhaled smoothly NO coughing Flowmate Ill displays results Index Unit Meas Pred 96 Pred Var when patient effort is acceptable vC L XX XXX XX XXX 37 Spirometrics Flowmate III Post Bronchodilator Testing User s Manual Rev 02 After giving the patient a series of baseline tests you may want to administer a bronchodilator and then retest the patient to measure the effect of the bronchodilator The Flowmate III calculates the differences in various Pre BD and Post BD indices BD Bronchodilator Post Bronchodilator Testing begins after the patient data is entered The Flowmate III will automatically be in testing mode Press Patient Press o R
12. 5 216 98 67 30 117 58 167 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 39 196 62 186 85 236 107 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 88 243 110 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 67 Spirometrics Flowmate III User s Manual Rev 02 Sample Test Reports The following reports are samples of some of the test reports available with the Flowmate III spirometer Some patient data can be included or excluded on these reports See Customization pg 18 PATIENT DATA and TEST CONDITIONS Name 02 27 98 09 28 ID No 123 45 6789 55 years male caucasian 70 in 175 lbs 0 cigarettes per day Tech Ambient Conditions 760 mm Hg at 22 2 C Last Calibration 02 25 98 Selected Normals Compos
13. Card 47 Saving Patient Tests on the Memory Card 49 Printing Tests Using the Memory Card 49 Erasing Patient Tests on the Memory Card 49 Interpretations eed Rede meinen 50 Maintenance Gi Maire x m 51 Cleaning the Flowmate lll sse 51 Disassembling the Flowmate IIl Flow Sensor 52 Cleaning the Flow Sensor sssssss 53 Assembling the Flowmate III Flow Sensor 54 Troubleshooting s cce ette eode aN 55 3 Spirometrics Flowmate III User s Manual Rev 02 Table of Contents Continued ADDOPOICBS mo cate rubo et Prep EI ru 59 Normals Fable udine eeiiil 59 ATPS and BTPS nma annn adnia 63 BTPS Correction Factors eeese 64 Feet Inches Centimeters Conversion Chart 65 Pounds Kilograms Conversion Chart 66 Sample Test Reports eessseeeeeeeeeees 67 Specificato zer decades seat Veeusat lec ibe ahaa E eden 71 Accessories Reorder information 75 4 Spirometrics Flowmate III User s Manual Rev 02 Definition of Statements Spirometrics Flowmate Ill These guidelines must be followed in WARNING This manual outlines the correct method of operating e order to ensure safe operation CAUTION Means there is a possibility of procedures which if not observed could result in damage to equipment NOTE Notes provide points of
14. EAR to stop algorithm and then checks to see if the FEV1 Pred is less than ENTER for challenge test 70 It is not recommended to continue testing if results are less than 70 The Flowmate lll displays a flashing Warning message recommending that the challenge be stopped CLEAR The Flowmate III will Which test would you like revert back to the test selection 1 FVC prompt but the baseline test is gt saved 2 MVV T lt O 4 CHAL or Output 40 Spirometrics Flowmate III User s Manual Rev 02 If ENTER is pressed E Administer 5 breaths of xx xx The methacholine test will mg ml n continue Press ENTER when ready for FVC tests NOTE In the display above xx xx is the dosage of methacholine in mg ml corresponding to sequence number n as set in the p customization routine pg 18 The baseline test has a sequence number of 1 There are up to seven sequences Once ENTER is pressed Index Unt Meas Base Chng Var The normal FVC test routine is performed but the display and c 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 the test indices FVC tests should be continued for this dosage until the Var is less than 5 The only indices reported in the E NOTE The DISPLAY key may be used as normal to scroll through methacholine challenge tests are the FEV1 and FVC Press TE
15. I will automatically be 1 FVC I in testing mode 2 SU 3 vC 4 CHAL or Output Insert a new filter for each patient Press c Begin MVV RUNNING See below to instruct the patient START When effort is good press ENTER to begin test Instruct the Patient 1 Place a noseclip on his her nose 2 Position mouthpiece in mouth past teeth and form a tight seal with lips Make sure the tongue is not blocking the mouthpiece 3 Breathe through the mouthpiece as rapidly and deeply as possible like a strenuous exercise 4 Press ENTER when the patient is breathing deep and regular The patient should continue to breathe for 12 seconds Patient Incentive Screen gt LS 3 2 10 1 2 34US Instruct the Patient 1 To look at the display while trying to make the bar move to the right and to the left as quickly and as far as he she can 2 As the patient breathes the Flowmate III shows the incentive display of inspiratory and expiratory volume The bar moves right on an exhale and left on an inhale This display indicates the breathing pattern 3 Remove the mouthpiece after 12 seconds have passed Press YES or NO gt Was the patient s effort Once the patient has performed acceptable an MVV effort the technician must determine if the effort is Press YES or NO acceptable 34 Spirometrics Flowmate III User s Manual Rev 02 Answering YES gt Calculating test results The Flowmate III compu
16. III c NOTE If calibration check message does not confirm the calibration setting Calibration O K clean the flow sensor 26 User s Manual Rev 02 m 3 Calibration What is the test syringe volume Now ENTER volume 1 9 liters MEDIUM rate injection about 1 5 sec Press ENTER when ready then inject Too Slow OKAY too fast Injection OK Now inject syringe to check calibration Injection too slow Please retry OR Injection too fast Please retry Injected volume 3 00 L Reading OK Review the calibration report Do you want to check calibration again Spirometrics ENTERING PATIENT DATA Flowmate III User s Manual Rev 02 If needed turn the Flowmate Ill on by pressing the POWER switch on the left side of the spirometer NOTE When the Flowmate III is plugged into the AC adapter The POWER switch indicator will be green To check for a full charge remove the AC adapter and turn the spirometer on If the POWER light remains green the batteries are fully charged Check the date and time shown on the display 01 15 94 09 30 If they are incorrect See setting the Time and Date on pg 23 or press PATIENT Press o Enter Patient ID number Up to 16 digits periods and slashes are acceptable The ID number can be the patient s social security number or any other appropriate identification number Eac
17. OMMUNICATION PORTS Serial RS232 I O port is a custom modular jack handshake CTS RTS or DTR DSR Port Use Sensor connection Parallel Standard DB 25 Female IBM PC pin out Connects to printers using standard centronics Parallel type interface Data Format Proprietary to Spirometrics Number of Patients 5 Patients optional RAM CARD 118 Patients FVC 6 trials each patient 3 Pre 3 Post MVV 2 trials each patient 1 Pre 1 Post VC 6 trials each patient 3 Pre 3 Post Internal RAM Size 128k Bytes Battery backup Internal RAM Memory Card Accepts a 68 pin battery backup 512 Kilobytes RAM CARD compatible with PCMCIA 2 0 connection TEST NUMBERING Numbers each patient s trials consecutively regardless of type for recall CALENDAR CLOCK Stamps time and date on test reports Time Selectable as 12 or 24 hr scale Date American MM DD YY European DD MM YY INSTRUMENT CALIBRATION Syringe Selectable 1 9 liters ATPS default is 3 liters Routine Display leads user through routine Calibration reports printout automatically 75 Spirometrics Flowmate III User s Manual Rev 02 ACCESSORIES REORDER INFORMATION The following is a list of accessories and model numbers for the Flowmate III Spirometry System Description Model Flowmate III Portable Spirometer 2500LTE Patient Data Memory Card 2122 Nose Clips Pkg of 100 2104 Filter Disposable Single Patient Use Box of 100 2195 3 Lit
18. Rev 02 Feet Inches Centimeters Conversion Chart FEET INCHES CENTIMETERS FEET INCHES CENTIMETRES 3 0 36 92 5 4 64 163 3 1 37 94 5 5 65 165 3 2 38 97 5 6 66 168 3 3 39 99 5 7 67 171 3 4 40 102 5 8 68 173 3 5 41 105 5 9 69 176 3 6 42 107 510 70 178 3 7 43 110 511 71 181 3 8 44 112 6 0 72 183 3 9 45 115 6 1 73 186 3 10 46 117 6 2 74 188 3 11 47 120 6 3 75 191 4 0 48 122 6 4 76 193 4 1 49 125 6 5 77 196 4 2 50 127 6 6 78 198 4 3 51 130 6 7 79 201 4 4 52 132 6 8 80 204 4 5 53 135 6 9 81 206 4 6 54 138 610 82 209 4 7 55 140 611 83 211 4 8 56 143 7 0 84 214 4 9 57 145 71 85 216 410 58 148 72 86 219 411 59 150 7 3 87 221 5 0 60 153 7 4 88 224 5 1 61 155 7 5 89 226 5 2 62 158 7 6 90 229 5 3 63 160 2r 3 ae 66 Spirometrics Flowmate III User s Manual Rev 02 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 69 202 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 78 210 95 61 28 111 50 161 78 211 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 7
19. ST to continue testing once the test results are displayed Administer five breaths Administer 5 breaths There are up to five sequences of methacholine 2 6 and then one of XX XX x sequence 7 of bronchodilator to Press ENTER when ready for FVC test open the airway back to normal Perform the FVC maneuver Continue to perform the FVC maneuver on the patient with the same dosage until the Var is less than 5 Administer Bronchodilator gt Administer Bronchodilator After a sequence of six tests has been performed or the patient s FEV 1 has dropped 20 administer a bronchodilator to open Press ENTER to continue the airway back to normal Press ENTER and perform another FVC test FEV 1 has Dropped gt If there is a 20 drop in the FEV1 FEV 1 has dropped xx A nuns challenge complete from the base line this will appear on the display Press ENTER to continue Press YES or NO gt Do you want to end challenge This question will appear if the test key is pressed after the YES NO or exhale for another bronchodilator sequence i e 1 7 YES end of challenge 41 Spirometrics Patient Reports Flowmate III User s Manual Rev 02 NOTE A patient report can be automatically printed after each spirometry effort is performed See Customization pg 18 Retrieving Test Results The Flowmate III stores each test in memory as the test is comple
20. Spirometrics Flowmate III User s Manual Rev 02 T a XS Spirometrics FLOWMATE Ill USER S MANUAL Copyright 2000 2004 Spirometrics P O Box 680 22 Shaker Road Gray ME 04039 USA http www spirometrics com REV 02 January 2004 1 Spirometrics Flowmate III User s Manual Rev 02 Congratulations You have a lot to look forward to with your new Flowmate lll You have purchased a Spirometrics Medical Equipment Co Flowmate Ill spirometer The brilliant simplicity and unmatched performance of the Flowmate Ill will allow both you and your patients to benefit from spirometry For generations Maine s reputation for affordable quality craftsmanship has endured the test of time It is this heritage which has inspired the people at Spirometrics We are proud to be a Maine owned and operated company and are dedicated to sharing Maine s tradition of excellence with you Spirometrics has created a complete line of premium diagnostic lung function testing equipment For over 16 years we have been helping the world s most successful health facilities achieve a common goal providing quality health care 2 Spirometrics Flowmate III User s Manual Rev 02 How To Use This Manual This guide is arranged by category for your convenience If you have any additional questions about this product or would like information on the full Spirometrics product line please call Inside Sales at 800 767 0004 Definition of State
21. atient Data RRR Press PATIENT this will bring you to the Main MENU Press o to review and or edit patient entries The entry routine will begin again showing the data that was entered Scroll through entries by pressing YES for correct entries and changing incorrect data Press ENTER when data is correct 29 Spirometrics Flowmate III User s Manual Rev 02 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 e Remove or loosen tight clothing such as tight collars or necktie e Remove dentures optional e Stand in front of the Spirometer Patient should not take the test sitting down unless he she can not stand e Elevate chin and extend neck slightly e Use a nose clip if available Have the patient pinch his her nose if unavailable see the Flowmate III Accessories pg 75 Demonstrate the procedure yourself Take the deepest breath possible Place mouth and teeth tightly around a 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 s
22. atory Time Extrapolated Vol CHOICE OF NORMALS INTERPRETATIONS GRAPHIC OUTPUT PRINTER Reports Flowmate III User s Manual Rev 02 Pertinent only for the FVC trials Largest regardless of trace Largest regardless of trace Best FEV1 Best FVC Taken from trace with greatest sum of FVC and FEV1 Requires clinician to evaluate acceptable or unacceptable patient effort Discards unacceptable trials upon answering NO to Was the Patient effort acceptable Compares indices of current test with best in memory displays and prints variability as deviation Variability greater than 596 for FVC and FEV1 is regarded as poor reproducibility prints message If forced expiratory time is Less than 6 seconds a TEST was short but OK Blow Longer message will be displayed A less than 1 second TEST is not accepted because it is too short If extrapolated volume is greater than 5 of FVC a SLOW START message will be displayed Composite Knudson incl pediatrics Crapo ITS ECCS HSU MORRIS LAM Knudson76 is an available option Call Inside Sales to inquire Obstruction Restriction or Abnormality ATS specification for Time Scale Volume Scale amp Flow rate Scale External Printer with selectable drivers optional Standard 81 2 X 11 paper printed reports Automatic printout after each trial selectable 74 Spirometrics Flowmate III User s Manual Rev 02 INPUT OUTPUT C
23. ave indicated that the patient s effort was acceptable the spirometer automatically displays the results of the test You can use the DISPLAY and PRINT key to control the data as follows DISPLAY KEY Press repeatedly to scroll gt through the various test indices After the last index is displayed the sequence will loop around to the first index The indices appear in the same order they are printed on the test report Printing Patient Reports PRINT KEY printer must be connected In Main MENU Press to Batch print the tests of all or some of the patients In Testing Mode Press to print a report of the current test If you select auto print in the customization routine the report automatically prints out at the completion of the test just as if you pressed print 43 Spirometrics Flowmate III User s Manual Rev 02 Erasing a Test ERASE KEY In Main MENU Press to erase the tests of all or some of the patients In Testing Mode Press to erase the test data from a gt single patient As a safety check the Flowmate III will always ask you if you are sure you would like to erase data Use the erase key if you have accepted a patient test but after review decide to delete the data Press ERASE Which test would you like 1 FVvC 2 mvv 3 vc at the test selection question 4 CHAL or Output Enter the number of the test that D Which test would you like to you want to erase erase
24. cleaning the Flow Sensor The outer surface of the Flowmate Ill needs no special cleaning WARNING Spirometrics recommends wearing rubber gloves while cleaning to protect against cross contamination Handle Assembly i Coiled Cable Flowmate lll Base Unit Modular Jack Serial 52 Spirometrics Flowmate III User s Manual Rev 02 Disassembling the Flowmate III Flow Sensor You must disassemble the flow sensor to clean it Refer to the figure below to learn the names of the different parts of the flow sensor CAUTION Do not use alcohol on Flow Sensor or any other Flowmate III parts WARNING 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 e 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 WARNING Always unplug the Flowmate lll before cleaning to avoid electric shock Disassembling the Flow Sensor 1 Unscrew the EASY CLEAN Cartridge with a counter clockwise motion 2 Continue to turn the EASY CLEAN Cartridge until the thread
25. d 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 Operators 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 7 Spirometrics Flowmate III User s Manual Rev 02 Warranty Card This page set aside for the WARRANTY CARD insert 8 Spirometrics Flowmate III User s Manual Rev 02 This page is intentionally left blank for warranty card attached to the previous page WARRANTY CARD insert 9 Spirometrics Flowmate Ill User s Manual Rev 02 MAIN KEYBOARD o Power C Ww x SS Spirometrics flowmate III 10 Spirometrics Flowmate III User s Manual Rev 02 PATIENT KEY This key allows you to clear the current screen at any point during calibration customization or a test in order to start over at the Main Menu MAIN MENU jy MENU 1 Patient ES 2 Customization 3 Calibration 4 Time or Output By press
26. e Enter the patient s ID number Press ENTER Press YES for Post BD testing This confirms that the tests which follow will be Post BD Press NO If you wanted to continue Pre BD testing on this patient Press ENTER repeatedly to scroll through patient data until you have reached the test options Make sure patient data is correct If not correct data Press desired test Press 0 0 0 i e 3 was chosen here c m 3 Calibration Ld Ero wd Eo Test No 3 VC Post Bronchodilator Exhale slowly Continue testing as usual Post BD testing and Pre BD testing are performed in exactly the same manner The only difference is that the test reports label the Pre BD and the Post BD results on the Best Test Summary Report NOTE In order to do Post BD testing on a patient the Flowmate III must have the patient s Pre BD tests stored in memory Only five patients can be stored in memory at the same time Therefore you must be careful not to accidentally erase the Pre BD data by testing a sixth patient before the first has had Post BD tests See Retrieving Test Results pg 41 EXCEPTION If a memory card is used you can store 118 patients 38 Spirometrics Flowmate III User s Manual Rev 02 Methacholine Challenge The methacholine challenge test is a means of determining airways reactivation It is useful for diagnosing variant asthma and to identify predictive factors in asthma pa
27. e an additional 118 patients See Accessories pg 75 46 Spirometrics Flowmate III User s Manual Rev 02 Memory Card The Flowmate III has a number of optional accessories to aid in spirometry testing The patient data memory card can be purchased separately for your Flowmate Ill By adding the optional memory card approximately 118 patients can be stored for future printing or processing The memory card is an extension of your spirometers memory When saving retrieving editing printing or erasing patient tests on the memory card follow the instructions in the respective sections in this manual The only difference when working with the memory card is that it must be installed in order to save patient tests and to work with this data Er CAUTION Do NOT use memory card as permanent storage CAUTION Do not remove or install memory card while the spirometer is turned on NOTE Please refer to the memory card reference This will accompany the memory card or be printed directly on it Power CO E W Q 2 cer NT SS Spirometrics C Or cl flowmate III 47 Spirometrics Installing the Memory Card 1 Make sure the spirometer is turned off Flowmate III User s Manual Rev 02 2 Slide the memory card into the slot making sure that the card is properly oriented as shown 3 Gently push until the memory card seats into place and can go no further Checkin
28. e different origin on the report See the Normals Table pg 59 E NOTE The predicted values for Black patients are 8596 of those for Press ENTER 72 30 89 inches in inches or centimeters Conversion chart feet in cm 90 250 centimeters See pg 65 Enter the patient s height D Er is the patient s height What is the patient s weight Press ENTER 165 Ibs optional enter in Lbs If the patient s weight is not desired on results do not enter weight Press ENTER Enter the patient s weight D See Customization pg 18 to configure Flowmate III to accept kilograms or to configure the Flowmate III not to ask this question by recording weight T Enter number of cigarettes per gt day Press ENTER Press 9 06 0 0 gt Which TEST would you like _ Ac Ew Exe NOTE This question is optional since weight is not a parameter in test result evaluation See Customization pg 18 How many cigarettes are smoked per day 0 60 28 Spirometrics Flowmate III User s Manual Rev 02 NOTE If the wrong test selection is entered press TEST key then re select desired test For example you may have pressed 1 for an FVC test and you wish to select an MVV test NOTE Following test selection as seen above the Flowmate III will automatically enter the testing mode NOTE If you breathe without selecting a test type then FVC test is assumed and the testing mode is entered Editing P
29. e syringe nozzle and the filter system The cap on the assembled filter system is tight 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 pg 54 This section contains possible solutions to patient storage problems Problem Flowmate III will not store more than 5 patients in the unit memory Flowmate III will not store more than 5 patients with a memory card A Memory Card will provide additional storage this is separate from the unit memory When the memory card is properly installed the display will read Pat Database usage SYS MEM 0 of 5 RAM Card 1 of 118 Press any key Solution In order to store more than 5 patients you will require a memory card Call your local distributor or Spirometrics Inside Sales Department You will need the following minimum 1 2 Megabyte SRAM card with a battery 68 pin PCMCIA 2 0 compatible See Accessories pg 75 Check that your Memory Card is properly installed into the Memory Card slot The card will only be accepted into the slot when properly inserted Check to see if your card is properly installed Press the DISPLAY key at the Main MENU to see if the Flowmate III recognizes the Memory Card The second line on the display will state the status of the Memory Card If it does not recognize the Memory Card no status w
30. ensor e Pull away from the mouthpiece 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 breathe it all back in Good job NOTE Testing may be affected if the patient e Smoked acigarette or drank caffeinated coffee or tea within the last hour e Has used an aerosol bronchodilator within the last six hours e Has eaten a heavy meal within the past hour e Is acutely ill or has suffered from upper or lower respiratory problems within the past three weeks 30 Spirometrics Flowmate III User s Manual Rev 02 TESTING Press Patient gt MENU 1 Patient 2 Customization 3 Calibration 4 Time or Output Press O gt What is the patient s ID number Enter patient ID Number Test Press ENTER or press Test Press enter repeatedly to scroll through patient data NOTE If a NEW patient See Entering Patient Data pg 26 If retrieving a previous patient s test scroll through patient data and change information as necessary Press 9 0 686 0 gt Which test would you like uc Ew Exc See the following test descriptions and operations 1 FVC Forced Vital Capacity Page 31 2 MVV Maximum Voluntary Page 33 Ventilation 3 VC Vital Capacity Page 35 4 POST Bronchodilator Page 37 Testing 5 CHAL Methacholine Page 38 Challenge 31 Spirometrics Flowmate III User s
31. er Calibration Syringe 2125 Adapter Seal Calibration Syringe 30 0015 Spirometer EASY CLEAN Cartridge Flowmate III 18225 Printer Cable 3355 Re Chargeable NiCad Batteries Requires 6 15120 Spirometer AC Adapter 18002 Flowmate IIl Operator s Manual M2500III Coiled Cord 15027 Call your local distributor for more information on Flowmate III Accessories Printers available through Spirometrics Please contact Inside Sales for complete computer printer options 207 657 6700 or 800 767 0004 Fax 207 657 4123 WWW Spirometrics com email spiro spirometrics com 76
32. er dose in mg ml breath 00 250 22 Spirometrics Flowmate III User s Manual Rev 02 e What is methacholine concentration 4 enter dose in mg ml breath 02 500 e What is methacholine concentration 5 enter dose in mg ml breath 10 000 e What is methacholine concentration 6 enter dose in mg ml breath 25 000 e What is the lower limit of normal enter cum dose in mg ml 8 Press YES or NO Would you like a printout of the settings you ve just made YES Printout of gt YES or NO customization settings you have just made if printer is connected NOTE Settings will be retained in memory when the spirometer is turned off Spirometrics recommends that you printout a copy of your customization settings and retain for future reference 23 Spirometrics Flowmate III SETTING THE TIME AND DATE User s Manual Rev 02 This routine sets the internal time date which are printed on reports Press PATIENT this will bring you to the Main Menu Press o Enter the Correct Time by entering four digits Press ENTER Press YES or NO The Flowmate III does not ask the question listed above if a 24 hour time is used Enter the correct time scale Press ENTER 122 American or 12 hour format 24 European or 24 hour format Press 1 or 2 Press ENTER 1 month day year American e day month year European Enter Correct Date Press ENTER Do not use the when entering
33. er 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 IIl automatically multiplies the volume measured by the Flow Sensor and the BTPS correction factor The inspiratory BTPS correction factor for the Flowmate lll is variable based on the average air temperature and average standard barometric pressure you entered in the Customization Routine See pg 20 64 Spirometrics Flowmate III User s Manual Rev 02 BTPS Correction Factors The Flowmate III 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 AMBIENT BTPS TEMPERATURE EXPIRATORY degrees FACTOR Cc F 10 50 0 1 153 11 51 8 1 148 12 53 6 1 143 13 55 4 1 138 14 57 2 1 133 15 59 0 1 128 16 60 8 1 123 17 62 6 1 118 18 64 4 1 114 19 66 2 1 111 20 68 0 1 102 21 69 8 1 096 22 71 6 1 091 23 73 4 1 085 24 75 2 1 080 25 77 0 1 075 26 78 8 1 068 27 80 6 1 063 28 82 4 1 057 29 84 2 1 051 30 86 0 1 045 31 87 8 1 039 32 89 6 1 032 33 91 4 1 026 34 93 2 1 020 35 95 0 1 014 36 96 8 1 007 37 98 6 1 000 38 100 4 0 994 39 102 2 0 987 40 104 0 0 980 65 Spirometrics Flowmate III User s Manual
34. g the Position of the Memory Card Press PATIENT Key Press DISPLAY Key WITH Memory card installed properly Press DISPLAY Key WITHOUT Memory card installed properly MENU c Patient l 2 Customization 3 Calibration 4 Time Output Pat Database usage SYS MEM 0 of 5 D RAM Card 1 of 118 Press any key Pat Database usage SYS MEM 0 of 5 gt Press any key 48 Spirometrics Flowmate III User s Manual Rev 02 NOTE For efficient management of memory we recommend that patient tests be erased from the memory card after printout NOTE There is a write protect switch located on the memory card The Flowmate Ill cannot communicate properly with the memory card when this switch is set to ON The switch must be turned to OFF in order to store patient tests Keep the write protect switch set to OFF ZN Insert this side into the Flowmate MI p bow The switch is OFF SESS Memory Card iP Write Protect Switch The write protect E switch is OFF writable PIS to the memory card L N initially The card can f E dsl not be written to when i the switch is in the ON EN S position as shown all The switch is ON 49 Spirometrics Flowmate III User s Manual Rev 02 Saving Patient Tests on the Memory Card The Memory Card is an extension of your spirometers memory Your spirometer unit memory has storage space to hold five patient
35. h patient must have a different ID number Do not start with a period NOTE You can use the Test key to jump directly to the Test Selection question without having to first enter patient data If you do this the Flowmate III will display and print the test results However the results will not include predicted percent of predicted or interpretations since there is no patient data on which gt Flowmate III version 2 6a Spirometrics Copyright 1999 gt MENU 1 Patient 2 Customization 3 Calibration 4 Time or Output E What is patient s ID number or press TEST 02 etc Press YES or NO Enter Patient s Age up to 3 digits Press ENTER Select patient s sex Press ENTER to base the predicted Also the patient s test results will not be Stored when you enter a new patient The PATIENT DATA REPORT will be marked with the fictitious name of John Doe 01 p Is this Post BD If already Pre BD test and no Post BD test yet gt What is the patient s age Enter the age in years 27yrs What is the patient s sex 1 male 2 female 27 Spirometrics Flowmate III User s Manual Rev 02 Select the patient s race D What is the patient s race Press 0 0 Caucasian Press ENTER 1 Caucasian 2 Black 3 Non Caucasian Caucasian or Non Caucasian patients as per most popular Normals studies Caucasian and non Caucasian are calculated equally and are used to denot
36. ill be displayed on the second line 58 Spirometrics Problem Can not recall a stored patient D Printer system memory Flowmate III NOTE The patient storage memory will always discard the earliest patient once the Flowmate III reaches the maximum patient storage Always print or erase patients in storage Remember that the Memory Card is only temporary storage for the patients until they are printed The Memory Card is only an extension of the User s Manual Rev 02 Storage of patient data is automatic Patients are stored by patient ID when patient data is first entered To determine what is stored in the Flowmate III s memory Connect a printer to the spirometers port Turn the printer on 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 printed Search for the ID of the patient desired by pressing ENTER repeatedly The following is a possible solution for a printer problem Your printer is not printing when it is connected to your Flowmate III Solution The Flowmate III has a specific number of printer drivers to choose from Printer drivers are instructions to control the format and behavior of your printer when connected to the Flowmate Ill If you do not find the selection of your printer in the Customization Routine refer to the printer s user manual It is po
37. ing the following keys at the MAIN MENU you may access the following options INPUT RESULT You can enter patient information and testing mode The customization parameters can be modified You may set and check the calibration By Pressing of the spirometer By Pressing o You can set the correct date and time By Pressing By Pressing TEST KEY Displays the test option selections Once you select the test you would like you are in TEST MODE Which test would you like 1 FVC gt 2 MVV 3 VC 4 CHAL or Output 11 Spirometrics Flowmate III User s Manual Rev 02 DISPLAY KEY At Main MENU the display indicates how many patients are stored either in unit memory or RAM card memory if RAM card is installed Database SYS MEM usage 1of5 zi Press any key In TEST MODE this display cycles through test indices on the display Index Unt Meas Pred Pred Var gt FVC L 3 67 2 86 128 n a SCROLL THROUGH INDICES Index Unt Meas Pred Pred Var FVC LXXX XXX XXX n a Press DISPLAY d Index Unt Meas Pred Pred Var FEV1 L XXX XXX XXX nla iL Repeatedly Press DISPLAY To Scroll Through the Indices 12 Spirometrics Flowmate III User s Manual Rev 02 PRINT KEY Prints reports after a test is given when printer is present At the Main MENU when you press PRINT you can choose to print specific patients or all patients patients a RESULT Print
38. ite Doctor Test No 01 FVC 02 27 98 09 28 Index Unt Meas Pred Pred Var FVC L 4 21 4 59 92 0 0 FEV 1 L 2 80 3 70 76 0 0 FEV1 FVC Lj 66 5 80 9 82 0 0 FEF25 75 L S 2 1 3 8 55 0 0 PEF L S 3 9 8 7 45 0 0 Forced Expiratory Time 6 3 sec 68 Spirometrics ID 123 45 6789 16 ELS 12 Base NUS ea Predicted Base FE oo Flowmate III 69 User s Manual Rev 02 02 27 98 T voor f irc u0c 0 Page 2 tJe mzt 2c pcaco Spirometrics Flowmate III User s Manual Rev 02 Page 1 PATIENT DATA and TEST CONDITIONS Post Bronchodilator Name 02 20 98 03 21 ID No 000 00 0000 29 years female caucasian 67 in 125 lbs 20 cigarettes per day Tech Ambient Conditions 760 mm Hg at 22 2 C Last Calibration 02 11 98 Selected Normals Composite Doctor Best Test Summary Tests 01 07 02 20 98 Index No Meas Pred Pred Var No POST Pred SVar FVC L 02 4 37 3 87 113 1 6 07 4 38 113 0 9 FEV 1 L 03 3 45 3 28 105 0 3 07 3 64 111 3 0 FEV1 FVC 78 9 84 7 93 1 4 83 1 98 2 2 FEF25 75 L S 02 3 0 3 8 79 16 7 07 3 9 103 Tek PEF L S 02 7 5 7 4 101 10 7 07 7 8 105 3 8 Spirometric results appear normal Risk of COPD 1g Risk if smoking stopped i Estimated lung age 23 years Curve selection from Test s 02 07 with greatest FVC FEV1 70 Spirometrics ID 000 00 0000 Base FEUI Post BD FEH 16 cL Flowmate III 71
39. ments sssessssssse 4 Introduction to the Flowmate Ill 5 Galuf amp S iier d orte E etui du UE Mec pD a UU 5 Maine yO Oars cue seed Ld dL dede i RO 9 Installation and Customization ssseeesssss 14 Standard Configuration Chart sueueuuuuuse 16 Customization Routine eeesseeeeseeeees 18 Setting the Time and Date ssseeesesssssss 23 C 3l bFallOE sd eicere drerit core reor are oper onec ebur doces 24 Entering Patient Dala 9 e Roe ote eene 26 Patient PreparatlOnis iiie o cde onte ete te cte rk xxu de rk Ux GA 29 LEATS ROAD ETC ES 30 FVC Testing Forced Vital Capacity Test 31 MVV Testing Maximum Voluntary Ventilation Mo C 33 VC Testing Vital Capacity Test 35 Post Bronchodilator Testing 37 Methacholine Challenge 38 Patient Reports ct tet exea 41 Retrieving Test Results 41 Printing Patient Reports 42 Erasing a TeSt ensia neee i et icula 43 Summary Reports eie Re een 44 Test Storage Capacities s 45 Memory Cards autero deter rtt eerte 46 Installing the Memory Card 47 Checking the Position of the Memory
40. needs Battery Information The Flowmate IIl is equipped with six standard AA NiCad rechargeable batteries for portable operation and a dual colored power light A GREEN POWER light in battery operation will indicate that the spirometer is fully charged A beeping sound and a RED POWER light indicates low battery power If the battery power is low the spirometer can be used while being powered by the AC adapter Charging Batteries Charging the Flowmate III is a simple procedure Spirometrics recommends that batteries be charged for at least 15 hours before portable operation The battery power will deplete after approximately 4 1 2 hours of continual use To charge the spirometer connect the AC adapter to the spirometer and plug it into a standard AC outlet The power switch can be in the on or off position while the unit is charging The battery will charge while the spirometer is in use with the AC adapter or when the power switch is off NOTE As with all NiCad batteries it is important to periodically allow the battery to be completely depleted before recharging This practice will ensure maximum battery life The use of batteries other than NiCads will result in leakage and or explosion resulting in damage to the unit PE 9 COMM Port Porat Pot LEFT SIDE VIEW RIGHT SIDE VIEW Flowmate Ill Model 2500LTE 15 Spirometrics Flowmate III User s Manual Rev 02 Printer Installation The Flo
41. osis Spirometry test data cannot stand by itself When the Flowmate IIl interprets a patient s spirometric test results as abnormal or suggests a disorder the patient should be referred to a pulmonary specialist for further testing It is important to coach patients to their maximal efforts physician The interpretations printed by the Flowmate III are Warning Spirometry tests must be evaluated by a qualified suggestive only and not conclusive Press Summary to print a Best Test Summary Report An interpretation of the test results will be printed at the end of the report You can choose NOT to print the interpretations in the Customizing Routine See pg 18 Interpretations are based entirely on two indices FVC and FEV1 The Flowmate III uses the best of each of these indices See Specifications Pg 73 Interpretations Table The following table gives the interpretation scheme and corresponding diagnostic messages PRED FVC PRED FEV1 FVC INTERPRETIVE FEV1 MESSAGE lt 75 lt 75 LOW FEV1 Suggests Obstructive Disorder lt 60 275 LOW FEV1 Suggests Ventilatory Disorder lt 75 275 LOW FVC Suggests Restrictive Disorder lt 60 lt 75 LOW FVC Suggests Ventilatory Disorder IN ALL OTHER CASES SPIROMETRICS RESULTS APPEAR NORMAL 51 Spirometrics Flowmate III User s Manual Rev 02 MAINTENANCE Cleaning the Flowmate lll The most important maintenance routine for the Flowmate Ill is
42. panded 3 Normals Composite Knudson Crapo Morris Hsu ECCS Lam or Industrial Version with Knudson Crapo Morris Hsu ECCS Knudson76 4 Automatic Test Printout No 5 Patient Weight es 6 Weight in Lbs or Kgs Lbs p peg 7 Location I D Z o Z o 8 Re enter Location D each time Flowmate III is turned on Yes 16 digits 9 Avg Ambient Air Temperature 2F 50 104F or 10 40C 10 Avg Barometric Pressure 760mm Hg 20 35in 500 900mm 11 Printer Type IBM Pro Epson LQ Epson FX IBM Pro IBM Pro X24 HP Laser DeskJet 17 Spirometrics Flowmate III User s Manual Rev 02 STANDARD CONFIGURATION CHART Cont Function Standard Configuration 13 Print Flow Volume Loops on Yes No Summary 14 Print Best Test Curves Both VT Curve FV Loop None 15 Print COPD Risk Yes 16 Print Lung Age Yes No 17 Inhalation Defaults Yes Default is NO Enter how many 5 breaths of breaths per inhalation concentration What is methacholine concentration What is the lower limit of normal Default 08 Enter cum dose in mg ml 18 Print Customization Settings No default Select Yes or No to print setting customization settings Once you have customized your spirometer the settings will be retained in memory protected by battery back up even after the unit is turned off Consider printing out your customization settings for future reference 18 Spiromet
43. red result to the predicted normal result for that index expressed as a percentage Predicted Measured Predicted X 100 Indicates the variability or reproducibility of the test index as compared to the best previous measured value for that index This value must be less than 5 for the FVC and FEV1 indices in order for the FVC test to be regarded as reproducible Continue testing until the Var is less that 5 for these indices The Var is not critical for other indices but it should be as low as possible Indicates the variability of test indices between Best Test Post effort to Best Test Pre effort The comparison is in indices units of measure Indicates the variability of test indices between Best Test Post effort to Best Test Pre effort The comparison is expressed in Difference since there are no indices in memory to compare it to E NOTE The variability VAR does not appear on the first test taken 45 Spirometrics Flowmate III User s Manual Rev 02 Test Storage Capacities The Flowmate III patient storage memory will automatically store up to five patients The patient storage memory will always discard the earliest patient once the Flowmate Ill reaches the maximum patient storage Always print or erase patients in storage The optional memory card is only an extension of the system memory It is only temporary storage for the patient tests until they are printed The optional memory card will stor
44. rics Flowmate III User s Manual Rev 02 CUSTOMIZATION ROUTINE Each question prompts you to choose a setting and shows you the current setting for that item If you simply press the ENTER key without entering a number first the current setting remains The Flowmate III then displays the next choice If you want to change only one item you can quickly scan through the routine Press the ENTER key repeatedly until you get to the item you want to change Press the PATIENT key after you enter the change to exit from the customizing routine to the Main MENU All other settings will remain unchanged NOTE All customization changes are saved and protected in NV RAM which has a Super Cap battery equivalent back up When p you turn your spirometer on it will use your customization settings from your previous use unless you choose to change them To Start Turn the Flowmate Ill on by pressing the POWER switch located on the left side of the unit Power on indicator will be green signaling a full charge and power on Check the date and time shown Flowmate Ill version 2 68 on the display If they are 04 06 99 09 30 Spirometrics incorrect See Setting the Time gt Copyright 1999 and Date pg 23 Press ANY KEY or wait 5 MENU seconds this will bring you to the 1 Patient MAIN MENU gt 2 Customization 3 Calibration 4 Time or Output Press 2 for Customization Routine Customization Routine Select desired fo
45. rmat Now 1 Press 1 or e c 1 short form 2 expanded form Press ENTER 1 short form e expanded form See pg 59 for indices reported in short and expanded forms respectively 19 Spirometrics Flowmate III User s Manual Rev 02 Press 1 or e C Diagnostic Interpretations Now 1 12 YES 2 NO Press ENTER Simple interpretation message of test data This prints at the end of the Best Test Summary Report Interpretation Scheme described on pg 50 Select Desired Normals Which Normals Now 4 Press0 0 0 0 0 Q e 1 Composite 2 Knudson Press ENTER See pg 59 62 for description 3 Crapo of Normals 4 Morris 5 Hsu 6 ECCS 7 Lam or optional Knudson 76 Press O or C Automatic Test Printout Now 2 Press ENTER 12 YES 2 NO YES prints test report Immediately after patient effort NO Must press PRINT to print reports Press Qo 2 gt Do you want to record patient Press ENTER weight Now 1 1 YES 2 NO NOTE Weight is not used in any of the Normals tables It is unnecessary in calculating test results Press O or gt Will weight be entered in LBS or Press ENTER KGS 1 LBS 2 KGS Now 1 Question will not be asked if you choose NOT to record weight Press O or 2 gt Do you use a Location ID Press ENTER number 1 YES 2 NO Now 2 You may want a Location ID if you test in a variety of locations and move the spirometer from site to site 20 Spirometrics Flowma
46. ro spirometrics com or call us at 207 657 6700 or 800 767 0004 Power Related This section contains solutions for solving possible power related problems such as AC adapter Battery power Memory back up Problem Solution Spirometer unit will not Check battery installation power on when power Connect provided AC adapter to base unit switch is on Plug into standard 120 volt 60hz outlet Turn the POWER switch on A green POWER light should be seen and the display screen will show text Spirometer unit will not Check outlet power even with AC Be sure your outlet has power adapter Test your outlet by plugging in a working lamp If the lamp lights your outlet has power If lamp does not light have your circuit breaker checked If your outlet works and your spirometer will not power up it is possible that your AC adapter is damaged Contact your local distributor or Spirometrics Batteries will not hold a To completely charge your batteries plug your AC charge adapter into a standard wall outlet and allow the spirometer to charge for 15 hours before portable use Indicator light is RED and Batteries used to power the spirometer are low the spirometer beeps Connect the base unit to provided AC adapter and continue use while adapter is connected If the spirometer continues to display the RED indicator light or beeps or fails to display then check the DC output voltage of the wall transformer should be be
47. s Min max cm Min max User s Manual Rev 02 HEIGHT HEIGHT in Min max 146 178 MALE 15 91 157 194 61 77 ECCS with Knudson 1983 Children ages 18 24 are evaluated as age 25 INDICES FVC FEV1 female FEV1 FVC FEF 25 75 PEF FEF 50 FIVC MVV vol vC CHILDREN CHILDREN male AGE Yrs Min max 25 90 6 10 11 17 25 90 6 11 12 17 61 HEIGHT cm Min max 145 0 180 0 106 7 147 3 132 1 182 9 155 0 195 0 111 8 154 9 139 7 193 0 HEIGHT in Min max Spirometrics Flowmate III User s Manual Rev 02 Morris INDICES SEX HEIGHT HEIGHT yrs Min max cm Min max in Min max FVC FEMALE 145 0 180 0 56 72 FEV1 FEV1 FVC 155 0 195 0 58 80 FEF 1 1 2 FEF 25 75 FEF 75 85 HSU 1979 Using Journal of Pediatrics 1979 INDICES AGE HEIGHT HEIGHT yrs Min max cm Min max in Min max FVC FEMALE 7 20 111 180 FEV1 MALE 7 20 111 190 43 75 PEF LAM 1982 AGE HEIGHT HEIGHT yrs Min max cm Min max in Min max FEMALE 5 74 Height range Height range not specified not specified in study in study MALE 5 74 Height range Height range not specified not specified in study in study 62 Spirometrics Flowmate III User s Manual Rev 02 COMPOSITE This is the Default normals selection These normals provide predicted values for most indices INDICES FEF 25 75 FEF 75 85 FEV
48. s and stores the test results of the patient s effort and prints report if autoprint is customized c Answering NO The Flowmate III will abandon the test and the patient must try effort again NOTE Patient effort is acceptable if the patient User s Manual Rev 02 Calculating test results e Started with the deepest possible inspiration Exhaled maximally with a good fast start Inhaled maximally after the expiration Inhaled and exhaled smoothly No coughing even if you see one of these messages the unit will still accept and NOTE The spirometer may display a message indicating that the test trial was too short or that the start was too slow Note that store the test in memory If test is under 1 second it is not accepted and another effort must be made Flowmate Ill displays c results FVC L when a patient test is accepted Press TEST or just breathe to start another test NOTE The patient should perform three valid tests e Three tests should be reproducible within 5 Index Unit Meas Pred 96 Pred 9e Var X XX X XX XXX X XX e The patient must put forth maximal effort both inhaling and exhaling 33 Spirometrics Flowmate III User s Manual Rev 02 MVV Testing Maximum Voluntary Ventilation Test Entering Testing Mode MVV testing begins after the D Which test would you like test would you like patient data is entered The Flowmate II
49. s all patients in storage By Pressing o including memory card if installed o Prints desired patient tests You must By Pressing first enter the patient ID Numbers you would like printed after pressing e for some patients 7 This will bring you back to the Main By Pressing MENU In Testing Mode you can print reports after a test is given when a printer is present SUMMARY KEY In the Main MENU you can print out a directory of the patients in the system memory and optional memory card The patient directory lists patients by ID number age and gender Prints the Best Test Summary Report In testing mode you can print the Best Test Summary Reports 13 Spirometrics Flowmate Ill User s Manual Rev 02 ERASE KEY At Main MENU erases test data but only if confirmed Erase all or part of patient database 1 All c 2 RAM Card only 3 None In Test Mode you can erase selected tests Sure you want to erase c Test No 01 Press YES or NO When Entering Patient Information c Indicates YES or enters responses c Indicates NO or clears last response c Press once Will erase last character entered Press twice Will erase last entry 14 Spirometrics Flowmate III User s Manual Rev 02 INSTALLATION AND CUSTOMIZATION This section provides you with information on the rechargeable batteries printer connection and customizing the Flowmate lll to meet your
50. s are dis engaged from the handle assembly 3 Pull Entire Easy Clean Cartridge when it is no longer engaged with the sensor core housing CAUTION Please DO NOT disassemble the core element The Easy Clean Cartridge can be cleaned fully assembled 53 Spirometrics Flowmate III User s Manual Rev 02 CLEANING THE FLOW SENSOR Core element 1 Clean the core element in cold sterilization fluid a protein dissolving solution Follow the manufacturer s instruction for disinfecting and sterilizing 2 Be sure to rinse in water thoroughly and allow to dry completely before attempting to re insert the Easy Clean Cartridge into the handle assembly CLEANING AND SANITIZING In addition to regular cleaning of the flow sensor as described above the remaining parts of the FLOWMATE III may become soiled and require occasional cleaning or sanitizing 1 ALWAYS UNPLUG THE FLOWMATE Ill 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 any 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 III is not waterproof or autoclavable CLEAN CARTRIDGE
51. ssible that your printer can be configured to one of the printer selections provided in the Flowmate III s Customization Routine Check your printer manual for customization options and configuration instructions 59 Spirometrics Flowmate III User s Manual Rev 02 APPENDICES Normals Table 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 III has normals tables from the following five studies stored in memory Select the table you want to use in Customizing the Flowmate III on pg 19 Note the applicable indices and ranges for each study Knudson 1983 INDICES HEIGHT HEIGHT Yrs Min max cm Min max in Min max FEMALE 106 7 147 3 42 58 FEV1 FVC 11 19 132 1 182 9 52 72 60 Spirometrics Crapo INDICES SEX FVC FEMALE FEV1 FEV3 FEV1 FVC FEF 25 75 MVV vol Flowmate III Yr
52. te III User s Manual Rev 02 If you answered 1 to the above question the Flowmate III will ask the following two questions Enter Location ID Number gt Enter the location ID number Press ENTER up to 16 digits Now 000 up to 16 digits including and Q Press 1 or 2 Do you want to re enter the Press ENTER gt Location ID each time you YES The spirometer will power up 1 YES 2 NO immediately ask for the location Now 2 ID each time the power is turned on NO You will have to enter the customizing routine to re enter the location ID each time you change locations Enter Temperature gt Enter the Average Air Press ENTER Temperature 50F 104F 10C 40C Now 722 F Average Ambient air temperature where the spirometer is being used This value affects BTPS correction pg 63 Enter Barometric Pressure p Enter the Average Barometric Press ENTER Pressure in inches or millimeters of 20 35 in 500 900 mm mercury Hg The Flowmate III automatically determines inches Now 760 mm Hg or centimeters when a number is entered NOTE It is important to enter the average barometric pressure based on the elevation of your location otherwise there will be an error in the BTPS correction Press 0 0 0 0 or gt Which printer Press ENTER 1 Epson FX 2 Epson LQ 3 IBM Pro 4 BM Pro X24 5 HP Laser DeskJet 21 Spirometrics Flowmate III User s Manual Rev 02
53. ted You can recall this test data later for displaying printing or erasing For example you may want to erase a previous test because it was poorly done or you may want to refer to a pre bronchodilator test while you are giving a post bronchodilator test Each test for a given patient has two digit test numbers 01 02 03 This number increases by one for each consecutive test on the patient regardless of the test type or whether the testing is in pre or post bronchodilator The Flowmate III displays the test number just before the patient takes the selected test The test number prints on each test report for all tests The number of the best test also prints on the Best Test Summary Report You can recall a test from memory by referring to its test number To Recall a Test Press PATIENT ES Press o Input Patient ID Number Press ENTER Press enter repeatedly until you reach the test selection question Press DISPLAY Enter test number you would like to select 42 m 3 Calibration What is the patient s ID number or press TEST Ero Ew Ee For which test would you like data enter number of test Spirometrics Flowmate III User s Manual Rev 02 NOTE If you are unable to remember the patient ID number you desire you may return to the Main MENU press PATIENT key Press the SUMMARY key for a printout of the patient directory When a patient has finished a test and you h
54. tes displays and stores the test results of the patient s effort and prints report if autoprint has been chosen in customization Answering NO The Flowmate III will abandon the test and the patient must try effort again NOTE Patient effort is acceptable if the patient e Made a maximum effort e asted a full 12 seconds e Did NOT cough Flowmate Ill displays results Index Unt Meas Pred Pred Var Mvv when patient test is accepted eee ub ee Sere ee Press TEST to start another test NOTE The MVV test is an exhausting test It should not be repeated without a rest period Some elderly or ill people cannot repeat this test even after a rest period 35 Spirometrics Flowmate III User s Manual Rev 02 VC Testing Vital Capacity Test Entering Testing Mode VC testing begins after the Which test would you like patient data is entered The 1 FVC Flowmate II will automatically be 2 MVV in testing mode 3 VC 4 CHAL or Output Insert a new filter for each patient Press e gt Test No 1 VC Exhale slowly Instruct the Patient 1 Place a noseclip on his her nose 2 Take as deep a breath as possible through the mouthpiece and hold it 3 To place mouthpiece in mouth past teeth and form a tight seal with lips Make sure the tongue is not blocking the mouthpiece 4 Exhale slowly push EVERY bit of air out 5 Remove the mouthpiece Patient Incentive Display 1
55. tests When you do Patient No 6 the memory card will save Patient No 1 The Memory Card stores the earliest patient in the unit memory When the Memory Card is full the Flowmate III will prompt the user Printing Tests Using the Memory Card Press PATIENT Key MENU Patient 1 Patient 2 Customization 3 Calibration 4 Time Output Press PRINT key Batch Print all or some patients 2 Some i 3 None 0 Batch print tests of all patients in memory e Print tests of selected patients must enter patient ID numbers This will bring the user back to the Main MENU Once you have printed patient tests you must press PATIENT to return to Main MENU NOTE If you are unable to remember the patient ID number you desire you may return to the Main MENU press PATIENT key Press the SUMMARY key for a printout of the patient directory Erasing Saved Patient Tests on the Memory Card Patient tests that are saved on D Erase all of the Patient Database the Memory Card can be deleted 1 All 22 RAM Card Only as a group or one at a time 3 None 50 Spirometrics Flowmate III User s Manual Rev 02 Interpretations The Flowmate Ill 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 All relevant data must be taken into account when making a valid diagn
56. the date Confirms time and date entered The Flowmate III will automatically bring you back to the Main MENU c 24 ew 3 Calibration What time is it 12 01 enter time or press ENTER if correct What time is it 12 01 Is that PM Press YES or NO Do you want time to be printed in 12 or 24 hour scale Now 12 Print American or European date format 1 mm dd yy 2 dd mm yy Now 1 Set the date Now 01 15 94 in American format slashes not needed m 3 Calibration Spirometrics Flowmate III User s Manual Rev 02 CALIBRATION Calibrating your Flowmate Ill ensures accurate test results Calibrate your spirometer before you use it for the first time Re calibrate your spirometer at routine intervals Spirometrics recommends daily calibrations to assure that the spirometer is calibrated and working properly 1 To perform a calibration a calibration syringe and a calibration syringe adapter seal will be needed See pg 75 for Flowmate lll accessories 2 Connect the adapter seal to the end of the calibration syringe See pg 75 for Flowmate lll accessories 3 Connect the Flow Sensor Mouthpiece firmly to the calibration syringe E NOTE 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
57. tients e Variant asthma This is an intermittent asthma which may occur with exercises cold air 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 non asthmatic A methacholine challenge test will demonstrate an abnormally high airways reactivation in patients with variant asthma e Predictive Factors The degree of airways reactivation 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 dose Only the FEV1 is important in this test Press PATIENT c VENUE LLL 1 Patient l 2 Customization This will bring you to the Main 3 Calibration MENS 4 Time or Output Press O gt Press ENTER repeatedly to scroll through patient data until you reach the test selection question Methacholine Challenge testing c Which test would you like begins after the patient data is 1 FVC entered The Flowmate lll will automatically be in testing mode 2 MVV i 3 vc 4 CHAL or Output l What is the patient s ID number or press TEST Insert a new filter for each patient Press gt Administer 5 breaths of diluent press ENTER when ready for FVC test 39 Spirometrics Flowmate III User s Manual
58. tion Check the Following e 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 57 Spirometrics Problem Can not keep the calibration puck within the tolerance window in the calibration routine The calibration puck will not move within the tolerance window of the calibration routine and the sensor will not detect flow Patient Storage Flowmate III User s Manual Rev 02 Calibration of the Flow Sensor requires a steady even injection from the calibration syringes Check the Following e 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 th
59. tween 9 12 volts Flowmate III will not hold A rechargeable Super Cap is used to retain the Time Date or Time Date and Customization Settings It is Customization possible that the memory back up voltage is low The Super Cap is designed to be periodically recharged This is accomplished by turning the unit on for 5 10 seconds every two to three weeks when the unit is not being used regularly 56 Spirometrics Flow Sensor This section contains possible solution Sensor such as e Connection to base unit e Cleaning e Core Element Placement Possible Problem The base unit does not recognize flow sensor Message Connect Sensor is displayed Calibration Flowmate III User s Manual Rev 02 s for solving problems related to the Flow Solution Check the connection of the Flow Sensor to the base unit Provided with your spirometer is a coiled retractable cable cord with modular plugs at both ends Plug either end into the Flow Sensor then the other into the base unit Use only the cord provided with your spirometer Use of other cords could cause damage to your spirometer This section contains possible solutions for calibration problems Problem 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 Solu
60. wmate III provides a parallel output so that you can connect a variety of parallel printers Connect your printer by attaching the standard parallel cable from the parallel output on the right side of the Flowmate Ill Refer to the printer s owner s manual for information on compatibility and operation The printer when properly connected prints after each test if you select the automatic test printout option You may select this in Customization p 18 NOTE You will probably need to select the spirometers customization to match the printer you are using If your printer is not named in the Customization Routine p 18 refer to the printer manual Most printers can emulate two or more types of printers Configure your printer to match one within the Flowmate III s customization routine Printer Requirements External parallel printer compatible with MS DOSQ with an emulation configurable to one of the following EPSON FX EPSONLQ IBM Proprinter IBM Proprinter X24 HP Laser DeskJet PRINTER CABLE PRINTER 16 Spirometrics Flowmate III User s Manual Rev 02 Customization Your Flowmate Ill spirometer comes pre set with the standard configuration You should however go through the customization routine See Customization Routine p 18 to customize operation according to your preferences and needs STANDARD CONFIGURATION CHART Function Standard aa Configuration 5 1 Short Form Expanded Form Short Ex

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