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1. If you are unable to achieve stable readings discontinue use Optimally the index middle or ring finger of the left hand should be used for Oximetry testing Keep the fingernail facing the light source and ensure that long fingernails are not interfering with proper finger position The finger clip should fit securely onto the finger Carefully read the instructional insert if provided with the sensor before use The SpirOxCard must be repaired by trained personnel only Do not immerse the SpirOxCard or sensors in liquid to clean Do not use abrasive or caustic cleaning agents on the sensors Do not sterilize sensors Oximetry Indications for Use Patient Population Male Female Patient s weighing greater than 30kg or 66lb Device Functionality Oximetry Oximetry Parameters SpO2 and Pulse Rate bpm Environment of Use Hospital Clinical and Home Use Oximetry 52 Oximetry Getting Started 1 Insert the SpirOxCard into the PC Card Reader 2 Connect Finger Clip Attach the data end of the finger clip connector to the 9 Pin connector on the PC Card Insert a finger preferably the index middle or ring finger of the left hand into the finger clip sensor until the end of the finger reaches the finger stop Performing an Oximetry Test Select patient and then select Test Quick Test Oximetry Displays pulse and SpO2 Test Oximetry Displays and optionally records pul
2. An Oximeter should be considered an early warning device As a trend towards patient de oxygenation is indicated blood samples should be analyzed by a laboratory co oximeter to completely understand the patient s condition External dyes fingernail polish paint etc may reduce light transmission and thereby affect SpO2 accuracy The SpirOxCard is calibrated to determine the percentage of arterial oxygen saturation of functional hemoglobin Significant levels of dysfunctional hemoglobin such as carboxyhaemoglobin or methemoglobin may affect the accuracy of the measurement The following factors may degrade pulse SpirOxCard performance Excessive ambient light incorrect sensor type excessive motion poor pulse quality electrosurgical interference venous pulsations arterial catheters blood pressure cuffs infusion lines moisture in the sensor improperly attached sensor sensor not at heart level anemia or low hemoglobin concentrations Cardiogreen and other intravascular dyes depending on the concentration may affect the accuracy of the SpO2 measurement Confirm the accuracy of real time clock settings each time the SpirOxCard is used to collect patient trend data The SpirOxCard may interpret motion artifact of sufficient amplitude and regularity as good perfusion green Oximetry 51 Cautions The SpirOxCard must record an accurate pulse before SpO2 readings can be deemed accurate
3. The acquisition window will appear on the screen with the patients real time ECG displayed Warning Avoid patient movement to reduce artifact The ECG Device is for acquiring resting ECGs only The device should not be used for stress testing Electrocardiography 59 About the Acquisition Window View Select Scrolls through the different leads when you view the 3 or 6 lead sets Lead Identifiers Identifies each of the 12 leads If a lead is disconnected leads off then a red circle with a diagonal line is placed over the lead identifier Connection Status Displays the status of the connected ECG cable Heart Rate bpm Displays the active Heart Rate of the patient Electrocardiography 60 Calibration Pulse Provides a visual indication of the combined sensitivity 1mV vertical height and speed 100ms horizontal width Sensitivity Changes the number of millimeters that represent one millivolt The available options are 5mm mV 10mm mV and 20mm mV Speed Changes the number of millimeters that are passed in one second The available options are 12 5mm s 25mm s and 50mm s Leads View 3 6 or 12 leads or 3x4 view The ability to select between the Limb leads and the Chest leads is also available when viewing 3 or 6 leads at a time A Custom Lead group can be defined in the ECG Options Power Filter Turns the Main filter on and off Note the default frequency of the Main filter is set i
4. 0 0739 A yrs 6 8865 FEV1 L 0 0519 H cm 0 0636 A yrs 6 1181 FEF50 L sec 0 0543 H cm 0 115 A yrs 6 3851 FEF75 L sec 0 0397 H cm 0 0057 A yrs 4 2421 FEF25 75 L sec 0 0539 H cm 0 0749 A yrs 6 199 FEV1 FVC 100 4389 0 0813 H cm MALE 25 years 62 77 in 157 5 195 6 cm FVC L 0 0844 H cm 0 0298 A yrs 8 7818 FEV1 L 0 0665 H cm 0 0292 A yrs 6 5147 FEF50 L sec 0 0684 H cm 0 0366 A yrs 5 5409 FEF75 L sec 0 031 H cm 0 023 A yrs 2 4827 FEF25 75 L sec 0 0579 H cm 0 0363 A yrs 4 5175 MALE 25 and lt 85 years FEV1 FVC 86 6862 0 105 A yrs FEMALE 6 10 years 42 58 in 106 7 147 3 cm FVC L 0 043 H cm 3 7486 FEV1 L 0 0336 H cm 2 7578 FEF50 L sec 0 1846 A yrs 0 7362 FEF75 L sec 0 0109 H cm 0 1657 FEF25 75 L sec 0 022 H cm 0 8119 FEV1 FVC 109 9739 0 1909 H cm 0 6655 A yrs FEMALE 11 19 years 52 72 in 132 1 182 9 cm FVC L 0 0416 H cm 0 0699 A yrs 4 447 FEV1 L 0 0351 H cm 0 0694 A yrs 3 7622 FEF50 L sec 0 0288 H cm 0 1111 A yrs 2 304 FEF75 L sec 0 0243 H cm 0 2923 A yrs 4 4009 0 0075 A yrs 2 FEF25 75 L sec 0 0279 H cm 0 1275 A yrs 2 8007 FEV1 FVC 109 9739 0 1909 H cm 0 6655 A yrs FEMALE 20 69 years 58 71 in
5. 18 43 3 70 9 in 110 180 cm X X X X X F 6 18 47 2 70 9 in 120 180 cm X X X X X Quanjer 1995 Qu M 6 18 43 3 80 7 in 110 205 cm X X X X F 6 18 43 3 72 8 in 110 185 cm X X X X Zapletal 1987 Za M 6 18 42 1 71 7 in 107 182 cm X X X X X X X X X X X F 6 18 42 1 71 7 in 107 182 cm X X X X X X X X X X X Morris 1971 73 Mo M 20 90 58 80 in 147 3 203 2 cm X X X X M 20 79 58 80 in 147 3 203 2 cm X X F 20 90 56 72 in 142 2 182 9 cm X X X X F 20 79 56 72 in 142 2 182 9 cm X X Cherniack 1972 Ch M 15 79 35 85 in 88 9 215 9 cm X X X X X X X X X F 15 79 35 85 in 88 9 215 9 cm X X X X X X X X X Roberts 1991 Ro M 18 86 63 4 77 2 in 161 196 cm X X X X X X F 18 86 57 5 69 7 in 146 177 cm X X X X X X Knudson 1983 Kn M 6 11 44 61 in 111 8 154 9 cm X X X X X X X M 12 24 55 76 in 139 7 193 cm X X X X X X X M 25 62 77 in 157 5 195 6 cm X X X X X X M 25 85 62 77 in 157 5 195 6 cm X X F 6 10 42 58 in 106 7 147 3 cm X X X X X X X F 11 19 52 72 in 132 1 182 9 cm X X X X X X X F 20 69 58 71 in 147 3 180 3 cm X X X X X X F 20 88 58 71 in 147 3 180 3 cm X X F 70 58 66 in 147 3 167 6 cm
6. 74 8 in 111 190 cm FVC L 0 00106 H cm 2 97 1000 FEV1 L 0 00173 H cm 2 85 1000 PEFR L min 0 000769 H cm 2 63 FEF25 75 L min 0 000913 H cm 2 45 FEMALE White 7 18 years 43 7 74 8 in 111 190 cm FVC L 0 00257 H cm 2 78 1000 FEV1 L 0 00379 H cm 2 68 1000 PEFR L min 0 00258 H cm 2 37 FEF25 75 L min 0 00379 H cm 2 16 FEMALE Black 7 18 years 43 7 74 8 in 111 190 cm FVC L 0 000834 H cm 2 98 1000 FEV1 L 0 00114 H cm 2 89 1000 PEFR L min 0 000551 H cm 2 68 FEF25 75 L min 0 00145 H cm 2 34 FEMALE Mexican American 7 18 years 43 7 74 8 in 111 190 cm FVC L 0 00125 H cm 2 92 1000 FEV1 L 0 00161 H cm 2 85 1000 PEFR L min 0 000697 H cm 2 64 FEF25 75 L min 0 00120 H cm 2 40 CRAPO 1981 Crapo et al Reference Spirometric Values using Techniques and Equipment that Meet ATS Recommendations American Review of Respiratory Disease 1981 123 659 664 MALE 15 91 years 61 8 76 4 in 157 194 cm FVC L 0 06 H cm 0 0214 A yrs 4 65 FEV05 L 0 0327 H cm 0 0152 A yrs 1 914 FEV1 L 0 0414 H cm 0 0244 A yrs 2 19 FEV3 L 0 0535 H cm 0 0271 A yrs 3 512 FEF25 75 L sec 0 0204 H cm 0 038 A yrs 2 133 Spirometry 40 FEV1 FVC 0 13 H cm 0 152 A yrs 110 49 100 FEV3 FVC 0 0627 H cm 0 145 A
7. Office Medic User s Manual For use with SpiroCard SpirOxCard Orbit Universal ECG 6000 5236 Rev M 04 2012 Table of Contents GENERAL CAUTIONS amp WARNINGS 4 GLOSSARY OF SYMBOLS 4 WARNINGS 5 CAUTIONS 6 ELECTRICAL SAFETY CLASSIFICATIONS 9 OFFICE MEDIC BASICS 10 SYSTEM REQUIREMENTS 10 INSTALLATION 10 BACKING UP AND RESTORING THE DATABASE 12 NAVIGATION 13 FILE MENU 14 TEST MENU 16 OPTIONS MENU 17 TOOLS MENU 19 HELP MENU 20 SPIROMETRY 20 SPIROMETRY CAUTIONS amp WARNINGS 20 SPIROMETRY GETTING STARTED 21 PROPER PATIENT PREPARATION 22 PROPER TESTING PROCEDURE 22 EFFORT QUALITY MESSAGES FOR ADULT SUBJECTS 23 TEST SESSION GRADES 24 UNACCEPTABLE SPIROMETRY TESTS 24 REPEATABILITY 24 PERFORMING A SPIROMETRY TEST 25 ABOUT THE SPIROMETRY TEST SESSION WINDOW 27 SPIROMETRY OPTIONS 28 SPIROMETRY TOOLS 33 PREDICTED VALUE EQUATIONS 36 LUNG AGE CALCULATION 47 SPIROMETRY INTERPRETATION 48 OXIMETRY 50 OXIMETRY CAUTIONS amp WARNINGS 50 OXIMETRY GETTING STARTED 52 PERFORMING AN OXIMETR
8. X X X X X X Hsu 1979 Hs M 7 20 43 7 74 8 in 111 190 cm X X X X X X M 7 20 43 7 74 8 in 111 190 cm X X X X X X M 7 20 43 7 74 8 in 111 190 cm X X X X X X F 7 18 43 7 74 8 in 111 190 cm X X X X X X F 7 18 43 7 74 8 in 111 190 cm X X X X X X F 7 18 43 7 74 8 in 111 190 cm X X X X X X Spirometry 37 Crapo 1981 Cr M 15 91 61 8 76 4 in 157 194 cm X X X X X X X F 17 84 57 5 70 1 in 146 178 cm X X X X X X X Warwick 1977 Wa M lt 18 35 4 74 in 90 188 cm X X X X X X X X F lt 18 35 4 70 1 in 90 178 cm X X X X X X X X Polgar 1971 Po M 4 17 43 3 67 in 110 170 cm X X X X X X X F 4 17 43 3 67 in 110 170 cm X X X X X X X Shaded LLN available MORRIS 1971 1973 Morris James F et Al Spirometric Standards for Healthy Non smoking Adults American Review of Respiratory Disease 1971 vol 103 1 57 67 Morris James F et al Normal values for the ratio of one second forced expiratory volume to forced vital capacity American Review of Respiratory Disease 1973 Vol 108 1000 1003 MALE 20 90 years 58 80 in 147 3 203 2 cm FVC L 0 148 H in 0 025 A yrs 4 241 FEV1 L 0 092 H in 0 032 A yrs 1 26 FEF25 75 L sec 0 047 H in 0 045 A yrs 2 513 MALE 20 79 years FEV1 FVC
9. 42 H cm 2 PEF L Sec 0 9267 0 06929 A yrs 0 001031 A yrs 2 0 00018623 H cm 2 MALE Black African American 8 19 years 48 0 76 4 in 122 194 cm FVC L 0 4971 0 15497 A yrs 0 007701 A yrs 2 0 00016643 H cm 2 FEV1 L 0 7048 0 05711 A yrs 0 004316 A yrs 2 0 00013194 H cm 2 FEV1 FVC 89 239 0 1828 A yrs 100 FEV6 L 0 5525 0 14107 A yrs 0 007241 A yrs 2 0 00016429 H cm 2 FEV1 FEV6 88 841 0 1305 A yrs 100 FEF25 75 L Sec 1 1627 0 12314 A yrs 0 00010461 H cm 2 PEF L Sec 0 2684 0 28016 A yrs 0 018202 A yrs 2 0 00027333 H cm 2 MALE Black African American 20 80 years 62 2 77 2 in 158 196 cm FVC L 0 1517 0 01821 A yrs 0 00016643 H cm 2 FEV1 L 0 3411 0 02309 A yrs 0 00013194 H cm 2 FEV1 FVC 89 239 0 1828 A yrs 100 FEV6 L 0 0547 0 02114 A yrs 0 00016429 H cm 2 FEV1 FEV6 88 841 0 1305 A yrs 100 FEF25 75 L Sec 2 1477 0 04238 A yrs 0 00010461 H cm 2 PEF L Sec 2 2257 0 04082 A yrs 0 00027333 H cm 2 FEMALE Black African American 8 17 years 46 5 72 4 in 118 184 cm FVC L 0 6166 0 04687 A yrs 0 003602 A yrs 2 0 00013606 H cm 2 FEV1 L 0 963 0 05799 A yrs 0 00010846 H cm 2 FEV1 FVC 91 655 0 2039 A yrs 100 FEV6 L 0 637 0 04243 A yrs 0 003508 A yrs 2
10. L sec 0 3118 H in 0 2422 A yrs 107 12 100 FEMALE 20 90 years 56 72 in 142 2 182 9 cm FVC 0 115 H in 0 024 A yrs 2 852 FEV1 0 089 H in 0 025 A yrs 1 932 FEF25 75 0 06 H in 0 03 A yrs 0 551 FEMALE 20 79 years FEV1 FVC L sec 0 0679 H in 0 1815 A yrs 88 7 100 CHERNIACK 1972 Cherniack RM and Raber MB Normal Standards for Ventilatory Function Using an Automatic Wedge Spirometer American Review of Respiratory Disease 1972 Vol 106 1 p38 46 MALE 15 79 years 35 85 in 88 9 215 9 cm FVC L 0 12102 H in 0 01357 A yrs 3 18373 FEV1 L 0 09107 H in 0 0232 A yrs 1 50723 FEF25 L sec 0 0903 H in 0 01987 A yrs 2 72554 FEF50 L sec 0 06526 H in 0 03049 A yrs 2 40337 FEF75 L sec 0 03583 H in 0 04142 A yrs 1 98361 FEF25 75 L sec 0 05948 H in 0 037 A yrs 2 61187 PEFR 0 14393 H in 0 02403 A yrs 0 22544 MVV 3 02915 H in 0 81621 A yrs 37 94893 FEMALE 15 79 years 35 85 in 88 9 215 9 cm FVC L 0 07833 H in 0 01539 A yrs 1 04912 FEV1 L 0 06029 H in 0 01936 A yrs 0 18693 FEF25 L sec 0 06876 H in 0 01926 A yrs 2 14653 FEF50 L sec 0 0622 H in 0 02344 A yrs 1 4264 FEF75 L sec 0 02334 H in 0 0345 A yrs 2 21596 FEF25 75 L sec 0 04931 H in 0 0312 A yrs 2 2
11. extended housing Housing PCMCIA Type II PC Card with extended housing Program Reporting software is stored on the computer Environmental Conditions Storage Conditions Ambient Temperature 15 to 50 C 5 to 122 F Relative Humidity lt 90 non condensing Atmospheric Pressure 700 to 1060 hPa Power Supply Internal 5Vdc less than 80 mA Supplied by the PCMCIA slot Operating Conditions Ambient Temperature 15 to 40 C 59 to 104 F Relative Humidity 10 to 90 non condensing Atmospheric pressure 700 to 1060 hPa Measurement Method FLOW Mouthpiece US Patent 4 905 709 VOLUME flow integration Range BTPS FLOW 14 liters second VOLUME 0 5 8 liters Accuracy BTPS FLOW 5 of indication or 200 ml sec whichever is greater for FEF 25 75 and 10 of indication or 300 ml s whichever is greater for PEF VOLUME 3 of indication or 50 ml whichever is greater for FVC and FEV1 10 of indication or 15 L min whichever is greater for MVV Precision BTPS FLOW 5 of indication or 150 ml sec whichever is greater for PEF VOLUME 3 of indication or 50 ml whichever is greater for FVC and FEV1 Calibration ATS 3 speed or standard calibration check Predicted Normals Crapo 1981 Cherniack 1972 Morris 1971 73 Knudson 1983 Polgar 1971 HSU 1979 Roberts 1991 Warwick 1977 ECCS ERS Quanjer 1993 NHANES III 1999 Zapletal 1987 Wang 1993 Quanjer 1995 Tests Performed
12. syringe volume 1 to 10 liters and select OK For ATS ERS 2005 calibration select ATS and enter the mouthpiece number and select OK A 3 liter syringe must be used 6 When both circles stop flashing and turn green push the syringe in fully Note The calibration check is for verification only If the spirometer is found to be out of calibration repeat with a different mouthpiece If the problem persists see Service Spirometry 35 To check calibration SpiroCard or SpirOxCard 1 Insert the PC Card into the PC Card Slot 2 Connect the pressure tube to the Luer fitting 3 Connect the pressure tube to the mouthpiece 4 Connect a syringe to the mouthpiece recommended 3 liter syringe Note The calibration syringe must form a tight seal around the mouthpiece If you are unable to get a tight seal contact Technical Support for more information 5 Select the desired calibration check For standard calibration select Begin Stnd enter the mouthpiece number and the syringe volume 1 to 10 liters and select OK For ATS ERS 2005 calibration select ATS and enter the mouthpiece number and select OK A 3 liter syringe must be used 6 When both circles stop flashing and turn green push the syringe in fully Note The calibration check is for verification only If the spirometer is found to be out of calibration repeat with a different mouthpiece If the problem persists see Service Spirometry 36 Predicted Valu
13. 028 A yrs 4 65 FEMALE 18 70 years 57 1 70 9 in 145 180 cm For subjects aged 18 25 years the predicted mean is the same as for subjects 25 year FVC L 0 0443 H cm 0 026 A yrs 2 89 FEV1 L 0 0395 H cm 0 025 A yrs 2 6 FEV1 FVC 0 190 A yrs 89 1 100 FEF25 L sec 0 0322 H cm 0 025 A yrs 1 6 FEF50 L sec 0 0245 H cm 0 025 A yrs 1 16 FEF75 L sec 0 0105 H cm 0 025 A yrs 1 11 FEF25 75 L sec 0 0125 H cm 0 034 A yrs 2 92 PEFR L sec 0550 H cm 0 030 A yrs 1 11 FIVC 0 0466 H cm 0 026 A yrs 3 28 NHANES III 1999 Hankinson John L Odencrantz John R Fedan Kathleen B Spirometric Reference Values from a Sample of the General U S Population Am J Respir Crit Care Med 1999 Vol 159 179 187 MALE Caucasian 8 19 years 48 0 75 6 in 122 192 cm FVC L 0 2584 0 20415 A yrs 0 010133 A yrs 2 0 00018642 H cm 2 FEV1 L 0 7453 0 04106 A yrs 0 004477 A yrs 2 0 00014098 H cm 2 FEV1 FVC 88 066 0 2066 A yrs 100 FEV6 L 0 3119 0 18612 A yrs 0 009717 A yrs 2 0 00018188 H cm 2 FEV1 FEV6 87 34 0 1382 A yrs 100 FEF25 75 L Sec 1 0863 0 13939 A yrs 0 00010345 H cm 2 PEF L Sec 0 5962 0 12357 A yrs 0 013135 A yrs 2 0 00024962 H cm 2 MALE Caucasian 20 80 years 62 2 76 4 in 158 194 cm
14. 147 3 180 3 cm FVC L 0 0444 H cm 0 0169 A yrs 3 1947 FEV1 L 0 0332 H cm 0 019 A yrs 1 821 FEF50 L sec 0 0321 H cm 0 024 A yrs 0 4371 Spirometry 39 FEF75 L sec 0 0174 H cm 0 0254 A yrs 0 1822 FEF25 75 L sec 0 03 H cm 0 0309 A yrs 0 4057 FEMALE 20 and lt 88 years FEV1 FVC 121 6777 0 1852 H cm 0 1896 A yrs FEMALE 70 years 58 66 in 147 3 167 6 cm FVC L 0 0313 H cm 0 0296 A yrs 0 1889 FEV1 L 0 0143 H cm 0 0397 A yrs 2 6539 FEF50 L sec 0 0118 H cm 0 0755 A yrs 6 2402 FEF75 L sec 0 0172 A yrs 1 8894 FEF25 75 L sec 0 0615 A yrs 6 3706 HSU 1979 Hsu Katharine et al Ventilatory Functions of Normal Children and Young Adults Mexican American White and Black J Pediatr 1979 95 14 23 To determine the Predicted FEV1 FVC value for this predicted set QRS software uses Pred FEV1 Pred FVC MALE White 7 20 years 43 7 74 8 in 111 190 cm FVC L 0 000358 H cm 3 18 1000 FEV1 L 0 000774 H cm 3 1000 PEFR L min 0 000335 H cm 2 79 FEF25 75 L min 0 000798 H cm 2 46 MALE Black 7 20 years 43 7 74 8 in 111 190 cm FVC L 0 00107 H cm 2 93 1000 FEV1 L 0 00103 H cm 2 92 1000 PEFR L min 0 000174 H cm 2 92 FEF25 75 L min 0 000361 H cm 2 60 MALE Mexican American 7 20 years 43 7
15. F type applied part patient isolation from electric shock Defibrillator proof type BF equipment Defibrillator proof type BF equipment complying with IEC Publication 601 CE Mark Indicates this device is in compliance with MDD 93 42 ECC 0086 is the Notified Body Number Do not reuse Class II Electrical Equipment REF Catalogue or Model Number S N Serial Number Manufacturer Authorized representative in the European community Waste Electronic Electrical Equipment WEEE Separate collection for waste electrical and electronic equipment Rx only Federal USA law restricts this device to sale by or on the order of a physician General Cautions amp Warnings 5 Latex Free Product is Latex Free Non Sterile Batch Code Use By Upper Limit of Temperature Warnings Do not use QRS Medical Devices in presence of flammable anesthetic mixture Do not operate QRS Medical Devices in an explosive atmosphere Use of accessory equipment not complying with EN60601 1 and or UL2601 1 or equivalent safety standard may lead to a reduced level of safety of the resulting system Computers and printers used with QRS Medical Devices should be evaluated to EN 60950 1 EN60601 1 or equivalent safety standard to maintain the safety of QRS Medical Devices Do not use any QRS Medical Device on children or vulnerable adults without proper supervision Ensure patient cabling or tubing is
16. FEV0 5 FEV1 FEV6 FEV1 FEV6 FEV3 FEV1 FVC FEV3 FVC PEFR PEFT FEF25 FEF50 FEF75 FEF25 75 FIVC FIV0 5 FIV1 FIV3 FIV1 FIVC FIV3 FIVC PIFR FIF50 FIF 25 75 FIF 2 1 2 FVC FIVC Extrapolated Volume Ext Vol BEV EOTV FET MVV RR MTV SVC Device Specifications 79 Universal ECG Specifications Hub Weight 280 300 grams 0 62 0 66 lb depending on cable options Hub Dimensions 85mm x 91mm x 20mm 3 3 x 3 6 x 0 8 Patient Leads Length 1 meter 3 3 ft PC Connection Length 1 3 meter 3 3 9 8 ft DB9 female connector or USB connector Patient Leads 6 Lead Cable 4 patient leads 12 Lead Cable 10 patient leads Case Material ABS Plastic Electrode Connections 4 mm Banana plug with tab or snap connectors Electrode Labeling Abbreviations and colors to comply with either IEC or AAMI standards Display and Operating Console Dependent on PC supplied by user Gain Sensitivity 5 10 20 mm mV Input Range 6mV Acquisition sample rate 1000 samples per second compressed to 500Hz with peak picking and averaging algorithm Heart Rate Range 20 bpm 170 bpm Frequency Response 0 05 to 175Hz 3dB Defibrillator Protection Patient leads are isolated from system and operator with 4kV protection Common Mode Rejection 60dB minimum Safety Standards Complies with AAMI EC11 EN60601 1 EN60601 1 2 and EN60601 2 25 Accuracy Accurate to AAMI EC11 1991 requirements
17. FVC Pre Post Testing Flow Volume Loop MVV SVC Measuring Time Up to 30 seconds Printed Scale Flow Volume vertical 5cm 1L S horizontal 1cm 1L Volume Time vertical 1cm 1L horizontal 1cm second Sample Rate 100 samples sec Resolution Flow Rate 2ml sec Volume 1ml Limits of Detection Flow Rate 2ml sec Volume 1ml Parameters Measured FVC FEV0 5 FEV1 FEV6 FEV1 FEV6 FEV3 FEV1 FVC FEV3 FVC PEFR PEFT FEF25 FEF50 FEF75 FEF25 75 FIVC FIV0 5 FIV1 FIV3 FIV1 FIVC FIV3 FIVC PIFR FIF50 FIF 25 75 FIF 2 1 2 FVC FIVC Extrapolated Volume Ext Vol BEV EOTV FET MVV RR MTV SVC Device Specifications 78 SpirOxCard Specifications Weight 85 grams 0 19 lb Height WxDxH 53mm x 140mm x 26mm 2 1 x 5 5 x 1 0 extended housing Housing PCMCIA Type II PC Card with extended housing Program Reporting software is stored on the computer Environmental Conditions Storage Conditions Ambient Temperature 15 to 50 C 5 to 122 F Relative Humidity lt 90 non condensing Atmospheric Pressure 700 to 1060 hPa Power Supply Internal 5Vdc less than 80mA Supplied by the PCMCIA slot Operating Conditions Ambient Temperature 15 to 40 C 59 to 104 F Relative Humidity 10 to 90 non condensing Atmospheric pressure 700 to 1060 hPa Measurement Method Spirometry FLOW Mouthpiece US Patent 4 905 709 VOLUME flow integration Range BTPS Spirometry FLOW 14
18. III 1999 Zapletal 1987 Wang 1993 Quanjer 1995 ADULT MVV Cherniack 1972 PEDIATRIC MVV Polgar 1971 Zapletal 1987 Interpretation ATS ERS 2005 BTS NICE 2004 2005 NLHEP 2000 Enright 1987 Report Format Pre test overlay with full page graphs Pre Post test overlay with full page graphs Parameters Measured FVC FEV0 5 FEV1 FEV6 FEV1 FEV6 FEV3 FEV1 FVC FEV3 FVC PEFR PEFT FEF25 FEF50 FEF75 FEF25 75 FIVC FIV0 5 FIV1 FIV3 FIV1 FIVC FIV3 FIVC PIFR FIF50 FIF 25 75 FIF 2 1 2 FVC FIVC Extrapolated Volume Ext Vol BEV EOTV FET MVV RR MTV SVC
19. RS232 port with a 128 byte minimum FIFO buffer USB The Office Medic software supports the ECG Device when connecting to a USB port when using the supplied USB Serial Converter or using a Universal ECG with a direct USB connection Note Supplementary Power Some serial ports do not provide enough power for the Universal ECG In this situation we recommend you use the supplied USB DC power boost cable P N 5000 1914 or the PS 2 DC power boost cable P N 5000 1897 to supplement the power supplied to the Universal ECG These cables connect from a USB keyboard or mouse port to a socket on the Universal ECG s Serial DB9 connector Electrocardiography 57 Performing an ECG Test 1 Connect the ECG device to the PC 2 Select a patient from the Patient Directory 3 Shave electrode sites if necessary Thoroughly clean the area and let dry 4 Prep skin by briskly rubbing with gauze being careful not to break or damage the skin 5 Remove electrodes from backing 6 Apply each electrode adhesive side down to desired site 7 For positive electrode contact start from outer edge and run your finger around the electrode several times working toward the center 8 Connect the lead wires to the patient ensuring correct lead placement Excess movement can cause artifact Patient should be stable V1 C1 V2 C2 V3 C3 V4 C4 V5 C5 V6 C6 Electrocardiography 58 9 Click the ECG icon on the Toolbar or select Test ECG
20. Syringe A large syringe which injects a measured amount of air into the mouthpiece Many syringes have a stop ring on the plunger which allows injecting various calibrated amounts of air Class II Equipment Double insulated equipment COPD Chronic Obstructive Pulmonary Disease EOTV End of test volume ERS European Respiratory Society EX TIME Expiratory Time expressed in seconds time elapsed between the beginning and completion of expiration FEF 25 75 Forced expiratory flow during the middle half 25 75 of the FVC formerly called the maximum middle expiratory flow rate expressed in liters per second This is the most sensitive measure of small airways obstruction typically seen in smokers FEFxx Forced Expiratory Flow at xx point of the FVC expressed in liters per second FET Forced Expiratory Time FEV1 FEV6 Ratio of FEV6 exhaled in one second May be used as a surrogate for FEV1 FVC FEV6 L forced expiratory volume Measured six seconds after commencement of expiration May be used as a surrogate for FVC FEVx FVC The percentage ratio of Forced Expiratory Volume timed to Forced Expiratory Vital Capacity expressed as a percentage FIF 2 1 2 Forced Inspiratory Flow between 200ml and 1200ml Flow of inspired air measured after the first 200ml And during the next 1000ml Glossary of Terms 75 FIF 25 75 Forced Inspiratory flow during the middle half 25 75 of the FIVC expressed in l
21. carefully routed on all QRS Medical Devices to reduce the possibility of patient entanglement or strangulation All numerical graphical and interpretive data should be evaluated with respect to the patient s clinical and historical picture Do not attempt to insert any QRS Medical Device including patient cables directly into an electrical outlet Restoring the database erases all of the data located in Office Medic and replaces it with the data contained in the back up file Data that was acquired after the date of the last back up will be lost and cannot be recovered Once deleted data can only be recovered from the date of your last back up Maintain regular back ups to ensure data is not lost The computer regulates the battery and will provide a warning message to inform the user that the battery is low in order to prevent data loss Do not load any other manufacturer s SCP files The Office Medic program is designed to work only with QRS Diagnostic SCP files Do not use 3rd party applications to review or analyze QRS Diagnostic SCP files Use only QRS approved accessories with QRS devices General Cautions amp Warnings 6 Cautions Disposal Instructions Due to the potential presence of hazardous substances in electrical or electronic equipment DO NOT dispose of QRS Diagnostic medical devices with municipal waste Improper disposal could have an adverse effect on the environment
22. described in the Proper Testing Procedure section Important Ensure the patient does not cover the fabric at the end of the mouthpiece Spirometry 26 5 Select YES to save the test and display the results Select NO to delete the test and return to Spirometry Test Session window Select another test button to perform additional maneuver Select Session Comments to enter text relevant to the session Spirometry 27 About the Spirometry Test Session Window Interp Button Provides an interpretation for the test visible in the test session window For additional information see the Spirometry Interpretation section Print Button Prints the individual test visible in the test session window Delete Button Deletes the individual test visible in the test session window Calibration Check Tab Checks the calibration of the Spirometer and appends the results to the patient s spirometry report For instructions on performing a calibration check see the Spirometry Calibration Check section Session Demographics Tab Select Session Demographics to update patient information This will affect current and future tests only When the session is complete select OK to save the session and return to the patient database Interp Button Print Button Delete Button Calibration Check Session Demographics Spirometry 28 Spirometry Options Select Options Spirometry from the menu bar General Tab Select General to change the graphical in
23. liters second VOLUME 0 5 8 liters Oximetry Saturation 0 100 Pulse Rate 18 to 300 pulses per minute Accuracy BTPS Spirometry FLOW 5 of indication or 200 ml sec whichever is greater for FEF 25 75 and 10 of indication or 300 ml s whichever is greater for PEF VOLUME 3 of indication or 50 ml whichever is greater for FVC and FEV1 10 of indication or 15 L min whichever is greater for MVV Oximetry SpO2 70 100 2 of full scale 1 S D Pulse Rate 3 1 digit Precision BTPS Spirometry FLOW 5 of indication or 150 ml sec whichever is greater for PEF VOLUME 3 of indication or 50 ml whichever is greater for FVC and FEV1 Calibration Spirometry ATS 3 speed or standard calibration check Predicted Normals Spirometry Crapo 1981 Cherniack 1972 Morris 1971 73 Knudson 1983 Polgar 1971 HSU 1979 Roberts 1991 Warwick 1977 ECCS ERS Quanjer 1993 NHANES III 1999 Zapletal 1987 Wang 1993 Quanjer 1995 Tests Performed Spirometry FVC Pre Post Testing Flow Volume Loop MVV SVC Measuring Time Spirometry Up to 30 seconds Printed Scale Spirometry Flow Volume vertical 5cm 1L S horizontal 1cm 1L Volume Time vertical 1cm 1L horizontal 1cm second Sample Rate Spirometry 100 samples sec Resolution Spirometry Flow Rate 2ml sec Volume 1ml Limits of Detection Spirometry Flow Rate 2ml sec Volume 1ml Parameters Measured Spirometry FVC
24. multiplying the number of cigarette packs smoked per day by the number of years the patient has smoked Office Medic Basics 15 Open Ctrl O Select a patient session or test and then select Open to view the selected data Delete Ctrl D Select a patient session or test and then select Delete to delete the selected data Delete All The Delete All option deletes the entire database Warning Once deleted data can only be recovered from the date of your last back up Maintain regular back ups to ensure data is not lost Print to File Creates an image file either JPEG TIFF or PDF of an Office Medic report Highlight the session or test in the patient tree and select this option Note The default location for image files is My Documents Diagnostic Test Data Image Files Batch Print The Batch Print option allows for the printing of multiple patient reports Print Preview Reports can be previewed by selecting the desired session or test and then select File Print Preview Print Ctrl P Select a patient session or test and select File Print to print a report Refresh Patient Tree F5 Select to refresh the patient database Database Connection Select to switch between local and network databases Exit Exits the Office Medic program Office Medic Basics 16 Test Menu Select a patient and then select the desired test from the Test menu to begin testing For details on spirometry testing see Performing a Spirometry T
25. patient databases For information about unattended remote synchronization with your Pocket PC see the General Options section MedicSync is designed to work with Microsoft ActiveSync version 3 5 or higher Before using MedicSync you should upgrade ActiveSync if necessary ActiveSync is a free download from the Microsoft website Important You should close all other applications on your PC before beginning a MedicSync session For details on the spirometry tools see Spirometry Tools Office Medic Basics 20 Help Menu User s Manual Opens the Office Medic User Manual ECG Physician s Guide Opens the Physician s Guide for the ECG interpretation algorithm About QRS Provides information for contacting QRS Diagnostic About Office Medic Displays the version of Office Medic and statistics about any connected device Spirometry 20 Spirometry Note The information in this chapter applies to spirometry tests acquired using an Orbit Portable Spirometer SpiroCard or SpirOxCard Spirometry Cautions amp Warnings Warnings Use only QRS mouthpieces manufactured to meet calibration requirements for the QRS Orbit Portable Spirometer SpiroCard or SpirOxCard Mouthpieces are single patient use only and MUST be replaced for each patient Exercise caution when performing spirometry testing on patients with a history of COPD Do not use mouthpieces on a patient with an injured mouth Do not obstru
26. the ECG Zoom Out Reduces the ECG Next Lead Previous Lead Scrolls through recorded leads Show Measurements Turns the averaged complex s measurements On and OFF Show Grid Turns the grid lines on and off Show Averaged Complexes Switches between averaged complexes and 10 second lead strip displays Show Toolbar NA Displays or removes the toolbar Show Measurements Panel NA Displays or removes the summary measurements panel Show Control Panel NA Displays or removes the Control Panel Electrocardiography 67 ECG Options Menu Menu Item Icon Function Cursor or Toggles the cursor between the Zoom tool used to increase or decrease the ECG display or the Measure tool used for on screen calipers Measurement Units NA Selects Millimeters or MicroVolts Filter Muscle Filter Activates the Muscle Filter Power Filter Activates the Mains Filter The Hz are set in the ECG Options Speed Changes the number of millimeters that are passed in one second The available options are 12 5mm s 25mm s and 50mm s Sensitivity Changes the number of millimeters that represent one millivolt The available options are 5mm mV 10mm mV and 20mm mV Edit Lead Order NA Select Edit Lead Order to change the lead order Remove Analysis NA Removes the detailed measurements The narrative interpretation and comments remain unchanged Re analyze NA Resets the interpretation to its original sta
27. 0 00013497 H cm 2 FEV1 FEV6 91 229 0 1558 A yrs 100 FEF25 75 L Sec 2 5379 0 43755 A yrs 0 012154 A yrs 2 0 00008572 H cm 2 PEF L Sec 1 2398 0 16375 A yrs 0 00019746 H cm 2 FEMALE Black African American 18 80 years 53 5 70 9 in 136 180 cm FVC L 0 3039 0 00536 A yrs 0 000265 A yrs 2 0 00013606 H cm 2 FEV1 L 0 3433 0 01283 A yrs 0 000097 A yrs 2 0 00010846 H cm 2 FEV1 FVC 91 655 0 2039 A yrs 100 FEV6 L 0 1981 0 00047 A yrs 0 00023 A yrs 2 0 00013497 H cm 2 FEV1 FEV6 91 229 0 1558 A yrs 100 FEF25 75 L Sec 2 0828 0 03793 A yrs 0 00008572 H cm 2 PEF L Sec 1 3597 0 03458 A yrs 0 000847 A yrs 2 0 00019746 H cm 2 MALE Hispanic Mexican American 8 19 years 47 2 70 9 in 120 180 cm FVC L 0 7571 0 0952 A yrs 0 006619 A yrs 2 0 00017823 H cm 2 FEV1 L 0 8218 0 04248 A yrs 0 004291 A yrs 2 0 00015104 H cm 2 FEV1 FVC 90 024 0 2186 A yrs 100 FEV6 L 0 6646 0 1127 A yrs 0 007306 A yrs 2 0 0001784 H cm 2 FEV1 FEV6 89 388 0 1534 A yrs 100 FEF25 75 L Sec 1 3592 0 10529 A yrs 0 00014473 H cm 2 PEF L Sec 0 9537 0 19602 A yrs 0 014497 A yrs 2 0 00030243 H cm 2 MALE Hispanic Mexican American 20 80 years 61 4 75 6 in 156 192 cm FVC L 0 2376 0 00891 A yr
28. 25 75 6 0 013 2 007 0 109 1 949 0 097 0 055 7 0 062 2 385 0 144 2 243 0 084 0 132 8 0 055 2 381 0 137 2 239 0 079 0 152 0 247 1 668 9 0 039 2 351 0 123 2 222 0 084 0 128 0 254 1 710 10 0 068 2 458 0 161 2 364 0 092 0 097 0 195 1 933 11 0 120 2 617 0 223 2 558 0 102 0 061 0 161 2 091 12 0 174 2 776 0 264 2 709 0 090 0 067 0 185 2 120 13 0 061 2 576 0 153 2 535 0 093 0 040 0 294 1 976 14 0 139 2 208 0 046 2 178 0 096 0 026 0 450 1 711 15 0 210 2 099 0 148 2 008 0 062 0 093 0 581 1 486 16 0 226 2 097 0 181 1 972 0 048 0 120 0 654 1 366 17 0 214 2 146 0 176 1 992 0 038 0 154 0 688 1 290 18 0 195 2 179 0 152 2 031 0 069 0 096 0 520 1 622 Spirometry 46 FEMALE Black 6 18 years Age years FVC FEV1 FEV1 FVC FEF25 75 6 0 172 2 117 0 288 2 182 0 109 0 059 7 0 135 2 132 0 250 2 158 0 104 0 030 8 0 176 2 362 0 276 2 295 0 103 0 066 0 283 2 990 9 0 200 2 452 0 294 2 330 0 097 0 104 0 025 2 062 10 0 230 2 571 0 344 2 507 0 120 0 043 0 051 2 028 11 0 204 2 526 0 308 2 460 0 089 0 105 0 078 2 006 12 0 107 2 342 0 219 2 312 0 115 0 021 0 225 1 804 13 0 042 2 294 0 117 2 196 0 051 0 148 0
29. 418 1 504 14 0 105 2 021 0 041 1 920 0 063 0 103 0 574 1 257 15 0 253 1 787 0 203 1 662 0 043 0 139 0 599 1 281 16 0 111 2 098 0 129 1 824 0 022 0 188 0 653 1 175 17 0 205 1 930 0 273 1 547 0 048 0 342 0 713 1 067 18 0 042 2 423 0 084 2 259 0 197 0 145 0 209 2 896 Spirometry 47 Lung Age Calculation Lung age is calculated for patients 20 84 years old Lung age is equal to the predicted FEV1 that matches the patient s actual FEV1 For example Predicted equation Crapo Patient demographics Height 5ft 10in Age 46 years Gender Male Race Caucasian Actual FEV1 4 49L Predicted FEV1 4 05L Patient s Lung Age 28 years Based on Crapo s predicted equation the patient s actual FEV1 4 49L is equal to the predicted FEV1 of a 28 year old Therefore the patient s lung age is 28 years old Note Lung age may differ based on the predicted equation selected Morris JF Temple W Spirometric lung age estimation for motivating smoking cessation Prev Med 1985 Sep 14 5 655 62 Note Lung age not available dialog box may appear when certain predictors and ages are selected because they are not supported for this function Spirometry 48 Spirometry Interpretation Note A disclaimer is provided on all spirometry reports All test results should be evaluated by a qualified physician Enright 1997 Office Spirometry A Practical Guid
30. 42 1 738 12 0 061 2 649 0 161 2 512 0 101 0 133 0 165 1 982 13 0 175 2 924 0 292 2 843 0 116 0 085 0 007 2 396 14 0 219 3 060 0 329 2 983 0 106 0 087 0 014 2 483 15 0 079 2 859 0 141 2 709 0 060 0 155 0 241 2 163 16 0 104 2 591 0 062 2 409 0 045 0 178 0 503 1 764 17 0 253 2 374 0 262 2 099 0 008 0 272 0 762 1 368 18 0 296 2 316 0 251 2 129 0 054 0 170 0 678 1 528 Spirometry 45 MALE Black 6 18 years Age years FVC FEV1 FEV1 FVC FEF25 75 6 0 088 1 961 0 166 1 723 0 091 0 152 7 0 040 2 040 0 122 1 846 0 091 0 153 8 0 094 2 323 0 225 2 271 0 118 0 104 0 097 1 544 9 0 074 2 308 0 142 2 059 0 079 0 218 0 255 1 248 10 0 110 2 417 0 157 2 117 0 047 0 303 0 230 1 428 11 0 138 2 453 0 176 2 166 0 048 0 263 0 256 1 438 12 0 224 2 710 0 307 2 548 0 084 0 162 0 085 1 936 13 0 342 2 975 0 486 2 962 0 141 0 018 0 121 2 476 14 0 337 3 035 0 472 3 010 0 123 0 050 0 115 2 536 15 0 226 2 889 0 318 2 789 0 070 0 140 0 170 2 120 16 0 058 2 425 0 074 2 140 0 018 0 289 0 663 1 299 17 0 148 2 310 0 053 2 223 0 095 0 087 0 505 1 618 18 0 152 2 341 0 130 2 121 0 041 0 190 0 859 1 053 FEMALE White 6 18 years Age years FVC FEV1 FEV1 FVC FEF
31. 561 PEFR 0 0913 H in 0 01776 A yrs 1 1316 MVV 2 13844 H in 0 68503 A yrs 4 86957 ROBERTS 1991 Roberts Michael C et al Reference values and prediction equations for normal lung function in non smoking white Spirometry 38 urban population Thorax 1991 46 643 650 MALE 18 86 years 63 4 77 2 in 161 196 cm FVC L 0 06628 H cm 0 028 A yrs 5 377 FEV1 L 0 03961 H cm 0 033 A yrs 1 558 FEV1 FVC 0 21476 H cm 0 242 A yrs 126 252 100 PEFR 0 05317 H cm 0 062 A yrs 3 884 FEF50 L sec 0 044 A yrs 6 456 FEMALE 18 86 years 57 5 69 7 in 146 177 cm FVC L 0 04321 H cm 0 023 A yrs 2 379 FEV1 L 0 03321 H cm 0 025 A yrs 1 394 FEV1 FVC 0 172 A yrs 88 134 100 PEFR 0 04087 H cm 0 05 A yrs 2 945 FEF50 L sec 0 038 A yrs 5 556 KNUDSON 1983 Knudson Ronald J et al Change in the Normal Maximum Expiratory Flow Volume Curve with Growth and Aging American Review of Respiratory Disease 1983 127 5 6 725 734 MALE 6 11 years 44 61 in 111 8 154 9 cm FVC L 0 0409 H cm 3 3756 FEV1 L 0 0348 H cm 2 8142 FEF50 L sec 0 0378 H cm 2 5454 FEF75 L sec 0 0171 H cm 1 0149 FEF25 75 L sec 0 0338 H cm 2 3197 FEV1 FVC 100 4389 0 0813 H cm MALE 12 24 years 55 76 in 139 7 193 0 cm FVC L 0 059 H cm
32. 60 hPa Power Supply 5 Vdc 5 100 mA or less from the host PC USB Port Operating Conditions Temperature 15 to 40 C 59 to 104 F Relative Humidity 10 to 90 non condensing Atmospheric Pressure 700 1060 hPa Spirometry Measurement Principle The pressure is converted to flow Volume measurement by flow integration Measurement Time FVC 60 sec SVC 60 sec MVV 15 sec Sampling Rate 125 Hz Range BTPS FLOW 14 liters second VOLUME 0 5 8 0 liters Accuracy BTPS FLOW FEF 25 75 5 of indication or 200 ml sec whichever is greater PEF 10 of indication or 300 ml sec whichever is greater VOLUME 3 of indication or 50 ml whichever is greater for FVC and FEV1 FVC and FEV1 3 of indication or 50 ml whichever is greater MVV 10 of indication or 15 L min whichever is greater Precision BTPS FLOW PEF 5 of indication or 150 ml sec whichever is greater VOLUME FVC and FEV1 3 or 50 ml whichever is greater Minimum Tracing Size FLOW VOLUME Flow vertical 5 mm L S Volume horizontal 10 mm L VOLUME TIME Volume vertical 10 mm L Time horizontal 20 mm S Calibration ATS 3 speed or standard calibration check Predicted Normals ADULT FVC Crapo 1981 Cherniack 1972 Morris 1971 73 Knudson 1983 Roberts 1991 ECCS ERS Quanjer 1993 NHANES III 1999 PEDIATRIC FVC Hsu 1979 Knudson 1983 Polgar 1971 Warwick 1977 NHANES
33. 74 A yrs 0 001023 A yrs 2 0 00022203 H cm 2 ZAPLETAL 1987 Zapletal A Lung Function in Children and Adolescents Methods Reference Values Progress in Respiration Research Vol 22 1987 MALE 6 18 years 42 1 71 7 in 107 182 cm FVC L 10 2 9236 2 936 log H cm 1000 FEV1 L 10 2 8652 2 8729 log H cm 1000 FEV1 FVC 90 6043 0 04104 H cm 100 FEF25 L Sec 10 4 0164 2 1541 log H cm FEF50 L Sec 10 4 2168 2 1771 log H cm FEF75 L Sec 10 4 5808 2 2116 log H cm FEF25 75 L Sec 10 4 6651 2 3588 log H cm PEFR L Sec 10 4 3722 2 3422 log H cm SVC L 10 2 5768 2 7799 log H cm 1000 MVV L Min 10 1 9178 3 0388 log H cm 1000 FEMALE 6 18 years 42 1 71 7 in 107 182 cm FVC L 10 2 704 2 8181 log H cm 1000 FEV1 L 10 2 6056 2 7413 log H cm 1000 FEV1 FVC 90 6043 0 04104 H cm 100 FEF25 L Sec 10 4 0164 2 1541 log H cm FEF50 L Sec 10 4 2168 2 1771 log H cm FEF75 L Sec 10 4 5808 2 2116 log H cm FEF25 75 L Sec 10 4 6651 2 3588 log H cm PEFR L Sec 10 4 3722 2 3422 log H cm SVC L 10 2 297 2 6361 log H cm 1000 MVV L Min 10 1 9178 3 0388 log H cm 1000 QUANJER 1995 Quanjer PhH et al Spirometric Values for White European Children and Adolescents Polgar Revisite
34. FVC L 0 1933 0 00064 A yrs 0 000269 A yrs 2 0 00018642 H cm 2 FEV1 L 0 5536 0 01303 A yrs 0 000172 A yrs 2 0 00014098 H cm 2 FEV1 FVC 88 066 0 2066 A yrs 100 FEV6 L 0 1102 0 00842 A yrs 0 000223 A yrs 2 0 00018188 H cm 2 FEV1 FEV6 87 34 0 1382 A yrs 100 FEF25 75 L Sec 2 7006 0 04995 A yrs 0 00010345 H cm 2 PEF L Sec 1 0523 0 08272 A yrs 0 001301 A yrs 2 0 00024962 H cm 2 FEMALE Caucasian 8 17 years 46 5 70 1 in 118 178 cm FVC L 1 2082 0 05916 A yrs 0 00014815 H cm 2 FEV1 L 0 8710 0 06537 A yrs 0 00011496 H cm 2 FEV1 FVC 90 809 0 2125 A yrs 100 FEV6 L 1 1925 0 06544 A yrs 0 00014395 H cm 2 FEV1 FEV6 90 107 0 1563 A yrs 100 FEF25 75 L Sec 2 5284 0 5249 A yrs 0 015309 A yrs 2 0 00006982 H cm 2 PEF L Sec 3 6181 0 60644 A yrs 0 016846 A yrs 2 0 00018623 H cm 2 FEMALE Caucasian 18 80 years 57 1 70 9 in 145 180 cm FVC L 0 356 0 0187 A yrs 0 000382 A yrs 2 0 00014815 H cm 2 FEV1 L 0 4333 0 00361 A yrs 0 000194 A yrs 2 0 00011496 H cm 2 FEV1 FVC 90 809 0 2125 A yrs 100 FEV6 L 0 1373 0 01317 A yrs 0 000352 A yrs 2 0 00014395 H cm 2 FEV1 FEV6 90 107 0 1563 A yrs 100 FEF25 75 L Sec 2 367 0 01904 A yrs 0 0002 A yrs 2 0 00006982 Spirometry
35. IES EXPRESSED OR IMPLIED INCLUDING WARRANTIES OF MERCHANTABILITY AND FITNESS AND IS HEREBY LIMITED TO REPAIR OR REPLACEMENT OF INSTRUMENTS FOUND DEFECTIVE DURING THE WARRANTY PERIOD AN AUTHORIZED QRS DIAGNOSTIC AGENT MUST MAKE ALL REPAIRS INSTRUMENTS SENT BY MAIL OR COMMON CARRIER SHOULD BE INSURED AGAINST LOSS OR DAMAGES AS THEY ARE NOT COVERED BY THIS WARRANTY Technical support on software is under warranty for 1 year This includes ECG lead wires A software support package is available after 1 year at an additional cost Glossary of Terms 74 Glossary of Terms PRED Ratio of patient s actual results compared to predicted normal values expressed as a percentage Abnormality is defined by using one standard deviation for each variable rather than any specific percentage below the predicted value Results above 100 are above average ATS American Thoracic Society a scientific medical organization active in pulmonary research and care of patients with lung diseases The ATS has recommended standards for spirometers BF Equipment Degree of protection against electrical shock Bronchodilator A type of drug i e Albuterol usually administered in an aerosol spray that is used to dilate air passages to reduce any restrictions to airflow BTPS Body Temperature and Pressure Saturated A number which uniformly expresses all Spirometry results at body temperature and pressure fully saturated with water Calibration
36. Medic CD ROM If the autorun feature on your computer is disabled go to the next instruction If not follow the on screen prompts 5 On the lower Windows toolbar select Start Run 6 Type d setup exe in the Open dialog box Note substitute the letter of your CD ROM drive if it is different from d 7 Select a language Note If you install an incorrect language you will need to uninstall Office Medic To do this go to your control panel click on Programs and Features and then find the Programs and select Uninstall a program Find Office Medic on the list and uninstall Finally reinstall Office Medic using the setup program and select the correct language Any data that was recorded will be preserved because uninstallation doesn t delete data 8 Follow the on screen instructions Office Medic Basics 11 Note You will be given a choice to install a local or network database The Network option requires an IDMS database To learn more about obtaining an IDMS database and networking Office Medic contact Technical Support An Office Medic shortcut will appear on your desktop when the installation is complete 9 Once the installation is complete connect the medical device to the PC with the CD ROM still inserted Follow the software prompts for installing the device driver Office Medic Basics 12 Backing up and Restoring the Database Database Back up Instructions Backing up your database protects you from los
37. Y TEST 52 OXIMETRY OPTIONS 53 OXIMETER CALIBRATION 53 ELECTROCARDIOGRAPHY 54 ECG CAUTIONS AND WARNINGS 54 ECG GETTING STARTED 56 PERFORMING AN ECG TEST 57 ABOUT THE ACQUISITION WINDOW 59 ECG OPTIONS 61 REVIEWING AN ECG 64 PRINTING AN ECG 70 ECG DEVICE VERIFICATION 71 ECG ANALYSIS PROGRAM 71 SERVICE INFORMATION 72 DEVICE CARE amp MAINTENANCE 72 SERVICE 73 LIMITED WARRANTY 73 GLOSSARY OF TERMS 74 DEVICE SPECIFICATIONS 77 SPIROCARD SPECIFICATIONS 77 SPIROXCARD SPECIFICATIONS 78 UNIVERSAL ECG SPECIFICATIONS 79 ORBIT PORTABLE SPIROMETER SPECIFICATIONS 80 General Cautions amp Warnings 4 General Cautions amp Warnings Before conducting tests read the General Caution amp Warnings and the specific Cautions amp Warnings pertaining to your particular medical device If you need further assistance see Service Glossary of Symbols Attention Consult Accompanying Documents Consult Instructions For Use Consult Accompanying Documents Consult Instructions For Use Consult Accompanying Documents Type BF Equipment Type B equipment with an
38. You will be informed when the patient has met the ATS ERS 2005 repeatability criteria when Three maneuvers have been accepted and The two highest FVC values from any of the maneuvers are within 150ml and the two highest FEV1 values from any of the maneuvers are within 150ml For tests with an FVC of 100ml both of these values are 100ml An ATS ERS 2005 warning will be displayed if more than 8 maneuvers are performed on a patient You will be informed when the patient has met the BTS NICE 2004 05 repeatability criteria when Three maneuvers have been accepted and The two highest FVC values from any of the maneuvers are within 100ml or 5 and the two highest FEV1 values from any of the maneuvers are within 100ml or 5 Spirometry 25 Performing a Spirometry Test 1 Prepare the patient as described in the Proper Patient Preparation section 2 Select the patient and then select Test Spirometry or the icon The Spirometry Test Session screen will appear Select one of the test buttons to conduct a maneuver Important Ensure correct patient is selected 3 Enter the Mouthpiece Number Enter the number on the mouthpiece label following the sign 4 Perform the Maneuver After the mouthpiece number is entered select OK when ready to test Two circles will flash red and yellow When both circles become green instruct the patient to begin the maneuver Ensure proper testing procedures are being followed as
39. and human health For QRS Diagnostic products NOT marked with please contact your local municipal waste company for proper disposal instructions For QRS Diagnostic products MARKED with please contact your local sales representative from whom you purchased the product or your local municipal waste company for proper disposal instructions Federal USA law restricts this device to sale by or on the order of a physician All QRS Devices are intended for use by a physician or by trained personnel under a physician s supervision Read all instructions for use and specifications provided prior to use Important QRS Diagnostic medical devices are intended for use in the electromagnetic environment s specified below Users of this equipment should ensure that it is used in such environment s General Cautions amp Warnings 7 Attention should be paid to the following EMC information prior to installing or using QRS Diagnostic medical devices Portable and mobile Radio Frequency RF communication equipment may interfere with the operation of QRS Diagnostic medical devices QRS Diagnostic medical devices have been tested and found to comply with IEC EN 60601 1 2 Computers cables and accessories not tested to 60601 1 2 may result in increased emissions or decreased immunity of QRS devices Verify normal operation if utilizing QRS Diagnostic medical devices adjacent to or stacked with other electrical e
40. based on printed 3x4 report with software filters off and using 1 1 scale 300dpi printer Frequency and impulse response have been evaluated according to methods A B and C of EC11 1991 3 2 7 2 4 2 7 2 Leads Off Indicators Connection status for each lead is shown on Acquisition screen Power Source Can be powered by the PC Serial port control lines in most cases depending on the PC being used Can draw extra power if necessary from a PC USB or PS 2 port Supply Voltage 4 16V DC Supply Current lt 17mA DC Permanent Filters High Pass 0 05Hz 1st order Low Pass 170Hz 1st order Baseline Wander Baseline reset by adaptive zeroing algorithm Notch filter Mains Noise Rejection 50Hz 4th order Butterworth 49 1Hz 50 9Hz 60Hz 4th order Butterworth 59 1Hz 60 9Hz Low pass Muscle Artifact Filter 35Hz 4th order Report Capabilities User selectable Report formats Environmental Conditions Operating Temperature 0 to 40 C 32 to 104 F Storage Temperature 20 to 70 C 4 to 158 F Humidity lt 85 non condensing Device Specifications 80 Orbit Portable Spirometer Specifications Weight 226 8 grams 0 5 lb Dimensions 109 2 mm x 94 0 mm x 43 2 mm 4 3 x 3 7 x 1 7 Communication Port USB Software Compatibility Office Medic Version 5 5 or later Storage Conditions Temperature 15 to 50 C 5 to 122 F Relative Humidity lt 90 non condensing Atmospheric Pressure 700 to 10
41. bjects aged less than 10 years and EOTV gt 40 mL Blast out harder PEF values do not match within 1 0 L s Deeper breath FEV6 values do not match within 150 mL Warning message does not appear Effort meets above criteria Good test session Two acceptable efforts meet the repeatability requirements Spirometry 24 Test Session Grades Each test session is given a grade which indicates the degree of confidence in the results Grade Criteria A At least 2 maneuvers with the largest two FEV1 values matching within 100mL and the largest two FEV6 values matching better than 100mL B At least 2 maneuvers with FEV1 values matching between 101 and 150 mL C At least 2 maneuvers with FEV1 values matching between 151 and 200 mL D Only one maneuver or more than one but the FEV1 values match gt 200mL Unacceptable Spirometry Tests A spirometry test is considered unacceptable when Insufficient initial inhalation lungs not completely filled before the test Slow or hesitant start of expiration Leakage around the mouthpiece or nose clip Mouthpiece obstruction by teeth tongues or lips Coughing during the test Large variation of FVC or FEV1 between tests Other problems as indicated by test evaluation messages displayed by the software Mouthpiece was obstructed during test Obstruction can cause the volume to be unusually high Repeatability
42. cannot be adjusted Spirometry 30 Printing Tab Select Printing to change or activate printing options Print Full Page Graphs Prints two additional pages containing full page F V and V T graphs in the report Overlay Pre Tests Overlays the best three Pretests in Color or Black amp White Note When a Post test is performed the report will overlay the best Pre and best Post test Once a Post test is performed the best three Pretests will not overlay on the report Custom Report Header Select Edit Report Header to create or edit a custom header Select the Custom Report Header checkbox to activate the custom report header Note Report headers contain patient demographics FVC Reports Prints the F V and or V T graphs at the bottom of the report Select the Graph Predicteds options to have the predicted values plot on the F V report Note Predicteds will not plot on V T graphs Spirometry 31 Predictors Tab Select Predictors to change or activate the Predictor options Predictors A first and second Predictor choice is allowed Should a patient fall out of the age or height range of the first choice predictor the second predictor will be used If the patient falls out of range of both predictors no predicted data will be shown See the Predicted Value Equations section for equation parameters Settings Sets a race correction for Blacks and Asians The correction is applied to the predicted value and predicted valu
43. centive displayed Interpretation Turn the Narrative Interpretation and Lung Age options ON and OFF For details on the interpretation criteria see the Spirometry Interpretation section For details on the Lung Age calculation see the Lung Age Calculation section Spirometry Standard Select between the ATS ERS 2005 and the BTS NICE 2004 05 standard Units Select to have results displayed in Liters per second L sec or Liters per minute L min Spirometry 29 Environmental Tab Select Environmental to adjust environmental conditions such as temperature elevation and barometric pressure Elevation Elevation is your altitude above sea level Use this option if you do not have a barometer Elevation with Relative Barometric Pressure The relative barometric pressure is the measured air pressure in your area and varies from day to day Absolute Barometric Pressure Absolute barometric pressure is the true barometric pressure observed at a specific elevation and not corrected for altitude above mean sea level Select Barometric Pressure Units Select the units of barometric pressure in either inches of Mercury Hg millimeters of Mercury mmHg or millibars hPa mb Current Settings Select the Update button to change temperature barometric pressure and elevation data BTPS Options Use BTPS Correction should be turned on when testing patients For calibration testing BTPS is automatically turned off and Room Temperature
44. ct the opening at the end of the mouthpiece Obstruction may result in erroneous results FVC and MVV testing can cause fatigue and some patients may be at risk for vertigo arrhythmia or syncope Patients should open handle and dispose of his her own mouthpiece to reduce the risk of cross contamination If condensation forms inside the pressure tube or the pressure tube becomes visibly kinked it must be replaced Warning The ATS ERS Task Force Standardisation of Lung Function Testing recommends daily calibration checks Cautions Physicians must properly train individuals under their care in the use of this product All tests must be evaluated by a qualified physician Indications for Use Diagnostic Spirometry Patient Population Male Female Pediatric to Adult Device Functionality Diagnostic Spirometry Spirometric Parameters FVC MVV SVC and FEF Environment of Use Hospital Clinical and Home Use Spirometry 21 Spirometry Getting Started For the Orbit Portable Spirometer 1 Insert the USB cable into an available USB Port on your PC 2 Connect the pressure tube to the Luer fitting Ensure the pressure tube is not kinked or restricted in any way 3 Connect the other end of the pressure tube to the disposable mouthpiece For the SpiroCard or SpirOxCard 1 Insert the PC Card into the PC Card Reader 2 Connect the pressure tube to the Luer fitting Ensure the pressure tube is not kinked or
45. d Pediatric Pulmonology 1995 19 135 142 MALE 6 18 years LnFVC l 1 2782 1 3731 0 0164 A yrs H m LnFEV1 l 1 2933 1 2669 0 0174 A yrs H m Spirometry 44 43 3 80 7 in 110 205 cm FEV1 FVC 86 2 FEMALE 6 18 years 43 3 72 8 in 110 185 cm LnFVC l 1 4507 1 4800 0 0127 A yrs H m LnFEV1 l 1 5974 1 5016 0 0119 A yrs H m FEV1 FVC 88 9 WANG 1993 Wang Xiaobin et al Pulmonary Function Between 6 and 18 Years of Age Pediatric Pulmonology 1993 15 75 88 MALE White 6 18 years 43 3 74 8 in 110 190 cm MALE Black 6 18 years 47 2 74 8 in 120 190 cm FEMALE White 6 18 years 43 3 70 9 in 110 180 cm FEMALE Black 6 18 years 47 2 70 9 in 120 180 cm LnFVC L lnHt m LnFEV1 L lnHt m LnFEV1 FVC L lnHt m LnFEF25 75 L s lnHt m Refer to the Wang look up tables for and Wang look up tables MALE White 6 18 years Age years FVC FEV1 FEV1 FVC FEF25 75 6 0 024 2 470 0 109 2 252 0 078 0 248 7 0 018 2 489 0 104 2 270 0 086 0 220 8 0 005 2 443 0 089 2 257 0 091 0 199 0 264 1 505 9 0 017 2 426 0 063 2 197 0 086 0 206 0 308 1 443 10 0 030 2 407 0 057 2 212 0 081 0 209 0 290 1 557 11 0 009 2 468 0 093 2 324 0 101 0 147 0 2
46. e Equations Predicted Study Summary Table Reference Abbreviation Gender Age Range yrs Height Range Caucasian Black Mexican American Asian FVC FEV1 FEV1 FVC FEV6 FEV1 FEV6 FEF25 75 PEFR FEF25 FEF50 FEF75 MVV SVC FEV0 5 FEV3 FEV3 FVC FET FIVC NHANES III 1999 Nh M 8 19 48 75 6 in 122 192 cm X X X X X X X X M 8 19 48 76 4 in 122 194 cm X X X X X X X X M 8 19 47 2 70 9 in 120 180 cm X X X X X X X X M 20 80 62 2 76 4 in 158 194 cm X X X X X X X X M 20 80 62 2 77 2 in 158 196 cm X X X X X X X X M 20 80 61 4 75 6 in 156 192 cm X X X X X X X X F 8 17 46 5 70 1 in 118 178 cm X X X X X X X X F 8 17 46 5 72 4 in 118 184 cm X X X X X X X X F 8 17 44 9 67 7 in 114 172 cm X X X X X X X X F 18 80 57 1 70 9 in 145 180 cm X X X X X X X X F 18 80 53 5 70 9 in 136 180 cm X X X X X X X X F 18 80 53 5 67 7 in 136 172 cm X X X X X X X X ECCS ERS Quanjer 1993 EC M 18 70 61 76 8 in 155 195 cm X X X X X X X X X X F 18 70 57 1 70 9 in 145 180 cm X X X X X X X X X X Wang 1993 Wg M 6 18 43 3 74 8 in 110 190 cm X X X X X M 6 18 47 2 74 8 in 120 190 cm X X X X X F 6
47. e LLN The software default is 12 for Blacks and 6 for Asians Enter 0 if you do not want to correct for race Spirometry 32 Optional Parameters Tab Select Optional Parameters to set the parameters displayed on reports Spirometry 33 Spirometry Tools Spirometry Calibration Check There are two methods for accessing and storing the Calibration test 1 Select Tools Spirometry Perform Calibration Check This method stores the calibration report chronologically under Calibration Data in the Patient Directory window 2 Select Calibration Check within a test session window This method appends the calibration results to the patient s spirometry test report There are two methods of calibration Standard A single volumetric test ATS ATS 3 speed flow and volume test Note The Spirometer does not require a calibration check in order to operate Spirometry 34 To check calibration Orbit Portable Spirometer 1 Insert the USB cable into the USB port 2 Connect the pressure tube to the Luer fitting 3 Connect the pressure tube to the mouthpiece 4 Connect a syringe to the mouthpiece recommended 3 liter syringe Note The calibration syringe must form a tight seal around the mouthpiece If you are unable to get a tight seal contact Technical Support for more information 5 Select the desired calibration check For standard calibration select Begin Stnd enter the mouthpiece number and the
48. e mouthpiece into their mouth and exhale forcefully and completely If a Flow Volume Loop is desired verbally instruct the patient to inhale after completely exhaling SVC instruct the patient to take the largest possible inhalation insert the mouthpiece into their mouth and exhale slowly and completely MVV instruct the patient to breathe as deeply and rapidly for 12 to 15 seconds into the mouthpiece This test is often difficult to perform for many patients Important Ensure the patient has a tight seal around the mouthpiece and is not covering or obstructing the fabric at the end of the mouthpiece with their hand Encourage the patient to keep exhaling as long as possible It is helpful to coach the patient with verbal commands and physical gestures A proper expiration should last at least six seconds Once finished have the patient remove the mouthpiece and breathe normally until they have recovered Important Using the mouthpiece more than 20 times or for more than 10 consecutive days may generate inaccurate results Use a new mouthpiece after 20 attempts and or 10 days to get the most accurate results Spirometry 23 Effort Quality Messages for Adult Subjects Warning Message Criteria Don t hesitate BEV Ext Vol gt 150 mL or 5 of the FVC Blast out faster PEFT gt 120 msec Blow out longer FET lt 6 0 s for subjects aged 10 years and older or FET lt 3 s for su
49. e to the Selection and Use of Spirometers by Paul L Enright M D Robert E Hyatt M D 1987 FEV1 FVC lt LLN FEV1 gt LLN FEV1 gt 65 of predicted FEV1 gt 50 of predicted FVC lt LLN No Borderline Obstruction Mild Obstruction Moderate Obstruction Severe Obstruction FVC gt 65 of predicted FVC gt 50 of predicted Sever Restiction Normal Spirometry Mild Restriction Moderate Restriction FVC lt LLN and low vital capacity cannot rule out superimposed restriction Yes Yes No No No Yes Yes Yes No No No Yes Yes Yes Spirometry 49 BTS NICE 2004 05 The British Thoracic Society BTS COPD Consortium Spirometry in Practice A Practical Guide to Using Spirometry in Primary Care Second Edition April 2005 National Institute for Clinical Excellence NICE Chronic obstructive pulmonary disease Management of chronic obstructive pulmonary disease in adults in primary and secondary care Clinical Guideline 12 February 2004 Developed by the National Collaborating Centre for Chronic Conditions FEV1 lt 80 of predicted FEV1 lt 50 of predicted FEV1 lt 30 of predicted FEV1 and FVC lt 80 of predicted Normal Spirometry Mild Obstruction Moderate Obstruction Restrictive Disorder Severe Obstruction No Yes Yes Yes No No Yes FEV1 FVC lt 0 7 70 Yes Normal Spirometry No No Spi
50. est For details on oximetry testing see Performing an Oximetry Test For details on ECG testing see Performing an ECG Test Office Medic Basics 17 Options Menu Select Options to change program settings General Options Office Medic Basics 18 Units Select Imperial or Metric Export File Creates tab delimited ASCII text files Session txt SpTest txt SpCalibr txt OxiSess txt and OxiTest txt The Export Flow Volume Points feature creates two files called SpGraph txt and SpCalGr txt Image File Directory Select the browse button to change the default path where image files are saved Allow remote handhelds to initiate unattended synchronization sessions MedicSync will launch automatically on the host computer and execute the existing handheld synchronization profile automatically within 30 seconds If a conflict occurs the handheld database will always overwrite the host computer database as no manual conflict resolution is available when using unattended synchronization Note If the host computer is set to delete data from the remote then data will be deleted from the remote during an automatic synchronization For details on changing the spirometry options see Spirometry Options For details on changing the oximetry options see Oximetry Options For details on changing the ECG options see ECG Options Office Medic Basics 19 Tools Menu General Tools MedicSync MedicSync synchronizes data between QRS
51. f abnormal performance is observed additional measures may be necessary such as reorienting or relocating QRS medical devices b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Recommended separation distances between portable and mobile RF communications equipment and QRS Diagnostic medical devices QRS Diagnostic medical devices are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of QRS Diagnostic medical devices can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and QRS Diagnostic medical devices as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter 150 kHz to 80 MHz 1 2 80 MHz to 800 MHz 1 2 800 MHz to 2 5 GHz 2 3 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufactu
52. g with a 10 second single channel rhythm strip 6X1 Format 2 Page Prints a ten second trace of each channel 2 page report 6X2 Format 1 Page Prints a five second trace of each channel 1 page report Measurements table Prints a chart with amplitude slope and duration data for all twelve channels Include Allows you to select whether to include Measurements Interpretation and or Comments in the report s Speed and Sensitivity Allows you to select the Speed 12 5 25 or 50mm s and Sensitivity 5 10 or 20 mm mV of the ECG reports Minor grid Allows you to select the minor grid Lines Dots or None Note when printing to a low resolution printer select Dots or None for the minor grid Electrocardiography 71 ECG Device Verification A periodic check of the ECG system with an ECG simulator is recommended Intervals for these checks can be set at the discretion of your Medical Director There are commercially available ECG simulators which may be used for this purpose refer to the accompanying information for instructions on the use of these For further information on device verification contact QRS Diagnostic at www QRSdiagnostic com ECG Analysis Program Office Medic provides analysis and interpretation of 12 channel ECGs This is based on algorithms developed by Cardionics S A For further information consult the ECG Physician s Guide What to expect from the analysis program The ECG Analysis Program provides an a
53. gnostic Service department with questions related to device damage and repair Service Information 73 Service Contact the QRS Diagnostic service department QRS Diagnostic 6901 East Fish Lake Rd Suite 188 Maple Grove MN 55369 USA Monday through Friday 8am to 5pm CST Phone 763 559 8492 Fax 763 559 2961 email support QRSDiagnostic com A Return Merchandise Authorization RMA number will be issued for repairs THE INSTRUMENT MUST BE RETURNED FOR REPAIRS AT THE EXPENSE OF THE PURCHASER IN WARRANTY REPAIRED UNITS ARE RETURNED AT THE EXPENSE OF QRS OR ITS AUTHORIZED AGENT FOR OUT OF WARRANTY WORK THE CUSTOMER IS RESPONSIBLE FOR ALL FREIGHT CHARGES Limited Warranty All instruments sold and supplied by QRS Diagnostic are guaranteed to be free from defects in material and workmanship for a period of 1 year from date of purchase All supplies and accessories carry a 90 day limited warranty This includes oximetry sensors If in the judgment of QRS Diagnostic the instrument is proven to be defective during the warranty period it will be repaired or replaced with no charge for parts or labor This warranty does not cover any instrument that has been damaged by accident misuse abuse or has been altered or repaired by anyone other than an authorized QRS Diagnostic agent This warranty also does not cover any unit that has had the serial number removed defaced or rendered illegible THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANT
54. ing your patient data should a catastrophic event occur Regular back ups of the database should be maintained Follow the steps below to back up the database 1 Close Office Medic 2 Open folder C Program Files Microsoft SQL Server MSSQL 1 MSSQL Data 3 Copy the two files OfficeMedic_Data MDF and OfficeMedic_Log LDF to a secure location This is the back up copy of your Office Medic database Copy these files as often as needed to maintain a current back up file Database Restore Instructions Warning Restoring the database erases all of the data located in Office Medic and replaces it with the data contained in the back up file Data that was acquired after the date of the last back up will be lost and cannot be recovered Follow the steps below to restore the database 1 Close Office Medic 2 Copy and paste the two back up files into the following location C Program Files Microsoft SQL Server MSSQL 1 MSSQL Data 3 Open Office Medic The database should look exactly as it did on the date of the last back up Office Medic Basics 13 Navigation Select the Office Medic icon to open the software The initial screen displays the directory of patients sessions and tests Contact QRS Technical Support for instructions on how to hide patient names Office Medic Basics 14 File Menu New Ctrl N Opens the Patient Information window Required fields are highlighted by an asterisk Note Smoking Pack Years is calculated by
55. ion Yes FEV1 gt 35 of predicted Severe Obstruction Yes Very Severe Obstruction No No Very Severe Restriction No And low vital capacity cannot rule out superimposed restriction FVC lt LLN Yes Oximetry 50 Oximetry Note the information in this chapter applies to oximetry tests acquired using a SpirOxCard Oximetry Cautions amp Warnings Warnings The Oximeter is intended as an adjunct in patient assessment It must be used with respect to the patient s clinical and historical picture Do NOT use the Oximeter as an apnea monitor Use only sensors provided by QRS Diagnostic with QRS SpirOxCard Use of other manufacturer s sensors may adversely affect device performance Check sensor application site frequently to determine circulation positioning and skin sensitivity Tissue damage can result from incorrect application of the sensor Do not use QRS SpirOxCard as a continuous monitoring device There are no visual or audible alarms Readings are for Spot Check and Record purposes only To avoid the risk of cross contamination the sensor must be cleaned between patient uses with isopropyl alcohol All tape residues must also be removed Do not use the SpirOxCard during magnetic resonance imaging MRI scanning Induced current could potentially cause burns The SpirOxCard may affect the MRI image and the MRI unit may affect the accuracy of the oximetry measurements
56. iters per second FIFxx Forced Inspiratory Flow at xx point of the FIVC expressed in liters per second FIVx FIC The percentage ratio of Forced Inspiratory Volume timed to Forced Inspiratory Vital capacity expressed as a percentage Flow vs Volume Curve Graph obtained by forced exhalation test Flow is plotted on the vertical axis and volume on the horizontal axis Forced Expiratory Flow It is the rate of flow expressed in liters per second at various points in the volumetric flow i e FEF25 FEF50 FEF75 Forced Expiratory Volume timed FEV t Maximal volume of air expressed in liters which can be expelled in specific time in a forced capacity test Forced Inspiratory Vital Capacity FIVC Total volume of air expressed in liters which can be inhaled during a rapid forced inhalation after a maximal expiration Forced Inspiratory Flow Inspiratory rate of flow expressed in liters per second at various points in the volumetric flow i e FIF25 FIF50 FIF75 Forced Vital Capacity FVC Total volume of air expressed in liters which can be exhaled during a rapid forced exhalation after a maximal inspiration LLN Lower limit of normal Maximum Voluntary Ventilation MVV The maximum volume of air that can be inhaled and exhaled repeatedly through the lungs over a period of time usually 12 seconds and extrapolated to one minute Obstruction Limitation of airflow It is shown b
57. l mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 lt 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles lt 5 UT gt 95 dip in UT for 5 sec lt 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles lt 5 UT gt 95 dip in UT for 5 sec Mains power quality should be that of a typical commercial or hospital environment If the user of QRS medical devices requires continued operation during power mains interruptions it is recommended that the computer to be used is powered by an uninterruptible power supply or a battery Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Note UT is the a c mains voltage prior to application of the test level General Cautions amp Warnings 8 Conducted RF IEC 61000 4 6 3 Vrms 150 KHz to 80 Mz 3 Vrms Portable and mobile RF Communications equipment should be used no closer to any part of QRS Diagnostic medical devices including cables than the recommended separation distance calculated fro
58. m the equation applicable to the frequency of the transmitter Recommended separation distance 1 2 1 2 80 MHz to 800 MHz 2 3 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency range b Interface may occur in the vicinity of equipment marked with the following symbol Radiated RF IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 3 V m NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which QRS medical devices are used exceeds the applicable RF compliance level above QRS medical devices should be observed to verify normal operation I
59. n the ECG Options Muscle Filter Turns the Muscle filter on and off Stop Stops the real time recording to view the previous 15 minutes of ECG The user can select the desired 10 seconds of ECG and select Save to save and exit the test Record Resumes recording data Once selected all paused data will no longer be available Print Allows you to print all or a selected portion of the stopped ECG This printed report is not intended for diagnostic use or as a patient record for that purpose print from the review window or use Save and Print Elapsed Time Minutes and seconds of current ECG acquisition Status Bar Represents whether 10 seconds of valid ECG data has been received When the status bar is full the Save button is activated and data can then be saved Audible Indication Audibly indicates a leads off status or QRS detection as selected in options Save Saves the test and closes the window Save and Review Saves the test and launches a review of the results Save and Print Saves the test and automatically prints a report or PDF optional Cancel Closes the test without saving Electrocardiography 61 ECG Options Select Options ECG General Tab Select General to set or change general ECG Options Electrocardiography 62 Analysis Tab Select Analysis to set or change the ECG analysis options Acquisition Settings Tab Select Acquisition Settings to se
60. nalysis of the amplitudes duration and morphologies of the ECG waveform The analysis is based upon standards of interpretation of these parameters and calculations of the electrical axis and relationship between leads The interpreted ECG is a tool to assist the physician in making a clinical diagnosis and is not a substitute for the physician s knowledge the patient s history results of the physical exam the ECG tracing or other findings Service Information 72 Service Information Device Care amp Maintenance Cleaning Clean surfaces with a damp cloth using water only Dry thoroughly AVOID CLEANING AROUND CONNECTORS Excess moisture in or on the case cables or air fittings could affect operation Replace vinyl cap when not in use To clean the ECG device wipe the surfaces of the case with a clean cloth moistened in water only To disinfect the ECG device wipe the case with a hospital grade disinfectant Handling Do not insert a dirty PC Card into a PC Card slot Do not insert a dirty USB cable into the USB port Avoid contaminating the Luer connector and connectors of the PC Card Storage Store the Device in a dry place Avoid sudden changes in temperature Physical Shock Avoid physical shock a card that has been dropped should have the calibration verified before use on a patient Inspection Inspect device for damage initially and before each use Do not use devices that show visual signs of damage Contact the QRS Dia
61. quipment Guidance and manufacturer s declaration electromagnetic emissions and immunity Emissions Test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 QRS Diagnostic equipment uses RF energy only for its internal function Therefore its RF emissions are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B QRS Diagnostic medical devices are suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Not applicable for QRS Devices other than Universal ECG Class A for Universal ECG Cable Voltage Fluctuations flicker emissions IEC 61000 3 3 Not applicable Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Electrostatic Discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines 1 kV for input output lines Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV differentia
62. rer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people General Cautions amp Warnings 9 Electrical Safety Classifications Note These classifications currently apply only to QRS Medical Devices Class II Equipment Type BF Equipment Note Universal ECG is Type BF with defibrillator proof applied part IPXO Ordinary Equipment Continuous Operation Not suitable for use in presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide Office Medic Basics 10 Office Medic Basics System Requirements Operating System Microsoft Windows XP or Vista 32 bit or Vista 64 bit or 7 32 bit or 7 64 bit Free Disk Space 600MB Internet Requirements Internet Explorer 6 0 SP1 or later RAM 512 MB or higher Processor Pentium III Compatible or higher 1GHz or higher recommended 500 MHz min Screen Resolution 1024x768 EKG Requirement Installation Important Do not connect the medical device to the PC prior to installing the software The device drivers step 9 must be installed prior to testing 1 Ensure you are logged in with Administrator rights 2 Remove all QRS devices from the computer 3 Log out and close all programs 4 Insert the Office
63. restricted in any way 3 Connect the other end of the pressure tube to the disposable mouthpiece Warning Ensure pressure tube is properly connected If condensation forms inside the pressure tube or the pressure tube becomes visibly kinked it must be replaced Spirometry 22 Proper Patient Preparation To obtain diagnostically reliable results Loosen tight clothing ties belts bras Remove patient s dentures Explain the procedure thoroughly including demonstrating it yourself with your own mouthpiece Have the patient sit or stand in an upright position during the test When standing place a chair behind them in case they become dizzy Before beginning the test have the patient take several slow deep inhalations exhalations to feel comfortable Proper Testing Procedure To obtain diagnostically reliable results proper testing procedures must be followed When the equipment is zeroing two circles flashing have the patient keep the mouthpiece away from their mouth When testing ensure the patient has a tight seal with their lips around the mouthpiece The patient should not bite the tube or have pursed lips Place a disposable nose clip securely on the patient s nose or instruct the patient not to exhale through the nose Verbally instruct the patient on properly performing the procedure FVC instruct the patient to take the largest possible inhalation insert th
64. rodes well clear of other electrodes or metal parts in contact with the patient Do not touch the patient bed or any conductive material in contact with the patient during defibrillation Cautions For diagnostic ECG according to the requirements of the AAMI EC11 1991 standard use factory default settings ECG diagnosis should be based on a printed 3x4 report with software filters off and using a 1 1 scale 300dpi printer The Universal ECG is designed for use with electrodes that comply with AAMI EC12 2000 Reseal electrode pouch after opening to prevent dehydrating Suggested maximum electrode duration is 8 hours Do not clean the case with alcohol Do not saturate or immerse the case with liquid during cleaning Do not sterilize ECG device Electrocardiography 55 ECG Indications for Use Receipt Storage Viewing Printing and Interpretive Analysis of 12 channel simultaneous ECGs Patient Population Adult Male Female Environment of Use Hospital Clinical and Home Use Electrocardiography 56 ECG Getting Started Connecting the 6 or 12 Channel ECG device to your PC There are three methods for connecting the ECG device to the PC Compact Flash CF Card optional Connect the serial connector of the ECG device to the CF Card Insert the CF Card into the CF to PC Card adapter and then insert into the PC Card Reader of your PC RS232 Serial Port You must have an
65. rometry 50 NLHEP 2000 Ferguson GT et al Office Spirometry for Lung Health Assessment in Adults A Consensus Statement from the National Lung Health Education Program NLHEP Chest April 2000 Volume 117 1146 1161 FVC is used in place of FEV6 when the predicted study does not provide an FEV6 predicted value LLN Are both the FEV1 FEV6 and the FEV1 lt LLN FEV1 gt 60 Predicted FEV1 gt 40 of predicted Is FEV6 lt LLN No Mild Obstruction Moderate Obstruction Severe Obstruction Patient has low vital capacity perhaps due to restriction of lung volumes Yes Yes No No Yes Normal Spirometry FEV1 FEV6 gt LLN Yes Yes No Spirometry 51 ATS ERS 2005 ATS ERS Task Force Interpretive strategies for lung function tests Standardisation of spirometry Eur Respir J Nov 2005 26 948 968 FEV1 gt 100 of predicted FEV1 gt 70 of predicted FEV1 gt 60 of predicted FVC lt LLN May be a physiological variant Mild Obstruction Moderate Obstruction Normal Spirometry FEV1 gt 50 of predicted Yes No No No Yes Yes No FEV1 FVC lt LLN Yes No FVC gt 70 Predicted Yes Mild Restriction Yes FVC gt 60 Predicted Moderate Restriction Yes No FVC gt 50 Predicted Moderately Severe Restriction Yes FVC gt 35 Predicted Severe Restriction Yes No No Moderately Severe Obstruct
66. s 0 000182 A yrs 2 0 00017823 H cm 2 FEV1 L 0 6306 0 02928 A yrs 0 00015104 H cm 2 FEV1 FVC 90 024 0 2186 A yrs 100 FEV6 L 0 5757 0 0286 A yrs 0 0001784 H cm 2 FEV1 FEV6 89 388 0 1534 A yrs 100 Spirometry 43 FEF25 75 L Sec 1 7503 0 05018 A yrs 0 00014473 H cm 2 PEF L Sec 0 087 0 0658 A yrs 0 001195 A yrs 2 0 00030243 H cm 2 FEMALE Hispanic Mexican American 8 17 years 44 9 67 7 in 114 172 cm FVC L 1 2507 0 07501 A yrs 0 00014246 H cm 2 FEV1 L 0 9641 0 0649 A yrs 0 00012154 H cm 2 FEV1 FVC 92 360 0 2248 A yrs 100 FEV6 L 1 241 0 07625 A yrs 0 00014106 H cm 2 FEV1 FEV6 91 644 0 1670 A yrs 100 FEF25 75 L Sec 2 1825 0 42451 A yrs 0 012415 A yrs 2 0 0000961 H cm 2 PEF L Sec 3 2549 0 47495 A yrs 0 013193 A yrs 2 0 00022203 H cm 2 FEMALE Hispanic Mexican American 18 80 years 53 5 67 7 in 136 172 cm FVC L 0 121 0 00307 A yrs 0 000237 A yrs 2 0 00014246 H cm 2 FEV1 L 0 4529 0 01178 A yrs 0 000113 A yrs 2 0 00012154 H cm 2 FEV1 FVC 92 36 0 2248 A yrs 100 FEV6 L 0 2033 0 0002 A yrs 0 000232 A yrs 2 0 00014106 H cm 2 FEV1 FEV6 91 664 0 167 A yrs 100 FEF25 75 L Sec 1 7456 0 01195 A yrs 0 000291 A yrs 2 0 0000961 H cm 2 PEF L Sec 0 2401 0 061
67. se and SpO2 for up to 24 hours Quick Test 1 Insert the patient s finger into the clip sensor until the end of the finger reaches the finger stop 2 Place the patient in a relaxed position 3 Select Test Quick Test Oximetry 4 Select OK to end the test Standard Test 1 Insert the patient s finger into the clip sensor until the end of the finger reaches the finger stop 2 Place the patient in a relaxed position 3 A patient must be selected 4 Select Test Oximetry or the icon 5 Select the Record button to begin recording Data will be saved at the interval chosen in Options Oximetry General 6 Recorded data will come into view in the Results window when the Stop button is engaged Select Session Comments to enter text relevant to the session Select SpO2 to view real time data or select OK to end session Select Cancel to end session without saving data Oximetry 53 Oximetry Options Select Options Oximetry from the menu bar Recording Interval Used to save the SpO2 and pulse rate data to the database This can be set at 5 10 30 or 60 second increments Oximeter Calibration The SpirOxCard sensors are calibrated during manufacturing To determine the calibration status contact QRS Technical Support Electrocardiography 54 Electrocardiography ECG Cautions and Warnings Warnings The computerized interpretation is only valid when used in conjunction with clinical findings All computer genera
68. t or change options available for the acquisition window Electrocardiography 63 Review Window Tab Select Review Window to set or change options available for the ECG Review Window Edit Lead Order Tab Select Edit Lead Order to change the lead order Note the setting applies to both the acquisition and review windows Electrocardiography 64 Reviewing an ECG Reviewing an ECG within the ECG Review Window Electrocardiography 65 File Menu Menu Item Icon Function Save NA Saves changes Printer Setup NA Opens the print setup window for the default printer Print Prints the ECG test Print Preview NA Previews the hardcopy report Print to File NA Creates an image file JPEG TIFF or PDF of the hardcopy report Close NA Closes open tests without closing the review window Exit NA Closes open tests and exits the review window Electrocardiography 66 View Menu Menu Item Icon Function 12 Lead Selects the 12 lead view of the ECG See 12 Lead View for an example Strips Selects the three lead strip view of the ECG See ECG Strips View for an example Zoom Selects the zoom view of the ECG See Zoom View for an example Details Displays the interpretation comments and detailed measurements See Details View for an example Rhythm Lead Position NA Toggles the Rhythm Lead to the top or the bottom of the screen 12 Lead view only Zoom In Enlarges
69. te and removes all changes made by the user to the narrative interpretation Electrocardiography 68 Views 12 Lead 12 channels of averaged complexes and a rhythm strip Strips Displays ECG strips Use the Leads Shown option to change the number of visible leads Zoom Displays a single lead strip or an averaged complex Electrocardiography 69 Details View The details view shows the interpretation comments detailed measurements and patient details of the ECG Interpretation and Comments Measurements Patient and Recording Details Warning The computerized interpretation provided by the Office Medic software is only valid when used in conjunction with clinical findings All computer generated tracings and interpretations must be confirmed by a qualified physician Electrocardiography 70 Printing an ECG Select File Print or the print icon Print Options Description Single Lead Report Prints a single strip or averaged complex with scale options 1x 2x 4x 8 16x 3X4 Simultaneous Prints 2 5 second segments of all twelve channels displayed at the same point in time along with a 10 second single channel rhythm strip 3X4 Sequential Report Prints 2 5 second segments of all twelve channels displayed at the same point in time progressing in four sequential columns along with a 10 second single channel rhythm strip Average Complexes Print an average QRS complex for all 12 channels alon
70. ted tracings and interpretations must be confirmed by a qualified physician Test interpretations are intended for the physician s use only All ECG numerical and graphical data should be evaluated with respect to the patient s clinical and historical picture The ECG Device is not intended for use in a sterile environment Do not use for direct cardiac application The ECG device is reusable Do not attempt to insert the ECG device including patient cables into an electrical outlet Avoid patient movement to reduce artifact The ECG Device is for acquiring resting ECGs only The device should not be used for stress testing Though false positive errors will intentionally outnumber false negative errors both will occur thus the necessity for over reading by a qualified physician of any computer interpreted ECG The computer interpretation does not produce a definitive diagnosis Ensure electrodes are connected only to patient Conductive parts of electrodes and connectors including neutral electrode should not contact other conductive parts including earth Select a three lead view during defibrillation to ensure signals are clearly separated following electrode polarization Defibrillator warnings Do not touch the patient during defibrillation Do not touch the defibrillator s paddle electrode surface when discharging the defibrillator Keep defibrillation elect
71. tion Testing in Children Techniques and Standards 1971 To determine the Predicted FEV1 FVC value for this predicted set QRS software uses Pred FEV1 Pred FVC MALE 4 17 years 43 3 67 in 110 170 cm FVC L 0 0000044 H cm 2 67 FEV1 L 0 0000021 H cm 2 8 FEF25 75 L min 207 70 2 621 H cm PEFR L min 425 5714 5 2428 H cm MVV 1 276 H cm 99 507 FEMALE 4 17 years 43 3 67 in 110 170 cm FVC L 0 0000033 H cm 2 72 FEV1 L 0 0000021 H cm 2 8 FEF25 75 L min 207 70 2 621 H cm PEFR L min 425 5714 5 2428 H cm MVV 1 276 H cm 99 507 ECCS ERS Quanjer 1993 Quanjer Ph H et al Lung Volumes and Ventilatory Flows Official Statement of the European Respiratory Society European Respiratory Journal 1992 1993 Supplement 15 16 5 40 MALE 18 70 years 61 76 8 in 155 195 cm FVC L 0 0576 H cm 0 026 A yrs 4 34 FEV1 L 0 0430 H cm 0 029 A yrs 2 49 FEV1 FVC 0 180 A yrs 87 21 100 FEF25 L sec 0 0546 H cm 0 029 A yrs 0 47 FEF50 L sec 0 0379 H cm 0 031 A yrs 0 35 Spirometry 41 For subjects aged 18 25 years the predicted mean is the same as for subjects 25 year FEF75 L sec 0 0261 H cm 0 026 A yrs 1 34 FEF25 75 L sec 0 0194 H cm 0 043 A yrs 2 7 PEFR L sec 0614 H cm 0 043 A yrs 0 15 FIVC 0 0610 H cm 0
72. y the FVC test Low FEV1 FVC ratio is the main indication of airways obstruction Reductions in FEV3 FVC and FEF25 75 best demonstrate obstruction of small airways PC Card Also known as a PCMCIA card A standard 68 pin computer card designed to add modular hardware to computers Perfusion Display indicating if the pulse waveform signal is of good quality and the SpO2 data is accurate Peak Expiratory Flow Rate PEFR Maximum instantaneous flow in the FVC test PFT Pulmonary Function Test PEFT Peak Expiratory Flow Time PIFR Peak Inspiratory Flow Rate expressed in liters per second Predictor Predicted value according to the normal equations used Pulmonary Functions Tests see PFT Pulse Rate Heart rate measured in beats per minute bpm Glossary of Terms 76 RR Respiratory Rate the average number of inhalations exhalations per minute performed during a test Signal Intensity Indication displaying the patient s pulse Slow Vital Capacity SVC Total volume of air expressed in liters which can be exhaled during a slow exhalation after a maximal inspiration Amount may be decreased because of disorders that cause volume restriction in the lung SpO2 Approximate percentage of oxygen saturation in hemoglobin Device Specifications 77 Device Specifications SpiroCard Specifications Weight 57 60 grams 0 13 lb Height WxDxH 53mm x 140mm x 16 27mm 2 1 x 5 5 x 0 6 1
73. yrs 112 09 100 FEMALE 17 84 years 57 5 70 1 in 146 178 cm FVC L 0 0491 H cm 0 0216 A yrs 3 59 FEV05 L 0 0238 H cm 0 0185 A yrs 0 809 FEV1 L 0 0342 H cm 0 0255 A yrs 1 578 FEV3 L 0 0442 H cm 0 0257 A yrs 2 745 FEF25 75 0 0154 H cm 0 046 A yrs 2 683 FEV1 FVC 0 202 H cm 0 252 A yrs 126 58 100 FEV3 FVC 0 0937 H cm 0 163 A yrs 118 16 100 WARWICK 1977 80 Warwick WJ Pulmonary Function in Healthy Minnesota Children Minnesota Medicine 1977 Supplement 60 435 440 Warwick WJ Pulmonary Function in Healthy Minnesota Children Minnesota Medicine March 1980 191 195 MALE lt 18 YEARS 35 4 74 in 90 188 cm LnFVC L 3 0131 ln H cm 14 0535 LnFEV1 L 2 7572 ln H cm 12 9007 LnFEV1 FVC 0 2679 ln H cm 1 2137 LnFEF50 L sec 2 1326 ln H cm 9 3589 LnFEF75 L sec 2 1534 ln H cm 10 2213 LnPEFR L sec 2 4991 ln H cm 10 7785 LnFET s 1 6208 ln H cm 7 2327 FEMALE lt 18 YEARS 35 4 70 1 in 90 178 cm LnFVC L 2 9446 ln H cm 13 8007 LnFEV1 L 2 7522 ln H cm 12 921 LnFEV1 FVC 0 2126 ln H cm 0 9719 LnFEF50 L sec 2 1958 ln H cm 9 6458 LnFEF75 L sec 2 2961 ln H cm 10 8666 LnPEFR L sec 2 4369 ln H cm 10 535 LnFET s 1 2423 ln H cm 5 3288 POLGAR 1971 Polgar and Promadhat Pulmonary Func

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