Puritan Bennett Renaissance II User Manual
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Puritan Bennett Renaissance II User Manual

Spirometry system
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Summary of Contents for Puritan Bennett Renaissance II

  • Page 2 WARNING The user should read and understand all product literature, labeling and warnings prior to operating the Renaissance II Spirometry System To obtain information about warranty for this product contact Puritan Bennett Technical Support at: 1-800-255-6774...

  • Page 3: Table Of Contents

    Indicators, Symbols, and Icons........7 Introduction to the Renaissance II Spirometry System ....8 Features .
  • Page 4 Technical References ......... . 57 Product Specifications Renaissance II Spirometer .......57 Product Specifications Renaissance II Base Station .
  • Page 5 Table of Contents Barometric Pressure vs. Altitude ......... . . 87 Glossary of Medical Terminology.

  • Page 6: Listing Of Warnings, Cautions, And Notes

    CAUTION: Cautions alert the user to exercise care necessary for the safe and effective use of the Renaissance II Spirometry System. NOTE: Indicates points of particular emphasis that make operation of the spirometer more efficient or convenient.
  • Page 7 Use Environment Warnings • The Renaissance II Spirometry System is not intended for use in an oxygen-enriched atmosphere or in the presence of flammable anesthetics. • To avoid risk of electrical shock, this unit should only be used in dry locations.
  • Page 8 Federal law restricts this device to sale by, or on the order of, a physician. Use Environment Cautions • Do not use the Renaissance II Spirometry System in areas of high humidity, dust, or in extreme environments. • Place the Renaissance II Spirometry System in a secure location, where it is unlikely to drop or fall.
  • Page 9 Service Caution • Do not remove the cover of the Renaissance II Spirometry System or base. Removal of the cover is permitted only by qualified service personnel. There are no user-serviceable parts inside. •...
  • Page 10 The American Thoracic Society (ATS) recommends performing a three- speed calibration check on a daily basis. • Puritan Bennett recommends that the 3 liter calibration syringe be recertified on an annual basis. • Verify that the temperature of the room is the same as the temperature noted for the calibration test.
  • Page 11 • When there is a low battery condition, the Renaissance II spirometer beeps every 30 seconds and a low battery icon is displayed. •...

  • Page 12: Indicators, Symbols, And Icons

    Figure 1: Renaissance II Spirometry System Indicators, Symbols, and Icons WARNING The Renaissance II Spirometry System is not intended for use in an oxygen- enriched atmosphere or in the presence of flammable anesthetics. CAUTION: Federal law restricts this device to sale by or on the order of a physician.

  • Page 13: Introduction To The Renaissance Ii Spirometry System

    Interference section on page 54 for more information. Intended Use The intended use of the Renaissance II Spirometry System is as a diagnostic tool to measure the maximal volume and flow of air that can be moved in and out of a patient’s lungs. The Renaissance II spirometer obtains the spirometric data by direct measurement of flow via the FSII sensor and pressure tube.

  • Page 14: Basic Spirometry System And Accessories

    17) Printer, Spirometer Compatible Connecting the AC Adapter Connect the AC adapter to the 12-volt DC input jack on the side of the Renaissance II spirometer or on the rear of the base station as shown in P-495220-00 Rev. D...

  • Page 15: Battery Operation

    Introduction to the Renaissance II Spirometry System Figure 3. A green LED indicator will light on the front panel of the Renaissance II spirometer and on the AC adapter when properly connected to an electrical outlet. WARNING • To avoid risk of electrical shock, this unit should only be used in dry locations.

  • Page 16: Connecting The Pressure Tube

    • Remove batteries if spirometer will not be used for at least two weeks. NOTE: Puritan Bennett recommends replacing the NiCad battery pack at least once per year. Connecting the Pressure Tube The Renaissance II spirometer is shipped FSII Flow Sensor with a pressure tube that connects the FSII flow sensor to the spirometer.
  • Page 17 Carefully read the flow sensor directions before use, including all warnings, cautions, and instructions. CAUTION: Do not spray liquids on the Renaissance II System. Follow the cleaning instructions outlined in the Service and Maintenance section starting on page 49 of this manual.

  • Page 18: Keypad Functions And Controls

    Introduction to the Renaissance II Spirometry System Keypad Functions and On/Off is controlled by Controls the key marked "I/O". The keypad functions and On/Off The enter key is used to controls are user friendly and select an option or intuitive. The keypad and Main...

  • Page 19: Initial Configuration

    Refer to System Configuration on page 78 for a complete listing and description of the system configuration settings. Warning The Renaissance II Spirometry System is not intended for use in an oxygen-enriched atmosphere or in the presence of flammable anesthetics.

  • Page 20: Spirometry Testing

    Several occupational related diseases such as “black lung” and “cotton dust lung” also result in a restrictive pattern. In addition to the FVC test, the Renaissance II spirometer can perform Flow- Volume Loop (FVL), Slow Vital Capacity (SVC), Maximal Voluntary Ventilation (MVV), and FEV6 tests.

  • Page 21: Obtaining Good Test Results

    Spirometry Testing Obtaining Good Test Results Unlike many other medical tests in which the patient is passive, spirometry requires active cooperation and strenuous effort by the patient. Obtaining the subject's full understanding and cooperation is essential. The 10 steps to good spirometry results are listed below: •...

  • Page 22: Pre-Test Procedures

    12 (see page 9) for verifying the calibration of the Renaissance II. The syringe should be recertified for volume accuracy and leaks per manufacturer recommended intervals. The Renaissance II can perform two types of calibration verifications: SSD and Cal Check. The SSD calibration verification satisfies both ATS and Social Security Disability requirements for verification at three flow rates.
  • Page 23 Pre-Test Procedures NOTE: If the patient test will be submitted for Social Security Disability (SSD) determinations, enter patient information prior to performing the SSD calibration verification. CAUTION: Prior to verifying calibration, visually verify that there is no foreign material in the pressure tube and the tube is not damaged or kinked. P-495220-00 Rev.
  • Page 24 Pre-Test Procedures 1. From the “MAIN” screen, press 2 on the keypad or scroll to TEST using the cursor key and press ENTER (Figure 8). 2. From the “PRE MED TEST” screen, press 3 on the keypad, or use the cur- sor key to scroll to SSD CAL and press ENTER (Figure 9).
  • Page 25 Pre-Test Procedures Figure 11: Swipe the sensor 10. Follow the directions on the screen and push the 3-Liter syringe plunger in over a period of approximately 6 seconds for the last SSD verifica- tion. 11. The final “SSD CAL” screen (Figure 13) will display the volume of the calibration syringe, the corrected measured volume and associated...

  • Page 26: Cal Check

    Pre-Test Procedures NOTE: Verify that the temperature of the room is the same as the temperature noted for the calibration test. For every degree discrepancy, there will be a corresponding 0.15% error in the test results. NOTE: Verify that the displayed barometric pressure is correct. If not correct, there will be an error in the inspired volume (FIVC) during an FVL maneuver of approximately -1.3% for every 1,000 feet above sea level.
  • Page 27 38 for more information on print- ing. NOTES: • The ATS does not require an Inspiratory Calibration. Figure 17: Cal Check complete • The Renaissance II’s Inspiratory Calibration function has been validated only for elevations below 4000 feet. P-495220-00 Rev. D...

  • Page 28: Patient Preparation

    The American Thoracic Society (ATS) recommends performing a three-speed calibration check on a daily basis. • Materials used to make this Renaissance II Spirometry System and accessories contain no Latex. Verify that the opening of the sensor is not blocked.
  • Page 29 Pre-Test Procedures WARNING • Results from spirometry testing should not be the sole source for determining a patient's diagnosis and treatment. Other clinical data, such as patient symptoms and respiratory history, should always be considered. • Predicted values will be extrapolated for patients with age or height outside the age and/or height limits supported by the selected author’s normal equations.

  • Page 30: Entering New Patient Data

    Entering New Patient Data Entering New Patient Data 1. From the “MAIN” screen press 1 on the keypad or use the cursor key to scroll to the NEW option and press ENTER. 2. When prompted to start a new patient, press the YES soft key. Pressing NO will return you to the “MAIN”...
  • Page 31 Entering New Patient Data 7. If desired, apply an adjustment factor to which the predicted value and LLN calculations will be multiplied. Table 2 lists the factory default set- tings and the range of adjustment. See the article Spirometric Reference (16) Values from a Sample of the General U.

  • Page 32: Pre-Med Testing Procedures

    Pre-Med Testing Procedures Pre-Med Testing Procedures FVC (Forced Vital Capacity) Test Procedure WARNING Patient fainting or falling due to dizziness may occur as a result of this test. Advise the patient to sit or stand comfortably near a chair during test.
  • Page 33 Pre-Med Testing Procedures 5. The spirometer will display an incentive message, such as “Keep Going” or “All the Way” and the elapsed time of the test, while the real-time curve is being drawn. The patient should keep blowing until the TEST COM- PLETE message appears.

  • Page 34: Svc (Slow Vital Capacity) Test Procedure

    Pre-Med Testing Procedures SVC (Slow Vital Capacity) Test Procedure WARNING Patient fainting or falling due to dizziness may occur as a result of this test. Advise the patient to sit or stand comfortably near a chair during test. 1. From the “MAIN” screen, press 2 on the keypad or scroll to TEST using the cursor key and press ENTER.

  • Page 35: Fvl (Flow Volume Loop) Test Procedure

    Pre-Med Testing Procedures FVL (Flow Volume Loop) Test Procedure WARNING Patient fainting or falling due to dizziness may occur as a result of this test. Advise the patient to sit or stand comfortably near a chair during test. 1. From the “MAIN” screen, press 2 on the keypad or scroll to TEST using the cursor key and press ENTER.
  • Page 36 Pre-Med Testing Procedures 5. When the spirometer detects that the expiratory portion of the maneuver is complete, the incentive message will change to "Deep Breath In!" 6. Instruct the patient to inhale as quickly, and fully as possible. 7. The spirometer will continue to display an incentive message and the elapsed time of the test while the real-time curve is drawn.

  • Page 37: Mvv (Maximal Voluntary Ventilation) Test Procedure

    Pre-Med Testing Procedures MVV (Maximal Voluntary Ventilation) Test Procedure WARNING Patient fainting or falling due to dizziness may occur as a result of this test. Advise the patient to sit or stand comfortably near a chair during test. 1. From the “MAIN” screen, press 2 on the keypad or scroll to TEST using the cursor key and press ENTER.

  • Page 38: Fev6 (Forced Expiratory Volume In 6 Sec.) Test Procedure

    Pre-Med Testing Procedures FEV6 (Forced Expiratory Volume in 6 sec.) Test Procedure WARNING Patient fainting or falling due to dizziness may occur as a result of this test. Advise the patient to sit or stand comfortably near a chair during test.
  • Page 39 Pre-Med Testing Procedures soft key. To view the results as a percentage of the predicted values press the %PRED soft key. 7. Press the SAVE soft key if the maneuver is acceptable. Press the DISCARD soft key if the maneuver is unacceptable. The display returns to the “PRE- MED TEST”...

  • Page 40: Post-Med Testing Procedures

    Post-Med Testing Procedures Post-Med Testing Procedures After completing the pre-medication (baseline) testing, administering the medication (usually an inhaled bronchodilator), and switching the spirometer to Post-Med test mode, the post-medication testing may begin. The patient’s session must be retrieved from memory if Post-Med testing is Figure 26: Change to Post-Med Test Mode performed on a patient whose Pre-Med test was performed more than 30 minutes...

  • Page 41: Post-Test Procedures

    Post-Test Procedures Post-Test Procedures Saving Results The Renaissance II spirometer saves all patient data and test data, provided the SAVE soft key is pressed after each maneuver. NOTES: • If a maneuver is saved, it is retained in memory until the entire patient session is deleted.
  • Page 42 Post-Test Procedures Table 3: View Options Displays results for the single best Pre-Med or Post-Med effort as determined by the “Best Criteria” configured in Spirometry Options.* Summarizes each Pre-Med or Post-Med maneuver with number of attempts, number of acceptable tests, number of reproducible tests, and interpretation if these options are enabled in Spirometry Options.* Displays test results for the best three Pre-Med or Post-Med efforts as determined by the “Best Criteria”...

  • Page 43: Printing Results

    3. Turn the printer on and verify that it is online and ready to print. 4. Dock the Renaissance II spirometer onto the base station. The spirometer must stay docked in the base station for the duration of printing. If you wish to alter the format of the printed report, press the OPTIONS soft key and change the information.
  • Page 44 Post-Test Procedures Table 4: Report Selections Prints the results for the single best Pre-Med and Post- Med effort for each type of maneuver as defined by the “Best Criteria” configured in Spirometry Options.* Prints a report suitable for Social Security Disability claims submissions.

  • Page 45: Printing Reports For Multiple Patients

    Cost per covered test • Reimbursement (per test) The Renaissance II calculates ROI and Payback in the following manner: ROI = (Reimbursement / Cost per covered test) x 100% Payback (months) = Purchase price / Net income (monthly) NOTE: The existence of coding does not guarantee coverage or payment for any procedure by any payer.

  • Page 46: Deleting Patient Data

    Deleting Patient Data The Renaissance II spirometer can store data for up to 1000 patients. When the memory becomes full or if the unit is sent in for repair or exchange, it may become necessary to erase patient data.

  • Page 47: Interpretation Of The Results

    Acceptability and Reproducibility Achieving high quality test results depends upon patient effort and technician coaching. The Renaissance II spirometer determines the quality of each patient effort by measuring the acceptability and reproducibility of the maneuver and displaying an “Acceptability Message” that will help both you and your patient achieve accurate results.
  • Page 48 Interpretation of the Results Table 5: Test Acceptability Messages Message Definition Coaching Instruction START Extrapolated volume is greater than 5% Patient must not hesitate or leak out FASTER of FVC or greater than any air at the beginning of the test. 150 ml (5% if FVC >...

  • Page 49: Grading Criteria

    FVC/FEV1, and FEV6/FEV1 measurements for that patient. The Renaissance II assigns a Quality Grade according to the criteria shown in Tables 6 and 7. Use the grade in conjunction with the Acceptability Messages and coaching instructions in Table 5 to improve patient test performance.

  • Page 50: Interpretation Criteria

    Interpretation Criteria Upon completion of an FVC or FEV6 test session, the Renaissance II spirometer will generate an interpretation of the test data. The interpretation criteria are those suggested by the American Thoracic Society statement, Lung Function testing.
  • Page 51 Interpretation of the Results Table 8: Interpretation Results *Physiological variant is interpreted as “Undetermined” in the Renaissance II if FVC and FEV1 are greater than 100% and FEV1% is less than 100%. If the FEV1/FVC ratio (FEV1%) is below the lower limit of the normal range, the patient is identified as having airway obstruction.

  • Page 52: Lung Age Interpretation

    Interpretation of the Results When the FVC is below the lower limit of normal, and the FEV1% is normal, the patient may have a restrictive disorder. The degree of restriction can be determined by the amount of reduction in the FVC. Note that a low FVC is often due to poor patient effort.

  • Page 53: Graphic Displays

    Interpretation of the Results Graphic Displays Spirometry maneuvers are usually illustrated by means of graphs showing flow rates and volumes during expiration and inspiration. Two types of graphs are used, Flow- Volume (FV) and Volume-Time (VT). A typical Flow-Volume graph is shown in Figure 30.

  • Page 54: Service And Maintenance

    Battery Installation The Renaissance II battery should be replaced at least once per year. Refer to the battery label to determine battery age. When there is a low battery condition (fewer than 20 patient tests can be performed), the Renaissance II spirometer beeps every 30 seconds and displays a low battery icon.
  • Page 55 8 days in the OFF position. Standard AA Alkaline or NiCad batteries may be used instead of the custom battery pack supplied with system. However, the Renaissance II will only charge the custom NiCad battery pack supplied with the unit.

  • Page 56: Troubleshooting Guide

    • When there is a low battery condition, the Renaissance II spirometer beeps every 30 seconds and displays a low battery icon. 3. Batteries may be low. Replace or recharge the custom battery pack.
  • Page 57 4. If the percent error is +3% or more, examine the flow sensor for foreign material contamination of the resistance medium. 5. Contact Puritan Bennett Technical Support if results are unsuccessful. NOTE: Replace the pressure tube every year. Recertify 3-liter syringes once per year.
  • Page 58 Troubleshooting Guide Patient test values displayed by the Renaissance II do not meet values expected by the physician. If the values are unusually high: 1. Check for damage to the flow sensor. 2. Verify that the flow sensor is not contaminated with sputum or secretions.

  • Page 59: Electromagnetic Interference

    7. Contact Puritan Bennett Technical Support if results are unsuccessful. Electromagnetic Interference The Renaissance II spirometer has been designed to provide reasonable protection against harmful interference in a typical medical environment. Because of the proliferation of radio frequency transmitting equipment and...

  • Page 60: Warranty Information

    • Reused when sold for single-patient use only • Connected to the wrong AC adapter CAUTION: Do not remove the cover of the Renaissance II spirometer or base station. Removal of the cover is permitted only by qualified service personnel. There are no user-serviceable parts inside.
  • Page 61 Troubleshooting Guide Also, the warranty may be voided if the system is used with any sensor other than those manufactured or licensed by Puritan Bennett for use with the Renaissance II Spirometry System. Please reference the warranty enclosed with your system for full clarification of the warranty.

  • Page 62: Technical References

    Hsu, Polgar, Dockery, NHANES III Interpretation Criteria: American Thoracic Society, 1991. Lung Function Testing: Selection of Reference Values and Interpretative Strategies. Am. Rev. Respir. Dis. 144.1202-1218, NHLEP *Contact Puritan Bennett Technical Support at 1.800.255.6774 for information regarding validation testing. P-495220-00 Rev. D...

  • Page 63: Product Specifications Renaissance Ii Base Station

    Technical References Table 9: Product Specifications Renaissance II Spirometer (cont.) Battery: 6V rechargeable (600mAh min. capacity) NiCad battery pack, also supports 4 AA Alkaline batteries or NiCad batteries Charge life: 10-12 hrs. with unit turned ON; approx. 8 days with unit turned OFF NOTE: Do not mix brands or types of batteries.

  • Page 64: The Fsii Single-Patient Use Flow Sensor

    Technical References Table 10: Product Specifications Renaissance II Base Station (cont.) Operating Temperature: +17 to +40° C Operating Humidity: 15% to 95% non-condensing Operating Altitude: Up to 15,000 feet Storage Temperature: -20° to +60° C Storage Humidity: 15% to 95% non-condensing...

  • Page 65: Predicted Normal Equations And References

    The patient’s height, birth date, and gender must be entered or no interpretation will be displayed. • Physiological variant is interpreted as “Undetermined” in the Renaissance II if FVC and FEV1 are greater than 100% and FEV1% is less than 100%. Equation Variables...
  • Page 66 Technical References Morris MALE Limits age (18-90 years) height (58-80 inches) -4.241 - 0.025A + 0.148Hi (Morris, et al.,1971) FVC - (1.645 * 0.74) (Morris, et al.,1971) (LLN) FEV1 -1.260 - 0.032A + 0.092Hi (Morris, et al.,1971) FEV1 FEV1 - (1.645 * 0.55) (Morris, et al.,1971) (LLN) FEV1%...
  • Page 67 Technical References Age ≥ 20 -0.735 - 0.025A + 0.049Hc (Knudson, et al.,1976) FEV0.5 -0.406 - 0.014A + 0.019Hc (Knudson, et al.,1976) FEF50 -0.4371 - 0.0240A + 0.0321Hc (Knudson, et al.,1983) FEF75 -0.1822 - 0.0254A + 0.0174Hc (Knudson, et al.,1983) Age ≥...
  • Page 68 Technical References Age > 40 0.734 * FVC (Knudson, et al.,1983) (LLN) FEV1 0.772 * FEV1 (Knudson, et al.,1983) (LLN) Knudson 1983 FEMALE Limits age (18-88 years) height (56-72 inches) Age < 20 -4.4470 + 0.0699A + 0.0416Hc (Knudson, et al.,1983) 0.749 * FVC (Knudson, et al.,1983) (LLN)
  • Page 69 Technical References Age ≥ 70 -0.1889 - 0.0296A + 0.0313Hc (Knudson, et al.,1983) 0.718 * FVC (Knudson, et al.,1983) (LLN) FEV1 2.6539 - 0.0397A + 0.0143Hc (Knudson, et al.,1983) FEV1 0.726 * FEV1 (Knudson, et al.,1983) (LLN) FEV3 -1.633 - 0.023A + 0.035Hc (Knudson, et al.,1976) FEV1% 113.694 - 0.2904A - 5.4024FVC...
  • Page 70 Technical References Age > 25 and < 35 0.8150 * FVC (Knudson, et al.,1976) (LLN) FEV1 0.8175 * FEV1 (Knudson, et al.,1976) (LLN) FEV1% 0.8762 * FEV1% (Knudson, et al.,1976) (LLN) Age > 35 0.7446 * FVC (Knudson, et al.,1976) (LLN) FEV1 0.7292 * FEV1...
  • Page 71 Technical References Age ≥ 20 and < 70 -1.774 - 0.022A + 0.037Hc (Knudson, et al.,1976) FEV1 -0.794 - 0.021A + 0.027Hc (Knudson, et al.,1976) FEV3 -1.633 - 0.023A + 0.035Hc (Knudson, et al.,1976) FEV1% 107.38 - 0.109A - 0.111Hc (Knudson, et al.,1976) FEF25-75 1.171 - 0.024A + 0.021Hc...
  • Page 72 Technical References Age ≥ 25 -5.993 - 0.035A + 0.094Hc (Knudson, et al.,1976) FEF50 -5.5409 - 0.0366A + 0.0684Hc (Knudson, et al.,1983) FEF75 -2.4827 - 0.0230A + 0.0310Hc (Knudson, et al.,1983) Crapo FEMALE Limits age (18-89 years) height (57-70 inches) -3.590 - 0.0216A + 0.0491Hc (Crapo, et al.,1981) FVC - 0.676...
  • Page 73 Technical References FEV0.5 .7778 * FEV1 (Hsu, et al.,1979) FEV3 .98 * FVC (Hsu, et al.,1979) -99.507 +1.267Hc (Polgar, et al.,1971) Age < 12 FEF50 -2.5454 + 0.0378Hc (Knudson, et al.,1983) FEF75 -1.0149 + 0.0171Hc (Knudson, et al.,1983) Age ≥ 12 FEF50 -6.3851 + 0.1150A + 0.0543Hc (Knudson, et al.,1983)
  • Page 74 Technical References Polgar MALE Limits age (4-17 years) height (43-67 inches) 4.4 * 10^-6 * Hc^2.67 (Polgar, et al.,1971) FVC * (1 - (1.645 * 0.13)) (Polgar, et al.,1971) (LLN) FEV1 2.1 * 10^-6 * Hc^2.80 (Polgar, et al.,1971) FEV1 FEV1 * (1 - (1.645 * 0.088)) (Polgar, et al.,1971) (LLN)
  • Page 75 Technical References NHANES III MALE (Hankinson, et al.,1999) Caucasian Age < 20 FEV1 -0.7453 - 0.04106A + 0.004477 * A^2 + 0.00014098 * Hc^2 FEV1 -0.7453 - 0.04106A + 0.004477 * A^2+ 0.00011607 * Hc^2 (LLN) FEV6 -0.3119 - 0.18612A + 0.009717 * A^2 + 0.00018188 * Hc^2 FEV6 -0.3119 - 0.18612A + 0.009717 * A^2 + 0.00015323 * Hc^2 (LLN)
  • Page 76 Technical References FEF25-75 -1.1627 + 0.12314A + 0.00010461 * Hc^2 FEF25-75 -1.1627 + 0.12314A + 0.00004819 * Hc^2 (LLN) African-American Age > 20 FEV1 0.3411- 0.02309A + 0.00013194 * Hc^2 FEV1 0.3411- 0.02309A + 0.00010561 * Hc^2 (LLN) FEV6 -0.0547- 0.02114A + 0.00016429 * Hc^2 FEV6 -0.0547- 0.02114A + 0.00013499 * Hc^2 (LLN)
  • Page 77 Technical References 0.0870 + 0.06580A - 0.001195 * A^2 + 0.00030243 * Hc^2 0.0870 + 0.06580A - 0.001195 * A^2 + 0.00021833 * Hc^2 (LLN) FEF25-75 1.7503 - 0.05018A + 0.00014473 * Hc^2 FEF25-75 1.7503 - 0.05018A + 0.00009020 * Hc^2 (LLN) NHANES III FEMALE (Hankinson, et al.,1999)
  • Page 78 Technical References African-American Age < 18 FEV1 - 0.9630 + 0.05799A + 0.00010846 * Hc^2 FEV1 - 0.9630 + 0.05799A + 0.00008546 * Hc^2 (LLN) FEV6 - 0.6370 - 0.04243A + 0.003508 * A^2 + 0.00013497 * Hc^2 FEV6 - 0.6370 - 0.04243A + 0.003508 * A^2 + 0.00010848 * Hc^2 (LLN) -0.6166 - 0.04687 A + 0.003602 * A^2 + 0.00013606 * Hc^2 -0.6166 - 0.04687 A + 0.003602 * A^2 + 0.00010916 * Hc^2...
  • Page 79 Technical References FEF25-75 -2.1825 + 0.42451A - 0.012415 * A^2 + 0.00009610 * Hc^2 FEF25-75 -2.1825 + 0.42451A - 0.012415 * A^2 + 0.00004594 * Hc^2 (LLN) Mexican-American Age > 18 FEV1 0.4529 - 0.01178A - 0.000113 * A^2 + 0.00012154 * Hc^2 FEV1 0.4529 - 0.01178A - 0.000113 * A^2 + 0.00009890 * Hc^2 (LLN)
  • Page 80 FVC(LLN) 0.822 * FVC FEV1(LLN) 0.823 * FEV1 FEV1%(LLN) 0.895 * FEV1% NOTE: The studies upon which these equations are based were not conducted by Puritan Bennett. The appropriate regulatory agencies should be consulted for independent validation. P-495220-00 Rev. D...

  • Page 81: Rs-232 Interface Specifications

    Technical References RS-232 Interface Specifications The Renaissance II Spirometry System 13 12 11 10 supports asynchronous commun- 25 24 23 22 21 20 19 18 17 16 15 14 ications to a computer system via a RS-232C compatible serial port. Data...

  • Page 82: Using The Renaissance Ii With A Pc And Dataflow™ Software

    Patient data can be stored and managed on a PC that has optional DataFlow™ Data Management Software installed. DataFlow software enables data transfer to and from the Renaissance II spirometer via a null modem cable connected between the PC and the spirometer base. DataFlow software allows you to: •Examine trends in patient pulmonary function...

  • Page 83: System Configuration

    The Renaissance II Spirometry System offers a wide range of configuration options that allow you to customize the operation and printed reports. The Renaissance II is preset at the factory with a default configuration. These settings can be easily changed. This section describes each configuration option.
  • Page 84 The test grades are A, B, C, D, and F. For specific grading criteria used by the Renaissance II, refer to the Grading Criteria section on page 44. Lung Age: If the lung age calculation option is enabled and the patient’s smoking history has been entered, the patient’s lung age will be calculated.

  • Page 85: Device Options (2)

    Print Options (3) Printer: The Renaissance II Spirometry System operates with a variety of parallel printers that use the Hewlett Packard graphic languages, as well as several other printer protocols. The following list indicates some of the printer types that are supported.
  • Page 86 System Configuration Format: You can choose between Clinical, Industrial, or User Defined formats for printing test results. Table 12 shows the information printed for each test performed. If you select either the Clinical or Industrial print option, and later change the marked selections using the VALUES soft key in Spirometry Options (see Spirometry Options (1) on page 78), the print format will automatically change to User Defined.
  • Page 87 System Configuration The following predicted points are plotted on each graph: Flow-Volume Graph Volume-Time Graph FEV0.5 FEF25 FEV1 FEF50 FEV3 FEF75 FVC or FEV6 FVC or FEV6 Graph: The graph format setting allows you to choose which graphs will appear on the printed reports. The options are: both (prints both volume-time (VT) and flow-volume (FV) graphs), volume-time (VT), flow-volume (FV), or none.

  • Page 88: Settings (4)

    System Configuration Settings (4) Language: Allows you to select the language in which the information will be displayed and printed. Date: Allows you to enter the day, month, and year using the numeric keypad. Time: Allows you to enter the time using the numeric keypad. The time will display in 12-hr (am/pm) or 24-hr time depending upon your selection in the device setup (see Device Options (2)).

  • Page 89: Setup And System Configurations

    System Configuration The following table lists the factory defaults and possible settings for all configuration options: Table 13: Setup and System Configurations Configuration Option Factory Alternate Settings Defaults Spirometry Options Interpretation Enright, None Adult Normals Knudson 83 Morris, Knudson 76, Crapo/Morris, NHANES III Pediatric Normals...
  • Page 90 System Configuration Table 13: Setup and System Configurations (cont.) Configuration Option Factory Alternate Settings Defaults Print Options Printer HP DJ B&W HP DJ Col, HP Laser Epson B&W, Epson Col, Canon B&W Paper 8.5” X 11” Format Clinical Industrial, User Defined Accept Msgs Interpretation Predicteds...

  • Page 91: Printing The System Configuration

    System Configuration Printing the System Configuration Perform the following steps to print the spirometer’s setup and system configuration: 1. From the “MAIN” screen press 6 on the keypad or use the cursor arrow key to scroll to PRINT and press ENTER. 2.
  • Page 92 System Configuration Barometric Pressure vs. Altitude Table 14: Barometric Pressure vs. Altitude Reference: 1984: Intermountain Thoracic Pulmonary Function Testing Second Edition; pg. 183 (Smithsonian 1963, Iribarne 1973) Reading the Barometric Pressure vs. Altitude Chart The barometric pressure at your elevation can be read to the nearest 100 feet using the chart above.
  • Page 93 Back Extrapolated Start Time - In order to measure the timed parameters more accu- rately and consistently, the ATS recommends using a technique called back extrapola- tion to determine the start of maneuver. The Renaissance II spirometer uses this technique. For more details, please reference "Standardization of Spirometry-1994 Update, ATS".
  • Page 94 Glossary of Medical Terminology FIVC - Forced Inspiratory Vital Capacity measured in liters -The maximum volume of air inspired with maximum effort after a complete exhalation. Flow-Volume Curve - A graphic printout of an FVC/FVL maneuver plotting flow vs. vol- ume.
  • Page 95 SVC - Slow Vital Capacity - The total amount of air that can be slowly exhaled from full inspiration. Also called the Vital Capacity or VC. Undetermined – An interpretation result generated by the Renaissance II when the FVC and FEV1 are greater than 100% and FEV1% is less than 100% of the predicted val- ues.
  • Page 96 References References Cherniack, R.M., Raber, M.B., Normal Standards for Ventilatory Function using an Automated Wedge Spirometer, American Review of Respiratory Disease, 1972, 106:38-46. Crapo, Robert O., et al. Reference Spirometric Values Using Techniques and Equip- ment that Meets ATS Recommendations, American Review of Respiratory Disease, 1981, 123: 659-674.
  • Page 97 Notes Notes P-495220-00 Rev. D...
  • Page 98 Notes P-495220-00 Rev. D...
  • Page 100 Tyco Healthcare Group LP Nellcor Puritan Bennett Division 4280 Hacienda Drive Pleasanton, CA 94588 USA Toll Free: 1.800.635.5267 Rx ONLY © 2003 Nellcor Puritan Bennett Inc. All rights reserved. P-495220-00 Rev. D 10/03...

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