Users Manual
100 Pages
Preview
Page 1
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
Table of Contents Listing of Warnings, Cautions, and Notes... 1 Indicators, Symbols, and Icons... 7 Introduction to the Renaissance II Spirometry System... 8 Features... 8 Intended Use... 8 Basic Spirometry System and Accessories... 9 Connecting the AC Adapter... 9 Battery Operation... 9 Connecting the Pressure Tube... 11 Keypad Functions and Controls... 13 Main Screen Icon Features... 13
Initial Configuration... 14 Spirometry Testing... 15 Introduction to Spirometry Testing... 15 Obtaining Good Test Results... 16
Pre-Test Procedures... 17 Calibration Verification... 17 SSD Calibration Verification... 17 Cal Check... 21 Patient Preparation... 23
Entering New Patient Data... 25 Pre-Med Testing Procedures... 27 FVC (Forced Vital Capacity) Test Procedure... 27 SVC (Slow Vital Capacity) Test Procedure... 29 FVL (Flow Volume Loop) Test Procedure... 30 MVV (Maximal Voluntary Ventilation) Test Procedure... 32 FEV6 (Forced Expiratory Volume in 6 sec.) Test Procedure... 33
Post-Med Testing Procedures... 35 Post-Test Procedures... 36 Saving Results... 36 Viewing Results... 36 P-495220-00 Rev. D
i
Table of Contents Printing Results...38 Printing Reports for Multiple Patients...40 Deleting Patient Data...41
Interpretation of the Results... 42 Acceptability and Reproducibility...42 Grading Criteria...44 Interpretation Criteria...44 Lung Age Interpretation...47 Risk of COPD...47 Graphic Displays...48
Service and Maintenance... 49 Cleaning...49 Battery Installation...49
Troubleshooting Guide... 51 Electromagnetic Interference... 54 Warranty Information...55
Technical References... 57 Product Specifications Renaissance II Spirometer...57 Product Specifications Renaissance II Base Station...58 The FSII Single-Patient Use Flow Sensor...59 Predicted Normal Equations and References...60 RS-232 Interface Specifications...76 Pin Function Descriptions...76 Using the Renaissance II with a PC and Dataflow™ Software...77
System Configuration... 78 Spirometry Options (1)...78 Device Options (2)...80 Print Options (3)...80 Settings (4)...83 Display (5)...83 Storage (8)...83 Setup and System Configurations...84 Printing the System Configuration...86
ii
P-495220-00 Rev. D
Table of Contents Barometric Pressure vs. Altitude... 87
Glossary of Medical Terminology... 88 References... 91
P-495220-00 Rev. D
iii
Listing of Warnings, Cautions, and Notes Listing of Warnings, Cautions, and Notes Throughout this manual there are three indicators to convey information of a specific nature. These indicators are warnings, cautions and notes. Carefully read and understand these notices as they relate to adjacent text.
WARNING Warnings alert the user to potential serious outcomes (death, injury, or adverse events) to the patient or user.
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.
1
P-495220-00 Rev. D
Listing of Warnings, Cautions, and Notes
WARNING The user should read and understand all product literature, labeling and warnings prior to operating the Renaissance II Spirometry System. •
Patient Safety Warnings This device should be used by trained healthcare professionals and is not intended for patient operation.
•
Physicians should assess patient’s ability to perform spirometry testing prior to administering the test.
•
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.
• •
• •
• •
Patient Data Warnings 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. 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. 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. Equipment Setup Warnings As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. When connecting the Renaissance II spirometer to any instrument, verify proper operation. Accessory equipment connected to the data interface must be certified according to IEC Standard 950 for data processing equipment or IEC Standard 601-1 for electromedical equipment. All combinations of equipment must be in compliance with IEC Standard 601-1-1 systems requirements. Anyone who connects additional equipment to the signal input port or signal output port, configures a medical system and is therefore responsible that the system complies with the requirements of IEC Standard 601-1-1 and the electromagnetic requirements of IEC Standard 601-1-2.
P-495220-00 Rev. D
2
Listing of Warnings, Cautions, and Notes WARNING •
User Warnings Chemicals from a broken LCD display panel are toxic when ingested. Use caution when handling a Renaissance II spirometer with a broken display panel.
•
Flow Sensor Warnings Carefully read the flow sensor directions before use, including all warnings, cautions, and instructions.
•
User should visually inspect the FSII sensor for loose particles/foreign materials prior to patient use.
CAUTION 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. Do not attempt to lift or carry the spirometer by the pressure tube or power cord.
•
The Renaissance II system may be susceptible to radio frequency interference. Refer to the electromagnetic interference section of this manual for more information. Equipment Setup Cautions
•
The Renaissance II Spirometry System and base station are designed for use only with the Puritan Bennett AC adapter (P-495208-00). Do not connect AC Adapter (P-495208-00) to an original Renaissance system (PB-100/110) or damage will result. Conversely, do not connect a PB100/ PB110 AC adapter (P-062521-00) to the Renaissance II Spirometry System.
•
Prior to verifying calibration, visually verify that there is no foreign material in the pressure tube and that the tube is not damaged or kinked.
3
P-495220-00 Rev. D
Listing of Warnings, Cautions, and Notes CAUTION •
Battery Cautions The NiCad battery pack or other batteries may discharge over time. Check batteries at least once per month for corrosion and verify batteries are fully charged. Store spirometer in base station to keep unit ready for use.
•
Remove batteries if spirometer will not be used for at least two weeks.
•
Dispose of batteries properly. Do not incinerate. Puritan Bennett recommends that customers or technical service personnel follow local governing ordinances and recycling instructions regarding disposal or recycling of batteries. 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.
•
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.
•
Use only the FSII flow sensor specifically designed for the Renaissance II Spirometry System.
•
The FSII sensor is for single-patient use only. In the interest of environmental protection, dispose of all sensors and nose clips properly.
Flow Sensor Cautions
Notes • •
•
Accuracy Notes For test accuracy, elevation must be entered. 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. Refer to the System Configuration section starting on page 78 for more information. The barometric pressure displayed is based on the initial elevation setting of the spirometer. However, the barometric pressure may be changed and the spirometer will, from that point on, use the new value entered. If you choose to obtain barometric pressure from an agency, such as the National Weather Service, verify that the value is NOT corrected to sea level.
P-495220-00 Rev. D
4
Listing of Warnings, Cautions, and Notes Notes •
• • •
•
•
•
•
•
•
5
Calibration Notes The date of the last valid calibration check will display as part of the spirometer's initialization sequence if a calibration check has not been performed in the current calendar day. The American Thoracic Society (ATS) recommends performing a threespeed 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. For every degree discrepancy, there will be a corresponding 0.15% error in the test results. Overestimation of the room temperature will cause lung volume to be underestimated by 5%; conversely, if temperature is underestimated, lung volume will be overestimated. Test Method Notes The “Val” (best value) method is recommended by the American Thoracic Society and mandated by NIOSH/OSHA standards and should be used for all industrial and disability testing. If the patient test will be submitted for Social Security Disability (SSD) determinations, enter patient information prior to performing the SSD calibration verification. Clinicians performing PFT studies should consider attending NIOSH training seminars and refresher courses to further their skills in spirometry testing and to stay current with industry standards. Spirometer Use Notes Demonstrating the test using your FSII sensor is strongly recommended for patients that have never performed a spirometry test before. Obstructing sensor opening with teeth, lips, or tongue while performing the test will cause low readings.
P-495220-00 Rev. D
Listing of Warnings, Cautions, and Notes Notes •
•
• • • •
•
• • •
Battery Notes The Renaissance II base station allows interfacing to parallel printers and computers and provides an alternate means for charging the custom NiCad battery pack. The Renaissance II Spirometry System is designed to recharge only the custom battery pack supplied with the system, and will not recharge batteries from other manufacturers. When there is a low battery condition, the Renaissance II spirometer beeps every 30 seconds and a low battery icon is displayed. Do not mix brands or types of batteries. Puritan Bennett recommends replacing the NiCad battery pack at least once per year. If the battery is removed, the unit will operate solely on AC power if connected to an electrical outlet via the AC adapter. Spirometer System Notes The serial numbers are located on a label affixed to the underside of the spirometer and base station. The first letter "G" represents the manufacturer. The next two numbers represent the year of manufacture. The two digits following the year represent either a base station (08) or a spirometer (07). The last five digits are sequential numbers assigned during manufacture. Materials used to make this Renaissance II Spirometry System and accessories contain no Latex. Replace the pressure tube every year. The LCD panel will turn off after 5 minutes (and the unit will power off after 30 minutes) with no user input. To bring back the display before the 30-minute limit, press any key.
P-495220-00 Rev. D
6
Indicators, Symbols, and Icons Indicators, Symbols, and Icons Renaissance II Spirometer Attention, consult accompanying documents Refers to degree of protection - Drip Proof Type BF equipment C
US
Agency Certification Class II equipment
Rx ONLY SN
CAUTION: Federal Law (US) restricts this device to sale by, or on the order of, a physician Serial Number
Base Station Connection for a printer port I/O communications port 12 volt DC adapter connection FSII Sensor Attention, consult accompanying documents Do not reuse - single patient use only Direction of flow through the flow sensor Bar coded calibration number Recyclable plastic. The number 6 represents polystyrene.
Figure 1: Renaissance II Spirometry System Indicators, Symbols, and Icons
WARNING The Renaissance II Spirometry System is not intended for use in an oxygenenriched atmosphere or in the presence of flammable anesthetics.
CAUTION:
Federal law restricts this device to sale by or on the order of a physician.
7
P-495220-00 Rev. D
Introduction to the Renaissance II Spirometry System Introduction to the Renaissance II Spirometry System The Renaissance II Spirometry System consists of a spirometer, docking base and optional accessories, as shown in Figure 2. The Renaissance II system provides long-term data storage capacity, and when connected to a printer generates printouts of the data. Patient data can also be downloaded to a computer. The spirometer test results can be compared to any of several adult or pediatric predicted normal values. The spirometer also performs pre/post medication comparisons. Features • Intuitive graphical user interface. • Graphic display for real-time viewing of Volume-Time, Flow-Volume and incentive displays. • Automatically compares results to predicted values. • Allows pre/post-medication comparisons. • Provides clinical interpretations with COPD Risk and Lung Age calculations. • Optional software allows data to be downloaded to a computer. • Memory stores demographic information, graphical data and patient results for up to 1,000 patients. • Operates with rechargeable NiCad batteries, alkaline batteries or an AC adapter. •
Provides printed reports when connected to a parallel printer. CAUTION: •
•
Place the Renaissance II Spirometry System in a secure location, where it is unlikely to drop or fall. Do not attempt to lift or carry the Renaissance II spirometer by the pressure tube or power cord. The Renaissance II system may be susceptible to radio frequency interference. Refer to the Electromagnetic 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. The flow is then electronically integrated to obtain volume. This testing can be used for the detection, assessment and monitoring of certain lung diseases. The system is intended for use with pediatric (4 to 17 years) and adult patients (18 to 99) in hospitals, physicians’ offices, laboratories, and occupational health testing environments.
P-495220-00 Rev. D
8
Introduction to the Renaissance II Spirometry System
Guide
Spirometry System User's Manual
Renaissance II Warranty Registration Form ®
ATTENTION: SPIROMÈTRE STATION LE PB710 PB700,BASE DE WITH USE FOR MODEL CAUTION: SPIROMETER STATION BASE OR PB710
UTILISER
Upon receipt of your system, verify that all required parts are present and undamaged. If any parts are missing or damaged, please contact Puritan Bennett Technical Support Department at 1800-255-6774.
Basic System Components
ADAPTER 8-00 AC/DC P-49520 P/N
Basic Spirometry System and Accessories The Renaissance II Spirometry System is available in a variety of configurations. The basic spirometry system consists of the spirometer, base station, pressure tube, AC adapter, FSII flow sensors, syringe adapter, battery pack, nose clips and associated documentation (See Table 1).
Optional Accessories
Figure 2: Renaissance II Spirometry System
Table 1: Basic Spirometry System and Accessories 1) Renaissance II Spirometer, PB-700
10) Base Station, PB-710
2) FSII Flow Sensor
11) Nose Clip, Plastic
3) AC Adapter, PB-700
Optional Accessories
4) Assy., Pressure Tube FSII
12) 3L Calibration Syringe
5) Syringe Adapter
13) Nose Clip, Plastic (25/pk)
6) User's Manual, PB-700/PB-710
14) Cable, Null Modem, NPB-510/PB-710
7) Warranty Card, PB-700/PB-710
15) DataFlow™ Data Management Software
8) Quick Guide, PB-700/PB-710
16) Cable, Printer
9) NiCad Battery Pack, PB-700
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 9
P-495220-00 Rev. D
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.
•
As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation.
CAUTION: The Renaissance II Spirometry System and Base Station are designed for use only with the Puritan Bennett AC adapter (P-495208-00). Do not connect AC Adapter (P-495208-00) to an original Renaissance system (PB100/PB110) or damage will result. Conversely, do not connect a PB100/PB110 AC adapter (P-062521-00) to the Renaissance II Spirometry System.
Battery Operation The Renaissance II spirometer includes a pre-installed rechargeable custom NiCad battery pack. As an option, the user can install 4 AA alkaline batteries or 4 standard AA NiCad cells. (Refer to Battery Installation on page 49 for installation instructions.) If NiCad cells are used, an external charger is required. NOTES: • The custom battery pack must be charged at least 24 hours before portable use. • The Renaissance II Spirometry System is designed to recharge only the custom battery pack supplied with the system, and will not recharge batteries from other manufacturers.
P-495220-00 Rev. D
Spirometer
Base Station
Pressure Tube
PB700 LE SPIRO, STATIO ST TION ATTEN TTENT N DE M¨TRE M TION: ION: TRE MOD¨ BASE OR UTILISMOD LE PB700 BASE ER AVEC STATIO ST AVEC SPIRO , TION N PB710 CAUTI METER ON: FOR MODE L
USE P/N WITH AC/D P-495 C ADA 208-0 PTER 0
AC Adapter
Figure 3: Setting up the System
10
Introduction to the Renaissance II Spirometry System The custom NiCad battery pack has a battery life of 10-12 hours in the ON position and a battery life of approximately 8 days in the OFF position. The pre-installed custom NiCad battery pack will continuously charge as long as power is connected to the spirometer through the AC adapter. During operation, the Renaissance II spirometer continually checks battery status. A low battery indicator will appear in the right hand corner of the screen when fewer than 20 patient tests can be performed. If the battery voltage drops below a reliable operating level, the unit will shut-off and not power-up until the batteries are recharged, changed, or the AC adapter is connected. NOTE: If the battery is removed, the unit will operate solely on AC power if connected to an electrical outlet via the AC adapter.
CAUTION: •
•
The NiCad battery pack or other batteries may discharge over time. At least once per month, check batteries for corrosion and verify batteries are fully charged. Store spirometer in base station to keep unit ready for use. 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 with a pressure tube that connects the FSII flow sensor to the spirometer. Upon receipt, inspect the pressure tube for damage. If the tube is damaged, contact Puritan Bennett Technical Support at 1-800-255-6774. Connect the pressure tube to the underside of the spirometer, as shown in Figure 3. Connect the other end of the pressure tube to the FSII flow sensor, as shown in Figure 4.
11
FSII Flow Sensor
Pressure Tube
Figure 4: Connecting the Pressure tube to the FS II flow sensor
P-495220-00 Rev. D
Introduction to the Renaissance II Spirometry System After the batteries have been installed and charged and the tube is connected, the spirometer is ready for use. The pressure tube does not need to be disconnected from the spirometer between patients. NOTE: Replace the pressure tube every year.
Warning •
•
The Renaissance II Spirometry System is not intended for use in an oxygen-enriched atmosphere or in the presence of flammable anesthetics. 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.
P-495220-00 Rev. D
12
Introduction to the Renaissance II Spirometry System Keypad Functions and Controls The keypad functions and controls are user friendly and intuitive. The keypad and Main screen icons, shown in Figure 5, represent some of the most frequently seen icons that will be displayed. The keypad and controls are used to access the various functions of the Renaissance II spirometer.
On/Off is controlled by the key marked "I/O".
On/Off The enter key is used to select an option or action in the graphic display.
Enter
Press the up, down, left or right arrow key to move the cursor.
Cursor Keys The four soft keys are used to select the functions displayed on the screen immediately above each key.
Main Screen Icon Features
Soft Keys
Allows the user to enter new patient data Begins or continues a spirometry test or allows SSD calibration Allows the user to view the test results Allows the user to edit previously entered patient data Initiates one-speed spirometer calibration
Provides a variety of printed test reports
Green Power Indicator Light
Soft Keys
1 4 7
ON/OFF
2 5 8 0
3 6 9
ENTER
Cursor Arrow Keys
Figure 5: Keypad and Main Screen
Locates a patient’s previously saved test data Allows the user to configure the spirometer
13
P-495220-00 Rev. D
Initial Configuration
Figure 6: Ready for Use
Figure 7: Initial Setup
Initial Configuration The Renaissance II spirometer has a number of user-selectable configuration options which have been preset at the factory. The first time the spirometer is powered on after leaving the factory, the user is prompted to select the configuration options. 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.
1. Press the key to power-up the spirometer. The spirometer will display an introductory screen while a self test is performed. Press the PROCEED soft key to go to the next screen (Figure 6). NOTE: The date of the last valid calibration check will display as part of the spirometer's power-up sequence if a calibration check has not been performed in the current calendar day.
2. In the “INITIAL SETUP” screen the user is prompted to select certain configurable options. This screen will be displayed each time the spirometer is powered-up until the user sets the displayed options (Figure 7). 3. Using the cursor key, highlight each option and enter the desired settings using the keypad. Press the DONE soft key to go to the “MAIN” screen (Figure 5). NOTE: For test accuracy, elevation must be entered.
4. From the “MAIN” screen, adjust the display appearance by pressing the LIGHTER, DARKER, and BACKLIT soft keys to the desired settings.
P-495220-00 Rev. D
14
Spirometry Testing Spirometry Testing Introduction to Spirometry Testing The purpose of a spirometry test is to assess and monitor a patient’s lung condition. The most common spirometry test is the Forced Vital Capacity (FVC) test. This test requires the subject to take a deep breath and then exhale into the spirometer as forcefully, rapidly and completely as possible. The FVC test results report how fast the air was exhaled (flow rate) and how much air was exhaled (volume). These parameters are compared to values derived from ‘Predicted Normal Equations” based on the patient's age, height, gender and race. These equations are listed starting on page 60. Depending on the results, the healthcare professional will be able to determine whether the patient is normal, or has an obstructive or a restrictive lung pattern. Obstructive diseases are characterized by an increased resistance to air flow. This resistance makes it more difficult to move air into and out of the lungs rapidly. An obstructive pattern is characterized by a reduction in the volume that can be exhaled in the first second of the FVC test (FEV1) and by a low FEV1/FVC ratio. The most common obstructive diseases are asthma, chronic bronchitis and emphysema. Asthma constricts the bronchial tubes but can be controlled by drug therapy. Bronchitis also constricts the bronchial tubes but may not respond to drug therapy. Emphysema is the slow, irreversible destruction of the alveoli, leading to collapsed airways. Restrictive diseases impair the movement of the lungs or the volume of air that can be expelled by the lungs. They are characterized by a reduction in the total volume of air that can be exhaled. The FEV1/FVC ratio remains normal or increases. Gross obesity, lung fibrosis, neuromuscular diseases or paralysis can cause restrictive diseases. 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 FlowVolume Loop (FVL), Slow Vital Capacity (SVC), Maximal Voluntary Ventilation (MVV), and FEV6 tests. These additional tests will sometimes provide more information that is helpful in the diagnosis of a patient's lung disorder.
15
P-495220-00 Rev. D
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: •
Patient should refrain from taking bronchodilators 6-8 hours prior to testing, unless instructed by a physician.
•
Loosen any restrictive clothing. Remove loose dentures, candy, gum, etc.
•
Ensure accurate input of ID#, height, weight, gender, birth date, and race.
•
Patient may sit or stand, but be consistent and record position.
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.
•
The use of nose clips is optional but recommended.
•
Explain procedure carefully and demonstrate how it is done.
•
Coaching is critical. Remind patient to "BLAST" out the air - don't just blow! Keep going as long, as hard, and as completely as possible (at least 6 seconds).
•
Watch the patient inhale maximally and exhale forcefully and completely with mouth and teeth firmly sealed around the mouthpiece. Watch and listen for the incentive display.
•
If the test is unacceptable, identify the reason(s) and explain how to correct the technique.
•
Obtain at least three acceptable and two reproducible tests. See pp. 1122 1123 of Reference 11 (page 91) for ATS acceptability and reproducibility criteria. If tests are below normal, consider administering a bronchodilator according to office protocol, then retest in 10 to 15 minutes, or as suggested by the physician.
As the test is performed, coaching messages or incentive messages, e.g.,“Start Test, Keep Going” appear on the display to encourage the patient. Depending on the user's preferences, a graph of the data or an animated incentive will be displayed during the test. These messages and graphics should be used to coach the subject to perform the test maximally.
Warning This device should be used by trained healthcare professionals and is not intended for patient operation.
P-495220-00 Rev. D
16