Operators Manual
106 Pages
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Patient Monitor Menu
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Vital Signs Service Manual
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SYSTO LIC (m m
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SpO2 % TEMP ERAT URE
DIAS TOLIC (m
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Pulse Tone
Volu me
PULS E (BPM
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Chargi ng Low B attery
CYC LE
Set Pow
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Operator’s Manual
CAUTION
United States Federal Law restricts this device to sale by or on the order of a licensed health care practitioner.
TABLE OF CONTENTS Section I - Introduction 1. About the Operator Manual ...1 2. Product Overview ...1 3. Indications/Contraindications For Use ...2 4. Special Features ...2 5. Supplies and Accessories ...3-5
Section II - Functions & Specifications 1. Blood Pressure Operating Modes ...7-8 a. Max/Min Blood Pressure and Pulse Ranges ...7 b. Blood Pressure Manual Mode ...8 c. Blood Pressure Automatic Mode ...8 2. Temperature Operating Modes ...9-10 a. Max/Min Temperature Ranges...9 b. Temperature Normal Mode ...9 c. Temperature Monitor Mode...10 3. SpO2 Operating Mode...10-11 a. Max/Min SpO2 Ranges ...11 b. SpO2 Monitor Mode ...11 4. Pulse Rate Feature ...12 a. Max/Min Pulse Rate Ranges...12 5. Performance Specifications...13-14 6. Technical Specifications...14-15 a. Mechanical Specifications ...14 b. Electrical Specifications ...15 c. Environmental Specifications ...15 d. Transportation/Storage Conditions ...15
Section III - System Installation 1. Unpacking Checklist ...16-17 2. Controls, Indicators and Connections...18-22 a. Front Panel ...18-20 b. Side & Rear Panel Connections ...21-22 3. Set Up Procedure ...22-29 a. Blood Pressure Hose & Cuff Connections ...22-23 b. Temperature Probe Connection ...24 c. SpO2 Sensor Connection ...25 d. AC Power Connection ...26 e. Charging the Battery ...26 f. Setting Up the Printer ...27-28 g. Changing the Date and Time Setting ...29 4. Safety Warnings and Cautions...30-32
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Section IV - Operating Procedures 1. Power On/System Check Procedure ...34 2. Choosing Operating Modes...34 3. Setting the Programmable Alarms ...35-38 a. Blood Pressure - High Systolic Limit ...35 b. Blood Pressure - Low Systolic Limit ...36 c. Blood Pressure - High Diastolic Limit ...36 d. Blood Pressure - Low Diastolic Limit ...37 e. Pulse Rate - High Limit ...37 f. Pulse Rate - Low Limit ...38 g. SpO2 - Low Limit ...38 4. Temperature Measurement Range Indicators ...39 5. Alarm Indications and Interpretation ...40 6. Setting the Default Inflation Pressure Preset Level...41 7. Blood Pressure Cuff Selection Criteria ...42 8. Positioning the Blood Pressure Cuff ...43 9. Manual Mode Blood Pressure ...43 10. Automatic Mode Blood Pressure ...44-45 11. Reviewing Information from Prior Cycles ...46 a. “Erase Data” Function ...46 12. Selecting the Temperature Scale...47 13. Selecting Temperature Operation Mode ...48 14. Taking Oral Temperature ...49-50 15. Taking Axillary Temperature...51-52 16. Taking Rectal Temperature ...52-53 17. SpO2 Operation Mode ...53-56 a. Using the Finger Clip Sensor...54 b. Other Sensors ...55 c. Taking an SpO2 Measurement...55 d. Using the SpO2 Pulse Tone ...56 18. Printer Operation/Symbols ...57 a. Printing Options: Batch Print or Streaming Print Mode ...58 19. Using the RS232 Computer Interface ...58 a. “Nurse Call” Interface ...58 20. Mean Arterial Pressure (MAP)/Data Send Mode/Data Stream Mode ...59
Section V - Troubleshooting/Maintenance/Calibration 1. Troubleshooting: Error Indications and Interpretation ...60-62 2. Troubleshooting: General Guide to Problems and Corrective Actions ...62-64 3. Maintenance ...65-66 a. Cleaning ...65 b. Storage ...65 c. Battery Removal and Replacement...66
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4. Calibration...67-68 a. Blood Pressure Calibration Check...67-68 b. Temperature Calibration Check ...68 c. SpO2 Calibration Check ...68
Section VI - Warranty and Service Information 1. Warranty Information ...70 2. Service Information ...70-72 a. Service Policy ...70 b. Technical Assistance/Service Centers...71-72 c. Service Manual/Spare Parts ...72 d. Service Loaners ...72
Appendix A: Nonin® Brand SpO2 Sensors Appendix B: Nellcor Puritan Bennett Brand SpO2 Sensors Appendix C: Mounting Accessories & Assembly Instructions Appendix D: Nurse Call Interface Wiring Diagram TM
WELCH ALLYN VITAL SIGNS MONITOR
OPERATOR MANUAL
SECTION I
INTRODUCTION 1. About the Operator Manual 2. Product Overview 3. Indications/Contraindications For Use 4. Special Features 5. Supplies and Accessories
WELCH ALLYN VITAL SIGNS MONITOR
OPERATOR MANUAL
I. 1 ABOUT THE OPERATOR MANUAL The operator manual is designed to help you understand the capabilities and operation of your Welch Allyn Vital Signs Monitor. The manual has six tabbed sections and the first page of each section outlines the contents so you can readily find the information you need. The information included in this manual is inclusive of all options available with the Welch Allyn Vital Signs Monitor (ie. SpO2, Temperature and Printer). The applicability of some sections of this operator manual will depend on the configuration of your particular unit. The first two sections, INTRODUCTION and FUNCTIONS & SPECIFICATIONS introduce you to the product, its applications and its capabilities. The next two sections, SYSTEM INSTALLATION and OPERATING PROCEDURES takes you step by step through the installation and functional operation of the monitor in a logical sequence. The final two sections, TROUBLESHOOTING/MAINTENANCE/CALIBRATION and WARRANTY AND SERVICE INFORMATION are resources to offer troubleshooting or other special help as needed. This information is intended as a comprehensive guide to the operation of the Welch Allyn Vital Signs Monitor. To achieve satisfactory results, the operator should read this manual thoroughly before attempting to use the monitor. A quick reference operator's guide is provided on the side of the monitor as a convenient reference for experienced operators.
I. 2 PRODUCT OVERVIEW The Welch Allyn Vital Signs Monitor is designed to non-invasively and automatically measure systolic and diastolic blood pressure, pulse rate, temperature and oxygen saturation (SpO2) for adult and pediatric patients. THE WELCH ALLYN VITAL SIGNS MONITOR IS NOT INTENDED TO BE USED ON NEONATAL PATIENTS. All blood pressure, pulse, temperature and SpO2 values are displayed on large, easy-to-read displays, and may be printed via an integrated thermal printer, as desired. The rechargeable battery and wide variety of mounting accessories make the Welch Allyn Vital Signs Monitor convenient for many locations. The operator may choose any combination of simultaneous measurement modalities. This flexibility, combined with features such as programmable alarms and automatic blood pressure cycles, makes the Welch Allyn Vital Signs Monitor ideal for a wide variety of patient monitoring needs. The Welch Allyn Vital Signs Monitor is intended for use in a wide variety of health care settings. This includes hospital departments, as well as patient transport within the hospital environment. The Welch Allyn Vital Signs Monitor is also intended for use in alternate care settings, such as physician offices, freestanding ambulatory care and surgery centers, health clinics and nursing homes. The Welch Allyn Vital Signs Monitor may also be used during patient transport within any of these alternate care environments. The Welch Allyn Vital Signs Monitor is not intended for the monitoring of patients during transport external to the health care environment (eg. ambulance, helicopter transport). The Welch Allyn Vital Signs Monitor is not intended for use in environments which are not supervised by a health care practitioner. 1
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I. 3 INDICATIONS/CONTRAINDICATIONS FOR USE The Welch Allyn Vital Signs Monitor is intended for monitoring of blood pressure, pulse rate, temperature and oxygen saturation (SpO2) of adult and pediatric patients. The device is not designed, sold or intended for use except as indicated. THE WELCH ALLYN VITAL SIGNS MONITOR IS NOT INTENDED TO BE USED ON NEONATAL PATIENTS.* To ensure pediatric blood pressure accuracy and safety, note that the Welch Allyn small cuff (5200-03) is the SMALLEST CUFF approved for use with young children and infants. The circumference of the child’s arm must fit within the range markings on the cuff. * Welch Allyn defines neonates as children 28 days or less of age if born at term (37 weeks gestation or more); otherwise, up to 44 gestational weeks. This definition comes from the AAMI SP10 1992 standard. The monitor should not be used on patients who are linked to heart/lung machines.
I. 4 SPECIAL FEATURES The following special features enhance the use of the Welch Allyn Vital Signs Monitor: Choice of Measurement Modalities Non-invasive blood pressure, temperature, and SpO2 measurements may be made independently or simultaneously. Operator Selectable BP Measurement Intervals Automatically takes BP measurements at intervals from 1 to 90 minutes. Special "STAT" mode allows continuous blood pressure measurements for up to 15 minutes. Programmable Alarms Both visual and audible alarms indicate readings outside of operator programmable high/low limits, and also indicate system hardware/software problems. Non-Invasive, Oscillometric BP Eliminates the risks associated with invasive monitoring, with no need for microphones or external transducers. Prior Data Recall Measurement data from up to 99 previous determinations is available at the touch of a button. Operator-Friendly Results Large, easy-to-read LED displays are complemented by an integrated thermal printer. AC or Self-Contained Battery Power The Welch Allyn Vital Signs Monitor is conveniently available in many locations, for a variety of monitoring needs, including interdepartmental transport within the facility. 2
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I. 5 SUPPLIES AND ACCESSORIES BLOOD PRESSURE ACCESSORIES AND SUPPLIES - LATEX FREE 5200-01 5200-02 5200-03 5200-10
Cuff Assembly: Cuff Assembly: Cuff Assembly: Cuff Assembly:
Adult (cuff, bladder and connector) Large Adult (cuff, bladder and connector) Small (cuff, bladder and connector) Extra-Large Adult (cuff, bladder and connector)
5082-59 5082-61 5082-63 5082-64
Cuff: Cuff: Cuff: Cuff:
5200-04 5200-05 5200-06 5200-11
Bladder: Bladder: Bladder: Bladder:
5200-07 5200-12
Coiled Pressure Hose (8ft.) (2.4M) Note: One additional hose may be connected to provide extended length. All appropriate connectors are included. Straight Pressure Hose (8ft.) (2.4M)
5200-08
Calibration T-Connector
Adult Large Adult Small Extra-Large Adult Adult (includes connector) Large Adult (includes connector) Small (includes connector) Extra-Large Adult (includes connector)
TEMPERATURE ACCESSORIES AND SUPPLIES 5200-20
Oral Probe: (9ft.) (2.7M)
5200-22
Rectal Probe: (9ft) (2.7M)
05031-101
Disposable Probe Covers (1000 covers, packaged 25/box)
06137-000
Temperature Calibration Key
01800-210
Model 9600 Temperature Calibration Kit, 110v
NONIN® PULSE OXIMETRY ACCESSORIES AND SUPPLIES 5200-40 5200-54 5200-41 5200-42 5200-44 5200-45 5200-46 5200-47 5200-50 5200-51 5200-52 5200-53 5200-55
Finger Clip Sensor with 9ft. (2.7M) cable Finger Clip Sensor with 3ft. (0.9M) cable Ear Clip Sensor Flex Sensor Reflectance Sensor Reflectance Sensor Holder (10) SpO2 Adult Finger Flexiform Sensors (10) SpO2 Pediatric Finger Flexiform Sensors (10) SpO2 Sensor Attachment Tape SpO2 Hydrogel Tape Strips SpO2 Extension Cable (3ft) (0.9m) SpO2 Finger Phantom Calibration Kit SpO2 Extension Cable (9ft) (2.7m) 3
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NELLCOR PURITAN BENNETTTM PULSE OXIMETRY ACCESSORIES AND SUPPLIES DS-lOOA DURASENSOR® Adult Oxygen Transducer EC-8 Extension Cable (8 ft.) D-YS DURA-Y® Oxygen Transducer (1 sensor, 40 wraps) D-YSE Ear Clip, (use with Dura-Y sensor) D-YSPD PediCheckTM Pediatric Spot-Check (use with Dura-Y sensor) D-25 OXISENSOR® II Adult Digit Oxygen Transducer (case of 24) D-25L OXISENSOR® II Adult Digit Oxygen Transducer, long cable (case of 24) D-20 OXISENSOR® II Pediatric Oxygen Transducer (case of 24) I-20 OXISENSOR® II Infant Digit Oxygen Transducer (case of 24) R-15 OXISENSOR® Adult Nasal Oxygen Transducer (case of 24) ® OXICLIQ A Adult Oxygen Transducer, use with OC-3 cable (case of 24) OXICLIQ® P Pediatric Oxygen Transducer, use with OC-3 cable (case of 24) OC-3 OXICLIQ® Sensor Cable OXI-A/N OXIBAND® Adult/Neonatal Oxygen Transducer (1 sensor, 50 wraps) OXI-P/I OXIBAND® Pediatric/Infant Oxygen Transducer (1 sensor, 50 wraps) RS-10 Reflectance Oxygen Transducer (6 sensors, 6 headbands) SRC-2 Portable Oximetry Tester
MOUNTING ACCESSORIES AND SUPPLIES 5200-60
COMPLETE MOBILE STAND UNIT includes: Accessory Pack Large Basket Pole and Base Assembly Transformer Mounting Kit Recommended for Models: 52STP, 52STO, 52OTP, 52OTO, 52NTP, 52NTO
5200-61
MODIFIED MOBILE STAND UNIT includes: Large Basket Pole and Base Assembly Transformer Mounting Kit Recommended for Models: 52OOO, 52OOP, 52SOO, 52SOP, 52NOO, 52NOP
5200-62
COMPLETE WALL MOUNT UNIT includes Accessory Pack Large Basket Wall Mount Bracket Transformer Mounting Kit Recommended for Models: 52STP, 52STO, 52OTP, 52OTO, 52NTP, 52NTO
5200-63
MODIFIED WALL MOUNT UNIT includes: Large Basket Wall Mount Bracket Transformer Mounting Kit Recommended for Models: 52OOO, 52OOP, 52SOO, 52SOP, 52NOO, 52NOP
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5200-64
COMPLETE IV POLE MOUNT UNIT includes: Accessory Pack Large Basket IV Pole Mount Bracket Transformer Mounting Kit Recommended for Models: 52STP, 52STO, 52OTP, 52OTO, 52NTP, 52NTO
5200-65
MODIFIED IV POLE MOUNT UNIT includes: Large Basket IV Pole Mount Bracket Transformer Mounting Kit Recommended for Models: 52OOO, 52OOP, 52SOO, 52SOP, 52NOO, 52NOP
5200-66
COMPLETE BED-RAIL MOUNTING UNIT includes: Accessory Pack (2) Bed-Rail Brackets Recommended for Models: 52STP, 52STO, 52OTP, 52OTO, 52NTP, 52NTO
5200-67
MODIFIED BED-RAIL MOUNTING UNIT includes: (2) Bed-Rail Brackets Recommended for Models: 52OOO, 52OOP, 52SOO, 52SOP, 52NOO, 52NOP
5200-68 5200-69 5200-70
Cuff Clip Accessory Pack Anti-Theft Kit for Mounting Devices
MISCELLANEOUS SUPPLIES 7052-25 5200-84 5200-85E 5200-145E 5200-88 5200-100 5200-101 5200-102 5200-103 5200-106 5200-110 5200-111 5200-112 5200-113 5200-114 5200-115
Printer Paper (6 rolls/box) Lead-acid Battery Operator Manual Service Manual Plastic Monitor Covers (pack of 5) Welch Allyn Vital Signs Monitor Carrying Case AC Power Transformer (desktop transformer, line cord not included) - North AmericanVersion AC Power Transformer (desktop transformer, line cord not included) - European Version AC Power Transformer (desktop transformer, line cord not included) - United Kingdom Version Transformer Mounting Kit (for use with the desktop transformer) Line Cord (United States/Canada/Japan version) Line Cord (European version) Line Cord (United Kingdom version) Line Cord (Australian version) Line Cord (Swiss version) Line Cord (South American version)
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SECTION II
FUNCTIONS AND SPECIFICATIONS 1. Blood Pressure Operating Modes a. Max/Min Blood Pressure and Pulse Ranges b. Blood Pressure Manual Mode c. Blood Pressure Auto Mode 2. Temperature Operating Modes a. Max/Min Temperature Ranges b. Temperature Normal Mode c. Temperature Monitor Mode 3. SpO2 Operating Mode a. Max/Min SpO2 Ranges b. SpO2 Monitor Mode 4. Pulse Rate Feature a. Max/Min Pulse Rate Ranges 5. Performance Specifications 6. Technical Specifications a. Mechanical Specifications b. Electrical Specifications c. Environmental Specifications d. Transportation/Storage Conditions
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II. 1. BLOOD PRESSURE OPERATING MODES When a blood pressure measurement cycle is initiated, the cuff will automatically inflate to the default pressure level. The cuff will immediately begin to deflate in a stepped fashion and will determine systolic pressure and diastolic pressure from the pulses sensed by the cuff at various pressure levels. This is the oscillometric method of non-invasive blood pressure monitoring. Blood pressure measurements may be initiated manually, or automatically at time intervals determined by the user. At the completion of a measurement cycle the systolic and diastolic pressures are displayed. If the Monitor is in Automatic Mode, the measured values are kept on display until the next BP measurement is initiated. When not in Automatic Mode, the measured values are displayed for two minutes, after which time the display screen is blanked. The most recent BP measurement may be recalled by pressing the REVIEW button. When in Automatic Mode, if the unit is unable to determine the systolic or diastolic value, the measurement will be automatically repeated once.
II. 1. A. MAX/MIN BLOOD PRESSURE RANGES The maximum and minimum ranges of blood pressure are detailed below: Measurement
Maximum
Minimum
Systolic Pressure
250 mmHg
60 mmHg
Diastolic Pressure
160 mmHg
30 mmHg
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II. 1. B. BLOOD PRESSURE MANUAL MODE In the Manual Mode, a single blood pressure determination is made only when the START button is pushed. The manual mode is the default mode of operation for blood pressure determinations. A measurement cycle may be cancelled at any time by pressing the CANCEL button. This action immediately initiates a rapid cuff deflation. The blood pressure measurement data will appear on the display immediately following the measurement. The display will blank after two minutes. If the display is blanked, pressing the REVIEW button on the front panel will recall the measurement. Up to 99 prior measurements are available for review or printing. In Blood Pressure Manual Mode, the following alarm limits may be activated; SYSTOLIC HIGH LIMIT, SYSTOLIC LOW LIMIT, DIASTOLIC HIGH LIMIT, DIASTOLIC LOW LIMIT, PULSE RATE HIGH LIMIT and PULSE RATE LOW LIMIT. Blood pressure determinations which activate alarms are indicated by flashing displays and a repetitive audible tone. If an alarm limit is violated, subsequent blood presssure determinations may be made only after the alarm condition is reset by pressing any button on the Monitor's display.
II. 1. C. BLOOD PRESSURE AUTOMATIC MODE The Automatic Blood Pressure Mode is entered by pressing the AUTO button. Pressing the AUTO button displays a choice of 11 cycle interval times as follows: "St" (STAT mode), 1 minute, 3 minutes, 4 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes and 90 minutes. These choices represent the time interval from the beginning of one cycle to the beginning of the next automatic cycle. STAT mode allows the monitor to take continuous blood pressure measurements for 15 minutes. In addition, the operator may choose to disable the Auto Mode by choosing "--" (two dashes). Note: In the 1-minute automatic cycle mode, the Welch Allyn Vital Signs Monitor will automatically take blood pressure measurements in 1-minute intervals for up to 15 minutes. A measurement cycle may be cancelled at any time by pressing the CANCEL button. This action immediately initiates a rapid cuff deflation. The blood pressure measurement data will appear on the display immediately following the measurement and will remain displayed until the next measurement cycle is initiated. In Blood Pressure Auto Mode, the following alarm limits may be activated; SYSTOLIC HIGH LIMIT, SYSTOLIC LOW LIMIT, DIASTOLIC HIGH LIMIT, DIASTOLIC LOW LIMIT, PULSE RATE HIGH LIMIT and PULSE RATE LOW LIMIT. Blood pressure determinations which activate alarms are indicated by flashing displays and a repetitive audible tone. Any alarm limit violation must be reset to continue automatically timed blood pressure determinations. The alarm may be reset by pressing any button on the Monitor's display. 8
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II. 2. TEMPERATURE OPERATING MODES Thermometry measurements are made with the integrated Welch Allyn SureTemp® thermometer. Oral and rectal probes utilize single-use disposable probe covers which limit cross-contamination. Oral, axillary or rectal temperatures are taken using 'Normal' or 'Monitor' operating modes. Axillary temperatures are taken using the oral probe. In Normal mode the thermometer's microprocessor "predicts" body temperature in about 4 seconds for oral temperatures, about 10 seconds for axillary temperatures and in about 15 seconds for rectal temperatures. The Monitor mode displays the patient's actual temperature after 3 minutes for oral/rectal mode and 5 minutes for axillary mode, and will continue to display an updated temperature as long as the probe remains in place. Note: Normal mode axillary temperatures (10 seconds) are accurate only for children under the age of four. Note: THE WELCH ALLYN VITAL SIGNS MONITOR IS NOT INTENDED TO BE USED ON NEONATAL PATIENTS. Temperature readings may be displayed in Fahrenheit or Celsius scales.
II. 2. A. MAX/MIN TEMPERATURE RANGES Measurement
Maximum
Minimum
Temperature, °F Temperature, °C
108.0°F 42.2°C
84.0°F 28.9°C
II. 2. B. TEMPERATURE NORMAL MODE In Normal mode, the device will measure temperature at discrete intervals and then calculate the rate of change according to a proven algorithm. This allows the thermometer to predict the end point that the thermistor would reach if it were left in the mouth until it reached mouth temperature. This predictive feature allows the thermometer to arrive at an accurate oral temperature reading in approximately 4 seconds. Normal mode is the default operating mode for temperature determinations. Operator selectable patient alarm limits are not available in temperature Normal mode. However, temperatures which are outside of the operating range of the device will be noted on the temperature display.
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II. 2. C. TEMPERATURE MONITOR MODE Continuous Monitor mode operation is normally used for longer term monitoring and when difficult situations prevent accurate temperatures from being taken in the Normal mode. The probe must be in contact with tissue for at least three (3) minutes for accurate oral/rectal temperature measurement and five (5) minutes for accurate axillary temperature measurement. Monitor mode temperatures may not be identical to predicted 'Normal' temperatures because of ambient temperature influence and other factors. The trend in temperature is the important standard to be observed when in the Monitor mode. Operator selectable patient alarm limits are not available in temperature Monitor mode. However, temperatures which are outside of the normal operating range of the device will be noted on the temperature display.
II. 3. SpO2 OPERATING MODE The Welch Allyn Vital Signs Monitor incorporates either the Nonin® or Nellcor Puritan BennettTM pulse oximetry module which determines arterial oxyhemoglobin saturation (SpO2%) by measuring the absorption of red and infrared light passed through the tissues. Changes in absorption caused by pulsation of blood in the vascular bed are used to determine arterial saturation and pulse rate. Oxygen saturation percent is calculated with each pulse detected, and thus the monitor display is continually updated. The pulse signal bar graph is an indicator of the strength and quality of the detected pulses. When SpO2 is measured, the patient's pulse rate is also measured and displayed. A pulse rate measurement from the SpO2 determination overrides a pulse rate measurement derived from a blood pressure measurement. When measuring SpO2 the user may enable the SpO2 Pulse Tone feature. A short audible tone is emitted with every patient heartbeat. The frequency of the tone is based on the patient’s SpO2 level. The lower the frequency of the tone, the lower the patients SpO2 level. In SpO2 monitoring mode, operator selectable alarm limits for low SpO2 % may be activated. A condition which violates the SpO2 low limit alarm is indicated by a flashing display and repetitive audible tone. Should a patient alarm condition for SpO2 or pulse rate occur, the Monitor will indicate an alarm condition (flashing & beeping) while continuing to monitor and display the patient's current SpO2%. The alarm will automatically reset when the patient's condition returns to within the preset alarm parameters. Should a patient alarm condition for SpO2 or pulse rate occur, the operator may invoke "Silence Mode" by pressing the SILENCE button. This will silence the audible tone (display will continue to flash), while the practitioner attends to the patient and the monitor. Silence mode resets automatically after 30 seconds, or when the patient's condition returns to within the preset alarm parameters.
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Removal of the SpO2 sensor from the patient will initiate an alarm, unless the SpO2 and pulse rate alarms are turned off. To reset the sensor alarm, press any button on the Monitor's display. SpO2 is generally measured via pulses detected using a finger sensor. However, for certain situations SpO2 may be measured at alternate sites including the earlobe, forehead and toes. Special sensors must be employed in these situations.
II. 3. A. MAX/MIN SpO2 RANGES The SpO2 sensor is designed to detect oxygen saturation as follows.
SpO2
Maximum
Minimum
99%
40%
II. 3. B. SpO2 MONITOR MODE The SpO2 monitor performs most accurately with the fingerclip sensor, which may be used on all fingers except the thumb. The finger clip sensor is recommended for spot checks or short term continuous monitoring. The device determines arterial oxyhemoglobin saturation (SpO2 %) by measuring the absorption of red and infrared light passed through the tissue. Oxygen saturation and pulse rate are displayed on the LED digital display. On each detected pulse, the pulse signal bar graph flashes. The intensity of this signal is a simple visual indicator of waveform signal strength, and can identify situations where the pulsatile nature of the tissue may not be adequate for an accurate SpO2 reading. The update interval of the bar graph should correspond to the patient's pulse rate. This is an indication of the quality of the SpO2 signal. All Welch Allyn Vital Signs Monitors with pulse oximetry capability are equipped with a pulse tone. This audible tone beeps in synchronization with each beat of the patient’s heart. In addition, the frequency of the tone will vary based on the patient’s oxygen saturation value. The higher the tone’s frequency, the higher the patient’s oxygen saturation value. The user may change the pulse tone volume, or turn this feature off as necessary.
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II. 4. PULSE RATE FEATURE The Welch Allyn Vital Signs Monitor is capable of determining pulse rate as an adjunct to the blood pressure measurement and the SpO2 measurement. The pulse rate, in beats per minute, will be determined primarily from the SpO2 measurement methodology. In the case where SpO2 is not available, or is disabled, the pulse rate display will be driven by data from the blood pressure measurement method. There are two operator selectable alarm limits for the pulse rate. They are PULSE RATE HIGH LIMIT and PULSE RATE LOW LIMIT. Pulse rates which activate alarm limits are indicated by a flashing display and a repetitive audible tone. Should a pulse rate alarm occur when the pulse rate measurement is derived from the blood pressure measurement, no subsequent blood pressure or pulse rate measurements may be made until the alarm is reset. The alarm may be reset by pressing any button on the Monitor's display. Should a pulse rate alarm occur when the pulse rate measurement is derived from the SpO2 measurement, the monitor will indicate an alarm condition (flashing & beeping) while continuing to monitor and display the patient's current SpO2% and pulse rate. The alarm will automatically reset when the patient's condition returns to within the preset alarm parameters. Should a patient alarm condition for pulse rate occur during SpO2 monitoring, the operator may invoke "Silence Mode" by pressing the SILENCE button. This will silence the audible tone (display will continue to flash), while the practitioner attends to the patient and Monitor. Silence mode resets automatically after 30 seconds, or when the patient's condition returns to within the preset alarm parameters. If an alarm limit is violated, subsequent determinations of any type may only be made after the alarm condition is reset.
II. 4. A. MAX/MIN PULSE RATE RANGES The maximum and minimum pulse rate ranges are as follows: Pulse Rate
Maximum 200 bpm
12
Minimum 40 bpm
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II. 5. PERFORMANCE SPECIFICATIONS The performance specifications of the Welch Allyn Vital Signs Monitor are as follows: PATIENT POPULATION The Welch Allyn Vital Signs Monitor is designed for use with adult and pediatric patients. THE MONITOR IS NOT INTENDED FOR USE WITH NEONATES. Welch Allyn defines neonates as children 28 days or less of age if born at term (37 weeks gestation or more); otherwise, up to 44 gestational weeks. This definition comes from the AAMI SP10 1992 standard. CUFF PRESSURE RANGE 0 mmHg - 300mmHg INITIAL CUFF INFLATION Default cuff inflation pressure is 160 mmHg. Operator may change this default in configuration mode. Options are 120, 140, 160, 180, 200, 240 and 280 mmHg. SYSTOLIC DETERMINATION Maximum: 250 mmHg Minimum: 60 mmHg DIASTOLIC DETERMINATION Maximum: 160 mmHg Minimum: 30 mmHg BLOOD PRESSURE ACCURACY Blood pressure accuracy meets or exceeds SP10-1992 AAMI standards for non-invasive blood pressure accuracy (AAMI standard: ± 5 mmHg mean error; 8 mmHg standard deviation). Blood pressure accuracy is validated for pressure measurement using the upper arm only, with the patient in a seated position. Blood pressure is validated against manual auscultatory readings for adults and children above the age of 3. For children under age 3 blood pressure is validated against intraarterial readings. The monitor is not validated for use with neonates. BLOOD PRESSURE DETERMINATION TIME 20 seconds to 45 seconds typical, 165 seconds maximum. PULSE RATE DETERMINATION Maximum: 200 bpm Minimum: 40 bpm PULSE RATE ACCURACY SpO2 Module Heart Rate (Nonin®) SpO2 Module Heart Rate (Nellcor Puritan BennettTM) Blood Pressure Algorithm Heart Rate
±3.0% ±3 bpm ±5.0%
OVERPRESSURE CUTOFF 295 mmHg to 330 mmHg TEMPERATURE DETERMINATION Normal and Monitor Modes: Maximum Minimum
108.0°F (42.2°C) 84.0°F (28.9°C)
TEMPERATURE ACCURACY Temperature accuracy meets ASTM E112-86: "Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature." 13
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TEMPERATURE DETERMINATION TIME Normal Mode: ORAL: 4 seconds typical, AXILLARY: 10 seconds typical, RECTAL: 15 seconds typical Monitor Mode: ORAL/RECTAL: 3 minutes, AXILLARY: 5 Minutes OXYGEN SATURATION RANGE (SpO2%) 40-99% oxygen saturation SpO2 ACCURACY Nonin® Pulse Oximeter Module Saturation (%SpO2 ± 1 Standard Deviation*) 70-99% ± 2 digits < 70% unspecified Nellcor Puritan BennettTM Pulse Oximeter Module Saturation (%SpO2 ± 1 Standard Deviation*) 70-99% ± 3 digits < 70% unspecified * Standard Deviation is a statistical measure: up to 32% of the readings may fall outside these limits. BATTERY CHARGING To at least 90% capacity in 12 hours. Unit will operate and charge battery simultaneously when connected to power source. A fully charged battery will support 200 "typical" blood pressure determinations taken at 3 minute intervals. Battery is 90-100% charged after 12 hours of charging. The battery automatically charges when the monitor is powered through the AC power transformer. The battery will charge faster when the instrument is not in operation.
II. 6. A. TECHNICAL SPECIFICATIONS: MECHANICAL SPECIFICATIONS DIMENSIONS Height Length Depth
6.5 inches 8.6 inches 5.0 inches
(16.5cm) (21.8cm) (12.7cm)
WEIGHT Approximately 6 pounds (2.8Kg) COLOR Oral/Axillary Temperature Probe - Blue Rectal Temperature Probe - Red
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