Welch Allyn VITAL SIGNS MONITOR Operation Manual

Power
Start
Cancel
Review
Auto
Silence
DIASTOLIC
PULSE
(BPM)
SpO
2 %
TEMPERATURE
Volume
SYSTOLIC
Low Battery
CYCLE
Set
Select Alarm
Charging
Tone
Pulse
Operator’s Manual
French Version
German Version
Spanish Version
Italian Version
Patient Monitor
Service Manual
C A U T I O N
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. SpO2Operating Mode..................................................................................................10-11
a. Max/Min SpO2Ranges ........................................................................................11
b. SpO2Monitor 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. SpO2Sensor 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
WELCH ALLYN VITAL SIGNS MONITOR OPERATOR MANUAL
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. SpO2Operation Mode ................................................................................................53-56
a. Using the Finger Clip Sensor................................................................................54
b. Other Sensors..........................................................................................................55
c. Taking an SpO2Measurement..............................................................................55
d. Using the SpO2Pulse 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
WELCH ALLYN VITAL SIGNS MONITOR OPERATOR MANUAL
4. Calibration......................................................................................................................67-68
a. Blood Pressure Calibration Check..................................................................67-68
b. Temperature Calibration Check ..........................................................................68
c. SpO2Calibration 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 SpO2Sensors Appendix B: Nellcor Puritan Bennett
TM
Brand SpO2 Sensors Appendix C: Mounting Accessories & Assembly Instructions Appendix D: Nurse Call Interface Wiring Diagram
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
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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 SpO2values 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.
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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 SpO2measurements 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.
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I. 5 SUPPLIES AND ACCESSORIES
BLOOD PRESSURE ACCESSORIES AND SUPPLIES - LATEX FREE
5200-01 Cuff Assembly: Adult (cuff, bladder and connector) 5200-02 Cuff Assembly: Large Adult (cuff, bladder and connector) 5200-03 Cuff Assembly: Small (cuff, bladder and connector) 5200-10 Cuff Assembly: Extra-Large Adult (cuff, bladder and connector)
5082-59 Cuff: Adult 5082-61 Cuff: Large Adult 5082-63 Cuff: Small 5082-64 Cuff: Extra-Large Adult
5200-04 Bladder: Adult (includes connector) 5200-05 Bladder: Large Adult (includes connector) 5200-06 Bladder: Small (includes connector) 5200-11 Bladder: Extra-Large Adult (includes connector)
5200-07 Coiled Pressure Hose (8ft.) (2.4M) Note: One additional hose may be
connected to provide extended length. All appropriate connectors are included.
5200-12 Straight Pressure Hose (8ft.) (2.4M)
5200-08 Calibration T-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 Finger Clip Sensor with 9ft. (2.7M) cable 5200-54 Finger Clip Sensor with 3ft. (0.9M) cable 5200-41 Ear Clip Sensor 5200-42 Flex Sensor 5200-44 Reflectance Sensor 5200-45 Reflectance Sensor Holder (10) 5200-46 SpO2Adult Finger Flexiform Sensors (10) 5200-47 SpO2Pediatric Finger Flexiform Sensors (10) 5200-50 SpO2Sensor Attachment Tape 5200-51 SpO2Hydrogel Tape Strips 5200-52 SpO2Extension Cable (3ft) (0.9m) 5200-53 SpO2Finger Phantom Calibration Kit 5200-55 SpO2Extension Cable (9ft) (2.7m)
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NELLCOR PURITAN BENNETTTMPULSE 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 PediCheckTMPediatric 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®AAdult 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 Cuff Clip 5200-69 Accessory Pack 5200-70 Anti-Theft Kit for Mounting Devices
MISCELLANEOUS SUPPLIES
7052-25 Printer Paper (6 rolls/box) 5200-84 Lead-acid Battery 5200-85E Operator Manual 5200-145E Service Manual 5200-88 Plastic Monitor Covers (pack of 5) 5200-100 Welch Allyn Vital Signs Monitor Carrying Case 5200-101 AC Power Transformer (desktop transformer, line cord not included)
- North AmericanVersion
5200-102 AC Power Transformer (desktop transformer, line cord not included)
- European Version
5200-103 AC Power Transformer (desktop transformer, line cord not included)
- United Kingdom Version
5200-106 Transformer Mounting Kit (for use with the desktop transformer) 5200-110 Line Cord (United States/Canada/Japan version) 5200-111 Line Cord (European version) 5200-112 Line Cord (United Kingdom version) 5200-113 Line Cord (Australian version) 5200-114 Line Cord (Swiss version) 5200-115 Line Cord (South American version)
WELCH ALLYN VITAL SIGNS MONITOR OPERATOR MANUAL
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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. SpO2Operating Mode a. Max/Min SpO2Ranges b. SpO2Monitor 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.
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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 108.0°F 84.0°F
Temperature, °C 42.2°C 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. SpO2OPERATING MODE
The Welch Allyn Vital Signs Monitor incorporates either the Nonin® or Nellcor Puritan Bennett
TM
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 SpO2is measured, the patient's pulse rate is also measured and displayed. A pulse rate measurement from the SpO2determination overrides a pulse rate measurement derived from a blood pressure measurement.
When measuring SpO2the user may enable the SpO2Pulse Tone feature. A short audible tone is emitted with every patient heartbeat. The frequency of the tone is based on the patient’s SpO2level. The lower the frequency of the tone, the lower the patients SpO2level.
In SpO2monitoring mode, operator selectable alarm limits for low SpO2% may be acti­vated. A condition which violates the SpO2low limit alarm is indicated by a flashing dis­play and repetitive audible tone. Should a patient alarm condition for SpO2or 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 SpO2or 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 SpO2sensor from the patient will initiate an alarm, unless the SpO2and pulse rate alarms are turned off. To reset the sensor alarm, press any button on the Monitor's display.
SpO2is generally measured via pulses detected using a finger sensor. However, for cer­tain situations SpO2may be measured at alternate sites including the earlobe, forehead and toes. Special sensors must be employed in these situations.

II. 3. A. MAX/MIN SpO2RANGES

The SpO2sensor is designed to detect oxygen saturation as follows.
Maximum
Minimum
SpO
2
99% 40%
II. 3. B. SpO2MONITOR MODE
The SpO2monitor 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 SpO2reading. The update interval of the bar graph should correspond to the patient's pulse rate. This is an indication of the quality of the SpO2signal.
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 SpO2measurement.
The pulse rate, in beats per minute, will be determined primarily from the SpO2measure­ment methodology. In the case where SpO2is 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 SpO2measurement, 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 SpO2monitoring, 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:
Maximum
Minimum
Pulse Rate 200 bpm 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
SpO2Module Heart Rate (Nonin
®
) ±3.0% SpO2Module Heart Rate (Nellcor Puritan BennettTM) ±3 bpm Blood Pressure Algorithm Heart Rate ±5.0%
OVERPRESSURE CUTOFF
295 mmHg to 330 mmHg
TEMPERATURE DETERMINATION
Normal and Monitor Modes: Maximum 108.0°F (42.2°C)
Minimum 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."
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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
SpO2ACCURACY
Nonin
®
Pulse Oximeter Module
Saturation (%SpO2± 1 Standard Deviation*)
70-99% ± 2 digits < 70% unspecified
Nellcor Puritan Bennett
TM
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 6.5 inches (16.5cm) Length 8.6 inches (21.8cm) Depth 5.0 inches (12.7cm)
WEIGHT
Approximately 6 pounds (2.8Kg)
COLOR
Oral/Axillary Temperature Probe - Blue Rectal Temperature Probe - Red
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MOUNTING
Self-Supporting on rubber feet IV Pole Mountable Custom Mobile Stand Wall Mountable Attaches to Bed Rail
PORTABILITY
- May be hand carried when held by the recessed handle.
- When attached to an IV pole, or mounted on its custom mobile stand, the monitor and accessories can be wheeled from patient to patient.
- When attached to the bed rail may be transported with the patient within the hospital environment.
OPERATOR INSTRUCTIONS/ALARM INTERPRETATION
Comprehensive Operator Manual available. Quick reference operator instruction card available.
II. 6. B. ELECTRICAL SPECIFICATIONS
POWER REQUIREMENTS
Patient-Rated isolation transformer is connected to AC mains power source:
North American Version: 120VAC, 60 Hz., 0.20A Input Source; 8Vdc, 0.75A Output Source International Versions: 230VAC or 240VAC, 50Hz., 0.20A Input Source; 8Vdc, 0.75A Output Source
BATTERY
Lead acid, with external recharge capability.
II. 6. C. ENVIRONMENTAL SPECIFICATIONS
OPERATING TEMPERATURE
+10°C to +40°C +50°F to +104°F
*Exception: Thermometry module will not maintain its performance
characteristics below 60°F (16°C).
OPERATING ALTITUDE
-170m to +4877m
-557ft. to +16,000ft.
II. 6. D. TRANSPORTATION/STORAGE CONDITIONS
STORAGE TEMPERATURE
-20°C to +50°C
-4°F to +122°F
RELATIVE HUMIDITY
15 to 90% (non-condensing)
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SECTION III

SYSTEM INSTALLATION

1. Unpacking Checklist
2. Controls, Indicators and Connections
3. Set Up Procedure a. Blood Pressure Hose & Cuff Connections b. Temperature Probe Connection c. SpO2 Sensor Connection d. AC Power Connection e. Charging the Battery f. Setting Up the Printer g. Changing the Time and Date Setting
4. Safety Warnings and Cautions
III. 1. UNPACKING CHECKLIST
After you have unpacked the Welch Allyn Vital Signs Monitor and the components, iden­tify each item with the checklist that follows and inspect for missing items. Retain the shipping materials in the event of shipping damage or for return, if necessary, to Welch Allyn/Tycos for repair or warranty service.
All Welch Allyn Vital Signs Monitors include the following components (A-G):
A. Welch Allyn Vital Signs Monitor
This device is a portable, light weight device designed to automatically measure and display blood pressure and pulse rate. Options available include pulse oxime­try, temperature and integrated printer.
B. Operator Manual (This manual)
To achieve satisfactory results, the operator should read this manual thoroughly before attempting to use the monitor. Save this manual for helpful product refer­ence.
C. Instrument Warranty Card
Fill this out today and return to Welch Allyn. This card validates your warranty.
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D. Large Adult Size Cuff Assembly
Includes cuff, bladder and pneumatic tubing with connector.
Note: A full range of cuff sizes are available (as accessory items) however, the Large Adult cuff will fit the majority of adults and give the most accurate blood pressure measurement.
E. Coiled Pressure Hose
With connector, connects a variety of blood pressure cuffs to the monitor.
F. Power Transformer and Cord Assembly
Operates the monitor and charges the internal battery.
G. Cuff Clip
Attaches to the rear of the monitor to hold the blood pressure cuff. Not used if mobile stand, pole mount or wall mount accessories are purchased.
Certain Welch Allyn Vital Signs Monitors will include the following items, based on the options purchased:
PRINTER OPTION
H. Box of Printer Paper
Six (6) rolls of thermal printer paper. One additional roll will be pre-loaded into the printer.
PULSE OXIMETRY (SpO2) OPTION
I. Finger Clip SpO2Sensor and Cord
Other sensors are available separately.
TEMPERATURE OPTION
J. Oral Temperature Probe
The blue oral probe is used for both oral and axillary temperature determinations. A red rectal probe is available separately.
K. Temperature Probe Covers
One box of 25 single use, disposable probe covers for both oral and rectal tempera­ture determinations.
Note: Report any signs of shipping damage to the carrier. If an item is missing or dam­aged, contact the Welch Allyn Service Center near you. See section VI of this manual for more information
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III. B. CONTROLS, INDICATORS AND CONNECTIONS
Note: In this section, all drawing and text are representative of the Welch Allyn Vital Signs Monitor with all available options (i.e. Blood Pressure plus Pulse Oximetry (SpO2), Temperature and Printer). Your Monitor may not include all functions, depending on the options purchased.
SpO2 %
SYSTOLIC
(mmHg)
DIASTOLIC
(mmHg)
PULSE
(BPM)
TEMPERA
TURE
CYCLE
Charging Low Battery
Set
Volume
Select Alarm
Power
Start Cancel
Review
Auto
Silence
Pulse Tone

FRONT PANEL

FRONT PANEL FUNCTIONS:
A. POWER Button & Indicator Light
This on/off button controls the power to the Monitor. The indicator light will glow when the unit is on. Battery power will be used unless the Monitor is powered through the AC power transformer.
B. START Button
Pressing this button initiates an on-demand blood pressure cycle.
C. CANCEL Button
If a blood pressure cycle is in progress, pressing this button aborts the cycle and immediately releases the cuff pressure. In "STAT" automatic blood pressure mode, pressing the cancel button aborts the cycle in process, and
cancels the "STAT" mode
as well.
When pressed for 3 seconds, the cancel button erases all stored data in the Welch Allyn Vital Signs Monitor.
A B
C D E F
Q
T
G
H
JJ
I
S
R
P
N
M
K
L
O
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D. REVIEW Button
Pressing this button will display the most current set of stored data including BP & pulse rate and/or SpO2and/or temperature. Subsequent presses will display the next most recent data sets.
E. AUTO Button & Indicator
Pressing this button allows the operator to scroll through the automatic blood pres­sure interval options. Time intervals are displayed in minutes on the CYCLE display (see "Q" below). Choosing any time interval except
"--" will cause the Auto indicator light to glow, and blood pressure determinations to be made according to the dis­played time interval.
F. SILENCE Button & Indicator
During SpO2monitoring, should an SpO2or Pulse Rate alarm condition occur, press­ing the Silence button invokes 'Silence Mode'. 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. In Silence Mode, the silence indicator light will glow.
G. SELECT ALARM Button
Pressing this button allows the operator to select a specific parameter for which an alarm threshold will be set. The HIGH ("HI") or LOW ("LO") indicator will show in the CYCLE display, and the current value will appear in the respective display.
H. SET Buttons (Arrow Up or Arrow Down)
These buttons increment or decrement the currently displayed alarm threshold. The SET-Arrow Up button has additional functionality. See section IV.19.
I. PULSE TONE Indicator
This indicator will be lit when the pulse tone function is enabled.
J. PULSE TONE Button
Pressing this button allows the operator to control the volume of the SpO2pulse tone.
K. SYSTOLIC Display
This red LED display shows the systolic blood pressure. Additionally, this display can show systolic alarm limits (see G, and H above).
L. DIASTOLIC Display
This red LED display shows the diastolic blood pressure Additionally, this display can show diastolic alarm limits (see G, and H above).
M. SpO2 Display
This red LED display shows the percent saturation of arterial hemoglobin (SpO2%). Additionally, this display can show SpO2low saturation alarm limits
(see G, and H above).
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N. PULSE SIGNAL BAR GRAPH
This bar graph gives a visual indication of the strength and quality of the pulses detected by the SpO2sensor. Additionally, this bar graph can indicate the volume level of the SpO2pulse tone. (see I and J above).
O. PULSE Display
This yellow LED display shows the pulse rate. Additionally, this display can show pulse rate alarm limits (see G and H above).
P. TEMPERATURE Display and Indicator
The red LED display shows the temperature in degrees Fahrenheit or Celsius. The temperature scale (°F or °C) will be shown by a green indicator. Also, temperature monitor mode is indicated by a green indicator.
Q. CYCLE Display
This red LED display shows the time (in minutes) between automatically initiated blood pressure measurements, or "St" for STAT mode (continuous blood pressure measurements for up to 15 minutes).
Additionally, this display identifies the high and low alarm limits for the various parameters, during alarm select mode, and the cycle number during review mode.
R. CHARGING Indicator
This flashing yellow indicator will signify that the internal battery is being charged when the Monitor is powered through the AC power transformer. When the Monitor is fully charged, the flashing will be replaced with a solid yellow indicator light.
S. LOW BATTERY Indicator
This yellow indicator light will remain on continuously as a visual indicator when the battery charge is weak. The indicator will flash as a visual indicator that the bat­tery charge is critically low.
T. MEMORY Indicator
This green indicator will flash when the unit has reached its maximum capacity of 99 data sets in storage. Also, it will remain on continuously when the operator is reviewing stored data sets.
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B. SIDE & REAR PANEL CONNECTIONS
1. SpO2Sensor Connection
Nine pin connector for the SpO2sensor.
2. Temperature Probe Connector
Connector for either oral/axillary (blue) or rectal (red) probe.
3. Temperature Probe Holder
Active temperature probe is inserted here when not in use. Removing and replacing the probe turns the temperature on and off, respectively.
4. RS232 Data Interface Connector
Port for the connection of a cable to an external computer, network, or nurse call system.
5. Transformer Power Connector
AC power transformer connector.
6. Pressure Hose Connector
Connector for black, coiled pressure hose.
7. Printer
Compartment and paper feed area for integrated thermal printer.
8. Print Button
Pressing this button initiates a print operation.
9. Printer Feed Button
Pressing this button advances the paper in the printer.
1
2
3
4
5
6
10
7
11
9
8
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10. Mounting Keyholes
Mounting accessories are attached via these keyholes.
11. Battery Compartment
Contains the internal battery. Removal of 4 screws allows changing battery without affecting other internal parts.
III. 3. A. SET-UP PROCEDURE: BLOOD PRESSURE HOSE & CUFF CONNECTIONS
Identify and have available each of the following items:
-The Welch Allyn Vital Signs Monitor
-Cuff and bladder assembly
-Black coiled pressure hose
Using the illustrations below for reference, perform the following set-up procedures:
1. Inspect the black coiled pressure hose and note that one end has a connector fitting and the other end does not. Attach the end without
the connector to the pressure hose connector on the monitor by fitting the pressure hose on to the connector as shown. Be sure that the pressure hose is completely inserted over the connector and into the recess, and that the fit is snug.
Attaching pressure hose to connector on monitor
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23
2. Join the other end of the black coiled pressure hose to the pneumatic tubing which is attached to the cuff. Twist the black connectors together until finger-tight. DO NOT OVER TIGHTEN.
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24
III. 3. B. SET-UP PROCEDURE: TEMPERATURE PROBE CONNECTION
The Welch Allyn Vital Signs Monitor is available with two probes; one for oral/axillary temperatures (blue), and one for rectal temperatures (red). The rectal probe is an accesso­ry item and must be ordered separately.
To install the temperature probe, press down on the tab on top of the connector and insert the connector into the temperature probe connector port on the side of the Monitor until the connector clicks into place. The temperature connector port on the Monitor is clearly labeled "TEMP." The probe connector can only be inserted one way, with the tab on top. The temperature probe should be inserted into the probe holder on the side of the Monitor.
Should removal of the tempera­ture probe be necessary, press down on the connector tab and slide the connector out.
Power
Start
Cancel
Review
Auto
Silence
DIASTOLIC
(mmHg)
PULSE
(BPM)
SpO
2 %
TEMPERATURE
Volume
SYSTOLIC
(mmHg)
Low Battery
CYCLE
Set
Select Alarm
Charging
Tone
Pulse
Placing the probe into the probe holder
Inserting the probe connector into the Monitor port
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