Welch Allyn VITAL SIGNS MONITOR Operation Manual

Patient Monitor

Service Manual

French Version

German Version

Spanish Version

Italian Version

SYSTOLIC

SpO2
(mmHg)
PULSE	(BPM)

%

	TEMPERATURE	Pulse
		Volume
		Tone
	Charging	Select
		Alarm
	Low
	Battery
	CYCLE
		Set
	Review
	Auto
		Silence

Operator’s 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.	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

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. 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

WELCH ALLYN VITAL SIGNS MONITOR		OPERATOR MANUAL
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 BennettTM 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

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.

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WELCH ALLYN VITAL SIGNS MONITOR	OPERATOR MANUAL

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.

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WELCH ALLYN VITAL SIGNS MONITOR	OPERATOR MANUAL

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	SpO2 Adult Finger Flexiform Sensors (10)
5200-47	SpO2 Pediatric Finger Flexiform Sensors (10)
5200-50	SpO2 Sensor Attachment Tape
5200-51	SpO2	Hydrogel Tape Strips
5200-52	SpO2	Extension Cable (3ft) (0.9m)
5200-53	SpO2	Finger Phantom Calibration Kit
5200-55	SpO2	Extension Cable (9ft) (2.7m)

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WELCH ALLYN VITAL SIGNS MONITOR	OPERATOR MANUAL

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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WELCH ALLYN VITAL SIGNS MONITOR		OPERATOR MANUAL
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)

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WELCH ALLYN VITAL SIGNS MONITOR	OPERATOR MANUAL

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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WELCH ALLYN VITAL SIGNS MONITOR	OPERATOR MANUAL

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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WELCH ALLYN VITAL SIGNS MONITOR	OPERATOR MANUAL

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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WELCH ALLYN VITAL SIGNS MONITOR	OPERATOR MANUAL

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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WELCH ALLYN VITAL SIGNS MONITOR	OPERATOR MANUAL

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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WELCH ALLYN VITAL SIGNS MONITOR	OPERATOR MANUAL

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.

Maximum Minimum

SpO2

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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WELCH ALLYN VITAL SIGNS MONITOR	OPERATOR MANUAL

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:

	Maximum	Minimum
Pulse Rate	200 bpm	40 bpm

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WELCH ALLYN VITAL SIGNS MONITOR	OPERATOR MANUAL

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®)		±3.0%
SpO2	Module 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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WELCH ALLYN VITAL SIGNS MONITOR	OPERATOR MANUAL

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	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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WELCH ALLYN VITAL SIGNS MONITOR	OPERATOR MANUAL

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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WELCH ALLYN VITAL SIGNS MONITOR	OPERATOR MANUAL

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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WELCH ALLYN VITAL SIGNS MONITOR	OPERATOR MANUAL

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 SpO2 Sensor 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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WELCH ALLYN VITAL SIGNS MONITOR	OPERATOR MANUAL

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.

	M	N		P	R	S	I
K						Pulse	Volume	J
						Tone
	SYSTOLIC (mmHg)		SpO2 %		TEMPERATURE
							Select	G
							Alarm
L					Charging
	DIASTOLIC (mmHg)		PULSE (BPM)		Low Battery
					CYCLE		Set	H
								Q
								T
	O	Power	Start	Cancel	Review	Auto	Silence
	A	B	C		D		E	F

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.

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WELCH ALLYN VITAL SIGNS MONITOR	OPERATOR MANUAL

D.REVIEW Button

Pressing this button will display the most current set of stored data including BP &

pulse rate and/or SpO2 and/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 SpO2 monitoring, should an SpO2 or 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 SpO2 pulse 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 SpO2 low saturation alarm limits (see G, and H above).

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WELCH ALLYN VITAL SIGNS MONITOR	OPERATOR MANUAL

N.PULSE SIGNAL BAR GRAPH

This bar graph gives a visual indication of the strength and quality of the pulses

detected by the SpO2 sensor. Additionally, this bar graph can indicate the volume level of the SpO2 pulse 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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WELCH ALLYN VITAL SIGNS MONITOR	OPERATOR MANUAL

B. SIDE & REAR PANEL CONNECTIONS

8

9

4 7

1

5

2

11

6 10

3

1.SpO2 Sensor Connection

Nine pin connector for the SpO2 sensor.

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.

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WELCH ALLYN VITAL SIGNS MONITOR	OPERATOR MANUAL

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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WELCH ALLYN VITAL SIGNS MONITOR	OPERATOR MANUAL

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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WELCH ALLYN VITAL SIGNS MONITOR	OPERATOR MANUAL

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.

Inserting the probe connector into the Monitor port

Should removal of the temperature probe be necessary, press down on the connector tab and slide the connector out.

SYSTOLIC

SpO2
(mmHg)
PULSE	(BPM)

%

	TEMPERATURE	Pulse
		olume
		Tone
		V
	Charging	Select
		Alarm
	Low
	Battery
	CYCLE
		Set
	Review
	Auto
		Silence

Placing the probe into the probe holder

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