Welch allyn Vital signs monitor 300 series Manual

Vital Signs Monitor

300 Series

Directions for use

Software version 1.2X

ii Welch Allyn Vital Signs Monitor 300 Series

publication, the purchaser of the product is permitted to copy this publication, for internal distribution only,

from the media provided by Welch Allyn.

Welch Allyn assumes no responsibility for any injury to anyone, or for any illegal or improper use of the

product, that may result from failure to use this product in accordance with the instructions, cautions,

warnings, or statement of intended use published in this manual.

Welch Allyn is a registered trademark of Welch Allyn.

SET and Masimo are registered trademarks of Masimo Corporation. Possession or purchase of a Masimo

SpO2-equipped monitor does not convey any express or implied license to use the device with

unauthorized sensors or cables which would, alone or in combination with this device, fall within the

scope of one or more of the patents relating to this device.

Software in this product is Copyright Welch Allyn or its vendors. All rights are reserved. The software is

protected by United States of America copyright laws and international treaty provisions applicable

worldwide. Under such laws, the licensee is entitled to use the copy of the software incorporated with

this instrument as intended in the operation of the product in which it is embedded. The software may not

be copied, decompiled, reverse-engineered, disassembled or otherwise reduced to human-perceivable

form. This is not a sale of the software or any copy of the software; all right, title and ownership of the

software remains with Welch Allyn or its vendors.

For information about any Welch Allyn product, visit www.welchallyn.com/en/about-us/locations.html.

DIR 80019417 Ver A

www.welchallyn.com

Welch Allyn Protocol Inc.

8500 SW Creekside Place

Beaverton, OR 97008

USA

Regulatory Affairs Representative

Welch Allyn Limited

Navan Business Park

Dublin Road, Navan

County Meath, Republic of Ireland

iii

Contents

1 - General information ......................................1

About this manual.................................................1

Intended use.....................................................1

Symbols ........................................................2

Product overview .................................................3

Warnings and cautions .............................................4

Displays, indicators, controls, and connections ..........................6

2-Setup ..................................................9

Connections .....................................................9

Power on, power-on self-test, and power off...........................15

Configuring operating parameters ...................................16

3-Patientmonitoring ......................................29

Monitoringbloodpressure.........................................29

Monitoringpulserate.............................................35

Monitoring SpO2.................................................36

Monitoringtemperature...........................................39

4-Alarmsandalerts .......................................47

Respondingtoapatientalarm ......................................47

Respondingtoanequipmentalert...................................47

Alarmindicators .................................................49

Setting alarms...................................................49

Nursecall ......................................................51

Errorcodes.....................................................53

5-Reviewingpatientdata...................................55

Displayingstoredpatientdata ......................................55

Printingpatientdata..............................................55

Erasingpatientdata ..............................................60

Replacingtheprinterpapersupply...................................61

6-Operatormaintenance ...................................63

Cleaning .......................................................63

Storage........................................................63

Recyclingmonitorcomponents .....................................64

iv Contents Welch Allyn Vital Signs Monitor 300 Series

7-Reference..............................................65

Battery operation ................................................65

Monitor specifications ............................................66

Factory default settings ...........................................74

Limitedwarranty ..........................................75

Index ....................................................77

General information

About this manual

This manual contains information about the Welch Allyn®Vital Signs Monitor 300 Series

monitor. The series includes the following models:

All operators must read and understand this manual before using the monitor.

All technicians and other service personnel must read and understand this manual before

attempting to set up, configure, troubleshoot, or service the monitor.

All information in this manual, including the illustrations, is based on a monitor configured

with the Temperature, SpO2, and Printer options. If your monitor configuration lacks any

of these options, then some information in this manual does not apply.

Intended use

The VSM series of monitors are intended to be used by clinicians and medically qualified

personnel for monitoring of noninvasive blood pressure, pulse rate, body temperature,

noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and body

temperature in normal and axillary modes of neonatal, pediatric and adult patients.

The most likely locations for patients to be monitored are general med/surg. floors,

general hospital and alternate care environments. This device is available for sale only

upon the order of a physician or licensed health care professional.

Model Features Model Features

53000 Standard (NIBP, Pulse Rate, and MAP) 53S00 Standard + Masimo®SpO2

5300P Standard + Printer 53ST0 Standard + Masimo SpO2+ Temperature

530T0 Standard + Temperature 53S0P Standard + Masimo SpO2+ Printer

530TP Standard + Temperature + Printer 53STP Standard + Masimo SpO2+ Temperature + Printer

2Chapter 1 General information Welch Allyn Vital Signs Monitor 300 Series

Symbols

The symbols illustrated on the following pages appear on the monitor or in this document.

Table 1. Symbols: Certification and Operation

Table 2. Symbols: Shipping, Storing, and Environment

Table 3. Symbols: Connectors

Table 4. Symbols: Printer Door

This device has been tested and certified by

the Canadian Standards Association

International to comply with applicable U.S.

and Canadian medical safety standards.

Urgent alarm notification (output to Nurse Call

system)

The CE Mark and Notified Body Registration

Number signify that the device meets all

essential requirements of the European

Medical Device Directive 93/42/EEC.

Recycle used batteries properly and in

accordance with local regulations.

Do not dispose of batteries in refuse containers.

Recycle the monitor and battery separately from other disposables. (See “Recycling monitor components”

on page 64.)

Australian Registered Importer Sealed lead-acid battery, 6V 4 Ah

Patient connections (NIBP/Temp) are Type BF,

and protected against defibrillation.

Patient connections (SpO2)areTypeBF.

WARNING Indicates conditions that could lead to illness, injury, or death.

Caution In this manual, indicates conditions that could damage equipment or other property.

Caution On the product, means “Consult accompanying documentation.”

Keep this end of the package or shipping

crate up.

Protect the monitor from exposure to rain.

Fragile contents—handle with care. Do not subject the monitor to altitudes outside

these limits.

Do not expose the monitor to relative

humidity above this limit.

Limit stacking to this number of units.

Do not expose the monitor to temperatures

outside these limits.

Temperature Probe Cable Connector SpO2 SpO2Sensor Cable Connector

RS232 Cable Connector AC Power Adapter Cable Connector

Nurse Call Cable Connector NIBP Hose Connector

Press to open the printer door Load paper this direction

Directions for Use Chapter 1 General information 3

The functions of the monitor front panel controls illustrated here are described in detail

elsewhere in this document.

Table 5. Front Panel Controls

Table 6. Front Panel Displays and Indicators

Product overview

The monitor can monitor systolic and diastolic noninvasive blood pressure (NIBP), pulse

rate, and MAP (mean arterial pressure). Units configured with the appropriate options can

also simultaneously monitor temperature and SpO2, and can continuously monitor

pulse rate.

All vital-sign measurements are displayed on the front panel of the monitor. These

measurements can also be printed, using the optional integrated thermal printer.

The monitor provides programmable audible and visual alarms and automatic NIBP

measurements at selectable intervals. It can also be configured to provide an alarm-

activated Nurse Call function.

Accessory equipment connected to the analog and digital interfaces must be certified to

the respective IEC standards (IEC 60950 for data-processing equipment, IEC 60601-1 for

medical equipment). All such configurations must comply with the system standard

IEC 60601-1-1.

Set alarm limits Power on/off

Silence alarms Print patient data

Scroll up/down

Scroll forward/back

Increase/decrease value

(The scroll icon appears as these two arrows

in the documentation.)

Review patient data

Set an NIBP automatic measurement interval Start/stop an NIBP cycle (AUTO button)

Cycle to the next menu selections

SYS

DIA

SpO2

Systolic pressure

Diastolic pressure

Arterial hemoglobin oxygen saturation

Temperature

Pulse rate pulse

amplitude

indicator

Pulse strength

message

window

MAP (mean arterial pressure) Neonatal

Degrees Celsius Pediatric

Degrees Fahrenheit Adult

Monitored temperature AC power

Battery charging (flashing)

Battery charged (steady)

Battery discharged

ºC

ºF

4Chapter 1 General information Welch Allyn Vital Signs Monitor 300 Series

Warnings and cautions

All operating and service personnel must be familiar with the information presented here,

and with other warnings and cautions which appear throughout this document.

Warning and caution labels can appear on the monitor, the packaging, the shipping

container, or in this document.

General warnings

Caution Anyone connecting additional equipment to the signal input part or

signal output part of this monitor configures a medical system and is

responsible for verifying that the system complies with the requirements of the

system standard IEC 60601-1-1. Changes or modifications not expressly approved

by Welch Allyn could void the purchaser’s authority to operate the equipment.

WARNING Many environmental variables, including patient physiology and

clinical application, can affect the accuracy and performance of the device. The

clinician must verify all vital signs information prior to patient intervention.

WARNING The monitor is for use only by medical clinicians. Although this

document might illustrate medical monitoring techniques, the monitor must be

used only by trained clinicians who know how to take and interpret a patient’s

vital signs.

WARNING Disconnect the SpO2cable from the monitor before defibrillating the

patient.

WARNING During defibrillation, keep the defibrillation discharge paddles away

from any conductive parts that might already be in contact with the patient.

WARNING Use only accessories approved by Welch Allyn. Visit

www.welchallyn.com. The use of any other accessories can result in inaccurate

patient data, can damage the equipment, and can void your product warranty.

WARNING Do not operate the monitor in the presence of magnetic resonance

imaging (MRI) or hyperbaric chambers.

WARNING Do not operate the monitor in the presence of a flammable

anesthetic mixture with air, oxygen, or nitrous oxide, or in oxygen-enriched

environments, or in any other potentially explosive environment.

WARNING It is the clinician’s responsibility to set or verify alarm limits

appropriate to each patient.

WARNING Never allow any liquid to enter any monitor connector. If a connector

does come in contact with liquid:

1. Remove the monitor from service.

2. Use warm, dry air to dry the connector.

3. Thoroughly test and verify operation before returning the monitor to service.

Directions for Use Chapter 1 General information 5

General cautions

WARNING Do not connect more than one patient to a monitor.

WARNING If the monitor is dropped or damaged, it must be thoroughly tested

by a qualified service person before it is returned to service.

WARNING Periodically check all cords and cables for damage, wear, or fraying;

replace as needed.

WARNING The monitor contains no operator-serviceable parts, other than the

replaceable paper roll.

WARNING If the battery shows any signs of damage, leakage, or cracking, it

must be replaced immediately, by a qualified service person, and only with a

battery approved by Welch Allyn.

WARNING Always recycle batteries according to local regulations. Never

dispose of batteries in refuse containers.

WARNING Do not use the monitor on patients who are linked to a heart

machine or a lung machine.

WARNING Do not use the monitor on patients who are experiencing

convulsions or tremors.

WARNING Do not use the pulse oximeter as a replacement or substitute for

ECG-based arrhythmia analysis.

Caution If the accuracy of any measurement is in doubt, verify the patient’s vital

sign by another method. If the monitor is not measuring accurately, have it

inspected by a qualified service person.

Caution Be sure that the monitor is securely located on a flat surface or properly

suspended by means of appropriate mounting equipment.

Caution Do not autoclave the monitor.

Caution Do not place cups, glasses, or other fluid containers or vessels on

the monitor.

Caution Users should check for audible alarm function every time the VSM 300

is used. During the normal power-up cycle, two audible tones are emitted

immediately after the self-test is complete. If these tones do not sound, the audio

has failed. Remove the device from service and contact Welch Allyn.

The loss of the audible alarm could cause a delay in a clinician learning of an alarm

condition for the following conditions: 1) hypotension or hypertension, 2) low

blood oxygen content (SpO2), 3) low or high pulse rate, 4) other alarm conditions

relating to the loss of monitoring of a patient (e.g., a “sensor off” condition). Such

delay could potentially result in injury to the patient.

6Chapter 1 General information Welch Allyn Vital Signs Monitor 300 Series

Displays, indicators, controls, and connections

This section describes the measurement displays, status indicators, function controls, and

connections of the monitor.

Numeric measurement and message displays

SYS,DIA, and SpO2.

Displays systolic and diastolic

blood pressure and SpO2, or

related alarm thresholds and

error codes. (See “Error codes”

on page 53.)

Displays pulse rate and

temperature, or related alarm

thresholds and error codes.

(Message window)

Displays the current date and time, MAP measurements, and alarm

thresholds. Displays configuration settings, error codes, software version

numbers, and printer status.

Directions for Use Chapter 1 General information 7

Status indicators

alarms not silenced

Battery Status

Pulse

Amplitude Indicator

ºF

mmHg

kPa

millimeters of

mercury

Patient type

NIBP Measurement Units

kilopascals

neonate

pediatric

adult

degrees Fahrenheit

Temperature Units

degrees Celsius

ºC

Temperature Type

monitored

charged ———

charging-----

discharged

alarms silenced

power

is on

power

is off

8Chapter 1 General information Welch Allyn Vital Signs Monitor 300 Series

Function controls

Connections

For information on the connections, refer to the following:

Review

Data

Set NIBP

Interval

Start/Stop NIBP

(AUTO button)

Set Alarm

Limits

Silence

Alarms

Up/Down

Power

is off

Power

is on

Alarms

Silenced

Power On/Off

AC power adapter “Connecting AC power” on page 9

Temperature probe “Connecting the temperature probe cable” on page 12

SpO2sensor “Connecting and disconnecting the SpO2 sensor cable” on page 13

NIBP cuff hose “Connecting the NIBP cuff hose” on page 11

Nurse call cable “Nurse call” on page 73

30V , 1A Max.

Temperature Probe

Cable Connector

SpO2Sensor Cable

Connector

DC Power Cable

Connector

RS232 Cable

Connector

Nurse Call Cable

Connector

SpO2

Setup

This chapter describes the set-up procedures for patient monitoring.

Connections

Use the procedures described below to connect components to the monitor.

Connecting AC power

The monitor operates on DC power, supplied by either the internal battery or the AC

power adapter. (For information on the battery, refer to “Battery operation” on page 65

and “Electrical” on page 68.)

When the AC power adapter is connected, it simultaneously powers the monitor and

charges the internal battery. When the AC power adapter is not connected, the monitor

operates on the internal battery.

WARNING Use only accessories approved by Welch Allyn. Visit

www.welchallyn.com. The use of any other accessories can result in inaccurate

patient data, can damage the equipment, and can void your product warranty.

Caution Using an unqualified power adapter can violate isolation requirements.

10 Chapter 2 Setup Welch Allyn Vital Signs Monitor 300 Series

To use the AC power adapter:

1. Plug the power adapter into the AC power source.

2. Plug the power adapter connector into the monitor DC port.

Use the AC power adapter to fully charge the battery before using the monitor. (This can

take up to 12 hours.)

• While the monitor is charging, the AC/charging indicator flashes.

•Whenthemonitoris90%charged,theAC/chargingindicator issteady.Tofully

charge the battery, leave the AC power adapter connected for a few more hours.

• After the monitor is fully charged for the first time, the monitor can be powered by the

AC power adapter or by the internal battery.

Caution Fully charge the battery before using the monitor for the first time.

Failure to do so will result in poor battery performance and reduced battery life.

AC Power

Adapter Port

Directions for Use Chapter 2 Setup 11

Connecting the NIBP cuff hose

Attach the hose to the monitor and the cuff as follows, referring to the illustration below:

1. Screw the hose connector onto the NIBP connector on the monitor.

2. Connect the monitor hose connector to the mating connector on the cuff.

For information on NIBP measurements, see “Patient monitoring” on page 29.

Threaded NIBP

Hose Connector

12 Chapter 2 Setup Welch Allyn Vital Signs Monitor 300 Series

Connecting the temperature probe cable

Follow these steps to connect the temperature probe cable to the monitor.

1. Locate the temperature probe connector port on the back of the monitor.

2. Holding the temperature probe cable connector with the spring tab on the right,

carefully insert it into the monitor temperature probe connector port. The spring tab

clicks out when the connector halves are fully and correctly mated.

3. To disconnect the temperature probe cable, depress the spring tab and withdraw the

cable connector.

For information on temperature measurements, see “Patient monitoring” on page 29.

TemperatureProbe

Connector Port

TemperatureProbe Cable

Connector

Directions for Use Chapter 2 Setup 13

Connecting and disconnecting the SpO2sensor cable

To connect the SpO2 sensor cable:

1. Locate the SpO2sensor cable connector (labeled SpO2) on the side of the monitor.

2. Note the hole patterns of the connector halves, and align the cable

connector accordingly.

3. Carefully insert the SpO2cable connector into the SpO2monitor connector.

If you are using a sensor extension cable, plug the sensor into the extension cable and

plug the extension cable into the monitor.

14 Chapter 2 Setup Welch Allyn Vital Signs Monitor 300 Series

To disconnect the SpO2cable, refer to the instructions shown in the illustration below.

For information on SpO2measurements, see “Patient monitoring” on page 29.

Note Always grasp the cable by the connector shoulder. Do not pull on the cable itself.

Thumb and forefinger squeeze the tabs

in the shoulder of the connector cable

to release the cable connector.

Directions for Use Chapter 2 Setup 15

Power on, power-on self-test, and power off

When the battery is charged, press to turn on the monitor.

The monitor runs a diagnostic self-test each time it powers up.

• If all tested functions are working normally, the various windows briefly display

start-up values (‘8’ and ‘--’) and a short tone sounds twice.

•Iftheself-testfails,anerrorcodeappearsintheSYSwindow.

When the self-test is complete, the software version appears briefly in the message

window, followed by the current time of day.

To shut off the monitor, press .