Welch Allyn 300 User Manual

Vital Signs Monitor 300 Series

Directions for use

Software version 1.2X

ii Welch Allyn Vital Signs Monitor 300 Series

© 2014 Welch Allyn. All rights are reserved. To support the intended use of the product described in this 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.

Nellcor is a registered trademark of Nellcor Puritan Bennett Inc.

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 80019418 Ver A

Welch Allyn Protocol Inc. 8500 SW Creekside Place Beaverton, OR 97008 USA

www.welchallyn.com

Regulatory Affairs Representative Welch Allyn Limited Navan Business Park Dublin Road, Navan County Meath, Republic of Ireland

Contents

1 - General Information ......................................1

iii

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 - Patient Monitoring ......................................29

Monitoring Blood Pressure .........................................29

Monitoring Pulse Rate ............................................36

Monitoring SpO2.................................................37

Monitoring Temperature...........................................40

4 - Alarms and Alerts .......................................51

Responding to a Patient Alarm ......................................51

Responding to an Equipment Alert ...................................52

Alarm Indicators .................................................54

Setting Alarms ..................................................54

Nurse Call ......................................................57

Error Codes.....................................................58

5 - Reviewing Patient Data...................................59

Displaying Stored Patient Data ......................................59

Printing Patient Data ..............................................59

Erasing Patient Data ..............................................65

Replacing the Printer Paper Supply ..................................66

6 - Operator Maintenance ...................................67

Cleaning .......................................................67

Storage ........................................................67

Recycling Monitor Components .....................................68

iv Contents Welch Allyn Vital Signs Monitor 300 Series

7 - Reference ..............................................69

Battery Operation ................................................69

Monitor Specifications ............................................71

Factory Default Settings ...........................................80

Limited Warranty ..........................................81

Index ....................................................83

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:

Model Features Model Features

53000 Standard (NIBP, Pulse Rate, and MAP) 53N00 Standard + Nellcor

5300P Standard + Printer 53NT0 Standard + Nellcor SpO2+ Temperature

530T0 Standard + Temperature 53N0P Standard + Nellcor SpO

530TP Standard + Temperature + Printer 53NTP Standard + Nellcor SpO

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.

SpO

+ Printer

+ Temperature + Printer

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.

2 Chapter 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

This device has been tested and certified by the Canadian Standards Association International to comply with applicable U.S. and Canadian medical safety standards.

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.

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

Recycle the monitor and battery separately from other disposables. (See “Recycling Monitor Components” on page 68.)

Patient connections are Type BF, and protected against defibrillation.

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.”

Table 2. Symbols: Shipping, Storing, and Environment

Keep this end of the package or shipping crate up.

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

Urgent alarm notification (output to Nurse Call system)

Recycle used batteries properly and in accordance with local regulations. Do not dispose of batteries in refuse containers.

Protect the monitor from exposure to rain.

these limits.

Do not expose the monitor to relative humidity above this limit.

Do not expose the monitor to temperatures outside these limits.

Table 3. Symbols: Connectors

Temperature Probe Cable Connector SpO2 SpO

RS232 Cable Connector AC Power Adapter Cable Connector

Nurse Call Cable Connector NIBP Hose Connector

Table 4. Symbols: Printer Door

Press to open the printer door Load paper this direction

Limit stacking to this number of units.

Sensor Cable Connector

Directions for Use Chapter 1 General Information 3

ºC

ºF

The functions of the monitor front panel controls illustrated here are described in detail elsewhere in this document.

Table 5. Front Panel Controls

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.)

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

Cycle to the next menu selections

Table 6. Front Panel Displays and Indicators

SYS

Systolic pressure

DIA

SpO2

message

window

Diastolic pressure Arterial hemoglobin oxygen saturation

Pulse rate pulse

MAP (mean arterial pressure) Neonatal

Degrees Celsius Pediatric

ºC

Degrees Fahrenheit Adult

ºF

Monitored temperature AC power

Battery discharged

Review patient data

Temperature

Pulse strength

amplitude

indicator

Battery charging (flashing) Battery charged (steady)

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 alarmactivated 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

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

medical equipment). All such configurations must comply with system standard IEC 60601-1-1.

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.

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

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 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

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.

General Cautions

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.

6 Chapter 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 SpO related alarm thresholds and error codes. (See “Error Codes” on page 58.)

,or

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

ºF

ºC

Status Indicators

NIBP Measurement Units

kilopascals

millimeters of mercury

Patient type

neonate

pediatric

adult

kPa

mmHg

Amplitude Indicator

power

is off

Pulse

power

is on

Temperature Units

degrees Fahrenheit

ºF

degrees Celsius

ºC

Temperature Type

monitored

alarms not silenced

alarms silenced

Battery Status

charged ——— charging-----

discharged

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

Function Controls

Up/Down

Power On/Off

Connections

Power

is on

SpO

Power

is off

Nurse Call Cable Connector

SpO

Sensor Cable

Connector

RS232 Cable Connector

DC Power Cable Connector

Review

Data

Set NIBP

Interval

30V , 1A Max.

Start/Stop NIBP

(AUTO button)

Set Alarm

Limits

For information on the connections, refer to the following:

AC Power Adapter “Connecting AC Power” on page 9

Temperature Probe “Connecting the Temperature Probe Cable” on page 12

Sensor “Connecting and Disconnecting the SpO2 Sensor Cable” on page 13

SpO

NIBP Cuff Hose “Connecting the NIBP Cuff Hose” on page 11

Silence Alarms

Temperature Probe Cable Connector

Alarms Silenced

Nurse Call Cable “Nurse Call” on page 79

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 69 and “Electrical” on page 74.)

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.

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.

10 Chapter 2 Setup Welch Allyn Vital Signs Monitor 300 Series

AC Power Adapter Port

Use the AC power adapter to fully charge the battery before using the monitor. (This can take up to 12 hours.)

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.

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

• When the monitor is 90% charged, the AC/charging indicator is steady. To fully 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.

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.

Threaded NIBP Hose Connector

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

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.

TemperatureProbe Connector Port

TemperatureProbeCable Connector

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

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.

Note

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

Verify that the sensor cable connector has slots on both sides. If the cable connector has a slot on only one side, then the sensor is not compatible with the monitor.

The SpO2connectors are notched and flanged to ensure proper fit. If the connectors do not join easily, stop and verify the following:

• You have the correct SpO2sensor.

• The cable connector is aligned correctly.

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.

Note

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

For information on SpO

Thumb presses the uppertab to free the connector.

Thumb and forefinger grasp the shoulder of the connector cable to pull the cable connector out of the connector port.

measurements, see “Patient Monitoring” on page 29.

Directions for Use Chapter 2 Setup 15

ºF

ºC

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.

mmHg

SYS

8.8.8

DIA

8.8.8

kPa

SpO2 %

****************

/min

SYS

SpO2 %

18.8

DIA

****************

/min

ºF

ºC

mmHg

SYS

DIA

SpO2 %

/min

ºF

SYS

DIA

SpO2 %

/min

8.8.8

1.8.8.8

****************

• If the self-test fails, an error code appears in the SYS window.

When the self-test is complete, the software version appears briefly in the message window, followed by the current time of day.

00:00:45

Caution Always observe the monitor during power-up. If any display fails to illuminate properly, or if an error code appears in the systolic window, inform your biomedical engineering department immediately, or call your nearest Welch Allyn Customer Service or Technical Support facility. Do not use the monitor until the problem is corrected.

To shut off the monitor, press .

Note

Shutting off the monitor erases all stored patient data but does not erase settings or configuration parameters.

16 Chapter 2 Setup Welch Allyn Vital Signs Monitor 300 Series

ºF

Configuring Operating Parameters

You can change several monitor operating parameters. When changed, these settings become the default power-up settings.

How to Use the Menu System

The monitor menu system contains three sets of menus—settings, configuration, and service.

Settings Menu

Access the settings menu by pressing the menu button while in normal operation. Then press repeatedly to reach the setting of interest.

Settings Menu

128

37.0

MAP 90mmHg

Power Off - all values saved except target inflation pressure

No action for 10 seconds or Press any button other than

Patient Type

Target Cuff Inflation Pressure

Temperature Units

Temperature Type

ºF

ºCºCM

Pulse Tone Volume

Directions for Use Chapter 2 Setup 17

ºFºFºFMM

ºCºCºCMM

Use the settings menu to select and set the following parameters:

Patient Type Neonate Term birth through 28 days, or up to 44 gestational weeks

Pediatric 29 days through 12 years

Adult 13 years and older

Target Pressure The initial cuff inflation pressure (set individually for each patient type)

Temp Modes Fahrenheit Predictive

Pulse Tone Volume From 0 (silent) to 5 (loudest)

ºF

Fahrenheit Monitored Celsius Predictive

ºC

Celsius Monitored

To change a settings parameter:

1. Select the parameter as indicated above.

2. Change the value by pressing or .

3. Set the displayed new value either by doing nothing for 10 seconds or by pressing any button other than or . If you press a function button (such as ), the monitor returns to normal operation with that function ( ) activated.

18 Chapter 2 Setup Welch Allyn Vital Signs Monitor 300 Series

Confi

Configuration Menu

The configuration menu is accessed by pressing and keeping it depressed for three seconds. You then press repeatedly until you reach the setting of interest.

gurationMenu

128

37.0

MAP 90 kPa

Press and hold for 3 seconds

Power Off - all values saved

Press and hold for 3 seconds

Set Time and Date

MAP

Enable

Disable

NIBP Units

mmHg

kPa

No action for 10 seconds

Press any button other than

Stream

Batch

Directions for Use Chapter 2 Setup 19

Use the configuration menu to select and set the following parameters:

Time and Date hour

MAP Measurement Enabled

Blood Pressure Measurement Units

Print Mode Batch

minute year month day

Disabled

mmHg (millimeters of mercury) kPa (kilopascals)

Stream

To change a configuration parameter:

1. Select the parameter as indicated above.

2. Change the value by pressing or .

20 Chapter 2 Setup Welch Allyn Vital Signs Monitor 300 Series

ºF

Changing the Time and Date

Follow these steps to change the time and date settings of the monitor internal clock.

1. Press and hold for 3 seconds. SET HOUR XX appears in the message window.

mmHg

SYS

SpO2 %

DIA

SET HOUR 00

/min

ºF

2. Press or as needed to change XX to the current hour.

3. Press once to set the hours and change the display to SET MINUTE XX.

4. Press or as needed to change XX to the current minute.

5. Press once set the minutes and to change the display to SET YEAR XX.

6. Press or as needed to change XX to the current year.

7. Press once to set the year and change the display to SET MONTH XXX.

8. Press or as needed to change XXX to the current month.

9. Press once to set the month and change the display to SET DAY XX.

10. Press or as needed to change XX to the current day.

Directions for Use Chapter 2 Setup 21

ºF

11. To save the displayed time and date settings, either do nothing for 10 seconds or press any button other than or . If you press a function button (such as ), the monitor returns to normal operation with that function ( ) activated.

mmHg

SYS

SpO2 %

DIA

/min

ºF

09:24:17

You cannot change the date and time while memory contains stored vital-signs data. If you attempt to change the date and time setting while data is stored, the question ERASE DATA? appears in the message window. If you confirm the data erasure, the monitor erases the data from memory and returns you to the date-set function. If you select NO, the stored data is retained in memory and the monitor returns to normal operation.

SYS

DIA

SpO2 %

ERASE DATA?

/min

SYS

SpO2 %

DIA

= YES = NO

/min

22 Chapter 2 Setup Welch Allyn Vital Signs Monitor 300 Series

ºF

Changing the Patient Type

The age range for each patient type is defined as follows:

Neonatal Term birth through 28 days, or up to 44 gestational weeks

Pediatric 29 days through 12 years

Adult 13 years and older

Default setting: ADULT.

Follow these steps to change the patient type setting.

1. Press . The current patient type ( , , or ) appears below the DIA window, and NEONATE, PEDIATRIC,orADULT appears in the message window.

2. Press or to display , , or .

3. To select the displayed patient type and return to normal operation, either do nothing for 10 seconds or press any button other than or . If you press a function button (such as ), the monitor returns to normal operation with that function ( ) activated.

mmHg

SYS

DIA

SpO2 %

/min

mmHg

SYS

ºF

DIA

SpO2 %

/min

ºF

ADULT

Changing the patient type has the following effects:

• Alarm limits are reset to the default limits for the new patient type

• Cuff inflation target pressure is reset to the default for the new patient type

If you cycle through the patient types but do not change the setting, the alarm limits and the cuff inflation target pressure settings do not change.

NEONATE

Directions for Use Chapter 2 Setup 23

ºF

MAP Measurement Enable and Disable

Default setting: MAP ENABLED for neonate; MAP DISABLED for adult and pediatric.

1. Depress for 3 seconds. SET HOUR XX appears in the message window.

2. Press repeatedly until MAP ENABLED or MAP DISABLED appears in the display window.

mmHg

SYS

SpO2 %

DIA

/min

ºF

MAP DISABLED

3. Press or to enable or disable MAP measurement.

Note

If you change the MAP enabled/disabled setting, refer to “How Changing the

Patient Type Affects MAP Defaults” on page 36.

4. To select the displayed state and return to normal operation, either do nothing for 10 seconds or press any button other than or . If you press a function button (such as ), the monitor returns to normal operation with that function ( ) activated.

mmHg

SYS

SpO2 %

DIA

/min

ºF

MAP ENABLED

For information about MAP measurements, see “Patient Monitoring” on page 29.

+ 63 hidden pages

Welch Allyn 300 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Directions for use

General Information

About This Manual

Intended Use

Symbols

Product Overview

Warnings and Cautions

Displays, Indicators, Controls, and Connections

Setup

Connections

Power On, Power-on Self-Test, and Power Off

Configuring Operating Parameters