WelchAllyn Vital Signs Monitor Series 300 Directions of Use Software Version 1.2x Rev A Sept 2009

ii

Welch Allyn Vital Signs Monitor 300 Series

© 2009 Welch Allyn. All rights are reserved. No one is permitted to reproduce or duplicate, in any form, this manual or any part thereof without permission from 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, call Welch Allyn Technical Support: USA

+ 1 315 685 4560 800 535 6663

Australia

+ 61 29 638 3000 800 074 793

Canada

800 561 8797

China

+ 86 216 327 9631

European Call Center

+ 353 46 906 7790

France

+ 33 1 6009 3366

Germany

+ 49 747 792 7186

Japan

+ 81 33 219 0071

Latin America

+ 1 305 669 9003

Netherlands

+ 31 15 750 5000

Singapore

+ 65 6419 8100

South Africa

+ 27 11 777 7555

United Kingdom

+ 44 207 365 6780

Sweden

+ 46 85 853 6551

REF: 810-2252-XX REF 810-2221-XX (Printed, English only) Manual Part Number 810-2223-03 Ver A, 2009-09

Welch Allyn, Inc. 8500 SW Creekside Place Beaverton, OR 97008-7107 USA

www.welchallyn.com

Welch Allyn Ltd 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 - 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

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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

1

1 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® SpO2

5300P Standard + Printer

53NT0 Standard + Nellcor SpO2 + Temperature

530T0 Standard + Temperature

53N0P Standard + Nellcor SpO2 + Printer

530TP Standard + Temperature + Printer

53NTP Standard + Nellcor SpO2 + Temperature + Printer

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.

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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

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. 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 expose the monitor to relative humidity above this limit.

Protect the monitor from exposure to rain. Do not subject the monitor to altitudes outside these limits. Limit stacking to this number of units.

Do not expose the monitor to temperatures outside these limits.

Table 3. Symbols: Connectors Temperature Probe Cable Connector

SpO2 SpO2 Sensor Cable Connector

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

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 Set alarm limits

Power on/off

Silence alarms

Print patient data

Scroll up/down Scroll forward/back Increase/decrease value

Review patient data

(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 DIA SpO2

Systolic pressure Diastolic pressure Arterial hemoglobin oxygen saturation Pulse rate

message MAP (mean arterial pressure) window Degrees Celsius ºC

Temperature

pulse Pulse strength amplitude indicator Neonatal Pediatric

ºF

Degrees Fahrenheit

Adult

M

Monitored temperature

AC power Battery charging (flashing) Battery charged (steady)

Battery discharged

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

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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 For the safety of patients, and to ensure the best product performance and accuracy, use only accessories and supplies recommended or supplied by Welch Allyn for the monitor, as listed in Products and Accessories (810-0409-XX). Always use accessories with strict adherence to the manufacturer’s directions for use. 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. WARNING Do not use the pulse oximeter as a replacement or substitute for ECG-based arrhythmia analysis.

General Cautions 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.

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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 SpO2, or related alarm thresholds and error codes. (See “Error Codes” on page 58.)

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

Status Indicators Temperature Units

NIBP Measurement Units kilopascals

Pulse Amplitude Indicator

kPa

millimeters of mmHg mercury

ºF degrees Fahrenheit ºC degrees Celsius Temperature Type

M monitored

Patient type neonate

alarms not silenced

pediatric

adult

alarms silenced Battery Status power is off

power is on

charged --- charging - - - - discharged

7

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Chapter 1 General Information

Welch Allyn Vital Signs Monitor 300 Series

Function Controls

Print

Menu

Up/Down

Power On/Off

Power is on

Power is off

Review Data

Set NIBP Interval

Start/Stop NIBP (AUTO button)

Set Alarm Limits

Silence Alarms

Alarms Silenced

Connections Nurse Call Cable Connector SpO2

30V

, 1A Ma

x.

Temperature Probe Cable Connector

SpO2 Sensor Cable Connector RS232 Cable Connector DC Power Cable Connector

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

SpO2 Sensor

“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 79

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2 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. Caution Use only the medical-grade AC power adapter approved by Welch Allyn. (Refer to the Welch Allyn Parts and Accessories Guide (810-0409-XX) for ordering information.) Using an unqualified power adapter can have the following results: •

violation of isolation requirements

•

hazard to the patient

•

damage to the monitor

•

nullification of the product warranty

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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.

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.

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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.

Temperature Probe Connector Port Temperature Probe Cable Connector

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

Directions for Use

Chapter 2 Setup

13

Connecting and Disconnecting the SpO2 Sensor Cable To connect the SpO2 sensor cable: 1.

Locate the SpO2 sensor 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

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 SpO2 connectors are notched and flanged to ensure proper fit. If the connectors do not join easily, stop and verify the following: •

You have the correct SpO2 sensor.

•

The cable connector is aligned correctly.

3. Carefully insert the SpO2 cable connector into the SpO2 monitor connector.

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

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Chapter 2 Setup

Welch Allyn Vital Signs Monitor 300 Series

To disconnect the SpO2 cable, 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.

Thumb presses the upper tab to free the connector. Thumb and forefinger grasp the shoulder of the connector cable to pull the cable connector out of the connector port.

For information on SpO2 measurements, see “Patient Monitoring” on page 29.

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. 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.

mmHg

888 .

.

/min

/min

kPa

SYS

SYS

SpO2 %

.

.

.

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

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

8.8.8.

SpO2 %

1.8.8.8.

DIA

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

•

.

DIA

/min

SYS

188 .

.

DIA

888

SpO2 %

1

2

3

4 /min

mmHg

SYS ºF ºC M

0

SpO2 %

0 ºF

DIA

0

00:00:45

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. 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.

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Chapter 2 Setup

Welch Allyn Vital Signs Monitor 300 Series

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 Then press repeatedly to reach the setting of interest.

while in normal operation.

Settings Menu

128 71

54

98

Patient Type

37.0

MAP 90mmHg

Target Cuff Inflation Pressure

Power Off - all values saved except target inflation pressure

Temperature Units Temperature Type

ºF ºC M No action for 10 seconds or Press any button other than

Pulse Tone Volume