Welch Allyn Spot Vital Signs LXi Directions For Use Manual

Welch Allyn Spot Vital Signs LXi

Directions for Use

Enter

7

21

7

3

5

8

9

62

01

BP

AM

SYS

TEMP

SpO2

PULSE

/min

mmHg

F

DIA

%

Weight

Respiration

Pain

4 WEST

Reading

Patient ID 0123456789

Height

Send/Next Reading

Clear

Spot Vital Signs LXi

Welch Allyn Spot Vital Signs LXi

Directions for Use

ii Welch Allyn Spot Vital Signs LXi

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. No other use, reproduction, or distribution of

the publication, or any part of it, is permitted without written 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

®

, Spot Vital Signs

®

, SureBP

®

Technology, and SureTemp

®

are registered trademarks of Welch

Allyn.

Braun ThermoScan

®

is a registered trademark of the Braun Company.

LNCS

™

is a trademark of, and SET

®

, LNOP

®

, and Masimo

®

are registered trademarks of, Masimo

Corporation. Possession or purchase of a Masimo SpO

2

-equipped device 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.

Nellcor

®

and

Oxi-Max

®

are registered trademarks of Nellcor Puritan Bennett Inc.

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 remain with Welch Allyn or its vendors.

For information about any Welch Allyn product, call Welch Allyn Technical Support:

Manual Material No. 705310 Rev. F

Printed in USA

USA +1 800 289 2501 Australia +61 2 9638 3000

Canada +1 800 561 8797 China +86 21 6327 9631

European Call Center +353 46 90 67790 France +33 15 5695 849

Germany +49 695 098 5132 Japan +81 3 6383 0852

Latin America +1 305 669 9003 Netherlands +31 202 061 360

Singapore +65 6419 8100 South Africa +27 11 777 7555

United Kingdom +44 207 365 6780 Sweden +46 85 853 6551

Welch Allyn

4341 State Street Road

Skaneateles Falls, NY

13153 USA

European Regulatory Manager

Welch Allyn Ltd.

Navan Business Park

Dublin Road

Navan, County Meath, Republic of Ireland

Tel.: +353 46 90 67700

Fax: +353 46 90 67755

EC REP

Directions for Use iii

Initial Configuration

Before using Spot LXi for the first time, you must program an initial configuration screen. See page 23 for

more details.

Change Local Defaults Menu

Language:

BP Units:

Temperature Units:

Height Units:

Weight Units:

Date Format:

Date:

Time Format:

Time:

Model No.: 45NTO

Serial No. 2005040004

Select

iv Welch Allyn Spot Vital Signs LXi

v

Contents

Initial Configuration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii

Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v

1 - Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

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

Safety Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Button Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Connection Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Agency Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Related Publications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Warnings and Cautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

General Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Blood Pressure Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Temperature Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

SpO

2

Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

General Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Blood Pressure Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Temperature Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

SpO

2

Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Mises en gardes et avertissements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Mises en garde générales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Mises en garde relatives à la pression artérielle . . . . . . . . . . . . . . . . . . . . . 13

Mises en garde relatives à la température. . . . . . . . . . . . . . . . . . . . . . . . . . 14

Mises en garde relatives au SpO

2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Avertissements généraux. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Avertissements relatifs à la pression artérielle. . . . . . . . . . . . . . . . . . . . . . . 17

Avertissements relatifs à la température . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Avertissements relatifs au SpO

2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Contents Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Possible Attachments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

2 - Controls, Display Window, and Connections . . . . . . . . . . . . . . . . . 21

Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Display Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Braun ThermoScan PRO 4000 Lock. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Blood Pressure Hose and Cuff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

vi Contents Welch Allyn Spot Vital Signs LXi

Thermometer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

SpO

2

Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Quick Reference Card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

AC Power Transformer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Power On/Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Standby Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

3 - Internal Configuration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

4 - Blood Pressure Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Blood Pressure Cuff Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Blood Pressure Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

5 - Temperature Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Temperature Operation Mode Selection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Normal Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Monitor Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Temperature Measurement Range Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Ear Temperatures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

6 - Pulse Oximetry Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

7 - Manual Entries and External Device Operation . . . . . . . . . . . . . . . 45

Manual Entries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Weight, Height, Respiration, and Pain Level . . . . . . . . . . . . . . . . . . . . . . . . 45

Body Mass Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Memory Recall. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

External Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

Printer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

Weight Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Barcode Scanner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

8 - Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Error Codes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Event Causes and Corrective Actions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

9 - Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

Blood Pressure Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

Temperature Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

SpO

2

Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Masimo Sensor Accuracy Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Masimo Patents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Nellcor

®

Sensor Accuracy Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

Nellcor Patents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

Mechanical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

Directions for Use Contents vii

Electrical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

Environmental. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

Patents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

Guidance and Manufacturer’s Declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

Emissions and Immunity Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

10 - Maintenance and Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

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

Spot Vital Signs LXi . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

Blood Pressure Cuff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

Blood Pressure Hose and Cable. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

SureTemp Plus Thermometer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

Braun ThermoScan PRO 4000 Thermometer . . . . . . . . . . . . . . . . . . . . . . . 64

SpO

2

Sensors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Printer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Battery Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

Spot Vital Signs LXi . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

Braun ThermoScan PRO 4000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

Printer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

Calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

Blood Pressure Calibration Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

Temperature Calibration Check. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

Masimo SpO

2

Calibration Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

Nellcor SpO

2

Functional Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

Product Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

Technical Assistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

Service Manual/Spare Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

Service Loaners . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

11 - Supplies and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

Blood Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

Pulse Oximetry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

Masimo Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

Nellcor Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

Miscellaneous. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

Service Contracts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

Spot LXi . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

viii Contents Welch Allyn Spot Vital Signs LXi

1

Introduction

This Directions for Use manual is a comprehensive guide designed to help you

understand the capabilities and operation of your Spot Vital Signs LXi. The information in

this manual includes all options available with Spot LXi (e.g., pulse oximetry, barcode

scanner, printer, mobile stand, and wall mount). The applicability of some sections of this

manual depends on the configuration of your particular device. Read this manual

thoroughly before attempting to use the device.

Intended Use

The Spot Vital Signs LXi automatically measures systolic and diastolic pressure (excluding

neonates), pulse rate, temperature (oral, adult axillary, pediatric axillary, rectal, and ear),

and pulse oximetry (SpO

2

) as well as calculates Mean Arterial Pressure (MAP).

Furthermore, Spot Vital Signs LXi allows the entry of height, weight, respiration rate, and

pain level. Spot Vital Signs LXi also calculates Body Mass Index (BMI) following height and

weight entry.

The device is intended to be used by clinicians and medically qualified personnel. It is

available for sale only upon the order of a physician or licensed health care provider.

Table 1. Available Versions of Spot Vital Signs LXi

REF Description

450T0 SureBP Technology with SureTemp Plus Thermometer

450E0 SureBP Technology with Braun ThermoScan PRO 4000 Thermometer

45MT0 SureBP Technology with Masimo SpO

2

and SureTemp Plus Thermometer

45ME0 SureBP Technology with Masimo SpO

2

and Braun ThermoScan PRO 4000 Thermometer

45NT0 SureBP Technology with Nellcor SpO

2

and SureTemp Plus Thermometer

45NE0 SureBP Technology with Nellcor SpO

2

and Braun ThermoScan PRO 4000 Thermometer

2 Introduction Welch Allyn Spot Vital Signs LXi

Symbols

The following symbols are associated with the Spot Vital Signs LXi.

Safety Symbols

Button Symbols

Connection Symbols

Identifies information within the

manual to avoid injury.

Identifies information within the

manual to avoid equipment failure.

Caution: consult accompanying

documents

Internally Powered, Lead Acid

Battery

Handle with Care Transport Temperature

Storage Humidity Recycle

Class II Equipment Equipment is not protected against

the ingress of liquid.

Type BF Equipment On/Off

Recycle the product separate from

other disposables, see “Product

Disposal” on page 68.

Non-ionizing radiation (RF

transmitter)

Mode of Operation: Continuous DC Power In

Pb

IPXØ

Navigation Buttons Select Power On/Off

Blood Pressure Memory

MEM

USB Connection Serial Port Connection

Directions for Use Introduction 3

Agency Symbols

Related Publications

Braun ThermoScan PRO 4000 User’s Guide - for models 450E0, 45NE0, 45ME0.

Masimo Directions for Use - for models 45MT0, 45ME0.

Nellcor Directions for Use - for models 45NT0, 45NE0.

CONFORMS TO:

UL STD 60601-1

IEC 60601-1

The CE mark on this product indicates that it has been tested to and conforms with

the provisions noted within the 93/42/EEC Medical Device Directive.

European Regulatory Manager

Welch Allyn Ltd.

Navan Business Park

Dublin Road

Navan, County Meath, Republic of Ireland

Tel.: +353 46 90 67700

Fax: +353 46 90 67755

0297

EC REP

4 Introduction Welch Allyn Spot Vital Signs LXi

Warnings and Cautions

Familiarize all operating personnel with the general safety information in this summary.

Specific warnings and cautions are also found throughout this manual.

General Warnings

A warning statement in this manual identifies a condition or practice, which if not

corrected or discontinued immediately, could lead to patient injury, illness, or death.

These warnings pertain to the entire Spot Vital Signs LXi device.

WARNING The information in this manual is a comprehensive guide to the

operation of Spot LXi. For best results, read this manual thoroughly before using

the device.

WARNING Spot LXi is designed for medical clinician use. Although this manual

may illustrate medical spot-check techniques, only a trained clinician who knows

how to take and interpret a patient’s vital signs should use this device.

WARNING Spot LXi is not intended for use in environments that are without

health care practitioner supervision.

WARNING Spot LXi is not intended for continuous monitoring. Do not leave

the device unattended while taking measurements on a patient.

WARNING To ensure data integrity, save readings and clear the Spot LXi display

between patients.

WARNING The Spot LXi is not defibrillator proof.

WARNING Spot LXi is not intended for use during patient transport.

WARNING This device is not suitable for use in the presence of a flammable

anesthetic mixture with air or oxygen or nitrous oxide. An explosion may result.

WARNING To ensure patient safety, use only accessories and supplies (i.e.,

cuffs, hoses, temperature probes, SpO

2

sensors, etc.) recommended for or

supplied with Spot LXi. Using unapproved accessories with Spot LXi can affect

patient and/or operator safety.

WARNING Take care to prevent water or other fluid from entering any

connectors on the device. Should this occur, dry the connectors with warm air.

Check the accuracy of all operating functions.

WARNING Every three months, inspect the blood pressure cuff, SpO

2

cable,

and other accessories for fraying or other damage. Replace as necessary.

WARNING Do not use Spot LXi on patients who are on heart/lung machines.

WARNING Electric shock hazard. There are no user-serviceable parts inside

Spot LXi other than battery replacement (see “Battery Replacement” on

page 65). An operator may only perform maintenance procedures specifically

described in this manual. For service, refer the device to an Authorized Service

Center.

WARNING This device is not intended for hand-held use during operation.

Directions for Use Introduction 5

WARNING Do not autoclave.

WARNING This device complies with current required standards for

electromagnetic interference and should not present problems to other

equipment or be affected by other devices. As a precaution, avoid using this

device in close proximity to other equipment.

WARNING Welch Allyn is not responsible for the integrity of any mounting

installation. Welch Allyn recommends that the customer contact their Biomedical

Engineering Department or maintenance service to ensure professional

installation for safety and reliability of any mounting accessory.

WARNING The Spot LXi consists of high-quality precision parts. Protect it from

severe impact and shock. A qualified service technician must check any Spot LXi

that is dropped or damaged for proper operation prior to further use. Do not use

the Spot LXi if you notice any signs of damage. Contact the Welch Allyn

Customer Service Department for assistance.

WARNING Do not use an SpO

2

finger clip sensor and a blood pressure cuff

simultaneously on the same limb. Doing so may result in inaccurate pulse rate

and perfusion readings.

WARNING All signal input and output (I/O) connectors are intended for

connection of only devices complying with IEC 60601-1, or other IEC standards

(for example, IEC 60950) as appropriate to the device. Connecting additional

devices to the Spot LXi may increase leakage currents. To maintain operator and

patient safety, it is necessary to consider the requirements of IEC 60601-1-1.

WARNING For proper patient electrical isolation, use only a Welch Allyn power

supply (4500-101A) to charge Spot Vital Signs LXi. Do not use the manufacturer

supplied charger for the weight scale while it is attached to Spot LXi.

NOTE: while charging the Spot LXi, it is acceptable to charge the Spot LXi

printer with the power supply (713703 or BC1300M).

6 Introduction Welch Allyn Spot Vital Signs LXi

Blood Pressure Warnings

These warnings pertain to the Spot LXi blood pressure feature.

WARNING Spot LXi is not intended to measure BLOOD PRESSURE on

neonatal patients. The AAMI SP10:2002 standard 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.

WARNING To ensure pediatric blood pressure accuracy and safety, the Child

Reusable Two-Piece Blood Pressure Cuff (4500-01), Infant Durable One-Piece

Cuff (REUSE-07-2MQ), and the Infant Disposable One-Piece Cuff (SOFT-07-2MQ)

are the smallest cuffs approved for use with young children and infants. The

child’s arm must fit within the range markings on the cuff.

WARNING Avoid compression of the blood pressure hose or cuff tubing of Spot

LXi. This may cause system errors to occur in the device.

WARNING Patients who are experiencing moderate to severe arrhythmias may

give inaccurate blood pressure measurements.

WARNING Spot LXi does not operate effectively on patients who are

experiencing convulsions or tremors.

WARNING Use only Welch Allyn blood pressure cuffs and/or hoses. Using other

manufacturers’ blood pressure cuffs and/or hoses may produce inaccurate blood

pressure readings.

WARNING When several blood pressure measurements are taken on the same

patient, regularly check the cuff site and extremity for possible ischemia, purpura,

and/or neuropathy.

WARNING Do not allow a blood pressure cuff to remain on the patient more

than 10 minutes when inflated above 10 mmHg. This may cause patient distress,

disturb blood circulation, and contribute to injury of peripheral nerves.

WARNING Do not place the cuff on any extremity that is used for intravenous

infusions or any area where circulation is compromised.

WARNING Excessive cuff tightness may cause venous congestion and

discoloration of the limb.

WARNING Wrapping the cuff too loosely (preventing proper inflation) may result

in errors.

WARNING Do not change the connector(s) on the blood pressure cuff tubing of

this device to luer type. Luer type connectors are commonly used in intravenous

infusion systems. Using the luer connectors on blood pressure cuff tubing

creates the risk that the blood pressure tubing could be mistakenly connected to

a patient's intravenous line, resulting in the introduction of air into the patient's

circulatory system.

Directions for Use Introduction 7

Temperature Warnings

These warnings pertain to the Spot LXi temperature feature.

SureTemp

®

Plus

These warnings are specific to the SureTemp Plus thermometer option.

WARNING Use only Welch Allyn probe covers. Using other manufacturers’

probe covers or no probe cover may produce temperature measurement errors

and/or inaccuracy.

WARNING Always use a probe cover whenever coming into contact with a

patient.

WARNING Long-term continuous monitoring beyond three to five minutes is

not recommended in any mode.

WARNING Oral/axillary probes (blue ejection button at top of probe) and blue

removable probe wells are used for taking oral and axillary temperatures only.

Rectal probes (red ejection button) and red removable probe wells are used for

taking rectal temperatures only. Use of the probe at the wrong site will result in

temperature errors. Use of the incorrect removable probe well could result in

patient cross-contamination.

WARNING The thermometer connectors and probe are not waterproof. Do not

immerse or drip fluids on these items. Should this occur, dry the connectors and

probe with warm air. Check all functions for proper operation and accuracy.

WARNING Do not take an axillary temperature through patient’s clothing. Direct

probe cover to skin contact is required.

WARNING Do not autoclave.

WARNING Use Welch Allyn single-use disposable probe covers to limit patient

cross-contamination.

WARNING Incorrect insertion of probe can cause bowel perforation.

WARNING Washing hands greatly reduces the risk of cross-contamination and

nosocomial infection.

WARNING To ensure optimal accuracy, always confirm that the correct mode is

selected.

8 Introduction Welch Allyn Spot Vital Signs LXi

Braun Thermoscan PRO 4000

These warnings are specific to the Braun ThermoScan PRO 4000 thermometer option.

SpO

2

Warnings

These warnings pertain to the Spot LXi SpO

2

feature.

WARNING Keep the probe window clean, dry, and undamaged at all times to

ensure accurate measurements. To protect the probe window, always keep the

thermometer in the storage cover while transporting or when not in use.

WARNING Only use Braun ThermoScan probe covers with this thermometer.

Using other manufacturer’s probe covers or no probe cover may produce

temperature measurement errors and/or inaccuracies. If the thermometer is used

without a probe cover attached, clean the lens (see “Braun ThermoScan PRO

4000 Thermometer” on page 64).

WARNING Do not autoclave.

WARNING The thermometer is not waterproof. Do not immerse or drip fluids

on it. Should this occur, dry the thermometer with warm air. Check for proper

operation and accuracy.

WARNING Only use Spot LXi with Masimo or Nellcor SpO

2

option with Masimo

or Nellcor brand sensors and accessories, respectively. Using the wrong or

unapproved sensors or cables may cause improper performance.

WARNING The SpO

2

sensor and extension cables are intended for use only for

pulse oximetry measurements. Do not attempt to connect these cables to a PC

or any similar device.

WARNING Before using, carefully read the sensor Directions for Use, including

all warnings, cautions, and instructions.

WARNING Do not use a damaged sensor or pulse oximetry cable or a sensor

with exposed optical components.

WARNING Incorrect application or a long duration of use of an SpO

2

sensor may

cause tissue damage. Inspect the sensor site periodically as directed in the

sensor’s Directions for Use.

WARNING Certain ambient environmental conditions, sensor application errors,

and certain patient conditions may affect SpO

2

readings and pulse signal.

WARNING Do not immerse the sensor or patient cables in water, solvents, or

cleaning solutions (the sensors and connections are not waterproof). Do not use

irradiation, steam, or ethylene oxide for sterilization.

WARNING The SpO

2

in the Spot LXi device is not intended for use as an apnea

monitor.

WARNING Consider the SpO

2

an early warning device. As a trend toward

patient deoxygenation is indicated, use laboratory instruments to analyze blood

samples to completely understand the patient’s condition.

Directions for Use Introduction 9

General Cautions

A caution statement in this manual identifies a condition or practice, which if not

corrected or discontinued immediately, could lead to equipment failure, equipment

damage, or data loss.

These cautions pertain to the entire Spot Vital Signs LXi device.

WARNING Tissue damage can be caused by incorrect application or duration of

use of a Nellcor OxiMax sensor. Inspect the sensor site as directed in the sensor

Directions for Use.

WARNING Do not use the sensors during magnetic resonance imaging (MRI)

scanning. Induced current could potentially cause burns. The MS board pulse

oximeter may affect the MRI image, and the MRI unit may affect the accuracy of

the oximetry measurements.

WARNING Carefully route patient cabling to reduce the possibility of patient

entanglement or strangulation.

WARNING Failure to cover the Nellcor OxiMax sensor site with opaque material

in high ambient light conditions may result in inaccurate measurements.

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 question, check the patient’s

vital sign(s) with an alternate method and then check to verify the device is

functioning properly.

Caution Place the device on a secure surface or use one of the optional

mounting accessories.

Caution Do not place fluids on or near the device.

Caution It is recommended that the device is used within stated operating

temperature ranges (see “Environmental” on page 59). The device will not meet

its performance specifications if used outside these temperatures ranges.

Caution For proper patient electrical isolation, use only a Welch Allyn power

supply (4500-101A) to charge Spot LXi. Do not use the weight scale

manufacturer’s charger while the weight scale is attached to the Spot LXi. While

charging the Spot LXi, it is acceptable to charge the Spot LXi printer with the

power supply (713703 or BC1300M).

Caution Always unplug the AC power transformer from the outlet before

moving the mobile stand to a new location.

Caution The basket has a three-pound weight limit. Take care not to exceed

this limit.

Caution Only use a 9V battery with the Healthometer scale. Remove and

discard the wall mounted power supply.

Caution When using the Healthometer scale, remove the two hex nuts on the

RS-232 cable, as supplied, before screwing the cable into the scale base.

10 Introduction Welch Allyn Spot Vital Signs LXi

Blood Pressure Cautions

These cautions pertain to the Spot LXi blood pressure feature.

Temperature Cautions

These cautions pertain to the Spot LXi temperature feature.

SpO

2

Cautions

These cautions pertain to the Spot LXi SpO

2

feature.

Caution Minimize extremity and cuff motion during blood pressure readings.

Caution If the blood pressure cuff is not at heart level, note the difference in

reading due to the hydrostatic effect. Add the value of 1.80 mmHg (.2 kPa) to the

displayed reading for every inch (2.5 cm) above heart level. Subtract the value of

1.80 mmHg (.2 kPa) from the displayed reading for every inch (2.5 cm) below

heart level.

Caution Proper blood pressure cuff size and placement is essential to the

accuracy of the blood pressure determination. See Reusable Two-Piece Cuff

Measurements (Table 10) or Durable One-Piece Cuff Measurements (Table 11)

on page 35 for sizing information.

Caution The position and physiologic condition of the subject can affect a blood

pressure reading.

Caution The SureTemp Plus feature only operates with the probe well in place.

Caution Do not use alkaline batteries in the Braun ThermoScan PRO 4000.

Caution Biting the probe tip may result in damage to the probe.

Caution The pulse oximeter is calibrated to determine the percentage of

arterial oxygen saturation of functional hemoglobin. Significant levels of

dysfunctional hemoglobin such as carboxyhemoglobin or methemoglobin may

affect the accuracy of the measurement.

Caution Some sensors may not be appropriate for a particular patient. If at

least 10 seconds of perfusion pulses cannot be observed for a given sensor,

change sensor location or sensor type for perfusion to resume.

Caution Physiological conditions, medical procedures, or external agents that

may interfere with the pulse oximeter’s ability to detect and display

measurements include dysfunctional hemoglobin, arterial dyes, low perfusion,

dark pigment, and externally applied coloring agents such as nail polish, dye, or

pigmented cream.

Caution When selecting a sensor, consider the patient’s weight and activity

level, the adequacy of perfusion, the available sensor sites, the need for sterility,

and the anticipated duration of monitoring.

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