Welch Allyn Connex ECG Module Directions For Use Manual

Welch Allyn Connex
Module

®

Devices ECG

Directions for use

For use with compatible Connex® devices running software version 2.3X

or higher

© 2018 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. No other use, reproduction, or distribution of this 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 and Connex are registered trademarks of Welch Allyn.

Software in this product is Copyright 2018 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, reverse­engineered, 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.

This product may contain software known as “free” or “open source” software (FOSS). Welch Allyn uses and
supports the use of FOSS. We believe that FOSS makes our products more robust and secure, and gives us and our
customers greater flexibility. To learn more about FOSS that may be used in this product, please visit our FOSS
website at

www.welchallyn.com/opensource. Where required, a copy of FOSS source code is available on our FOSS

website.

For patent information, please visit

www.welchallyn.com/patents.

For information about any Welch Allyn product, contact Welch Allyn Technical Support: www.welchallyn.com/

support.

DIR 80024036 Ver. A
Revision date: 2018-09

This manual applies to REF 901106 ECG Plug-in module, REF 901060 Vital
Signs Monitor, and REF 901028 Vital Signs Monitor Wall System.

Authorized Representative in Europe

Global Instrumentation, LLC
8104 Cazenovia Road
Manlius, NY 13104

Arazy Group GmbH
Am Kalkofen 8
61206 Woellstadt
Germany

Distributed by Welch Allyn, Inc.

Welch Allyn, Inc.
4341 State Street Road
Skaneateles Falls, NY 13153-0220 USA

www.welchallyn.com

Contents

Introduction ............................................................................................. 1

Symbols ................................................................................................... 3

Screen elements ...................................................................................... 5

iii

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

Indications for use ................................................................................................ 1

Contraindications ................................................................................................. 2

About warnings and cautions ................................................................ 7

General warnings and cautions ............................................................................ 7

ECG module warnings and cautions .................................................................. 10

Setup ...................................................................................................... 15

Controls, indicators, and connectors .................................................................. 15

Mount and connect the ECG module ................................................................ 16

Alarms .................................................................................................... 17

Physiological alarm summary ............................................................................. 17

ECG acquisition ..................................................................................... 19

Lead placement overview .................................................................................. 19

Attach the leads to the patient ........................................................................... 22

Maintenance .......................................................................................... 25

Clean the equipment .......................................................................................... 25

Inspect the equipment ....................................................................................... 26

Store the equipment .......................................................................................... 26

Discard the equipment ....................................................................................... 26

Troubleshooting ................................................................................................. 26

EMC guidance and manufacturer’s declarations ................................ 27

EMC compliance ................................................................................................ 27

Emissions and immunity information ................................................................. 27

Specifications ........................................................................................ 29

Appendix ................................................................................................ 35

Approved accessories ........................................................................................ 35

Limited warranty ................................................................................................ 36

iv Contents Welch Allyn Connex® Devices ECG Module

Introduction

This manual describes the capabilities and operation of the Welch Allyn ECG/Impedance
Respiration module. This module is designed as an option for the Welch Allyn Connex®
Vital Signs Monitor (VSM) and the Connex® Integrated Wall System (IWS). This module
might not be available in your region.

When connected to the Connex VSM or the Connex IWS, the module supports the
measurement and continuous display of 3- or 5-lead ECG waveforms, ECG heart rate
readings, and ECG impedance respiration readings. The module also provides optional
pacemaker and arrhythmia detection (ventricular tachycardia, ventricular fibrillation, and
asystole), as well as associated technical and physiological alarms.

1

Before using the ECG module, read this manual as well as the sections of the Welch
Allyn Connex® Devices directions for use that pertain to your use of the module.

Intended use

CAUTION

United States Federal law restricts this device to sale, distribution, or use
by or on the order of a physician or licensed healthcare professional.

The ECG/Impedance Respiration module is intended for continuous measurement of
respiration rate, heart rate, and detection of cardiac standstill (asystole), ventricular
tachycardia, and ventricular fibrillation in general medical and surgical floors, general
hospital and alternate professional healthcare environments. The system is indicated for
use in pediatric and adult patients.

Indications for use

The Welch Allyn ECG/Impedance Respiration module and associated software acquires
and analyzes ECG signals from patients. Patients are people with coronary problems,
suspected coronary problems, or recent medical procedures that require cardiac
monitoring.

This ECG module can be used on adult and pediatric patients.

The ECG module is indicated for use by healthcare professionals whenever there is a
need to monitor a patient’s physiological parameters for the following:

ECG

•

• ECG with alarms for ventricular tachycardia, ventricular fibrillation, and asystole

• Impedance respiration

2 Introduction Welch Allyn Connex® Devices ECG Module

Contraindications

The Welch Allyn ECG/Impedance Respiration module is not intended for infants
weighing less than 10 Kg (22 lbs) or neonatal patients.

This module is not designed for direct cardiac application.

This module is not suitable for transport.

Computer-assisted ECG data acquisition and interpretation is a valuable tool when used
properly. However, no automated interpretation is completely reliable. Interpretations
should be reviewed by a qualified physician before treatment, or non-treatment, of any
patient.

Symbols

For information on the origin of these symbols, see the Welch Allyn symbols glossary:

www.welchallyn.com/symbolsglossary.

Documentation symbols

WARNING The warning statements in this manual identify conditions or practices that could
lead to illness, injury, or death.

3

CAUTION The caution statements in this manual identify conditions or practices that could
result in damage to the equipment or other property, or loss of data. This definition applies to
both yellow and black and white symbols.

Follow the operating instructions/directions for use (DFU) — mandatory action.

A copy of the DFU is available on this website.

A printed copy of the DFU can be ordered from Welch Allyn for delivery within 7 days.

Miscellaneous symbols

USB

LED status indicator

No LED: Off, not powered

Steady green: Powered

Flashing green: Powered,
enumerated, sending patient data

Steady yellow: Powered, internal
error or POST

IOIOI

Serial interface

By prescription or order of
physician or dentist

Manufacturer Date of manufacture

4 Symbols Welch Allyn Connex® Devices ECG Module

Recycle the product separate from
other disposables

Reorder number Serial number

Defibrillation-proof Type CF applied
parts

China RoHS markings for control of
pollution caused by electronic
information products. XX indicates
Environmentally Friendly Use
Period in years.

Consult the manual

Screen elements

ECG, Heart rate/Pulse rate, and Impedance respiration

Heart rate / Pulse rate Beats per minute (to

5

ECG frame and lead selector

represent heart rate / pulse
rate)

Saved waveform icon
(Review tab)

Waveform snapshot button

Saved waveform icon, alarm
condition (Review tab)

6 Screen elements Welch Allyn Connex® Devices ECG Module

About warnings and cautions

Warning and caution statements can appear on the ECG module, on the packaging, on
the shipping container, or in this document.

The ECG/Impedance Respiration module is safe for patients and clinicians when used in
accordance with the instructions and the warning and caution statements presented in
this manual.

Before using the module, you must familiarize yourself with all warnings and cautions
and with the sections of this directions for use that pertain to your use of the module. In
addition, you must review the warnings and cautions presented in the Welch Allyn
Connex® Devices directions for use that pertain to using a connected ECG module.

•

Failure to understand and observe any warning statement in this manual could lead
to patient injury, illness, or death.

• Failure to understand and observe any caution statement in this manual could lead to
damage to the equipment or other property, or loss of patient data.

7

General warnings and cautions

WARNING Many environmental variables, including patient physiology and
clinical application, can affect the accuracy and performance of the Connex
device and ECG module. Therefore, you must verify all vital signs
information before treating the patient. If there is any question about the
accuracy of a measurement, verify the measurement using another
clinically accepted method.

WARNING To comply with Federal Communications Commission (FCC)
RF exposure requirements and to avoid exposure to radio-frequency (RF)
radiation, always use the monitor in accordance with the operating
conditions and instructions provided in this manual.

WARNING Always check the patient mode (adult, pediatric, or neonate)
when monitoring a new patient. The patient mode determines default
alarm limits and internal algorithm settings. Alarm limits are patient­specific. Make sure the monitor has settings that are appropriate before
monitoring the patient. For alarms to function properly, you must set or
verify alarm limits appropriate for each patient. Each time the Connex
device is powered on, you must check that the alarm settings are
appropriate for your patient before you start monitoring.

8 About warnings and cautions Welch Allyn Connex® Devices ECG Module

WARNING The Connex device and ECG module might not meet their
performance specifications if stored or used outside the specified
temperature and humidity ranges.

WARNING Use only Welch Allyn approved accessories, and use them
according to the manufacturer’s directions for use. Using unapproved
accessories with the monitor can affect patient and operator safety and can
compromise product performance and accuracy.

WARNING Inaccurate measurement risk. Do not connect more than one
patient to a Connex device.

WARNING Inaccurate measurement risk. Liquids and excessive moisture
can damage patient sensors and cause them to perform inaccurately or fail.

WARNING Patient harm risk. Always remove sensors from patients and
disconnect them completely from Connex devices before bathing.

WARNING Safety risk and potential shock hazard. Cords, cables, and
accessories damaged from prior misuse can affect patient and operator
safety. Inspect all cords, cables, and accessories for strain relief wear,
fraying, or other damage according to the recommendations presented in
the Maintenance and service section of this manual. Replace as necessary.
Inspect the AC cord for exposed copper before touching the cord. Unplug
the AC cord only by pulling on the plug, never the cord. Never lift the
Connex device by the power cord or patient connections. Never lift the
ECG module by the USB cable or the patient cable.

WARNING The ECG module may not function properly if dropped or
damaged. Protect it from severe impact and shock. Do not use the ECG
module if you notice any signs of damage. Qualified service personnel
must check any ECG module that is dropped or damaged for proper
operation before putting the device back into use.

WARNING Electric shock hazard. Do not open the ECG module. Do not
attempt repairs. The ECG module has no user-serviceable internal parts.
Only perform routine cleaning and maintenance procedures specifically
described in this manual.

WARNING Use the ECG module only as described in this directions for
use. Do not use the ECG module on patients as described in the
Contraindications.

WARNING Personal/patient injury risk. Wall-mounted equipment and
accessories must be installed in accordance with accompanying
instructions. Improper installation can result in the equipment falling off the
wall and injuring someone. Welch Allyn is not responsible for the integrity
of any installation not performed by authorized Welch Allyn service
personnel. Contact an authorized Welch Allyn service representative or
other qualified service personnel to ensure professional installation for
safety and reliability of any mounting accessory.

WARNING Personal/patient injury and equipment damage risk. Carefully
route patient cabling to reduce the possibility of patient entanglement or
strangulation. When transporting the Connex device and ECG module on a
mobile stand, properly secure all patient cables and cords to keep them
clear of the wheels and to minimize trip hazards for patients and clinicians.

Directions for use About warnings and cautions 9

WARNING For operator and patient safety, peripheral equipment and
accessories that can come in direct patient contact must comply with all
applicable safety, EMC, and regulatory requirements.

WARNING Cross-contamination or nosocomial infection risk. Clean and
disinfect the ECG module on a routine basis according to your facility's
protocols and standards or local regulations. Thorough hand-washing
before and after contact with patients greatly reduces the risk of cross­contamination and nosocomial infection.

WARNING For patient safety, do not use the device or any accessory
during MRI scanning. Induced current could cause burns.

WARNING Do not pause or turn off an audible alarm if the patient safety
might be compromised.

CAUTION United States Federal law restricts this equipment to sale,
distribution, or use by or on the order of a physician or licensed healthcare
professional.

CAUTION Electromagnetic interference risk. The equipment complies
with applicable domestic and international standards for electromagnetic
interference. These standards are intended to minimize medical equipment
electromagnetic interference. Although the Connex device and ECG
module are not expected to present problems to other compliant
equipment or be affected by other compliant devices, interference issues
still may occur. As a precaution, avoid using the equipment in close
proximity to other equipment. In the event that equipment interference is
observed, relocate the equipment as necessary or consult manufacturer's
directions for use.

CAUTION Keep the Connex device outside of MRI suites and any areas
marked for high magnetic or electric field strength.

10 About warnings and cautions Welch Allyn Connex® Devices ECG Module

ECG module warnings and cautions

In addition to the preceding warnings and cautions, consider the following when using
the ECG module.

WARNING Liquids can damage electronics inside the ECG module.
Prevent liquids from spilling on the ECG module.
If liquids are spilled on the ECG module, remove it from service.

Note The module provides no protection against liquid ingress.

WARNING Do not operate the Connex device and ECG module near

equipment that emits strong electromagnetic or radio-frequency signals.
Electronic equipment of this type can cause electrical interference with
device operation, which can distort the ECG signal and prevent accurate
rhythm analysis.

WARNING Patient safety risk. Life-threatening arrhythmias can trigger one
of two optional high alarm tones for ventricular tachycardia (V-Tach),
ventricular fibrillation (V-Fib), and asystole. If you are monitoring a patient
for life-threatening arrhythmias, verify the alarm tone that your facility or
floor has chosen.

WARNING Patient injury risk. Do not perform waveform analysis on the
ECG acquisition display as these ECG representations are not true to scale.
Make manual measurements of ECG intervals and magnitudes on printed
ECG reports only.

WARNING The arrhythmia analysis program is intended to detect V-Tach,
V-Fib, and asystole. It is not intended to detect other arrhythmias.
Occasionally it may incorrectly identify the presence or absence of an
arrhythmia. Therefore a physician must analyze the arrhythmia information
in conjunction with other clinical findings.

WARNING Arrhythmia detection (for V-Tach, V-Fib, and asystole) and
impedance respiration are not intended for neonatal patients.

WARNING Computer-assisted ECG data acquisition and interpretation is a
valuable tool when used properly. However, no automated interpretation is
completely reliable and a qualified physician shall review the interpretations
before treatment, or non-treatment, of any patient. The ECG module must
be used in conjunction with clinical signs and symptoms. This device is
only intended to be an adjunct in patient assessment. Certain arrhythmias
or pacemaker signals could adversely affect heart rate indications or
alarms.

WARNING Patient injury risk. The data captured from this device should
not be used as a sole means for determining a patient’s diagnosis or
prescribing treatment.

Directions for use About warnings and cautions 11

WARNING Physiological variations in the patient population generate a
nearly infinite range of possible ECG waveform morphologies. In some
cases, the Connex device occasionally may not alarm or alarm
inappropriately for some arrhythmia (V-Tach, V-Fib and asystole)
waveforms. It is the operator 's responsibility to set alarm limits as
appropriate for each individual patient. High risk patients must be kept
under close surveillance.

WARNING For patients with a pacemaker, maintain a minimum of 6
inches between the device and pacemaker. Power down the ECG module
immediately and provide appropriate patient care if you suspect the ECG
module has affected the pacemaker.

WARNING Patient safety risk. Use of impedance respiration monitoring
can affect the operation of some pacemakers. Keep pacemaker patients
under close observation. If pacemaker operation is affected, turn off
impedance respiration.

WARNING Impedance respiration must be disabled when using ECG wrist
clip electrodes.

WARNING Inaccurate measurement risk. Impedance respiration
monitoring is not reliable when ECG electrodes are placed on the limbs.

WARNING Patient safety risk. Correctly set pacemaker detection and
keep pacemaker patients under close observation. A pacemaker pulse can
be counted as a QRS, which could result in an incorrect heart rate and
failure to detect cardiac arrest and some life-threatening arrhythmias (V­Tach, V-Fib, and asystole). If your patient has a pacemaker, turn pacemaker
detection ON to avoid this hazard.

WARNING Inaccurate measurement risk. When an external pacemaker is
being used on a patient, arrhythmia monitoring (to detect V-Tach, V-Fib and
asystole) is severely compromised due to the high energy level in the
pacemaker pulse. This may result in the arrhythmia algorithm’s failure to
detect pacemaker non-capture or asystole.

WARNING Patient safety risk. Implantable pacemakers, which are minute­ventilation-rate adaptive, can occasionally interact with the impedance
respiration measurement of cardiac monitors causing the pacemakers to
pace at their maximum. Keep pacemaker patients under close observation.

WARNING Inspect device and accessories before each use. Use only
Welch Allyn approved accessories. Peripheral equipment and accessories
that touch the patient must comply with all appropriate safety, EMC, and
regulatory requirements.

WARNING Frequently inspect—electrically and visually—all cables,
sensors, and electrode wires. Replace any damaged cables, sensors, or
wires. Failure to properly inspect and keep in excellent working order all
cables, sensors, and electrode wires can result in hazards to patients and
to equipment failure and damage.

WARNING Always keep patient motion to a minimum. Motion artifact can
cause inaccurate measurement of patient vital signs.

12 About warnings and cautions Welch Allyn Connex® Devices ECG Module

WARNING The conductive parts of electrodes and associated connectors
for type BF or CF applied parts, including neutral electrode, should not
contact other conductive parts including earth.

WARNING Skin irritation may result from the continuous application of the
ECG electrodes. Examine the skin for signs of irritation or inflammation and
avoid placing the electrode in those areas. If you observe skin irritation,
replace the electrodes or change the location of the electrodes every 24
hours.

WARNING Connect patient lead wires only to the patient electrodes.

WARNING Patient safety risk. The most important aspect of obtaining a

quality electrocardiogram is a proper electrode hook-up. Failure to properly
apply the electrodes and patient cable may result in noisy signal, false
alarms, or sub-optimal electrocardiogram analysis, which could cause
patient harm. Any of these events could potentially contribute to patient
harm.

WARNING Patient injury risk. Use only accessories approved by Welch
Allyn, including electrodes, lead wires, and patient cables. These approved
accessories are required for electrical protection of the patient during
cardiac defibrillation. Refer to the accessory list or www.welchallyn.com.

WARNING Patient injury risk. Use only ECG cables supplied or specified
by Welch Allyn. Use of any other ECG cables can negate defibrillator
protection and can create a risk of patient injury due to shock.

WARNING To avoid serious injury or death, take precautions consistent
with good clinical practice during patient defibrillation:

• Avoid contact with the electrocardiograph, patient cable, and patient.

• Place defibrillator paddles properly in relation to electrodes.

WARNING To avoid serious injury or death, take precautions consistent
with good clinical practice during patient defibrillation:

• Before defibrillation, verify that patient leads are properly connected to the
patient and the ECG module. Loose ECG leads can divert defibrillator
current.

• After defibrillation, pull each patient lead out of the patient cable and inspect
the tips for charring (black carbon marks). If there is any charring, the patient
cable and individual leads must be replaced. If there is no charring, fully
reinsert the leads into the patient cable. (Charring can occur only if a lead is
not fully inserted into the patient cable before defibrillation.)

WARNING Electric shock hazard. Before cleaning the monitor, disconnect
the AC power cord from the mains outlet and the power source.

WARNING This equipment must not be connected to any other
equipment that is not compliant with EN60601-1. The combined leakage
currents could exceed safe limits.

WARNING Use of accessories, transducers, and cables other than those
specified may result in degraded electromagnetic compatibility
performance of this device.

Directions for use About warnings and cautions 13

WARNING Do not operate this product with MRI (Magnetic Resonance
Imaging) equipment.

WARNING When using ECG Wrist Clip electrodes, although a normal
Lead I QRS waveform is produced on the monitor, this waveform should
not be used for serious clinical interpretation because the electrodes are
not properly triangulated around the patient 's heart.

WARNING Inaccurate measurement risk. To use ECG wrist clip electrodes
effectively, consider the following:

• The size of ECG wrist clip electrodes is fixed; you cannot adjust it.

• Proper orientation of the clip with the monitor depends on repositioning the
clip until you achieve a snug fit.

• The preferred position of the clip is the patient's wrist, but you can move it
up the patient's arm toward the torso.

• The clip might not work with patients who have small wrists and arms.

• Exercise caution when placing the clip so that it doesn't impede circulation
along the patient's wrist and arm.

• If you cannot achieve a snug fit with the wrist clip, use some other method
to monitor ECG.

WARNING Do not pause or turn off an audible alarm if the patient safety
might be compromised.

WARNING Always ensure that the appropriate electrode placement is
employed for the lead configuration selected.

WARNING The ECG module should not be used on patients who are
linked to heart lung machines.

WARNING If an electrosurgical unit is used, place the ECG cable and
wires as far as possible from the site of the surgery and from the
electrosurgical cables. This will minimize interference and the risk of burns
to the patient. Ensure that the electrosurgical return cable (neutral) is well
attached and making good contact with the patient.

WARNING Patient injury risk. To prevent cross-contamination and the
spread of infection:

• Dispose of single-patient use components (for example, electrodes) after
use.

• Regularly clean and disinfect all components that come in contact with
patients.

• Reprocess the device accessories (for example, patient cable, leads, and
reusable electrodes) between patients.

WARNING Personal /patient injury risk. Wall-mounted equipment and
accessories must be installed in accordance with accompanying
instructions. Improper installation can result in the equipment falling off the
wall and injuring someone.

WARNING Personal/patient injury risk. Wall Mount must be mounted
using the appropriate hardware for the type of wall structure. Your facility
may need to provide the appropriate hardware needed to install for your
type of wall structure.

14 About warnings and cautions Welch Allyn Connex® Devices ECG Module

WARNING Personal/patient injury risk. Wall Mounts must be installed by
authorized Welch Allyn service personnel or a Biomedical engineer to
ensure mounting integrity and proper placement.

WARNING Personal/patient injury risk. Only authorized Welch Allyn
service personnel or a Biomedical engineer should attach or remove the
device from the wall mount.

WARNING Personal/patient injury risk. Any modification made to a Welch
Allyn mounting solution removes Welch Allyn from responsibility or liability
and voids the warranty.

WARNING Personal/patient injury risk. Welch Allyn is not responsible for
the integrity of any installation not performed by authorized Welch Allyn
service personnel.

WARNING Personal/patient injury risk. Welch Allyn is not responsible for
the integrity of any wall structure or wall mounting interface. Welch Allyn
recommends that you contact your Biomedical Engineering Department or
maintenance service to ensure professional installation, safety, and
reliability of any mounting accessory.

CAUTION Position the wall mount so that the screen, controls, and
connectors are accessible and support optimal and ergonomic use of the
device.

CAUTION Never use acetone, ether, freon, petroleum derivatives, or other
solvents to clean the ECG Module. Never immerse the ECG module or the
patient cable in liquid. Never autoclave or steam clean the ECG module or
the patient cable. Never pour alcohol directly on the ECG module or the
patient cable, and never soak any components in alcohol. If any liquid
enters the ECG module, remove the ECG module from service, and have it
inspected by a qualified service person before using it again.

CAUTION Verify that dates on applicable accessories have not expired.

CAUTION Connect the USB cable to the Connex device in a manner that

minimizes entangling.

CAUTION To prevent accidental loosening of the USB cable and the
potential loss of ECG connection to the device, you must close the door
and tighten the screw to secure the cable in place.

Setup

Controls, indicators, and connectors

The ECG/Impedance respiration assembly includes the ECG acquisition module, an ECG
patient cable with either 3 or 5 leads to snap connectors, a built-in clip to facilitate
mounting the module, and a USB cable to connect to the host device.

15

No. Feature Description

1 USB cable Connects module to the Connex Vital Signs Monitor; provides

power to the ECG module and supports data transmission
between the module and monitor

2 USB cable connector Provides connection for a USB cable to power the module and

transmit data between the module and the monitor

16 Setup Welch Allyn Connex® Devices ECG Module

No. Feature Description

3 LED module status indicator Indicates to module status as follows:

• No LED: Off, not powered

• Steady green: Powered

• Flashing green: Powered, enumerated, sending patient data

• Steady yellow: Powered, internal error or POST

4 ECG patient cable connector Provides connection for an ECG patient cable with either 3 or 5

leads to snap connectors

5 ECG patient cable Connects to the module and to either 3 or 5 leads to snap

connectors

6 Mounting clip Provides the surface onto which the back of the module slides to

mount the module on a bin or basket

Mount and connect the ECG module

To mount the ECG module on the desired mounting apparatus (basket, bin, wall
mount), follow the instructions presented in the "Connex® Devices ECG Module
Assembly Instructions" packaged with the module.

CAUTION Mount the ECG module before use. Position the
module as instructed using only the provided mounting
fixture. Any other mounting position or setup will
compromise water ingress protection.

CAUTION Connect the USB cable to the Connex device in a
manner that minimizes entangling.

CAUTION To prevent accidental loosening of the USB cable
and the potential loss of ECG connection to the device, you
must close the door and tighten the screw to secure the
cable in place.

CAUTION Accessories attached to this device must run on
battery power. Do not use any accessory's external power
supply when it is attached to the monitor.

Note On some stands, the mounting bracket partially overlaps the

USB door. If you observe this overlap, loosen the screw on
the mounting bracket and shift the device forward just
enough on the bracket to open the USB door, then slide the
device back on the mounting bracket.

Note If you loosened the mounting bracket in order to open the

USB door, shift the device forward on the bracket, close the
door, and then slide the device back into its mounted
position. Ensure that the device is seated firmly on the
bracket, then tighten the screw on the bracket into the
screw hole on the back of the device. (See "Mount the
monitor on a stand" in the Welch Allyn Connex® Devices
directions for use for more detail.)

Alarms

17

The Connex device displays physiological and technical alarms triggered by the ECG/
Impedance Respiration module. Physiological alarms occur when vital sign
measurements fall outside of set alarm limits. Technical alarms occur when there is the
problem with the module, an accessory connected to the module, the Connex device, or
the network. The module can communicate alarms to the monitor and an external Nurse
Call, if available, in the Continuous Monitoring profile. Technical alarms occur in all
profiles.

See the Welch Allyn Connex® Devices directions for use for detailed descriptions of
alarm behavior, controls, and messages.

Physiological alarm summary

Alarm condition Alarm threshold

Asystole

Ventricular tachycardia

Ventricular fibrillation

Heart rate

Impedance respiration rate

Alarm limits Upper limit range of entry Lower limit range of entry

Ventricular tachycardia 150 beats per minute 100 beats per minute

No detectable beat for ≥4 seconds

Default: 120 bpm ±3 bpm for 6 consecutive beats

Range: 100 to 150 bpm ±3 bpm for 6 consecutive beats

Fibrillatory waveform persisting for ≥4 seconds

Heart rate above high rate alarm or below low rate alarm threshold

Respiration rate above high rate or below low rate alarm threshold

Heart rate 300 beats per minute 20 beats per minute

Impedance respiration rate 100 breaths per minute 5 breaths per minute

18 Alarms Welch Allyn Connex® Devices ECG Module

ECG acquisition

For details on how the ECG module operates with the host device, see the ECG
section of the the Welch Allyn Connex® Devices directions for use.

Lead placement overview

WARNING Patient safety risk. To minimize interference and the danger of
burns to the patient, use only approved ECG cables. Keep the ECG cable as
far away as possible from any electrosurgical cables. Make sure that the
electrosurgical return conductor (neutral) is properly attached to the patient
and makes a good contact.

19

Proper lead placement is important for a successful ECG. The most common ECG
problems are caused by poor electrode contact and loose leads.

The following table shows the relationships between IEC and AHA leads as well as their
placement.

IEC Lead

R Red RA White Right arm

L Yellow LA Black Left arm

F Green LL Red Left leg

C or C1 White V or V1 Brown 4th intercostal (IC) space at right border of the

N Black RL Green Right leg

IEC Color AHA Lead AHA Color Placement

sternum

20 ECG acquisition Welch Allyn Connex® Devices ECG Module

Lead placement, 3-lead

IEC

R - Red

L - Yellow

F - Green

AHA

Lead placement, 5-lead

RA - White

LA - Black

LL - Red

IEC

N - Black

R - Red

L - Yellow

C - White

F - Green

Directions for use ECG acquisition 21

AHA

RL - Green

RA - White

LA - Black

V - Brown

LL - Red

Impedance respiration

In some patients, impedance respiration detection may be inadequate using the standard
ECG electrode placement. In these cases, change the LL and RA electrode placement to
the mid-axillary line on each side of the chest as shown in the illustrations.

Note Respiration can only be acquired from Lead II.

IEC

N - Black

R - Red

L - Yellow

C - White

F - Green

AHA

RL - Green

RA - White

LA - Black

V - Brown

LL - Red

22 ECG acquisition Welch Allyn Connex® Devices ECG Module

Attach the leads to the patient

Proper lead attachment is important for a successful ECG. The most common ECG
problems are caused by poor electrode contact and loose leads. Follow your local
procedures for attaching the leads to the patient. Here are some common guidelines.

WARNING Electrodes can cause allergic reactions. To avoid this, follow
the electrode manufacturer’s directions.

WARNING Skin irritation may result from the continuous application of the
ECG electrodes. Examine the skin for signs of irritation or inflammation and
avoid placing the electrode in those areas. If you observe skin irritation,
replace the electrodes or change the location of the electrodes every 24
hours.

WARNING Connect patient lead wires only to the patient electrodes.

WARNING Patient safety risk. The most important aspect of obtaining a

quality electrocardiogram is a proper electrode hook-up. Failure to properly
apply the electrodes and patient cable may result in noisy signal, false
alarms, or sub-optimal electrocardiogram analysis, which could cause
patient harm. Any of these events could potentially contribute to patient
harm.

WARNING Patient injury risk. Use only accessories approved by Welch
Allyn, including electrodes, lead wires, and patient cables. These approved
accessories are required for electrical protection of the patient during
cardiac defibrillation. Refer to the accessory list or www.welchallyn.com.

WARNING Inaccurate measurement risk. Impedance respiration
monitoring is not reliable when ECG electrodes are placed on the limbs.

WARNING When using ECG Wrist Clip electrodes, although a normal
Lead I QRS waveform is produced on the monitor, this waveform should
not be used for serious clinical interpretation because the electrodes are
not properly triangulated around the patient 's heart.

WARNING Inaccurate measurement risk. To use ECG wrist clip electrodes
effectively, consider the following:

• The size of ECG wrist clip electrodes is fixed; you cannot adjust it.

• Proper orientation of the clip with the monitor depends on repositioning the
clip until you achieve a snug fit.

• The preferred position of the clip is the patient's wrist, but you can move it
up the patient's arm toward the torso.

• The clip might not work with patients who have small wrists and arms.

• Exercise caution when placing the clip so that it doesn't impede circulation
along the patient's wrist and arm.

• If you cannot achieve a snug fit with the wrist clip, use some other method
to monitor ECG.

Directions for use ECG acquisition 23

WARNING Respiration Rate must be disabled when using ECG wrist clip
electrodes.

To attach the leads to the patient

1. Prepare the patient.

• Describe the ECG procedure. Explain the importance of holding still during the
test. (Movement can create artifact.)

• Verify that the patient is comfortable, warm, and relaxed. (Shivering can create
artifact.)

• Put the patient in a supine position.

2. Prepare the electrode locations.

• Shave and gently abrade the areas where you will place the electrodes. Take
care not to compromise skin integrity.

• Thoroughly clean the skin, and lightly rub it dry. You may use soap and water,
isopropyl alcohol, or skin preparation pads.

3. Confirm that the patient cable is attached to the module, and then snap the lead wire
to each the electrode.

4. Apply the electrodes (disposable or reusable) to the patient according to the "Lead
placement overview" presented earlier in this section.

• For reusable electrodes: Use electrode paste, gel, or cream to cover an area

the size of each electrode but no larger.

Note Check for buildup of materials on reusable electrodes

which can reduce waveform quality.

• For all disposable electrodes: Lightly tug on the connector to ensure that the

lead is securely attached. If the electrode comes off, replace it with a new
electrode. If the connector comes off, reconnect it.

WARNING Patient injury risk. To prevent cross­contamination and the spread of infection:

• Dispose of single-patient use components (for example, electrodes) after
use.

• Regularly clean and disinfect all components that come in contact with
patients.

• Reprocess the device accessories (for example, patient cable, leads, and
reusable electrodes) between patients.

24 ECG acquisition Welch Allyn Connex® Devices ECG Module

Note To maintain the quality of signals during long-term

monitoring, replace the electrodes at least every 48 hours.
Over longer periods, the electrode gel can dry out and the
patient's skin can be irritated by the gel or adhesive. When
replacing the electrodes, do not position the new electrodes
on exactly the same locations, but a little to the side of the
original position.

Maintenance

Clean the equipment

WARNING Keep the ECG module, reusable electrodes, and the patient
cable clean. Patient contact with contaminated equipment can spread
infection.

25

CAUTION Never use acetone, ether, freon, petroleum derivatives, or other
solvents to clean the ECG module or patient cable. Never immerse the
ECG module or the patient cable in liquid. Never autoclave or steam clean
the ECG module or the patient cable. Never pour alcohol directly on the
ECG module or the patient cable, and never soak any components in
alcohol. If any liquid enters the ECG module, remove the ECG module from
service, and have it inspected by a qualified service person before using it
again.

Clean the ECG module with one of the following approved cleaning wipes or solutions:

•

Clorox HP - Hydrogen Peroxide Cleaner Disinfectant Wipes (Clorox Healthcare®)

• Dispatch Hospital Cleaner Disinfectant Towels with Bleach (Clorox Healthcare®)

• CleanCide Wipes (Wexford Labs)

• 70% Isopropyl Alcohol

• 10% Chlorine Bleach

Follow these steps to clean the equipment:

1.

Power down the device and disconnect AC power.

2. Dampen a cloth with any of the acceptable cleaning solutions or select one of the
approved cleaning wipes, and wipe the exterior of the ECG module.

WARNING Clean any reusable electrodes you might use
between each patient. Follow manufacturer's instructions for
cleaning reusable electrodes.

CAUTION Wring out excess disinfectant from cleaning
wipes or towels before using them.

CAUTION Avoid using cleaning solutions on metal parts,
such as USB interface pins and patient connector pins, to
prevent corrosion.

3. Dry the module with a clean, soft cloth or paper towel.

4. Clean the cables in the same manner.

Maintenance Welch Allyn Connex® Devices ECG Module

26

5. Before you turn on the ECG module again, wait at least 10 minutes for all traces of
liquid to evaporate.

Inspect the equipment

Perform the following inspections daily:

• Check for cracks or breaks in the ECG patient cable, the USB cable, and the ECG
module housing.

• Check for bent or missing pins on all cables.

• Check all cable and cord connections; reseat if any connectors are loose.

Store the equipment

When storing the ECG module, cords, and accessories, observe the environmental
storage conditions that are identified in the product specifications.

Discard the equipment

Discard the ECG module, cables, and accessories according to local laws.

Troubleshooting

See the Welch Allyn Connex® Devices directions for use for troubleshooting
information.

Do not dispose of this product as unsorted municipal waste. Prepare this product for reuse or
separate collection as specified by Directive 2002/96/EC of the European parliament and the
Council of the European Union on Waste Electronic and Electrical Equipment (WEEE). If this
product is contaminated, this directive does not apply. For more specific disposal information,
see www.welchallyn.com/weee.

EMC guidance and manufacturer’s declarations

EMC compliance

Special precautions concerning electromagnetic compatibility (EMC) must be taken for all
medical electrical equipment. This device complies with IEC EN 60601-1-2:2007.

• All medical electrical equipment must be installed and put into service in accordance
with the EMC information provided in this document and the Welch Allyn Connex
Devices Directions for Use.

• Portable and mobile RF communications equipment can affect the behavior of
medical electrical equipment.

27

The monitor complies with all applicable and required standards for electromagnetic
interference.

•

It does not normally affect nearby equipment and devices.

• It is not normally affected by nearby equipment and devices.

• It is not safe to operate the monitor in the presence of high-frequency surgical
equipment.

• However, it is good practice to avoid using the monitor in extremely close proximity
to other equipment.

Emissions and immunity information

The ECG module is designed for and has been tested as part of a Connex Devices
system (Connex Vital Signs Monitor or Connex Integrated Wall System). Therefore, the
Emissions and immunity information provided for Connex Devices includes the
connected ECG module accessory. For information about electromagnetic compatibility
(EMC) of this system, see the Welch Allyn website:

http://www.welchallyn.com/emc-CVSM-CIWS

You can order a printed copy of the Emissions and immunity information from Welch
Allyn for delivery within 7 calendar days.

28 EMC guidance and manufacturer’s declarations Welch Allyn Connex® Devices ECG Module

Specifications

Physical specifications

Characteristic Specification

Length 101.6 mm (4.00 in.)

29

Width 57.15 mm (2.25 in.)

Height 27.94 mm (1.10 in.)

Weight 73.71 g (2.60 oz.)

Protection against the ingress of liquid IPX0 = No protection against liquid ingress.

Device classification

EMC Class Class IIB

IEC Type Type CF

Environmental specifications

Characteristic

Operating temperature 50° F to +104° F (10° to 40° C)

Storage temperature -4° F to +122° F (-20° to +50° C)

Operating humidity 15 to 95% non-condensing

Specification

Storage humidity 15 to 95% non-condensing

Operating altitude -557 to 10,000 ft. (-170 to 3048 m)

Storage altitude -557 to 50,000 ft. (-170 to 15500 m)

30 Specifications Welch Allyn Connex® Devices ECG Module

ECG specifications

Characteristic Specification

Heart rate detection range 20 to 300 beats per minute

Heart rate accuracy ±3 beats per minute or ±3%, whichever is greater

QRS detection amplitude

Tall T wave rejection Rejects Tall T waves less than 1.4 mV

Heart rate meter accuracy and response to
irregular rhythm

Response time of heart rate meter to
change in heart rate

Time to alarm for tachycardia Waveform B1

≥0.3 mV and ≤5.0 mV with QRS width of between 40 ms and 120 ms

The Heart Rate shall stabilize within 20 seconds and report the following
Heart Rates for data sets A.1 to A.4 with accuracy of ±5 BPM:

A.1 Ventricular bigeminy 80 BPM

A.2 Slow alternating ventricular bigeminy 60 BPM

A.3 Rapid alternating ventricular bigeminy 120 BPM

A.4 Bidirectional systoles 90 BPM

Increasing from 80 to 120 beats/minute: 10 sec

Decreasing from 80 to 40 beats/minute: 10 sec

Amplitude – Average time to alarm:

• 0.5 mV – 10 seconds

• 1.0 mV – 10 seconds

• 2.0 mV – 10 seconds

Waveform B2

Amplitude – Average time to alarm:

• 1.0 mV – 10 seconds

• 2.0 mV – 10 seconds

• 4.0 mV – 10 seconds

Data storage capacity 24 hours

Pacemaker detection

±2 mV to ±700 mV amplitude; 0.5 ms to 2.0 ms pulse width per EN
60601-2-27: 2011.

Rejects pacemaker signals, including double-paced signals, with over/
undershoot with the exception of pacemaker signals having an overshoot
with a time constant from 4 ms to 100 ms.

Note

A/D bit resolution

Dynamic range

Sampling rate

0.5 μV

±300 mV (95% gain accuracy)

250 ±2% samples per second

For leads I, II, III only. The module does not detect or
display pacemaker pulses on lead V.

Directions for use Specifications 31

Characteristic Specification

Mains filter 50 Hz, 60 Hz, off (default = 60 Hz)

Frequency range 0.5 to 70 Hz

Power source USB (4.5 V to 5.5 V)

Digital data interface Serial (USB – Full Speed)

Monitoring period Continuous

ECG channels Supports 3-lead or 5-lead

Sweep speed 25 mm/sec, 50 mm/sec

Resolution 14 bit ECG data, 30 mV peak-to-peak dynamic range minimum

Lead-off detection 3-lead or 5-lead

Applied currents Lead connection failures are detected by a bias current with respect to

the reference electrode.

User-adjustable parameters See Alarms

ECG cable specifications

Characteristic

Connector at ECG module 80 in. ±1 shielded cable to a 24 in. ±1 lead fan-out to electrode

ECG cables 3-lead or 5-lead to snap connection

Patient cables Conforms to ANSI/AAMI EC53

Specification

connection

Impedance respiration specifications

Characteristic

Impedance Respiration accuracy ±2 breaths per minute or ±2%, whichever is greater

Range 5 to 100 breaths per minute

Breath detection range 0.4 ohms to 3.0 ohms

Specification

Respiration lead source Lead II (right arm and left leg)

Respiration can only be acquired from Lead II.

Respiration, leads-off sensing and active
noise suppression (applied currents)

Note

Respiration – Excitation signal characteristics Less than 25 uA RMS at
31 kHz pseudo sine wave

Lead off – DC current of 50nA max for RA ,LA, LL, V; 200nA max for RL

32 Specifications Welch Allyn Connex® Devices ECG Module

Characteristic Specification

Noise suppression – DC current of 200nA max for RL

Software and alarm specifications

Characteristic Specification

Ventricular tachycardia threshold default 120 beats per minute ±3 beats per minute for 6 consecutive beats

Variable ventricular tachycardia settings 100 beats per minute to 150 beats per minute ±3 beats per minute for 6

consecutive beats

Asystole threshold default No detectable beat for ≥4 seconds

Ventricular fibrillation threshold default A fibrillatory waveform persisting for ≥4 seconds

Configurable mains filter ON or OFF; 50 Hz or 60 Hz

Data stream bytes output Maximum latency <100 ms

Heart rate averaging method per IEC
60601-2-27:2011 Clause 201.7.9.2.9.101

Response to change in Heart rate per IEC
60601-2- 27:2011 Clause 201.7.9.2.9.101

Number of consecutively detected beats:
>10: Heart rate = 60/(average of last 10 detected consecutive R-R

intervals)

>2 and <10 : Heart rate = 60/(average of the detected consecutive R-R
intervals)

Increasing from 80 to 120 beats/minute: 6.0 sec

Decreasing from 80 to 40 beats/minute: 16.0 sec

Protection against defibrillation

Defibrillation protection per EN60601-2-27:2011. ECG device will resume according to
the table below.

Parameter

HR value Acquiring 3 sec +5 beats Depends on patient heart

ECG waveform Waveform ≤5 sec

Initial report after
defibrillation

Maximum time to
recover

Note

rate

Respiration value Acquiring 3 sec +5 breaths Depends on patient

respiration rate

Pacer detect Pacer marker in waveform ≤5 sec

Arrhythmia Acquiring or

Cannot analyze

5 sec +5 beats Depends on patient heart

rate

Directions for use Specifications 33

Protection against electrosurgical

Electrosurgical protection per EN60601-2-27:2011. ECG device will resume as per the
table below.

Parameter Initial report after

HR value Acquiring 10 sec +5 beats Depends on patient heart

ECG waveform Waveform ≤10 sec

Respiration value Acquiring 10 sec +5 breaths Depends on patient

Pacer detect Pacer marker in waveform ≤10 sec

Arrhythmia Acquiring or

Device classification

ECG device will operate per table below after startup and after changes to parameter
configurations (e.g., filter on/off) or lead off recovery.

Parameter

defibrillation

Cannot analyze

Initial report after
defibrillation

Maximum time to
recover

10 sec +5 beats Depends on patient heart

Maximum time to
recover

Note

rate

respiration rate

rate

Note

HR value Acquiring 10 sec +5 beats Depends on patient heart

ECG waveform Waveform ≤3 sec

Respiration value Acquiring 10 sec +5 breaths Depends on patient

Pacer detect Pacer marker in waveform ≤3 sec

Arrhythmia Acquiring or

Default settings

Characteristic

Lead color code AHA

Lead for view II

Sweep speed 25 mm/second

Cannot analyze

rate

respiration rate

10 sec +5 beats Depends on patient heart

rate

Specification

34 Specifications Welch Allyn Connex® Devices ECG Module

Characteristic Specification

Gain 10 mm/mV

Arrhythmia detection Enabled

Impedance Respiration Disabled

Print on V-Tach, V-Fib, and Asystole alarms Enabled

Pacer Disabled

Regulatory compliance

The ECG module complies with the following standards1:

IEC 60601-1

IEC 60601-1-2

IEC 60601-1-6

IEC 60601-2-27

2

ISO 10993

IEC 62304

IEC 62366

1

Standard is essentially the IEC 60601-1 General standard plus the listed country's National Deviations(e.g., AS/NZ,

CAN/CSA, EN Harmonized version, etc.).

2

Alarms might display and sound during an Electrosurgery Interference event.

Appendix

Approved accessories

ECG

Part Number Description

35

6000-ECG ECG module

6000-CBL3I Patient cable 3L IEC

6000-CBL3A Patient cable 3L AHA

6000-CBL5I Patient cable 5L IEC

6000-CBL5A Patient cable 5L AHA

6000-ECG3I Module + USB + Patient cable 3L IEC

6000-ECG3A Module + USB + Patient cable 3L AHA

6000-ECG5I Module + USB + Patient cable 5L IEC

6000-ECG5A Module + USB + Patient cable 5L AHA

106550 ECG mounting accessory, stand or wall

6200-11 Electrode pads (30 pads/pack, 20 packs/box)

106560 Connex ECG Module CD, Directions for Use, Quick Reference Cards, Multi-language

36

Appendix Welch Allyn Connex® Devices ECG Module

Limited warranty

Welch Allyn, Inc., warrants that the ECG/Impedance Respiration module (the Product)
meets the labeled specifications of the Product and will be free from defects in materials
and workmanship that occur within 1 year after the date of purchase, except that
accessories used with the Product are warranted for 90 days after the date of purchase.
Such accessories include cables and electrodes.

The date of purchase is the date specified in our records, if you purchased the Product
directly from us. If you purchased from a distributor, the date of purchase is the date
specified on your invoice.

This warranty does not cover damage caused by: 1) handling during shipping, 2) use or
maintenance contrary to labeled instructions, 3) alteration or repair by anyone not
authorized by Welch Allyn, and 4) accidents.

If a product or accessory covered by this warranty is determined to be defective because
of defective materials, components, or workmanship, and the warranty claim is made
within the warranty period described above, Welch Allyn will, at its discretion, replace
the defective Product or accessory free of charge with a like-new Product.

You must obtain a return authorization from Welch Allyn to return your Product before
you send it to Welch Allyn’s designated service center for repair. Contact Welch Allyn
Technical Support.

THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED,
INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF
MERCHANTABILTY AND FITNESS FOR A PARTICULAR PURPOSE. WELCH ALLYN’S
OBLIGATION UNDER THIS WARRANTY IS LIMITED TO REPAIR OR REPLACEMENT
OF PRODUCTS CONTAINING A DEFECT. WELCH ALLYN IS NOT RESPONSIBLE FOR
ANY INDIRECT OR CONSEQUENTIAL DAMAGES RESULTING FROM A PRODUCT
DEFECT COVERED BY THE WARRANTY.