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.
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