WARNING!
Do not attempt to use this equipment without
thoroughly reading and understanding these
instructions.
Manufacturer
Manufacturer MRL, Inc.
A Welch Allyn Company
1000 Asbury Drive
Buffalo Grove, IL 60089
USA
(847) 520-0300
Product Name Welch Ally n AED20
Device Type Automated External Defibrillator
FDA Medical Device Registration
The FDA Safe Medical Device Act stipulates that each enduser is required under penalty of law, to register with the
manufacturer all information pertinent to each medica l
device.
Please fill out the enclosed FDA Medical Device
Registration postcard and return it promptly to Welch Allyn.
990020 – Rev. KPreface i
This card must be filled in and returned within 30 days of
product delivery.
If the medical device is transferred from your possession,
you must notify Welch Allyn of the new registration
information.
Manufacturer’s Responsibility
Welch Allyn, Inc. is responsible for the safety, reliability,
and performance of the Welch Allyn AED20, only if the
following conditions are met:
v Assembly operations, extensions, readjustments,
modifications, or repairs are carried out by persons authorized
by Welch Allyn.
v The Welch Allyn AED20 equipment is used in accordance
with the instructions for use.
User’s Responsibility
The user is required to be trained in basic monitoring, vital
signs assessment, and emergency cardiac care. The user
should be completely knowledgeable of the information in
the Welch Allyn AED20 Users Manual. As with all other
electronic patient care monitors, good clinical judgment
should be used when operating the Welch Allyn AED20. To
ensure patient safety and proper operation, use only Welch
Allyn-authorized parts and accessories.
ii Welch Allyn AED20 Users Manual 990020 – Rev. K
User must save all shipping containers and packaging
materials. When shipping the Welch Allyn AED20 and
accessories for calibration, service, or upgrades, the original
shipping containers and packaging materials must be used.
Contact and Technical Support
Please contact Welch Allyn, Inc. if you have any questions
regarding this notice.
Telephone 847.520.0300
Toll-free 800.462.0777
Fax 847.520.0303
Internet www.welchallyn.com
990020 – Rev. K Preface iii
Declaration of Conformity
Manufacturer:
Medical Research Laboratories, Inc., Welch Allyn Ireland
a Welch Allyn company Navan Business Park
1000 Asbury Drive Dublin Road
Buffalo Grove, IL 60089 Navan, Co. Meath
USA Republic of Ireland
Phone (847) 520-0300 Phone 011-353-466-7775
Fax (847) 520-0303
declares that the CE-marketed product
Product Name : Welch Allyn AED20
Device Type : Defibrillator / ECG Monitor
Model Number: 972200
Accessories: See list in manual
complies with Council Directive 93/42/EEC (Medical Device Directive) of
June 14 1993 class IIb Annex II
Standards
General:ISO 9001
EN 46001
Safety: EC 60601-1 / EN 60601-1 Class II, Type BF,
Joel Orlinsky Date
Director of Q.A. and Regulatory Affairs
iv Welch Allyn AED20 Users Manual 990020 – Rev. K
Safety
Welch Allyn AED20 Users Manual
Conventions Used in the Manual
This section includes a list of conventions used in this
manual.
Warnings
Warnings alert the user to a special condition that could
result in serious personal injury or death. In this manual,
warnings are displayed as shown in the following example:
WARNING!
Conditions, hazards, or unsafe practices that can
result in serious personal injury or death.
Cautions
Cautions alert the user to a special condition that could
result in minor personal injury or damage to the equipment.
In this manual, cautions are displayed as shown in the
following example:
Caution
Conditions, hazards, or unsafe practices that can
result in minor personal injury, damage to the
Welch Allyn AED20, or loss of data.
990020 – Rev. KSafety v
Notes
Notes contain information that augments or clarifies an
operating step. Notes do not normally contain actions. They
follow the procedural steps to which they refer. In this
manual, notes are displayed as shown in the following
example:
¥ If the Welch Allyn AED20 is used more than once per
month, it is recommended that authorized service
personnel perform a periodic inspection servicing at
least once per year.
Voice Prompts
The Welch Allyn AED20 provides audio instructions
through the built -in speaker to provide operating instruction
and assist the user during defibrillation. In this manual,
voice prompts are displayed as shown in the following
example:
— Low battery
Safety information is organized in six groups:
v General Cautions and Notices
v Patient Safety
v Defibrillator and Electrode Pads
v Battery and Charger
v Care and Storage
v Safety Symbols
vi Welch Allyn AED 20 Users Manual 990020 – Rev. K
General Cautions and Notices
Dropped or Damaged
If the device has been dropped or damaged in
any way, refer the device to qualified service
personnel for servicing.
Ferromagnetic Equipment
ECG electrodes and cables contain
ferromagnetic materials. They must not be
used in the presence of large magnetic fields
created by magnetic resonance imaging (MRI)
equipment. The large magnetic fields
generated by an MRI device could move
ferromagnetic equipment with an extremely
violent force that could cause serious personal
injury or death to persons between the
equipment and the MRI device.
Labels
Observe all CAUTION and WARNING labels
on the equipment and accessories.
Performance
The Welch Allyn AED20 may not meet
performance specifications if stored,
transported or used outside the specified
storage or operating environmental range
limits.
990020 – Rev. K Safety vii
Notices
Patient Safety
General
Warning Not for use on pediatric patients
Caution Patient Physical Harm
Caution Use Automated Mode only when these
U.S. Federal law restricts this device to use by
or on the order of a physician. If the battery
pack is removed for any reason, labeling of the
Welch Allyn AED20 is required indicating
out-of-service for battery operation.
This defibrillator is not to be used on patients
less than 8 years old.
Place the Welch Allyn AED20 in a position
where it cannot harm the patient should it fall.
Keep all cables and connectors away from the
patient’s neck.
conditions have been met
Use Automated Mode only on victims of
cardiac arrest who exhibit unconsciousness,
absence of breathing, and absence of pulse.
Shock Hazard
Warning Defibrillation current can cause injury
Do not touch the patient during defibrillation.
Do not touch equipment connected to or me tal
objects in contact with the patient during
defibrillation. Disconnect other electrical
viii Welch Allyn AED 20 Users Manual 990020 – Rev. K
equipment from the patient before
defibrillating.
Caution Manual mode is for qualified users only
Only by qualified operators who have been
trained in rhythm recognition and treatment
through manual charging and delivery of
defibrillation shocks. Follow all instructions in
this users manual.
Burns
WarningProperly place defibrillation pads
Do not allow defibrillation pads to touch each
other, or to touch other ECG electrodes, lead
wires, dressings, transdermal patches, etc.
Such contact can cause patient skin burns
during defibrillation and may divert
defibrillating current away from the heart.
Remove excessive body hair, which may cause
skin burns or ineffective energy transfer.
Warning Use Welch Allyn electrode monitoring
cables only
Do not replace the electrode monitoring cable
with a substitute. Using any other cable may
cause burns to the patient.
Electrical Energy
Warning Welch Allyn AED20 can deliver 360 joules
of electrical energy
Before charging the defibrillator, verify that
the energy selected on the display is the
desired output. Disconnect any medical
electronic device that is not labeled
990020 – Rev. K Safety ix
“defibrillation protected” from the patient. If
this electrical ene rgy is not discharged
properly, it could cause personal injury or
death to the operator or bystander. During
defibrillation, the operator and all other people
must stand clear of the patient, bed, and all
conductive surfaces in contact with the patient.
Warning Properly place defibrillation pads
Do not place electrodes near the generator of
an internal pacemaker. Always apply
electrodes to flat areas of skin. Avoid
application over folds of skin such as those
underneath the breast or on obese patients.
Excessive hair, poor adhesion, or air under
electrode may produce burns.
ECG Misinterpretation
Warning Properly place defibrillation pads
Improperly placed pads may produce incorrect
analysis and an inappropriate shock or no
shock decision advisory.
Warning Do not move patient
Handling or transporting the patient during
ECG analysis can cause incorrect or delayed
diagnosis. Follow all instructions in the
Advanced Users Manual.
Warning Cardiac pacemakers may affect rhythm
analysis
Patient pacemakers may reduce the sensitivity
of the Welch Allyn AED20 analysis and errors
in detecting shockable rhythms.
x Welch Allyn AED 20 Users Manual 990020 – Rev. K
Warning Radio frequency (RF) interference
Do not operate the Welch Allyn AED20 in
conjunction with electrocautery or diathermy
equipment. Any equipment that emits strong
radio frequency signals can cause electrical
interference and distort the ECG signal to
cause inaccurate interpretation of rhythm.
Caution Do not use the electrode monitoring cable
for Automatic Rhythm Analysis
Proper skin preparation and the use of fresh,
high-quality monitoring electrodes are
imperative to minimize artifact when using the
electrode monitoring cable.
Defibrillator and Electrode Pads
Explosion
Warning Explosion hazard
Do not use the Welch Allyn AED20 in the
presence of flammable anesthetics or
concentrated oxygen.
Electrical Shock or Fire Hazard
Warning No internal, operator -serviceable parts
Do not open unit, remove covers or attempt to
repair the Welch Allyn AED20. All servicing
must be performed by qualified personnel.
990020 – Rev. K Safety xi
Warning Improper use can cause injury
The Welch Allyn AED20 contains an
automatic disarm of the stored energy. If the
operator has not delivered the energy to a
patient or a test load, an internal timer will
disarm the stored energy. This stored electrical
energy can potentially cause death or injury if
discharged improperly. Follow all instructions
in this users manual.
Caution Do not immerse or expose the Welch Allyn
AED20 to water or other liquids
Do not use the defibrillator if unit has been
immersed in liquid or if excessive
condensation is visible on the device.
Caution Conductive parts should not contact other
conductive parts including the earth
Improper Device Performance
Warning Use only Welch Allyn-approved accessories
Do not use defibrillation pads , batteries, and
other accessories not approved by Welch Allyn. Use of unauthorized accessories may
cause the device to operate improperly and
provide false measurements. Follow all
labeling instructions on the defibrillation pads
and the rechargeable battery.
Warning Do not administer a shock using the
electrode monitoring cable .
The electrode monitoring cable has protective
circuitry that prevents defibrillation energy
from being delivered to the patient. Always
check the expiration date on defibrillation
xii Welch Allyn AED 20 Users Manual 990020 – Rev. K
pads. Do not use pads if the packaging has
been previously opened. The Welch Allyn
AED20 may interpret excessively dry
defibrillation pads as an attached electrode
monitoring cable.
Caution Do not repeatedly charge and discharge
defibrillator in rapid succession
If a need for repetitive testing arises, wait at
least 1 minute for every third discharge to
avoid damaging equipment.
Caution Improper maintenance can cause improper
performance
Follow instructions in the Advanced Users
Manual.
Caution Use Manual Mode properly
In the manual mode, if a new energy level is
selected after the charge button is pushed and
while the defibrillator is charging, the
defibrillator will automatically charge to the
new energy selection. The CHARGE button
need not be pressed again to select the new
energy level.
Battery and Charger
Battery Care
Caution Battery is shipped discharged
Charge rechargeable battery fully before use.
990020 – Rev. K Safety xiii
Caution Use only Welch Allyn PowerStick batteries
Use either the rechargeable NiMH PowerStick
or the non-rechargeable Lithium PowerStick.
Use of any other battery can damage the
Welch Allyn AED20.
Caution Make sure the rechargeable battery is fully
charged
Loss of power during patient care could result
in injury. Always have a fully charged backup battery available.
Caution Never attempt to recharge a non-
rechargeable battery.
Caution Check capacity of a non-rechargeable
battery after each use
Replace battery if “Low Battery” is indicated.
Caution Replace rechargeable battery at 24 months
Battery replacement at 24 months is
recommended due to degradation of the battery
chemistry. Periodic maintenance and testing is
highly recommended to ensure proper battery
performance.
Charger Care
Caution Use the battery charger to maintain a full
battery charge
Make sure the charger is plugged into an AC
power source. Keep the charger in a dry,
moisture-free location, away from direct
sunlight or other heat sources. Do not block
the ventilation slots or remove the cover.
xiv Welch Allyn AED 20 Users Manual 990020 – Rev. K
Care and Storage
Cleaning and Sterilization
Caution Clean and maintain the Welch Allyn AED20
according to instructions.
See Chapter 4, Maintaining the Welch Allyn
AED20.
Do not clean the Welch Allyn AED20 with
alcohol, ketone, or any flammable agent. Do
not autoclave the Welch Allyn AED20 or
attempt to sterilize the Welch Allyn AED20 or
any of its accessories.
Electrodes
Warning Follow manufacturer’s instructions for use
of defibrillation electrodes
Improper use of defibrillation electrodes may
cause the Welch Allyn AED20 to function
improperly or may cause skin burns. Do not
use expired, dry electrodes. Do not reuse
disposable electrodes. When obtaining a new
supply, verify that the electrodes connect
properly to the Welch Allyn AED20 prior to
putting them into service.
Caution Properly store and use defibrillation pads
Store electrodes in a cool, dry location
(between 60° and 95°F or 15° and 35 °C.). Do
not sterilize the pads, immerse, or clean the
electrodes with alcohol or solvents.
990020 – Rev. K Safety xv
Safety Symbols
Graphical symbols, letter symbols, and signs listed below
may be found on the Welch Allyn AED20 and accessories.
Please note the use of these symbols for safe and proper use
of the equipment. For a list of icons that display operating
status information, see Chapter 1 Introducing the WELCH ALLYN AED.
Attention, consult
accompanying
documents
Auxiliary power
operation
Caution, high voltage Positive input terminal
Dangerous voltage
Defibrillator protected,
type BF patient
connection
Earth (ground)
Negative input
terminal
Recycle battery
xvi Welch Allyn AED 20 Users Manual 990020 – Rev. K
Chapter 1
Introducing the Welch Allyn AED20
Welch Allyn AED20 Users Manual
This chapter provides an introduction to the Welch Allyn
AED20 system and presents an overview of the Welch Allyn
AED20 controls, indicators, displays, and prompts. It also
provides instructions for getting the Welch Allyn AED20 ready
for use and preparing the unit for storage.
Overview of the Welch Allyn AED20 1-3
Features .......................................................................................1-3
Systems Upgrades and Options..............................................1-4
The Welch Allyn AED20 (automated external defibrillator)
is a safe, easy to use defibrillation device designed for use
by basic life support (BLS) personnel. The unit is
lightweight and mobile and can be used in situations where
there could be several minutes before the arrival of advanced
life support (ALS) personnel.
The Welch Allyn AED20 recognizes ventricular fibrillation
and other ventricular tachycardia and guides operators
through the defibrillation process. When properly connected
to a patient who is unconscious, not breathing, and without a
pulse, the Welch Allyn AED20 analyzes the patient’s heart
rhythm, provides text and audio instruction prompts,
determines if a shockable situation exists, and, if
appropriate, automatically arms the Shock button.
The Welch Allyn AED20 delivers the defibrillation shock
through two self-adhesive, pre-gelled, low -impedance
electrode defibrillator pads. The pads, cable, and connector
are sold as disposable kits.
The Welch Allyn AED conforms to the AAMI DF39, AHA
Scientific Statement AED: Specifying and Reporting
Arrhythmia Analysis Algorithm Performance, and the IEC
standard 601-2-04 for AEDs currently under development.
Features
Welch Allyn AED20 features in clude:
v 3-step operation
v extensive voice and visual prompts for the operator
v continuous ECG, audio, and event recording for reporting
v daily self -test to ensure readiness
v rechargeable battery
v biphasic energy output
v lock -out protection to prevent inadvertent defibrillation
System Upgrades and Options
The Welch Allyn AED20 is an automated external
defibrillator designed for easy operation. However, It is
designed so that optional features can be added as simple
software upgr ades.
Display options include providing an ECG trace in
automated mode, showing a biphasic defibrillation
waveform, and on-screen log data review. Another option
allows the unit to be switched from automated mode to
manual mode. Manual mode allows qualified users to set the
defibrillation energy level, charge the unit, and deliver a
shock.
Qualified Operators
The Welch Allyn AED permits trained users to administer a
brief electrical shock to patients experiencing fibrillation or
sudden cardiac arrest (SCA).
A qualified operator is someone who has successfully
completed a CPR AED training course (e.g., AHA
Heartsaver course or the Red Cross CPR/AED course).
Carefully unpack and inspect all the Welch Allyn AED20
system c omponents and accessories. If using the
rechargeable NiMH PowerStick battery, charge the battery
fully before installing it. Install the battery, run the self-test,
and set the date and time (see chapter 3 for instructions)
before putting the unit into ser vice.
Unpacking and Inspecting
Visually inspect the carton for any signs of damage or
mishandling (carton perforations, cuts, or dents; bent or
collapsed corners; or broken carton seal). Remove the Welch
Allyn AED from the carton and inspect it carefully.
Before proceeding:
1. Open and carefully unpack each carton.
2. Examine the instruments and accessories for
signs of damage.
3. Check the packing list to determine that all
accessories have been received.
4. Contact Welch Allyn, Inc. Service Department at
847.520.0300 if anything looks damaged or is
missing.
Installing the Battery
The Welch Allyn AED20 can use either a NiMH (Nickel
Metal Hydride) PowerStick rechargeable battery or an
extended-life, Lithium PowerStick non-rechargeable battery.
v Use the NiMH PowerStick rechargeable battery for
battery ready
applications involving frequent use.
v Use the Lithium PowerStick non-rechargeable battery for
standby use.
The battery slides into the AED case and locks firmly in
place. The battery forms the carrying handle of the We lch
Allyn AED20 and therefore, you can always be sure that the
battery is properly installed.
¥ Using a non-rechargeable battery for training or
testing will reduce the shelf -life and operating time
of the battery.
To install the battery:
1. Align the thin, flat end of the battery with the
opening in the lower front portion of the Welch
Allyn AED case.
2. Push the battery in until it “clicks” and locks into
place.
lower left of the display indicates tha t the battery
has the sufficient charge. If the status indicator
displays anything other than the Battery Ready
icon, the Welch Allyn AED20 is not ready for
use.
To replace the battery:
1. Push the lock release on the bottom of the Welch
Allyn AED case where the battery inserts into the
unit.
2. Replace the battery with a backup. Recharge the
removed battery, if it is a rechargeable battery.
Running a Self-Test
After installing the battery, press the ON button to power-up
the Welch Allyn AED and automatically perform a self-test.
At power -up, the following tests are performed: battery,
main processor, memory and program, stuck key, ECG
preamp, and defibrillator.
The Welch Allyn AED20 is an automated exter nal
defibrillation (AED) device designed for use by trained
personnel. It features a straightforward, three -step operating
design that uses extensive voice and visual prompts to assist
the operator. With continuous ECG, audio, and event
recording, the Welc h Allyn AED20 maintains a detailed log
that can be viewed on screen or reported directly to a
computer or printer.
Welch Allyn AED20 Configurations
Three Welch Allyn AED configurations are available:
Primary AED, Secondary AED, and Manual AED.
Primary AED In this configuration, the unit provides
automated text and voice prompts to guide
the operator. It does not have an ECG
tracing capability on the display.
Secondary AED This configuration requires the optional ECG
display upgrade. Automated Text and voice
prompts are provided and a continuous ECG
tracing displays on the LCD during
operation.
Manual AED This configuration requires the optional ECG
display and Manual mode upgrades. This
configuration includes automated text and
voice prompts and an ECG tracing display.
In addition, an authorized
operator/supervisor with the proper pass
code can manually override the automated
operation of the AED. This allows the user to
manually select energy settings and
administer defibrillation shocks.