810-2485-02 Eng - S
810-2485-02 Eng - S
810-2485-02 Eng - S
TM
User Manual
Software version 7.09X
ii Welch Allyn AED 20 Automated External Defibrillator
Copyright 2007 Welch Allyn. All rights are reserved. No one is permitted to reproduce or duplicate, in any
form, this manual or any part thereof without permission from Welch Allyn.
Welch Allyn assumes no responsibility for any injury to anyone, or for any illegal or improper use of the
product, that may result from failure to use this product in accordance with the instructions, cautions,
warnings, or statement of intended use published in this manual.
Welch Allyn® is a registered trademark of Welch Allyn. AED 20TM is a trademark of Welch Allyn.
Software in this product is Copyright Welch Allyn or its vendors. All rights are reserved. The software is
protected by United States of America copyright laws and international treaty provisions applicable
worldwide. Under such laws, the licensee is entitled to use the copy of the software incorporated with
this instrument as intended in the operation of the product in which it is embedded. The software may not
be copied, decompiled, reverse-engineered, disassembled or otherwise reduced to human-perceivable
form. This is not a sale of the software or any copy of the software; all right, title and ownership of the
software remain with Welch Allyn or its vendors.
For information about any Welch Allyn product, call the nearest Welch Allyn representative:
Caution! Changes or modifications not expressly approved by Welch Allyn could void the purchaser’s
authority to operate the equipment.
Welch Allyn
8500 SW Creekside Place
Beaverton, Oregon 97008-7107
www.welchallyn.com
Printed in USA
iii
Contents
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v
1 - Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Conventions Used in the Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
General Cautions and Notices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Patient Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Defibrillator and Electrode Pads . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Battery Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Care and Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Electrodes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Safety Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2 - Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
System Upgrades and Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Qualified Operators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Preparing the Defibrillator for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Getting to Know the Defibrillator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Defibrillator Configurations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Battery Charging and Conditioning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Preparing the Defibrillator for Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
3 - Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Operating Procedures—Quick Reference. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Operating Procedures—Detail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
4 - Programming. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Menu Structure Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Menu Structure Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Accessing the User Menu from Automated Mode. . . . . . . . . . . . . . . . . . . . . . . 37
Accessing the User Menu from Manual Mode . . . . . . . . . . . . . . . . . . . . . . . . . 37
User Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Supervisor Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
5 - Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
6 - Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Frequently Asked Questions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
iv Contents Welch Allyn AED 20 Automated External Defibrillator
A - Glossary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
B - Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
AED 20 Pediatric Energy Reducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
C - Parts List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
D - Summary Of Studies Of Waveform Safety & Effectiveness . . . . . 83
v
Preface
WARNING Do not attempt to use this equipment without thoroughly reading
and understanding these instructions.
Manufacturer’s Responsibility
Welch Allyn is responsible for the safety, reliability, and performance of the defibrillator
only if the following conditions are met:
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 Directions for Use. As with all other electronic patient care monitors,
good clinical judgment should be used when operating the defibrillator. To ensure patient
safety and proper operation, use only Welch Allyn-authorized parts and accessories.
User must save all shipping containers and packaging materials. When shipping the
defibrillator and accessories for calibration, service, or upgrades, the original shipping
containers and packaging materials must be used.
US Customers
Welch Allyn provides the following indemnity to persons or legal entities (the Purchaser)
that originally purchase or lease a Welch Allyn AED 20 from Welch Allyn or an authorized
distributor appointed by Welch Allyn.
Welch Allyn will, at its cost, defend, indemnify, and hold harmless the Purchaser from
third-party claims or legal actions for liability or damages resulting from bodily injury or
death caused by a mechanical or electrical failure of the Purchaser's Welch Allyn AED 20
or the malfunction of the Purchaser's Welch Allyn AED 20 due to a defect in its design or
manufacture.
This indemnity does not extend to or cover any claim or legal action for liability or
damages in connection with the use of the Purchaser's Welch Allyn AED 20 to the extent
caused by: 1) negligent operation of the Welch Allyn AED 20, or failure to follow the
sequential operating instructions for use of the Welch Allyn AED 20, or 2) failures or
malfunctions of the Welch Allyn AED 20 that are due to improper maintenance, including
without limitation, malfunctions of pads or batteries that occur after expiration of their
shelf life or malfunctions of repairs, replacement parts, pads, or batteries that are not
provided by Welch Allyn.
Welch Allyn
4341 State Street Road
Skaneateles Falls, NY 13153
Phone: 315-685-2500
Fax: 315-685-4496
1
1 Safety
Conventions Used in the 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:
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:
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:
Voice Prompts
The defibrillator 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.”
2 Safety Welch Allyn AED 20 Automated External Defibrillator
Damaged
If the defibrillator has been damaged in any way, refer it to qualified service personnel.
Labels
Observe all CAUTION and WARNING labels on the defibrillator and accessories.
Performance
The defibrillator may not meet performance specifications if stored, transported, or used
outside the specified storage or operating environmental range limits.
Notices
U.S. Federal law restricts this defibrillator to be used by or on the order of a physician. If
the battery pack is removed for any reason, the user must label the defibrillator as “Out of
service due to battery operation.”
Patient Safety
General
WARNING An accessory adapter is required for use on pediatric patients. The
defibrillator is not to be used in Automated mode on patients younger than 8
years old or weighing less than 25 kg (55 lbs) unless it is equipped with the
accessory AED 20 Pediatric Energy Reducer (part number 002174-U).
WARNING Do not use the AED 20 Pediatric Energy Reducer when the
defibrillator is in Manual Mode.
Caution Manual mode is for use 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 user manual.
Shock Hazard
WARNING Defibrillation current can cause injury. Do not touch the patient
during defibrillation. Do not touch equipment connected to or metal objects in
contact with the patient during defibrillation. Disconnect other electrical
equipment from the patient before defibrillating.
Caution Use Automated Mode only on victims of cardiac arrest who are
unconscious, not breathing and unresponsive.
Burns
WARNING Properly 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 The defibrillator 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 labelled
“defibrillation protected” from the patient. If this electrical energy 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 the defibrillation pads. Improperly placed pads may
produce incorrect analysis and an inappropriate shock or no shock decision
advisory.
4 Safety Welch Allyn AED 20 Automated External Defibrillator
WARNING Do not move the patient. Handling or transporting the patient during
ECG analysis can cause incorrect or delayed diagnosis. Follow all instructions in
the User Manual.
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.
Caution Conductive parts should not contact other conductive parts including
the earth.
User Manual Safety 5
Improper Performance
WARNING Use only accessories approved by Welch Allyn. 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 labelling instructions on the defibrillation
pads and the 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 pads. Do not use pads if the packaging has been previously opened.
The defibrillator may interpret excessively dry defibrillation pads as an attached
electrode monitoring cable.
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 Care
Caution The battery is shipped discharged. Charge the rechargeable battery
fully before use.
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 defibrillator.
Caution Make sure the rechargeable battery is fully charged. Loss of power
during patient care could result in injury. Always have a fully charged back-up
battery available.
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.
6 Safety Welch Allyn AED 20 Automated External Defibrillator
Electrodes
WARNING Follow manufacturer’s instructions for use of defibrillation
electrodes. Improper use of defibrillation electrodes may cause the defibrillator 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 defibrillator before 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.
Safety Symbols
Graphical symbols, letter symbols, and signs listed below may be found on the
defibrillator and accessories. Note the use of these symbols for safe and proper use of
the equipment.
Recycle the defibrillator and battery separately from other disposables (www.welchallyn.com/weee)
This device has been tested and certified by the Canadian Standards Association International to comply
with applicable U.S. and Canadian medical safety standards.
The CE Mark and Notified Body Registration Number signify the device has met all essential requirements
of European Medical Device Directive 93/42/EEC.
8 Safety Welch Allyn AED 20 Automated External Defibrillator
9
2 Introduction
This chapter introduces the defibrillator system, introduces the controls, indicators,
displays, and prompts, and provides instructions for preparing the defibrillator for use and
for storage.
Overview
The AED 20 is a safe, easy-to-use defibrillator for use by basic life support (BLS)
personnel. It is light and mobile and can be used where several minutes could elapse
before the arrival of advanced life support (ALS) personnel.
The defibrillator 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 unresponsive (that is, without signs of circulation),
the defibrillator analyzes the patient’s heart rhythm, provides text and audio instruction
prompts, determines whether a shockable situation exists and, if appropriate, arms the
Shock button.
The defibrillator delivers the shock through two self-adhesive, pre-gelled, low-impedance
electrode defibrillator pads. The pads, cable, and connector are sold as disposable kits.
Features
• 3-step operation
Display options include providing an ECG trace in automated mode and showing a
biphasic defibrillation waveform. 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.
10 Introduction Welch Allyn AED 20 Automated External Defibrillator
Qualified Operators
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).
1. Carefully unpack and inspect all defibrillator system components and accessories.
2. Install the battery. (If using the rechargeable NiMH PowerStick battery, charge the
battery fully before installing it.)
4. Set the date and time. (See “Setting the Date” on page 42.)
Before proceeding:
3. Check the packing list to determine that all accessories have been received.
4. Contact Welch Allyn (see page ii) if anything looks damaged or is missing.
The battery slides into the defibrillator case and locks firmly in place. The battery forms
the carrying handle of the defibrillator and therefore, you can always be sure that the
battery is properly installed.
• Use the NiMH PowerStick rechargeable battery for applications involving frequent
use.
• Using a non-rechargeable battery for training or testing will reduce the shelf-life
and operating time of the battery.
1. Align the thin, flat end of the battery with the opening in the lower front portion of the
defibrillator case.
Battery
ready 1 ON
OFF
2
3
AED20
Battery
Release
on
other
side
3. Make sure the battery ready indicator in the lower left of the display indicates that the
battery has sufficient charge. If the status indicator displays anything other than the
Battery Ready icon, the defibrillator is not ready for use.
1. Push the lock release on the bottom of the defibrillator case where the battery inserts
into the unit.
Running a Self-Test
After installing the battery, press the ON button to power-up the defibrillator 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.
If the built-in sensors in the defibrillator detect a problem prior to or during operation, the
unit provides a voice or screen prompt indicating the problem.
Defibrillator Configurations
Available defibrillator configurations are ECG Display and Manual Mode.
ECG Display Provides automated Text and voice prompts and continuous ECG
tracing displays on the LCD during operation.
Manual Mode Provides 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 defibrillator. This allows the user to manually select energy
settings and administer defibrillation shocks.
Functions
Display On/Off
Menu ON F F
Shock
selection
O
1
2
3
Defibrillator Speaker
pads connector
20
D
E
A
Battery ready ry
te se
Bat ea
Rel on r
he
ot de
indicator Battery
si
G
HIN
AS
FL
E
US
T
NO
DO
Y
AD
RE
Controls
The defibrillator is designed for ease of operation. After putting the defibrillator pads on
the patient and connecting them to the defibrillator, the operator performs this simple
three-step process:
2. Follow text prompts on the screen and voice prompts from the speaker.
1 Power on
1 ON
OFF
Display
Text prompts, patient data, and event information appear on the screen, which is divided
into functional areas of operating information and user instructions.
1 ON
OFF
2
3
AED20
Battery
Release
on
other
side
ECG trace
Energy
Prompts
Log
E F
Icons Defib
Menu bar
ECG Trace (ECG or manual mode add-on option) ECG trace as a moving
waveform. If the defib pads are not properly attached to the
patient or connected to the unit, a dashed line is drawn.
Prompts Up to three lines of text (user instructions, directions for patient
care, error messages). See descriptions below.
Elapsed Time Time elapsed since the system was powered ON, or time used
on current patient. The time format is HH:MM:SS by default, but
can be changed by the user.
Energy (Manual Mode only) Temporary window when the Charge button
is pressed or a Shock Advised situation is detected. The selected
energy level is highlighted.
Heart Rate (ECG or Manual Mode add-on option) Heart rate (beats per
minute). A dashed line appears when the heart rate is out of
range or when a defibrillation pad fault exists.
Icons System status prompts, such as Charging and Energy Delivered.
Menu Bar Areas corresponding to four buttons on the case below the LCD.
Menu Selection Manual Mode or Supervisor Mode menu choices. (See
“Programming” on page 35.)
Text Prompts
Text prompts provide operating information and instructions. The prompts display in the
lower half of the LCD above the icon window.
NO SHOCK ADVISED System has analyzed the patient's heart rhythm and
determined that a shockable condition does not exist.
SHOCK ADVISED System has analyzed the patient's heart rhythm and
determined that a shockable condition exists.
SHOCK NOW Prepare to administer the shock.
STAND CLEAR Defibrillator is charged and ready for shock. Do not touch or
move the patient.
Voice Prompts
The defibrillator provides audio instructions through the built-in speaker to provide
operating instruction and assist the user during defibrillation. The voice prompts listed in
the following table parallel the text and icon displays shown on the LCD.
Analyzing heart rhythm. Defibrillator pads are properly attached and connected;
Do not touch the patient. assessing heart rhythm.
Analyzing interrupted. Patient or electrode moved; check the defibrillation pads.
Motion detected.
Check patient. Prompt to press the Analyze button.
Check airway, check (3-Shock mode) Check patient’s airway, breathing, and
breathing, check for responsiveness or signs of circulation.
responsiveness (check
circulation).
Apply defib pads to (at unit power up) Attach electrode pads to the patient and
patient’s bare chest. connect cables to the defibrillator.
Connect cable
If not breathing and (3-Shock mode) Check the patient for responsiveness or
unresponsive (if needed), signs of circulation and begin a 60-second CPR cycle.
begin CPR.
Apply defib pads. Defibrillator pads are not properly attached to the patient
Connect cable. or properly connected to the defibrillator.
Begin CPR. Begin CPR in accordance with the procedures and
techniques presented in your training.
Low battery. Low battery charge. Replace or recharge the battery.
Memory card full. Internal memory card is full.
No shock advised. A shockable condition does not exist.
Shock advised. A shockable condition exists.
Shock now. Press Push the red SHOCK button.
the red button now.
Stand clear. The defibrillator is charged and ready to shock. Do not
touch or move the patient.
Stop CPR. Stop CPR. Wait for further instructions.
It is safe to touch the The defibrillator shock has been delivered or a
patient. non-shockable condition was detected and it is safe to
touch the patient.
16 Introduction Welch Allyn AED 20 Automated External Defibrillator
Status Indicators
Optional auxiliary power unit is plugged in.
Aux
Battery is low.
LOW
Non-rechargeable battery.
Rechargeable battery.
CPR Timer
User-adjustable CPR Timer (seconds).
0 60
Log
Memory available for log entries.
E F
1 ON
OFF
2
3
AED20
Battery
Release
on
other
side
Do Not Use Battery is not properly installed or is too low for effective operation,
or some other system failure has occurred.
Event Documentation
The defibrillator stores event documentation including patient status, ECG traces, and
treatment summary. The information is stored in an internal log or an optional PCMCIA
external memory card. Event documentation is time stamped and can be downloaded to
a computer through the serial port on the defibrillator.
Quick Charger/Conditioner
Yellow (charging)
Yellow blinking (discharging)
Green (charging completed)
Red (battery fault, charge aborted)
The Welch Allyn Quick Charger/Conditioner is easy to use. The NiMH PowerStick is
inserted directly into the charger, and status lights indicate the condition of the battery.
1. Insert the battery into the charger. When the battery is firmly seated, the yellow Run
light illuminates.
2. Monitor the status lights. A steady yellow Run light means the battery is charging. A
red Fail light means that the battery is not charging due to a fault condition
The Run light will turn off and the green Ready light will turn on to indicate that the
battery is fully charged.
• Charging the battery at temperatures above 30 ºC (86 ºF) increases the charging
time and may result in a gradual decline in battery capacity.
• When removing a battery from the charger, always allow at least 3-5 seconds for
the system to reset prior to inserting another battery.
2. Press the conditioning button on the charger control panel within 5 seconds of
insertion. The yellow Run light blinks as the battery is being discharged.
At the end of the conditioning, the charger automatically begins a normal charge
cycle.
3. Monitor the charging light. The yellow Run light turns off and the green Ready light
turns on when the battery is fully charged.
User Manual Introduction 19
During storage, the defibrillator performs periodic self-tests including the functionality of
the unit and the status of the battery and internal circuitry. A more detailed test of the
unit's operation and battery status should be performed on a regular basis. See
“Maintenance” on page 55 for more information.
20 Introduction Welch Allyn AED 20 Automated External Defibrillator
21
3 Operation
This chapter provides information for using the defibrillator with a patient. It also provides
instructions for operating the defibrillator in automated or manual mode and the
procedures to follow after using the unit.
Overview
The defibrillator can operate in automated or in manual mode. In either, the operator must
be trained to use the unit and understand the indications and contraindications for use.
Trained Operators
The defibrillator is intended to treat patients in cardiopulmonary arrest. It is for use in
either in-hospital or out-of-hospital arrests. It is intended that the operator is authorized by
a physician/medical director, and has the following training skills:
Manual Mode
• American Heart Association Advanced Cardiac Life Support certification or equivalent.
Automated Mode
• American Heart Association Heartsaver course, American Red Cross CPR/AED
course or equivalent
Defibrillation is the delivery of a brief, high-energy pulse of electricity to the heart muscle
using a device called a defibrillator. Defibrillation restores the normal cardiac electrical
activity and allows the heart’s natural pacemaker areas to regain normal function.
The defibrillator, using direct current, applies a brief, high-energy pulse of electricity to the
heart to counteract fibrillation of the heart muscle and restore a normal heartbeat.
22 Operation Welch Allyn AED 20 Automated External Defibrillator
• Cardiac arrest
• Ventricular fibrillation
• Ventricular tachycardia
Indications
Before using the defibrillator, the patient should be assessed by a trained person (see
“Trained Operators” on page 21). If defibrillation with the defibrillator is indicated, all of
the following signs should be present during patient assessment:
• Unconsciousness
• Absence of breathing
• Unresponsiveness (no signs of circulation)
Contraindications
The defibrillator should NOT be used if the patient exhibits any of the following signs:
• Patient is conscious
• Patient is breathing
• Patient is responsive (has signs of circulation)
a. Push the green ON/OFF button located at the upper right corner of the
defibrillator next to the large number “1.”
b. Listen to voice prompts and read text instructions on the screen next to the large
number “2.”
c. If prompted press the red Shock button next to the large number “3.”
a. Push the green ON/OFF button located at the upper right corner of the
defibrillator next to the large number “1.”
b. Press the button below Manual to display the manual mode password screen.
c. Enter the numeric manual mode passcode. Press Enter to accept the passcode
and display the Manual Mode operating screen.
f. Press the red flashing Shock button next to the large number “3” to deliver the
shock.
Operating Procedures—Detail
1. Assess the patient.
• Unconscious
• Not breathing
Push the green ON/OFF button next to the large number “1” to power-on the
defibrillator.
The unit starts in Automated Mode. To operate the unit in Manual Mode:
24 Operation Welch Allyn AED 20 Automated External Defibrillator
a. Press the button below Manual on the status bar to display the manual mode
passcode screen.
b. Use the buttons below the arrows on the display to select the numeric passcode.
c. Press the button below Enter to accept the passcode and display the manual
mode operating screen.
c. Press the pads firmly to make sure they adhere securely to the chest.
WARNING Excessive body hair may affect the operation of the electrodes or
cause skin burns on the patient. Remove body hair as needed to ensure that the
electrode pads make proper contact with the patient's chest.
e. Peel off the backing from the electrode pad labelled RA. Place this pad just below
the patient’s right collar bone (sternum).
White (AHA)
Red (IEC)
RA electrode placement
Red (AHA)
Green (IEC)
LL electrode placement
f. Peel off the backing from the electrode pad labelled LL. Place this pad over the
ribs on the patient’s left side below the breast (apex).
g. Plug the pad connector into the defibrillator on the left side of the unit.
User Manual Operation 25
1 ON
OFF
AED20
Battery
Release
on
other
side
h. Check the battery level icon above the Menu bar on the display screen to make
sure there is sufficient power to charge the defibrillator.
1 ON
2
3
System ready status
AED20
Battery
Release
on
other
side
If pads are not properly applied or the cable is not properly connected to the
defibrillator, it will alert the user with text and voice.
i. Apply the pads to patient’s bare chest and connect the pads to the cable.
When the pads are properly applied and connected, the defibrillator announces,
and then analyzes the patient's heart rhythm to determine whether a shock is
indicated:
Caution Do not touch or move the patient while the defibrillator is analyzing the
heart rhythm.
If the condition is not shockable, the defibrillator alerts the user with text and voice:
No shock advised.
If a shockable condition is detected, the defibrillator will alert user with text and voice:
Shock advised.
To deliver a shock
1. Make sure the Shock button next to the large number “3” is flashing to indicate that
the unit is properly charged.
WARNING Make sure no one is touching the patient before you press the Shock
button. Loudly announce, “Stand back! Do not touch the patient.” Look down the
entire length of the patient to ensure there is no contact with a bystander or
conductive surface before pressing the Shock button.
Stand clear.
1 ON
OFF Shock
2
3
AED20
Battery
Release
on
other
side
The defibrillator does not allow the operator to charge or discharge the defibrillator unless
a shockable rhythm is detected while in automated mode.
After delivering a shock, the defibrillator will prompt for immediate CPR. (Note: In the 3-
shock cycle configuration, the defibrillator continues to analyze the heart rhythm and
determine whether additional shocks are indicated in 3-shock mode. In 1-shock mode, the
defibrillator will prompt for immediate CPR). The defibrillator is programmed for a
User Manual Operation 27
When the power is on the defibrillator starts in automated mode. It may be switched
to manual mode at anytime during the use in automated mode by pressing the
Manual button and entering a password. Press Enter to accept the manual mode
password. If the number is correct, the manual mode operating screen is displayed.
Log Log
E F E F
123
0 0 0 Enter
From the manual mode screen, the operator can Charge or Disarm the defibrillator
and adjust the energy level of the charge to be delivered.
Press the buttons under the up/down energy arrows to increase or decrease the
energy level of the charge. The energy charge levels available are: 2, 5, 7, 10, 20, 30,
50, 70, 100, 150, 200, 300, and 360 Joules. The energy level selected displays in the
lower right corner of the LCD.
Press the Charge button to charge the defibrillator. An intermittent tone sounds as the
defibrillator charges. A bar extends upward on the right side of the display until it
reaches the selected energy level. When the selected energy level is reached, a
steady tone sounds and the red Shock button flashes.
Charge time is approximately 8 seconds. The unit can deliver back-to-back shocks in
less than 30 seconds.
28 Operation Welch Allyn AED 20 Automated External Defibrillator
4. Deliver a shock.
a. Make sure the Shock button next to the large number “3” is flashing to indicate
that the unit is properly charged.
1 ON
OFF
Shock
2
3
AED20
Battery
Release
on
other
side
WARNING Make sure no one is touching the patient before you press the Shock
button. Loudly announce, “Stand back! Do not touch the patient.” Look down the
entire length of the patient to ensure there is no contact before pressing the
Shock button.
Defibrillator Disarm
If the defibrillator is charged and the Shock button is not pressed, the defibrillator must be
disarmed.
• In Manual Mode, the operator can disarm the defibrillator by pressing the Disarm
button.
User Manual Operation 29
The operator can press the ON/OFF button and turn off the unit.
Perform CPR
If the patient is unconscious, not breathing and unresponsive, when directed, perform
cardiopulmonary resuscitation in accordance with the procedures and techniques
presented in your CPR training. During the CPR cycle, the defibrillator will not assess the
patient’s heart rhythm unless the user presses the Analyze button to initiate an analysis
cycle.
At the end of the CPR Cycle (15, 30, 60, 90, 120, 150 or 180 seconds), the defibrillator will
prompt you to stop CPR and not touch the patient so it can assess the heart rhythm,
confirm its analysis, and determine if a shockable rhythm exists.
Stop CPR.
If the heart rhythm is not treatable with defibrillation, the defibrillator displays and
announces the message No Shock Advised in 1-Shock CPR mode. The defibrillator will
direct the user to perform a cycle of cardiopulmonary resuscitation.
No shock advised.
Begin CPR.
If a shockable rhythm is detected, the defibrillator will charge and prompt the user to
deliver a shock in 1-Shock CPR mode.
Shock advised.
Stand clear.
In 1-Shock CPR mode, the defibrillator behaves as if in 3-Shock CPR mode except every
shock will be followed by a CPR cycle.
EMS Mode
EMS mode is a feature specifically designed for use by an Emergency Medical Technician.
EMS mode is recommended when continuous defibrillator mode analysis is required
while transporting a patient or performing another procedure such as intubation. EMS
Mode is a supervisor selectable mode of operation that performs continuous background
analysis, but requires the user to press the Analyze button for full analysis in response to a
prompt from the defibrillator. The following section describes the operation and various
features of EMS mode.
When the defibrillator is powered on in EMS mode, it is automatically set to a Voice Off
mode. The defibrillator analyzes silently (without voice prompts) unless it detects a
shockable rhythm.
Monitoring ECG
Press to Analyze
Log
E F
If a shockable rhythm is detected, the screen changes and the defibrillator speaks and
displays CHECK PATIENT.
User Manual Operation 31
Check Patient
Press to Analyze
Log
E F
When the “CHECK PATIENT” prompt is spoken, verify that the patient is unconscious,
not breathing and unresponsive, and eliminate sources of motion artifact before pressing
the Analyze button to Enter Voice On mode. In Voice On mode, the defibrillator will issue
verbal prompts, fully analyze the patient’s heart rhythm and charge the defibrillator if
necessary. Follow normal defibrillator mode operating procedures in Voice On mode.
Note The Analyze button can be pressed at any time in EMS mode to perform a full
analysis of the patient’s heart rhythm.
Note The “Check Patient” prompt may be spoken in response to excessive motion
artifact or CPR. Eliminate sources of motion artifact before pressing the Analyze
button.
Electrode monitoring is recommended for use in manual mode for extended monitoring or
monitoring while in transport. When the electrode monitoring cable is attached, the
defibrillator analyzes the patient’s rhythm while in automated mode but does not charge
the defibrillator or allow the operator to deliver a shock.
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.
WARNING Always check the expiration date on defibrillation pads and do not
use pads if the packaging has been previously opened. The defibrillator may
interpret excessively dry defibrillation pads as an attached electrode monitoring
cable.
32 Operation Welch Allyn AED 20 Automated External Defibrillator
2. Properly prepare the patient's skin prior to attaching the electrodes. Clean the skin
sites with a coarse, dry terry cloth. Then, clean the skin with alcohol and allow to dry
completely before applying the electrodes.
3. Connect each lead of the electrode monitoring cable to the appropriate disposable
electrode. Arrange the electrodes as shown below. Attach an electrode to the
sternum (RA) area of chest and the other to the apex area (LL) of the chest.
Caution Do not use the electrode monitoring cable for Automatic Rhythm
Analysis due to the possibility of artifact. Proper skin preparation and the use of
fresh, high-quality monitoring electrodes are imperative to minimize artifact when
using the electrode monitoring cable.
White (AHA)
Red (IEC)
RA electrode placement
Red (AHA)
Green (IEC)
LL electrode placement
Monitor Only
Log
E F
When the operator presses the Charge button, an audible tone sounds and CHANGE TO
PADS flashes on the display.
User Manual Operation 33
Change to Pads
Log
E F
If the operator attempts to deliver a shock using the electrode monitoring cable, SHOCK
NOT DELIVERED displays on the screen and no energy is delivered to the patient.
Caution Do not replace the electrode monitoring cable with a substitute. Using
any other cable may cause burns to the patient.
Change to Pads
Log Monitor
E F Only
Manual Analyze Vol Menu
While the electrode monitoring cable is attached, the defibrillator analyzes the heart
rhythm only when the Analyze button is pressed. Do not move or touch the patient while
analyzing with the electrode monitoring cable. When the Analyze button is pressed, the
defibrillator begins an analysis cycle.
Press the Analyze button and the defibrillator speaks Analyzing and displays ANALYZING
and STAND CLEAR and goes through the analysis cycle.
i
If the result is a non-shockable waveform, the defibrillator sounds a double beep and
displays NO SHOCK ADVISED. If the result is a shockable waveform, the defibrillator
34 Operation Welch Allyn AED 20 Automated External Defibrillator
speaks Change to Pads, sounds 5 beeps, and displays CHANGE TO PADS, CHECK
PATIENT, IF NEEDED, BEGIN CPR.
i
The defibrillator continues to wait for the Analyze button to be pushed while in Automated
Mode. It does not allow the user to shock the patient with the monitoring cable attached.
Post-Use Procedures
After each use, the defibrillator should be inspected, cleaned, and a new supply of
electrode pads restocked to prepare the unit for its next use. Any event documentation
should be retrieved from the internal log or external memory card and printed.
Print or transfer the log information from the internal memory or the external memory
PCMCIA card. After data retrieval, clear the internal memory. Any error messages or
malfunctions should be reported and corrective actions taken before storing the unit for
reuse.
During storage, the defibrillator performs periodic self-tests including the functionality of
the unit and the status of the battery and internal circuitry. A more detailed test of the
unit's operation and battery status should be performed on a regular basis. See
“Maintenance” on page 55.
35
4 Programming
This chapter explains how to set the basic system operating options through the User
Menu (Automated or Manual Mode). It also provides information on accessing and setting
the advanced system operating options using the Supervisor Menu.
Caution Advanced system operating options, such as Manual Mode and EMS
Mode, are intended for use only by trained medical professionals. These options
should be selected only if defined by a Supervisor as part of the usage protocol
for this device.
36 Programming Welch Allyn AED 20 Automated External Defibrillator
Manual Mode
This menu appears at startup. If Manual Mode is purchased, “Manual”
appears in place of “Contrast” at startup.
Log Log
E F E F
Disarm
Log
Date
Time Menu items are accessible by
Settings pressing the Menu button.
Supervisor
EMS ON/OFF
Log
E F Menu
↑ ↓ Select Back
User Manual Programming 37
The defibrillator has the capability for certain menu buttons to auto repeat. Buttons with
more than one choice will auto repeat, and the up and down arrows will scroll through the
choices for a selection. To make a button auto-repeat, hold it down until the desired choice
is selected.
Self-Test Passed
Log
E F
4 Vol Menu
If the Manual Mode is purchased, MANUAL appears in place of the contrast menu on the
start-up screen.
When the defibrillator is powered up with the Manual Mode option installed, the
defibrillator performs a self test and the manual mode start-up screen displays.
38 Programming Welch Allyn AED 20 Automated External Defibrillator
Self-Test Passed
Log
E F
123
0 0 0 Enter
2. Press the button below the corresponding number to select that digit of the manual
mode passcode.
3. Repeat Step 2 for each digit of the passcode until the correct number displays.
4. Press Enter to accept the passcode. If the number is correct, the defibrillator enters
manual mode.
Log
Date
Time
User menu
Settings
Supervisor
EMS ON/OFF
Log
E F
↑ ↓ Select Back
User Menu
Use the two arrow buttons on the bottom menu to move from one menu selection to the
next. The selected menu item is highlighted by a black box. Push the Select button to
select the highlighted menu item.
Log
Date
Time
Settings
Supervisor
EMS ON/OFF
Log
E F
↑ ↓ Select Back
For each menu item selected, the corresponding option appears at the bottom of the
display. If Supervisor or EMS is selected, the user must enter the correct supervisor
passcode in order to enter the Supervisor Menu selection screen or to change the EMS
mode.
40 Programming Welch Allyn AED 20 Automated External Defibrillator
ON FF
O
1
2
3
20
D
E
A
ry
tte e
Ba leas
Re on r
he
ot de
si
Connect cable end with
FL
A SH
IN
G bead to the data port
E
US
T
NO
DO
Y
AD
RE
Note The Welch Allyn AED PC Data Transfer/Serial Communication Kit (002170-E or
002171-E) is required for this connection.
ECG or Text can be used to transfer data to a PC or the RS232 option with Welch Allyn
Smartlink software can be used for easy data archiving and playback.
1. Connect the Serial Communication Cable (551778) into the defibrillator serial data port
and the other end into the PC Data Transfer Adapter (520468).
2. Connect the PC Data Transfer Adapter to the 9-pin serial port on your PC.
3. Use the Terminal or Serial Communications program on the PC to set the port
settings to 57600 baud, N, 8, 1.
When the printer or PC is properly set up, turn on the output device and the defibrillator.
User Manual Programming 41
1. Access the User’s Menu. Select Log to display the Log menu bar.
Log
Clear Print Setup Back
3. Select Text, ECG 112, ECG A4 or ECG 8.5 and the appropriate serial port rate. Press
Back to return to the Log menu bar.
Note ECG 112 setting prints on 4 3/8” (112mm) continuous roll thermal paper. This
option is only supported for 112mm printers with a printing resolution of 8 dots/
mm and Seiko ESC/P printer command-language conformity. Use 38400 bps for
the Seiko DPU-3445-20A microprinter.
ECG A4 setting prints on A4 size paper (210mm x 297mm) printers with a printing
resolution of 300 dpi and HP PCL3-6 printer command language conformity.
ECG 8.5 setting prints on 8.5 x 11 inch paper (216mm x 279mm) printers with a
printing resolution of 300 dpi and HP PCL3-6 printer command language
conformity.
4. Press Print to print the log report. A steady printer icon replaces the log icon to
confirm printing. Stop printing by turning off the printer and pressing Stop.
Note A flashing printer icon indicates an error. Verify that the cable and adapter are
connected correctly and check that the printer is online and has paper.
The “No Shock Advised” chart message has been changed to also show the heart rate
with format “HR= nn.” If the heart rate is out of range, the format is “HR= ---.”
NAME:
Incident #:
System On 01/01/01 12:11:22
TOTAL EVENTS: 02
TOTAL SHOCKS: 02
ELAPSED TIME: 0:00:48
S/N: -1
SW Rev: 04.02.99 2/14/01
12:11:32 System On
12:11:34 Power Up Self Test
12:11:34 SELF TEST PASSED
12:11:34 Lead Connect
1 cm/mV
42 Programming Welch Allyn AED 20 Automated External Defibrillator
1. Access the User Menu. Select Date and display the Date menu bar.
Date
Month Day Year Save
2. Press the buttons below the month, date, and year to change the date displayed.
3. Press Save to enter the date displayed and return to the User Menu.
Note Setting the date will force a new patient into the entry log.
1. Access the User Menu. Select Time to display the Time menu bar.
Time
Hour Minute Save
2. Press the buttons below the hour and minute to change the time displayed.
3. Press Save to enter the time displayed and return to the User Menu.
Note Setting the time will force a new patient into the entry log.
1. Access the User Menu. Select Settings to display the Settings screen and menu bar.
Time
4 mm/dd/yy Vol Back
User Manual Programming 43
2. Press the contrast button to change the contrast of the LCD. The number next to
the contrast icon changes corresponding to increases in the contrast (1-9).
1. Access the User Menu. Select Settings to display the Settings screen and menu bar.
Settings
4 mm/dd/yy Vol Back
2. Press the Date Format button (mm/dd/yy) to change the date format used for printing
reports. The date format changes to one of six formats.
1. Access the User Menu. Select Settings to display the Settings screen and menu bar.
Settings
4 mm/dd/yy Vol Back
2. Press Vol to change the volume of the voice prompts through the speaker. The
indicator in the volume icon changes to one of four positions.
Log
Date
Time
Settings
Supervisor
EMS Enter Supervisor Code
0 0 0 Enter
1. Access the User Menu. Select EMS Off to display the Passcode Entry screen.
3. If the passcode is correct, the defibrillator reboots with EMS Mode ON.
Enter Settings
Supervisor Supervisor
Passcode
EMS ON/OFF
Setup Diag
Menu Menu
Manual CPR Shock Mode Back Prg AED Erase Info Back
Menu
Software Load Save Back
↓ ↑ Select Back
CPR Timr Tempo Back
AED Prgm
XX.XX.XX
↓ ↑ 120 Back SRAM
512 KB
↑ XX/XX/XX
↓ 100 Back
1-Shock CPR
3-Shock CPR
3-Shock Analyze
↓ ↑ Select Back
46 Programming Welch Allyn AED 20 Automated External Defibrillator
Supervisor Menu
This explains how to access the Supervisor Mode Menu and set the options available
through that menu.
2. Use the up and down arrows to choose Supervisor, and press Select.
Log
Date
Time
Settings
Supervisor
EMS ON/OFF
Log
E F
↑ ↓ Select Back
3. Enter the passcode and press Enter. The Supervisor menu appears.
123
0 0 0 Enter
Language
Protocol
Diag
Card
Setup
Upgrade
Code
Language Select text and audio language using the buttons below the Menu Bar.
(Restart the defibrillator to activate the language selected.)
Protocol Select the energy level protocol using the buttons below the Menu Bar.
Standard (default) protocol is 200J, 300J, and 360J (150J, 200J, 300J in
the UK).
Diag View software revisions/reset factory defaults.
User Manual Programming 47
Selecting a Language
The language used for text on icons, screen displays, and prompts as well as used for
voice prompts can be changed in the defibrillator.
1. Access the Supervisor Menu. Select Language and display the Language screen and
menu bar.
Language
English ↓ ↑ Save
3. Press Save to select the language displayed and return to the Supervisor Menu.
4. Restart the defibrillator to activate the language selected and change the screen text
and voice prompts.
1. Access the Supervisor Menu. Select Protocol and display the protocol menu bar.
Protocol
200 300 360 Save
3. Press Save to enter the charge displayed and return to the Supervisor Menu.
Using Supervisor > Language to select a different language no longer causes a change
in the energy protocol for any language. Before installing software from a PCMCIA card, it
is necessary to record the energy protocol setting, load the software and restore the
energy protocol setting if it is not the default.
Diagnostics
Use the diagnostics screen to view the installed versions of the software and restore
factory defaults.
1. Access the Supervisor Menu. Select Diag to display the Diagnostics screen and
menu bar.
Diag
SW Rev Cal Defaults Back
2. Press SW Rev to display the revisions of the current software for the motherboard
(xx.xx.xx), defibrillator (DEF:) and the power supply (PS).
Protocol
XX.XX.XX DEF: B PS: A Back
Note Pressing the leftmost button while the motherboard software revision is displayed
displays the FPGA device revision.
3. Press Back to return to the Diag menu. Press Back again to return to the Supervisor
Menu.
1. Access the Supervisor Menu. Select Diag. to display the Diagnostics Menu.
Diag
SW Rev Cal Defaults Back
Language
Prg AED Erase Info Back
Protocol
Diag AED PRGM
Card XX.XX.XX
Setup Software Load Save Back SRAM
Upgrade 512 KB
Code XX/XX/XX
↓ ↑ Select Back
1. Access the Supervisor Menu screen. Select Card to display the Card menu bar.
Card
Prg AED Erase Info Back
2. Press Info to view the size, type, contents, and format date.
1. Access the Supervisor Menu screen. Select Card to display the Card Menu bar.
4. Select Software.
5. Enter the Reprogram code and press Save. The defibrillator reprograms and reboots
with new software.
3. Insert a Memory Card with Write Protect off in the memory card slot.
Note After exiting the card menu, the card must be removed and reinserted before
collecting any data.
Setting Options
Use the Setup screen to access system options and parameters. From this screen:
• Enable or disable the ECG trace, audio prompts, and adjust the notch filter.
• Access the SAED menu to enable setting of the CPR timer, the Shock Mode and
SAED-Manual mode Main Menu button configuration.
50 Programming Welch Allyn AED 20 Automated External Defibrillator
Language
Options Unit ID SAED Back
Protocol
Diag
Card
Setup ECG OFF Audio ON 60 Hz Back
Upgrade
Code
↓ ↑ Select Back
1. Access the Supervisor Menu screen. Select Setup to display the setup menu bar.
3. Press ECG to toggle between ECG trace ON and ECG trace OFF.
Note This option appears only when ECG tracing has been purchased.
4. Press Aud ON to toggle between Audio Recording ON and Audio Recording OFF.
To set Unit ID
1. Access the Supervisor Menu screen. Select Setup to display the setup menu bar.
↓ ↑ Select Back
3. Press the up/down arrows to enter the code numbers of the Unit ID.
4. Press Save to save the number and return to the Setup screen.
1. Access the Supervisor Menu screen. Select Setup to display the Options setup
screen and menu bar.
2. Press SAED to display the SAED menu which presents the CPR selection.
3. Press CPR to display the CPR menu bar. Press CPR Tmr to display the CPR Timer
screen and menu bar.
User Manual Programming 51
↓ ↑ 60 Back
4. Press the up/down arrows to change the time displayed for the CPR Timer.
Note Values available are 15, 30, 60, 90, 120, 150, and 180 seconds.
5. Press Save to accept the time set and return to the CPR screen (Manual Mode only).
Note In Automated Mode, pressing Save resets the CPR Timer and restarts the
defibrillator.
Note Selection of a CPR Tempo option (other than Disable) provides an audible tone
that assists in regulating the tempo of compressions administered during CPR.
1. Access the Supervisor Menu screen. Select Setup to display the Options setup
screen and menu bar.
2. Press SAED to display the SAED menu which presents the CPR selection.
3. Press CPR to display the CPR menu bar. Press CPR Tempo to display the CPR Tempo
screen and menu bar.
↓ ↑ 90 Back
4. Press the up/down arrows to change the compressions per minute of the CPR
Tempo.
Note Values available are 90, 95, 100, 105, 110, 115, 120, (compressions per minute)
and Disable.
5. Press Save to accept the set CPR Tempo and return to the CPR screen.
1. Access the Supervisor Menu screen. Select Setup to display the Options setup
screen and menu bar.
2. Press SAED to display the SAED menu which presents the Shock Mode selection.
SAED
Manual CPR Shock Mode Back
52 Programming Welch Allyn AED 20 Automated External Defibrillator
3. Press Shock Mode to display the Shock Mode menu which presents the shock
variables.
1-Shock CPR
3-Shock CPR
3-Shock Analyze
Shock Mode
↓ ↑ Select Back
4. Use the up and down arrows to select either 1-Shock CPR, 3-Shock CPR or 3-Shock
Analyze and press select to make a selection.
To change a passcode
1. Access the Supervisor Menu. Select Code to display the Code setup menu bar.
Language
Protocol
Diag
Manual Supr Back
Card
Setup
Upgrade ↓ ↑ Select Back
Code
4. Press Save to accept the new passcode and return to the Code Menu.
User Manual Programming 53
1. Access the Supervisor Menu screen. Select Upgrade and display the Upgrade screen
and menu bar.
Language Biphasic +
Protocol ECG +
Diag Manual +
Card Review -
Setup
Upgrade
Code
↓ ↑ Select Back
↓ ↑ Select Save
Note A plus (+) indicates that an option is currently installed and a minus (-) indicates
that the option is not installed.
Note Each upgrade purchased has a unique upgrade password code that must be
entered before the upgrade can be installed on the defibrillator.
3. Press the up/down arrows to select each the upgrade passcode digit.
1. Access the Supervisor Menu screen. Select Setup to display the Setup screen and
menu bar.
2. Press SAED to display the SAED menu which presents the SAED-Manual mode Main
Menu configuration selection.
54 Programming Welch Allyn AED 20 Automated External Defibrillator
SAED
Manual CPR Shock Mode Back
3. Press the left button to toggle from “Manual” (default setting) to “Menu” to the
Contrast icon.
The default SAED-Manual mode Main Menu has “Manual” on the left and “Menu” on
the right. (Versions 07.01.01, 06.01.01, and later).
If the Supervisor > Setup > SAED > Manual/Menu/Contrast menu item is set to
“Menu,” then the Main menu has “Menu” on the left and “Manual” on the right:
If the Supervisor > Setup > SAED > Manual/Menu/Contrast menu item is set to “- -,”
then the Main Menu has “- -” on the left and “Manual” on the right. (Versions
05.XX.XX, 04.XX.XX, and earlier). If supervisors select this configuration, then entry
into Manual mode with a password is necessary to access any menu.
4 Vol Manual
SAED-Manual Mode Main Menu when the Contrast Icon is selected.
55
5 Maintenance
This section contains information on inspecting, maintaining, cleaning, and servicing the
defibrillator.
Inspection
To ensure the readiness and optimum working condition of the defibrillator, it should be
inspected and tested daily, weekly, or monthly, depending on the frequency of its use.
The checks outlined in the operator checklists should be planned according to the
inspection schedule outlined below. The goal is to maintain the defibrillator in an
operation-ready state.
Also check new pads or other accessories for compatibility with the defibrillator when
they are first received.
Scheduling Inspections
Inspect each defibrillator regularly to ensure that it is ready for service when needed. The
following table presents guidelines for determining an appropriate inspection schedule for
your defibrillators.
Note When powered by a non-rechargeable battery, the defibrillator must be used very
infrequently to prolong battery life.
Note If the defibrillator is used more than once per month, it is recommended that
authorized service personnel perform a periodic inspection servicing at least once
per year.
If the built-in sensors in the defibrillator detect a problem prior to or during operation, the
defibrillator provides a voice or screen prompt indicating the problem.
56 Maintenance Welch Allyn AED 20 Automated External Defibrillator
Note See the preparedness checklists later in this chapter for specific inspection
requirements.
If a defibrillator needs servicing, contact a Welch Allyn authorized service agent (see page
ii). Be prepared to provide the following information:
• Model
• Serial number
• Description of the problem
If the defibrillator needs to be returned for servicing, use the original shipping container. If
the shipping container is not available, please contact Welch Allyn (page ii) for packing
instructions prior to shipping so that the defibrillator is not damaged in shipping.
Note Information such as circuit diagrams, parts lists, descriptions, and calibration
procedures needed to aid in repairing components designated as field repairable
may be requested from Welch Allyn.
FDA Checklist
An important part of a successful maintenance program is the creation of a maintenance
log in which information is recorded on a regular basis. The log provides a:
• Record of the maintenance performed, who performed it, and when it was
completed.
Maintenance Schedule
Caution Improper maintenance may cause the defibrillator to malfunction.
Maintain the defibrillator as described in this manual.
Prepare a customized maintenance schedule for the defibrillator to reflect how the unit
will be used. The schedule should account for how often the defibrillator is used and
where it is used. In addition, the schedule should consider how familiar the operators are
with the operation of the defibrillator. Here are some guidelines for preparing a
maintenance schedule at your facility:
Battery Maintenance
Two types of batteries can power the defibrillator:
• Rechargeable NiMH (Nickel Metal Hydride) PowerStick battery for frequent use.
60 Maintenance Welch Allyn AED 20 Automated External Defibrillator
• Non-rechargeable Lithium PowerStick battery for standby use. This type of battery
cannot be recharged. The charger does not attempt to charge a non-rechargeable
battery.
• Place the charger in an area where air is allowed to circulate freely on all sides.
• Always charge stored batteries prior to use. Stored batteries lose charge and may
cause the defibrillator to fail without warning.
• Recharge a rechargeable battery until it is fully charged and the Ready light on the
charger indicates a solid green.
• Keep spare batteries in a Welch Allyn charger where their status can be quickly
determined. This is the most positive means of maintaining a fully charged
battery.
User Manual Maintenance 61
• Rotate spare batteries routinely. The charge level gradually diminishes in a battery
after it is removed from the charger.
Note Perform the capacity test with a fully charged rechargeable battery. Do NOT
perform this test on a non-rechargeable battery.
1. Connect a patient simulator or a defibrillator test load to the connector cable. Without
the simulated patient connection, the monitor automatically shuts off in ten minutes.
Turn on the monitor and note the starting time.
3. Note the time when the battery runs out. This duration of time relates to the current
battery capacity. A typical battery should provide at least 2.5 hours of monitoring time.
4. If the operating time is less than 2.5 hours, recharge the battery and repeat the test. If
the operating time remains less than 2.5 hours, remove the battery from service and
replace it.
Due to the critical nature of battery packs, replacement of the battery is recommended
every 24 months. Do not use the battery pack after the “Do Not use after: ________” date
labeled on the battery pack.
62 Maintenance Welch Allyn AED 20 Automated External Defibrillator
If the defibrillator or battery (NiMH or Li) is contaminated, this directive does not apply.
• Clean the defibrillator with the battery in place to keep liquids out of the battery
contact area. Make sure liquid does not get into the electrode pads connector or
the RJ45 connector.
• Use a soft cloth. Do not use abrasive materials, cleaners, or strong solvents such
as acetone or acetone-based cleaners.
Caution Do not immerse any portion of the defibrillator in water or other liquids.
Avoid spilling any liquids on the defibrillator or accessories. Liquids may damage
the defibrillator or present a fire or shock hazard.
The following are recommended cleaning agents for use on the exterior of the
defibrillator:
• Fantastik®
• Formula 409®
• Hydrogen peroxide solution
• INCIDIN®
• Liquid soap
• T.B.Q.®
• Warm water
• Wex-cide®
• Windex®
User Manual Maintenance 63
• Acetone
• Ammonia cleaner
• Benzene
• Butyl alcohol
• Denatured ethanol
• Enviroquat
• Ether
• Freon
• Glutaraldehyde
• Isopropyl alcohol
• Chlorine bleach solution
• Misty
• Staphene
• Trichloroethane, trichloroethylene
• Vesphene II
64 Maintenance Welch Allyn AED 20 Automated External Defibrillator
65
6 Troubleshooting
This chapter provides information on how to troubleshoot situations and conditions that
arise during the operation of the defibrillator and gives answers to frequently asked
questions.
Overview
If the built-in sensors in the defibrillator detect a problem before or during operation, the
unit provides a voice or screen prompt indicating the problem.
Use the information in the following tables to troubleshoot. The tables list fault indicators
and possible corrective actions.
Note In some situations, the operator will be instructed to change the battery or
defibrillation pads. It is important to always have spare batteries, PCMCIA cards,
and other accessories available.
Analyzing Interrupted
Indicator/Possible Cause Corrective Action
Defibrillator pad removed. Press defibrillation pad to firmly attach it to patient's skin. If
needed, replace the pad.
Electrical interference or radio transmissions. Remove possible sources of electrical or radio interference.
Electrical/radio frequency interference. Move hand-held communication devices or other suspected
devices away from the defibrillator.
66 Troubleshooting Welch Allyn AED 20 Automated External Defibrillator
Electrode disconnected from patient or defibrillator. Check the connection to the defibrillator.
Patient movement. Move patient to stable location when possible.
Patient motion (CPR, seizures, etc.). Stop patient motion if possible.
Transportation of the patient during vehicle motion. Stop patient movement or, if possible, stop vehicle
transportation during analysis.
Printing Problems
Indicator/Possible Cause Corrective Action
Flashing Printer Icon. Incorrect or broken adapter. Check adapter and baud rate settings.
Flashing Printer Icon. Incorrect or broken cable. Check or replace with correct cable.
Defibrillator will not print. Incompatible printer, printer is Check for Welch Allyn-approved printer. Put printer in on-line
off-line, or no paper. mode. Replace paper in tray.
Defibrillator prints unreadable characters. Incorrect baud Ensure adapter and defibrillator have matching baud rate
rate settings. settings.
Error Tone. Incorrect Log Setup selection. Select Text or ECG and the correct Baud Rate in the
Log>Setup Menu.
No Shock Delivered
Indicator/Possible Cause Corrective Action
Defibrillation pad connector not properly connected to Push pads connector firmly into the connector socket.
the socket.
Improper pad placement or pads touching each other. Check pad placement. Use the pictures on the pads to make
sure they are in correct location.
Pads, cable, or connector damaged. Replace pads.
Poor defibrillation pad contact with patient’s bare chest. Press pads firmly to patient’s bare chest.
Wipe moisture from chest and/or shave excessive hair from
chest.
Replace the pad, if needed.
Shock button not pressed within fixed time limit. Press Shock button within 30 seconds (Automated Mode) or
60 seconds (Manual Mode) after the ready message.
Electrode disconnected from patient or defibrillator. Check the connection to the defibrillator.
Electrode Monitoring Cable is attached. Connect defibrillator pads to defibrillator.
User Manual Troubleshooting 67
Defibrillator
Indicator/Possible Cause Corrective Action
Defibrillator operates, but LCD is too dark or too light. Adjust the contrast setting.
Defibrillator turns off or will not turn on. Reinstall or replace the battery.
Battery depleted or disconnected. Reinstall or replace the battery.
Displayed time or date is incorrect. Change the defibrillator time setting. Verify that time is
correct after a power ON/OFF cycle. If not, the internal 3V
battery may need to be replaced.
Electrical/radio frequency interference. Move hand-held communication devices or other suspected
devices away from the defibrillator.
Operating temperature is too low or too high. Operate the defibrillator between 0° to 50°C (32° to 122°F).
Battery
Indicator/Possible Cause Corrective Action
Defibrillator needs service. Replace battery. If condition is not corrected, contact
authorized service personnel.
Depleted battery. Replace battery. If condition is not corrected, contact
No display or messages after ON button is pushed. authorized service personnel.
Low battery charge. Replace the battery.
Battery not properly charged.
Operating time is short when using a rechargeable Recondition the battery and run the battery capacity test. If
battery. operating time is still short, replace the battery.
Other Problems
Indicator/Possible Cause Corrective Action
A fault requires service. Continue to use the defibrillator if it is possible and needed.
Contact authorized service personnel as soon as possible to
repair the defibrillator.
Defibrillator operates, but LCD is blank. Operate the defibrillator between 0° and 50 °C (32° and
Operating temperature is too low or too high. 122 °F).
LCD not operating properly. Contact authorized service personnel.
68 Troubleshooting Welch Allyn AED 20 Automated External Defibrillator
Do I select the energy level with successive shocks? No. The energy level is pre-set
when operating the defibrillator in Automated Mode. You can override the pre-set
levels in manual mode. (See “Operating Procedures—Detail” on page 23.)
What is the capacity of the battery? Battery capacity depends on the battery type and
how long the battery has been in storage. See “Specifications” on page 71 for battery
capacity specifications. When the unit is in storage, battery capacity will diminish over
time. The defibrillator continuously monitors and reports battery capacity while in
storage. The battery level status indicator alerts you when the battery needs to be
replaced.
69
A Glossary
AED Automated external defibrillator
defibrillation High energy pulse of electricity (shock) delivered to the heart muscle to
restore normal cardiac activity
defibrillation protocol Pre-set order and level of the shock energy delivered at
defibrillation (i.e. 150, 200, 300 J)
ECG Electrocardiogram
ECG trace Waveform displayed on the LCD representing the heart rhythm
fibrillation Rapid twitching movements that replace the normal rhythmic contraction of
the heart and may cause a lack of circulation and pulse
Manual AED Defibrillator mode that provides text and voice prompts and ECG tracing;
can be operated in manual mode
nonshockable rhythm Patient heart rhythms that are not a candidate for defibrillation
pulse
Primary AED Defibrillator mode that provides text and voice prompts; does not provide
ECG tracing
RF Radio frequency
RJ45 port Connector located in the front of the defibrillator case used to transfer data
from the log to a computer
Secondary AED Defibrillator mode that provides text and voice prompts and ECG tracing
shockable rhythm Abnormal heart rhythm which is a candidate for defibrillation pulse
B Specifications
Physical
Dimensions 9.4”L x 8.9”W x 3.3”H (23.9L x 22.6W x 8.4 H cm)
Weight Less than 5.4 pounds (2.45 kg) without battery
Operating temperature 32 ºF to 122 ºF (0 ºC to 50 ºC)
Storage temperature -22 ºF to 150 ºF (-30 ºC to 65 ºC)
(without battery)
Humidity Up to 95% (non-condensing)
Altitude -500 to 15,000 feet (-150 to 4570 m)
Shock Mil Std 810E method 516.4, procedure 1 (40G, 6-9 ms pulse, 1/2 sine each axis)
Vibration Mil Std 810E method 514.4, category 10 (minimum integrity test for helicopters)
Water resistance IEC 60529 IPX4
In-flight use Complies with RTCA/DO-160E, Section 21, Category M limits for radio frequency
interference
Data Management
Event documentation Internal and via Welch Allyn Datacard
Internal memory capacity 1MB: 75 4-sec ECG samples or 500 time-stamped events
Datacard capacity 4MB - 90 min of Continuous ECG
40 min of ECG and audio
8MB - 3 hrs of Continuous ECG
80 min of ECG and audio
16MB - 6 hrs of Continuous ECG
2.5 hrs of ECG and audio
Playback Welch Allyn PIC or Smartview
Quick report Treatment Summary, Event Log, Test Log
Datacard compatibility Compatible with Welch Allyn PIC Advance Life Support Defibrillator
Communication Serial port via RS-232 to PC and printer
72 Specifications Welch Allyn AED 20 Automated External Defibrillator
Defibrillator
Output Biphasic Truncated exponential
Energy sequence (user configurable) Shock 1: 150 J, 200 J
Shock 2: 150 J, 200 J, 300 J
Shock 3: 150 J, 200 J, 300 J, 360 J
Manual energy selection (J) 2, 5, 7, 10, 20, 30, 50, 70, 100, 150, 200, 300, 360
Automatic energy selection (J) 2, 5, 7, 10, 20, 30, 50, 70, 100, 150, 200, 300, 360
Manual lockout Via passcode
Charge time to maximum energy Frequent use: Less than 8 seconds with a fully charged battery; Less than 8
(manual operation) seconds with a battery depleted by 15 maximum-energy discharges.
Infrequent use: Less than 8 seconds with a battery depleted by six maximum-
energy discharges; Less than 8 seconds with a battery depleted by 15 maximum-
energy discharges.
Charge time to maximum energy from Frequent use: Less than 25 seconds with a battery depleted by 15 maximum-
initially switching power on, or from energy discharges.
within any operator programming Infrequent use: Less than 30 seconds with a battery depleted by six maximum-
mode (manual operation) energy discharges; Less than 35 seconds with a battery depleted by 15
maximum-energy discharges.
Charge time to maximum energy from Frequent use: Less than 30 seconds with a battery depleted by 15 maximum-
activation of the rhythm recognition energy discharges.
detector (AED operation) Infrequent use: Less than 35 seconds with a battery depleted by six maximum-
energy discharges; Less than 40 seconds with a battery depleted by 15
maximum-energy discharges.
Charge time to maximum energy from Frequent use: Less than 40 seconds with a battery depleted by 15 maximum-
initially switching power on, or from energy discharges.
within any operator programming Infrequent use: Less than 45 seconds with a battery depleted by six maximum-
mode (AED operation) energy discharges; Less than 50 seconds with a battery depleted by 15
maximum-energy discharges.
Analysis time 12 to 16 sec.
Audible prompts Minimum of 20 audible prompts
Visual prompts Minimum of 13 text screen prompts
Controls 2 buttons - On/Off, Discharge
4 software-configurable buttons
Waveform details The table below provides details of the biphasic truncated exponential waveform
delivered by the defibrillator when set to the maximum energy selection and
connected to resistive loads. The waveforms are characterized by typical values
for peak current (Ip), duration of the first output phase (tphase 1), and duration of
the second output phase (tphase 2). Values shown are accurate to within +15%.
Ip1
Phase 1
Phase 2
Ip2
User Manual Specifications 73
Energy Selectionsa
Test
Load 2 5 7 10 20 30 50 70 100 150 200 300 360
Display
Type 1/4 VGA Monochrome LCD
Size 5.7” (145 mm) diagonal
Resolution 320 x 240
Freq response 0.5 - 40 Hz
Heart rate 20 - 300 bpm, user-configurable
ECG input Via defib pads, isolated, type BF, defibrillator-proof
ECG sweep speed 25 mm/sec
Low battery indicator Battery Icon gauge on display with 10 capacity levels
Backlight (optional) EL backlight
74 Specifications Welch Allyn AED 20 Automated External Defibrillator
Battery
Rechargeable NiMH 12V, 2.1 Ah
Capacity 80 discharges at 360 Joules or
120 discharges at 200 Joules or
150 discharges at 150 Joules or
3 hours ECG monitoring
Charge time 1.5 - 2.5 hr
Non-rechargeable Lithium 12V, 5.2 Ah
Capacity AED Mode Manual Mode
200 discharges at 360 Joules or 150 discharges at 360 Joules or
285 discharges at 200 Joules or 215 discharges at 200 joules or
300 discharges at 150 Joules or 225 discharges at 150 Joules or
6 hours ECG monitoring 6 hours of ECG monitoring
Shelf life (25 ºC ± 15 ºC) 10 years (5 years storage + 5 years
standby)
5 years (standby after installation)
Capacity may be diminished at extremes of operating temperature.
User Manual Specifications 75
Electromagnetic Compatibility
Special precautions concerning electromagnetic compatibility (EMC) must be taken for all
medical electrical equipment. The AED 20 complies with IEC EN 60601-1-2:2001 and the
requirements of EN60601-2-4:2003.
• 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 AED 20
User Manual.
The defibrillator complies with all required standards for electromagnetic interference.
However, it is good practice to avoid using the defibrillator in extremely close proximity to
other equipment.
76 Specifications Welch Allyn AED 20 Automated External Defibrillator
Medical Electrical Equipment needs special precautions regarding EMC and needs to be
installed and put into service according to EMC information provided in this document.
User Manual Specifications 77
a. ESD ±4 kV air and ±2 kV contact allows no equipment change per EN60601-2-4:2003; follows normal EN60601-1-2:2001
criteria otherwise.
78 Specifications Welch Allyn AED 20 Automated External Defibrillator
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects, and people.
a. The ISM (industrial, scientific and medical) bands between 150 KHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567
MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
b. No unintended energy delivered at 20 V/m per EN60601-2-4:2003.
c. The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz are
intended to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently
brought into patient areas. For this reason, an additional factor of 10/3 is used in calculating the recommended separation distance
for transmitters in these frequency ranges.
d. Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless) telephones and land mobile radios, amateur
radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the defibrillator is used exceeds the applicable RF compliance level above, the defibrillator should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or
relocating the defibrillator.
e. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
User Manual Specifications 79
Performance
C Parts List
001829 Welch Allyn NiMH PowerStick - Rechargeable battery
001830 Welch Allyn PowerStick - Non-rechargeable battery
981125E Battery Charger, 1Bay (to be used with 001829)
900216 Welch Allyn AED Carrying Case
001855 Multipurpose Defibrillation Pads (10 pair / box)
002120 Welch Allyn AED PC Data Transfer / Serial Comm Kit
002170 AED 20 Serial Communication Kit with SmartLink Event
Reporting Software program
002171 AED 20 Serial Communication Kit with SmartLink Lite
Reporting Software program
002128 IEC Electrode Monitoring Cable
002130 AHA Electrode Monitoring Cable
001726 Welch Allyn multi-purpose electrodes
980136 Welch Allyn Cardiolog Datacard – 4 MB
980143 Welch Allyn AED Trainer
001910 Welch Allyn Smartview Software Review Program
980139 Welch Allyn Patient Simulator
002174 AED 20 Pediatric Energy Reducer (p/n 002172), carrying
pouch and instructions for use.
To purchase Welch Allyn accessories, contact your local Welch Allyn distributor (see
page ii).
82 Parts List Welch Allyn AED 20 Automated External Defibrillator
83
Study 1
Objective
To evaluate the MRL Orbital Biphasic waveform defibrillator against a monophasic
damped sinusoidal waveform defibrillator.
Methods
A canine model (n=5, 71±7 lbs) was used in a study that was approved by the Institutional
Animal Care and Use Committee. The animals were anesthetized with 20 mpk sodium
pentothal i.v., and maintained as required through an intravenous catheter in the foreleg.
The external jugular vein was cannulated and a bipolar pacing catheter was introduced
under fluoroscopic control and advanced into the right ventricle. The femoral artery was
cannulated and an intra-arterial line was placed for continuous measurement of arterial
blood pressure. The chest was shaved and defibrillating patch electrodes (R2 part number
3200-1715) were placed on the left and right chest walls.
Fibrillation was induced by delivering 60 Hz current to the right ventricular electrode. The
energy required to defibrillate was determined by a protocol that has been used in several
other biphasic comparison studies. An initial shock strength of 50 to 70 joules was used. If
successful, VF is reinduced after a 4-minute rest period, and the shock strength is
reduced by approximately 20% for the next defibrillation attempt. If the initial shock fails, a
rescue shock is delivered, and after a rest period, VF is again induced. The energy is now
84 Summary Of Studies Of Waveform Safety & Effectiveness Welch Allyn AED 20 Automated External Defibrillator
increased about 20% for the next defibrillation attempt. This procedure was continued
until at least 3 reversals in result were observed with each waveform. Two ED50
estimation procedures were run in parallel, with the device being used alternated on each
shock. In practice, actual clinical units were used, so the energy steps were limited to
those selectable on the devices tested.
Results
The study consisted of 82 total fibrillation/defibrillation episodes. ID50 peak currents and
ED50 delivered energies are shown below for each group. The mean impedance for these
animals was 62 Ω. The mean ED50 energies were compared and were found to be
significantly different. The significance of difference (p-value) was calculated by the Wald
test in each case, and is shown below. The mean ED50 peak current for the biphasic
waveform was 39 percent of that required with the MDS waveform.
Study 1 Conclusion
The MRL Orbital Biphasic waveform is capable of converting fibrillation episodes using
less energy than the MDS waveform, and requires lower peak currents than MDS
waveform defibrillators.
Study 2
Objective
Comparison of the defibrillation effectiveness of the MRL Orbital Biphasic waveform
defibrillator, with a commercially available Biphasic 2KV defibrillator capable of 360 J and a
monophasic truncated exponential defibrillator.
Methods
A canine model (n=6, 61.6 ± 5.5 lbs) was used in a study that was approved by the
Institutional Animal Care and Use Committee. The animals were anesthetized with an
intravenous injection of 20 mg/kg sodium pentothal. They were then intubated with a
cuffed endotracheal tube, and maintained on isoflurane gaseous anesthetic. The femoral
artery was cannulated and an intra-arterial line was placed for continuous measurement of
arterial blood pressure, and for acquiring samples for arterial blood gas and electrolyte
monitoring. The chest was shaved and adhesive defibrillating electrode pads were placed
on the left and right chest walls.
User Manual Summary Of Studies Of Waveform Safety & Effectiveness 85
Fibrillation was induced by delivering 60 Hz current to the external electrodes. The ED50
energy (that required to defibrillate with 50% probability) was determined by a protocol
modeled after that of Dixon. An initial shock strength of 30 joules was used, which was
applied after 15 seconds of ventricular fibrillation (VF). If successful, VF was re-induced
after a 4-minute rest period, and the shock strength was reduced by one energy step for
the next defibrillation attempt. If the initial shock failed, a rescue shock was delivered, and
after a rest period, VF was again induced. The energy was now increased one energy step
for the next defibrillation attempt. This procedure was continued until a nominal sample
size of six episodes was achieved (both sides of the first reversal in result, plus 4
episodes). Three ED50 estimation procedures were run in parallel, with the device being
used alternated on each shock. After each of the three independent ED50 estimation
procedures had been completed, the entire protocol was repeated twice more, each time
starting all devices at an energy of 30 joules. The ED50 peak current and energy was then
estimated for each animal by logistic regression analysis. Individual phase durations and
overall pulse durations were measured and recorded on each shock.
Results
The study consisted of 344 total fibrillation/defibrillation episodes. The mean ED50 and
ID50 estimates (to one decimal place) are shown below. The significance of difference (p-
value) was calculated by the Wald test in each case, and is shown below. Also shown are
the mean total durations measured for each device.
Study 2 Conclusion
The MRL Orbital Biphasic waveform was as effective as the Biphasic 2KV waveform, and
more effective than the monophasic waveform. While both biphasic waveforms required
less peak current than the monophasic waveform, the MRL OrbitalTM Biphasic waveform
required statistically less peak current than the 2 KV biphasic waveform defibrillator.
86 Summary Of Studies Of Waveform Safety & Effectiveness Welch Allyn AED 20 Automated External Defibrillator
Study 3
Objective
Comparison of the defibrillation effectiveness of the MRL Orbital Biphasic waveform
defibrillator, with a commercially available Biphasic 2KV defibrillator capable of 360 J in a
simulated higher impedance model.
Methods
A canine model (n=6, 53.7 ± 6.1 lbs) was used in a study that was approved by the
Institutional Animal Care and Use Committee. The animals were anesthetized with 20
mpk sodium pentothal i.v., and maintained as required through an intravenous catheter in
the foreleg. The femoral artery was cannulated and an intra-arterial line was placed for
continuous measurement of arterial blood pressure. The chest was shaved and
defibrillating patch electrodes were placed on the left and right chest walls.
Fibrillation was induced by delivering 60 Hz current to the chest electrodes. The energy
required to defibrillate was determined by a protocol that has been used in several other
biphasic comparison studies. An initial shock strength of 70 to 100 joules was used. If
successful, VF was re-induced after a 5 minute rest period, and the shock strength was
reduced by approximately 20% for the next defibrillation attempt. If the initial shock failed,
a rescue shock was delivered, and after a rest period, VF was again induced. The energy
was now increased about 20% for the next defibrillation attempt. This procedure was
continued until approximately 4 reversals in result were observed with each waveform.
Two ED50 estimation procedures were run in parallel, with the device being used
alternated on each shock. In practice, actual clinical units were used, so the energy steps
were limited to those selectable on the devices tested. The ED50 peak current and
energy was then estimated for each animal by logistic regression analysis.
This study simulated a higher impedance patient by having a 32-Ω resistor placed in series
with each subject.
Results
The study consisted of 98 total fibrillation/defibrillation episodes. The mean ED50 and ID
50 estimates for peak current and energy for each animal (to one decimal place) are
shown below. The significance of difference (p-value) was calculated by the Wald test in
each case, and is shown below. Also shown are the mean total durations measured for
each device.
Study 3 Conclusion
The MRL Orbital Biphasic waveform was as effective as the 2KV Biphasic waveform in
this model of a higher impedance patient. When these devices are compared on the basis
of peak current, the MRL Orbital Biphasic required less peak current than the 2KV
Biphasic waveform.
The reasons for conducting animal trials (as opposed to additional human clinical studies)
are:
1. Animal studies can use a much larger sample size (more shocks per subject), and
thus, result in far more accurate comparisons.
2. Animal studies do not place human subjects at risk from additional (and clinically
unneeded) shocks.
3. The animal hearts can be inspected for damage after the defibrillation studies.
• The data suggests that the MRL Orbital Biphasic waveform in the Welch Allyn AED 20
is at least as effective as, and may be more effective than, either of the two tested
monophasic waveforms, appearing to allow termination of fibrillation episodes using
lower energies.
• The MRL Orbital Biphasic waveform in the Welch Allyn AED 20 is as effective as the
2KV biphasic truncated exponential waveform in another commercially available
defibrillator.
• The MRL Orbital Biphasic waveform in the Welch Allyn AED 20 requires less peak
current to achieve defibrillation effectiveness than either of the two monophasic
waveforms or the 2KV biphasic truncated exponential waveform that is used in
another commercially available defibrillators.
88 Summary Of Studies Of Waveform Safety & Effectiveness Welch Allyn AED 20 Automated External Defibrillator