padz, stat-padz, ped i-pad z, RescueNet, Real CPR Help, Rectilinear Biphasic and ZOLL ar e trademarks or
registered trademarks of ZOLL Medical Corporation in the United States and/or other countr ies.
All other trademarks and registered trademarks are the property of their respective owners.
Ta b l e of Cont e n t s
PREFACE................................................................................................................................................................................................... V
SAFETY SUMMARY.................................................................................................................................................................................. VI
Cautions..................................................................................................................................................................................................... vii
Indications for Use................................................................................................................................................................................... vii
Contraindications for Use .....................................................................................................................................................................vii
Intended Users of the Device...............................................................................................................................................................vii
Tracking Requirements.......................................................................................................................................................................... viii
Notification of Adverse Events............................................................................................................................................................viii
Conventions............................................................................................................................................................................................. viii
Using the Fully Automatic AED Plus.....................................................................................................................................................1
Operating Controls and Indicators........................................................................................................................................................3
Using the Fully Automatic AED Plus Graphical User Interface ......................................................................................................5
Using the LCD Display .............................................................................................................................................................................9
Using the Passive Airway Support System (PASS) .......................................................................................................................... 10
Using Electrodes...................................................................................................................................................................................... 11
Applying pedi-padz II (Infant/Child Electrodes)................................................................................................................................ 13
Using the CPR Monitoring Function — Real CPR Help................................................................................................................ 13
Using the Audio Recording Option.................................................................................................................................................... 14
Inspecting the Unit.................................................................................................................................................................................. 15
Preparing the Fully Automatic AED Plus for Use............................................................................................................................ 15
Using the Self Test Feature................................................................................................................................................................... 16
Battery Installation Self Test ...................................................................................................................................................................................... 16
Power On Self Test ..................................................................................................................................................................................................... 17
Installing or Replacing Batteries........................................................................................................................................................... 18
Cleaning the Fully Automatic AED Plus ............................................................................................................................................ 22
Optional Maintenance for Technical Professionals......................................................................................................................... 23
International Customers............................................................................................................................................................................................. 25
Setting Up Data Communications....................................................................................................................................................... 26
Clinical Trial Results for the M Series Biphasic Waveform...........................................................................................................40
Randomized Multi-Center Clinical Trial for Defibrillation of Ventricular Fibrillation (VF) and Ventricular Tachycardia (VT) .......... 40
The Fully Automatic AED Plus® Administrator’s Guide is to be used by responsible medical
authorities in conjunction with the Fully Automatic AED Plus Operator’ s Guide (
The Fully Automatic AED Plus is to be used by trained rescuers to provide emergency defibrillation.
It incorporates a sequence of visual and voice prompts to help rescuers follow established AHA/ERC
Guidelines 2010 protocols for use of AEDs. It also incorporates recording/memory capabilities to
allow medical control authorities to review rescuer’s use of the device. Recording includes ECG
rhythms, event data, device identification, and optionally, voice recording of rescuer and ambient
sounds. This information is available via an upload capability to a personal computer for event review
and archiving.
Both the American Heart Association (AHA) and the European Resuscitation Council (ERC) publish
extensive information regarding the use of automatic external defibrillators and their relationship to
cardiopulmonary resuscitation. The following publications provide supplemental material to be used
in conjunction with the ZOLL Fully Automatic AED Plus Admin istrato r’s Guide and Operator’s Guide:
1. 2010 American Heart Association Guidelines for CPR and ECC; Supplement to Circulation,
2. European Resuscitation Council Guidelines for Resuscitation 2010; Resuscitation (2010) Volume
This guide provides information about the operation and care of the Fully Automatic AED Plus unit.
The administrator, and user should read each section carefully. Make sure to read the Safety Summary
section.
This guide is divided into six sections.
Preface - This page.
Safety Summary - Describes General Warnings and Cautions.
Introduction- Provides a general product overview of the Fully Automatic AED Plus.
Section 1 - Operation - Describes the functions of all controls and indicator lights of the Fully
Automatic AED Plus.
Section 2 - Installation, Self Test, Maintenance and Troubleshooting- Describes configuration of the
unit, data communications, troubleshooting, maintenance and how to order accessories and supplies.
Appendices - Provides the specifications of the Fully Automatic AED Plus, characteristics of the
ZOLL Rectilinear Biphasic™ waveform, and information on the ECG Analysis Algorithm Accuracy.
REF 9650-0310-01).
Volume 192, Issue 18, November 12, 2010.
81, October 2010.
Fully Automatic AED Plus Administrator’s Guidev
Safety Summar y
The following section describes general warnings and safety considerations for administrators, rescuers,
and patients.
Warn ing s
• Use the Fully Automatic AED Plus unit only as described in this manual. Improper use of the device
can cause death or injury.
• DO NOT use or place the Fully Automatic AED Plus unit in service until you have read the Fully
Automatic AED Plus Operator’s and Administrator’s Guides.
• DO NOT use or place the Fully Automatic AED Plus unit in service if the unit’s status indicator
window (located on the left side of the handle) displays a red “X”.
• DO NOT use or place the Fully Automatic AED Plus unit in service if the unit emits a beeping tone.
• Connect the electrode cable to the Fully Automatic AED Plus unit after installing batteries.
• Keep the electrode cable connected to the Fully Automatic AED Plus unit at all times.
• This device should only be used by properly trained individuals.
• Only use electrodes labeled “Infant/Child” on children less than 8 years old or weighing less than
55 lbs (25 kg). Use CPR-D-padz
• Always stand clear of victim when delivering a shock. Defibrillation energy delivered to the victim
may be conducted through the victim’s body and cause a lethal shock to those touching the victim.
• DO NOT TOUCH the electrode surfaces, the victim, or any conductive material touching the victim
during ECG analysis or defibrillation.
• Move victim away from electrically conductive surfaces prior to use of equipment.
• DO NOT use this unit near or within puddles of water.
• Keep the victim as motionless as possible during ECG analysis.
• DO NOT use this unit near flammable agents, such as gasoline, oxygen-rich atmospheres or
flammable anesthetics.
• Avoid radio frequency interference from high-power sources that might cause the defibrillator to
interpret cardiac rhythms incorrectly by turning off cell phones and 2 way-radios.
• Disconnect non-defibrillation protected electronic devices or equipment from victim before
defibrillation.
• Dry victim’s chest, if wet, before attaching electrodes.
• Apply freshly opened and undamaged electrodes, within the electrode expiration date, to clean and
dry skin to minimize burning.
• DO NOT place the electrodes directly over the victim’s implanted pacemaker. Pacemaker stimuli
may degrade the accuracy of ECG rhythm analyses or the pacemaker may be damaged by
defibrillator discharges.
• Check labeling inside the Fully Automatic AED Plus cover before using the cover as a Passive
Airway Support System (PASS) device. Ensure it is intended for this use.
• DO NOT use Passive Airway Support System (PASS) if there is a suspected head or neck injury.
Place victim on a firm surface before performing cardiopulmonary resuscitation.
• DO NOT recharge, disassemble, or dispose of batteries in fire. Batteries may explode, if mistreated.
• Do not use or stack the Fully Automatic AED Plus unit with other equipment. If the unit is used or
stacked with other equipment, verify proper operation prior to use.
®
if victim is older than 8 years or weighs more than 55 lbs (25 kg).
viFully Automatic AED Plus Administrator’s Guide
Cautions
• Do not disassemble the unit. A shock hazard exists. Refer all servicing to qualified personnel.
• Use only commercially available type 123A lithium manganese dioxide batteries. Discard batteries
properly after removal from unit. Use only batteries from recommended manufacturers.
• If the device is stored outside the recommended environmental conditions, the electrode pads and/
or batteries may be damaged or their useful life reduced.
• Safety and effectiveness data submitted by ZOLL Medical Corporation to the Food and Drug
Administration (FDA) under section 510(K) of the Medical Device Act to obtain approval to
market are based upon the use of ZOLL accessories such as disposable electrodes. The use of
electrodes from sources other than ZOLL is not recommended. ZOLL makes no representations or
warranties regarding the performance or effectiveness of its products when used in conjunction
with electrodes from other sources. If unit failure is attributable to the use of accessories not
manufactured by ZOLL, this may void ZOLL's warranty.
• The CPR-D-padz electrode can be connected to other ZOLL Defibrillators with Multifunction
Cables. Defibrillation can be administered when connecte d to ot her ZOLL Defibrillators. CPR
monitoring will only work if the device is configured to work with CPR-D-padz.
Indications for Use
Use the Fully Automatic AED Plus when a suspected cardiac arrest victim has an apparent LACK OF
CIRCULATION as indicated by:
• Unconsciousness; and
• Absence of normal breathing; and
• Absence of a pulse or signs of circulation.
When the victim is less than 8 years of age or weighs less than 55 lbs (25 kg), the Fully Automatic AED
Plus should be used with Fully Automatic AED Plus Pediatric Electrodes (pedi
should not be delayed to determine the victim’s exact age or weight.
-padz
®
II). Therapy
Contraindications for Use
Do NOT use the Fully Automatic AED Plus when the victim:
• Is conscious; or
• Is breathing; or
• Has a detectable pulse or other signs of circulation.
Intended Users of the Device
The ZOLL AED Plus Fully Automatic external defibrillator is intended to be used by responders who
have been trained and certified in CPR and the use of an AED to defibrillate victims of cardiac arrest.
The CPR monitoring function provides a metronome designed to encourage rescuers to perform chest
compressions at the AHA recommended rate of 100 compressions per minute. Voice and visual prompts
encourage a minimum compression depth of 2 inches for adult patients. The CPR monitoring function
is not intended for use on patients under 8 years of age.
Fully Automatic AED Plus Administrator’s Guidevii
Tracking Requirements
U.S Federal Law (21 CFR 821) requires the tracking of defibrillators. As an owner of this devi ce, you
have the responsibility under this law to notify ZOLL Medical Corporation if this product has been
received, lost, stolen or destroyed or has been donated, resold or otherwise distributed to a different
organization.
If any of the events described above occur, please contact ZOLL Medical Corporation in writing with the
following information:
1. Originator’s organization - Company Name, Address, Contact Name and Contact Phone Number.
2. Part Number/Model Number and Serial Number.
3. Disposition of Device (e.g. received, lost, stolen destroyed, distributed to another organization).
4. New Location and/or Organization (if different from #1 above) - Company Name, Address, Contact
Name and Contact Phone number.
5. Date change took effect.
Notification of Adverse Events
As a health care provider, you may have responsibilities under the Safe Medical Devices Act (SMDA)
for reporting to ZOLL and possibly to the FDA, the occurrence of certain events. These events, described
in 21 CFR Part 803, include device related death and serious injury or illness. In any event, as part of our
Quality Assurance Program, ZOLL should be notified of any device failures or malfunction. This
information is required to assure that ZOLL provides only the highest quality products.
Unpacking
• Carefully inspect each packing container for damage.
• Examine the unit for any signs of damage that may have occurred during shipping.
• If the contents are incomplete or damaged or if the unit fails to pass its self test as indicated by a Red
“X” in the status indicator window after battery installation, contact ZOLL Medical Corporation’s
Technical Service Department.
• Review the shipping list to insure that all items ordered were received.
Conventions
Throughout this document, voice prompts are indicated by capital italicized letters, such as
CALL FOR HELP.
WARNING! Warning statements describe conditions or actions that can result in personal
injury or death.
CAUTION! Caution statements describe conditions or actions that can result in damage to the
unit.
NOTE Notes contain additional information on using the defibrillator.
viiiFully Automatic AED Plus Administrator’s Guide
Symbols
Symbols used in this manual or on the equipment include the following:
Class II equipment
Defibrillation protected Type BF patient connection
ATTENTION: Refer to manual for more information
DANGEROUS VOLTAGE
Not new battery cells
New battery cells
Do Not push button
Push button
Do not use this manufacturer
Ok to use this manufacturer
Unit equipped to treat adult and pediatric victims
Manufacturer
Authorized representative in the European
Community
Serial Number
Catalogue number
Consult instructions for use
Fully Automatic AED Plus Administrator’s Guideix
x Fully Automatic AED Plus Administrator’s Guide
Introduction
Using the Fully Automatic AED Plus
The Fully Automatic AED Plus is an automatic external defibrillator (AED) that uses voice prompts
and visual indicators to guide the rescuer through a resuscitation sequence that may include
defibrillation and/or cardiopulmonary resuscitation (CPR). The unit incorporates the ZOLL
Rectilinear Biphasic Defibrillation waveform, and operates in either adult or pediatric mode.
The Fully Automatic AED Plus supports both adult and pediatric defib rillation electrode pads, and
automatically adjusts the defibrillation energy based on the type of electrode pads connected to it.
Following attachment of electrodes to a victim’s chest, the defibrillator monitors the
electrocardiographic (ECG) rhythm of the victim’s heart, analyzes that rhythm, and determines
whether the rhythm is shockable or non-shockable. When needed, defibrillat ion energy is delivered
automatically by the device without the user taking any action, through these same electrodes. When
the unit detects a shockable rhythm, it charges and issues the warning SHOCK WILL BE DELIVERED IN THREE (TWO), (ONE), followed by a loud shock tone. A shock is then delivered automatically by
the unit. The rescuer will then be prompted to perform CPR for a period of two minutes, after which
the unit automatically initiates a new ECG analysis.
Some versions of the Fully Automatic AED Plus include a cover that can also be used as a PASS
(Passive Airway Support System) to support the victim’s neck and shoulders in a position that assists
in maintaining an open airway . Some versions also contain disposable accessories (razor, barrier mask,
scissors, and a towel). The Fully Automatic AED Plus is powered by ten commercially available
consumer brand lithium-manganes e dioxide batteries.
The Fully Automatic AED Plus can:
• Perform periodic self tests to ensure its continual readiness.
• Use a one-piece electrode assembly (CPR-D-padz) that facilitates proper electrode placement and
that is easy to apply to the victim.
• Analyze heart rhythm and inform the rescuer if the rhythm is shockable or non-shockable.
• Deliver defibrillation treatment to victims of cardiac arrest who exhibit shockable ECG rhythms.
• Provide voice prompts and graphics to guide the rescuer regarding what to do and when to do it
during a cardiac emergency, such as calling for help or giving CPR to the victim.
• Provide audible beeps to encourage rescuers to provide CPR compressions at 100 CPM (requires
CPR-D-padz).
• Monitor the depth of chest compressions during CPR and provide voice prompts, if compression
depth is inadequate (requires CPR-D-padz).
• Provide a unit cover that functions as a Passive Airway Support System (P ASS). (Note the PASS
feature is standard with some versions of the product and optional with others.)
• Upload data from the defibrillator to a computer to store events or print event reports.
• Use commercially available batteries.
Fully Automatic AED Plus Administrator’s Guide1
Using Real CPR Help
The CPR-D-padz include a sensor that detects the rate and depth of CPR chest compressions. This
sensor is placed (as part of the electrodes application) on the victim’s chest so that it is located between
the rescuer’s hands and the victim’s lower sternum during chest compressions. When the rescuer
performs CPR compressions, the sensor detects their rate and depth and sends the information to the
Fully Automatic AED Plus unit. When used with CPR-D-padz, the Fully Automatic AED Plus
monitors the depth and rate of CPR chest compressions. It provides a CPR metronome function
designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of
100 compressions per minute (CPM) as well as voice and visual prompts to encourage a minimum
compression depth of 2 inches for adult victims.
WARNING! Real CPR Help is intended for use on adult victims only; do not use on victims
under 8 years of age.
The adaptive metronome function is disabled during periods when CPR should not be performed (for
example, during ECG analyses and defibrillation shock sequences). During periods when CPR may be
indicated, the metronome begins issuing audible beeps following detection of th e rescuer’s first few
compressions. The beeps continue automatically (at rates described below) until a few seconds after
chest compressions are halted by the rescuer or until the recommended “CPR period” ends (2 minutes
for AHA and ERC protocols). If the rescuer ceases chest compressions during the CPR period,
metronome beeps stop within a few seconds after compressions are halted. Audible beeps resume
during the CPR period following any re-initiation of CPR compressions. If no CPR compressions are
detected during “CPR periods”, the Fully Automatic AED Plus periodically re-issues the CONTINUE CPR prompt.
The rate of beeps issued by the Fully Automatic AED Plus adaptive metronome function adapts to the
rescuer’s actual chest compression rate. The metronome will beep at 100 CPM when chest
compressions are delivered at greater than 80 compressions per minute (CPM). Should the rescuer fail
to deliver compressions at 80 CPM or greater, the metronome will beep at a rate that is approximately
15 CPM higher than the rescuer’s actual rate. This increased metronome rate is intended to encourage
the rescuer to increase his/her chest compression rate until the recommended 100 CPM rate is achieved.
The metronome beeps at a minimum rate of 60 CPM in cases where the rescuer’s compression rate is
substantially below 60 CPM.
During CPR, the Fully Automatic AED Plus may issue one or more audible prompts based on the depth
of chest compressions detected. When Real CPR Help determines that compression depth is
consistently less than 2 inches, a PUSH HARDER prompt will be issued. A GOOD COMPRESSION
prompt will be issued if the rescuer responds by increasing compression depth to 2 inches or more.
The Fully Automatic AED Plus unit can be configured to display the FULLY RELEASE text prompt to
remind the user to lift the hands off the chest during CPR. By default, this text prompt is not enabled.
®
2Fully Automatic AED Plus Administrator’s Guide
Operation
Automatic
LCD Display (not supplied on
some units)
GraphicsIndicator Lights
Electrode Connector
Status
Indicator
Carrying Handle
IrDA Port (on side of unit)
Shock Indicator
Speaker (bottom)
Battery Compartment (bottom)
On/Off Button
This section describes the following functions:
• Operating Controls and Indicators
• Using the Fully Automatic AED Plus Graphical User Interface
• Voice Prompts
• Using the LCD Display
• Using the Passive Airway Support System (PASS)
• Using Electrodes
• Applying CPR-D-padz
• Applying pedi-padz II (Infant/Child Electrodes)
• Using the CPR Monitoring Function — Real CPR Help
• Using the Audio Recording Option
Operating Controls and Indicators
See Table 1: Control Functions for an explanation of each of these controls.
Figure 1: Identifying Operating Controls and Indicators
Fully Automatic AED Plus Administrator’s Guide3
Table 1: Control Function
Control/IndicatorDescription
ON/OFF Button Turns power ON or OFF.
When held depressed for > 5 seco nds ini tiates self test or data
communications.
If it is necessary to abort a shock when the unit is charged, pressing this
button will discharge the unit.
Indicator lightsIlluminates to indicate which step rescuer must take to treat a victim.
Shock IndicatorIlluminates when the Fully Automatic AED Plus is charged and in the
process of delivering a shock to the victim.
When the Fully Automatic AED Plus is not charged the lighted indicator is
extinguished.
PictogramsIcons that explain the series of steps needed for resuscitation and
defibrillation.
Status Indicator
Illuminated check mark indicates the unit passed its last self test and is ready
for use.
Illuminated “X” indicates unit has failed its self test and is not ready for use
LCD DisplayDisplays elapsed time, shock count, user prompts, CPR compression depths
and ECG waveforms.
IrDA Port™Provides a communications link between the defibrillator and a personal
computer or another IrDA equipped device.
PASS Cover
(optional)
Some Fully Automatic AED Plus models include a cover that may be used as
a shoulder support to aid victim airway management. The PASS can be
ordered separately for other Fully Automatic AED Plus models (see
“Ordering Accessories” on page 27).
Battery
Holds 10 123A lithium manganese dioxide batteries used to power the unit.
Compartment
Electrode ConnectorConnector for attaching electrodes to the Fully Automatic AED Plus.
SpeakerProvides audio prompts and metronome beeps that direct rescuers on what to
do during a rescue; also provides voice prompts to indicate if service is
required.
Microphone
(optional)
When voice recording option is installed, this microphone picks up and
records ambient sounds, including rescuer’s voice.
4Fully Automatic AED Plus Administrator’s Guide
Using the Fully Automatic AED Plus Graphical User
Interface
The Fully Automatic AED Plus graphical user interface (see Figure 2) is visible on the top of the unit
when the cover is removed. The pictograms are reminders of the steps to follow when performing a
rescue and reinforce instructions provided through voice prompts and optional display messages.
Each pictogram on the device is associated with an indicator light (LED) and voice prompts. This
combination draws attention to the graphics in a sequence defined by current protocols for use of an
Automated External Defibrillator (AED) by the AHA and ERC.
Figure 2: Graphical User Interface
The Fully Automatic AED Plus unit contains an LCD display (some special models do not have an
LCD) that displays elapsed time, number of shocks delivered, text messages corresponding to the
voice prompts, and depth of CPR compressions. The LCD can also be configured to display the
acquired ECG signals.
When the Fully Automatic AED Plus is turned on, the unit automatically initiates the sequence of
voice prompts and graphic illuminations for a rescue event. The sequence continues until the Fully
Automatic AED Plus is turned off or the electrodes are disconnected from the victim for an extended
period of time. As soon as electrodes are attached to the victim and impedance of the connection is
verified, the unit stops cycling through the above-mentioned voice and graphic illumination sequence
and automatically begins analysis of the ECG rhythm.
Following the results of this ECG analysis, voice prompts tell the rescuer whether a shockable or
non-shockable rhythm has been detected. If a shockable ECG rhythm is present, the graphics
illuminate and voice prompts automatically inform the user that a shock is about to be delivered. When
no shock is advised, the Fully Automatic AED Plus issues the audio prompts, NO SHOCK ADVISED
Fully Automatic AED Plus Administrator’s Guide5
and START CPR, and illuminates the CPR-related graphics. A period of 2 minutes (depending upon
device configuration) is then allowed for rescuer CPR. Following this “CPR period”, the Fully
Automatic AED Plus automatically re-initiates a new ECG rhythm analysis.
The Fully Automatic AED Plus automatically adjusts defibrillation energy to adult or pediatric levels
based on the type of electrodes attached to the unit. In its factory default configuration, the unit delivers
the first three shocks at 120J, 150J, and 200J respectively in adult mode, and at 50J, 70J, and 85J in
pediatric mode. However, the device can be configured to deliver shocks at other energy levels, as long
as the setting for each successive shock is the same or greater than the setting for the preceding shock.
Shocks are delivered automatically; the heart icon (and associated LED) located in the center of the
graphical user interface will light up, and the unit will emit a loud tone when a shock is delivered.
Consult the Fully Automatic AED Plus Operator’s Guide for more details on the graphics included in
the unit’s graphic interface, the audio prompts issued at each step in the treatment protocol and the
rescuer action associated with these audio and visual prompts.
Loss of contact between the electrodes and the victim interrupts ECG analysis and/or shock delivery
until the electrodes are re-attached and results in a CHECK ELECTRODE PADS prompt to the operator .
Voice Prompts
During clinical use of the Fully Automatic AED Plus, you may hear the following voice prompts.
Table 2: Clinical Voice Prompts
Voice PromptDefinition
UNIT OK.Fully Automatic AED Plus has successfully passed its power up
self tests.
UNIT FAILED.Fully Automatic AED Plus has failed its power up self tests and
is not usable for victim care.
CHANGE BATTERIES.Fully Automatic AED Plus self test has detected a low battery
condition that is insufficient for the device’s use for victim care.
Replace batteries immediately.
STAY CALM.Relax as much as possible and focus on the rescue effort.
CHECK RESPONSIVENESS.Check victim for responsiveness/consciousness by gently
shaking the victim and shouting “Are you all right?”.
CALL FOR HELP.Activate the EMS system or ask a bystander to do it for you.
OPEN AIRWAY.Place victim in the supine position and perform Head Tilt – Chin
Lift or Jaw – Thrust maneuver to open victim’s airway. (This
prompt is off by default.)
CHECK BREATHING.Look, listen or feel for the presence of breathing and/or airflow
from the victim’s lungs. (This prompt is off by default.)
GIVE TWO BREATHS.If victim is not breathing, give two rescue breaths. (This prompt
is off by default.)
PLUG IN CABLE.Ensure that the electrode cable is properly connected to the Fully
Automatic AED Plus electrode connector.
6Fully Automatic AED Plus Administrator’s Guide
Loading...
+ 36 hidden pages
You need points to download manuals.
1 point = 1 manual.
You can buy points or you can get point for every manual you upload.