| An Interactive HOW TO USE CD ROM (Comes with
the Purchase of a Packaged Unit)
Also see: Emergency
University
Highlights From Zoll's AED Plus User
Documentation
The ZOLL 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 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 and the European Resuscitation Council
publish extensive information regarding the use of automated
external defibrillators and their relationship to cardiopulmonary
resuscitation. See, for example, the following two publications:
Guidelines 2000 for Cardiopulmonary Resuscitation and Emergency
Cardiac Care, International Consensus on Science, Circulation.
2000;102, 8 and International Guidelines 2000 for CPR and ECC
A Consensus on Science, Resuscitation; 2000; 46, 1-3. Both
of these documents provide supplemental material to be used in
conjunction with this Guide and the Operating Instructions for
the ZOLL AED PLUS.
These instructions provide basic, limited information about
the operation and care of the AED unit. The administrator, and
user should read ALL MATERIALS SUPPLIED WITH THE UNIT AND DOWNLOADABLE
FROM Zoll Medical's Web Site http://Zoll.com. Make sure to read
the Safety Summary section. This guide is to be used in conjunction
with the ZOLL AED PLUS Operator's Guide (ZOLL p/n 9650-0300-01).
The following section describes general warnings and safety
considerations for administrators, rescuers, and patients.
Warnings
This device should only be used by properly trained individuals.
Defibrillation energy delivered to the patient may be conducted through the
patient's body and cause a lethal shock to those touching the patient. Always
stand clear of patient when delivering treatment.
DO NOT TOUCH the electrode surfaces, the patient, or any conductive material
touching the patient during ECG analysis or defibrillation.
Move patient away from electrically conductive surfaces prior to use of equipment.
DO NOT use the unit near or within puddles of water.
DO NOT use this unit on children less than 8 years of age.
Keep the patient as motionless as possible during ECG analysis.
DO NOT use the 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/or 2 way-radios.
Disconnect non-defibrillation protected electronic devices or equipment from
patient before defibrillation.
Dry patient's chest, if wet, before attaching electrodes.
Apply freshly opened and undamaged electrodes within the expiration date
to clean and dry skin to minimize burning.
DO NOT place the electrodes directly over the patient's implanted pacemaker
because pacemaker stimuli may degrade the accuracy of ECG rhythm analyses or
the pacemaker may be damaged by defibrillator discharges.
Check labeling inside the ZOLL AED PLUS cover before using the cover as a
Passive Airway Support (PASS) device. Ensure it is intended for this use.
DO NOT use Passive Airway Support System (PASS) if suspected head or neck
injury. Place patient on a firm surface before performing CPR.
DO NOT recharge, disassemble, or dispose of batteries in fire. Batteries
may explode, if mistreated.
The system should not be used adjacent to or stacked with other equipment.
If it is, verify proper operation prior to use.
Cautions
Do not disassemble the unit. A shock hazard exits. 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.
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 connected to
other ZOLL Defibrillators. The CPR function does not operate with any device
other than the AED PLUS.
Indications for Use Use the AED 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.
Contraindications for Use:
- Do NOT use the AED when the patient is:
- Conscious; or
- Breathing; or
- Has a detectable pulse or other signs of circulation.
The ZOLL AED PLUS is not indicated for use on patients under
8 years of age (Per AHA Guidelines 2000 for Cardiopulmonary Resuscitation
and Emergency Cardiovascular Care, I-64, 2000). Intended Users
of the Device
The ZOLL AED PLUS external defibrillator is intended to be used by personnel
who are qualified by training in the use of the AED PLUS, basic life support,
or advanced life support, or other physicianauthorized emergency medical response
to defibrillate victims of cardiac arrest. The CPR monitoring function provides
a metronome designed to encourage rescuers to perform chest compressions at
the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual
prompts encourage a compression depth of 1? - 2 inches for adult patients.
Tracking Requirements
U.S Federal Law (21 CFR 821) requires the tracking of defibrillators. As an
owner of this device, 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 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.
Introduction
Using the ZOLL AED PLUS
The ZOLL AED PLUS is an automated external defibrillator that uses voice prompts
and visual graphics to guide the rescuer through a resuscitation sequence
that may include defibrillation and/or cardiopulmonary resuscitation. It
incorporates the ZOLL Rectilinear Biphasic Defibrillation waveform. Following
attachment of electrodes to a patient's chest, the defibrillator monitors
the electrocardiographic (ECG) rhythm of the patient's heart, analyzes that
rhythm, and determines whether the rhythm is shockable or non-shockable.
When needed, defibrillation energy is also delivered through these same electrodes.
When the unit detects a shockable rhythm, it charges and issues the warning
DON'T TOUCH PATIENT, PRESS TREATMENT BUTTON. The rescuer presses the Treatment/Shock
Button to deliver the shock. If the patient remains in VF or shockable VT,
additional shocks can be administered after subsequent analyses of the patient's
heart rhythm. The rescuer may be prompted to perform CPR if the initial or
subsequent defibrillation attempts are unsuccessful.
Some versions of ZOLL AED PLUS include a cover that can also
be used as a PASS (Passive Airway Support System) to support
the patient'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
defibrillator is powered by ten commercially available consumer
brand lithiummanganese dioxide batteries.
The ZOLL AED PLUS can do the following:
Perform periodic self tests to ensure its continual readiness.
Use one piece electrode assembly that facilitates proper electrode placement
and that is easy to apply to the patient.
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 patient.
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 (PASS).
(Note the PASS feature is standard with some versions of the product and optional
with others.)
Upload data from the defibrillator to a PC to store events or print event
reports.
Use commercially available batteries.
Using the CPR Function
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 patient's chest so that it is located between the rescuer's hands
and the patient'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 ZOLL AED PLUS unit. When used with ZOLL CPR-D padz
the ZOLL 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 compression
depth of 1? - 2 inches for adult patients. The metronome function is disabled
during periods when CPR should not be performed (e.g. during ECG analyses
and defibrillation shock sequences). During periods when CPR may be indicated,
the metronome begins issuing audible beeps following detection of the 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 (1 minute for AHA protocols and
1-3 minutes for ERC protocols). If the rescuer ceases chest compressions
during the CPR period, metronome beeps will stop within a few seconds after
compressions are halted. Audible beeps will resume during the CPR period
following any re-initiation of CPR compressions. If no CPR compressions are
detected during CPR periods, the ZOLL AED PLUS will periodically reissue
IF NO CIRCULATION, CONTINUE CPR prompts.
The rate of beeps issued by the ZOLL AED PLUS 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 ZOLL AED PLUS may issue one or more audible
prompts based upon the depth of chest compressions detected.
When the CPR monitoring system determines that compression depth
is consistently less than 1? inches, a PUSH HARDER prompt will
be issued. A GOOD COMPRESSION prompt will be issued if the rescuer
responds by increasing compression depth to 1? inches or more.
Operation Overview
This section describes the following functions:
Operating Controls and Indicators
Using the AED Graphics
Using Voice Prompts
Using the LCD Display
Using the Passive Airway Support System (PASS)
Using Electrodes
Applying CPR-D padz
Using the CPR Monitoring Function
Using the Audio Recording Option
Identifying Operating Controls and
Indicators
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See Below for an explanation of each of
these controls.
Indicator Lights
Patient Connector
IrDA Port (on side of unit)
LCD Display (not supplied on some units)
Treatment Button
Microphone (hidden)
Battery Compartment (bottom)
Status
Indicator
Carrying Handle
Off/On Button
Speaker (bottom) |
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Control Function
Control/Indicator What it does:
ON/OFF Button Turns power ON or OFF.
- When held depressed for >5 seconds initiates self test
or data communications. Indicator Lights Illuminates to indicate
which step rescuer must take to treat a patient.
Treatment Button This button illuminates
when the AED is charged and ready to deliver treatment to the
patient.
- When pressed, causes the charged and ready defibrillator
to discharge its energy into the patient.
- When defibrillator is not charged the lighted button is extinguished.
- Pressing this button initiates a voice prompt that indicates
the number of defibrillator shocks delivered since the unit
was powered on.
Pictograms Icons Explain the series
of steps needed for resuscitation and defibrillation.
Status Indicator
- Illuminated Check 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 Display Displays 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 ZOLL AED
PLUS models include a cover that may be used as a shoulder support
to aid patient airway management. The PASS can be ordered separately
for other ZOLL AED PLUS models.
Battery Compartment Holds ten (10)
123A lithium manganese dioxide batteries used to power the unit.
Patient Connector Connector for attaching
electrodes to the AED.
Speaker Provides audio prompts and
metronome beeps that direct rescuers what to do during a resuscitation.
It 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.
Using the AED Graphics
The graphical user interface is revealed on the top of the unit when the cover
is removed. The graphics are reminders of the steps to follow when performing
a rescue and to reinforce instructions provided in the form of voice prompts
and optional display messages. The graphics incorporated on the device are
each combined with an indicator light (LED) and the listed voice prompts
to draw attention to the graphics in a sequence defined by current protocols
for use of an AED by the American Heart Association and the European Resuscitation
Council.
Graphical User Interface
The device contains an LCD display (some special models do not have an LCD)
that displays elapsed time, number of shocks delivered, text messages consistent
with the voice prompts, depth of CPR compressions, and can be configured
to display the acquired ECG signals. When the device is turned on, the sequence
of voice prompts and graphics illuminations are automatically initiated and
will continue until the device is turned off or the electrodes are disconnected
from the patient for an extended period of time. Analysis of the ECG rhythm
will occur after electrodes are attached to the patient and impedance of
the connection is verified.
Following the results of this ECG analysis, voice prompts tell
the rescuer whether a shockable or nonshockable rhythm has been
detected. If a shockable ECG rhythm is present, the graphics
illuminate and voice prompts guide the rescuer through the defibrillation
sequence. When no shock is advised, the AED issues the following
series of audio prompts: NO SHOCK ADVISED. OPEN AIRWAY. CHECK
BREATHING. CHECK CIRCULATION. IF NO CIRCULATION START CPR and
illuminates the CPR related graphics. A period of 1 3 minutes
(depending upon device configuration) is then provided for performing
rescuer CPR. Following this CPR period, the AED automatically
re-initiates additional ECG rhythm analyses.
In the continuing presence of a shockable ECG rhythm, the AED
is designed to perform up to three ECG analyses and stacked shocks
before it prompts the rescuer to initiate CPR. Shocks are delivered
by depressing the Treatment Button (indicated by the heart and
associated LED) located in the center of the graphic user interface.
Consult the ZOLL 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 expected rescuer response to these audio and visual prompts. Loss of
contact between the electrodes and the patient will interrupt ECG analysis
and/or shock delivery until the electrodes are re-attached and will result
in a CHECK ELECTRODE PADS prompt to the operator.
Using Voice Prompts
During clinical use of the ZOLL AED PLUS, you may hear the following voice
prompts.
UNIT OK. ZOLL AED PLUS has successfully
passed its power up self tests.
UNIT FAILED. ZOLL AED PLUS has failed
its power up self tests and is not usable for patient care.
DATA STORED. Clinical event data
recorded during a prior rescue attempt is still stored in memory
and has not been uploaded. This data will be overwritten by data
collected during the next clinical use of the ZOLL AED PLUS.
CHANGE BATTERIES. ZOLL AED PLUS power
up self test has detected a low battery condition inconsistent
with the device's use for patient care. Replace batteries immediately.
STAY CALM. Relax as much as possible
and focus on the rescue effort.
CHECK RESPONSIVENESS. Check patient
for responsiveness/consciousness by gently shaking the patient
and shouting Are you all right?.
CALL FOR HELP. Activate
the EMS system or get a bystander to do it for you.
OPEN AIRWAY. Place patient in the
supine position and perform Head Tilt - Chin Lift or Jaw Thrust
maneuver to open patient's airway.
CHECK BREATHING.
GIVE TWO BREATHS. Look, listen or
feel for the presence of breathing and/or airflow from the patient's
lungs. If patient is not breathing give two rescue breaths.
CHECK CIRCULATION. Check patient
for the presence of a pulse or other signs of circulation such
as normal breathing, movement or coughing.
PLUG IN CABLE. The electrode cable
is not properly connected to the AED patient connector.
ATTACH ELECTRODE PADS. Attach defibrillation
electrodes to the patient.
CHECK ELECTRODE PADS. Previously
attached electrodes are not making good contact with the patient's
skin or the electrodes are defective.
DON'T TOUCH PATIENT, ANALYZING. Don't
touch patient, an ECG rhythm analysis is in progress or about
to begin.
TREATMENT ADVISED. ECG rhythm analysis
has detected the presence of VF or shockable VT.
NO TREATMENT ADVISED. ECG rhythm analysis
has detected a rhythm that is not treatable by defibrillation.
ANALYSIS HALTED. KEEP PATIENT STILL. ECG
rhythm analysis has been halted due to the presence of excessive
ECG signal artifact. Halt any ongoing CPR and keep the patient
as motionless as possible.
DON'T TOUCH PATIENT.
PRESS TREATMENT BUTTON. Warn all
persons in attendance of the patient to stand clear and stop
touching the patient. Press the Treatment Button to deliver defibrillation
therapy.
RELEASE TREATMENT BUTTON. Treatment
Button was depressed before the defibrillator was ready to defibrillate.
Release the Treatment Button and press after the ready tone sounds.
TREATMENT DELIVERED. A defibrillation
shock has just been delivered to the patient.
NO TREATMENT DELIVERED. No treatment
(shock) was delivered to the patient because rescuer failed to
press Treatment Button or an error condition was detected.
# SHOCKS DELIVERED. A total of n
shocks have been delivered since the AED was turned on.
IF NO CIRCULATION, START CPR. Check patient for the presence
of a pulse or other signs of circulation. If no signs of circulation
are detected begin CPR. IF NO CIRCULATION, CONTINUE CPR. Continue
providing CPR. This prompt may also be issued if the ZOLL AED
PLUS CPR monitoring function fails to detect chest compressions
at least ? of an inch deep.
PUSH HARDER. CPR compressions are
consistently less than 1 ? inches deep.
GOOD COMPRESSIONS. After prompting
to Push Harder, rescuer has succeeded in delivering chest compressions
at least 1 ? inches deep.
STOP CPR. Stop CPR, the AED is about
to begin an ECG rhythm analysis.
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