Zoll Aed Pro Manual
Zoll Aed Pro Manual
Zoll Aed Pro Manual
Operator’s Guide
Appendix A Specifications
Device Specifications..........................................................................................................A-2
Battery Pack Specifications ................................................................................................A-4
Guidance and Manufacturer’s Declaration — Electromagnetic Emissions.........................A-5
Electromagnetic Immunity Declaration (EID) ..............................................................A-6
Rectilinear Biphasic Waveform Characteristics ..................................................................A-9
Clinical Trial Results for the M Series Biphasic Waveform ...............................................A-12
Randomized Multicenter Clinical Trial for Defibrillation of Ventricular Fibrillation (VF)
and Ventricular Tachycardia (VT) ...........................................................................A-12
ECG Analysis Algorithm Accuracy....................................................................................A-14
Index
Manual Updates
ZOLL Medical Corporation provides manual updates to inform customers of changes in device
information and use. Customers should carefully review each update to understand its
significance, and then file the update in its appropriate section within the manual for subsequent
reference.
Product documentation is available through the ZOLL website at www.zoll.com. From the
Products menu, choose Product Documentation.
Related Manuals
In addition to this manual, the following ZOLL publications provide information about this
product and related products and accessories:
REF Title
9650-0054-01 ZOLL Base PowerCharger 4x4 Operator’s Manual
9650-0120-01 ZOLL Base PowerCharger 1x1 Operator’s Manual
9651-0801-01 AED Pro Simulator Operator’s Guide
Conventions
This guide uses the following conventions:
Within text, the names and labels for physical buttons and softkeys appear in boldface type (for
example, “Press the Shock button or the DISARM softkey”).
This guide uses uppercase italics for audible prompts and for text messages displayed on the
screen (for example, DON’T TOUCH PATIENT, ANALYZING).
WARNING! Warning statements alert you to conditions or actions that can result in personal injury
or death.
Caution Caution statements alert you to conditions or actions that can result in damage to the unit.
Safety Considerations
All operators should review these safety considerations before placing the AED Pro unit into
service.
These operating instructions describe the functions and proper operation of the AED Pro unit.
This manual does not substitute for a formal training course. Operators must obtain formal
training from an appropriate authority before using this device for patient care.
Follow all recommended maintenance instructions. If a problem occurs, obtain service
immediately. Do not use the device until it has been inspected by appropriate personnel.
Do not disassemble the unit. A shock hazard exists. Refer all problems to authorized service
personnel.
The AED Pro unit is capable of delivering 200 joules. To completely deactivate the unit, turn it
off and remove the battery pack.
To manually disarm a charged (or charging) defibrillator, do one of the following:
• Turn the unit off for at least 3 seconds.
• Press the DISARM softkey (manual mode only).
For safety, the AED Pro unit automatically disarms a fully charged defibrillator after
60 seconds in manual mode or 30 seconds in semiautomatic mode if the Shock button is not
pressed.
General
Federal (U.S.A.) law restricts this device to use by or on the order of a physician.
Proper operation of the unit and correct electrode placement is critical to obtaining optimal
results. Operators must be thoroughly familiar with proper device operation.
The use of external defibrillation electrodes or adapter devices from sources other than ZOLL
is not recommended. ZOLL Medical Corporation makes no representations or warranties
regarding the performance or effectiveness of its products when used with defibrillation
electrodes or adapter devices from other sources. Device failures attributable to the use of
defibrillation electrodes or adapters not manufactured by ZOLL might void the warranty on the
ZOLL equipment.
This device is protected against interference from radio frequency emissions typical of the
two-way radios and cellular phones (digital and analog) used in emergency service or public
safety activities. You should assess the device’s performance in your typical operating
environment to determine the likelihood of radio frequency interference (RFI) from high-power
sources. Radio frequency interference can cause shifts in the monitor baseline, trace
compression, changes to brightness of the display, or transient spikes on the screen.
The AED Pro unit might not perform to specifications when stored at the upper or lower
extreme limits of storage temperature and then immediately put into use.
Do not use or stack the unit with other equipment. If the unit is used or stacked with other
electrical equipment, verify proper operation before using it.
Do not use or place the unit in service if it beeps while turned off.
Do not use or place the unit in service if the Ready indicator (at the upper right of the front
panel) shows a red “X”.
Defibrillation
Emergency defibrillation should be performed only by appropriately trained, skilled personnel
who are familiar with the operation of the equipment. The prescribing physician should
determine what training, such as Advanced Cardiac Life Support (ACLS) or Basic Life Support
(BLS) certification, is appropriate for operating this device.
ECG analysis
A patient must be motionless during ECG analysis. Do not touch the patient during analysis.
Cease all patient movement by stretcher or vehicle before beginning ECG analysis in
semiautomatic mode.
Battery care
Keep a fully charged spare battery pack with the device at all times.
When the unit displays the message CHANGE BATTERY, immediately replace the battery pack
with a fully charged one.
Regular use of a partially charged battery pack without fully recharging it between uses might
permanently reduce the battery’s capacity and result in early failure.
Regularly test rechargeable battery packs. A rechargeable battery pack that does not pass its test
could fail without warning.
Do not disassemble a battery pack or dispose of it in fire. Do not try to recharge a
nonrechargeable battery pack. If mistreated, a battery pack might explode.
Dispose of battery packs in accordance with federal, state, and local regulations. Battery packs
should be shipped to a reclamation facility for recovery of metal and plastic compounds as the
proper method of waste management.
Operator Safety
Do not use the unit near oxygen-rich atmospheres, flammable anesthetics, or other flammable
agents (such as gasoline).
Do not use the unit within standing water.
Before discharging the defibrillator, warn everyone to stand clear of the patient.
Do not discharge the defibrillator except as indicated in the instructions. Discharge the
defibrillator only when defibrillation pads are properly attached to the patient. Never discharge
the unit with the defibrillation pads shorted together or in open air.
Electrical shock
Before defibrillation, be sure to disconnect from the patient all electromedical equipment that is
not defibrillation-protected. Keep defibrillation electrodes away from all other equipment
attached to the patient and from metal objects in contact with the patient.
During defibrillation, do not touch the bed, the patient, conductive material, or any equipment
connected to the patient; a severe shock can result. To avoid hazardous pathways for the
defibrillation current, do not allow exposed portions of the patient's body to touch any metal
objects, such as a bed frame.
Accessory equipment
The use of accessory equipment that does not comply with the equivalent safety requirements
of the AED Pro device could reduce the level of safety of the resulting system. When selecting
accessory equipment, consider the following:
• Use of the accessory in the patient vicinity
• Evidence that the safety certification of the accessory has been performed in accordance
with the appropriate IEC (EN) 60601-1 and/or IEC (EN) 60601-1-1 harmonized national
standards.
Patient Safety
The AED Pro unit detects ECG electrical signals only and does not detect a pulse (effective
circulatory perfusion). Always verify pulse and heart rate by physical assessment of the patient.
Never assume that the display of a nonzero heart rate means that the patient has a pulse.
ECG rhythm analysis does not warn of patient asystole, which is not a shockable rhythm.
Implanted pacemakers
Do not place electrodes directly over an implanted pacemaker. Implanted pacemakers might
cause the heart rate meter or ECG rhythm analysis to count the pacemaker rate during incidents
of cardiac arrest or other arrhythmia. Carefully observe pacemaker patients. Check the patient's
pulse; do not rely solely on heart rate meters. Patient history and physical examination are
important factors in determining the presence of an implanted pacemaker.
Cautions
Do not sterilize the device or the ECG monitoring cable.
Do not immerse any part of the device into water.
Do not use ketones (such as MEK or acetone) on the device.
Avoid using abrasives (including paper towels) on the display screen and IrDA port.
Equipment
Before unpacking the AED Pro unit, carefully inspect each shipping container for damage. If
the container or cushioning material is damaged, keep it until you have checked the contents for
completeness, and the unit has been tested for mechanical and electrical integrity.
Examine the unit for any signs of damage that might have occurred during shipping. Review
the shipping list to ensure that you received all ordered items. If the contents are incomplete, if
there is mechanical damage, or if the device does not pass its electrical self-test (as indicated by
a red “X” in the Ready indicator after battery installation), contact the ZOLL Technical Service
Department or the nearest ZOLL authorized representative. If the shipping container is
damaged, notify the carrier also.
Symbol Description
Dangerous voltage.
Keep dry.
Temperature limitation.
Symbol Description
2%
$
45
,%!
2.
Contains lead. Recycle or dispose of properly.
2%#9#,%
0B 5(
1
,2
7
85
/L
5(&<&/(
/L,21
Do not crush.
Nonrechargeable battery.
Date of manufacture.
Use by.
Latex-free.
Do not reuse.
Symbol Description
Do not fold.
Not sterile.
Manufacturer.
Serial Number.
Catalogue number.
Fax: 1-978-421-0010
When requesting service, please provide the following information to the service
representative:
• Unit serial number
• Description of the problem
• Department using the equipment and name of the person to contact
• Purchase order to allow tracking of loan equipment
• Purchase order for a unit with an expired warranty
Defibrillation
Never use the AED Pro unit for defibrillation when the patient
• Is conscious, or
• Is breathing, or
• Has a detectable pulse or other sign of circulation.
CPR Monitoring
The CPR monitoring function is not intended for use on patients under 8 years of age.
Intended Users
In semiautomatic mode, the AED Pro unit is intended to be used by rescuers and emergency
care personnel who have completed training and certification requirements applicable to the
use of a defibrillator where the operator controls delivery of shocks to the patient.
In manual mode, the AED Pro unit is intended to be used only by qualified medical personnel
trained in Advanced Life Support skills.
In ECG monitoring mode, the AED Pro unit is intended to be used by personnel who are
qualified by training in the use of the AED Pro device, basic life and/or advanced life support,
or other physician-authorized emergency medical training.
Defibrillator Precautions
Inappropriate defibrillation of a patient (for example, with no malignant arrhythmia) can
precipitate ventricular fibrillation, asystole, or other dangerous types of arrhythmia.
Without proper application of electrode pads, defibrillation might be ineffective and cause
burns, particularly when repeated shocks are necessary. Erythema or hyperemia of the skin
under the defibrillation pads often occurs. This reddening effect, often enhanced along the
perimeter of the pad, should diminish substantially within 72 hours.
Product Overview
The AED Pro device provides the following clinical modes:
• Semiautomatic defibrillation with CPR monitoring
• Manual defibrillation
• ECG monitoring
To guide the operator through rescue protocols, the AED Pro unit issues instructions through
text messages displayed on its screen and by voice prompts played through a speaker.
This chapter introduces the AED Pro unit, and contains the following sections:
• “Defibrillation” on page 1-2
• “Semiautomatic Mode Defibrillation and CPR Monitoring” on page 1-2
• “Manual Mode Defibrillation” on page 1-3
• “ECG Monitoring” on page 1-3
• “Audio Recording” on page 1-4
• “Nonrescue Mode” on page 1-5
• “Standby State” on page 1-5
• “Automatic Shutoff” on page 1-5
• “Accessories” on page 1-6
• “The Front Panel” on page 1-7
Defibrillation
The AED Pro unit uses the ZOLL rectilinear biphasic waveform and ZOLL single-use
defibrillation electrode pads for defibrillation.
Escalating energy levels for the first three shocks are preconfigured into the unit for adult and
pediatric patients. (The unit selects the appropriate levels by detecting the type of defibrillation
electrode pads in use.) After the first three shocks, all subsequent shocks are delivered at the
same energy as the third shock.
The factory default energy levels in joules are as follows:
Defibrillation Modes
The AED Pro unit can be manufactured to run in one of three defibrillation modes:
• Semiautomatic Mode Defibrillation with CPR Monitoring
• Manual Mode Defibrillation
• Semiautomatic Mode Defibrillation with CPR Monitoring and Manual Mode Override
ECG Monitoring
The optional ECG monitoring mode provides ECG rhythm and heart rate display, as well as
performing background ECG analysis to detect shockable rhythms. If the AED Pro unit detects
a shockable rhythm during monitoring, it immediately alerts the rescuer through displayed and
voiced prompts; if defibrillation pads are attached, the unit automatically switches to
semiautomatic mode.
For ECG monitoring, you can use
• AED Pro-compatible defibrillation electrode pads
• Standard ECG electrodes (with an AED Pro ECG cable)
While ECG electrodes (not defibrillation electrode pads) are connected to the unit, the only
available mode is ECG monitoring.
All ECG monitoring is performed in the lead II configuration. The operator cannot select
another lead.
For more information, refer to Chapter 5, "ECG Monitoring Mode".
Audio Recording
When installed and enabled, the Audio Recording Option allows the AED Pro unit to record up
to 20 minutes of continuous audio and clinical event data during a rescue. (The AED Pro unit
can record and store at least 7 hours of clinical event data when the Audio Recording Option is
disabled.) The recorded audio data is synchronized to the clinical event data.
Note: The AED Pro unit records up to three minutes of audio data prior to electrode
placement.
The AED Pro unit can record and store data for only a single rescue when audio recording is
enabled -- when the electrode pads are placed on the patient, the unit deletes any stored data
(ECG, Audio, and Event data) and begins recording data from the current rescue.
When you start the AED Pro unit in Non-rescue Mode, it does not delete stored rescue data.
Nonrescue Mode
The AED Pro unit provides the following functions in nonrescue mode:
• Data transfer
• Device configuration
The following sections briefly describe these functions. For more information, refer to
Chapter 6, "Nonrescue Mode".
Data Transfer
The AED Pro unit includes nonvolatile memory, which automatically records
• Device history
• Clinical data
Stored information can be transferred to a remote device (such as a computer) through an IrDA
(infrared wireless) connection. The clinical data format is compatible with ZOLL RescueNet™
Code Review software, which can be used to review and analyze the patient data.
The unit retains the device history and clinical data even when powered off or when the battery
pack is removed. Clinical data is erased only when the device is powered on and electrodes are
attached to a new patient. If configured to do so, the unit can store data for more than one
patient.
Device Configuration
The AED Pro unit provides configurable settings that can be used to tailor the device for local
rescue protocols and procedures. Using the ZOLL Administration Software on a personal
computer, you can view or modify the unit’s configuration.
Standby State
When the unit is turned off with a good battery installed, the unit enters standby state. While in
standby, the unit periodically starts up automatically to perform a self-test, and then returns to
standby. The Ready indicator shows the result of the self-test. The frequency of self-tests while
the unit is in standby state is a configurable setting.
Automatic Shutoff
The unit automatically powers off if no patient connection is detected within 10 minutes
(configurable).
Accessories
The following related accessories and equipment are available.
Item REF
Adult CPR-D•padz electrodes
™ 8900-0800-01
Adult stat•padz II electrodes
® 8900-0801-01
Pediatric pedi•padz II electrodes
™ 8900-0810-01
ECG electrodes 8900-0003
AED Pro ECG cable
AAMI 8000-0838
IEC 8000-0839
Defibrillation analyzer (universal) adapter cable 8000-0804-01
Rechargeable PD 4410 battery pack
Standard 8004-0009
Smart 8004-0103-01
Smart Ready 8004-0104-01
Disposable sealed lithium manganese dioxide battery 8000-0860-01
pack
AED Pro carry bag
Soft case 8000-0810-01
Hard case 8000-0832-01
IrDA adapter for personal computer
USB 8000-0815
RS-232 8000-0816
Base PowerCharger™ 4x4 battery Charger/Tester with 8050-0002-01
AutoTest and three batteries
Base PowerCharger™ 4x4 battery Charger/Tester with 8050-0012-01
AutoTest (no batteries included)
Base PowerCharger™ 1x1 Autotest Charger without 8050-0022-01
battery
Base PowerCharger™ 1x1 Autotest Charger with 8050-0025-01
Smart Ready Battery
AED Pro simulator 8000-0829-01
AED Pro ZOLL Administration Software (ZAS) CD 9658-0800-01
Patient cable
connector
Display screen
Shock button
Microphone
On/Off button
(optional)
Ready
indicator
Speaker
Battery compartment
latch
Battery compartment
cover
ZM040001A
USB connector
(inside battery compartment)
ZM050001A
Feature Description
Shock button When the defibrillator is fully charged and ready, the Shock button
repeatedly flashes. To deliver a shock, press and hold the button.
On/Off button To start the unit, press this button and release it within 5 seconds.
To start the unit in nonrescue mode, press and hold this button for
more than 5 seconds.
To turn the unit off and place it in standby state, press and hold this
button for 1 second.
Ready indicator Shows the status of the unit, based on
its last self-test.
A green check indicates the unit is
ready for use.
A red “X” indicates the unit is not ready
ZM040010A for use.
IrDA port Provides a way to connect the unit to an external device for
transferring patient data, unit status information, or configuration
information.
Speaker Issues voice prompts and alerts.
Softkeys Directly below the display, two unlabeled buttons control various
functions depending on the operating mode. Labels for the softkeys
appear at the bottom of the display above each softkey to indicate
its function.
Patient cable connector Used for plugging in defibrillation electrodes or an AED Pro ECG
cable.
This connector is a defibrillator-proof type BF patient
connection.
USB connector (Reserved for future use — do not connect any equipment.)
With software support, provides a way to transfer data to an
external device.
Microphone (optional) Allows the AED Pro Unit to record audio rescue data. Only AED Pro
units that have been ordered with the Audio Recording Option have
a microphone installed.
Display Screen
The display screen shows the following items (depending on the activity in progress):
Elapsed time — Shows the total time (in hours, minutes, and seconds) since the unit was
turned on. The counter resets to 00:00:00 after 23 hours, 59 minutes, and 59 seconds, or when
the unit is turned off.
ECG size — Shows the amplitude scale for the displayed ECG in centimeters per millivolt
(cm/mV). The device adjusts the scale automatically.
Heart rate and heartbeat symbol — (Manual and ECG monitoring modes only) Shows the
current heart rate in beats per minute. The symbol flashes with each detected heartbeat.
Chest compression depth gauge— Shows the depth of chest compression during CPR when
ZOLL CPR-D•padz are connected. The bar extends downward as the depth of compression
increases, with scale marks representing 0, 1.5 inches, and 2 inches.
Softkey labels — Labels for the softkeys appear at the bottom of the display directly above
each softkey to indicate its function.
Text prompts and messages — In semiautomatic mode, text prompts guide the rescuer. In all
modes, messages alert the operator about problem conditions.
ECG rhythm — Displays the patient’s ECG.
Shock symbol and number of shocks delivered — Shows the number of shocks delivered
since the unit was powered on.
Current mode — Displays MANUAL in manual mode, or MONITOR in ECG monitoring
mode. No mode label appears in semiautomatic mode.
Figure 1-3 shows the layout of the screen and the location of the above items.
Shock symbol
1 00:03:45
MANUAL 142
ECG X0.5
ECG rhythm
Chest compression
depth gauge (with
CPR-D•padz only)
Text prompts
and messages
150 J SELECTED
When the unit displays the message CHANGE BATTERY, immediately replace the battery with
a fully charged battery pack.
WARNING! Do not use a rechargeable battery pack if the unit’s standby period will exceed 90 days.
Procedure
To install or replace a battery pack:
ZM040004A
ZM040004A
ZM040006A
6 Align the tab of the new battery with the The shape of the battery pack allows it to seat
finger access area on the left side of the itself properly.
battery compartment, then place the
battery into the compartment.
ZM040005A
ZM040007A
ZM040007A
Important: If you change the battery while the unit is in clinical use (that is, with a cable
connected), the unit automatically powers on in nonrescue mode and then shuts
down. Press and release the On/Off button to restart the unit.
WARNING! To ensure the availability of adequate power during an emergency, keep a fully charged
spare battery pack with the device at all times.
Whenever the unit issues the prompt CHANGE BATTERY, immediately replace the used
battery pack with a fully charged one to ensure continuous operation and to avoid unexpected
device shutdown. After removing a depleted rechargeable battery pack from the unit, recharge
the pack as soon as possible.
Procedure
To prepare an AED Pro unit for clinical use:
Step Action
1 Inspect all external surfaces of the unit to ensure that they are clean (with no fluid spills)
and free from structural damage, such as cracks and broken or missing parts.
2 Inspect the patient cable connector to ensure that the pins are not broken, bent, or missing.
3 Inspect all cables. Replace any item that is cut or frayed, or that has bent pins.
4 Install a fully charged battery pack that is appropriate for your application.
5 Ensure that you have an adequate supply of defibrillation and ECG electrodes.
6 Verify that the defibrillation electrodes have not expired and are not close to expiration.
7 Follow the instructions provided with the defibrillation electrodes to preconnect them to the
patient cable connector.
Note: If electrodes are not preconnected, the unit will fail its next self-test in standby state.
8 Press and release the On/Off button to turn on the unit and initiate a power-on self-test.
The message UNIT OK indicates that the battery pack and electrodes are properly
installed and that the unit is ready for service.
The message UNIT FAILED indicates that the unit is not ready for service.
9 Verify that the unit correctly detects the type of electrodes that are attached (with the
message ADULT PADS or PEDIATRIC PADS).
10 Press and hold the On/Off button for 1 second to turn off the unit.
11 Wait 2 minutes. Verify that the Ready indicator displays a green check, and that the unit
does not beep.
While the unit is in service, periodically check the Ready indicator to ensure that it displays a
green check and inspect the unit for physical damage.
Performing a Self-Test
The AED Pro unit performs automatic or manual self-tests to verify its integrity and readiness
for emergency use. These tests verify the following:
• Battery energy — Verifies that the battery energy is sufficient for at least two hours of
continuous monitoring and ten shocks at maximum energy.
• Defibrillation electrodes connection — Verifies that defibrillation electrodes are properly
preconnected to the unit.
• ECG circuitry — Verifies that the ECG signal acquisition and processing electronics are
functional.
• Defibrillator charge and discharge circuitry — Verifies that the defibrillator electronics are
functional and can charge and discharge at 2 joules.
• Microprocessor hardware and software — Verifies the proper function of the
microprocessor electronics and the integrity of the software.
• CPR circuitry and sensor — Verifies that the CPR monitoring and compression depth
detection are functional (when CPR-D•padz are attached).
• Audio circuitry — Verifies that the audio output circuitry is functional.
• Display — Verifies that the visual indicators are functional.
After the successful completion of the self-test, the Ready indicator
displays a green check, indicating that the unit is ready for use.
If the Ready indicator displays a red “X” after a self-test, the unit is not
ready for use and might be defective. Remove the unit from service
and consult the Troubleshooting chapter of this guide.
ZM040010A
Automatic Self-Tests
The unit performs a self-test whenever it is turned on or a battery pack is installed, or at
periodic intervals while in standby state. The interval for automatic self-tests in standby state is
a configurable setting; the default interval is one day. For more information, refer to
Appendix C, "Configurable Settings".
Manual Self-Test
You can manually initiate a self-test by pressing and holding the On/Off button for 5 seconds.
The unit illuminates the Shock button and issues voice and text messages so that you can verify
the visual and auditory output functions. In addition, the screen shows information about the
unit’s hardware and software.
00:00:18
VERSIONS
B:05.00 P:05.10 L:05.00
C:02.00 H:00.00
ZM040008A
The AED Pro unit supports both adult and pediatric electrode pads. The device adjusts
defibrillation energy to adult or pediatric levels depending on the type of electrodes connected
to it. Always use electrode pads that are appropriate for the patient.
WARNING! Do not use adult defibrillation electrode pads or CPR-D•padz on patients under 8 years
of age.
The electrode packaging allows you to connect the cable to the unit while the pads remain in a
sealed envelope.
• To prepare for future emergencies, after each use connect a new package of electrodes by
plugging the electrode cable into patient cable connector.
• To ensure that the electrodes are fresh and ready to use in an emergency, regularly check the
electrode expiration date on the preconnected electrode pack.
• Replace expired electrodes.
• After completing its power-on self-test, the unit issues a voice and text message to indicate
the type of electrodes that are connected (ADULT PADS or PEDIATRIC PADS). Verify that
the connected electrodes are appropriate for the patient. If necessary, replace the connected
electrodes with appropriate ones.
If the electrode cable is not properly connected to the unit, the unit issues the voice and text
prompt PLUG IN CABLE.
If the electrodes are not properly attached to the patient, the unit issues the voice and text
prompt CHECK DEFIB PADS or ATTACH DEFIB PADS TO PATIENT’S BARE CHEST.
Messages
While preparing the AED Pro unit for use, the following messages can be seen and/or heard:
Message Description
UNIT FAILED The unit failed its power-on self-test and is not usable
for patient care.
ADULT PADS The unit detected the specified type of electrode pads
and adjusted defibrillation energy settings accordingly.
PEDIATRIC PADS
POWERING OFF The On/Off button was pressed and held for 1 second
to turn the unit off.
Defibrillation electrode pads connect to the AED Pro unit through the patient cable connector.
Preconnect a set of electrode pads so that they are ready for use in an emergency.
WARNING! Do not open the sealed electrodes until immediately prior to use.
You can also use defibrillation electrode pads for ECG monitoring.
Before applying defibrillation electrode pads to the patient, be sure to
• Remove all clothing covering the patient’s chest.
• Clip or shave any excessive hair to ensure proper adhesion of the pads.
• Use alcohol to wash away any oil or dirt at the electrode site.
• Dry any moisture at the electrode site.
WARNING! Poor adherence or air pockets under the defibrillation electrode pads can lead to arcing,
skin burns, or reduced energy delivery.
For proper placement of electrodes for defibrillation, refer to the graphics on the electrode
packaging.
Check the expiration date on the defibrillation electrode packaging. Do not use expired pads.
Note: ZOLL electrodes contain no hazardous materials and may be disposed of in general
trash unless contaminated with pathogens. Use appropriate precautions when
disposing of contaminated electrodes.
WARNING! ZOLL CPR-D•padz are for adult patients only; do not use them on patients under
8 years of age.
Step Action
3 Hold the CPR sensor in place with your right hand, and
use your left hand to pull the number 2 tab and peel the
protective backing from the electrode.
Note: If the patient has an implanted pacemaker or
defibrillator in his/her upper right chest, angle
the electrode slightly to avoid placing it over the
device. Ensure that the CPR sensor remains
over the lower half of the breastbone.
Step Action
4 Hold the CPR sensor in place with your left hand, and
use your right hand to pull the number 3 tab and peel
the protective backing from the electrode.
WARNING! ZOLL stat•padz II electrodes are for adult patients only; do not use them on patients
under 8 years of age.
Step Action
For female
patients, place the
electrode under
the patient’s left
breast.
WARNING! ZOLL pedi•padz II electrodes are for pediatric patients only; these pads provide
defibrillation energy levels that might be inadequate for adult patients.
Procedure
To apply pedi•padz II defibrillation electrode pads:
Step Action
Semiautomatic Defibrillation
In semiautomatic mode, the AED Pro unit analyzes the patient’s ECG rhythm to determine
whether it is shockable or not. If a shock is needed, follow the text and voice prompts to
defibrillate the patient.
WARNING! During ECG analysis, do not touch or move the patient. If conveying the patient in a
vehicle or stretcher, cease all patient movement.
After three successive episodes of ECG analysis resulting in delivery of a shock, or after any
no-shock-advised result, the unit initiates a period of CPR.
Note: If the AED Pro unit is configured to use a one or two shock sequence, the unit initiates
a period of CPR after a single episode of ECG analysis and shock (one shock
sequence) or two successive episodes of ECG analysis and shock (two shock
sequence), or after a no-shock-advised result.
In semiautomatic mode, the screen shows the shock count, elapsed time, ECG size, ECG
rhythm, and text messages.
If CPR-D•padz are attached to the patient, the screen includes a chest compression gauge that
shows the depth of each chest compression as detected by the CPR sensor.
1 02:04:45
ECG X1.5
GOOD COMPRESSIONS
The rhythm recognition detector continues analyzing the ECG after detecting a
shockable rhythm and the defibrillator is charged and ready but will not bring the
unit into a state where defibrillation is prohibited.
Procedure
To defibrillate the patient in semiautomatic mode:
1 Press and release the On/Off button to turn On successful completion of the power-on
on the unit. self-test, the unit issues the voice and text
message:
UNIT OK
and then indicates the type of attached
electrodes.
If the defibrillation pads are not attached to
the patient, the unit issues the voice and
text prompt:
ATTACH DEFIB PADS TO PATIENT’S
BARE CHEST
2 If prompted, apply defibrillation electrode When the pads are properly attached to the
pads to the patient. patient, the unit issues the voice and text
message:
(Refer to “Applying Defibrillation Electrode
Pads” on page 3-2.) DON’T TOUCH PATIENT, ANALYZING
and then begins ECG analysis.
3 Allow the unit to analyze the patient’s ECG. The unit determines whether or not the
patient has a shockable rhythm and then
displays and voices its recommendation:
SHOCK ADVISED
or
NO SHOCK ADVISED
5 Wait for the defibrillator to charge. When fully charged, the unit emits a
charge-ready tone, repeatedly flashes the
Shock button, and issues the voice and
text prompts:
DON’T TOUCH PATIENT
PRESS FLASHING SHOCK BUTTON
WARNING! You have 30 seconds to perform the following step, otherwise the
defibrillator automatically disarms itself. (During the final 10 seconds, the
charge-ready tone sounds intermittently to indicate that time is expiring.)
6 Press and hold the Shock button until The unit delivers the shock and updates
treatment is delivered. the shock count.
Depending on the number of shocks that
have been delivered, the unit either
resumes ECG analysis or prompts you to
ZM040011A perform CPR.
7 Does the unit resume ECG analysis? When the unit resumes ECG analysis, it
displays the message:
— If NO, continue with step 8.
DON’T TOUCH PATIENT, ANALYZING
— If YES, return to step 3.
8 Follow the prompts to perform CPR, until The following prompts can appear:
directed to stop.
• OPEN AIRWAY
• CHECK BREATHING
• GIVE TWO BREATHS
• CHECK PULSE
• IF NO PULSE START CPR
At the end of the defined CPR period, the
unit displays the message:
STOP CPR
(CPR-D•padz only) After the first few chest Note: If CPR-D•padz are attached, the unit
compressions, the metronome begins also monitors the rate and depth of chest
beeping. Try to time each compression with compressions and can issue these related
the metronome beep. Check the on-screen voice and text prompts:
gauge to ensure that the compression depth • PUSH HARDER
is adequate. • GOOD COMPRESSIONS
In addition, if the unit does not detect chest
compressions, it issues the following voice
and text prompt every 15 seconds:
• IF NO PULSE CONTINUE CPR
9 When the unit resumes ECG analysis, return During ECG analysis, keep the patient
to step 3. motionless, and do not touch the patient.
Message Description
UNIT OK The unit successfully passed the power-on self-test.
UNIT FAILED The unit failed the power-on self-test and is not usable for
patient care.
CHANGE BATTERY The self-test detected a low energy condition that is insufficient
for patient care. Replace the battery pack immediately.
ADULT PADS The unit detected the specified type of electrode pads and
adjusted defibrillation energy settings accordingly.
PEDIATRIC PADS
PLUG IN CABLE The unit started up without an electrode cable plugged in. Plug
the cable into the unit.
ATTACH DEFIB PADS TO The unit does not detect attachment of the defibrillation
PATIENT’S BARE CHEST electrode pads to the patient.
Check the cable for damage.
Make sure that the pads are properly applied to the patient.
If this message continues, check the electrode sites to ensure
that they are clean, dry, and free of excess hair. Check the
expiration date on the electrode package.
CHECK PATIENT Check the patient for responsiveness or consciousness by
gently shaking the patient and shouting “Are you all right?”
CHECK PULSE Check the patient for a pulse or other signs of circulation, such
as normal breathing, movement, or coughing.
IF NO PULSE START CPR Indicates the beginning of a CPR period. If you cannot detect
the patient’s pulse or other signs of circulation, begin CPR.
STOP CPR Indicates the end of the CPR period. Discontinue CPR.
DON’T TOUCH PATIENT, Indicates the beginning of an ECG analysis period. Make sure
ANALYZING everyone stands clear of the patient. Keep the patient
motionless during ECG analysis.
NO SHOCK ADVISED ECG analysis did not detect a shockable rhythm.
Message Description
DON’T TOUCH PATIENT The unit is analyzing the patient’s ECG, charging the
defibrillator, or holding a charge. Do not touch the patient.
PRESS FLASHING SHOCK After detecting a shockable rhythm, the unit charged to the
BUTTON preselected energy level. Within 30 seconds, press the Shock
button to deliver a shock to the patient.
RELEASE SHOCK BUTTON The Shock button was depressed too soon. Wait until the unit
issues the prompt PRESS FLASHING SHOCK BUTTON.
CHECK DEFIB PADS The defibrillation electrode pads became disconnected.
Check the pads to ensure that they are properly applied to the
patient, and verify that the cable is undamaged and plugged
into the unit.
RELEASE LEFT SOFTKEY A softkey was pressed for more than 10 seconds. Release the
softkey.
or
RELEASE RIGHT SOFTKEY
ANALYSIS HALTED. KEEP ECG rhythm analysis halted due to excessive ECG signal
PATIENT STILL. artifact. Stop CPR, and keep the patient as motionless as
possible.
SHOCK DELIVERED A shock was delivered to the patient.
NO SHOCK DELIVERED No shock was delivered to the patient because the rescuer
failed to press the Shock button, or an error condition was
detected.
STAY CALM Relax as much as possible and focus on the rescue effort.
CALL FOR HELP Activate the local emergency medical services (EMS) system
or ask a bystander to do it for you.
OPEN AIRWAY Place the patient in the supine position and perform a head tilt,
chin lift, or jaw thrust to open the patient’s airway.
CHECK BREATHING Look, listen, or feel for signs of breathing or airflow from the
patient’s lungs.
GIVE TWO BREATHS If the patient is not breathing, give two rescue breaths.
IF NO PULSE CONTINUE CPR (Optional prompt) Perform CPR until directed to stop unless
you detect a pulse or other sign of circulation in the patient.
PUSH HARDER (With CPR-D•padz only) Apply more force so that chest
compressions are at least 1.5 inches (3.8 cm) deep. Observe
the compression indicator on the display screen.
GOOD COMPRESSIONS (With CPR-D•padz only) The unit detected proper chest
compression depth during CPR.
WARNING! During shock delivery, do not touch the patient or any other equipment connected to
the patient. A severe shock can result. To avoid unwanted pathways for defibrillation
current, do not allow exposed portions of the patient’s body to touch metal objects, such
as a bed frame.
In manual mode, the screen shows the shock count, elapsed time, mode (MANUAL), heart rate,
heartbeat symbol, ECG size, ECG rhythm, text messages, and the label CHARGE or
DISARM above the left softkey.
1 00:03:45
MANUAL 142
ECG X1.5
150 J SELECTED
CHARGE
Procedure
To override semiautomatic mode and begin manual mode:
1 Press and hold both (unlabeled) softkeys The MANUAL and SEMI-AUTO softkey
simultaneously for at least 3 seconds. labels appear.
2 To change to manual mode, press the The unit changes to manual mode, and
MANUAL softkey. displays the CHARGE softkey label.
Or to remain in semiautomatic mode, press
the SEMI-AUTO softkey.
Note: If you do not press either softkey
within 10 seconds, the unit reverts
to semiautomatic mode.
To return to semiautomatic mode after manual override, turn the unit off and then back on
again.
Manual Defibrillation
With manual defibrillation, you must evaluate the ECG rhythm to determine whether or not it is
shockable. If a shock is needed, you manually charge the defibrillator and then deliver a shock
to the patient.
Procedure
To manually defibrillate the patient:
1 Press the CHARGE softkey to begin The unit displays the message:
charging the defibrillator.
DON’T TOUCH PATIENT, CHARGING
If you need to disarm the defibrillator before
The CHARGE softkey label changes to
it reaches full charge, press the DISARM
DISARM.
softkey.
The charge-ready tone indicates that the
defibrillator is charged and ready. The Shock
button flashes repeatedly.
WARNING! You have 60 seconds to perform the following step, otherwise the
defibrillator automatically disarms itself. (During the final 10 seconds, the
charge-ready tone sounds intermittently to indicate that time is expiring.)
2 Press and hold the Shock button until The unit delivers the shock to the patient.
treatment is delivered.
The unit updates the shock count and shows
the energy level for the next shock:
XXX J SELECTED
ZM040011A
Message Description
CHECK PATIENT Evaluate the status of the patient. The unit detected
either a shockable rhythm or a low heart rate.
RELEASE SHOCK BUTTON The Shock button was pressed while the unit was
charging.
Do not press the Shock button until the unit emits the
charge-ready tone, and the button begins flashing.
RELEASE LEFT SOFTKEY A softkey was pressed for more than 10 seconds; the
unit automatically switched to semiautomatic mode.
or
Release the softkey.
RELEASE RIGHT SOFTKEY
In ECG monitoring mode, the screen shows the shock count, elapsed time, mode (MONITOR),
heart rate, heartbeat symbol, ECG size, ECG rhythm, and text messages.
If defibrillation electrode pads are in use, the label SEMI-AUTO appears above the right
softkey.
1 00:24:18
MONITOR 34
ECG X1.0
CHECK PATIENT
SEMI-AUTO
WARNING! An implanted pacemaker might cause the heart rate meter or ECG rhythm analysis to
count the pacemaker rate during incidents of cardiac arrest or other arrhythmia.
Carefully observe pacemaker patients. Check the patient's pulse; do not rely solely on
the heart rate meter. Patient history and physical examination are important in
determining the presence of an implanted pacemaker.
ZM048004A
F (green) LL (red) Between sixth and
seventh intercostal space
on the patient’s left
midclavicular line.
3-lead RA LA
configuration
(AHA)
LL
ZM048003A
Procedure
To apply ECG electrodes to the patient:
Step Action
ZM040030A
ZM040031A
ZM040032A
Step Action
ZM040030A
Procedure
To start and operate the unit in ECG monitoring mode:
2 Press and release the On/Off button to turn The unit starts up and the screen displays
on the unit. MONITOR as the current mode.
3 Allow the unit to monitor the patient’s ECG. If it detects a shockable rhythm while
monitoring, the unit issues the voice and text
prompts:
CHECK PATIENT
PLUG IN DEFIB CABLE
The latter message remains on screen until
defibrillation pads are attached.
If the detected heart rate is lower than the
configured minimum heart rate limit, the unit
issues the voice and text prompt:
CHECK PATIENT
This message remains on screen as long as
the patient’s heart rate is below the limit.
Procedure
To change from semiautomatic to ECG monitoring mode:
1 Press and hold the left (unlabeled) softkey The unit displays MONITOR as the current
for at least 5 seconds. mode, and the SEMI-AUTO softkey label
appears.
1 00:24:18
MONITOR 34
ECG X1.0
CHECK PATIENT
SEMI-AUTO
Message Description
PLUG IN DEFIB CABLE The unit detected a shockable rhythm while monitoring
the patient with ECG electrodes.
An ECG cable was plugged in, but the unit is not
configured for ECG monitoring.
Plug in the defibrillation cable.
CHECK ECG ELECTRODES Ensure that the ECG electrodes are properly attached
to the patient and that the cable is plugged into the unit.
CHECK DEFIB PADS Ensure that the defibrillation electrode pads are
properly attached to the patient and that the cable is
plugged into the unit.
ATTACH DEFIB PADS TO PATIENT’S The unit does not detect attachment of the defibrillation
BARE CHEST electrode pads to the patient.
Attach defibrillation pads to the patient.
The unit includes nonvolatile memory for storing device status and clinical event information.
You can retrieve stored data using a personal computer or personal digital assistant with ZOLL
RescueNet Code Review software through an IrDA connection with the AED Pro unit.
You can configure an AED Pro device using a personal computer with ZOLL Administration
Software (ZAS) through an IrDA connection with the device.
This chapter contains the following sections:
• “Entering Nonrescue Mode” on page 6-2
• “Data Storage” on page 6-3
• “ZOLL Administration Software” on page 6-4
• “Communicating with an External Device” on page 6-5
• “Device Configuration” on page 6-5
• “Messages in Nonrescue Mode” on page 6-6
Procedure
To place the AED Pro unit in nonrescue mode:
1 If the unit is on, press and hold the On/Off The unit powers off.
button for 1 second to turn off the unit.
Wait until the message POWERING OFF
disappears.
2 Press and hold the On/Off button for at If an IrDA connection is established with an
least 5 seconds. external device, the unit issues the voice and
text message:
NON-RESCUE MODE
Data Storage
The AED Pro unit stores device history and patient clinical data in nonvolatile memory.
The unit retains the device history and clinical data even when powered off or when the battery
pack is removed. Clinical data is erased only when the device is powered on and electrodes are
attached to a new patient. If configured to do so, the unit can store data for more than one
patient.
Device History
The AED Pro unit keeps a log of its status information, including:
• Unit model name
• Device serial number
• Hardware revision number
• Application software and boot code revision numbers
• Language file version number
• Total shocks delivered
• Battery life status (percentage of charge remaining)
• Ready indicator status
• Elapsed time since installation of the battery
• Date and results of last self-test
• Error log
To view device history, use ZOLL Administration Software.
For more information, refer to the RescueNet Code Review User’s Guide.
Device Configuration
The AED Pro unit provides configurable settings to suit the needs of your organization and its
medical protocols. Before putting the unit into service for the first time, the administrator
should inspect the factory settings and make any required adjustments.
Operators cannot adjust these settings while the unit is in clinical use.
For more information, refer to Appendix C, "Configurable Settings".
Message Description
COMMUNICATIONS The unit successfully contacted the external device.
ESTABLISHED
DATA DOWNLOAD COMPLETE Data transfer was successful.
DATA DOWNLOAD FAILED Data transfer halted because the external device detected
an error or the operator canceled transmission through the
communication program.
Check the communications package or utility on the external
device for the source of the error.
NON-RESCUE MODE The device is operating in nonrescue mode.
To ensure that the AED Pro unit is functioning properly and is ready for use in an emergency,
general maintenance procedures should be performed before putting the unit into service and
after each clinical use.
This chapter contains the following sections:
• “General Troubleshooting” on page 7-2
• “ECG Monitoring Troubleshooting” on page 7-4
• “Defibrillator Troubleshooting” on page 7-5
• “Cleaning the Unit” on page 7-6
• “Optional Maintenance for Technical Professionals” on page 7-7
If trouble persists after consulting this chapter, contact the appropriate technical personnel or
ZOLL Technical Service Department.
General Troubleshooting
Table 7-1 lists general issues with the unit and their associated corrective action.
Unit beeps or displays a red “X” while Turn the unit on. Follow the prompts to resolve the
turned off. problem.
If the unit continues to fail, take it out of service, and
contact ZOLL Technical Service.
Ready indicator shows a red “X” while the Turn the unit off and then on again. Follow the prompts
device is powered on. to resolve the problem.
If the unit continues to fail, take it out of service, and
contact ZOLL Technical Service.
Unexpected shutdown in clinical mode. Note: In clinical mode, the unit automatically powers
off if it does not detect a patient connection
within 10 minutes (configurable).
Turn the unit on. Follow the prompts to resolve the
problem.
If the unit continues to fail, take it out of service, and
contact ZOLL Technical Service.
Message: Release the Shock button. Wait until the unit issues the
RELEASE SHOCK BUTTON prompt PRESS FLASHING SHOCK BUTTON before
pressing the button.
Noisy ECG, artifact, or wandering Turn off nearby two-way radios and cell phones.
baseline.
Before attaching electrodes, properly prepare the
patient’s skin (refer to “Applying ECG Electrodes” on
page 5-4).
Check for proper adhesion of the electrodes to the
patient.
Arrange the cable and leads so that they do not pull
on the electrodes or swing excessively.
Poor ECG signal level. Replace the ECG electrodes, and change their
position on the patient.
Irregular heart rate. Observe the patient’s ECG. Verify that the irregular
heart rate is not caused by noise, low amplitude
R waves, extra-systoles, or arrhythmias.
Replace the ECG electrodes, and change their
position on the patient.
ECG data recording stops. If the unit is turned off and then turned on again within
10 seconds, ECG recording is interrupted.
Defibrillator Troubleshooting
Table 7-3 lists common issues with defibrillation and their associated corrective action.
Defibrillator does not charge. The patient’s ECG rhythm is not shockable because it
is not either ventricular fibrillation (VF) or wide complex
ventricular tachycardia (VT), or is VF with amplitude
less than 100 µV (semiautomatic mode only). Verify the
rhythm.
Confirm that the defibrillation cable is plugged in and
the pads are attached to the patient.
Install a fully charged battery pack.
Defibrillator takes more than 15 seconds Install a fully charged battery pack.
to charge.
Energy does not discharge when the A fully charged defibrillator automatically disarms itself
Shock button is pressed. after 60 seconds in manual mode or 30 seconds in
semiautomatic mode. Charge the defibrillator again,
and deliver the shock while the charge-ready tone
sounds.
The Shock button was pressed before the unit was fully
charged. Wait for the charge-ready tone and a flashing
Shock button before pressing and holding the Shock
button.
No apparent energy delivery to patient. Under certain circumstances, a patient might not
display a physical reaction when energy is delivered.
Replace the electrodes if they are dried out or expired.
Ensure that the electrodes are making proper contact
with the patient’s skin.
Test the defibrillator. (Refer to “Optional Maintenance
for Technical Professionals” on page 7-7.)
If the message CHECK DEFIB PADS appears, check
and correct the attachment or position of the
electrodes.
Required equipment
• AED Pro simulator (or equivalent)
Procedure
To test the unit:
Step Action
1 Connect the AED Pro simulator to the unit’s patient cable connector.
5 After the sequence of patient assessment prompts, verify that the unit does the following:
• Issues the voice and text prompt DON’T TOUCH PATIENT, ANALYZING.
• Analyzes the ECG rhythm.
• Issues the voice and text message SHOCK ADVISED.
• Charges the defibrillator.
• Issues the voice and text prompts DON’T TOUCH PATIENT and PRESS FLASHING
SHOCK BUTTON.
6 Verify that the AED Pro unit sounds the charge-ready tone and that the Shock button
flashes repeatedly.
7 Press the Shock button. Verify that the simulator indicates that a shock was delivered and
that the unit updates the displayed shock count.
Note: The simulator can verify the unit’s ability to deliver energy but cannot verify that the
correct energy was delivered. To verify the level of delivered energy, use a
defibrillator analyzer and universal adapter cable in place of the simulator.
8 Immediately after shock delivery, change the simulator to send a normal sinus rhythm
(NSR) to the AED Pro unit.
Step Action
9 Verify that the AED Pro unit performs a new rhythm analysis, resulting in the message NO
SHOCK ADVISED, followed by voice and text prompts such as:
OPEN AIRWAY
CHECK BREATHING
CHECK PULSE
IF NO PULSE START CPR
12 After approximately one minute of CPR, verify that the unit issues the voice and text prompt
STOP CPR.
13 Verify that the AED Pro unit begins a new ECG analysis.
15 Verify that the Ready indicator displays a green check before disconnecting the simulator
and attaching defibrillation electrode pads.
For instructions on placing the unit back into service, refer to “Preparing the Unit for Clinical
Use” on page 2-5.
Device Specifications
General
Size 3 in • 9.24 in • 9.4 in
(height • width • length) 7.62 cm • 23.47 cm • 23.88 cm
Weight 5.19 lb. (2.35 kg) without battery pack
5.97 lb. (2.70 kg) with nonrechargeable battery pack
Power Battery pack
Environmental
Temperature Operating: 0°C to 50°C
Storage and shipping: –30°C to 70°C
Humidity 10% to 95% relative humidity, noncondensing
Defibrillator
Waveform ZOLL rectilinear biphasic waveform
Energy selection Configurable preset energy levels for adult and pediatric patients in
three-shock stacks.
Charge time Less than 10 seconds with a new, fully charged battery; with depleted
battery packs, the charge time will be longer.
For the fifteenth discharge at maximum energy (200 joules), the
charge time is less than 10 seconds.
Charge hold time Semiautomatic mode: 30 seconds
Manual mode: 60 seconds
Energy display Display screen shows selected energy level (manual mode only).
ECG Monitoring
Input protection Fully defibrillation-protected.
Heart rate alert • Configurable low heart rate limit in the range 30 to 100 beats per
minute
• Off
Data Recording and Storage
Type Nonvolatile memory
Display Screen
Display type Liquid crystal display (LCD)
High resolution, 320 pixels by 240 pixels
Viewable area 2.27 in • 3.02 in
(height • width) 5.76 cm • 7.68 cm
Sweep speed 25 mm/s ±5%
Weight 1 kg
2.2 lb.
Nominal voltage 10 V
Weight 0.4 kg
0.9 lb.
Nominal voltage 12 V
The ZOLL AED Pro device is intended for use in the electromagnetic environment specified
below. The customer or operator should ensure that the device is used in such an environment.
Table A-1. EMC Specifications
Electromagnetic Environment –
Emissions Test Compliance
Guidance
RF emissions Group 1 The ZOLL AED Pro unit uses RF energy
for its internal function only. Therefore, its
CISPR 11
RF emissions are very low and are not
likely to cause any interference in nearby
electronic equipment.
RF emissions Class B
CISPR 11
Harmonic emission Not applicable
IEC 61000-3-2
Voltage fluctuations/ Not applicable
flicker emission
IEC 61000-3-3
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.
Notes
(1) At 80 MHz and 800 MHz, the higher frequency range applies.
(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. 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 or 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.
c. Field strengths from fixed transmitters, such as base stations for radio (cellular or 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
AED Pro unit is used exceeds the applicable RF compliance level above, the AED Pro unit should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the AED Pro unit.
d. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
Table A-3. Delivered Energy at Each Defibrillator Setting into a Range of Loads
Selected Energy
Load 50 J 70 J 85 J 120 J 150 J 200 J
25Ω 40 J 61 J 66 J 95 J 111 J 146 J
50Ω 51 J 80 J 85 J 124 J 144 J 183 J
75Ω 64 J 89 J 111 J 148 J 172 J 204 J
100Ω 62 J 86 J 108 J 147 J 171 J 201 J
125Ω 63 J 89 J 110 J 137 J 160 J 184 J
150Ω 67 J 93 J 116 J 127 J 148 J 168 J
175Ω 61 J 86 J 107 J 119 J 138 J 155 J
Accuracy ±15% ±15% ±15% ±15% ±15% ±15%
The AED Pro rectilinear biphasic waveform employs the same first and second phase timing,
similar first and second phase currents/voltages, and essentially the same mechanisms for
controlling defibrillation waveshape as the ZOLL M Series. The ZOLL M Series and AED Pro
defibrillation waveforms are considered substantially equivalent.
Figures A-1 through A-6 show the rectilinear biphasic waveforms that are produced when the
AED Pro defibrillator is discharged into loads of 25, 50, 75, 100, 125, 150, and 175 ohms at
each energy setting (200, 150, 120, 85, 70, and 50 joules).
The vertical axis shows the current in amperes (A); the horizontal axis shows the duration in
milliseconds (ms).
35 25Ω
50Ω
30 75Ω
100Ω
25
125Ω
20 150Ω
175Ω
15
10
5
A 0
-5
-10
-15
-20
-25
-30
0 2 4 6 8 10 12 14 16 18 20
ms
25Ω
30
50Ω
75Ω
25
100Ω
20 125Ω
150Ω
15 175Ω
10
A 0
-5
-10
-15
-20
-25
0 2 4 6 8 10 12 14 16 18 20
ms
25Ω
30
50Ω
75Ω
25
100Ω
125Ω
20
150Ω
175Ω
15
10
A 0
-5
-10
-15
-20
0 2 4 6 8 10 12 14 16 18 20
ms
25Ω
25
50Ω
75Ω
20 100Ω
125Ω
15 150Ω
175Ω
10
A 0
-5
-10
-15
-20
0 2 4 6 8 10 12 14 16 18 20
ms
25Ω
25
50Ω
75Ω
20 100Ω
125Ω
15 150Ω
175Ω
10
A 0
-5
-10
-15
-20
0 2 4 6 8 10 12 14 16 18 20
ms
25Ω
20
50Ω
75Ω
100Ω
15
125Ω
150Ω
10 175Ω
A 0
-5
-10
-15
0 2 4 6 8 10 12 14 16 18 20
ms
Monophasic Biphasic
First shock efficacy 93% 99%
p-value 0.0517
95% confidence interval –2.7% to 16.5%
90% confidence interval –1.01% to 15.3%
1. Kerber RE, et al., “Automated External Defibrillators for Public Access Defibrillation: Recommendations for Specifying and Reporting
Arrhythmia Analysis Algorithm Performance, Incorporating New Waveforms, and Enhancing Safety,” Circ J Am Heart Assoc.
1997;95:1677-1682.
“… the task force suggests that to demonstrate superiority of an alternative waveform over standard waveforms, the upper boundary
of the 90% confidence interval of the difference between standard and alternative waveforms must be <0% (ie, alternative is
greater than standard).”
Successful defibrillation with rectilinear biphasic shocks was achieved with 58% less delivered
current than with monophasic shocks (14±1 amperes versus 33±7 amperes, p=0.0001).
The difference in efficacy between the rectilinear biphasic and the monophasic shocks was
greater in patients with high transthoracic impedance (greater than 90 ohms). The first shock,
first induction efficacy of biphasic shocks was 100% versus 63% for monophasic shocks for
patients with high impedance (p=0.02, 95% confidence interval of the difference of –0.0217%
to 0.759% and 90% confidence interval of the difference of 0.037% to 0.706%).
Monophasic Biphasic
First shock efficacy 63% 100%
(high impedance patients)
p-value 0.02
95% confidence interval –0.0217% to 0.759%
90% confidence interval 0.037% to 0.706%
A single patient required a second biphasic shock at 150 joules to achieve 100% efficacy versus
six patients for whom monophasic shocks of up to 360 joules were required for 100% total
defibrillation efficacy.
Conclusion: The data demonstrate the equivalent efficacy of low energy rectilinear biphasic
shocks compared to standard high energy monophasic shocks for transthoracic defibrillation for
all patients at the 95% confidence level. The data also demonstrate the superior efficacy of low
energy rectilinear biphasic shocks compared to standard high energy monophasic shocks in
patients with high transthoracic impedance at the 90% confidence level. There were no unsafe
outcomes or adverse events due to the use of rectilinear biphasic waveform.
Intermediate 68
Fine VF 50 Report only 92.00% 82.62%
Other VT 18 Report only 88.89% 68.97%
Nonshockable Specificity
(155 patients)
NSR 208 >99% 100% (208/208) 98.6%
AF, SB, SVTa, heart block, 348 >95% 99.4% (346/348) 98.2%
idioventricular, PVCs
Asystole 29 >95% 100% (29/29) 90.2%
Intermediate
(16 patients)
Fine VF 0 Report only — —
Other VT 40 Report only 90% (36/40) 78.6%
a. 161 of the 348 abnormal rhythm records were SVT (72 patients). The SVT heart rates ranged
from 152 to 302 beats per minute.
Arrhythmia performance is reported according to the article, Kerber RE, Becker LB,
Bourland JD, Cummins RO, Hallstrom AP, Michos MB, Nichol G, Ornato JP, Thies WH,
White RD, Zuckerman BD. “Automated External Defibrillators for Public Access
Defibrillation: Recommendations for Specifying and Reporting Arrhythmia Analysis
Algorithm Performance, Incorporating New Waveforms, and Enhancing Safety,” Circ J Am
Heart Assoc. 1997;95:1677-1682.
References
Young KD, Lewis RJ. “What is confidence? Part 2: Detailed definition and determination of
confidence intervals”. Ann Emerg Med. September 1997;30:311-318.
Beyer WH. Percentage Points, F-Distribution Table. CRC Standard Mathematical Tables.
28th ed. Boca Raton, Fla: CRC Press; 1981:573.
WARNING! Regular use of a partially charged battery pack without a full recharge between uses
results in permanently reduced capacity and early failure of the battery pack.
Many factors contribute to the loss of battery capacity, including the frequency of use, the
number of battery packs available for operations, and the pattern of discharging and recharging
battery packs. Because of this, ZOLL recommends that operators schedule a preventive routine
for replacing and discarding used battery packs. Base your replacement schedule for
rechargeable battery packs on anticipated use patterns, battery pack testing results, and
experience with the device in actual operation.
When stored and not in use, a battery pack can lose 2% to 3% of its energy per month.
ZOLL recommends purchasing new batteries every eighteen months or sooner.
WARNING! Test battery packs regularly. A battery that does not pass its test might shut down
unexpectedly.
For information on using battery chargers, refer to the ZOLL Base PowerCharger manuals
listed in “Related Manuals” on page vi.
DO exercise or test battery packs every 90 days (or sooner as they age).
DO NOT assume that a shift check of the unit verifies adequate battery pack
run time.
Test the unit daily to verify its readiness for use. This test, however, does not verify adequate
charge state or capacity of the battery pack and might leave the unit with inadequate run time.
If the message CHANGE BATTERY appears during testing, replace the battery pack
immediately. If the removed battery pack is rechargeable, recharge it immediately.
Charge battery packs at or near normal room temperature (15°C to 35°C or 59°F to 95°F).
DO NOT remove a partially charged battery pack from the battery charger.
Always fully charge a battery pack before returning it to use. If you must use a partially charged
battery pack, be sure to fully charge the pack before its next use.
Continue CPR • On
When this option is checked (On), the prompt IF NO • Off — default
PULSE/CIRCULATION CONTINUE CPR is repeated
every 15 seconds during a CPR period if the unit does
not detect chest compressions (CPR-D•padz only).
UNIT OK • On — default
When this option is checked (On), the unit issues the • Off
message UNIT OK after a successful power-on
self-test.
D Equipment
accessory ix
Data general information xi
communications 6-5, 7-5 layout 1-7
device history and clinical event 6-1, 7-1, B-2 servicing xv
storage specifications A-3 warranty xiv
Defibrillation Escalating energy levels 1-2
manual mode 1-3, 4-4 Events, adverse xiii
semiautomatic mode 1-2, 3-8
Defibrillation pads
applying 3-3, 3-6, 3-7 F
disposing 3-2
ECG monitoring 5-7 FDA tracking requirements xiii
preconnecting 2-7 Front panel 1-7
Defibrillator
implanted 3-3
intended use xvi H
output energy xvii
precautions xvii Heart rate 1-9, B-4
specifications A-2 Heartbeat indicator 1-9
Device History data 1-5, 6-1, 7-1
communications 6-5, 7-5 Hold time, defibrillator charge 3-10, 4-4, A-2
configuration 6-5, 7-5, B-2 Humidity A-2
history 1-5, 6-1, 7-1
Disarming defibrillator (manual mode) 4-4
Display screen 1-7, 1-9 I
specifications A-4
Disposing of electrodes 3-2 Implanted devices ix, 3-3, 5-2
Indications for use xvi
Indicator
E chest compression 1-9
current mode 1-9
ECG analysis (semiautomatic mode) B-3 heartbeat 1-9
algorithm A-14 unit readiness 1-8
shockable rhythms A-3 Ingress, particle and water A-2
ECG monitoring 5-1, 5-6, B-4 Installing
cable 1-3, 1-6, 5-5, 5-6, B-4 battery pack 2-2
electrodes ix, 1-6, 5-3, 5-4 ZAS on a PC 6-4, 7-4
rhythm display 1-9, B-4 Intended use xvi
specifications A-3 IrDA port 1-5, 1-8, 6-5, 7-5
switch to semiautomatic mode 5-7
Elapsed time 1-9
Electrocardiogram — See ECG. M
Electrodes, defibrillation
applying 3-3, 3-6, 3-7 Manual
disposing 3-2 how to use vi
preconnecting 2-7 updates to vi
Electrodes, ECG Manual mode 1-3, 4-1
applying 5-4 defibrillation 4-4
placement 5-3 switching to 4-3
Electromagnetic emissions A-5 Messages 1-9
Emissions, electromagnetic A-5 ECG monitoring mode 5-8
Energy, defibrillator general 2-8
escalating levels 1-2 manual mode 4-5
output xvii nonrescue mode 6-6, 7-6
Environmental specifications A-2 semiautomatic mode 3-11
Metronome, CPR 3-5, 3-10
Models, AED Pro 1-6
U Warranty xiv
Water ingress A-2
USB connector 1-8 Waveform, rectilinear biphasic A-9
Use, intended xvi Weight A-2
V X