Defibrillators and Noninvasive Pacemakers Procedure No.

408-20140616

Adapt Procedure For

Defibrillator/Pacemakers, External [17-882]
Defibrillators, External, Automated [17-116]
Defibrillators, External, Manual [11-134]
Defibrillator/Cardioverters [18-502]

Scope
Applies to manual defibrillators, many of which have an automated program for recognizing shockable
arrhythmias and/or an external noninvasive pacemaker shockable arrhythmias and/or an external
noninvasive pacemaker. This procedure does not apply to public access defibrillators, which typically only
require periodic visual checks, or to implanted, transesophageal, or transvenous pacemakers. See Procedure
418 for transvenous pacemakers.

Interval
6 Months

Time Required
0.4 Hours

Overview
Defibrillators deliver a high-amplitude current impulse to the heart in an attempt to restore normal rhythm
and contractile function in patients who are experiencing ventricular fibrillation (VF) or ventricular
tachycardia (VT) that is not accompanied by a pulse. Manual (conventional) defibrillators include an
electrocardiogram (ECG) monitor that the user observes to decide whether a shock needs to be delivered;
when appropriate, the operator selects an energy level and depresses the "Charge" and "Shock" button(s) to
deliver the shock to the patient.

Many defibrillators have an automated program that analyzes the ECG to determine whether defibrillation is
necessary. This rhythm-recognition capability, which is the major difference between conventional
defibrillators and automated external defibrillators (AEDs), eliminates the need for the user to interpret the
cardiac rhythm. The automated program analyzes a patient's rhythm to determine whether a defibrillating
shock is indicated; if it is, the unit is automatically charged in preparation for shock delivery. Shock delivery,
however, is not typically automatic; most units require an operator to activate a discharge. Some
defibrillators have a log (e.g., memory card) to store event information and allow data to be transferred to
another location for storage or for the purposes of medical control and/or quality assurance activities.

Units with manual capability frequently include pacing and synchronization capabilities. A pacemaker is used
to control cardiac arrhythmias (irregular heart rhythms) by applying a repetitive electrical stimulus to the
heart via electrodes placed on the patient's thorax. In the fixed-rate pacing mode, the pacemaker emits a
stimulus at regular intervals, regardless of cardiac activity. Fixed-rate pacing is sometimes used when a
pacemaker is initially set up to confirm that the signal amplitude is adequate to capture, or pace, the heart.
If fixed-rate pacing is used and the heart reverts to its own rhythm, competition may occur between the
pacemaker stimuli and the natural cardiac signals. This may cause ventricular fibrillation or a decrease in
cardiac output. To minimize this possibility, the demand, or ventricular-inhibited, mode of operation is
usually used. In this mode, the pacemaker circuitry senses the heart's intrinsic electrical signal and attempts
to pace the heart only if the intrinsic signal is too infrequent or absent. When the heart rate is above the set
pacing rate, pacemaker output is inhibited.

Synchronized cardioversion is used on patients with certain cardiac rhythms when it is necessary to avoid
applying the defibrillation pulse at an inappropriate time – which could result in further deterioration of the
cardiac rhythm. Defibrillation pulse delivery is timed from the ECG so that it is delivered within a short time
after the QRS portion of the waveform and before a period of time (vulnerable period) of the ECG when
fibrillation may be induced. Synchronized cardioversion cannot be used on patients in ventricular fibrillation.

Many defibrillators can be equipped with optional monitoring capabilities, such as pulse oximetry (SpO2),
end-tidal carbon dioxide (ETCO2), and noninvasive blood pressure (NIBP). SpO2 is commonly monitored
during patient transport and can also be useful for some pre-hospital and general resuscitation cart
applications. SpO2 has the ability to measure carbon dioxide and hemoglobin. This allows for the diagnosis
of carbon monoxide exposure in fire victims, and low hemoglobin which can be indicative of internal
bleeding. ETCO2, NIBP, invasive blood pressure (IBP), and temperature monitoring may also be performed

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during patient transport and can, in some cases, eliminate the need for a separate transport monitor. Newer
defibrillators now offer clinical and maintenance features that enhance the use and operation of the device.

Some units also offer CPR feedback devices. For example, a disc can be placed on the patient’s chest to
provide feedback on the depth and rate of chest compressions. This helps clinicians adjust their movements
to be within American Heart Association (AHA)-recommended guidelines. Most units provide an algorithm to
help clinicians recognize, classify, and provide quicker access to specialized treatment to patients with ST-
elevated myocardial infarction (STEMI) based on 12-lead ECG and other physiological parameters.

Test Apparatus and Supplies

Electrical safety analyzer [Acceptance]
Defibrillator analyzer with ECG simulator (VF and normal sinus rhythm waveforms)
Stopwatch or watch with a second hand
Noninvasive pacemaker analyzer (for testing units with pacing capability if not included in defibrillator analyzer)
Adapters for connecting pacing cable leads to test equipment (for units with pacing capability)

Special Precautions
WARNING: During defibrillator discharge or pacing, the high voltage present at the paddles or electrodes is
extremely dangerous and possibly lethal. Never perform tasks alone. A second person must be present to
summon help and/or apply CPR in the event of an emergency. Never apply the defibrillation or pacing
paddles or electrodes to anyone, and never hold or contact the conductive electrode portion of the
defibrillation or pacing electrodes or paddles.

Testing input isolation requires the use of a line voltage source. Although this source should include a
current-limiting resistor, use caution to avoid contact with any portion of the circuit while it is energized.

Defibrillators and pacemakers must always be available to clinical staff in the event of an emergency and
inspection testing may deplete the battery. Either the inspection should be performed in the vicinity of the
defibrillator's usual storage location with a fully charged battery available before beginning testing or a unit
with which the clinical staff is familiar should be made available as a substitute during the inspection. Do not
test all the units in an area at one time, as this will leave the staff inadequately equipped to handle
emergencies.

Procedure
Be sure that you understand how to operate the equipment and the purpose of each control, indicator, and
alarm. Before beginning an inspection, carefully read this procedure and the inspection and preventive
maintenance procedure recommended by the manufacturer (typically included in the service manual). Use
BiomedicalBenchmark’s Support Assessment Form to document a scheduled maintenance interval and
procedure that reflects past experience with this model and type of equipment and the environment where it
is used. Also consider BiomedicalBenchmark Maintenance Data for this model and type of equipment.

Units that are used frequently and/or in ambulances and other pre-hospital settings, should be considered
for semiannual inspection. For other units, it may be reasonable to perform an annual inspection.

In addition to periodic inspection, clinical staff should perform visual inspections at least daily and after each
use, paying particular attention to the condition of defibrillation cables and connectors, and ensure that
batteries are charging. Discharge testing should be performed at least once a week.

This procedure includes tasks for inspecting a noninvasive pacemaker; delete these tasks if the model does
not have this feature. Refer to Multi-parameter Physiologic Monitors Procedure 493 for inspecting units that
include additional monitoring functions such as pulse oximetry, capnography, or noninvasive blood pressure.
This procedure should be modified by adding inspection tasks for assessing monitoring capabilities and CPR
feedback when a model is so-equipped.

Perform the inspection with the unit on battery power to check that its batteries are charged and can hold a
charge.

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Qualitative Tasks
Chassis/Housing [Acceptance]
Check for shipping damage; report any damage to the manufacturer, shipper, or service organization, and
arrange for repair or replacement.
Examine the exterior of the unit for cleanliness and general physical condition. Ensure that plastic housings
are intact, that all assembly hardware (e.g., screws, fasteners) is present and tight.

Chassis/Housing [Scheduled]
Examine the exterior of the unit for cleanliness and general physical condition. Ensure that plastic housings
are intact, that all assembly hardware is present and secure, and that there are no signs of spilled liquids or
other serious abuse.

Mounts/Fasteners [Acceptance]
If the defibrillator is mounted on a cart or a stand, ensure that the assembly is stable and that the
defibrillator will not fall or tip over when pushed or when a caster is jammed on an obstacle (e.g., line cord,
threshold), as may occur during transport. If the defibrillator is designed to rest on a shelf, ensure that it
has nonslip legs or supports.

Mounts/Fasteners [Scheduled]
If the defibrillator is mounted on a stand or cart, examine the condition of the mount.

Casters/Brakes [Acceptance]
If the defibrillator is cart-mounted, verify that the cart has appropriate (e.g., size, correct swivel) casters.
Verify caster and brake operation, if the cart is so equipped.

Casters/Brakes [Scheduled]
If the defibrillator is cart-mounted, check the casters. Look for accumulation of lint and thread, and ensure
that the casters turn and swivel, as appropriate. Check the operation of brakes and swivel locks, if the cart
is so equipped.

AC Plug [Acceptance]
A solidly constructed, good quality plug with adequate strain relief is acceptable, but the use of a Hospital
Grade plug (identifiable by a green dot and/or labeling) will eliminate guesswork and ensure a plug of
acceptable construction quality. Right-angle plugs are unacceptable for devices that are moved frequently. A
good quality two-prong plug is acceptable for double-insulated devices. Replace the plug or have the
supplier replace it if it is not Hospital Grade or otherwise suitable. Hospital Grade molded plugs are
acceptable.

Examine the AC power plug on the defibrillator and/or the battery charger for damage. Attempt to wiggle
the blades to determine if they are secure. Shake non-molded plugs and listen for rattles that could indicate
loose screws.

AC Plug [Scheduled]
Examine the AC power plug on the defibrillator and/or the battery charger for damage. Attempt to wiggle
the blades to determine whether they are secure. Shake the plug, and listen for rattles that could indicate
loose screws. If any damage is suspected, open the plug and inspect it.

Receptacles [Acceptance]
If the defibrillator is mounted on a cart that has electrical receptacles for additional equipment, inspect them
for damage. Verify that the receptacles are energized and correctly wired and verify correct tension of all
three connections. See Electrical Receptacles Procedure/Form 437 for more information.

Receptacles [Scheduled]
If the defibrillator is mounted on a cart that has electrical receptacles, insert an AC plug into each, and
check that it holds firmly.

Line Cord [Acceptance]

Ensure that the line cord (if applicable) is long enough for the defibrillator's intended application; an
extension cord should not be required. (A length of 10 ft [3 m] is suitable for most applications.)
The cord should be of suitable quality and current-carrying capacity. Hard Service (SO, ST, or STO), Junior
Hard Service (SJO, SJT, or SJTO), or an equivalent-quality cord should be used. Check line cords of battery
chargers.

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Equipment having a detachable power cord should have adequate capture devices, cleats, or channels to
hold the cord in place. If these are absent, request that the supplier provide suitable means of securing the
cord.

Line Cord [Scheduled]

Inspect the defibrillator and/or battery charger line cord for signs of damage. If the cord is damaged,
replace the entire cord or, if the damage is near one end, cut out the defective portion.

Strain Reliefs
Examine the strain reliefs at both ends of the line cord. Ensure that they hold the cord securely.

Cables
Check that the unit has been left with the cables and electrodes ready for clinical use. Some units may be
left in a "test" mode (e.g. with special test plugs or with leads connected to a test load) that can result in
users failing to properly connect the disposable electrodes cable to the defibrillator. Should it be the practice
of organizations to follow such policies, make sure that users are well trained and versed in the steps
needed to ensure that the electrodes are properly connected.

Examine any reusable cables used with the defibrillator (e.g., the disposable-defibrillation-electrode cable,
the ECG leads, the paddle cable) for their strain reliefs and general condition. Examine cables carefully to
detect breaks in the insulation and to ensure that they are gripped securely in the connectors at each end to
prevent rotation or other strain. On defibrillators equipped with an ECG monitor, verify that an ECG can be
displayed with the disposable-defibrillation-electrode cable and through the paddle cable. (Alternatively, use
an ohmmeter to verify continuity from each paddle or electrode connector to the appropriate pin of the
connector.) Wiggle, bend, and pull the cable to check that continuity is not affected.

Fittings/Connectors
Examine all cable connectors for general condition. Electrical contact pins or surfaces should be straight and
clean. Verify that leads and electrodes are firmly gripped in their appropriate connectors. Disconnect the
connectors and look for misaligned pins, damaged receptacles, and carbon deposits from arcing. Pay
particular attention to the connector where disposable defibrillation electrodes are connected as there have
been reports of damage and failure to defibrillate associated with failure at this connection.

Paddles/Electrodes [Acceptance]
Confirm that an adequate supply of disposable defibrillation electrodes (or reusable paddles), ECG
electrodes, pacing electrodes, or combination defibrillation/pacing electrodes (if applicable) are present and
that they are within their expiration dates. Confirm that special paddles or electrodes (e.g., pediatric,
internal) are available, if appropriate.

Paddles/Electrodes [Scheduled]
Confirm that an adequate supply of disposable defibrillation electrodes (or reusable paddles), ECG
electrodes, pacing electrodes, or combination defibrillation/pacing electrodes (if applicable) are present and
that they are within their expiration dates. Confirm that special paddles or electrodes (e.g., pediatric,
internal) are available, if appropriate.

If paddles are used, examine all paddles for physical condition and cleanliness. Alert clinical personnel
responsible for the instrument to the presence of dried electrode gel, physiologic fluids, or debris on the
paddle surface or handles. Dirty electrodes prevent good electrical contact and can cause burns. Electrode
gel or other debris on the insulating portion of the paddle can cause operator shocks. Clean the paddles, if
needed, including the electrode surface and handle seams, and make sure that they are completely dry
before proceeding with any further testing.

Controls/Switches
Verify that software setup parameters accessible through hidden or service menus are correctly set for the
appropriate application and are consistent for all defibrillators. For units with an automated rhythm
recognition program, in addition to any other setup parameters, verify that the correct set of audible and
visual user prompts and defibrillation sequences are set and/or that necessary updates have been installed
and implemented. Resuscitation guidelines (e.g., American Heart Association) and hospital procedures may
vary or change with time. Discuss appropriate settings with the department head and users and ensure that
training for any newly introduced protocols is provided.

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Examine all controls and switches for physical condition, secure mounting, and correct motion. Where a
control should operate against fixed-limit stops, check for proper alignment, as well as positive stopping.
During the course of the inspection, check that each control and switch (including membrane switches)
performs its proper function.

If the defibrillator has redundant control functions (e.g., a charge button on the front panel and on a
paddle), ensure that both controls function properly. Verify that activating just one paddle discharge button
will not cause the defibrillator to discharge. A front-panel discharge button should control only internal
paddles (or disposable defibrillator electrodes, on some units) and should not cause discharge when external
paddles are connected.

Recorder (ECG)
Apply a simulated ECG waveform and confirm that the recorder operates smoothly, that the paper feeds
evenly and does not stray from side to side, that the trace is of good quality (i.e., dark and thin) and that
QRS pulses are evenly spaced at all paper speeds.

Data Recording [Acceptance]

Leave the memory module or data card in place during acceptance testing so that data will be recorded.
Verify that the output of the playback or data management system accurately reflects the recorded
waveforms.

Battery/Charger [Acceptance]
Determine the replacement interval for all batteries and document the interval(s). Be sure to include
batteries/cells for clocks and/or memory logs.

For defibrillators with removable batteries that are charged in a separate charger, inspect the physical
condition of the batteries and battery connectors, and verify that the batteries in the charger are properly
installed and that the charging or ready light is on. Verify that the line cord is firmly attached at the wall
outlet and instrument end. For defibrillators that can be connected to AC line power for the purposes of
charging, verify that the unit is plugged into a live AC outlet, the line cord is firmly attached at the wall
outlet and instrument end, the charger is attached to the defibrillator (i.e., the charger cable is attached or
the defibrillator is firmly seated into the charging stand or mount) and that the charging light is on.

Operate the defibrillator on battery power for several minutes to verify that the battery is charged and can
hold a charge. Activate the battery test function, if so equipped. Check the condition of the battery charger,
and verify that battery charge indicators function. Provide users with instructions and/or checklist procedure
to ensure adequate battery charging and performance.

Battery/Charger [Scheduled]
For defibrillators with removable batteries that are charged in a separate charger, inspect the physical
condition of the batteries and battery connectors, and verify that the batteries in the charger are properly
installed and that the charging or ready light is on. Verify that the line cord is firmly attached at the wall
outlet and instrument end. For defibrillators that can be connected to AC line power for the purposes of
charging, verify that the unit is plugged into a live AC outlet, the line cord is firmly attached at the wall
outlet and instrument end, the charger is attached to the defibrillator (i.e., the charger cable is attached or
the defibrillator is firmly seated into the charging stand or mount) and that the charging light is on.

Operate the defibrillator on battery power for several minutes (this can be done while conducting the
inspection) to verify that the battery is charged and can hold a charge. Activate the battery test function, if
so equipped. Check the condition of the battery charger, and verify that battery charge indicators function.

Some manufacturers recommend a periodic check of battery capacity either through an automated battery
test function or by measuring battery-powered operating time. If recommended, verify that such checks are
being performed on schedule.

Indicators/Displays
During the course of the inspection, confirm the operation of all lights, indicators, meters, and visual
displays on the monitor and the charger (if appropriate). For units with an ECG monitor, observe a simulated
ECG signal on the display, and verify compliance with the following criteria:

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The baseline should be flat and without 50/60 Hz interference or other noise with the ECG simulator
attached. All portions of a simulated ECG waveform should be clear and visible, including the P-wave and
QRS.

Ambient light should not affect the visibility of the trace. (If monitor reflects ambient light, making the ECG
difficult to see, try adjusting the display brightness and/or contrast.)

For units with pacing capabilities, connect the monitoring leads to an ECG simulator or pacemaker analyzer.
Connect the pacing cable to an appropriate test load or a pacemaker analyzer, start the pacemaker, and
print a strip. Verify that a pacing pulse marker appears on the monitor and strip. Verify that the pacing
marker rate varies as the pacing rate control is adjusted.

Self-Test
Most defibrillators perform a self-test function when the unit is turned on. In addition, many defibrillators
have self-test diagnostic capabilities that are accessed through a configuration menu that typically requires
hidden keystrokes. Such features should be exercised and verified when present.

Time/Date Settings
Verify that the time and date settings on the defibrillator are correct and they appear with a printed ECG
strip.

Connectivity [Acceptance]
This task applies to a variety of connectivity circumstances in which a medical device is connected to other
devices or systems for data exchange. Systems that a device might connect with include standalone
networks, an EMR, or the hospital’s corporate IT network. Connectivity may be achieved, for example, via
Ethernet or wirelessly and may be through a virtual local area network [VLAN]). Ensure that the necessary
information to identify and properly troubleshoot connected devices is documented appropriately in the
facility’s computerized maintenance management system (CMMS). Such information would include device
identifiers, operating system, software versions, IP (internet protocol) addresses, configuration settings, and
ports.

Assess any potential risks and vulnerabilities to the confidentiality, integrity, and privacy of electronic
information stored or transmitted by the device or system and take appropriate preventive measures (e.g.,
adhere to Health Insurance Portability and Accountability Act [HIPAA] requirements). As appropriate, verify
that confidentiality and security measures are taken (e.g., password protection, wireless security protocols,
authentication, audit trails). Address any cybersecurity issues such software patches, anti-malware software,
and firewalls. Ensure that hospital policies such as wireless management policies, HIT-related policies, are
followed. Comply with change management policies as appropriate. Carry out any pre-implementation
testing as appropriate (e.g., performance, load testing). Confirm that data back-up processes are activated
and verified. If possible and as applicable, arrange with IT to perform periodic network penetration tests to
ensure that the device and any associated information systems are well protected in the event of a network
breach.

Connectivity [Scheduled]
Review measures taken to ensure protection against the potential risks and vulnerabilities to the
confidentiality, integrity, and availability of electronic information stored or transmitted by the device or
system and verify that preventive measures are still active. For example, are passwords being applied
correctly, have OS and virus protection patches and upgrades been installed, is the device still operating on
a VPN (virtual private network) and are wireless security measures still in place. Verify that data backup
processes are activated and that data can be retrieved from backups.

Synchronized Cardioverter
In the "synch" mode, verify that the defibrillator will not discharge when no ECG signal is present and that it
will discharge when a simulated ECG is applied. In this mode, the peak of each R wave of the ECG waveform
should have a marker and the display should indicate that this mode has been selected.

Integral Output Tester

Check the operation and accuracy of the integral defibrillator test load, if so equipped. Verify that the
indicator is consistent with the delivered energy setting.

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Alarms [Acceptance]
Verify that configurable alarm features are appropriately set and consistent among all defibrillators. It
should not be possible for critical alarms to be turned off, silenced, or defeated without adequate warning to
the operator or automatic alarm reactivation after a short delay.

Verify that alarms are loud, distinctive, and/or bright enough to be noticed in the environment in which the
defibrillator will normally be used. If a remote alarm indicator is required, verify that it is available and
functioning. Audible alarm-volume controls should not allow the alarm to be turned off or lowered to an
indiscernible volume.

Operate the defibrillator in such a way as to activate each audible and visual alarm (e.g., heart rate alarm, if
so equipped). Check for adequate alarm tone volume and any associated features (e.g., automatic direct
writer activation, display freeze function). If the defibrillator has an alarm-silence feature, check the method
of reset (i.e., manual or automatic) against the manufacturer's specifications.

Alarms [Scheduled]
Operate the defibrillator in such a way as to activate each audible and visual alarm (e.g., heart rate alarm, if
so equipped). Check for adequate alarm tone volume and any associated features (e.g., automatic direct
writer activation, display freeze function). If the defibrillator has an alarm-silence feature, check the method
of reset (i.e., manual or automatic) against the manufacturer's specifications.

Pacemaker Demand-Mode Activation/Inhibition

The pacemaker should inhibit demand-mode pacing whenever a heart rate greater than the set pacing rate
is detected. Connect the pacemaker output to a pacemaker analyzer and use an ECG simulator to apply a
normal sinus rhythm to the ECG input. Verify that pacing is inhibited when the simulated heart rate (bpm)
exceeds the set pacing rate (ppm) and that pacing activates when the simulated heart rate falls below the
set pacing rate. A difference of up to 10 bpm between inhibition and activation rates is common.

Audible Signals
Operate the defibrillator to activate any audible signals (e.g., QRS beeper, charge tone, voice prompts). For
each audible signal confirm appropriate volume, clarity, and proper operation of the volume control. Verify
that the signal can be easily heard in the area in which the defibrillator will be used.

Labeling
Check that all necessary placards, labels, and instruction cards are present and legible.

Accessories [Acceptance]
Verify that all necessary features and accessories have been supplied with the defibrillator, including (as
appropriate):
ECG electrodes
Defibrillation, pacing or multifunction electrodes - including pediatric and backup sets
Electrode gel
SpO2 sensor and cable*
NIBP cuff*
EtCO2 sensor and mask*
Spare recorder paper
*This item is applicable only if the unit has the named accessory or capability
A copy of the operators and service manuals (electronic or hard copy) should be shipped with the
defibrillator.

Accessories [Scheduled]
Verify that the following are stored with the defibrillator, including (as appropriate):
ECG electrodes
Defibrillation, pacing or multifunction electrodes - including pediatric and backup sets
Electrode gel
SpO2 sensor and code*
NIBP cuff*
EtCO2 sensor and mask*
Spare recorder paper
*This item is applicable only if the unit has the named accessory or capability
Notify appropriate clinical personnel if any accessories are missing.

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Quantitative Tasks
Grounding Resistance [Acceptance] 0.5 
Measure the resistance between the grounding pin of the power cord (if so equipped) and exposed
(unpainted and not anodized) metal on the chassis. Grounding resistance should not exceed 0.5 . If the
unit is double insulated, grounding resistance need not be measured. Grounding resistance measurement is
not applicable to double insulated devices.

Depending upon circumstances, including prior history of grounding failures or power cord damage,
frequency of use, and environmental factors, this task should be considered for inclusion in major
inspections.

Touch Current [Acceptance] ≤500µA

Touch (chassis leakage) current must be measured with the device powered by a conventional (grounded)
power system, even if it is normally used in an area with isolated power. ECRI Institute does not
recommend touch current tests of double-insulated devices.

With the polarity of the power line normal and the equipment ground wire disconnected, measure touch
current with the device operating in all normal modes, including on, standby, and off. Maximum touch
current should not exceed 500 µA.

Inspect AC adapters used to power (or recharge) certain devices for CE mark or UL (or other testing
laboratory) listing and to verify that it is labeled to identify the device with which it is to be used. ECRI
Institute recommends testing of adapters, particularly those that are not listed, by measuring the leakage
current from each secondary (low voltage) connection to ground. The leakage current should not exceed the
limit for the device touch current.

Lead-to-Ground Leakage Current [Acceptance] ≤100µA grounded; ≤500µA ungrounded

For defibrillators that can be operated on line power, measure leakage current from patient leads to ground.
Perform the test with the defibrillator on and with the ground wire intact and open, in all normal operating
modes. DO NOT MEASURE LEAKAGE CURRENT FROM PADDLES OR DEFIBRILLATION OR PACING
ELECRODES WITH THE DEFIBRILLATOR CHARGING OR CHARGED OR WITH THE PACEMAKER ON!

Manual Mode Defibrillator Output ±4 J low; ±15% high

For those defibrillators that have a manual mode, measure output energy at minimum, intermediate, (e.g.,
50 J) and maximum energy settings. After each discharge, note the indicated energy (displayed on the
defibrillator) and the delivered energy (measured by the defibrillator analyzer) immediately after the
discharge.

The output energy should be within 4 J of the set energy at low settings (below 25 J) and 15% of the set
energy at higher energy settings. If the output of the defibrillator is unusually low at very low control
settings, check for a break in the cables or a defective connector.

Automated Mode Analysis and Defibrillator Output per mfr/hosp policy

Attach the electrode cable to the ECG simulator. Select a normal sinus rhythm, and verify that the unit
reaches a no-shock decision. Then select a VF waveform and measure output energy of each sequential
discharge (energy level may vary depending on model and hospital policy).

Multiple Discharge Output Energy and Charge Time 10 sec

WARNING: Do not perform this task on all units in an area on the same day unless provisions are made for
backup defibrillators or spare charged batteries. Batteries may take considerable time to recharge, and a
fully charged defibrillator must be available for emergencies.

In the manual mode, charge the unit to maximum energy and discharge 10 times through the analyzer
(verify that the analyzer load will not be damaged by repeated discharge). On the 10th cycle, record the
charge time (i.e., the time for the ready indicator to activate) and the delivered energy. To avoid excessive
battery depletion, stop the test and record the number of discharges and the values measured if the
charging time exceeds 10 sec before the 10th discharge. Also stop the test if the battery-condition meter
indicates a depleted battery or, on some defibrillators, if the internal circuitry terminates the charge early.

The time required for the defibrillator to charge to maximum energy should not exceed 10 sec. The output
energy should be within 15% of the set energy at higher energy settings.

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Pediatric Mode Output Energy 50 J

For those defibrillators that have a pediatric mode (typically activated by plugging in pediatric electrodes)
activate this mode and verify that the output energy is limited to 50 J or as specified for the unit.

Internal Paddle Energy Limit [Acceptance]) 50 J

Perform this task on all defibrillators equipped with this feature, regardless of intended location for the
defibrillator. Connect the internal paddles, charge the defibrillator to maximum energy, and discharge it into
the defibrillator analyzer. Verify that the output does not exceed 50 J.

Internal Paddle Energy Limit [Scheduled] 50 J

Test this feature on any unit that is located where it may be used with internal paddles or that may be
moved to such a location. Connect the internal paddles, charge the defibrillator to maximum energy, and
discharge it into the defibrillator analyzer. Verify that the output does not exceed 50 J.

Energy after 50 Sec (Manual Mode) 85%

Charge the defibrillator to its maximum setting, but do not discharge for 50 sec. The delivered energy
should be at least 85% of that obtained when the defibrillator is discharged immediately (as in the Output
Energy task) and should meet manufacturer specifications for charge leakage. (Note that some defibrillators
are designed to intentionally bleed or discharge the capacitor charge if the defibrillator is not discharged
within a set time period. These defibrillators should meet manufacturer specifications.)

Synchronized Cardioverter Operation [Acceptance] 60 msec after R-wave

Connect the defibrillator to a defibrillator analyzer with synchronization test feature. Set the defibrillator to
deliver low output energy (50 J or less). Confirm that, with the ECG simulator off, the defibrillator does not
discharge. Then apply an ECG amplitude sufficient to activate the marker or indicator. Depress the discharge
buttons. The defibrillator should discharge in 60 msec or less following the R-wave peak. Most defibrillators
will trigger on the first QRS pulse after the buttons are depressed, although some units are designed to
delay until the second or third QRS to avoid unintentional discharges.

Paper Speed [Acceptance] ±2%

On defibrillators with a recorder, set the ECG simulator to 60 bpm and activate the recorder. At the typical
speed setting of 25 mm/sec and with the pulse interval (1,000 msec) of the simulated 60 bpm ECG
simulator, the distance between the first and last of five successive peaks (R waves) should be 100 ±2 mm
(±2%).

Heart Rate 5%

Using a simulated ECG with rates of 60 and 120 pulses per minute, verify that the heart rate indicator
displays a rate within 5% or 5 bpm, whichever is greater, of the set rate (55 to 65 bpm, 114 to 126 bpm).
Verify that the QRS visual and audible indicators are functioning.

Heart Rate Alarm

Use the same setup as for the previous task. For typical low- and high-rate alarm settings of 40 and 120
bpm, respectively, verify that the alarm activates when the input rate is set just below or above the
respective rate alarm settings.

Pacing Rate 5%

Connect the pacemaker to a pacemaker analyzer. Set the pacemaker output to approximately 100 mA in the
fixed-rate mode. Pacemakers should be checked at maximum and minimum rates and at 60 ppm. Measured
current should be within 5% of settings.

Pacing Amplitude 10%

Using the pacemaker analyzer, check pacemaker output accuracy at settings of 50 and 100 mA. Amplitude
accuracies should be within 10%.

Pacing Pulse Width [Acceptance] 10%

To determine the pacemaker output pulse width, connect the pacemaker to a pacemaker analyzer. Set the
pacemaker to approximately 100 mA at 60 bpm. Typical pulse widths are 20 and 40 msec. A pulse width
within 10% of the pacemaker's specified width is satisfactory.

©2014 ECRI INSTITUTE 9

Defibrillators and Noninvasive Pacemakers Procedure No. 408-20140616

Demand-Mode Sensitivity [Acceptance] 0.5 mV or mfr spec

Using the pacemaker analyzer, verify that the pacemaker sensitivity meets the manufacturer's
specifications; most pacemakers will begin to sense an ECG waveform with a QRS complex of 0.5 mV or
less.

Preventive Maintenance [Does not apply to Acceptance Procedure]

Replace
Replace the battery if any of the test procedures indicate that it is weak or defective. Batteries should be
marked with the date of installation. For defibrillators that have more than one battery, ensure that all
batteries are checked, maintained, and replaced as required.

©2014 ECRI INSTITUTE 10