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Procedure No. 408-20081015-01 ( Major ) Defibrillators and Noninvasive Pacemakers

Defibrillators and Noninvasive Pacemakers

Procedure No. 408-20081015-01 ( Major )

BiomedicalBenchmark™ © 2011 ECRI Institute. All Rights Reserved. 2

Used For:
Defibrillator/Pacemakers, External [17-882]
Defibrillators, External, Automated [17-116]
Defibrillators, External, Manual [11-134]

Commonly Used In:

Coronary and special care areas, emergency departments, operating rooms, ambulances, patient care
areas

Scope:
Applies to manual defibrillators, many of which have an automated program for recognizing shockable
arrhythmias and/or an external noninvasive pacemaker. See Multiparameter Physiologic Monitors
Procedure 493 for inspecting units that include additional monitoring functions such as pulse oximetry,
capnography, or noninvasive blood pressure. 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.

Risk Level: High

Type Interval Time Required

Major 12 Months 0 hours

Minor 6 Months 0 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.
Defibrillators are critical resuscitation devices. Their failure to perform effectively may result in the
death of a patient undergoing resuscitation or cause further cardiac damage or even death in a patient
undergoing cardioversion of a life-threatening arrhythmia.
Failure to successfully defibrillate a patient may occur for a number of reasons, including inadequate
predefibrillation cardiopulmonary resuscitation (CPR) technique, operator error (e.g., incorrect paddle
application), or depleted or defective batteries (the most common cause of defibrillator failure with
battery-powered units). There is no time to troubleshoot or correct even minor difficulties during
emergencies, since every minute of delay significantly decreases the probability of a successful
resuscitation attempt.
In addition to periodic inspections, clinical staff should perform visual inspections, paying particular
attention to the condition of defibrillation cables and connectors, and ensure that batteries are charging.
These operator checks should be performed at the beginning of each work shift and after each use of the
unit, although discharge testing may only need to be performed once a week.

Test Apparatus, Supplies, Parts:

 Electrical safety analyzer (may be included in defibrillator analyzer)

 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 and 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, the significance of each control and indicator,
and the alarm capabilities. Before beginning an inspection, carefully read this procedure, the operators
manual, and the inspection and preventive maintenance procedures recommended by the manufacturer
(typically included in the service manual). Use the BiomedicalBenchmark Support Assessment Form to
document a maintenance decision that reflects past experience with this type of equipment and the
environment where it is used. Then use the IPM Procedure Customization Tool to modify this procedure
as needed; the program will generate a documentation form with the corresponding changes.
This procedure includes tasks for inspecting a noninvasive pacemaker. Delete these tasks if the model
does not have this feature.
Before performing an inspection, note the settings and except for acceptance inspections, remove the
memory module or card so that inspection test results will not be recorded or displace event information
that may not have been previously downloaded. Perform the inspection with the unit on battery power to
check that its batteries are charged and can hold a charge.
If the battery needs replacement (based on the installation date of the installed battery or battery
performance assessment) replace the battery and perform the inspection after a suitable charge period.

Qualitative tasks: Chassis/Housing.

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.

If the defibrillator is mounted on a stand or cart, examine the condition of the mount.

Casters/Brakes.

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.

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.

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.
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 .

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.
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.

Battery/Charger.

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:
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 an automated self-test function when the unit is turned on. In addition, many
defibrillators have autotest 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.

Network/Wireless Interfaces.

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.

Synchronizer.

In the synchronization 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 synch mode, the peak of each R
wave of the ECG waveform should have a marker.

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.

Alarms.

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. With a test load across the pacemaker output, 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.

Verify that the following are stored with the defibrillator, including (as appropriate):
A spare, fully charged battery
Paper for the printer
Memory cards (as appropriate)
Defibrillator gel – well before expiration date
Notify appropriate clinical personnel if any accessories are missing.

Quantitative tasks: Grounding Resistance.

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 Ω. If the
unit is double insulated, grounding resistance need not be measured.

Manual Mode Defibrillator Output.

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.

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.

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 15 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 15 sec. 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.

Pediatric Mode Output Energy.

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.

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 60 Sec (Manual Mode).

Charge the defibrillator to its maximum setting, but do not discharge for 1 min. 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.)

Heart Rate.

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.

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.

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

Preventive Maintenance: 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.