BiomedicalBenchmark™ © 2011 ECRI Institute. All Rights Reserved.

1
Procedure No. 420-20081015-01 ( Major ) Apnea Monitors

Apnea Monitors

Procedure No. 420-20081015-01 ( Major )

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

Used For:
Recorders, Graphic, Trend, Respiration Rate [16-305]
Monitors, Bedside, Respiration, Apnea [12-575]
Monitors, Bedside, Respiration [12-662]

Commonly Used In:

Critical care units, neonatal intensive care units, nurseries, delivery rooms, ambulances, homes

Scope:
Applies to apnea monitors, which alarm if a patient stops breathing, and respiration rate monitors, which
display the patient's breathing rate and alarm when previously selected high or low limits are exceeded;
applies to adult and infant monitoring units or modules, as well as impedance-, motion-, thermistor-, and
airway-pressure-type monitors; does not apply to other types of monitors with respiration monitoring
functions (e.g., capnometers, pulse oximeters); some apnea monitors also include other monitoring
capabilities (e.g., ECG and blood pressure), which should be checked using the appropriate
procedure/checklist unless the function is very limited (e.g., heart rate alarm without other ECG
features). For modular respiration/apnea monitors, consider incorporating this procedure's unique
inspection tasks into Multiparameter Physiologic Monitors Procedure no. 493.

Risk Level: High

Type Interval Time Required

Major 12 Months 0 hours

Minor 0 NA 0 hours

Overview:
ECRI Institute's evaluations of infant apnea monitors have stressed that apnea monitoring is still an
imperfect science. Apnea monitors must include a heartbeat detector (or other backup mechanism to the
primary apnea detection function).
Some apnea monitors have documentation capabilities that typically can record two or more channels of
patient event data ranging from several hours to several months, depending on the amount and format of
data and the parameters stored. Recorded data are available in two categories: patient (respiratory rate,
heart rate) and equipment (power on/off, low battery). Patient data can be recorded and printed as either
tabular data or waveforms. These data can be used to ensure that the monitor is being used properly, to
distinguish true from false alarms, and to troubleshoot equipment problems.
Activation of memory waveform recording can be automatic or continuous. Automatic activation is
triggered when an event occurs that exceeds preset monitor limits. In the continuous mode, all data from
the selected channels are recorded for a specific duration. The data stored in the memory can be managed
one of three ways. Some apnea monitors overwrite the old data with more recent events; others keep the
data that satisfy specific criteria based on the duration of the events; and some documentation monitors
stop storing data when the memory is filled.
Test Apparatus, Supplies, Parts:
 Electrical safety analyzer

 Stopwatch or a watch that displays seconds

 Respiration simulator (needed for impedance-type monitors only; variable base impedance from
100 to 5,000 Ω, variable respiration resistance change amplitude from 0.1 to 1 W)

 ECG simulator with variable rate may be required (may be part of the respiration simulator or
may be a separate unit)

 Memory interface and documentation hardware and software (where applicable)

Special Precautions:

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.
Do not test the monitor while it is in use. Arrange to be notified when the monitor is available.
Before inspecting apnea monitors with memory and documentation capabilities, it may be desirable to
print a log identifying the chronology, type, and duration of patient and equipment alarms and events to
keep with the inspection form. At the end of the procedure, the memory contents should be reviewed to
verify that programming and alarms induced during inspection have been correctly stored.

Qualitative tasks: Chassis/Housing.

Examine the exterior of the apnea monitor for cleanliness and general physical condition. Be sure that
plastic housings are intact, that necessary assembly hardware is present and tight, and that there are no
signs of spilled liquids or other serious abuse. The monitor top should not be used as a storage area for
other material (e.g., formula).

Mount .

If the apnea monitor is mounted on a stand or cart, check the mount's condition. Be sure that all fasteners
are tight and that the mount is sturdy. Apnea monitors should not be placed on top of incubators where
they can be easily dislodged or obscure the view of an infant. A wall-supported shelf or bracket
dedicated to the monitor is recommended.

AC Plug/Receptacles .

Examine the AC power plug for damage. Attempt to wiggle the blades to determine that 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. If the apnea monitor has electrical receptacles for accessories, insert an AC plug
into each and check that it is held firmly. If accessories are plugged and unplugged often, consider a full
inspection of the receptacle.

Line Cord.

Inspect the cord for signs of damage. If damaged, either replace the entire cord or, if the damage is near
one end, cut out the defective portion. Also, check battery charger line cords.

Strain Reliefs.

Examine the strain reliefs at both ends of the line cord. Be sure that they hold the cord securely.

Circuit Breaker/Fuse.

If the apnea monitor has a switch-type circuit breaker, check that it moves freely. If the apnea monitor is
protected by an external fuse, check its value and type against that marked on the chassis, and ensure that
a spare fuse is provided.

Cables.

Inspect the cables (e.g., patient sensor, remote alarm) and their strain reliefs for general condition.
Examine cables carefully to detect breaks in the insulation and to ensure that they are gripped securely in
the connectors of each end to prevent rotation or other strain. Electrode leads and cables are often fragile
and may lack adequate strain relief; intermittent contact can provide false indications.
The lead-electrode connector should be of the type that cannot be inadvertently plugged into a 115 VAC
outlet or power cord.
Attach a pair of electrodes to the patient cable and hold the RA and LA electrodes together so that they
are touching. Connect the patient cable to the monitor, turn the apnea monitor on at maximum
sensitivity, and jiggle the leads. If either breaths or lead faults are indicated, suspect damaged cables or
weak contact with the electrodes.
For monitors using belts, bands, a thermistor, a mattress pad, or other sensor, connect the sensor to the
monitor, turn on the monitor, and jiggle the sensor cable, being careful not to disturb the sensor in such a
way as to simulate a breath. Observe the monitor for artifacts that would indicate a defective cable or
connector.

Fittings/Connectors.

Examine all fittings and connectors, including electrical cable connectors, for general condition.
Electrical contact pins or surfaces should be straight, clean, and bright.

Electrodes/Transducers.

Confirm that any necessary electrodes and/or transducers are on hand and check their physical condition.
If disposable electrodes are used, be sure an adequate supply is on hand.
Verify that the insulation on thermistor sensors is intact. Carefully examine sensor belts, bands, or pads
(magnetic, capacitive, or pressure transducer) for intact insulation. If there are cracks or defects in the
insulation, remove the sensor from service.
Controls/Switches .

Before changing any controls and alarm limits, check and record their settings. If any appear inordinate
(e.g., a gain control at maximum, alarm limits at the ends of their range), consider the possibility of
inappropriate clinical use or of incipient device failure. Investigate questionable control settings on a
home care monitor. Consult with the patient's physician to determine correct settings. The parents should
receive additional training if required. Record the settings of those controls that should be returned to
their original positions following the inspection. Examine all controls and switches for physical
condition, secure mounting, and correct motion or proper activation. Where a control should operate
against fixed-limit stops, check for proper alignment, as well as positive stopping. Check membrane
switches for membrane damage (e.g., from fingernails, pens). During the course of the inspection, be
sure to check that each control and switch performs its proper function.

Battery/Charger .

Inspect the physical condition of batteries and battery connectors, if readily accessible. Check operation
of battery-operated power-loss alarms, if so equipped. The apnea monitor must indicate whether it is
operating on battery power or is being powered (and charged) from line power.
Operate the apnea monitor on battery power for several minutes to check that the battery is charged and
can hold a charge. Check the condition of the battery charger and, to the extent possible, confirm that it
does, in fact, charge the battery. When it is necessary to replace a battery, label it with the date.

Indicators/Displays.

During the course of the inspection, confirm the operation of all lights, indicators, and visual displays on
the apnea monitor and charger, if so equipped. Verify that the display amplitude increases as the
impedance change setting of the simulator is increased.

Time/Date Settings.

Verify that the time and date settings on the unit are correct.

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.

Alarms.

Operate the apnea monitor in such a way as to activate each audible and visual alarm. If the apnea
monitor has an alarm-silence feature, check the method of reset (i.e., manual or automatic) against the
manufacturer's specifications. Some apnea alarms that reset automatically when breathing resumes have
a separate indication that an apneic episode has occurred; this reminds clinical personnel that the patient
needs closer attention. To verify that this indicator functions properly, halt simulated respiration until the
apnea alarm sounds, then resume the simulated respiration. Check that the reset control functions. If the
apnea monitor is used with a remote alarm indicator, verify its function.

Labeling.

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

Accessories .

Verify that electrode gel, if used, is available.

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.

Open Electrode Indicator.

This check is for impedance-type monitors only. Connect the monitor to the respiration simulator. Vary
the base impedance and determine the resistance value at which the apnea monitor first indicates an
electrode fault. This is usually in the range of 1,000 to 2,000 Ω.

Sensitivity.

If the monitor has a manual sensitivity control, set it at maximum sensitivity. Connect the respiration
simulator and, if adjustable, set it for a base impedance of 500 Ω, resistance change of 1 Ω, and
breathing rate of 30 bpm (15 bpm for an adult monitor). Verify that the monitor detects each resistance
change. Decrease the resistance change on the simulator and record the minimum value for which
breaths are reliably detected. Most monitors will detect resistance changes of 0.1 to 0.3 Ω at maximum
sensitivity.
Increase the rate to 100 bpm and verify that the sensitivity does not change abnormally.
Discrepancies between similar monitors or from previous readings greater than 25% suggest significant
deterioration of the monitor and should be investigated.
With the monitor set at maximum sensitivity, verify that breaths are not detected when the simulator is
set to 0 bpm or turned off. Some simulators, when turned off, may present a high base resistance to the
monitor that can cause extraneous noise pickup.
For other types of monitors, only qualitative tests of sensitivity can be made with other types of sensors.
Simulate breaths in the appropriate manner for each monitor, and observe that the sensitivity varies with
the control setting. In some cases, sensitivity will vary with the simulated respiration rate. Confirm the
absence of artifacts at maximum sensitivity.

ECG Features.

Perform trace quality and additional testing as required. Test the heart rate alarm as part of this task using
an ECG simulator to verify rate accuracy and high and low alarm activation guided by the ECG Monitor
inspection tasks in Procedure 493 for multiparameter physiologic monitors.
Apnea Alarm Delay Time.

Check the apnea alarm delay by stopping simulated respirations. Time the delay between cessation of
respiration and apnea alarm. Measured times should agree with indicated times within 20%. Check all
times, if discrete times are available. If the control is continuously variable, check both shortest and
longest times. Check the alarm-silence function, if so equipped.

Ratemeter Accuracy.

Using the respiration simulator, check the rate display on respiration rate monitors at low rate (about 15
bpm for adult apnea monitors and 30 bpm for infant apnea monitors) and high rate (100 bpm). Read the
ratemeter when it reaches equilibrium. Indicated rates should be accurate to within 5%.
If the ratemeter is digital, vary the simulated rate to check for malfunctioning digits. A display of "8" in
the tens and units position will check all elements of a segmented or dot display; a "1" and "0" in the
hundreds place is all that is needed there.

Rate Alarm Accuracy.

Record the default low and high respiration rate limits, verifying that they are reasonable for the intended
application. Set the low and high respiration rate alarms at 20 and 70 bpm, respectively. Simulate a
respiration rate of about 30 bpm, set the apnea delay to at least 10 sec, and reset any alarms that may
have been triggered during setup. Reduce the simulated respiration rate to about 20 bpm. Observe the
ratemeter, and verify that the low-rate alarm is activated when the indication falls below 20 bpm. Some
monitors have fixed alarm delays; check the instruction manual to determine whether this feature is
present.
Next, simulate a rate of about 60 bpm, reset any alarms, then increase the simulated rate above 70 bpm,
and verify the operation of the high-rate alarm. Reset the low- and high-respiration limits to their default
settings.

Preventive Maintenance: Clean.

Clean the exterior of the apnea monitor with a damp cloth, if needed.

Replace.

Replace battery as needed or at intervals recommended by the manufacturer.