Apnea Monitors

Procedure No. 420-20150701

Adapt Procedure For

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

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.

Interval
12 Months

Time Required
0.3 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 and Supplies

Electrical safety analyzer [Acceptance]
Stopwatch or a watch that displays seconds
Respiration simulator (needed for impedance-type monitors only; variable base impedance from 100 to 5,000 ,
variable respiration resistance change amplitude from 0.1 to 1
ECG simulator with variable rate may be required (may be part of respiration simulator or a separate unit)
Memory interface and documentation hardware and software (where applicable)

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
BiomedicalBenchmarks 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.
The following procedure contains tasks for Acceptance and Scheduled inspections; tasks not labeled
[Acceptance] or [Scheduled] apply to both types of inspections.

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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 [Acceptance]

Check for shipping damage; report any damage to the manufacturer, shipper, or service organization, and
arrange for repair or replacement.
Check that the apnea monitor is suitably constructed to withstand normal hospital or home use and abuse.
For instance, a unit with venting on the top of the housing or poorly protected or sealed controls and
indicators may be prone to fluid entry.
Examine the exterior of the apnea monitor 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 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 [Acceptance]

If the apnea monitor is mounted on a stand or cart, ensure that the assembly and weight distribution is
stable and that the unit will not 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 apnea monitor is designed to rest on a shelf, ensure
that it has nonslip legs or supports.
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.
Mount [Scheduled]

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 [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 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/Receptacles [Scheduled]

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 [Acceptance]

Ensure that the line cord is long enough for the apnea monitor's intended application; an extension cord
should not be required. (A length of 10 ft [3 m] is suitable for most applications, although 18 ft [5.5 m] has
been suggested for operating room equipment.)

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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.
Verify that the apnea monitor has adequate protection against power loss (e.g., from accidental
disconnection of a detachable power cord, disconnection of the power cord from the wall, or depleted battery
if a battery-powered device is not plugged in). Equipment having a detachable power cord should also 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. Verify that the apnea monitor has adequate alarms or
indicators for line-power loss and battery depletion and an adequate battery-charging indicator.
Line Cord [Scheduled]

Inspect the cord for signs of damage. If damaged, either replace the entire cord. 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 [Acceptance]

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, verify that the fuse type is labeled and that all fuses and spares are the
proper current rating and type. If the value and type are not labeled, check the manual for the proper
current rating and type and permanently mark this information on the apnea monitor housing near the fuse
holder.
Circuit Breaker/Fuse [Scheduled]

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.

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Controls/Switches [Acceptance]

Verify that software setup parameters accessible through hidden or service menus are correctly set for the
appropriate application and are consistent for all apnea monitors.
Examine all controls and switches for physical condition, secure mounting, and correct motion. If a control
has fixed-limit stops, check for proper alignment, as well as positive stopping.
Controls/Switches [Scheduled]

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 [Acceptance]

Determine the replacement interval for all batteries and document the interval(s) in an equipment control
system or a hard copy file for the apnea monitor. Be sure to include batteries/cells for clocks and/or memory
logs. For critical care monitors and therapeutic devices, it may be desirable to disconnect the battery and
determine if the device still operates on line power.
The apnea monitor must indicate whether it is operating on battery power or is being powered (and
charged) from line power. For home use, monitors must also include a power-loss alarm (non-batteryoperated unit) and a remote alarm; verify operation of these two alarms.
Operate the apnea monitor 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. Provide users with instructions and/or
checklist procedure to ensure adequate battery charging and performance.
Battery/Charger [Scheduled]

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.
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 hospitals 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 Such
information could include device identifiers, operating system, software versions, IP (internet protocol)
addresses, configuration settings, etc. 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). Address any cyber security issues such

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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.
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.
Alarms [Acceptance]

Verify that configurable alarm features are appropriately set and consistent among all apnea monitors. 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. Such deficiencies should usually be
recognized during pre-purchase evaluation. However, if any are found, review the justification for purchasing
this apnea monitor and discuss corrective action with the manufacturer. (Alarm features may be optional or
programmable.) If no remedy is available, a user training program should be instituted to reduce the risk of
incorrect use. A warning label on the apnea monitor or a poster in the area of use may be appropriate.
Verify that alarms are loud, distinctive, and/or bright enough to be noticed in the environment in which the
apnea monitor 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.
Induce alarm conditions to activate audible and visual alarms. If the apnea monitor has an alarm-silence
feature, check the method of reset (i.e., manual or automatic) against the manufacturer's specifications.
Alarms [Scheduled]

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.
Coincidence Circuit [Acceptance]

Monitors typically have coincidence circuitry designed to compare breathing and heart rate signals or data
and to reject detected breaths that may, in fact, be erroneously detected QRS complexes. Connect the
monitor to respiration and ECG simulator(s) and set breathing and heart rates to 60. The monitor's apnea
alarm should activate.
Labeling

Check that all necessary placards, labels, and instruction cards are present and legible.
Accessories [Acceptance]

Verify that all necessary features and accessories (e.g., transducers) have been supplied with the apnea
monitor. At least one copy each (two are generally preferred) of the instruction and service manuals,
including schematics, should be shipped with the apnea monitor and filed in the central equipment file. A
copy of the instruction manual should be kept with the apnea monitor.
Accessories [Scheduled]

Verify that electrode gel, if used, is available.

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 .
Grounding resistance is not applicable to double insulated devices.

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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 scheduled
inspections.
Touch Current [Acceptance] 500 A

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 leakage 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 A.
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
limits for the device touch current.
Lead-to-Ground Leakage Current [Acceptance] 100 A grounded; 500 A ungrounded

Measure leakage current from all patient leads connected together to ground. Perform the test with the
device on and with the ground wire intact and open, in all normal operating modes. Confirm that leakage
current to ground is 100 A or less with the unit ground intact and 500 A or less with the ground open.
Open Electrode Indicator 1,000 to 2,000

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 .
Sensitivity 0.3 at max varies w/setting, no breaths at 0 bpm

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 , resistance change of 1 , 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 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 per Procedure 493

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 20%

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.

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Ratemeter Accuracy 5%

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 20 bpm

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

[Does not apply to Acceptance procedure]

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.

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