Procedure No. 420-20081015-01 

 Acceptance       Major     Minor

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

Also CalledCardiorespiratory monitors, apnea alarms and respiration monitors, apnea detectors

Commonly Used InCritical care units, neonatal intensive care units, nurseries, delivery rooms, ambulances, homes

ScopeApplies 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

TypeInterval Time Required

Major 12 Months 0 HoursMinor 0 NA 0 Hours

OverviewECRI 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, Parts

Electrical safety analyzerStopwatch or a watch that displays secondsRespiration 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 the respiration simulator or may be a separate unit)Memory interface and documentation hardware and software (where applicable)

Special Precautions

ProcedureBe 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 TasksChassis/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 ( Major )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    ( Major )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 nonmolded plugs and listen for rattles that could indicate loose screws.

AC Plug/Receptacles    ( Major )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.)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 ( Major )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 ( Acceptance, Major )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 ( Major )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 ( Acceptance, Major )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 ( Acceptance, Major )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 ( Acceptance, Major )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    ( 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    ( Major )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-battery-operated 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    ( Major )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 ( Acceptance, Major )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 ( Acceptance, Major )Verify that the time and date settings on the unit are correct.

Network/Wireless Interfaces ( Acceptance )Assess the potential risks and vulnerabilities to the confidentiality, integrity, and availability of electronic information stored or transmitted by the device or system and take appropriate preventive measures.  Make sure that necessary information, including device identification, operating system, IP (internet protocol) address, is documented in the appropriate log. As appropriate, verify that confidentiality (e.g., password protection) and malicious software protective (including mechanisms for future OS and virus protection patches and upgrades) measures are implemented. Determine if a VPN (virtual private network) is needed. For wireless devices, ensure that appropriate wireless security measures have been implemented and that requirements of the healthcare organization's wireless management policies have been met. Verify that data backup processes are activated and verified.

Network/Wireless Interfaces ( Major )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 prepurchase 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 ( Major )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 ( Acceptance, Major )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    ( Major )Verify that electrode gel, if used, is available.

Quantitative TasksGrounding Resistance ( Acceptance, Major ) 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.

Chassis Leakage Current ( Acceptance ) 500 ALeakage 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 chassis leakage current tests of double-insulated devices.With the polarity of the power line normal and the equipment ground wire disconnected, measure chassis leakage current with the device operating in all normal modes, including on, standby, and off. Maximum leakage 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 chassis leakage current to ground.

Lead-to-Ground Leakage Current (Isolated Lead) ( Acceptance ) 0 µA grounded; 0 µA open groundMeasure leakage current from patient leads (or other applied parts, such as probes) to ground. Perform the test with the unit on and with the ground wire intact and open, in all normal operating modes. If the unit housing is not grounded, measure leakage current from each lead to the housing.When the unit has isolated patient connections, it should be labeled "Isolated" on the front panel by the manufacturer or have the IEC symbol signifying isolation (a heart within a square). These

units are designed to be safe for use when connected to a conductive lead or fluid-filled catheter that is within, or in contact with, the heart. Usually, only one lead of the unit will be in contact with the heart (or create a conductive path to the heart). Individually test each isolated lead to confirm that leakage current to ground is 10 A or less with the unit ground intact and 50 A or less with the ground open.

Interlead Leakage Current (Isolated Lead) ( Acceptance ) 0 µA grounded; 0 µA open groundMeasure the leakage current between leads on units with multiple patient leads or contacts. Measure between each lead (except ground). Perform the test with the unit on and with the ground wire both intact and open, in all normal operating modes. For isolated input connections, the leakage current should not exceed 10 A with the unit ground intact or 50 A with the ground open

Lead Input Isolation ( Acceptance ) 0 µA groundedWARNING: Testing input isolation requires the use of a line voltage source. Perform this test only with an electrical safety analyzer or other setup that allows safe application of the voltage to the patient leads. Be sure that a current-limiting resistor is included in the setup, but continue to be careful not to contact any exposed leads, since it is still possible to receive a shock.Apply 120 VAC (line voltage applied through a current-limiting resistor) to each isolated patient connection individually, and measure the resulting current (sink current) with the unit turned on and operating and the power cord grounding connector intact. The current should not exceed 50 A at the patient end of the cable.

Open Electrode Indicator ( Acceptance, Major ) 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 ( Acceptance, Major ) 0.3  at max varies w/setting, no breaths at 0 bpmIf 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 ( Acceptance, Major ) per Procedure 493Perform 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 ( Acceptance, Major ) 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.

Ratemeter Accuracy ( Acceptance, Major ) 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 ( Acceptance, Major ) 20 bpmRecord 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 MaintenanceClean ( Major )Clean the exterior of the apnea monitor with a damp cloth, if needed.

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

NotesInterval Note: Apnea monitors used for home care should be inspected between patient rentals.

System Components0