Apnea Monitor PM/Inspection

Apnea Monitor PM/Inspection
Apnea Monitor
Apnea is defined as the absence of breathing. An apnea monitor is designed to detect this
condition. The apnea monitor senses by measuring changes in the electrical impedance of the
thoracic cavity during respiration. Typically, electrodes are attached to the patient with lead
wires connected to the monitor. The monitor will usually display the patient’s heart rate and
respiration rate, with the limits of these parameters adjustable by the user. An audible alarm will
sound when the alarm limits are exceeded or if the monitor or when an apnea condition is
detected. These types of monitors are typically used to monitor high-risk infants.
Recommended functional test frequency: Semiannual
Sample Risk Assessment
Criteria – choose 1 rating from each category
Clinical Function
No patient contact
Device may make contact with patient but function is non-critical
Device is used for patient diagnosis, or direct monitoring
Device is used to deliver direct treatment to the patient
Device is used for a life support
Physical Risk
Device poses no appreciable risk due to failure
Device failure will result in low risk
Device failure will result in inappropriate therapy, misdiagnosis or loss of monitoring
Device failure could result in severe injury to, or death of, patient or user
Problem Avoidance Probability
Maintenance or inspection would not impact reliability of the device
Common device failure modes are unpredictable or not very predictable
While common device failure modes are not very predictable, device history indicates that TSP
testing frequently detects problems
Common device failure is predictable and can be avoided by preventive maintenance
Specific regulatory or manufacturers requirements dictate preventive maintenance or testing
Incident History
No significant History
A significant history of incidents exists
Manufacturers / Regulatory Requirements For Specific Schedules
No requirements.
There are requirements for testing independent of a numerical rating system.
Total Score:
Assignment: 0.0x 0.5x 1x 2x 3x 4x (times per year tested)
Weight
Score
1
2
3
4
5
3
1
2
3
4
4
1
2
3
3
4
5
1
2
1
2
2
1
13
2
Procedure: Apnea Monitor
Estimated Time: 25 Minutes
EQUIPMENT INFORMATION
Control Number:____________________ Hospital:____________________________
Manufacturer:_______________________ Model:_____________________________
Serial Number:______________________ Location:____________________________
TEST INFORMATION
Technician:_________________________ Date:_______________________________
Test Type: Incoming_____ Post Repair_____
Test Equipment Needed: ISA 601 Electrical Safety Analyzer (or equivalent)
MPS450 Multiparameter Simulator (or equivalent)
Stop watch or watch with a second hand
Test Result
Pass Fail N/A
Pass Fail N/A
Pass Fail N/A
Pass Fail N/A
PHYSICAL CONDITION
Device is clean and decontaminated
No Physical Damage to case, display, mounts, cart, or components
Switches and controls operable and correctly aligned
Display intensity adequate for daytime use
Control numbers, labeling, warnings present and legible
Inlets and hoses
Power cord, accessory cables, charger
Filters and vents clean
PREVENTATIVE MAINTENANCE
Replace battery every 24 months
Complete model specific preventive maintenance
ELECTRICAL SAFETY
Ground wire resistance
< 0.5Ω
Chassis leakage
< 300μA new
< 500μA existing
Patient leakage current
< 10μA
Patient lead leakage current – isolation test
< 50μA
(mains on patient applied part)
Insulation test (optional) 500V
<2MΩ
PERFORMANCE TESTING
Verify unit operates on battery
Heart rate accuracy
±5%
Respiratory rate accuracy
±5%
Apnea alarm function
Apnea alarm delay time
±20%
60 BPM rejection of ECG artifact
Alarm function
Complete model specific performance testing
PHYSICAL CONDITION
Physical Condition: Check the physical condition of the device, as described in the General
Equipment Procedure.
PREVENTIVE MAINTENANCE
Replace Battery: The battery should be replaced every 24 months. Replace if necessary.
Complete model specific preventive maintenance: Refer to the monitor’s service manual for
preventative maintenance tasks specific to the device. Complete the preventative maintenance
per manufacturer’s procedure.
ELECTRICAL SAFETY
Electrical Safety: Perform electrical safety checks as described in Chapter 5, Electrical Safety.
Check ground wire resistance, chassis leakage, and lead leakage.
PERFORMANCE INSPECTION
Verify unit operates on battery: Check that the AC power indicator is lit up when the power
cord is plugged into an outlet. Unplug the AC power cord and perform the remainder of the
functional test on battery power. The AC power indicator should go out when the power cord is
unplugged and the battery indicator should light up. Be sure to plug the power cord back in at the
conclusion of the test.
Heart rate accuracy, Respiratory rate accuracy: Connect the patient leads to the lead
connectors on the MPS450. The respiratory signal from the MPS450 is sent to the left arm (LA)
lead on the default setting. Change the respiratory signal to the left leg (LL) if necessary. From
the main menu, hit ‘0’ (‘Setup’), hit the leftmost blue arrow key for ‘Resp’, and then again for
‘Lead’. This will toggle the respiratory lead from LA to LL. For most purposes, the respiratory
lead can be left on left arm.
Set the heart rate on the MPS450 to 120bpm. Hit ‘1’ (‘NSR’), and then use the soft keys marked
‘Up’ and ‘Down’ to change the heart rate to 120bpm.
Set the respiration rate to 60breaths/min. Hit ‘2’ (‘RESP’) and then use the soft keys to change
the respiration rate.
The heart rate and respiration rate should be within 5% of the set rates. For a simulated heart rate
of 120bpm, the displayed rate should be between 114bpm and 126bpm. For a respiration rate of
60breaths/min, the displayed respiration rate should be between 57breaths/min and
63breaths/min.
Apnea alarm function: On the MPS450, hit the button marked ‘2’ (‘RESP’). To simulate an
apnea condition, hit the rightmost soft key button ‘APNE’. Use the soft keys marked ‘PREV’
and ‘NEXT’ to cycle through the apnea durations and select ‘CONTINUOS’. Hit the soft key
labeled ‘RUN’ to start the apnea condition. To stop the apnea condition and return to normal
respiration, hit the soft key labeled ‘STOP’. The alarm should sound for an apnea condition.
Most monitors will alarm within 30 seconds.
Apnea alarm delay time: Simulate an apnea condition as described in the step above. Set the
apnea duration to continuous. Starts the apnea simulation by hitting the soft key labeled ‘RUN’
and begin timing on the stop watch. Stop timing when the apnea alarm sounds. Hit the soft key
labeled ‘END’ to return to normal respiration and silence the alarm. Compare the actual time for
the alarm to sound with the monitor’s alarm delay. The time should be with 20% of the delay
setting. For an apnea delay of 30 seconds, the alarm should sound within 36 seconds.
60bpm rejection of ECG artifact: This test checks the coincidence circuit designed to reject
detected breaths that may be erroneously detected QRS complexes from the ECG signal.
Hit ‘2’ (‘RESP’) to enter the Respiration menu on the MPS450. Set the respiration rate to
60breaths/min. Hit ‘1’ (‘NSR’) to enter the Normal Sinus Rhythm menu. Set the heart rate to
60bpm. The monitor should alarm. Set the heart rate back to 120bpm.
Alarm function: Check that all alarms are functional and that the volume is adequately loud.
Ensure that appropriate visual indicators are functioning.
Check heart rate and respiration rate alarms separately. Note the alarm settings on the monitor.
Hit ‘1’ (‘NSR’) on the MPS450 to enter the Normal Sinus Rhythm menu on the MPS450. Bring
the heart rate down to just below the monitor’s low heart rate limit. The alarm should sound.
Increase the heart rate above the low alarm point. Clear the alarm if necessary. Increase the heart
rate to just above the high heart rate limit. Note that the alarm sounds when the heart rate
increases beyond the high alarm limit. Set the heart rate back to 120bpm and clear any alarms.
Hit ‘2’ (‘RESP’) to enter the Respiration menu. Repeat the process for the respiration rate as
done for the heart rate above. Ensure that the monitor alarms when the respiration rate falls
below the set low respiration limit and above the high respiration limit. Set the respiration rate to
60breaths/min and clear any alarms.
Check the function of the accidental power off alarm. Apnea monitors that are used on infants
are often equipped with a ‘sibling alarm’ that sounds when the monitor is turned off accidentally.
These monitors will require a key sequence to power off without sounding an alarm, such as
holding the reset button while turning the power off. Check the operator’s manual for the
device’s specific operation. To check the alarm, press the power button without performing the
power off button sequence. The monitor should shut down, but an alarm will sound. Follow the
instructions in the operator’s manual to clear this alarm.
Complete model specific performance testing: Refer to the service manual for performance
inspection tasks specific to the device. Complete the performance inspection per manufacturer’s
procedure.
Return to service:
Before returning to use, return any alarms that were adjusted back to their original settings.
Ensure that the volume of the audible alarms is loud enough to be heard in normal operating
conditions. Plug in the power cord to ensure that the battery remains charged.
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