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.
* Your assessment is very important for improving the work of artificial intelligence, which forms the content of this project