Home

Medical Equipment Quality Assurance: J. Tobey Clark

1. Ground wire resistance lt 0 3 Q Chassis leakage lt 100 pA NC lt 500 pA SFC Patient leakage current lt 100 pA B and BF lt 10 pA CF Patient lead leakage current isolation test lt 100 pA BF mains on patient applied part lt 10 pA CF Insulation test optional 500 V lt 2 MQ Clean vents and filters Replace battery every 24 months Complete model specific preventive maintenance Verify unit operates on battery Fan operation Temperature accuracy 0 3 C Temperature alarms Alarm function Complete model specific performance testing 128 uUniversity of Vermont Rev 2 Confidential Physical condition Check the physical condition of the device as described in the General Equipment Procedure Electrical safety Perform electrical safety checks as described in Chapter 5 Electrical Safety Check ground wire resistance and chassis leakage Preventive maintenance Clean vents and filters Inspect vents and air filters Clean or replace filters as necessary Ensure that filters are installed properly Replace battery The battery should be replaced every 24 months Replace if necessary Complete model specific preventive main tenance Refer to the monitor s service manual for preventive maintenance tasks specific to the device Complete the preventive maintenance per manufacturer s procedure Biomedical Performance inspection Verif
2. Verify operation of alarms Check that all alarms are functional and that the volume is adequately loud Ensure that appropriate visual indicators are functioning Electrocardiographs designed for diagnosis usually do not include hear rate alarms Note the alarm settings on the monitor Press I NSR to enter the Normal Sinus Rhythm menu 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 neces sary 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 60 bpm and clear any alarms Complete model specific performance test ing 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 to their original settings Ensure the volume of the audi ble alarms is loud enough to be heard in normal operating conditions Plug in the power cord to ensure the battery remains charged Electrosurgical unit Electrosurgical units ESU use electrical energy for cutting tissue and for controlling bleeding by causing coagulation using a high frequency electric current Tissue resistance to the high frequency hi
3. 18 TR RAND B A minor problem found during the scheduled performance testing 19 TR RAND C A major problem found during the scheduled performance testing 23 TR MAINT B A minor problem found during the scheduled performance inspection that could have been prevented with maintenance 24 TR MAINT C A major problem found during the scheduled performance inspection that could have been prevented with maintenance 60 PLANNED Planned maintenance 57 NOT TESTED Device not tested during the regularly scheduled performance inspection 58 FT AFTER 57 Device that missed its regularly scheduled inspection has received a performance inspection 15 INCOMING P 63 TR B NFR A minor problem found during the scheduled performance testing that does not require follow up 64 TR C NFR A major problem found during the scheduled performance testing that does not require follow up 65 TR A NFR Scheduled maintenance e g battery replacement was not performed no additional follow up is necessary Device passes initial performance inspection performed before the device is put into service 16 INCOMING F Device does not pass initial performance inspection 25 FT ADD P Device passes initial performance inspection performed after the device is already in service 26 FT ADD F Device does not pass initial performance inspection and has already been in service 27 FT NO ADD P Device passes initial perfo
4. Serial number Location Test information Technician Date Test type Incoming Post repair Test equipment needed DPM 4 Pressure Meter or equivalent Test Result Pass Fail N A Stopwatch or watch with a second hand Tubing and connectors to connect to DPM 4 PVC pipe to attach cuff to 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 and warnings present and legible Inlets and hoses Power cord accessory cables charger Filters and vents clean Check condition of tubing cuffs and hoses Complete model specific preventive maintenance Gauge zero 1 mmHg Leak test lt 15 mmHg min Pressure accuracy 3 mmHg Complete model specific performance testing 132 uUniversity of Vermont Rev 2 Confidential Physical condition Check the physical condition of the device as described in the General Equipment Procedure Electrical safety Perform electrical safety checks as described in Chapter 5 Electrical Safety Check ground wire resistance and chassis leakage Preventive maintenance Check condition of tubing cuffs and hoses Inspect hoses and cuffs for signs of wear Look for holes cracks and dry rot Ensure that all connections a
5. Biomedical Respiration rate Set up the VT PLUS HF analyzer and the ventilator as described above The respiration rate can be read on the volume screen of the analyzer I E ratio Set up the VT PLUS HF analyzer and the ventilator as described above The inspi ration to expiration ratio can be read on the volume screen of the analyzer Pressure accuracy Press 1 PRESSURE on the VT PLUS HF to switch to the pressure screen If the ventilator has a pressure control mode enter a pressure of 40 cmH20 and a rate of 6breaths min otherwise enter a tidal volume of 1000 mL and a rate of 6 breaths min Start the ventilator Compare the pressure measured on the analyzer with the pressure displayed on the ventilator The measured pressure should be within 10 of the displayed pressure Fora displayed pressured of 40 cmH20 the measured pressure should be between 36 cmH20 and 44 cmH20 PEEP Put the ventilator into volume control mode with a tidal volume of 1000 mL and a rate of 6 breaths min Begin ventilating Watch the pressure airway pressure gauge during ventilation Following expiration the pressure gauge should return to zero Set the PEEP post expiratory end pressure to 10 cmH20 The airway pressure gauge should drop to 10 cmH20 following expiration instead of returning to zero Measure the actual PEEP using the VT PLUS HF PEEP is displayed on the pressure screen University of Vermont Rev 2 Confidential 1
6. J Tobey Clark Director Instrumentation amp Technical Service Faculty Biomedical Engineering School of Engineering Michael Lane Associate Director Instrumentation amp Technical Services Leah Rafuse Clinical Engineer Instrumentation amp Technical Services Instrumentation amp Technical Services University of Vermont 280 East Avenue Suite 2 Burlington VT 05401 Introduction oss csnsigcctateanccastananietuinetanieanian EE EEEE AEE AEE 2 Definiti ns nieou aeiaai 3 Using a Risk Based Assessment for Establishing a Medical Equipment Maintenance Program eee 5 General Procedures iisisti uakai ak aN aK iKa 11 Electri al Safety ooccisniericedsesctnsinsviensanianennieiannarieranraeaginsdvasnrenarsaen 24 Equipment Inspection Procedures 0 ccceeceeeeceeeeereeteeneeenee 37 General Equipment sssrinin teen eee i eee 38 Apnea MONON 2 sesese2hcazcceshancipsszatachesses ees eE nea EEE ena ENEE On Ea REES a rA EAEn Eao 41 ASpir to arina aa E AN 45 Cardiac Output Unit screenen anaa EEaren VE EAE EE hands TAAN EAEAN nein aicia a 49 Central Station Monitoring System oo eseseeeeneeeeeeeeeeeeeaeeeeaeeeeseseeaeeeesseeesaeeeens 52 Compression UNI sossen n eaaa oi tected rere wedged avn TAE ERA eer tee 55 Defbnlator atc cecvaviinondin Matias anne clan ated cia 59 EIGCIROCATCIOGT ap li acena total ved ead teh i cseeatd fei ees a ieee tees 65 Electrosurgical UNI cornisa a teres awe ae ied een he 69 ET
7. continued on page 112 University of Vermont Rev 2 Confidential 111 procedure Estimated time 45 minutes continued from page 111 Test Result Pass Fail N A Clean flow detector Replace battery every 24 months Complete model specific preventive maintenance Verify unit operates on battery Door lock Pole clamp function Load dose 10 Flow rate accuracy 10 Volume accuracy 10 PCA dose 10 Lock out interval 5 Dose limit KVO rate 10 Occlusion detection pressure 1 psi Alarm function Complete model specific performance testing 112 University of Vermont Rev 2 Confidential Physical condition Check the physical condition of the device as described in the General Equipment Procedure Electrical safety Perform electrical safety checks as described in Chapter 5 Electrical Safety Check ground wire resistance and chassis leakage Preventive maintenance Clean flow detector Inspect the flow detector on the PCA pump Clean any debris from the flow sensor Replace battery The battery should be replaced every 24 months Replace if necessary Complete model specific preventive main tenance Refer to the monitor s service manual for preventive maintenance tasks specific to the device Complete the preventive maintenance per manufacturer s procedure Performance inspection Verify unit operates on battery
8. A significant history of incidents exists No requirements There are requirements for testing independent of a numerical rating system 2 Total Score Assignment 0 0x 0 5x 1x 2x 3x 4x times per year tested 8o University of Vermont Rev 2 Confidential oroceqdure Estimated time 30 minutes Equipment information EE Biomedical 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 Cables to connect fetal monitor to PS320 Fetal Simulator or equivalent analyzer MFH 1 Mechanical Fetal Heart or equivalent Stopwatch or clock with second hand Ultrasound gel Test Result Pass Fail N A 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 and warnings present and legible Inlets and hoses Power cord accessory cables charger Filters and vents clean Electrical safety O SE Ground wire resistance lt 0 3 Q Chassis leakage lt 100 pA NC lt 500 pA SFC Patient leakage current lt 100 pA B and BF lt 10 pA CF Patient lead leakage current isolation test
9. BW MO 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 No significant history Oly WO Ne A significant history of incidents exists No requirements N 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 University of Vermont Rev 2 Confidential 10 l 65 orocequre 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 Test Result Pass Fail N A 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 and warnings present and legible Inlets and hoses Power cord accessory cables charge
10. Ground wire resistance 0 3 Q Current in pA Applied part Type Type Type B BF CF Equipment leakage alternative method For accessible conductive parts of Class I equipment con nected or not connected the protective ih conductor 1090 1000 1000 For Class II ME equipment 500 500 500 Equipment leakage direct or different method Equipment leakage current for accessible conductive parts of Class I ME equipment connected or not connected to the 500 500 500 protective earth conductor Equipment Leakage current for Class II ME equipment NC 100 100 100 Applied part leakage current alternative method a c Applied part leakage current of applied part lt 5000 lt 50 Applied part leakage current direct method a c Total patient leakage current mains voltage on applied part 5000 100 Insulation test optional 500 V dc applied lt 2 MQ Tested by Date University of Vermont Rev 2 Confidential 29 To grounded portion of enclosure Figure 9 ESA601 connected to a device under test Physical condition Verify the case integrity and look for damage Ensure the device is not contaminated Check the controls indicators and displays Verify the labeling is appropriate not damaged and legible Check the fuse has the proper rating Visually inspect the power cord plug any cables connectors chargers or other external connections Verify any mecha
11. Manufacturer Model Serial number Location Test information Technician Date Test type Incoming Post repair Test equipment needed ISA 601 Electrical Safety Analyzer or equivalent DPM 4 Pressure Meter or equivalent Stopwatch or watch with a second hand Squeeze bulb with bleed valve Tubing and connectors to connect to DPM 4 PVC pipe to attach tourniquet cuff to Test Result Pass Fail N A 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 and warnings present and legible Inlets and hoses Power cord accessory cables charger Filters and vents clean Check condition of tubing cuffs and hoses Ground wire resistance lt 0 3 Q Chassis leakage lt 100 pA NC lt 500 pA SFC Patient leakage current lt 100 pA B and BF lt 10 pA CF Patient lead leakage current isolation test lt 100 pA BF mains on patient applied part lt 10 pA CF Insulation test optional 500 V lt 2 MQ Replace battery every 24 months Complete model specific preventive maintenance Verify unit operates on battery Verify function of control valve Controller stability 10 mmHg after 15 min Cuff pressure accuracy 5 Timer accuracy 2 min after 15 min Maximum cuff
12. piration rate of 60 breaths min the displayed respiration rate should be between 57 breaths min and 63 breaths min Apnea alarm function On the MPS450 press the button marked 2 RESP To simulate an apnea condition press the rightmost soft key button APNE Use the soft keys marked PREV and NEXT to cycle through the apnea durations and select CONTINUOUS Press the soft key labeled RUN to start the apnea condi tion To stop the apnea condition and return to normal respiration press 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 Start the apnea simulation by pressing the soft key labeled RUN and begin timing on the stop watch Stop timing when the apnea alarm sounds Press 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 43 University of Vermont Rev 2 Confidential 60 bpm 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 Pres
13. Be sure the disper sive electrode is placed on a non conductive surface where the electrode will not come into contact with anyone The load resistance may need to be adjusted for bipolar operation Repeat the output measurements detailed above for both cut and coagulation modes according to the table below Test results Cut 100 50 W 42 5 W 57 5 W 75 37 5 W 31 9 W 43 1 W 50 25 W 21 3 W 28 8 W 25 12 5 W 10 6 W 14 4W Coagulation 100 50 W 42 5 W 57 5 W 75 37 5 W 31 9 W 43 1 W 50 25 W 21 3 W 28 8 W 25 12 5 W 10 6 W 14 4W Return electrode monitor Connect the dispersive electrode to the ESU and connect the two wires of the dispersive electrode to the red and black VAR LOAD connectors of the QA ES II To make a quick test set from a dis posable dispersive electrode cut the electrode from the cable and separate the two wires in the dispersive cable Strip the wires and attach banana plug connectors Press F2 KNOB PARAM on the QA ES II until the asterisk appears next to Mode Use the encoder knob to select REM test and then press enter to select the test Press F2 KNOB PARAM to select Delay Turn the encoder knob to set the delay to 3000 ms Press F3 START on the QA ES II The load resistance will start at 10 Q and gradually increase Press F3 STOP to stop the test when 72 University of Vermont Rev 2 Confidential the alarm sound
14. 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 UW5 Ultrasound wattmeter or equivalent Stopwatch or watch with a second hand Test Result Pass Fail N A 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 and warnings present and legible Inlets and hoses Power cord accessory cables charger Filters and vents clean Ground wire resistance lt 0 3 Q Chassis leakage lt 100 pA NC lt 500 pA SFC Patient leakage current lt 100 pA B and BF lt 10 pA CF Patient lead leakage current isolation test lt 100 pA BF mains on patient applied part lt 10 pA CF Insulation test optional 500 V lt 2 MQ Inspect sound head Complete model specific preventive maintenance Verify unit operates on battery Output accuracy 20 Duty cycle Timer accuracy 10 sec Alarm function Complete model specific performance testing 138 vUniversity of Vermont Rev 2 Confidential Physical condition Check the physical condition of the device as described in the General Equipment Procedure Electric
15. 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 BIW NO w 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 oje WO N No significant history 1 1 A significant history of incidents exists N No requirements There are requirements for testing independent of a numerical rating system 2 Total Score Assignment 0 0x 0 5x 1x 2x 3x 4x times per year tested University of Vermont Rev 2 Confidential 49 orocequre Estimated time 20 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 Test Result Pass Fail N A MPS450 Multiparamete
16. Index 2 for a manual simulation with the SpO2 126 uUniversity of Vermont Rev 2 Confidential at 96 and the heart rate 80 bpm Initiate a measurement on the pulse oximeter Adjust the SpOz on the Index 2 to 100 The high 02 alarm on the pulse oximeter should activate Bring the SpOz back down to 96 and clear the alarm Adjust the SpOz on the Index 2 to 88 The low 02 alarm on the pulse oximeter should activate Bring the SpO2 back to 96 and clear the alarm Set the high heart rate alarm on the pulse oximeter to 120 bpm and set the low heart rate alarm to 60 bpm Adjust the heart rate on the Index 2 to 125 bpm The high heart rate alarm should activate Return the heart rate to 80 bpm and clear the alarm Adjust the heart rate on the Index 2 to 55 bpm The low heart rate alarm should activate Return the heart rate to 80 bpm and clear the alarm Return all alarm limits to their original settings Complete model specific performance testing Refer to the service manual for perfor mance inspection tasks specific to the device Complete the performance inspection per manufacturer s procedure Return to service Before returning to use return any settings that were adjusted to their original settings Ensure the volume of the audible alarms is loud enough to be heard in normal operating conditions Plug in the power cord to ensure the battery remains charged Radiant warmer Radiant warmers provide
17. On the defibrillator set the ECG source to Lead II The heart rate should be within 5 of the set rate For a simulated heart rate of 60 bpm the displayed rate should be between 57 bpm and 63 bpm Set the heart rate on the Impulse 4000 bpm to 120 bpm The displayed heart rate should be between 114 bpm and 126 bpm Recorder speed Set the heart rate on the Impulse 4000 bpm to 60 bpm Record a strip on the defibrillator Measure the distance between the peaks of the QRS complex With a recorder speed of 25 mm sec the QRS peaks should be between 24 mm and 26 mm apart Verify operation of alarms Check that all alarms are functional and that the volume is adequately loud Ensure appropriate visual indi cators are functioning Note the alarm settings on the defibrillator Set the low limit to 35 bpm and the high limit 155 bpm The alarm limits may not be able to be set to these exact values depending on the defibrillator If that is the case set the alarm limits to the next closest value keeping the low limit above 30 bpm and the high limit below 160 bpm Press F3 ECG on the Impulse 4000 to enter the ECG menu Press F1 NORM to select a normal sinus rhythm Set the heart rate to 30 bpm The alarm should sound Increase the heart rate to 80 bpm and clear the alarm if necessary Set the heart rate to 160 bpm Verify that the alarm sounds when the heart rate increases beyond the high alarm limit Set the heart rate back to 8
18. Place the cuffs around a piece of PVC pipe or other sturdy cylindrical object to simulate placement on a limb Inflate the proximal cuff Ensure the tourniquet is able to hold pressure Inflate the distal cuff Again Ensure the tour niquet is able to hold pressure and then deflate the cuff Inflate both cuffs together Hold the pressure for a short time and then deflate If the tourniquet has multiple channels repeat the test for each channel Controller stability Attach a 3 way connec tor to the pressure port on the DPM 4 Attach a squeeze ball to one leg of the connector Ensure the bleed valve on the squeeze ball is closed Attach another 3 way connector to the other leg Connect the remaining two legs between the hose and the cuff of the tourniquet Set the pressure on the pneumatic tourniquet to 400mmHg and inflate the cuff Allow the pressure to stabilize for 15 minutes After 15 minutes the pressure should be between 390 mmHg and 410 mmHg Cuff pressure accuracy Set the pressure on the pneumatic tourniquet to 200 mmHg and inflate the cuff Observe the pressure for at least two minutes to Ensure the pressure remains stable The displayed pressure should be within 5 of the measured pressure For a displayed pressure of 200 mmHg the measured pressure should be between 190 mmHg and 210 mmHg Set the cuff pressure to 450 mmHg and repeat the measurement At this setting the measured pressure should be between 427 5 mmHg and 47
19. Press the soft key labeled OPTIONS on the BP Pump 2 to cycle through the available preset blood pres sure simulations Select a blood pressure of 120 80 on the analyzer Initiate a blood pressure measurement on the NIBP monitor The displayed pressure should be within 10 mmHg of the set pressure For a set blood pressure of 120 80 the systolic pressure should be between 110 mmHg and 130 mmHg and the diastolic pressure should be between 70 mmHg and 90 mmHg Repeat the measure ments for a blood pressure of 200 150 and a blood pressure of 80 50 University of Vermont Rev 2 Confidential 107 Auto interval time Select a standard blood pressure on the BP Pump 2 of 120 80 Put the NIBP into automatic mode with an interval of 5 minutes Use a stopwatch or a watch with a second hand to measure the length of time between BP measurements The measured time should be within 10 of the set interval For a set interval of 5 minutes the measured interval should be between 4 minutes 30 seconds and 5 minutes 30 seconds Stop Cancel Deflate Initiate a blood pres sure measurement on the NIBP monitor Allow the cuff to inflate Stop the measurement on the monitor The cuff should deflate in less than 10 seconds NIBP alarms Select STANDARD BP on the BP Pump 2 Press the soft key labeled OPTIONS on the BP Pump 2 and set the simu lated blood pressure to 200 155 Set the high alarm limits on the NIBP monitor lower than the s
20. Refer to the service manual for perfor mance inspection tasks specific to the device Complete the performance inspection per manufacturer s procedure Return to service Before returning to use return any settings that were adjusted to their original settings Ensure the volume of the audible alarms is loud enough to be heard in normal operating conditions Plug in the power cord to ensure the battery remains charged University of Vermont Rev 2 Confidential 133 Therapeutic stimulator Therapeutic stimulators cause controlled mus cular contractions by applying electrical stimuli to nerves that control muscle activity They are typically used during physical therapy for pain management and to reduce swelling These devices consist of a pulse generator intensity Sample risk assessment Criteria choose 1 rating from each category No patient contact controls and a timer A controlled electrical current is delivered to the muscles through electrodes applied to the patient s skin Thera peutic stimulators are often used in conjunction with therapeutic ultrasound Recommended functional test frequency annual Weight Score 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 Device poses no appreciable risk due t
21. The skin is a high electrical resistance but internal body components such as blood and muscle are a low electrical resis tance Currents as low as 20 microamps can cause ventricular fibrillation in experiments conducted with dogs when a conductor made direct contact to the heart Microshock is the term used to describe direct shocks to the car diac muscle From the data for macroshock and micro shock limits have been established for leakage current These limits are contained in various standards worldwide In the case of equipment designed for low resistance direct contact with patients including indwelling catheters elec trical isolation design techniques are applied to reduce the current flowing to the patient to microamperes even at line voltage levels Even under device failure or short circuit conditions the patient is protected from microshock These techniques may utilize isolation transformers and optical circuits Thus electrical safety stan dards specify low microampere limits for direct patient contact equipment 1 mA Cardiac fibrillation Muscle contraction suffocation Let go current Sensitivity limit 10 mA 100 mA 1A 10A 100 A Figure 4 Effects of current flowing from one skin contact point to another 24 University of Vermont Rev 2 Confidential To reduce leakage current to negligible levels chassis grounding is utilized to shunt any leak age or fault current to gr
22. University of Vermont Rev 2 Confidential 89 oroceqdure Estimated time 120 minutes continued from page 89 Test Result Pass Fail N A Verify unit operates on battery Fan operation Warm up time 20 Air temperature accuracy 1 C Skin temperature accuracy 0 3 C Temperature overshoot 2 C Relative humidity 10 Air flow lt 0 35 m s Air temperature alarms Skin temperature alarms High temperature protection lt 40 C Noise level lt 60 dB normal conditions lt 80 dB alarm activated gt 80 dB alarm activated 3 m from incubator Alarm function Complete model specific performance testing 90 uUniversity of Vermont Rev 2 Confidential Physical condition Check the physical condition of the device as described in the General Equipment Procedure Electrical safety Perform electrical safety checks as described in Chapter 5 Electrical Safety Check ground wire resistance and chassis leakage Preventive maintenance Clean cooling vents and filters Inspect vents and air filters Use a portable vacuum to clean dust from air ducts Clean or replace filters as necessary Ensure that filters are installed properly Inspect gaskets for signs of deterioration Check rubber or plastic gaskets and seals for signs of deterioration Replace as necessary Inspect port closures and port sleeves Inspect port doors and iris seals
23. are functioning Remove one of the electrode cables from the scope probe being careful not to touch the exposed electrode Verify that the electrode disconnection alarm activates Complete model specific performance testing Refer to the service manual for perfor mance inspection tasks specific to the device Complete the performance inspection per manufacturer s procedure Return to service Before returning to use return any settings that were adjusted to their original settings Ensure the volume of the audible alarms is loud enough to be heard in normal operating conditions Therapeutic ultrasound Therapeutic ultrasounds deliver ultrasonic waves that penetrate tissues and cause thermal and non thermal effects and are typically used to speed healing in soft tissue injuries Energy from the sound waves is absorbed and causes heating in the tissue resulting in an increase in blood flow which speeds healing and reduces swelling Sound waves also cause a cavitational annual Sample risk assessment Criteria choose 1 rating from each category No patient contact Weight Biomedical effect from the vibration of the tissue causing microscopic air bubbles to form The air bub bles transmit the vibrations and stimulate cell membranes Therapeutic ultrasounds consist of a radio frequency generator usually 1 MHz to 3 MHz an intensity controller and an applicator containing a piezoelectric transducer Recom
24. maintenance interval is given as a length of time i e every 6 months but can also be given in hours of equipment operation i e every 10 000 hours Managed inventory A record of medical equipment used in the facility that only includes equipment requiring scheduled maintenance Mean time between failures The average time between failures of a device or system This is used as an indication of reliability Nosocomial infection An infection con tracted by a patient during a hospital stay Performance inspection A procedure to ensure a device operates appropriately The device should meet safety and performance requirements of regulatory agencies the health care facility and the manufacturer Performance inspections will vary by device type and each device type should have a written procedure that includes the characteristics that are tested how to test them and acceptable operational limits Performance inspections are performed periodically to ensure proper operation of devices prior to being put into service for the first time after a repair or anytime the operation of the device is questioned Physical risk The risk associated with device failure Preventive maintenance PM Periodic procedures to reduce the risk of device failure The maintenance interval may be based on time e g every 12 months or operational usage e g every 1 000 hours Preventive maintenance is designed to ensure continuous operation of
25. under channel 1 and then press ENT Use the arrow keys to highlight FLOW and press ENT Select PRIME Close the stopcock port con nected to the feeding tubing leaving the ports to the syringe and the IDA 4 Plus open Inject the solution in the syringe into the IDA 4 Plus until START appears on the screen Select AutoSTART The IDA 4 Plus will start the flow test when it detects flow from the pump Close the port to the syringe leaving the ports to the tubing and the IDA 4 Plus open 75 U niversity of Vermont Rev 2 Confidential Set the flow rate on the feeding pump to 60 mL hr and set the dose to 10 mL Start the feeding pump When the pump alarms com plete select END on the IDA 4 Plus to end the test At this rate and volume the dose should be complete in approximately 10 minutes Clear the alarm on the pump The measured flow rate should be within 10 of the set rate For a flow rate of 60 mL hr the flow rate should be between 54 mL hr and 66 mL hr Set the flow rate on the pump to 120 mL hr and the dose to 10 mL Repeat the flow test at the higher flow rate The IDA 4 Plus is equipped with four chan nels to analyze infusion devices Four pumps can be run simultaneously Volume accuracy Set up the feeding pump and the IDA 4 Plus as described previously in Flow Rate Accuracy The IDA 4 Plus will mea sure flow rate and volume simultaneously The delivered volume should be
26. ure The power failure alarm should activate Complete model specific performance testing Refer to the service manual for perfor mance inspection tasks specific to the device Complete the performance inspection per manufacturer s procedure Return to service Before returning to use return any settings that were adjusted to their original settings Ensure the volume of the audible alarms is loud enough to be heard in normal operating conditions Plug in the power cord to ensure the battery remains charged Sphygmomanometer A sphygmomanometer is a device for measur ing blood pressure It consists of an inflatable cuff an inflation bulb with a one way valve and a pressure meter The pressure meter may be either a mercury manometer or an aneroid gauge although many healthcare institutions no longer allow the use of mercury Typically the cuff is placed around the patient s arm and then inflated until the artery is occluded Biomedical The cuff is then deflated slowly while a clini cian uses a stethoscope to listen for Korotkoff sounds the sound of blood flow through the artery at the brachial pulse The pressure at which the first sound is heard as the cuff is deflating is the systolic pressure The pressure at which sounds are no longer heard is the diastolic pressure Recommended functional test frequency annual Sample risk assessment Criteria choose 1 rating from each category No pat
27. 110 University of Vermont Rev 2 Confidential 12 l EEE Biomedical orocequre Estimated time 45 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 IDA 4 Plus Infusion Device Analyzer or equivalent PCA trigger interface Tubing set for PCA pump Reservoir to connect to tubing set bag bottle or syringe 20 cc or larger syringe 3 way stopcock Cable to connect PCA trigger interface to PCA pump Tubing and connectors to connect infusion set to IDA4 Plus Tubing and connectors to connect to IDA 4 Plus Test Result Pass Fail N A 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 and warnings present and legible Inlets and hoses Power cord accessory cables charger Filters and vents clean Ground wire resistance lt 0 3 Q Chassis leakage lt 100 pA NC lt 500 pA SFC Patient leakage current lt 100 pA B and BF lt 10 pA CF Patient lead leakage current isolation test lt 100 pA BF mains on patient applied part lt 10 pA CF Insulation test optional 500 V lt 2 MQ
28. 5 Recorder speed 4 Verify operation of alarms Output accuracy 15 Output energy at maximum setting for 10 charge cycles 15 Charge time after 10 discharge cycles lt 15 sec Energy after 60 sec of full charge gt 85 Internal discharge function Synchronizer operation lt 60 msec Pacer output accuracy 10 Pacer rate accuracy t 5 Demand mode sensitivity Complete model specific performance testing University of Vermont Rev 2 Confidential 61 Physical condition Check the physical condition of the device as described in the General Equipment Procedure Electrical safety Perform electrical safety checks as described in Chapter 5 Electrical Safety Check ground wire resistance chassis leakage and lead leakage Preventive maintenance Replace battery The battery should be replaced every 24 months Replace if necessary Verify electrodes and defibrillator gel or dispos able paddles are stored with the defibrillator and are within expiration dates Verify that ECG electrodes are stored with the unit If hard paddles are used verify that defibrillator gel is stored with the unit The conductive gel should be for use with defibrillators and lotion skin lubricant or ultrasound gel should not be used If hard paddles are not used verify that dis posable pads are stored with the unit Check the expiration date on the electrodes gel and disposable paddles Verify proper time and date Correct if
29. Analyzer or equivalent MPS450 Multiparameter Simulator or equivalent Ohmmeter Can be part of a multimeter such as the Fluke 73 series digital multimeter Cables and connectors to connect defibrillator to analyzer Test Result Pass Fail N A 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 and warnings present and legible Inlets and hoses Power cord accessory cables charger Filters and vents clean Ground wire resistance lt 0 3 Q Chassis leakage lt 100 pA NC lt 500 pA SFC Patient leakage current lt 100 pA B and BF lt 10 pA CF Patient lead leakage current isolation test mains on patient applied part lt 100 pA BF lt 10 pA CF Insulation test optional 500 V lt 2 MQ Replace battery every 24 months Verify electrodes gel and paddles are stored with the defibrillator and are within expiration dates Verify proper time and date correct if necessary Complete model specific preventive maintenance continued on page 61 60 University of Vermont Rev 2 Confidential Biomedical continued from page 60 Test Result Pass Fail N A Verify unit operates on battery Paddle continuity lt 0 15 Q Heart rate accuracy
30. CABLES OR CONNEC TORS TO COME IN CONTACT WITH CONDUCTIVE SURFACES SUCH AS METAL TABLES DEACTIVATE THE ESU BEFORE ADJUSTING OR REMOVING CONNECTIONS ESU with handpiece connected to QA ES II FLUKE Biomedical Performance inspection Inspect dispersive electrode Inspect reusable dispersive electrodes for cracks bends burn marks severe scratching or a build up of gel Electrodes should be smooth and clean to allow the maximum contact area to the patient Operation of footswitch Check the physical condition of the footswitch Ensure the foot switch does not stick in the on position Both cut and coagulation mode should be able to be activated from the footswitch Output power Connect the monopolar active electrode of the ESU to the red VAR LOAD connector on the QA ES II Connect the dis persive electrode of the ESU to the black VAR LOAD connector on the QA ES II Put the QA ES II in continuous mode From the main menu press F2 KNOB PARAM until an asterisk appears beside Mode Turn the encoder knob until Cont Oper appears on the screen Press F2 to adjust the test load An asterisk should appear by Load on the screen Use the encoder knob to select the load resis tance Check the ESU s service manual for the appropriate load resistance Press F3 START to start measuring the energy output Put the ESU in cut mode and set the energy output to minimum Activate the ESU and
31. Check the ac power indicator is lit when the power cord is plugged into an outlet Unplug the ac power cord and perform the remainder of the func tional test on battery power The ac power indicator should go out when the power cord is unplugged and the battery indicator should light Be sure to plug the power cord in at the conclusion of the test Door lock Inspect the door assembly Ensure the door swings smoothly and locks with the key Pole clamp function Check the physical condition of the pole clamp The pole clamp should be securely fastened to the pump The clamp mechanism should move freely The pole clamp should secure the pump to the IV pole Ensure the pole clamp cannot be released when the pump is locked Biomedical Load dose Fill the reservoir with a 1 deter gent solution in de ionized water Prepare a 1 stock solution of detergent such as Cole Parmer Micro 90 in volume using de ionized water this may be stored in a closed vessel for up to 6 months This solution should then be diluted 10 1 with de ionized water for daily use If the water used causes too much foaming a 20 1 dilution is recommended Do not use tap water or solutions intended for patient use as these may harm the transducers in the IDA 4 Plus Connect the infusion tubing to the reser voir Prime the set so that there is no air in the tubing With the tubing draining into a container or sink open the flow control mecha nism on the tub
32. Connect a tee to this tubing and attach tubing and connectors Connect the two legs of the tee between the hose and the cuff of the NIBP monitor Place the NIBP monitor in service mode to perform the leak test Select LEAK TEST on the BP Pump 2 Press SETUP to change the test pressure set point Use the number keys to enter a test pressure of 250 mmHg and then press ENT Press the soft key labeled START on the analyzer to start the test Allow the test to run for at least 30 seconds and then press the soft key labeled STOP to end the test The leak rate should be less than 15 mmHg min Static pressure accuracy With the NIBP monitor in service mode select Static Pressure on the BP Pump 2 Press the soft key labeled SOURCE Set the test pressure on the analyzer to 200 mmHg Start the test by pressing the soft key labeled START Compare the pressure displayed on the NIBP monitor with the mea sured pressure displayed on the analyzer The measured pressure should be within 3 mmHg of the displayed pressure For displayed pressure of 200 mmHg the measured pressure should be between 197 mmHg and 203 mmHg 101 University of Vermont Rev 2 Confidential Pressure relief test Place the NIBP monitor into service mode Select PRESSURE RELIEF on the BP Pump 2 and set the test pressure to 380 mmHg Press the soft key labeled START to start the test Once the high pressure relief
33. Inspection labels warranty labels and battery labels are also placed on the device when appropriate The equipment can now be placed into service If the device does not pass the inspection it is not placed into service and the deficiencies are noted Many devices receiving an incoming inspection are covered under warranty In this case the vendor should be contacted to either exchange or repair the equipment The equip ment should not be placed into service until it can successfully pass the incoming inspection Biomedical Incoming inspection of temporary medical equipment Temporary medical equipment is equipment that is not owned by the hospital and which is either used for patient care on a sporadic basis or which will be used for a limited amount of time at the facility typically 90 days or less Such equipment may include rental equipment a sales demo or patient owned equipment Temporary medical equipment needs to be properly maintained just as hospital owned equipment does to protect the safety of the patient All medical equipment needs to undergo an incoming inspection Medical equipment that will be at the facility for a single time of 90 days or less does not need to be added to the equip ment inventory although a record should be kept of the initial incoming inspection Equip ment that will be at the facility for longer than 90 days should be added to the equipment inventory to be tracked just like hosp
34. Likewise as the reliability of medi cal devices improves fewer problems are found during functional testing In addition newer technology often requires fewer scheduled parts for replacement as electronic controls are replacing mechanical systems For example anesthesia machines are beginning to use electronically controlled flow controls instead of the traditionally used mechanical needle valve assemblies Electronically controlled devices tend to be more accurate and do not have parts that wear like mechanical systems do These devices may no longer continue to benefit from frequent inspections University of Vermont Rev 2 Confidential 9 In addition to tracking problems found during functional testing other types of device prob lems should be tracked Device problems that cannot be reproduced and perceived problems arising from incorrect use are indicators that clinical staffs need additional education on the proper use of these devices For example if it is noticed that there is a high incidence of work orders with no problems found for patient moni tors the clinical staff may need to be retrained on the proper operation of the monitors Devices that have been abused may indicate the need for additional staff education or a change in clinical protocol such as equipment storage or cleaning Device failures that could have been prevented with proper maintenance such as tubing and filters that need to be changed in a venti
35. Power cord accessory cables charger Filters and vents clean Ground wire resistance lt 0 3 Q Chassis leakage lt 100 pA NC lt 500 pA SFC Patient leakage current lt 100 pA B and BF lt 10 pA CF Patient lead leakage current isolation test lt 100 pA BF mains on patient applied part lt 10 pA CF Insulation test optional 500 V lt 2 MQ Replace filters as necessary Complete model specific preventive maintenance Inspect dispersive electrode Operation of footswitch Output power 15 Return electrode monitor Alarms Complete model specific performance testing 70 University of Vermont Rev 2 Confidential Physical condition Check the physical condition of the device as described in the General Equipment Procedure Electrical safety Perform electrical safety checks as described in Chapter 5 Electrical Safety Check ground wire resistance and chassis leakage Preventive maintenance Replace filters Inspect filters and replace as necessary Refer to the device service manual for filter replacement Complete model specific preventive main tenance Refer to the monitor s service manual for preventive maintenance tasks specific to the device Complete the preventive maintenance per manufacturer s procedure MPORTANT DO NOT TOUCH THE CABLES AND CONNECTORS FROM THE ACTIVE OR DISPERSIVE ELECTRODES WHILE THE ESU IS ACITVE DO NOT ALLOW
36. SFC is single fault conditions Some of the measurements are only applicable to manufacturer design testing EEE Biomedical Earth Enclosure Patient Patient Patient leakage Patient Patient Patient leakage leakage leakage leakage current mains auxiliary auxiliary auxiliary Leakage current current current AC current DC on applied current current DC current AC current pA mA HA HA HA HA HA HA HA Type B NC 5 100 100 10 100 10 100 SFC 10 500 500 50 500 50 500 Type BF NC 5 100 100 10 100 10 100 SFC 10 500 500 50 5000 500 50 500 Type CF NC 5 10 10 10 SFC 10 50 50 50 50 Other important points about IEC 60601 1 are the use of up to 25 amperes AC for protec tive earth testing leakage current is measured at 110 of mains voltage and performance of dielectric strength insulation testing A new IEC standard is used for medical device testing in hospitals IEC standards 62353 applies to testing of medical equipment and medical electrical systems which comply with IEC 60601 1 IEC 62353 was developed because IEC 60601 1 is a type testing standard with no risk management criteria and is impractical for testing in the hospital environment IEC 62353 tests include those prior to use on patients during schedule periodic testing and after repair Thus this standard is for hospi tals and does not address equipment design In Annex E of the
37. Switches and controls operable and correctly aligned Display intensity adequate for daytime use Control numbers labeling and warnings present and legible Inlets and hoses Power cord accessory cables charger Filters and vents clean Ground wire resistance lt 0 3 Q Chassis leakage lt 100 pA NC lt 500 pA SFC Patient leakage current lt 100 pA B and BF lt 10 pA CF Patient lead leakage current isolation test lt 100 pA BF mains on patient applied part lt 10 pA CF Insulation test optional 500 V lt 2 MQ Inspect and clean reservoir Lubricate motor Complete model specific preventive maintenance Fluid level Flow rate Temperature accuracy 1 C High temperature protection gt 43 C Low temperature protection lt 1 C Temperature probe accuracy ELC Alarms Complete model specific performance testing University of Vermont Rev 2 Confidential 85 Physical condition Check the physical condition of the device as described in the General Equipment Procedure Electrical safety Perform electrical safety checks as described in Chapter 5 Electrical Safety Check ground wire resistance and chassis leakage Preventive maintenance Inspect and clean reservoir Empty the water reservoir Check for cracks and leaks Inspect the condition of rubber seals and replace as necessary Clean any debris or mineral build up from the reservo
38. 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 No significant history aje wo Nj A significant history of incidents exists 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 94 University of Vermont Rev 2 Confidential 12 EE Biomedical oroceqdure Estimated time 45 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 Tubing set for infusion pump IDA 4 Plus Infusion Device Analyzer or equivalent 20 cc or larger syringe Reservoir to connect to tubing set bag or bottle 3 way stopcock Tubing and connectors to connect to IDA 4 Plus Test Result Pass Fail N A 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 and warnings present and legible Inlets and hoses Power cord accessory cables
39. The measured irradiance should be between 198 pW cm2 and 1760 pW cm2 Refer to the phototherapy unit s service manual for the unit s output range Alarm function Check that all alarms are functional and that the volume is adequately loud Ensure that appropriate visual indicators are functioning Complete model specific performance testing Refer to the service manual for perfor mance inspection tasks specific to the device Complete the performance inspection per manufacturer s procedure Return to service Before returning to use return any settings that were adjusted to their original settings Ensure the volume of the audible alarms is loud enough to be heard in normal operating conditions Pneumatic tourniquet Tourniquets are used to prevent blow flow to a limb during surgery A pneumatic tourniquet consists of an inflatable cuff an air pump pressure sensors and a processor to control cuff pressure The cuff is placed on the limb proximal to the operative site The cuff is then inflated to a preset pressure occluding vessels semiannual Sample risk assessment Criteria choose 1 rating from each category No patient contact Biomedical Weight and arteries and preventing blow flow past the cuff The pneumatic tourniquet measures and displays the cuff pressure and inflation time The cuff itself is typically dual chambered allowing for alternation of the pressure site Recommended functional te
40. analyzer As above the displayed heart rate should be within 5 of the set rate Fora simulated heart rate of 120 bpm the displayed rate should be between 114 bps and 126 bps Disconnect the cables from the PS320 analyzer To test the operation of the ultrasound trans ducers connect the MFH 1 Fetal Heart Simulator to the US1 port of the PS320 analyzer The analyzer will need to be used with the battery eliminator as the MFH 1 cannot run on battery power Connect an ultrasound transducer to the fetal monitor Place the transducer face up on a flat surface and coat with ultrasound gel Place the MFH 1 on top of the transducer with the simulation window facing the transducer The fetal heart rate will be displayed on the monitor and should be within 5 of the set rate For a simulated heart rate of 120 bpm the displayed rate should be between 114 bpm and 126 bpm Repeat this process for each ultrasound trans ducer Remove the MFH 1 from the PS320 Maternal heart rate accuracy Connect the ECG cable to the connectors on the side of the PS320 Use the maternal up and down buttons to set a maternal heart rate of 60 bpm The dis played heart rate should be within 5 of the set rate For a simulated heart rate of 60 bpm the displayed rate should be between 57 bpm and 63 bpm Intrauterine pressure accuracy Connect the TOCO cable from the TOCO connector on the fetal monitor to the TOCO port of the PS320 Use the TOCO button to scrol
41. and minus keys to scroll through the available makes Select the make of the pulse oximeter to be tested When the correct make appears on the screen press the ESC key to return to the main menu University of Vermont Rev 2 Confidential 125 From the main menu press the soft key labeled SIM to enter the simulation mode Begin a manual simulation by pressing the soft key labeled MAN Use the plus and minus keys to adjust the O2 level and heart rate Set the heart rate to 80 bpm Turn on the pulse oxime ter and initiate a measurement The displayed heart rate should be within 5 of the set heart rate For a simulated heart rate of 80 bpm the displayed heart rate should be between 76 bpm and 84 bpm O2 accuracy Adjust the O2 level on the Index 2 to 96 Initiate a measurement on the pulse oximeter The displayed SpO2 value should be within 3 of the set value For a simulated SpO2 of 96 the displayed value should be between 93 and 99 Recorder operation After taking some O2 measurements print the results with the recorder Ensure the recorder prints clearly and legibly If the date and time is present on the recorded strip Ensure the date and time is accurate Alarm function Check that all alarms are functional and that the volume is adequately loud Ensure that appropriate visual indicators are functioning Set the high O2 alarm on the pulse oximeter to 98 Set the low O2 alarm to 90 Set the
42. are not placed over important information such as warnings contraindications and instructions 18 University of Vermont Rev 2 Confidential PERFORMANCE TESTED BY TECHNICAL SERVICES PROGRAM Name Date TSP UVM ANESTHESIA VAPORIZER PROGRAM OUTPUT VERIFICATION DUE BY OVERHAUL REMANUFACTURER DUE DONE DONE Figure 3 Label samples Forms Testing checklists should be developed for each device type These lists are useful because they outline recommended maintenance procedures and provide numerical criteria for quantitative tests The maintenance checklists should be filled out during an incoming inspection or testing following a repair The University of Vermont uses documentation by exception policy and does not fill out a maintenance checklist for the successful completion of a scheduled perfor mance inspection Maintenance forms can be either paper or electronic format Placing main tenance checklists on a handheld device such as a PDA that can be filled out electronically may be useful The maintenance forms should contain infor mation on what equipment is being inspected the date the inspection occurs and who is to perform the inspection A list of maintenance tasks should be broken down by subsystem and numerical criteria given for quantitative tests For example the measured flow rate of an infusion pump should be within 10 of the set rate This criterion app
43. avoid the possibility of microshock Electrical safety testing involves testing the ground wire resis tance current leakage to the chassis and current leakage to the patient leads Equipment inventory A record of medi cal equipment used in a facility The inventory may include equipment that does not receive scheduled maintenance as well as managed equipment for tracking purposes Estimated time The estimated amount of time needed to perform the scheduled main tenance The estimated time includes the time from test set up to the conclusion of the maintenance Exception testing Following scheduled performance inspections only failures are documented Equipment that has not been documented as needing repair or adjustment is assumed to be safe and ready for use This method of testing is useful when performing preventive maintenance and performance inspections on a large number of devices General equipment Equipment that cannot be classified as either clinical or utilities equipment Incoming inspection A performance test performed on a piece of medical equipment before being put into use to verify the safety of the device Life support equipment Medical equipment that takes over a function of the human body and whose loss will cause immediate death University of Vermont Rev 2 Confidential 3 Maintenance interval Also referred to as testing frequency or the length between scheduled maintenance Most commonly the
44. contact transducer During invasive monitoring elec trodes are placed on the scalp or other exposed skin of the fetus to measure the fetal heart rate Intrauterine pressure is measured directly through a pressure transducer located on a catheter that is inserted into the uterus Fetal monitors may have additional monitoring capa bilities such as maternal heart rate and blood pressure Recommended functional test frequency annual Weight Score 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 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 C1 Pl W N e Device failure could result in severe injury to or death of patient or user Maintenance or inspection would not impact reliability of the device Common device failure modes are unpredictable or not very predictable testing frequently detects problems While common device failure modes are not very predictable device history indicates that TSP Common device failure is predictable and can be avoided by preventive maintenance No significant History Specific regulatory or manufacturers requirements dictate preventive maintenance or testing
45. 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 No significant history ajej wo ND ja A significant history of incidents exists 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 4 University of Vermont Rev 2 Confidential 127 orocequre Estimated time 35 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 INCU incubator analyzer or equivalent Test Result Pass Fail N A 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 and warnings present and legible Inlets and hoses Power cord accessory cables charger Filters and vents clean
46. down on the floor A cylinder standing on end is easily knocked over Do not drag roll or slide cylinders as this can damage the valve Combustible substances such as oil and grease should not be used with compressed gas Likewise you should not handle cylinders hoses regulators or other gas system compo nents with oily hands or gloves Oxidizing gases such as oxygen and nitrous oxide will ignite violently when combined with a heat source such as an electrical spark or even frictional heat caused by gas moving through narrow hoses and a combustible fuel Make sure connections to high pressure sys tems are secure High pressure gas can cause connectors to become projectiles To avoid connectors from suddenly disconnecting use threaded or positive locking connectors Do not use friction fittings as they will not stand up to a high pressure Infection control Another risk inherent to maintaining medical equipment is biological hazards Infection control guidelines need to be followed in order to prevent both contracting diseases and to avoid the spread of nosoco mial infections The easiest and most effective method to prevent the spread of infection is with proper hand washing Hand washing should be performed before eating after handling soiled equipment after removal of gloves after the end of a shift before you leave the facility and any time hands are obviously soiled 22 University of Vermont Rev 2 Confidenti
47. e USA uses UL2601 1 The deadline was December 31 2004 e Europe uses EN60601 1 The deadline was June 13 1998 e Canada uses CAN CSA C22 2 No 601 1 M90 The deadline was January 1 2000 27 U niversity of Vermont Rev 2 Confidential Electrical safety testing Testing requirements and sequence according to IEC 62353 Annex C are shown below Only measurement equipment that meets IEC 61010 1 Selection of the test see 4 1 Insulation resistance should be used 4 The sequence outlined in Figure Visual inspection 55 Functional test 7 should be followed For example BEE protective earth resistance should x x be measured prior to leakage cur Protective earth resistance see 5 3 1 Reporting of results rent measurements v v Leakage current see 5 3 2 Evaluation v Check and prepare for normal use see 5 3 3 see 5 4 see 5 1 see 5 2 see 5 2 Figure 7 Testing requirements and sequence according to IEC 62353 Annex C General connections to an electrical safety e Tests and measurements analyzer ESA are shown in Figure 8 Consult e Date type and outcome results of the operational manual for specifics for your ESA Visual inspections Documentation requirements for IEC 62353 Measurements measured values include measuring method measuring equipment e Identification of the testing group hospital Func
48. ficient to 0 595 Set the injectate volume to 10 cc Set the injectate temperature to 24 C Connect the cardiac output box to the CO TEMP port on the right hand side of the MPS450 Connect the blood temperature therm istor cable from the cardiac output monitor to the small 4 pin connector on the cardiac output adapter Connect the injectate temperature from the cardiac output monitor to the large 4 pin connector on the cardiac output box located just above the resistance trimpot Connecting the cardiac output monitor to the MPS450 FLUKE Biomedical Turn on the MPS450 Press the button labeled 8 CO to enter the cardiac output menu The blood temperature displayed on the car diac output monitor should read 37 C 0 2 C Verify cardiac output accuracy With the cardiac output monitor and MPS450 set up as above enter the cardiac output menu on the MPS450 by pressing 8 CO Press the soft key labeled INJ to toggle the injectate temperature between 0 C and 24 C Set the injectate tem perature to 24 C Turn the trimpot on the cardiac output box until the injectate temperature on the cardiac monitor reads 24 C The simulated flow rate on the MPS450 can be set to 2 5 L min 5 0 L min and 10 0 L min by pressing the soft keys labels PREV and NEXT to scroll through the values The car diac output should be checked at each of these settings Set the volume on the MPS45
49. is being used on a patient and cannot be removed or if the equip ment has been sent out for repair Every effort should be made to locate and inspect equipment marked as Not Tested and working with clinical staff to locate this equipment will be required A list of missing equipment should be sent to the department so that the staff can keep watch for the missing equipment A protocol should be established for clinical staff when they find the equipment If possible the equipment should be set aside for testing Designating a storage area for this purpose is desired At the University of Vermont a work order is created for devices that were not tested during their scheduled test round The work order is left open for up to thirty days while biomedi cal equipment technicians attempt to locate the equipment During this time nursing staff is asked to assist in locating the equipment A notice is sent to the department manager with a list of equipment that needs to be located for inspection If nursing staff locates the missing equipment the equipment is set aside if pos sible until it can be inspected and biomedical personnel are notified Once the equipment has been inspected another work order is created to show that the equipment received its scheduled maintenance This work order has a type that indicates a functional test following a Not Tested work order Again the coding system is important as it allows these t
50. measure the energy output on the screen of the QA ES II Adjust the ESU output to its maximum cut set ting Measure the output on the QA ES II in cut mode according to the table below The actual output should be within 15 of the set output For an output setting of 300 W the measured output should be between 225 W and 345 W Measure the output at 75 50 and 25 of the maximum setting Repeat the output measurements with the ESU in coagulation mode according to the table below Start with the minimum setting and then outputs at 100 75 and 25 of the maximum setting All measurements should be within 15 of the set output University of Vermont Rev 2 Confidential 71 Power setting Output 15 Test results Cut 100 300 W 255 W 345 W 75 225 W 191 3 W 258 8 W 50 150 W 127 5 W 172 5 W 25 715 W 63 8 W 86 3 W Coagulation 100 120 W 102 W 138 W 75 90 W 76 5 W 103 5 W 50 60 W 51 W 69 W 25 30 W 25 5 W 34 5 W Remove the monopolar electrode from red VAR LOAD connector on the QA ES II and the dispersive electrode from the black connector Connect the ESU bipolar active electrode to the red VAR LOAD connector Connect the return of the bipolar electrode to the black VAR LOAD connector The dispersive cable will need to remain connected to the ESU to avoid activating Power setting Output 15 the return electrode alarm
51. mecha nism on the tubing set Hold the reservoir high enough above the tubing so that fluid flows through the tubing under the force of gravity Allow fluid to flow through the tubing until no air bubbles can be seen in the tubing Insert the set into the infusion pump Connect the three way stopcock to the channel 1 port on the IDA 4 Plus Connect the patient infusion tubing to one port of the stopcock Fill the syringe with the detergent solution and connect this to the other port of the stopcock Connect a piece of tubing to the drain port of channel 1 and run the tubing into a container to catch the used solution From the main menu of the IDA 4 Plus use the arrow keys to highlight SETUP under channel 1 and then press ENT Use the arrow keys to highlight FLOW and press ENT Select PRIME Close the stopcock port connected to the infusion tubing leaving the ports to the syringe and the IDA 4 Plus open Inject the solution in the syringe into the IDA 4 Plus until START appears on the screen Select Auto START The IDA 4 Plus will start the flow test when it detects flow from the pump Close the port to the syringe leaving the ports to the tubing and the IDA 4 Plus open Set the flow rate on the infusion pump to 60 mL hr and set the dose to 10 mL Start the infusion pump When the pump alarms com plete select END on the IDA 4 Plus to end the test At the set rate and volume the dos
52. met in order to ensure the safe use of medical equipment A medical equipment maintenance program needs to meet or exceed all local standards All relevant standards should be reviewed to ensure program compliance The following Chapter discusses some standards that biomed ical personnel should be familiar with IEC 60601 1 The International Electrotechnical Commission IEC is a worldwide organization that pro motes global standardization in the electronics industry IEC 60601 1 titled Medical electri cal equipment Part 1 General requirements for basic safety and essential performance addresses the issues of safely designing medi cal equipment and serves as the foundation for safe manufacturing practices This standard is mainly used in the design and manufacture of medical equipment In 2005 the third edition of 60601 1 was published The object of the standard is to pro vide general requirements for safety of medical devices and to provide the basis for more spe cific standards This edition combines product requirements with manufacturing processes such as risk management This edition also addresses the concept of essential performance parts of the equipment operation that directly affect the safety of the patient and operators The rationale behind the standard is to iden tify specific hazards associated with medical equipment and to define an acceptable level of risk for each hazard Additionally it provides an
53. necessary Verify the time and date displayed on the defibrillator is correct If the time and date is not displayed on the defibrillator moni tor print a strip from the recorder The time and date should appear on the printed strip Correct the time and date as necessary Complete model specific preventive main tenance Refer to the monitor s service manual for preventive maintenance tasks specific to the device Complete the preventive maintenance per manufacturer s procedure Performance inspection Verify unit operates on battery Check that the ac power indicator is lit 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 Be sure to plug the power cord in at the conclusion of the test 62 uUniversity of Vermont Rev 2 Confidential Paddle continuity Connect the ohmmeter between a paddle and the appropriate pin on the paddle connector The resistance should not be higher than 0 15 Q Repeat for the other paddle This step can be skipped if only dispos able paddles are used Heart rate accuracy Connect the ECG leads to the lead connectors on the Impulse 4000 On the Impulse 4000 press F3 ECG to enter the ECG menu Press F1 NORM to select a normal sinus rhythm Press F2 60 to set the heart rate to 60 bpm
54. not exceed 300 mQ Leakage current for Class I medical equipment should not exceed 500 pA using the direct measurement method leakage current for Class II medical equipment should not exceed 100 pA Electrical safety testing is discussed in detail in Chapter 5 of this manual Electrical Safety IEC 62353 goes on to further specify that safety related functions of the equipment are to be inspected The standard does not specify which functions need to be tested or how often only that the device functionality should be tested The standard also specifies that safety inspec tions need to be documented NFPA 99 The National Fire Protection Agency is an international organization that advocates the consensus of codes and standards for fire elec trical and building safety NFPA building codes have been adopted in the United States The standard NFPA 99 Standard for Health Care Facilities establishes criteria to minimize the risk of fire explosion and electrical hazards in health care facilities NFPA 99 covers nearly all aspects of fire safety in the hospital environment including building electrical systems vacuum and gas 148 OUniversity of Vermont Rev 2 Confidential systems and emergency management It is important to note that this is a voluntary stan dard However many localities have adopted NFPA 99 as part of their fire codes NFPA 99 includes a Chapter on electrical equipment that is of particular interest t
55. of 36 0 C the measured temperature should be between 35 7 C and 36 3 C Temperature overshoot From a stabilized incubator temperature of 32 C increase the incubator temperature to 36 C Allow the temperature to stabilize During temperature stabilization the temperature in the incubator should not overshoot the set temperature by CAUTION DO NOT USE THE AIR FLOW SENSOR IN THE PRESENCE OF OXYGEN THE SENSOR USES A HOT WIRE TECHNIQUE FOR AIR VELOCITY MEASUREMENT AND MAY BECOME A SOURCE OF IGNITION 92 OUniversity of Vermont Rev 2 Confidential more than 2 C For a set temperature of 36 C the incubator temperature should not exceed 38 C during temperature stabilization Relative humidity If the incubator is equipped with a display for relative humid ity note the relative humidity measured on the INCU The measured relative humidity should be within 10 of the displayed relative humidity For a displayed relative humidity of 50 the measured relative humidity should be between 45 and 55 Air flow With the INCU placed in the center of the incubator rotate the air flow sensor so that it is perpendicular with the airflow in the incubator Note the air velocity measurement on the INCU The air velocity should not exceed 0 35 m s Air temperature alarms Set the incubator temperature to 36 C and allow the tempera ture to stabilize Open the incubator hood to room air Verify that the l
56. patient s limbs in order to facilitate the return of blood through the veins They are used to reduce the risk of deep vein thrombosis during long periods of immobiliza tion which can lead to pulmonary embolism Compression units are also used during and immediately following surgery to minimize venous stasis A compression unit typically Biomedical tubing and cuffs that wrap around the patient s limbs Air is pumped through the tubing into the cuffs until the pressure inside the cuff reaches a set pressure The cuff remains inflated at the set pressure for a set period of time Pressure is then relieved from the cuff and the cuff remains deflated for another set period of time The compression unit will continuously repeat this cycle of inflation and deflation Recommended functional test frequency consists of an air compression pump a pres annual sure control mechanism a timing mechanism Sample risk assessment Criteria choose 1 rating from each category Weight Score 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 Device poses no appreciable risk due to failure O11 BP W D Re Device failure will result in low risk Device failure will result in inappropriate therapy misdiag
57. per manufacturer s procedure 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 press O SETUP press 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 Biomedical Set the heart rate on the MPS450 to 120 bpm Press 1 NSR and then use the soft keys marked UP and DOWN to change the heart rate to 120 bpm Set the respiration rate to 60 breaths min Press 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 120 bpm the displayed rate should be between 114 bpm and 126 bpm For a res
58. required for the analyzer to be able to measure the low rate The measured rate should be within 10 of the infusion pump s KVO rate For a KVO rate of 1 mL hr the measured rate should be between 0 9 mL hr and 1 1 mL hr Occlusion detection pressure From the channel set up menu on the IDA 4 Plus select OCCLUSION Prime the IDA 4 Plus with the syringe if necessary Set the flow rate on the infusion pump to 100 mL hr Set the volume to 10 mL or more so that the volume will not be delivered before the test is complete Start the pump Select START on the IDA 4 Plus Select END on the IDA 4 Plus when the pump alarms occlusion Note the pressure at which the pump alarms Compare the measured pressure to the occlusion pressure of the pump The occlusion pressure will be specific to the model Check the service manual for the specific pressure The measured occlusion pressure should be within 1 psi of the pump s occlusion pressure For an occlusion pressure of 20 psi the mea sured pressure should be between 19 psi and 21 psi Piggyback infusion From the channel set up menu on the ID A4 Plus select DUAL FLOW Prime the IDA 4 Plus with the syringe if neces sary Use the arrow keys to enter the flow rates and volumes to be tested Enter 60 mL hr for the secondary rate 10 mL for the secondary volume 12 OmL hr for the primary rate and 10 mL for the primary volume Select AutoSTART to start the flow measurem
59. the tubing Turn the reser voir upside down until a bubble of air is pulled through the tubing Turn the reservoir right side up When the air bubble gets to the pump the pump should alarm air in line Clear the alarm Remove the tubing from the pump and prime the set so that there is no air in the tubing Reinsert the tubing set into the pump and restart the pump Simulate an empty container situation either by turning the reservoir upside down so that no fluid can get to the tubing or by removing the tubing from the reservoir The pump should alarm when no fluid flow is detected Complete model specific performance testing Refer to the service manual for perfor mance inspection tasks specific to the device Complete the performance inspection per manufacturer s procedure Return to service Before returning to use return any settings that were adjusted to their original settings Ensure the volume of the audible alarms is loud enough to be heard in normal operating conditions Plug in the power cord to ensure the battery remains charged Non invasive blood pressure monitor A non invasive blood pressure NIBP monitor measures and displays blood pressure using external sensors These devices consist of an inflatable cuff hose pressure sensors proces sor and a display Typically NIBP monitors use an oscillometric method to measure blood pressure The cuff is attached to a patient s arm and then inflated until blood
60. thermal stability to infants They are used to provide thermal sup port to newborns and critically ill infants and also for infants undergoing long procedures in a cool environment Unlike incubators radi ant warmers are not enclosed allowing direct access to the infant These devices typically consist of an overhead heater and a temperature turns off semiannual Sample risk assessment Criteria choose 1 rating from each category No patient contact Biomedical Weight probe Typically the radiant warmer is set to a temperature and a temperature probe is attached to the infant s skin The heater will turn on while the infant s skin temperature is below the set temperature When the skin tem perature reaches the set temperature the heater Recommended functional test frequency Score 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 Device poses no appreciable risk due to failure Ol RB W NM e 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 Maintenance or inspection would not impact reliability of the device AIUJIN Common
61. valve is triggered on the NIBP monitor the moni tor will vent the pressure from the cuff Note the pressure at which the relief valve is triggered The over pressure limit should be less than 330 mmHg Check the service manual for the exact value Dynamic pressure accuracy Place the NIBP monitor into the normal operating mode Select STANDARD BP on the BP Pump 2 Press the soft key labeled OPTIONS on the BP Pump 2 to cycle through the available preset blood pressure simulations Select a blood pressure of 120 80 on the analyzer Initiate a blood pressure measurement on the NIBP monitor The displayed pressure should be within 10 mmHg of the set pressure For a set blood pressure of 120 80 the systolic pressure should be between 110 mmHg and 130 mmHg and the diastolic pressure should be between 70 mmHg and 90 mmHg Repeat the measure ments for a blood pressure of 200 150 and a blood pressure of 80 50 Heart rate accuracy With the NIBP monitor in normal operating mode select STANDARD BP on the BP Pump 2 Set the simulated blood pres sure to 120 80 The simulated heart rate will be 80 bpm Initiate a blood pressure measurement on the NIBP monitor The displayed heart rate should be within 5 of the set heart rate For a simulated heart rate of 80 bpm the displayed heart rate should be between 76 bpm and 84 bpm Auto interval time Select a standard blood pressure on the BP Pump 2 of 120 80 Put the NIBP into auto
62. within 10 of the set volume For a set volume of 10 mL the mea sured volume should be within 9 mL and 11 mL Occlusion detection pressure From the channel set up menu on the IDA 4 Plus select OCCLUSION Prime the IDA 4 Plus with the syringe if necessary Set the flow rate on the feeding pump to 100 mL hr Set the volume to 10 mL or more so that the volume will not be delivered before the test is complete Start the pump Select START on the IDA 4 Plus Select END on the IDA 4 Plus when the pump alarms occlusion Note the pressure at which the pump alarms Compare the measured pressure to the occlusion pressure of the pump The occlusion pressure will be specific to the model Check the service manual for the specific pressure The measured occlusion pressure should be within 1 psi of the pump s occlusion pressure For an occlusion pressure of 20 psi the mea sured pressure should be between 19 psi and 21 psi 76 University of Vermont Rev 2 Confidential Alarm function Check that all alarms are functional and that the volume is adequately loud Ensure appropriate visual indicators are functioning Set the rate on the pump to 100 mL hr and set the volume to 100 mL Start the pump Occlude the tubing between the reservoir and the pump The tubing can be occluded either by closing a clamp attached to the tubing or by pinching the tubing with a set of hemostats or pliers The pump should alarm upstream oc
63. 0 bps and clear any alarms Return the alarm limits to their previous settings Output accuracy Connect the defibrillator paddles to the paddle contacts on the Impulse 4000 The Apex contact is on the right and the Sternum contact is on the left If disposable paddles are being used you will need a test set to connect from the defibrilla tor cable to the Impulse 4000 A simple test set can be made from a set of disposable paddles Cut the pads off of the set leaving the connec tor and two lengths of wire Strip the ends of the wires and install banana plugs Insert the banana plugs into the paddle contacts of the Impulse 4000 Connect the test set to the defi brillator cable With the Impulse 4000 set to a heart rate of 80 bpm set the ECG source on the defibrillator to paddles View the ECG trace on the defibril lator If the trace appears upside down reverse the paddle connections Return to the main menu of the Impulse 4000 Press F1 DEFIB to enter the defibrillator menu Press F1 ENERGY then F2 HIGH The high setting is for energy output up to 1000 J the low setting is for measuring 50 J and below Measure the energy output of the defibrillator throughout its range Ata minimum measure the output at the lowest setting a mid level setting and the highest setting The output should be within 15 of the set energy level At 360 J the energy output should be between 306 J and 414 J Biomed
64. 0 to 2 5 L min Initiate a cardiac output measurement on the monitor Press the soft key labeled RUN on the MPS450 to start the simulation If you need to end the simulation before the cardiac output calculation is complete press the soft key labeled STOP Repeat this measurement for the 5 0 L min and 10 0 L min rates Complete model specific performance testing Refer to the service manual for perfor mance inspection tasks specific to the device Complete the performance inspection per manufacturer s procedure Return to service Before returning to use return the cardiac output monitor to its original settings University of Vermont Rev 2 Confidential 51 Central station Central stations are monitors that are designed to be positioned in a central location usually at a nurse s station and consolidate information from individual bedside and telemetry moni tors The central station usually displays an ECG waveform for each patient being monitored and also any alarms that are triggered Central sta tions typically consist of one or more displays a computer that runs the central station speakers for audible alarms and a recorder for printing monitors annual Sample risk assessment Criteria choose 1 rating from each category No patient contact ECG strips Bedside monitors will be connected to the central station computer through the hospital s network If telemetry transmitters are use
65. 00 1 00 0 00 Errors Per Device Type Per Quarter University of Vermont Rev 2 Confidential 11 3 worksheet Device information Device type Owner Hosp Vendor MD Other Manufacturer Department Model Tester Hosp TSP Mfr User Serial number Prev maint Hosp TSP Mfr User Control number Tests year 1x 2x 3x 4x Inclusion assessment The intent is to capture all powered devices that by function physical risk maintenance requirements or a history of incidents or safety problems should be managed as a part of the medical equipment management system Some devices have a borderline inclusion between medical equipment and utilities so tests for inclusion in the utilities management program are included Would failure of this device result in immediate death of the patient And Yes No Is the powered device used for direct patient treatment or care Yes No An answer of Yes to both of the above questions indicates that the device should be managed in the medical equipment inventory as a life support device Is the powered device used for direct patient treatment or care Yes No Does the powered device provide diagnostic monitoring information used in treatment Yes No Does this powered device come in contact with the patient Yes No An answer of Yes to any of the above three questions indicates that the device should be included in the medical equipment management progr
66. 00 pA BF lt 10 pA CF mains on patient applied part Insulation test optional 500 V lt 2 MQ Check condition of tubing cuffs and hoses Clean recorder paper compartment rollers and paper guides Lubricate motor and paper drive mechanism Verify proper time and date correct if necessary Replace battery every 24 months Complete model specific preventive maintenance Verify unit operates on battery Leak test lt 15 mmHg min Static pressure accuracy 3 mmHg Pressure relief test lt 330 mmHg Dynamic pressure accuracy 10 mmHg Heart rate accuracy 5 Auto interval time 10 Stop Cancel Deflate lt 10 sec Recorder operation Alarm function Complete model specific performance testing 100 uUniversity of Vermont Rev 2 Confidential Physical condition Check the physical condition of the device as described in the General Equipment Procedure Electrical safety Perform electrical safety checks as described in Chapter 5 Electrical Safety Check ground wire resistance and chassis leakage Preventive maintenance Check condition of tubing cuffs and hoses Inspect hoses and cuffs for signs of wear Look for holes cracks and dry rot Ensure that all connections are secure Clean recorder paper compartment roll ers and paper guides Inspect the rollers and paper guides and remove any debris Check for bits of torn paper caught in the rollers Lubricate m
67. 1 psi Alarm function Complete model specific performance testing 74 O OUniversity of Vermont Rev 2 Confidential Physical condition Check the physical condition of the device as described in the General Equipment Procedure Electrical safety Perform electrical safety checks as described in Chapter 5 Electrical Safety Check ground wire resistance and chassis leakage Preventive maintenance Clean flow detector Inspect the flow detector on the feeding pump Clean any debris from the flow sensor Replace battery The battery should be replaced every 24 months Replace if necessary Complete model specific preventive main tenance Refer to the monitor s service manual for preventive maintenance tasks specific to the device Complete the preventive maintenance per manufacturer s procedure Performance inspection Verify unit operates on battery Check that the ac power indicator is lit 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 Be sure to plug the power cord in at the conclusion of the test Pole clamp function Check the physical condition of the pole clamp The pole clamp should be securely fastened to the feeding pump The clamp mechanism should move freely The pole clamp should secure
68. 2 5 mmHg 121 University of Vermont Rev 2 Confidential Timer accuracy Inflate the cuff on the pneumatic tourniquet Use a stopwatch or a watch with a second hand to measure the elapsed time Allow the cuff to remain inflated for 15 minutes The elapsed time displayed on the tourniquet should be between 13 and 17 minutes Maximum cuff pressure Set the pressure on the pneumatic tourniquet to its maximum setting Inflate the cuff and allow the pres sure to stabilize Use the squeeze ball to slowly increase the pressure in the cuff until the pressure relief valve vents the pressure in the cuff Note the pressure at which the relief valve is triggered The over pressure limit should be less than 550 mmHg Check the manufacturer s service manual for the exact value 122 OUniversity of Vermont Rev 2 Confidential Alarm function Check that all alarms are functional and that the volume is adequately loud Ensure that appropriate visual indicators are functioning Inflate the tourniquet cuff Slowly open the bleed valve on the squeeze ball to simulate a leak The tourniquet leak alarm should activate Complete model specific performance testing Refer to the service manual for perfor mance inspection tasks specific to the device Complete the performance inspection per manufacturer s procedure Return to service Before returning to use return any settings that were adjusted to their original settings Ensure the v
69. 2 level and heart rate Set the heart rate to 60 bpm to match the heart rate from the MPS450 Adjust the O2 level on the Index 2 to 96 Initiate a measurement on the pulse oximeter The displayed SpO2 value should be within 3 digits of the set value For a simulated SpOz of 96 the displayed value should be between 93 and 99 SpOz2 alarms Set the high O2 alarm on the pulse oximeter to 98 Set the low O2 alarm to 90 Set the Index 2 for a manual simula tion with the SpO2 at 96 and the heart rate 80 bpm Initiate a measurement on the pulse oximeter Adjust the SpO2 on the Index 2 to 100 The high 02 alarm on the pulse oxime ter should activate Bring the SpOz back down to 96 and clear the alarm Adjust the SpOz on the Index 2 to 88 The low 02 alarm on the pulse oximeter should activate Bring the Sp02 back to 96 and clear the alarm Set the high heart rate alarm on the pulse oximeter to 120 bpm and set the low heart rate alarm to 60 bpm Adjust the heart rate on the Index 2 to 125 bpm The high heart rate alarm should activate Return the heart rate to 80 bpm and clear the alarm Adjust the heart rate on the Index 2 to 55 bpm The low heart rate alarm should activate Return the heart rate to 80 bpm and clear the alarm Return all alarm limits to their original settings Invasive pressure accuracy Set the blood pressure transducer sensitivity on the MPS450 according to manufacturer requirements Press the button lab
70. 3x 4x times per year tested University of Vermont Rev 2 Confidential 10 i f 45 orocequre Estimated time 20 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 DPM 4 Pressure Meter or equivalent Stopwatch or watch with a second hand Tubing and connectors to connect to DPM 4 Test Result Pass Fail N A 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 and warnings present and legible Inlets and hoses Power cord accessory cables charger Filters and vents clean Ground wire resistance lt 0 3 Q Chassis leakage lt 100 pA NC lt 500 pA SFC Patient leakage current lt 100 pA B and BF lt 10 pA CF Patient lead leakage current isolation test lt 100 pA BF mains on patient applied part lt 10 pA CF Insulation test optional 500 V lt 2 MQ Replace battery every 24 months Replace filters Lubricate motor Complete model specific preventive maintenance Verify unit operates on battery Vacuum gauge accuracy 10 Maximum vacuum Thoracic low volume gt 40
71. 45 Oz accuracy Before measuring oxygen con centration using VT PLUS HF Ensure the sensor displays the oxygen concentration at 100 02 If not perform the oxygen calibration according to the VT PLUS HF operator s manual If possible remove the 02 sensor from the breathing circuit and allow the sensor to sit in room air for approximately 5 minutes The 02 reading in room air should be 21 Calibrate the sensor according to the ventilator manu facturer s recommended procedure if possible Return the sensor to the breathing circuit Set up the ventilator with a tidal volume of 1000 mL a breath rate of 6 breaths min and an inspiration to expiration ratio of 1 2 and start the ventilator Press 3 02 on the VT PLUS HF to switch to the Oz screen The Oz percentage is displayed on the VT PLUS HF Compare this value to the value displayed on the ventilator The measured O2 percentage should be within 2 digits of the displayed value In 100 Oz the measured oxygen percentage should be at least 98 Alarm function Check that all alarms are functional and that the volume is adequately loud Ensure that appropriate visual indicators are functioning Remove the 02 sensor from the breathing circuit and expose it to room air Set the low 02 alarm to 30 Verify that the alarm activates Return the O2 sensor to the breathing system and return the alarm to its previous setting 146 9 OUniversity of Vermont Rev 2 Confid
72. 601 Electrical Safety Analyzer or equivalent Test Result Pass Fail N A VT PLUS HF Ventilator Analyzer or equivalent Test lung such as ACCULUNG Hoses and connectors to connect to VT PLUS HF 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 and warnings present and legible Inlets and hoses Power cord accessory cables charger Filters and vents clean Ground wire resistance lt 0 3 Q Chassis leakage lt 100 pA NC lt 500 pA SFC Patient leakage current lt 100 pA B and BF lt 10 pA CF Patient lead leakage current isolation test lt 100 pA BF mains on patient applied part lt 10 pA CF Insulation test optional 500 V lt 2 MQ Clean vents and filters Replace tubing Replace battery every 24 months Complete model specific preventive maintenance continued on page 143 142 OUniversity of Vermont Rev 2 Confidential Ee Biomedical oroceqdure Estimated time 50 minutes continued from page 142 Test Result Pass Fail N A Verify unit operates on battery Gas cylinders and regulators Hoses tubing and connectors Volume accuracy 10 Respiration rate I E ratio Pressure accuracy 10 PEEP O2 accuracy 2 Ala
73. A 4 Plus when the pump alarms occlu sion Note the pressure at which the pump alarms Compare the measured pressure to the occlusion pressure of the pump The occlusion pressure will be specific to the model Check the service manual for the specific pressure The measured occlusion pressure should be within 1 psi of the pump s occlusion pressure For an occlusion pressure of 20 psi the mea sured pressure should be between 19 psi and 21 psi Alarm function Check that all alarms are functional and that the volume is adequately loud Ensure that appropriate visual indicators are functioning Set the continuous rate on the pump to 15 mL hr and start the pump Occlude the tubing between the reservoir and the pump Biomedical The tubing can be occluded either by closing a clamp attached to the tubing or by pinching the tubing with a set of hemostats or pliers The pump should alarm upstream occlusion Clear the alarm and restart the pump Occlude the tubing after the pump The pump should alarm downstream occlusion Clear the alarm If the pump is equipped with an air detector introduce air into the tubing This can be done by turning the reservoir upside down until a bubble of air is pulled through the tubing Turn the reservoir right side up When the air bubble gets to the pump the pump should alarm air in line Clear the alarm Remove the tubing from the pump and prime the set so that there is no air in the tubing Rein
74. Activate the control for ground wire resistance measurement and record the reading or docu ment by exception only uUniversity of Vermont Rev 2 Confidential 31 DEVICE UNDER TEST CONDUCTIVE PART Figure 11 Mains insulatioin resistance test configuration Insulation tests Switch Remove the red test lead from the chassis Diagram Reference ESA601 Name Action grounding point Switch the function switch to S3 Earth Open measure insulation first from earth ground then from the patient applied part 32 University of Vermont Rev 2 Confidential Biomedical APPLIED PART DEVICE UNDER TEST CONDUCTIVE PART Switch Diagram Reference Action Sl Neutral Variable S2 Polarity Variable S3 Earth Open s4 Appledpars variable S5 Figure 12 Earth leakage current test configuration Earth electrical leakage current Measure the earth leakage current by switch ing the function switch to the Earth Leakage setting and following the ESA procedure Make measurement without the red lead attached to the device The measurement should be made under Normal and Reverse Polarity Ensure the ESA is not quickly switched between Normal and Reverse Polarity Record the reading or document by exception University of Vermont Rev 2 Confidential 33 DEVICE UNDER TEST CONDUCTIVE PART TEST
75. Biomedical Cardiac output unit temperature of the surrounding blood is measured through a thermistor located near the tip of the catheter Once the catheter is inserted ice water is injected through the catheter and emerges from a small hole approx imately 12 inches before the end of the catheter The cardiac output unit processes the signal from the thermistor and displays a thermal dilution curve from which cardiac output and A cardiac output unit measures the volume of blood pumped by the heart during a period of time typically measured in liters per minute L min Cardiac output represents the volume of blood that is delivered to the body is an indicator of overall cardiac status and tissue perfusion Blood flow from the heart is mea sured using the thermal dilution technique in which a cold solution is injected upstream of other hemodynamic parameters such as stroke the heart and the temperature differential is volume can be derived monitored on the downstream side A balloon Recommended functional test frequency catheter is inserted through the heart The annual Sample risk assessment Criteria choose 1 rating from each category Weight Score 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 Ol RB O N e w
76. DIFY soft key Enter the new value using the number keys on the front of the analyzer and then press the ENTER soft key Press the BACK soft key to return to the measurement screen on the analyzer Match the VT PLUS HF correction mode setting to that used by the ventilator manufacturer usually found in the ventilator service manual Connect a patient breathing circuit to the ventilator Connect the Y piece of the patient tubing to the high flow inlet on the right side of the VT PLUS HF analyzer Set up the test lung such as ACCULUNG resistance and compliance settings by selecting a pair of resistance and compliance settings that most closely matches the patients served by the hospital owning the ventilator e g resistance Rp20 compliance C20 Connect the test lung to the flow exhaust on the left side of the analyzer Enter the volume screen on the analyzer by pressing 2 VOLUME Set up the ventilator with a tidal volume of 200 mL a breath rate of 25 breaths min and an inspiration to expira tion ratio of 1 2 and start the ventilator The ventilator may take a few breaths to stabilize the delivered volume The measured volume should be within 10 of the set volume For a set tidal volume of 200 mL the measured tidal volume should be between 180 mL and 220 mL Repeat the measurement with a tidal volume of 1300 mL and a rate of 8 breaths min The tidal volume should be between 1170 mL and 1430 mL
77. LEAD APPLIED PART Figure 13 Enclosure leakage current test configuration Chassis electrical leakage current Measure the chassis leakage current following the ESA procedure Make measurement with the red lead attached to the device The measurement should be made under Normal and Reverse polarity Ensure the ESA is not quickly switched between Normal and Reverse polarity Record the reading or document by exception only 34 University of Vermont Rev 2 Confidential Switch Diagram Reference ESA601 Name Action S3 Earth Open Biomedical n t L2 Figure 14 Patient leakage current test configuration DEVICE UNDER TEST CONDUCTIVE PART Switch Diagram Reference Action Sl Neutral Variable S2 Polarity Variable S3 Earth Variable s4 amiei pants variablo S5 el Patient applied part leakage current Ensure the patient applied leads are attached to the appropriate connectors on the ESA e g see Figure 8 per the ESA manual Switch the func tion switch to Patient Lead Leakage or Applied Parts Leakage per the ESA instructions Make measurements with the red lead attached to the device The measurement should be made under Normal and Reverse polarity Ensure the ESA is not quickly switched between Normal and Reverse polarity The test should be performed by selecting all leads connected together and individual leads mea
78. Pacer menu press F3 DEMAND With the pacer in demand mode press F1 START The Impulse 4000 will display the calculated underdrive and overdrive ECG rates A havertriangle waveform will be displayed on the ECG trace Pacing spikes should appear on the ECG trace Press F2 OVER to select the overdrive ECG rate Verify that the pacing stops with this higher rate Turn off the pacer and return the output and rate to their previous settings Return to service Before returning to use return any alarms that were adjusted to their original settings Ensure the volume of the audible alarms is loud enough to be heard in normal operating conditions Ensure the pacer is turned off and that any settings that were adjusted are returned to their original settings Plug in the power cord to ensure the battery remains charged and ready for use Complete model specific performance testing Refer to the service manual for perfor mance inspection tasks specific to the device Complete the performance inspection per manufacturer s procedure Measuring pacer output with the Impulse 4000 Electrocardiograph An electrocardiograph ECG records the electri cal activity of the heart over time by measuring the changes of electrical potential caused by electrical activity of the heart muscle during the heartbeat Leads affixed to the patient transmit the electrical signal to the processor which then produces a graph of the amplitu
79. The IDA 4 Plus will display the basal flow rate Allow the pump to deliver at least 10 mL and then compare the measured flow rate to the set rate The mea sured flow rate should be within 10 of the set rate For a flow rate of 15 mL hr the measured flow rate should be between 13 5 mL hr and 16 5 mL hr 114 University of Vermont Rev 2 Confidential Volume accuracy Continue to run the PCA pump as described above The IDA 4 Plus will display the total volume delivered Allow the pump to deliver at least 10 mL and then com pare the measured volume displayed on the analyzer to the volume displayed on the pump The measured volume should be within 10 of the pump volume For a volume of 10 mL the measured volume should be between 9 mL and 11 mL PCA dose Continue to run the PCA pump as described above The IDA 4 Plus will display the delivered bolus volume Allow the pump to deliver a bolus and then compare the measured volume displayed on the analyzer to the set volume Verify that the actual bolus volume is within 10 of the set volume For a dose of 1 mL the measure volume should be between 0 9 mL and 1 1 mL Lock out interval Continue to run the PCA pump as described above The IDA 4 Plus will attempt to trigger a PCA dose 60 seconds before the lock out time expires Allow the PCA pump to deliver at least 2 doses The interval time will be displayed on the IDA 4 Plus The measured interval time should be within 5 of t
80. a second hand Test Result Pass Fail N A 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 and warnings present and legible Inlets and hoses Power cord accessory cables charger Filters and vents clean Ground wire resistance lt 0 3 Q Chassis leakage lt 100 pA NC lt 500 pA SFC Patient leakage current lt 100 pA B and BF lt 10 pA CF Patient lead leakage current isolation test lt 100 pA BF mains on patient applied part lt 10 pA CF Insulation test optional 500 V lt 2 MQ Inspect leads and electrodes Complete model specific preventive maintenance Output accuracy 10 Timer accuracy 10 sec Alarm function Complete model specific performance testing University of Vermont Rev 2 Confidential 135 Physical condition Check the physical condition of the device as described in the General Equipment Procedure Electrical safety Perform electrical safety checks as described in Chapter 5 Electrical Safety Check ground wire resistance and chassis leakage Preventive maintenance Inspect leads and electrodes Inspect leads and electrodes for signs of wear such as frayed wires or broken strain reliefs Inspect electrodes for corrosion or a build up of conductiv
81. accuracy Connect the temper ature cable to the CO TEMP port on the side of the MPS450 Press the key labeled 7 TEMP to start the temperature simulation Use the up and down keys to set the tempera ture to 37 C The temperature displayed on the monitor should be within 0 3 C of the set tem perature For a simulated temperature of 37 C the displayed temperature should be between 36 7 C and 37 3 C Temperature alarms Set the high tempera ture alarm on the monitor to 38 C and set the low temperature alarm to 34 C Adjust the temperature on the MPS450 to 40 C The high Biomedical alarm should activate Return the temperature on the MPS450 to 37 C and clear the alarm Adjust the temperature on the MPS450 to 24 C The low temperature alarm should activate Return the temperature on the MPS450 to 37 C and clear the alarm Carbon dioxide concentration accuracy Connect the gas canister to the patient sample line of the monitor Inject the gas into the sample line The displayed CO2 concentration should be within 0 4 vol of the gas sample For a gas sample with 5 0 COz the monitor should display a CO2 concentration between 4 6 and 5 4 Carbon dioxide alarm Set the high carbon dioxide alarm limit on the monitor to below the CO2 concentration of the test gas Inject the gas into the patient sample tubing The high C02 concentration alarm should activate Return the alarm limit to its origi
82. ailure of the device would cause inappropriate therapy perhaps not giving the patient supplemental oxygen and or loss of monitoring Problem avoidance would score 2 Historically speaking failures of pulse oximeters are unpredictable and impending problems are usually not uncovered during periodic testing Both incident history and manufacturer regulatory requirements score 1 Historic data does not show a history of inci dents involving pulse oximeters and there are no specific requirements for maintenance of these devices This gives the pulse oximeter a total score of 10 Based in the maintenance work sheet this is justification for annual testing Problem Manufacturer Clinical Physical Avoidance Incident or Regulatory Testing Device Type Function Risk Probability History Requirements Frequency Ventilator 5 4 4 2 2 17 Semiannual Electrosurgical unit 4 4 2 2 1 13 Semiannual Infusion pump 4 3 2 2 1 12 Annual Pulse oximeter 3 3 2 1 1 10 Annual Exam table 2 2 2 1 1 8 Bi annual 8 University of Vermont Rev 2 Confidential The electrosurgical unit is a device that uses high frequency electric current for cutting or destroying tissue The clinical function category would score 4 because the device is used for direct treatment of the patient Physical risk would score 4 because failure of the device could cause severe injury to the patient Problem avoidance would score 2 Historically spe
83. aking failures of electrosurgical units are unpredict able and impending problems are usually not uncovered during periodic testing Incident history would score 2 Historical data reveals that electrosurgical units have been involved with patient incidents Manufacturer regula tory requirements would score 1 as there are no specific requirements for maintenance of these devices This gives the electrosurgical unit a total score of 13 Based in the maintenance worksheet this is justification for semiannual testing As it can be seen from the previous exam ples devices that have more risk associated with them need more maintenance than other devices In the example electrosurgical units will receive maintenance twice per year based on a risk assessment while pulse oximeters will receive maintenance once per year One should note that devices were scored as generic device type only and are not model specific The risk criterion is used as a tool for determining maintenance intervals If a specific model has testing or maintenance requirements different from other devices of the same type the maintenance schedule can be adjusted on a case by case basis Evaluating the effectiveness of the maintenance program Every maintenance program should be periodi cally evaluated for effectiveness Performance standards for medical equipment manage ment should support the efforts of hospitals to manage health care technology for the purpos
84. al Food and drinks should be kept away from benches shelves and other areas where poten tially contaminated medical equipment is being serviced or stored Applying cosmetics and handling contact lenses should also be avoided in these areas Equipment should only be inspected or repaired after it has been disinfected Clinical staff should be educated on the proper way to disinfect equipment and what type of disin fectant to use Certain disinfectants can cause damage to equipment such as breaking down the plastics used for the outer case and caus ing the case to become brittle Check with the equipment s user manual or the manufacturer for instructions on how to disinfect equipment and what disinfectants can be used safely If work must be done on equipment that has not been cleaned wear personal protective equipment such as gloves mask and gown Disinfect the work area when done and wash hands thoroughly after removing the protective equipment The Blood borne Pathogen Standard became a federal regulation in the United States enforced by the Occupational Health and Safety Administration OSHA on March 6 1992 The purpose of the regulation is to limit occupa tional exposure to blood and other potentially infectious materials The focus of the mandate is to utilize universal precautions and work practice controls to reduce the exposure risk to HIV hepatitis and other infectious diseases Biomedical equipment technicians a
85. al for preventive maintenance tasks specific to the device Complete the preventive maintenance per manufacturer s procedure Performance inspection Verify unit operates on battery Check that the ac power indicator is lit when the power cord is plugged into an outlet Unplug the ac power cord and perform the remainder of the Biomedical functional test on battery power The ac power indicator should go out when the power cord is unplugged and the battery indicator should light Be sure to plug the power cord in at the conclusion of the test Pressure accuracy A tubing set that can connect to the compression unit and to the DPM 4 will be needed for this test A simple test set can be constructed from a disposable compres sion set Cut the tubing a short distance from the connector for the compression unit Insert a luer connector into the tubing to connect to the DPM 4 If the compression set has multiple infla tion tubes occlude the remaining open tubing using tie wraps Connect the test set to the compression unit The DPM 4 defaults to pressure units in mmHg If the pressure gauge is in another unit press the soft key labeled UNIT and then select the desired units Most compression units measure pressure in mmHg The DPM 4 should read 0 0 mmHg when the pressure port is open to atmosphere Connect the test set to the pressure port of the DPM 4 Start the compression cycle on the compres sion unit Me
86. al discharge function Charge the defibrillator and do not discharge Allow the energy to be discharged internally Attempt to discharge into the Impulse 4000 Verify that no energy has been delivered Sychronizer operation Set the ECG source on the defibrillator to Lead II Put the defibrilla tor into synch mode Return to the main menu of the Impulse 4000 Press F1 DEFIB to enter the defibrillator menu Press F2 CARDIO for the cardioversion menu and then F2 HIGH Press F1 NSR for a normal sinus rhythm Charge the defibrillator Press and hold the discharge button s on the defibrillator The delay time should not be more than 60 mSec 63 University of Vermont Rev 2 Confidential Pacer output accuracy Connect the ECG leads to the lead connectors on the MPS450 Set the heart rate on the MPS450 to 60 bpm Press 1 NSR and then use the soft keys marked UP and DOWN to change the heart rate to 60 bpm On the defibrillator set the ECG source to Lead II Connect the pacing cable to the defibrillator if necessary You will need a test set to connect the pacing cable to the Impulse 4000 A test set can be made from the disposable pads as described previously From the main menu of the Impulse 4000 press F2 PACER Press F1 INT50 to select the internal 50 Q test load Press F1 PULSE to enter the pacer measurement mode Set the pacing rate on the defibrillator to 120 p
87. al safety Perform electrical safety checks as described in Chapter 5 Electrical Safety Check ground wire resistance and chassis leakage Preventive maintenance Inspect sound head Inspect the sound head for signs of wear such as frayed wires or broken strain reliefs Look for corrosion or a build up of conductive gel Clean if necessary Complete model specific preventive main tenance Refer to the monitor s service manual for preventive maintenance tasks specific to the device Complete the preventive maintenance per manufacturer s procedure Biomedical Performance inspection Output accuracy Ensure the UW5 is level before testing If necessary level the UW5 using the adjustable leveling jacks on the underside of the unit Place the transducer cone on the mounting pin in the transducer well Fill the transducer well with 850 ml 50 ml de ionized and degassed water The water should be at room temperature Turn on the UW5 and allow at least 5 minutes for it to stabilize at room temperature Press the ZERO button to zero the wattmeter Place the appropriately sized centering ring over the transducer well Place the sound head in the transducer well so that it is centered and vertical The sound head should be completely coupled with water Start the ultrasound with a continuous duty cycle and bring the output to the maximum setting Measure the ultrasound output on the UWS5 The measured output should be w
88. am and be inventoried under those provisions Does this device facilitate life support functions Yes No Does this device support infection control systems Yes No Does this device support facility environmental systems Yes No Does this device support critical facility utility systems Yes No Does this device support essential communications systems Yes No If the device fails to meet the medical equipment requirements but there are any Yes answers to the utilities equipment questions the device should be included in the utilities equipment management program Does the device pose risk to the patient or staff when used in the facility Yes No Would failure or loss of use of the device adversely affect the deliver of health care Yes No Does this product or class of device have a history of incidents or safety recalls Yes No 5 Maintenance requirements Does the device require periodic inspection in order to ensure safe delivery of care Yes No Does the device require periodic performance testing to ensure safe delivery of care Yes No Does the device require periodic preventive care to ensure safe delivery of care Yes No If the device fails to meet the requirements for Medical or Utilities Equipment but there are YES answers to the above questions in Clinical and Physical risk or Maintenance Requirements the device should be managed on a general equipment inventory with preventive maintenanc
89. ance tasks specific to the device Complete the preventive maintenance per manufacturer s procedure Performance inspection Verify unit operates on battery Check that the ac power indicator is lit 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 106 uUniversity of Vermont Rev 2 Confidential is unplugged and the battery indicator should light Be sure to plug the power cord in at the conclusion of the test Heart rate accuracy Connect the patient leads to the lead connectors on the MPS450 Set the heart rate on the MPS450 to 60 bpm Press 1 NSR and then use the soft keys marked UP and DOWN to change the heart rate to 60 bpm The heart rate should be within 5 of the set rate For a simulated heart rate of 60 bpm the displayed rate should be between 57 bpm and 63 bpm Set the heart rate on the MPS450 to 120 bpm The displayed heart rate should be between 114 bpm and 126 bpm Amplitude accuracy With the patient leads connected to the MPS450 input a normal sinus rhythm by pressing 1 NSR Press the soft key marked SEL to select AMPL Use the soft keys marked up and down to change the amplitude to 1 0 mV Set the sensitivity on the electrocardiograph to 20 mm mV Record a strip on the electrocardiograph Measure the height of th
90. andards Also referred to as codes Guide line documentation of practices agreed upon by industrial professional or governmental orga nizations The standard will usually establish a specific value used for evaluation compliance with the standard Utilities equipment Equipment that supports medical equipment life support infection con trol environmental communication or critical utility systems User checks Also known as operator checks Performance checks on medical equipment that can be performed by the clinical user These are often simple operational checks that do not require the use of tools or test equipment CHAPTER 3 Goals of the maintenance program The goal of any medical equipment maintenance program is to ensure that medical equipment is safe accurate and ready for patient use Quality assurance is achieved with periodic checks of the equipment The purpose of estab lishing risk based maintenance intervals is to provide high quality cost effective inspections based on risk and function historical data on problems found and the effect of maintenance on the reduction of problems The PM Inspection procedures should be based on need that includes the maintenance requirements of the device risk classification device function and history of incidents Main tenance and performance inspections do not prevent random failures particularly related to electronic equipment and low risk devices do not need p
91. 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 perfor mance 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 to their original settings Ensure the volume of the audible alarms is loud enough to be heard in normal operating conditions Plug in the power cord to ensure the battery remains charged Aspirator An aspirator is sometimes known as a suction pump or a vacuum It uses suction to remove gas fluid tissue or other materials from a body cavity An aspirator typically consists of a suction pump a collection container tubing a pressure gauge and a means for adjusting the annual Sample risk assessment Criteria choose 1 rating from each category No patient contact Biomedical Weight vacuum pressure The mot
92. assis leakage lt 100 pA NC lt 500 pA SFC Patient leakage current lt 100 pA B and BF lt 10 pA CF Patient lead leakage current isolation test lt 100 pA BF mains on patient applied part lt 10 pA CF Insulation test optional 500 V lt 2 MQ Calibrate to manufacturer s specifications Check all fluid levels Replace battery every 24 months Clean exterior Lubricate as required Complete model specific preventive maintenance Verify unit operates within manufacturer s specifications Operates on battery power Audible alarms Visual alarms Remote alarms Complete model specific performance testing 38 uUniversity of Vermont Rev 2 Confidential Physical condition and electrical safety are general maintenance requirements that apply to all medical equipment This information will appear on all checklists and should be per formed during all inspections These general maintenance tasks will not be discussed in the specific device procedures Physical condition These tasks check the physical condition of the equipment These tasks should be performed for all medical equipment e Device is clean and decontaminated Ensure the equipment has been cleaned following patient use Examine the exte rior of the unit for cleanliness If there are signs of blood or other spilled liquids the device should be cleaned per the hospital s equipment disinfection policy and t
93. asure the reading using the DPM 4 and compare this value with the display on the compression unit If the compression unit has multiple settings measure the pressure readings throughout its range The pressure displayed on the compression unit should be within 2 of the pressure measured on the DPM 4 For a pressure reading of 45 mmHg the measured pressure should be between 44 mmHg and 46 mmHg University of Vermont Rev 2 Confidential 57 Timing cycle accuracy Disconnect the DPM 4 and test tubing from the compression unit and connect a complete compression set For testing attach the compression set to a piece of PVC pipe or other rigid pipe to simu late a limb Start the compression cycle Use a stopwatch or a watch with a second hand to measure the length of time the pressure is held When the compression unit deflates measure the length of time before the next inflation Compare the measured times to the compres sion unit s setting The measured time should be within 2 of the set time 58 Ouniversity of Vermont Rev 2 Confidential Alarm function Check that all alarms are functional and that the volume is adequately loud Ensure that appropriate visual indicators are functioning Complete model specific performance testing Refer to the service manual for perfor mance inspection tasks specific to the device Complete the performance inspection per manufacturer s procedure Return to service Before r
94. ate infusion of liquids to a patient through intravenous epidural or subcutaneous routes These pumps may utilize a peristaltic pump mechanism a volumetric pump mechanism that repeatedly compresses a specific amount of fluid into a cassette or a syringe driven mechanism settings and alarms annual Sample risk assessment Criteria choose 1 rating from each category No patient contact for propelling the infusate Adjustable settings control the flow rate and volume to be infused Audible and visual alarms alert the user to flow changes or malfunctions Most infusion pumps include a memory function that records does Recommended functional test frequency Weight Score 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 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 Ol RW N e Device failure could result in severe injury to or death of patient or user Maintenance or inspection would not impact reliability of the device B W ND Common device failure modes are unpredictable or not very predictable While common device failure modes are not very predictable device history indicates that
95. ay be required to be tested four times per year based on AABB or CAP requirements Maintenance strategy assignment Maintenance Program Warranty Attach coverage Check Ends Comment Full manufacturers service contract Manufacturers service contract with first look by TSP CAPP contract with first look by TSP TSP scheduled maintenance and repair Hospital scheduled maintenance and repair TSP repair on failure only User maintenance only Replace on failure only Completed by Date University of Vermont Rev 2 Confidential 7 Clinical function is how invasive the equipment is to the patient At the low end of this category is a device that does not make patient contact for example an exam light The high end of this category is a device used for life support such as a ventilator Physical risk is an evaluation of what will be the outcome if the device fails At the low end is low risk failure is more of an inconvenience than actual harm such as an otoscope Failure of this type of device does not pose a threat to the patient s outcome and the clinician can easily use an alternate device with little impact to patient care At the high end is severe injury or death of the patient such as ventilator Failure of this type of equipment can have a serious detri mental effect on the patient s outcome Problem avoidance probability is based on historic data relate
96. blems Common device failure is predictable and can be avoided by preventive maintenance Specific regulatory or manufacturers requirements dictate preventive maintenance or testing aA w ND No significant history A significant history of incidents exists 2 2 i No requirements There are requirements for testing independent of a numerical rating system 2 Total Score 14 Assignment 0 0x 0 5x 1x 2x 3x 4x times per year tested University of Vermont Rev 2 Confidential 77 orocequre Estimated time 20 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 SigmaPace 1000 External Pacemaker Analyzer or equivalent Cables and connectors to connect pacemaker to analyzer Test Result Pass Fail N A 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 and warnings present and legible Inlets and hoses Power cord accessory cables charger Filters and vents clean Ground wire resistance lt 0 3 Q Chassis leakage lt 100 pA NC lt 500 pA SFC Patient l
97. bles charger Filters and vents clean Ground wire resistance lt 0 3 Q Chassis leakage lt 100 pA NC lt 500 pA SFC Patient leakage current lt 100 pA B and BF lt 10 pA CF Patient lead leakage current isolation test lt 100 pA BF mains on patient applied part lt 10 pA CF Insulation test optional 500 V lt 2 MQ Clean recorder paper compartment rollers and paper guides Lubricate motor and paper drive mechanism Verify proper time and date correct if necessary Replace battery every 24 months Complete model specific preventive maintenance Verify unit operates on battery Heart rate accuracy 5 SpO2 accuracy 3 Recorder operation Alarm function Complete model specific performance testing 124 OUniversity of Vermont Rev 2 Confidential Physical condition Check the physical condition of the device as described in the General Equipment Procedure Electrical safety Perform electrical safety checks as described in Chapter 5 Electrical Safety Check ground wire resistance and chassis leakage Preventive maintenance Clean recorder paper compartment roll ers and paper guides Inspect the rollers and paper guides and remove any debris Check for bits of torn paper caught in the rollers Lubricate motor and paper drive mecha nism Follow the manufacturer s instructions in the service manual for lubricating the motor and
98. cal rating system Total Score Assignment 0 0x 0 5x 1x 2x 3x 4x times per year tested 52 University of Vermont Rev 2 Confidential Ee Biomedical oroceqdure Estimated time 35 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 Test Result Pass Fail N A MPS450 Multiparameter Simulator or equivalent Index 2 SpO Simulator or equivalent Vacuum or canned air for clearing dust from cooling fans 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 and warnings present and legible Inlets and hoses Power cord accessory cables charger Filters and vents clean Ground wire resistance lt 0 3 Q Chassis leakage lt 100 pA NC lt 500 pA SFC Patient leakage current lt 100 pA B and BF lt 10 pA CF Patient lead leakage current isolation test lt 100 pA BF mains on patient applied part lt 10 pA CF Insulation test optional 500 V lt 2 MQ Clean dust from cooling fans Complete model specific preventive maintenance V
99. calibration process Class I medical equipment Electrical medical equipment with accessible conductive parts or internal conductive parts protectively grounded in addition to basic insulation Class II medical equipment Electrical medical equipment that uses double insulation or reinforced insulation for protection against electric shock in addition to basic insulation Clinical equipment Medical equipment used for diagnosis treatment or monitoring of a patient Clinical equipment is further broken down to life support and non life support equipment Clinical risk The risk associated with the clinical use of the equipment taking into account how invasive the equipment is to the patient Corrective maintenance Also known as repair Corrective maintenance entails isolating the cause of the device failure Affected compo nents are adjusted or replaced to restore normal function A performance inspection is performed following corrective maintenance before the device is placed back into service to ensure proper operation of the device Biomedical Device inclusion How a device is used determines whether or not to include the device on the managed inventory The device inclusion categories include clinical equipment utili ties equipment and general equipment Most equipment on the inventory will be classified as clinical equipment Electrical safety testing Testing of equip ment to assure it is electrically sound to
100. charger Filters and vents clean Ground wire resistance lt 0 3 Q Chassis leakage lt 100 pA NC lt 500 pA SFC Patient leakage current lt 100 pA B and BF lt 10 pA CF Patient lead leakage current isolation test lt 100 pA BF mains on patient applied part lt 10 pA CF Insulation test optional 500 V lt 2 MQ Clean flow detector Replace battery every 24 months Complete model specific preventive maintenance Verify unit operates on battery Pole clamp function Flow rate accuracy 10 Volume accuracy 10 Infusion complete KVO Occlusion detection pressure 1 psi Piggyback infusion Alarm function Complete model specific performance testing University of Vermont Rev 2 Confidential 95 Physical condition Check the physical condition of the device as described in the General Equipment Procedure Electrical safety Perform electrical safety checks as described in Chapter 5 Electrical Safety Check ground wire resistance and chassis leakage Preventive maintenance Clean flow detector Inspect the flow detector on the infusion pump Clean any debris from the flow sensor Replace battery The battery should be replaced every 24 months Replace if necessary Complete model specific preventive main tenance Refer to the monitor s service manual for preventive maintenance tasks specific to the device Complete the preventive mai
101. clusion Clear the alarm and restart the pump Occlude the tubing after the pump The pump should alarm downstream occlusion Clear the alarm If the pump is equipped with an air detector introduce air into the tubing This can be done by turning the reservoir upside down until a bubble of air is pulled through the tubing Turn the reservoir right side up When the air bubble gets to the pump the pump should alarm air in line Clear the alarm Remove the tubing from the pump and prime the set so that there is no air in the tubing Reinsert the tubing set into the pump and restart the pump Simulate an empty container situation either by turning the reservoir upside down so that no fluid can get to the tubing or by removing the tubing from the reservoir The pump should alarm when no fluid flow is detected Complete model specific performance testing Refer to the service manual for perfor mance inspection tasks specific to the device Complete the performance inspection per manufacturer s procedure Return to service Before returning to use return any settings that were adjusted to their original settings Ensure the volume of the audible alarms is loud enough to be heard in normal operating conditions Plug in the power cord to ensure the battery remains charged External pacemaker External pacemakers electric impulse to the heart through the chest wall in order to tempo rary pacing of the heart External pacemakers consi
102. cy assigned After this is done the maintenance history of the device should be monitored in order to evaluate the effec tiveness of the maintenance program The process is shown in Figure 1 6 OUniversity of Vermont Rev 2 Confidential Inspection frequency may be too low A New device type added to inventory Complete Maintenance Strategy Worksheet Assign inspection frequency Accumulate device history l Evaluate device history Frequent failures or problems found during testing Infrequent failures and no problems found during testing No Infrequent failures some minor repairs or adjustments needed during testing Yes Device has efficient testing frequency Inspection frequency may be too high Yes worksheet Rating system for risk based inspections Ee Biomedical Most device types have been evaluated and classified for test frequency already For new device types use the scoring system to evaluate the frequency of testing University of Vermont Technical Services Program Criteria Choose one rating from each category Weight Score No patient contact 1 Device may make contact with patient but function is non critical 2 Device is used for patient diagnosis or direct monitoring 3 Device is used
103. d for remote monitoring an antenna system and receivers will be necessary for receiving the radio signal Central stations are used for remote monitoring of patients in one or more areas of a hospital They do not replace bedside Recommended functional test frequency Weight Score 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 Device poses no appreciable risk due to failure Ol RP WO N e 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 Maintenance or inspection would not impact reliability of the device AJOIN 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 No significant history oje WO N A significant history of incidents exists No requirements bak There are requirements for testing independent of a numeri
104. d life support equipment whereas a hemodialysis machine is not considered life support Even though the hemodialysis machine takes over the function of the kidney removal of the patient from hemodialysis will not cause immediate death Biomedical All major device classes should be assessed for inclusion based on function risk maintenance requirements historical incidents and regula tions and each device type should be evaluated Evaluations should be performed on new device types as they arrive at the hospital All equip ment used in the hospital should be evaluated regardless of ownership Most commonly devices will fall into the clinical classification A maintenance schedule should be determined for these devices based on the risk criteria dis cussed in Chapter 3 Device inclusion must be performed and documented prior to any equipment use prefer ably during the technology planning stage prior to arrival at the facility This process should be utilized for owned rented loaned demonstra tion or leased equipment The factors must include function risk main tenance requirements and history of incidents The University of Vermont has developed a Device Inclusion Worksheet to facilitate this process 13 00 12 00 User Error and No Problem Found Work Orders By Device Type Excludes Devices With Inventory Count lt 15 11 00 10 00 9 00 8 00 7 00 6 00 5 00 4 00 3 00 2
105. d to deliver direct treatment to the patient Device is used for a life support 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 Ol R O N e Device failure could result in severe injury to or death of patient or user Maintenance or inspection would not impact reliability of the device BLOW D e 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 No significant history aje wo N j A significant history of incidents exists 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 University of Vermont Rev 2 Confidential 17 141 oroceqdure Estimated time 50 minutes Equipment information Control number Hospital Manufacturer Model Serial number Location Test information Technician Date Test type Incoming Post repair Test equipment needed ISA
106. d to medical equipment repair and maintenance The low end of this category is maintenance or inspection having no impact on the reliability of the device the high end is common device failures are predictable and can be avoided by preventive maintenance This category also has an additional level specific regulatory or manufacturer s requirements that dictate preventive maintenance or testing The device incident history is also based on historic data This category only has two scores and is answered as yes or no If a device had a history of being involved in an incident resulting in patient harm the device would score high Otherwise the device would score low The last category is manufacturer s or regu latory requirements This is also either yes or no If the device has a specific requirement for maintenance or testing the device would score high otherwise the device would score low The chart shown gives the scores from the main tenance strategy worksheet for a few medical devices To illustrate the application of the Mainte nance Strategy Worksheet two examples are given below outlining the use of the worksheet The first example is the pulse oximeter the second is the electrosurgical unit The pulse oximeter is a device used for non invasive monitoring of blood oxygen levels The clinical function category would score 3 because the device is used for direct patient monitoring Physical risk would score 3 because f
107. de of the signal versus time as the electrocardiogram The electrocardiogram is used particularly in diagnosing abnormalities of the heart Diag nostic ECGs typically have 10 physical lead wires but measures the electrical potential annual Sample risk assessment Criteria choose 1 rating from each category EEE Biomedical Weight from 12 groups of leads These are commonly referred to as 12 lead ECGs In addition diag nostic ECGs typically contain an interpretation function where the measured signals of the cardiac activity are analyzed using an internal algorithm Diagnostic ECGs do not usually have heart rate alarms An ECG monitor will have 3 or 5 lead wires and is used for monitoring as opposed to diagnosis ECG monitors will have adjustable heart rate alarms Recommended functional test frequency Score 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 Device poses no appreciable risk due to failure Ol RB O NM e 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 Maintenance or inspection would not impact reliability of the device
108. device inclusion and rating criteria and standards e General and device specific procedures and forms for inspection preventive mainte nance safety evaluation and performance testing An appendix with reference information Forms tables diagrams illustrations and photos are used to aid in the understanding of the content The publication takes into consideration the advances in device reliability reduced preventive maintenance requirements and internal device surveillance self test along with changes in standards Due to the ongoing efforts at global harmonization international standards are used and referenced where applicable such as electrical safety testing references IEC 62353 CHAPTER 2 A meaningful preventive maintenance program requires consistent terminology This section contains practical definitions of terms used in this manual Adverse event Sometimes referred to as a device incident An event or circumstance arising during care that could have or did lead to unintended or unexpected harm loss or damage Calibration The process of determining the accuracy of a device by comparing it to a known measurement standard The device is then adjusted to agree with the standard within a recommended tolerance Minor adjustments to achieve the specified accuracy are considered part of the calibration process Major readjust ments and parts replacement are considered repairs and are not included in the
109. dical equipment There are gen eral and specific standards for medical device electrical safety The primary standard for medical devices has been IEC 60601 General requirements for protection against electric shock hazards are covered in IEC 60601 1 Section 3 In this standard each instrument has a class e Class I Live part covered by basic insulation and protective earth e Class II Live part covered by double or reinforced insulation e Class IP Internal power supply Each patient applied part or patient lead has a type Type B Patient applied part earthed e Type BF Patient applied part floating surface conductor e Type CF Patient applied part floating for use in direct contact with the heart 26 University of Vermont Rev 2 Confidential D Oo f Al v The terminology used in IEC 60601 1 includes Protective earth resistance Earth leakage current Enclosure leakage current Patient leakage current e Patient auxiliary current e Mains on applied part MAP To represent the impedance of a patient the test load in Figure 6 has been developed Leakage current measuring devices use this impedance circuit for measurements 10 000 Q 0 015 pF Milli Input 7 voltmeter Figure 6 Impedance of a patient test load Leakage measurements IEC 60601 1 Sec tion 3 Clause 19 limits have been developed for equipment types and measurements NC is normal conditions and
110. document the manufacturer is requested to provide information on testing interval and procedure based on risk typical usage and device history Minimum interval requirements for life support and other critical equipment is set at 24 months In the United States there are several primary and secondary organizations setting standards 1 National Fire Protection Association NFPA NFPA 99 Standard for Healthcare Facilities is the primary standard addressing electrical safety testing affecting healthcare institutions Other publications are NFPA 70 National Electrical Code and NFPA 7OE Electrical Safety in the Workplace 2 Association for the Advancement of Medi cal Instrumentation AAMI ANSI AAMI ES1 Safe Current Limits for Electromedical Apparatus is another commonly accepted standard 3 Underwriters Laboratories UL UL544 Medical Equipment requirements is a stan dard for manufacturers not hospitals These standards may be referenced by accredi tation code or regulatory organizations such as the Joint Commission Occupational Health and Safety Administration or other organizations monitoring healthcare institutions in the United States The Appendices describe the above standards and test setups Global harmonization of standards has lead to the development of world wide standards After the deadlines below equipment must be certi fied to the IEC60601 1 standard or the device cannot be sold in that country
111. e of improving the quality of care containing the cost of health care delivery and improving the safety of patients hospital staff and visitors Biomedical Tracking device histories is useful for evaluating the effectiveness of the maintenance program A computerized system is especially useful for this task as different types of equipment problems will need to be tracked Maintenance inspection intervals should be reviewed annually to make changes as justified as well as following any changes in regulations or guidelines The review is done by analyz ing the data generated from the maintenance history To facilitate analysis coding in the com puterized maintenance management system on the types of problems encountered is required The University of Vermont uses a system where a work order is generated for every maintenance event of a device The work orders are coded by type of maintenance event and the work order types categorize the service performed Work order types for maintenance user errors no problem found recalls upgrades and other risk categories are tracked through the equip ment problem summaries These summaries are available for reporting to the Safety Commit tee to improve patient care and create a safe environment Devices that frequently have problems found during the periodic performance inspection or that have a high failure rate in between inspections may need to have more frequent inspections
112. e QRS peak The measured amplitude should be within 5 of the set amplitude For an amplitude setting of 1 mV and a sensitivity of 20 mm mV the peak should be between 19 mm and 21 mm Heart rate alarms Set the high heart rate alarm on the monitor to 120 bpm Set the low heart rate alarm on the monitor to 40 bpm Adjust the heart rate on the MPS450 to 140 bpm The high rate alarm should activate Return the heart rate on the MPS450 to 60 bpm and clear the alarm Adjust the heart rate on the MPS450 to 30 bpm The low rate alarm should activate Return the heart rate on the MPS450 to 60 bpm and clear the alarm Return the alarm limits on the monitor to their original settings Recorder speed Set the heart rate on the MPS450 to 60 bpm Record a strip on the elec trocardiograph Measure the distance between the peaks of the QRS complex With a recorder speed of 25 mm sec the QRS peaks should be between 24 mm and 26 mm apart Respiration rate accuracy Set the respira tion rate on the MPS450 to 20 breaths min Press 2 RESP and then use the soft keys to change the respiration rate The respiration rate should be within 5 of the set rate For a simulated respiration rate of 20 breaths min the displayed rate should be between 19 breaths min and 21 breaths min Respiration alarms Set the high respiration rate alarm on the monitor to 60 breaths min Set the low respiration rate alarm on the moni tor to 20 bpm Adjust th
113. e a timing function that allows a lockout interval to prevent an overdose of the analgesic Recommended functional test frequency annual Weight Score 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 Device poses no appreciable risk due to failure O11 W N Re 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 Maintenance or inspection would not impact reliability of the device AJIUIN Common device failure modes are unpredictable or not very predictable testing frequently detects problems While common device failure modes are not very predictable device history indicates that TSP Common device failure is predictable and can be avoided by preventive maintenance No significant history Specific regulatory or manufacturers requirements dictate preventive maintenance or testing oje Ww N 1 jas A significant history of incidents exists No requirements There are requirements for testing independent of a numerical rating system 2 Total Score Assignment 0 0x 0 5x 1x 2x 3x 4x times per year tested
114. e gel Clean if necessary Complete model specific preventive main tenance Refer to the monitor s service manual for preventive maintenance tasks specific to the device Complete the preventive maintenance per manufacturer s procedure Performance inspection Output accuracy Connect the scope probe to channel A of the oscilloscope Press the SCOPE button on the 199XRAY to enter oscil loscope mode Press the A button on the scope to access the settings for channel A Press the F3 PROBE A and set the probe type to cur rent Connect the stimulator electrode cable to the scope probe Set the simulator to a Rus sian waveform with a continuous cycle Start 136 vUniversity of Vermont Rev 2 Confidential the stimulator and adjust the output to 20 mA Read the current measured on the scope The measured current should be within 10 of the set current With a set current of 10 mA the measured current should be between 9 mA and 11 mA Repeat the measurement for 25 mA 50 mA and 100 mA Timer accuracy Set the treatment timer on the stimulator for 1 minute Start the stimulator and begin timing with a stopwatch or a watch with a second hand The treatment timer should sound between 50 seconds and 70 seconds Verify that the there is no output after the timer stops Alarm function Check that all alarms are functional and that the volume is adequately loud Ensure that appropriate visual indicators
115. e or testing as appropriate This device will be assigned as Life Support Equipment Yes No This device will be assigned as Medical Equipment Yes No This device will be assigned as Utilities Equipment Yes No This device will be assigned as General Equipment Yes No This device will be NOT be included in any equipment management program Yes No Completed by Date 14 OUniversity of Vermont Rev 2 Confidential Incoming inspections The initial test for a new piece of equipment prior to the use in patient care is called the Incoming Inspection This inspection serves to ensure the equipment passes all performance and safety requirements prior to use This is typically the most rigorous test performed of all inspections A test form should be used to docu ment test results Incoming inspections should be done on all medical equipment regardless of whether owned rented leased loaned or on demonstration equipment Each device should be evaluated per the Device Inclusion Worksheet to determine the inventory classification All medical equipment determined to be on a management program needs to receive a performance and safety test prior to patient use Working with clinical staff is required to ensure all medical equipment receives an incoming inspection including demo equipment brought in by vendors If the equipment passes the inspection the device should be entered into the hospital s inventory
116. e respiration rate on the MPS450 to 80 breaths min The high rate alarm should activate Bring down the respiration rate on the MPS450 to 30 breaths min and clear the alarm Adjust the respiration rate on the MPS450 to 15 bpm The low rate alarm should activate Bring down the respiration rate on the MPS450 to 20 breaths min and clear the alarm Return the alarm limits on the monitor to their original settings To simulate an apnea condition press the soft key button APNE Use the soft keys marked PREV and NEXT to cycle through the apnea durations and select CONTINUOS Press the soft key labeled RUN to start the apnea condi tion To stop the apnea condition and return to normal respiration press the soft key labeled STOP The alarm should sound for an apnea condition Most monitors will alarm within 30 seconds Leak test Connect a hose and cuff to the NIBP monitor Place the cuff around a piece of PVC pipe or other sturdy cylindrical object to simulate placement on a limb Connect a piece of tubing to the pressure port on the BP Pump 2 Connect a tee to this tubing and attach tubing and connectors Connect the two legs of the tee between the hose and the cuff of the NIBP monitor Place the NIBP monitor in service mode to perform the leak test Select LEAK TEST on the BP Pump 2 Press SETUP to change the test pressure set point Use the number keys to enter a test pressure of 250 mmHg and t
117. e should be complete in approximately 10 minutes Clear the alarm on the pump The measured flow rate should be within 10 of the set rate For a flow rate of 60 mL hr the flow rate should be between 54 mL hr and 66 mL hr Set the flow rate on the pump to 120 mL hr and the dose to 10 mL Repeat the flow test at the higher flow rate The IDA 4 Plus is equipped with four chan nels to analyze infusion devices Four pumps can be run simultaneously Volume accuracy Set up the infusion pump and the IDA 4 Plus as described previously in Flow Rate Accuracy The IDA 4 Plus will mea sure flow rate and volume simultaneously The delivered volume should be within 10 of the set volume For a set volume of 10 mL the mea sured volume should be within 9 mL and 11 mL Infusion complete KVO At the conclusion of an infusion the infusion pump should alarm infusion complete or KVO If the pump alarms KVO it is supplying a very low flow rate in order to keep the vein open if another infusion needs to be given Measure the KVO rate using the FLOW function on the IDA 4 Plus Biomedical Set up the infusion pump with a high flow rate and low volume such as 300 mL hr and 2 mL Start the pump and allow the infusion to complete When the infusion is complete do not stop the pump instead silence the alarm and let the pump run Enter the FLOW screen on the IDA 4 Plus to measure the KVO rate Several minutes may be
118. e time and date is not displayed on the monitor print a strip from the recorder The time and date should appear on the printed strip Correct the time and date as necessary Complete model specific preventive main tenance Refer to the monitor s service manual for preventive maintenance tasks specific to the device Complete the preventive maintenance per manufacturer s procedure 82 University of Vermont Rev 2 Confidential Performance inspection Verify unit operates on battery Check that the ac power indicator is lit 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 Be sure to plug the power cord in at the conclusion of the test Fetal heart rate accuracy If the fetal moni tor uses fetal scalp electrodes connect the ECG cable to the connectors on the side of the PS320 Use the fetal up and down buttons to set a fetal heart rate of 120 bpm The displayed heart rate should be within 5 of the set rate For a simulated heart rate of 120 bpm the displayed rate should be between 114 bps and 126 bps Connect the ultrasound cable from the ultrasound connector on the fetal monitor to the US1 port of the PS320 If the fetal monitor is equipped with two ultrasound inputs con nect a second ultrasound cable to the US2 port of the
119. eakage current lt 100 pA B and BF lt 10 pA CF Patient lead leakage current isolation test lt 100 pA BF mains on patient applied part lt 10 pA CF Insulation test optional 500 V lt 2 MQ Replace battery every 24 months Complete model specific preventive maintenance Verify unit operates on battery Rate accuracy 5 Output accuracy 10 Pulse width 10 Alarm function Complete model specific performance testing 78 University of Vermont Rev 2 Confidential Physical condition Check the physical condition of the device as described in the General Equipment Procedure Electrical safety Perform electrical safety checks as described in Chapter 5 Electrical Safety Check ground wire resistance chassis leakage and lead leakage Preventive maintenance Replace battery The battery should be replaced every 24 months Replace if necessary Complete model specific preventive main tenance Refer to the monitor s service manual for preventive maintenance tasks specific to the device Complete the preventive maintenance per manufacturer s procedure Performance inspection Verify unit operates on battery Check that the ac power indicator is lit 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 ind
120. ears on the test form next to the task for flow rate accuracy Biomedical The checklist has an option for each main tenance task as either passed failed or not applicable Devices that have maintenance tasks that fail should not be put back into ser vice until the problem has been corrected The not applicable category is necessary as the maintenance checklists are generic by device type and since device operation varies from model to model not every maintenance task can be performed on every device For example the centrifuge maintenance checklist includes timer accuracy operation of the brake and alarm activation High end centrifuges will have all of these functions However simpler centrifuges may not have these functions to be tested This doesn t mean the device is unsafe to use it simply means the equipment does not have those functions Every maintenance task that needs to be performed on every device can be included on the maintenance checklist Device function and operation vary greatly by model and manu facturer Reference to the equipment s service manual for any additional maintenance tasks is required A sample form for Infusion Pumps is shown on page 20 uUniversity of Vermont Rev 2 Confidential 19 oroceqdure Estimated time 45 minutes Equipment information Control number Hospital Manufacturer Model Serial number Location Test information Technician Da
121. eck the physical condition of the power cord Look for cuts frayed wires and missing insulation Check the physical condi tion of the plug looking for bent or loose prongs Ensure strain reliefs are intact Check the physical condition of cables looking for frayed wires and loose or bent connections Ensure connections are clean and free of cor rosion and build up such as gel or hair Verify that disposable accessories are within their expiration dates Filters and vents clean Ensure filters and vents are free of dust and other build up Pay special attention to cooling fans Clean or replace filters as necessary 39 University of Vermont Rev 2 Confidential Electrical safety These tasks check the electrical safety of the equipment and are important to prevent a shock to the patient Follow the procedures given in Chapter 5 Electrical Safety Measure ground wire resistance chassis leakage Measure current leakage to patient leads if applicable Electrical safety should be checked for all medical equipment e Device specific tasks Preventive maintenance and performance inspection include maintenance tasks and testing criteria that are specific for each device type These tasks should be per formed in addition to the general physical and electrical safety tests As a general guideline rechargeable bat teries should be replaced every 24 months Certain batteries in low use situations such as automatic external defibri
122. ed time 20 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 20 cc or larger syringe IDA 4 Plus Infusion Device Analyzer or equivalent 3 way stopcock Tubing set for feeding pump Tubing and connectors to Reservoir to connect to tubing set bag or bottle connect to IDA 4 Plus Test Result Pass Fail N A 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 and warnings present and legible Inlets and hoses Power cord accessory cables charger Filters and vents clean Ground wire resistance lt 0 3 Q Chassis leakage lt 100 pA NC lt 500 pA SFC Patient leakage current lt 100 pA B and BF lt 10 pA CF Patient lead leakage current isolation test lt 100 pA BF mains on patient applied part lt 10 pA CF Insulation test optional 500 V lt 2 MQ Clean flow detector Replace battery every 24 months Complete model specific preventive maintenance Verify unit operates on battery Pole clamp function Flow rate accuracy 10 Volume accuracy 10 Occlusion detection pressure
123. ed warm up time should be within 20 of the manufacturer s specified warm up time For a warm up time of 30 minutes the measured warm up time should be within 24 minutes and 36 minutes uUniversity of Vermont Rev 2 Confidential 91 Air temperature accuracy Set the incuba tor temperature to 32 C Place the INCU in the center of the incubator Place the T1 and T3 temperature probes so that they are placed ver tically in opposite corners Place the T2 probe in the center holder Attach the air flow sensor and rotate the sensor so that it is perpendicular to the air flow within the incubator If the incuba tor is equipped with a skin temperature probe place the skin probe in close proximity to the T2 sensor Allow the incubator temperature to stabilize Press the SELECT button on the INCU to cycle through the readings The measured air temperature should be within 1 C of the set temperature For a set temperature of 32 C the measured temperature should be between 31 C and 33 C Set the temperature on the incubator to 36 C and allow the temperature to stabilize Repeat the temperature measurements at 36 C Skin temperature accuracy Place the skin temperature probe in close proximity to the T2 sensor on the INCU Allow the incubator tem perature to stabilize The measured temperature on the T2 sensor should be within 0 3 C of the displayed skin temperature on the incubator For a displayed skin temperature
124. ego ries clinical function physical risk problem avoidance probability incident history and reg ulatory or manufacturer requirements Devices are given a score for each of these categories The scores for each category are added up and a total score is given for each device type Main tenance strategies are determined based on the total score A combined score of 13 or more is justification for semiannual testing a score of 9 12 is justification for annual testing and a score of 8 or less is justification for less than annual testing either bi annual or no scheduled testing depending on clinical application The result is a more cost effective test program that will result in improved patient care through less equipment downtime and more dollars for direct patient care activities The risks identified are used to assist in deter mining the strategies for maintenance testing and inspection of medical equipment In addi tion the identified risks are used to guide the development of training and education programs for staff that use or maintain equipment All medical equipment is screened at the time of delivery and appropriate training and testing of new equipment takes place prior to use on patients University of Vermont Rev 2 Confidential 5 The risk assessment should be done for each new device type during the incoming inspection when the device is added to the inventory The device will then have a test ing frequen
125. eled O SETUP to access the set up menu Press the soft key labeled BP SENSE and then use the soft keys to toggle the sensitivity between 5 pV V mmHg and 40 pV V mmHg Press the key labeled 3 BP to enter the blood pressure menu on the MPS450 Press the BPI soft key and then press ZERO to zero the channel if necessary Connect the invasive blood pressure cable to the BP1 port on the side of the MPS450 Press the DYNA soft key to start a dynamic pressure simulation Select an arterial pressure of 120 80 Press RUN to begin the simulation The pressure displayed on the monitor should be within 5 of the set pressure For a simu lated pressure of 120 80 the displayed systolic pressure should be between 114 mmHg and 126 mmHg and the diastolic pressure should be between 76 mmHg and 84 mmHg Invasive pressure alarms Set the high pressure alarm limits on the monitor lower than 120 80 Set the high systolic alarm limit to 115 mmHg and the high diastolic alarm limit to 75 mmHg The high alarms should activate Clear the alarms on the monitor and return the alarm limits to their original settings Set the low pressure alarm limits on the monitor higher than 120 80 Set the low systolic alarm limit to 125 mmHg and the low diastolic alarm limit to 85 mmHg The low alarm should activate Clear the alarms on the monitor and return the alarm limits to their original settings Temperature
126. ential Close the 02 cylinder and disconnect the pipeline The low O2 pressure alarm should activate Reconnect the pipeline and clear the alarm Repeat this for other gases if necessary Set up the ventilator with a tidal volume of 1000 mL a rate of 6 breaths min and an I E ratio of 1 2 and start the ventilator Note the maximum airway pressure during ventilation Set the high pressure limit about 10 cmH20 below the peak inspiratory pressure If the Peak inspiratory pressure is 40 cmH20 set the high pressure limit to 30 cmH20 Verify that the ventilator immediately stops delivering the breath when the pressure limit is reached and allows the breath to be exhaled Verify that the alarm activates Return the high alarm limit to its previous setting and clear the alarm Disconnect the inspiratory limb of the patient circuit from the ventilator The low pressure alarm should activate Complete model specific performance testing Refer to the service manual for perfor mance inspection tasks specific to the device Complete the performance inspection per manufacturer s procedure Return to service Before returning to use return any settings that were adjusted to their original settings Ensure the volume of the audible alarms is loud enough to be heard in normal operating conditions Plug in the power cord to ensure the battery remains charged Standards are used to give a baseline APPENDIX 1 performance that needs to be
127. ents when flow is first detected 97 U niversity of Vermont Rev 2 Confidential On the infusion pump set the primary rate for 120 mL hr and the primary volume to 10 mL Set the piggyback flow rate to 60 mL hr and the piggyback volume to 10 mL Start the piggyback infusion The IDA 4 Plus will display the rate and volume for the piggyback infusion as FLOW 1 When the piggyback infusion is completed the infusion pump should automatically switch over to the primary infusion and will usually sound an audible tone The rate and volume for the primary infusion is displayed on the IDA 4 Plus as FLOW 2 The delivered flow rates and vol umes should be within 10 of their set rates Alarm function Check that all alarms are functional and that the volume is adequately loud Ensure that appropriate visual indicators are functioning Set the rate on the pump to 100 mL hr and set the volume to 100 mL Start the pump Occlude the tubing between the reservoir and the pump The tubing can be occluded either by closing a clamp attached to the tubing or by pinching the tubing with a set of hemostats or pliers The pump should alarm upstream occlusion Clear the alarm and restart the pump Occlude the tubing downstream from the pump The pump should alarm downstream occlusion Clear the alarm 98 OUniversity of Vermont Rev 2 Confidential If the pump is equipped with an air detector introduce air into
128. equipment Preventive maintenance tasks may include replacing parts lubricating and adjust ing Preventive maintenance excludes tasks normally carried out by the user Problem avoidance probability The like lihood of a device to fail based on historic data related to medical equipment repair and maintenance 4 University of Vermont Rev 2 Confidential Procedure Maintenance tasks that need to be completed for effective performance testing and preventive maintenance Quality assurance A systematic process of checking to see whether a product or service is meeting specified requirements Regulatory requirements Specific criteria that must be met as set forth in codes and standards Regulatory requirements often have the power of law behind them from a governing body Repair Also known as Corrective Mainte nance Entails isolating the cause of the device failure and replacing or adjusting affected components to restore normal function A performance inspection is performed following corrective maintenance before the device is placed back into service to ensure proper operation of the device Risk assessment The identification and quantification of possible hazards A risk assess ment involves a numerical scoring system to quantify the amount of risk Risk management A process by which possible hazards are identified and assessed Procedures are put into place to minimize the risks from the identified hazards St
129. er cord is plugged in to ensure the battery remains charged and the equipment is ready for use Apnea monitor Apnea is defined as the absence of breathing An apnea monitor is designed to detect this condition The apnea monitor senses by mea suring 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 semiannual Sample risk assessment Criteria choose 1 rating from each category No patient contact Biomedical Weight respiration rate with the limits of these param eters 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 Score 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 Device poses no appreciable risk due to failure Ol RP WO N e 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
130. erformance verification at the same frequency or intensity of higher risk devices Medical equipment should be evaluated to determine how often testing should be per formed If a device is not tested often enough it may fail before the next scheduled mainte nance or give erroneous results If a device is tested too frequently time that could be better spent maintaining other equipment is wasted The biomedical professional s job is to achieve a balance between the time and effort needed for periodic functional testing and the safe use of medical equipment Risk based inspection intervals In order to maintain an efficient maintenance program the frequency of inspection must be determined Effort should be spent on equip ment where testing is likely to have an impact on the continued safe operation of the medical device Biomedical The University of Vermont has developed a risk based system for determining the mainte nance frequency Intervals are established for equipment inspection based on risk require ments logistics and history Written criteria are used to identify risks associated with medi cal equipment per the Maintenance Strategy Worksheet The risks include equipment function physical risks associated with use and equipment history as it relates to patient safety Life support equipment is specifically identified and receives the highest priority for actions The risk criterion is divided into five cat
131. erify display is clear and legible Verify monitoring capabilities of hard wired monitors Verify monitoring capabilities of telemetry transmitters Verify recorder accuracy 4 Verify operation of alarms Complete model specific performance testing University of Vermont Rev 2 Confidential 53 Physical condition Check the physical condition of the device as described in the General Equipment Procedure Electrical safety Perform electrical safety checks as described in Chapter 5 Electrical Safety The central station will not be able to be removed from power for testing and will need to be tested as perma nently installed medical equipment Preventive maintenance Clean dust from cooling fans The comput ers that run central station monitoring systems are often situated under desks As the cooling fans accumulate a lot of dust and debris they can become clogged and lead to overheating of the computer system Use a small vacuum or a canned air to remove dust from the fans and vents A vacuum is preferred over compressed air as it will not blow dust around the patient care area Complete model specific preventive main tenance Refer to the monitor s service manual for preventive maintenance tasks specific to the device Complete the preventive maintenance per manufacturer s procedure Performance inspection Verify display is clear and legible The monitor should be clear a
132. eturning to use return the compression cycle setting to its origi nal setting Plug in the power cord to ensure the battery remains charged Defibrillator Defibrillators deliver electric impulse to the heart through the chest wall in order to restore a normal rhythm in patients experiencing ven tricular fibrillation or ventricular tachycardia The high electrical energy stops the indepen dent action of the individual muscle fibers so that the natural pacemaker of the heart can take over A set charge is generated and is delivered through a set of paddles or disposable defibrillation electrodes through the chest wall The defibrillator s output energy is typically Sample risk assessment Criteria choose 1 rating from each category Biomedical selectable from O J to 360 J Most defibrillators also include an electrocardiograph to moni tor the patient s rhythm Some defibrillators include a pacer function Electrical impulses are delivered to the heart causing the heart to contract This is used for emergency treatment of asystole severe bradycardia implantable pacemaker failure or other conditions requiring emergency cardiac pacing Recommended functional test frequency semiannual Weight Score 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 patie
133. fidential EE Biomedical oroceqdure Estimated time 120 minutes Equipment information Control number Hospital Manufacturer Model Serial number Location Test information Technician Date Test type Incoming Test equipment needed Test Result Pass Fail N A Post repair ISA 601 Electrical Safety Analyzer or equivalent INCU incubator analyzer or equivalent Stopwatch or watch with a second hand Heat Gun 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 and warnings present and legible Inlets and hoses Power cord accessory cables charger Filters and vents clean Ground wire resistance lt 0 3 Q Chassis leakage lt 100 pA NC lt 500 pA SFC Patient leakage current lt 100 pA B and BF lt 10 pA CF Patient lead leakage current isolation test lt 100 pA BF mains on patient applied part lt 10 pA CF Insulation test optional 500 V lt 2 MQ Clean cooling vents and filters Inspect and clean ducts heater and fans Inspect gaskets for signs of deterioration Inspect port closures and port sleeves Replace battery every 24 months Complete model specific preventive maintenance continued on page 90
134. flow is stopped As heart rate annual Sample risk assessment Criteria choose 1 rating from each category No patient contact Biomedical Weight the cuff is deflated transducers measure pres sure fluctuations The monitor then processes the information from the pressure transducers and displays the systolic diastolic and mean pressure typically in mmHg millimeters of mercury Most NIBP monitors will also display Recommended functional test frequency Score 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 Device poses no appreciable risk due to failure C1 P Ww N e 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 Maintenance or inspection would not impact reliability of the device AIIN 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 p
135. for proper closure Inspect the port gloves for holes or other signs of wear Biomedical Replace battery The battery should be replaced every 24 months Replace if necessary Complete model specific preventive main tenance Refer to the monitor s service manual for preventive maintenance tasks specific to the device Complete the preventive maintenance per manufacturer s procedure Performance inspection Verify unit operates on battery Check that the ac power indicator is lit 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 Be sure to plug the power cord in at the conclusion of the test Fan operation Inspect the fan blades for damage Look for chips warping melting and missing blades Ensure there is adequate clear ance around the fan assembly Look for signs of rubbing around the fan housing Lubricate the fan motor per the manufacturer s specification Follow the manufacturer s instructions in the service manual for lubricating the pump motor Not all motors will need to be lubricated Warm up time With the incubator at room temperature set the incubator temperature for 12 C above ambient temperature typically 36 C Use a stopwatch to time how long it takes for the temperature to stabilize The mea sur
136. gauge must be verified prior to this test The values on the test form are guidelines based on common practice Refer to the aspirator s opera tor manual for its actual performance capability If the measured vacuum is low look for air leaks particularly in collection bottle caps and hoses Release the occlusion on the tubing 47 U niversity of Vermont Rev 2 Confidential Vacuum rise time With the aspirator set to its maximum setting occlude the suction tubing Use a stopwatch or a watch with a second hand to measure the time it takes to reach the vacuum level indicated on the test form Tho racic aspirators should reach 30 mmHg in less than 4 seconds Emergency surgical or tracheal aspirators should reach 300 mmHg in less than 4 seconds Uterine aspirators should reach 300 mmHg in less than 3 seconds Breast pumps should reach 150 mmHg in less than 2 seconds Again these are general guidelines based on 48 uUniversity of Vermont Rev 2 Confidential common practice Refer to the aspirator s opera tor manual for its actual performance capability Complete model specific performance testing Refer to the service manual for perfor mance inspection tasks specific to the device Complete the performance inspection per manufacturer s procedure Return to service Before returning to use return the suction setting to its original setting Plug in the power cord to ensure the battery remains charged EEE
137. gh density current results in a heating effect that causes tissue destruction Electrical current is delivered and received through cables and electrodes The electrodes may be activated by either a switch semiannual Sample risk assessment Criteria choose 1 rating from each category No patient contact Biomedical Weight on the hand piece holding the electrode or by a footswitch An ESU may use a monoploar or a bipolar mode In monoplar mode electrical current is delivered to the patient by an active cable and electrode and returns to unit through a return electrode In bipolar mode two elec trodes typically the tips of a pair of forceps or scissors serve as the equivalent of the active and dispersive leads in the monopolar mode Recommended functional test frequency Score 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 Device poses no appreciable risk due to failure Ol PP d N e 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 Maintenance or inspection would not impact reliability of the device DB oO dN e Common device failu
138. hat the cleaning solution that was being used to disin fect the pumps between patients was causing the plastic cases to turn brittle and crack Working with the manufacturer of the pumps a recommendation for a suitable disinfectant was made Always check the equipment operation manual in the proper way to disinfect the equipment The manual should list the pre ferred cleaning method and what cleaners can be used Also be aware that cleaners can sometimes discolor etch or soften materials such as plastics often used in equipment cases Always test cleaners in an inconspicuous area before using 23 University of Vermont Rev 2 Confidential CHAPTER 8 Electrical safety is an area of concern related to medical devices Electrical shock can cause dis ruptions during healthcare procedures injury and death Physiological effects range from a tingling sensation to serious burns and electro cution Excitable human tissue is very sensitive to current in the frequency range of electrical power systems worldwide 50 50 Hertz Figure 4 shows the effects of current flowing from one skin contact point to another Macroshock is the term applied when electrical current is applied externally The electrical safety issue takes on added significance related to electrically susceptible patients For cardiac procedures electrically conductive catheters may be placed into the heart while the patient is connected to medi cal equipment
139. he manu facturer s approved cleaning instructions e No physical damage to case display mounts cart or components Examine the device for general physical condition Ensure plastic housings are intact and that all assembly hardware is present and tight Examine the exterior for cracks and chips Check that shelves and brackets are secure Check the condition of castors and ensure they turn and swivel as appropriate Check the operation of the brakes e Switches and controls operable and cor rectly aligned Ensure all switches buttons knobs and other controls are operable Verify knobs are properly aligned with markings on the control panel Biomedical Display intensity adequate for daytime use Verify all lights LEDs and displays can be easily seen in ambient light Displays should be able to be read easily under normal operating conditions Control numbers labeling and warn ings present and legible Ensure all control numbers device labels warning labels or other labels can be easily read Verify control numbers and inspection stickers do not cover up any cautions warning labels or other device information Inlets and hoses Check the condition of all external tubing and hoses Ensure they are not cracked or kinked Check the general condition of the connectors Look for damage such as stripping or cross threading Verify that connectors are tight Power cord patient and accessory cables charger Ch
140. he set lock out interval For a lock out interval of 5 minutes the measured interval time should be between 4 minutes 45 seconds and 5 min utes 15 seconds Dose limit Continue to run the PCA pump as described above and allow it to deliver 20 mL When the pump reaches the dose limit the dose limit alarm should activate The pump should no longer deliver the continuous rate nor allow any boluses The pump may continue to deliver a KVO rate KVO rate When the PCA pump reaches its dose limit it will go into a KVO rate to supply a very low flow rate in order to keep the vein open if another infusion needs to be given Measure the KVO rate using the FLOW function on the IDA 4 Plus Allow the pump to reach its dose limit but do not stop the pump Instead silence the alarm and let the pump run Enter the FLOW screen on the IDA 4 Plus to measure the KVO rate It may take several minutes for the analyzer to be able to measure the low rate The measured rate should be within 10 of the infusion pump s KVO rate Check the service manual for the exact rate For a KVO rate of 1 mL hr the measured rate should be between 0 9 mL hr and 1 1 mL hr Occlusion detection pressure From the channel set up menu on the IDA 4 Plus select OCCLUSION Prime the IDA 4 Plus with the syringe if necessary Set the flow rate on the PCA pump to 15 mL hr and start the pump Select START on the IDA 4 Plus Select END on the ID
141. he time and date should appear on the printed strip Correct the time and date as necessary Electrocardiograph with leads connected to MPS450 FLUKE Biomedical Clean rollers and paper guides Inspect the rollers and paper guides and remove any debris Check for bits of torn paper caught in the rollers Lubricate motor and paper drive mecha nism Follow the manufacturer s instructions in the service manual for lubricating the motor and paper drive mechanism Not all motors will need to be lubricated Complete model specific preventive main tenance Refer to the monitor s service manual for preventive maintenance tasks specific to the device Complete the preventive maintenance per manufacturer s procedure Performance inspection Verify unit operates on battery Check that the ac power indicator is lit 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 Be sure to plug the power cord in at the conclusion of the test Heart rate accuracy Connect the patient leads to the lead connectors on the MPS450 Set the heart rate on the MPS450 to 60 bpm Press T NSR and then use the soft keys marked UP and DOWN to change the heart rate to 60 bpm The heart rate should be within 5 of the set rate For a simu
142. hen press ENT Press the soft key labeled START on the Biomedical analyzer to start the test Allow the test to run for at least 30 seconds and then press the soft key labeled STOP to end the test The leak rate should be less than 15 mmHg min Static pressure accuracy With the NIBP monitor in service mode select STATICPres sure on the BP Pumpz2 Press the soft key labeled SOURCE Set the test pressure on the analyzer to 200 mmHg Start the test by press ing the soft key labeled START Compare the pressure displayed on the NIBP monitor with the measured pressure displayed on the ana lyzer The measured pressure should be within 3 mmHg of the displayed pressure For dis played pressure of 200 mmHg the measured pressure should be between 197 mmHg and 203 mmHg Pressure relief test Put the NIBP monitor into service mode Select PRESSURE RELIEF on the BP Pump 2 and set the test pressure to 380 mmHg Press the soft key labeled START to start the test The test will end when the high pressure relief valve is triggered on the NIBP monitor and the monitor vents the pres sure from the cuff Note the pressure at which the relief valve is triggered The over pressure limit should be less than 330 mmHg Check the manufacturer s service manual for the exact value Dynamic pressure accuracy Place the NIBP monitor into the normal operating mode Select STANDARD BP on the BP Pump 2
143. hermia unit The low reservoir alarm should sound Fill the reservoir with distilled water until the alarm clears Complete model specific performance testing Refer to the service manual for perfor mance inspection tasks specific to the device Complete the performance inspection per manufacturer s procedure Return to service Before returning to use return any settings that were adjusted to their original settings Ensure the volume of the audible alarms is loud enough to be heard in normal operating conditions If the hypo hyper thermia unit is going to be used in the near future Ensure there is an adequate water level in the reservoir If the hypo hyperthermia unit will not be used soon drain the water from the reservoir 87 University of Vermont Rev 2 Confidential Infant incubator Infant incubators provide a closed controlled environment to maintain appropriate tempera ture humidity and oxygen levels for infants and are used mainly for premature infants and other newborns that cannot regulate their body temperature by themselves Infant incu bators typically consist of a clear removable plastic hood with a mattress a heater a fan for Sample risk assessment Criteria choose 1 rating from each category No patient contact circulating warm air and temperature controls Temperature sensors may measure air tem perature inside the incubator the infant s body temperature through a skin probe or b
144. 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 No significant history Oly WwW N rR A significant history of incidents exists 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 10 i University of Vermont Rev 2 Confidential 103 oroceqdure Estimated time 50 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 BP Pump 2 NIBP Analyzer or equivalent Index 2 SpO2 Analyzer or equivalent Stopwatch or watch with a second hand Cables to connect to MPS450 Tubing and connectors to connect to BP Pump 2 PVC pipe to attach BP cuff to Gas with a known quantity of C02 Test Result Pass Fail N A 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 numbe
145. ical Output energy at maximum setting for 10 charge cycles Set the energy on the defibrillator to the maximum setting Charge the defibrillator and then discharge into the Impulse 4000 Repeat this charge and dis charge cycle 10 times On the tenth shock the energy output should still be within 15 of the setting Charge time after 10 charge cycles Mea sure the charge time on the maximum energy setting after 10 discharge cycles From the DEFIB menu on the Impulse 4000 select F3 MEXE Press F2 HIGH for the high energy range Connect the defibrillator paddles to the paddle contacts on the Impulse 4000 Press F3 START and immediately start charg ing the defibrillator When the defibrillator is fully charged immediately discharge into the Impulse 4000 The energy output and the charge time will be displayed The charge time should not exceed 15 s Energy after 60 sec of full charge Charge the defibrillator at its maximum setting Wait 60 seconds and then discharge into the Impulse 4000 The output should be at least 85 of the energy setting At a setting of 360 J the output should be at least 306 J Internal discharge function The defibrilla tor should have a method of discharging stored energy Some models have a button on the front panel for this function Others release the energy after a set time or when the defibril lator is turned off Check the service manual for specific operation of the intern
146. icator should light Be sure to plug the power cord in at the conclusion of the test Output accuracy Connect the pacemaker to the input jacks on the front of the analyzer Power on the analyzer and press F1 NONINV to select non invasive pacing Press F3 BRAND to cycle through the available manufacturers The preset test load will appear for each manu facturer If necessary press F4 LOAD to adjust the test load Refer to the pacemaker s manual for the proper load Press F1 NEXT once the proper manufacturer and test load have been selected Set the pacing rate on the pacemaker to 80 ppm Set the pacemaker output to the mini mum setting and start pacing The SigmaPace 1000 will display the pacer output amplitude in mA Measure the pacer output over its entire Biomedical range The measured output should be within 10 of the set output For an output setting of 100 mA the measured output should be between 90 mA and 110 mA Rate accuracy While measuring pacer output the SigmaPace 1000 also displays the pulse rate The measured pulse rate should be within 5 of the set rate For a rate of 80 ppm the pulse rate should be between 84 ppm and 76 ppm Slowly adjust the pulse rate on the pacemaker and measure the pulse rate through out its range Pulse width While measuring pacer output the SigmaPace 1000 will display the pulse width Typical pulse widths are between 0 5 mSec to 2 0 mSec Mea
147. ice Before returning to use return any alarms that were adjusted to their original settings Ensure the volume of the audible alarms is loud enough to be heard in normal operating conditions Clean ultrasound gel from the transducers Plug in the power cord to ensure the battery remains charged 83 University of Vermont Rev 2 Confidential Hypo hyperthermia unit Hypo hyperthermia units regulate a patient s temperature using circulating water By adjust ing the temperature of the water the patient may be either heated or cooled These devices typically consist of a water reservoir a heat ing element a cooling system a pump for Sample risk assessment Criteria choose 1 rating from each category No patient contact circulating water and a blanket designed for water circulation The units will also have a thermostat and circuitry for maintaining a set temperature Recommended functional test frequency annual Weight Score 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 Device poses no appreciable risk due to failure Ol RP O N e Device failure will result in low risk Device failure will result in inappropriate therapy misdiagnosis or loss of monitoring Device failure could result in seve
148. ient contact Weight Score 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 Device poses no appreciable risk due to failure Ol BP ws NM w 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 Maintenance or inspection would not impact reliability of the device B OO e 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 No significant history A significant history of incidents exists 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 University of Vermont Rev 2 Confidential 131 oroceqdure Estimated time 5 minutes Equipment information Control number Hospital Manufacturer Model
149. imulated pressures Set the high systolic alarm to 195 mmHg the high diastolic alarm to 150 mmHg and the high mean pressure alarm to 160 mmHg Initiate a blood pressure mea surement on the NIBP monitor The high alarms should activate Clear the alarms on the moni tor and return the alarm limits to their original settings Select STANDARD BP on the BP Pump 2 and set the simulated blood pressure to 60 30 Set the low alarm limits on the NIBP monitor higher than the simulated pressures Set the low sys tolic alarm to 65 mmHg the low diastolic alarm to 35 mmHg and the low mean pressure alarm to 45 mmHg Initiate a blood pressure mea surement on the NIBP monitor The low alarms should activate O2 accuracy Attach a finger probe to the pulse oximeter Place the finger sensor on the finger simulator of the Index 2 simulator From the main menu of the Index 2 press the soft key labeled MORE for the second menu and then press the soft key labeled MAKE Use the plus and minus keys to scroll through the available makes Select the make of the pulse oximeter to be tested When the correct make appears on the screen press the ESC key to return to the main menu 108 uUniversity of Vermont Rev 2 Confidential From the main menu press the soft key labeled SIM to enter the simulation mode Begin a manual simulation by pressing the soft key labeled MAN Use the plus and minus keys to adjust the O
150. in a healthcare is tested using the PPD Mantoux skin test prior to work in the environment with clinical follow up is required for a positive test result Staff are tested annually thereafter for the presence of the TB virus Storage Equipment that is not used every day is often put into a storage room Equipment should be cleaned before being put into storage Equip ment that has a battery should be stored plugged in to keep a charge on the battery Equipment in active storage will need to have scheduled maintenance like other equip ment even if it has not been used since the last performance inspection Regularly scheduled performance inspections Ensure the equipment is safe and ready for use Biomedical Cleaning equipment Medical equipment needs to be cleaned to prevent the spread of inspections and also to keep the equipment in operational condition For example residue from adhesive tape can make displays difficult to read The manufac turer s cleaning procedures in the equipment s operation manual should always be followed to prevent damage caused by cleaning Some cleaners may damage equipment The University of Vermont has found problems associated with cleaning solutions including cracked and brittle cases on equipment and degradation of panel membranes In this case work order trending revealed a high percentage of damaged work orders for infusion pumps Upon further investigation it was found t
151. ing set Hold the reservoir high enough above the tubing so that fluid flows through the tubing under the force of gravity Allow fluid to flow through the tubing until no air bubbles can be seen in the tubing Insert the set into the pump Connect the three way stopcock to the channel 1 port on the IDA 4 Plus Connect the patient infusion tubing to one port of the stopcock Fill the syringe with the detergent solution and connect the syringe to the other port of the stopcock Connect a piece of tubing to the drain port of channel 1 and run the tubing into a container to catch the used solution Connect the PCA trigger interface box to the connector on the back of the IDA 4 Plus Attach a cable from channel 1 of the trigger output to the patient dose cable port on the PCA pump If multiple PCA pumps are to be tested simultane ously additional pumps can be connected to the other channels on the interface box From the status screen on the IDA 4 Plus select UTIL to enter the utilities menu and then select TEST PARAMATERS from the utilities menu Use the arrow keys to adjust the PCA Pre Trig Time to 60 seconds This is the time prior to the expiry of the lock out interval that the IDA 4 Plus will begin attempting to trigger the PCA dose 113 University of Vermont Rev 2 Confidential Return to the main set up screen and use the arrow keys to select SETUP under channel 1 Use the arrow keys on the set up menu to se
152. ion All maintenance scheduled and unscheduled should be recorded in the equip ment history The University of Vermont uses documentation by exception to report the results of scheduled performance inspections Documentation by exception is the process of documenting fail ures only A work order is completed only for those devices that fail to meet a routine sched uled inspection against safety performance or quality assurance criteria Devices that pass the scheduled inspection criteria are rendered acceptable and do not require written test forms or additional work orders All incoming inspections other additions to inventory and devices that have undergone corrective maintenance should have a docu mented PM inspection form and work order completed Locating missing equipment As stated above the University of Vermont uses a system of documentation by exception A work order needs to be opened for each prob lem noted during the scheduled test round The work order coding system contains specific work order types for problems encountered during scheduled maintenance One work order type Not Tested is par ticularly useful This work order type is used to mark equipment that did not receive its scheduled inspection Equipment may miss its scheduled inspection for a variety of reasons Biomedical most commonly because the equipment could not be physically located The equipment may also miss an inspection if it
153. ir Refill the reservoir tank with distilled water Do not fill with tap water as this may cause mineral build up in the device Lubricate motor Follow the manufacturer s instructions in the service manual for lubricat ing the pump motor Not all motors will need to be lubricated Complete model specific preventive main tenance Refer to the monitor s service manual for preventive maintenance tasks specific to the device Complete the preventive maintenance per manufacturer s procedure Performance inspection Fluid level Ensure there is an adequate water level in the reservoir There should be sufficient water for circulating throughout the blanket but the water reservoir should not be overfilled 86 University of Vermont Rev 2 Confidential Flow rate Connect a blanket to the hypo hyperthermia unit Connect a water flow meter between the outlet of the hypo hyperthermia unit and the inlet of the blanket Check the ser vice manual for flow rate specifications Temperature accuracy Connect the tem perature probe to the Temp connector on the side of the DPM 4 If the temperature units need to be changed press the soft key labeled UNIT on the DPM 4 and then use the menu scroll keys until C F is displayed Press the soft key labeled C F to toggle between the Celsius and Fahrenheit scales Connect a blanket to the hypo hyperthermia unit Insert the temperature probe into the water reservoir to mea
154. ital owned equipment Equipment that will be brought repeatedly to the facility such as a rental device will need to have an incoming inspection and be added to the inventory Additionally the vendor should be required to certify that each time the device is brought to the facility the equipment has been maintained and that the device is safe and ready for use The University of Vermont uses the following Vendor Safety Certification Form to ensure these devices are safe and ready for use when they are brought into the facility University of Vermont Rev 2 Confidential 15 Vendor Safety Certification Form Medical equipment often is provided to facili ties for use as loaners demonstration rental or lease It is sometimes not possible for the hospital or its biomedical equipment agent to adequately test these devices before they are used clinically As a prerequisite to patient use of devices that cannot be fully tested by the hos pital the hospital requires the vendor to provide a certification that the device s is are safe for use at the facility for a specific period of time or under specific circumstances of use Clinical Use Prohibited Without This Certification Hospital Department Manager Date Device Description Vendor Contact Serial Numbers of All Devices Intended Use of the Device Dates of Use Start Stop Vendor completes
155. iteral Teeding PUI secs scac5 285s caves oases Moar aatadh odes cuthetea evas cat aneasestase Genetic even ote 73 External Pacemaker jikri ireua dadinira 77 Fetal MODICON sessies aen eaaa aaa Ean Spa iaraa aaa EEan aa ea N Eri Eiaa 80 Hypo Hyperthermia Unit esrerenienieoneeasnintinak a 84 Miam MODA ersi rete rr epee pierre ere erence rr eet eget 88 nison PUND auaa aa 94 Non Invasive Blood Pressure Monitor oscsscsocnanananiosunnisnnnanrani 99 Patient MONOT sissa ea ESE 103 POR PUNI e cucu here cacatnes essa caedsestexeancaetexenestsattunsesnetecseseesiaicy 110 Phototherapy UNI ccncccescsicnsicesciceccocsscvecssvssdeesecwstdtestescucecdecesevsesstandeusecwatudesdeuscncecssepses 116 PHEUMatiG TUMU L assis ccs feet ose cence ci cedvaceeieet A 119 PUISE ORUMOCCT yine teces teas das ea aa aaa ee ae a aaa adasia 123 Radiant Warmer gosayisserieser oinaren aae a ea e R EA Aaa E EASE E EEEE E EAN EEEN 127 SPAY GMOMANOMEClED ainn achiennenenaenene anes 131 Therapeut SULA ON 5 acs ss secs Sati 22s copes evedat bens O 134 THEKAP SUG WIT ASO UN ecaa aa a 137 Ventilator yo i55 tees hescesenss tseseseciecsass erviase cas enevsteds saoes aciendsass creas ts ERER A EEEa Aaaah 141 RENNES acct serch A A A E eater taeda antenna 147 IEG GOG OM asses cod sctesctects essa iesec cis esd a a aa dpe 147 TEC CLS Sera sa as see n tt tees neat Aca catreges I eevee ESEE 147 NEPA Os sceptics deta vals ccescedeascenwa coats oboesatece ted cd sarseedesaveneas oeieraeer taasisdesenee
156. ithin 20 of the set output For a set output of 20 W the measured output should be between 16 W and 24 W Repeat this measurement for all frequencies Duty cycle Start an ultrasound treatment at 10 W and a continuous 100 duty cycle The output on the UW5 should be approximately 10 W Adjust the duty cycle to 50 The ultra sound output on the wattmeter should fall to 50 of the output setting or 5 W Cycle through all of the available duty cycles and verify the output Timer accuracy Set the treatment timer on the stimulator for 1 minute Start the stimulator and begin timing with a stopwatch or a watch with a second hand The treatment timer should sound between 50 seconds and 70 seconds Verify that the there is no output after the timer stops University of Vermont Rev 2 Confidential 139 Alarm function Check that all alarms are functional and that the volume is adequately loud Ensure that appropriate visual indicators are functioning Disconnect the sound head cable from the ultrasound Verify that the sound head discon nection alarm activates Complete model specific performance testing Refer to the service manual for perfor mance inspection tasks specific to the device Complete the performance inspection per manufacturer s procedure Remove the water from the transducer well of the UW5 when the measurements are complete Using the drain tube located in the bottom front 140 OUniversity of Vermo
157. itive components Mechanical hazards Mechanical and pneumatic assemblies pose hazards as well and should be given appropriate caution Moving parts can cause injuries such as cuts and crushed fingers Unsecured fittings on pneu matic systems can blow off under pressure and become projectiles Compressed gases also pose fire as well as suffocation hazards When inspecting equipment with moving parts for example irrigation units and elec tric beds fingers and clothing should be kept away from the moving parts Maintenance such as visually inspecting for wear cleaning and lubrication should be done with the equipment powered off and unplugged if possible Jewelry should be removed to avoid getting caught on moving parts and loose clothing such as ties should be secured uUniversity of Vermont Rev 2 Confidential 21 Compressed gas cylinders pose unique haz ards and should be handled carefully Oxidizing gases such as oxygen and nitrous oxide pose a serious fire hazard Additionally gases such as nitrogen nitrous oxide and carbon dioxide are a suffocation hazard in large amounts Damage to the cylinder valve can have catastrophic effects The cylinder will rapidly discharge its contents possibly causing a suffocation or fire hazard and as the cylin der discharges will become a projectile Care should be taken to never drop a gas cylinder If a cylinder for a piece of equipment is removed the cylinder should be laid
158. itors may sometimes be referred to as vital signs monitors Patient moni tors contain circuitry to acquire and process information from physiological sensors such as electrodes catheters and transducers The monitors are usually customizable as to what annual Sample risk assessment Criteria choose 1 rating from each category No patient contact Device may make contact with patient but function is non critical Device is used for patient diagnosis or direct monitoring Biomedical Weight parameters are able to be measured and a single model may have several possible config urations Most commonly these monitors display at least ECG waveforms SpO and blood pres sure Each component of the monitor should be tested to Ensure the device is accurate Recommended functional test frequency Score Device is used to deliver direct treatment to the patient Device is used for a life support Device poses no appreciable risk due to failure O11 P W N e 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 Maintenance or inspection would not impact reliability of the device BLO N e Common device failure modes are unpredictable or not very predictable While common device failure modes are not very predictable device
159. l through the available settings The displayed intrauterine pressure should be within 2 of the set pressure For a simulated pressure of 50 mm the displayed pressure should be between 49 mm and 51 mm Biomedical Recorder speed Record a strip on the fetal monitor Use the mark function on the recorder to place a mark on the paper Use a stopwatch or clock to time 150 seconds 2 5 minutes Place another mark on the paper Measure the distance between the marks With a recorder speed of 3 cm min the marks should be between 72 mm and 78 mm Verify operation of alarms Check that all alarms are functional and that the volume is adequately loud Ensure that appropriate visual indicators are functioning Note the alarm settings on the monitor Adjust the fetal heart rate on the PS320 down to just below the monitor s low heart rate limit The alarm should sound Increase the fetal heart rate above the low alarm point Clear the alarm if necessary Increase the fetal 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 fetal heart rate back to 120 bpm and clear any alarms Repeat the process for the maternal heart rate alarm Complete model specific performance testing Refer to the service manual for perfor mance inspection tasks specific to the device Complete the performance inspection per manufacturer s procedure Return to serv
160. lated heart rate of 60 bpm the displayed rate should be between 57 bpm and 63 bpm Set the heart rate on the MPS450 to 120 bpm The displayed heart rate should be between 114 bpm and 126 bpm 67 U niversity of Vermont Rev 2 Confidential Amplitude accuracy With the patient leads connected to the MPS450 input a normal sinus rhythm by pressing 1 NSR Press the soft key marked SEL to select AMPL Use the soft keys marked up and down to change the amplitude to 1 0 mV Set the sensitivity on the electrocar diograph to 20 mm mV Record a strip on the electrocardiograph Measure the height of the QRS peak The measured amplitude should be within 5 of the set amplitude For an amplitude setting of 1 mV and a sensitivity of 20 mm mV the peak height should be between 19 mm and 21 mm Recorder speed Set the heart rate on the MPS450 to 60 bpm Record a strip on the elec trocardiograph Measure the distance between the peaks of the QRS complex With a recorder speed of 25 mm sec the QRS peaks should be between 24 mm and 26 mm apart Paper cue Verify the operation of the paper cue if equipped Initiate a page advance on the electrocardiograph The paper should stop at the beginning of the next page If the paper does not stop or stops at an incorrect location ensure the correct paper is being used with the electrocardiograph Clean the optical sensor if necessary 68 OUniversity of Vermont Rev 2 Confidential
161. lator indicate that the maintenance sched ule should be reevaluated or that additional technical education is needed 10 University of Vermont Rev 2 Confidential Performance standards should be clear and reasonable as well as ensure that local regula tions are met The most obvious example of a performance standard is the functional test ing completion rate The University of Vermont has found a realistic goal for the functional test completion rate is 95 of clinical devices with 100 of life support devices Other performance standards should be developed such as the number of use error related problems and dam aged devices If an evaluation finds the goals are not met an action plan should be developed to address the problems The underling cause of the problem must be discovered and then steps to solve the problem must be taken After a plan has been implemented the plan should be monitored to determine progress and evaluate whether or not the plan was effective CHAPTER 4 Inventory control Understanding what devices are in the facility in order to provide a quality maintenance program is critical Inventory data is used for a variety of applications including establishing a mainte nance schedule tracking medical device hazards and recalls and deciding when to replace aging equipment Using a computerized medical equipment management system A computerized medical equipment manage ment system is a
162. le and visual alarms alert the user to flow changes or Recommended functional test frequency Score 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 Device poses no appreciable risk due to failure Ol BR W NM 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 Maintenance or inspection would not impact reliability of the device PLO NO 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 No significant history oly wo ND A significant history of incidents exists 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 University of Vermont Rev 2 Confidential 73 oroceqdure Estimat
163. lect PCA Use the arrow keys to enter the basal flow rate total volume bolus volume lockout time and loading dose to be tested Enter a basal flow rate of 15 mL hr Enter a total volume of 20 mL Enter a bolus volume of 1 mL Enter a lockout time of 5 minutes O seconds Enter a loading dose of 1 mL After the test information is entered the PCA test screen will appear Use the arrow keys to highlight PRIME Close the stopcock port connected to the infusion tubing leaving the ports to the syringe and the IDA 4 Plus open Inject the solution in the syringe into the IDA 4 Plus until START appears on the screen Select AutoSTART The IDA 4 Plus will start the flow test when it detects flow from the pump Close the port to the syringe leaving the ports to the tubing and the IDA 4 Plus open Set up the PCA pump as entered on the IDA 4 Plus Set the continuous flow rate to 15 mL hr the bolus volume to 1 mL the lockout time to 5 minutes and the loading dose to 1 mL If the PCA pump has a dose limit set the limit to 2 mL Start the pump The loading dose will appear on the PCA test screen Verify that the actual bolus volume is within 10 of the set volume For a dose of 1 mL the measure volume should be between 0 9 mL and 1 1 mL The IDA 4 Plus is equipped with four chan nels to analyze infusion devices Four pumps can be run simultaneously Flow rate accuracy Continue to run the PCA pump as described above
164. llators may last longer The manufacturer battery replace ment schedule should be followed if provided in the documentation Electrical safety checks should be performed following a bat tery replacement Always verify the operation of the device before replacing the battery A functional test should be performed following battery replacement These procedures are written for general device types Check the equipment s service manual for any additional model specific tests and maintenance 40 uUniversity of Vermont Rev 2 Confidential Preventive maintenance Complete model specific preventive mainte nance Refer to the monitor s service manual for preventive maintenance tasks specific to the device Complete the preventive maintenance per manufacturer s procedure Performance inspection Complete model specific performance testing Refer to the service manual for perfor mance inspection tasks specific to the device Complete the performance inspection per manufacturer s procedure Returning the device to service Upon completion of maintenance all controls should be returned to their previous clinical set tings Return all alarm limits adjusted during the functional test to their original locations Adjust the alarm volume to an audible level The alarms should be able to be heard easily in the normal operating environment If the device will not immediately be returned to use make sure the pow
165. lt 100 pA BF mains on patient applied part lt 10 pA CF Insulation test optional 500 V lt 2 MQ Replace battery every 24 months Clean rollers and paper guides Lubricate motor and paper drive mechanism Verify proper time and date correct if necessary Complete model specific preventive maintenance Verify unit operates on battery Fetal heart rate accuracy 5 Maternal heart rate accuracy 5 Intrauterine pressure accuracy 2 Recorder speed 3 cm min 4 Alarm function Complete model specific performance testing University of Vermont Rev 2 Confidential 81 Physical condition Check the physical condition of the device as described in the General Equipment Procedure Electrical safety Perform electrical safety checks as described in Chapter 5 Electrical Safety Check ground wire resistance chassis leakage and lead leakage Preventive maintenance Replace battery The battery should be replaced every 24 months Replace if necessary Clean rollers and paper guides Inspect the rollers and paper guides and remove any debris Check for bits of torn paper caught in the rollers Lubricate motor and paper drive mecha nism Follow the manufacturer s instructions in the service manual for lubricating the motor and paper drive mechanism Not all motors will need to be lubricated Verify proper time and date correct if necessary Verify the time and date displayed on the monitor is correct If th
166. matic mode with an interval of 5 minutes Use a stopwatch or a watch with a second hand to measure the length of time between BP measurements The measured time should be within 10 of the set interval For a set interval of 5 minutes the measured interval should be between 4 minutes 30 seconds and 5 minutes 30 seconds Stop Cancel Deflate Initiate a blood pressure measurement on the NIBP monitor Allow the cuff to inflate Stop the measurement on the monitor The cuff should deflate in less than 10 seconds 102 uUniversity of Vermont Rev 2 Confidential Recorder operation After taking some blood pressure measurements print the results with the recorder Ensure the recorder prints clearly and legibly If the date and time is present on the recorded strip Ensure the date and time is accurate Alarm function Check that all alarms are functional and that the volume is adequately loud Ensure that appropriate visual indicators are functioning Select STANDARD BP on the BP Pump 2 Press the soft key labeled OPTIONS on the BP Pump 2 and set the simulated blood pressure to 200 155 mmHg Set the high alarm limits on the NIBP monitor lower than the simulated pres sures Set the high systolic alarm to 195 mmHg the high diastolic alarm to 150 mmHg the high mean pressure alarm to 160 mmHg and the high heart rate alarm to 75 bpm Initiate a blood pres sure measurement on the NIBP monitor The high alarms should activa
167. mended functional test frequency Score 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 Device poses no appreciable risk due to failure Ol BR W NM 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 Maintenance or inspection would not impact reliability of the device Bl wl hN e 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 No significant history ajej WO N A significant history of incidents exists 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 12 University of Vermont Rev 2 Confidential 137 oroceqdure Estimated time 25 minutes Equipment information
168. ment before first use after servicing or periodic safety inspections The standard specifies how to test for elec trical safety and gives limits for acceptable measurements Specific tests for measuring the protective earth resistance leakage current applied part leakage current and insulation resistance are outlined These terms are defined as Protective earth resistance Sometimes referred to as ground wire resistance Resis tance between any conductive part of the equipment and the protective connector of the main power supply plug the protective connector of the appliance inlet or the protec tive conductor permanently connected to the supply mains Equipment leakage current Current flow ing from the supply mains to earth through the protective earth conductor and accessible conductive parts University of Vermont Rev 2 Confidential 147 Applied part leakage current Sometimes referred to as lead leakage The current flowing from the supply mains and accessible conduc tive parts to the applied parts or patient leads Insulation resistance The resistance of the insulation between the supply mains and protective earth the supply mains and acces sible conductive parts or the supply mains and the patient leads The insulation resistance is calculated by applying a voltage and measuring the resulting current IEC 62353 sets specific limits for electrical safety testing The protective earth resistance should
169. mmHg Emergency surgical tracheal uterine gt 400 mmHg Breast pump gt 200 mmHg Vacuum rise time Thoracic lt 4 sec 30 mmHg Emergency Surgical Tracheal lt 4 sec 300 mmHg Uterine lt 3 sec 30 mmHg Breast pump lt 2 sec 150 mmHg Complete model specific performance testing 46 uUniversity of Vermont Rev 2 Confidential Physical condition Check the physical condition of the device as described in the General Equipment Procedure Electrical safety Perform electrical safety checks as described in Chapter 5 Electrical Safety Check ground wire resistance and chassis leakage Preventive maintenance Replace battery The battery should be replaced every 24 months Replace if necessary Replace filters Inspect filters and replace as necessary Refer to the device service manual for filter replacement Lubricate motor Follow the manufacturer s instructions in the service manual for lubricat ing the pump motor Not all motors will need to be lubricated Complete model specific preventive main tenance Refer to the monitor s service manual for preventive maintenance tasks specific to the device Complete the preventive maintenance per manufacturer s procedure Verifying aspirator vacuum accuracy with the DPM 4 FLUKE Biomedical Performance inspection Verify unit operates on battery Check that the ac power indicator is lit when the power cord is plugged into an
170. n 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 Ol Pl WO Nj pa ji No significant history A significant history of incidents exists 2 No requirements 1 1 There are requirements for testing independent of a numerical rating system 2 Total Score Assignment 0 0x 0 5x 1x 2x 3x 4x times per year tested University of Vermont Rev 2 Confidential 11 23 oroceqdure Estimated time 20 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 Index 2 SpO Analyzer or equivalent Test Result Pass Fail N A 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 and warnings present and legible Inlets and hoses Power cord accessory ca
171. nal setting and clear the alarm Alarm function Check that all alarms are functional and that the volume is adequately loud Ensure that appropriate visual indicators are functioning Complete model specific performance testing Refer to the service manual for perfor mance inspection tasks specific to the device Complete the performance inspection per manufacturer s procedure Return to service Before returning to use return any settings that were adjusted to their original settings Ensure the volume of the audible alarms is loud enough to be heard in normal operating conditions Plug in the power cord to ensure the battery remains charged University of Vermont Rev 2 Confidential 109 PCA pump PCA patient controlled analgesic pumps are infusion pumps that deliver an analgesic drug on when requested by the patient These pumps typically utilize tubing designed specifi cally for use with PCA infusion pumps which is then connected to an infusion catheter or other infusion device such as an implanted infusion port PCA pumps can typically be pro grammed to deliver in one of three ways as a Sample risk assessment Criteria choose 1 rating from each category No patient contact continuous infusion as a demand dose only or as a continuous infusion with a demand dose A demand dose is initiated by the patient pressing a button A predetermined amount of the drug is delivered rapidly as a bolus PCA pumps hav
172. nd bright enough to read Look for distortion around the edges of the screen Verify monitoring capabilities of hard wired monitors Connect the MPS450 to a monitor following the instructions given in the Patient Monitor procedure At a minimum simu late a heart rate and respiration Attach the ECG lead wires to the lead connectors on the left side of the MPS450 The MPS450 will default to a normal sinus rhythm of 80 bpm Admit a test patient in this bed on the central station Verify that the central station displays the ECG wave heart rate and other monitored parameters Discharge the test patient Verify monitoring capabilities of telemetry transmitters Connect the ECG leads of the telemetry transmitter to the lead connections on 54 OUniversity of Vermont Rev 2 Confidential the left side MPS450 Press 1 NSR to enter the normal sinus rhythm menu Set the heart rate to 80 bpm If the telemetry has SpO capabilities connect the finger probe to the Index 2 Pulse Oximeter Simulator as described in the Pulse Oximeter Procedure Ensure that a battery is installed in the telemetry transmitter Admit a test patient on this telemetry channel Verify that the central station displays the ECG rhythm and heart rate Discharge the test patient when finished The process will need to be repeated for each telem etry transmitter Verify recorder accuracy With a test patient admitted to the central station and the ECG leads c
173. nd inspecting medical equipment involves a number of risks including electrical and mechanical hazards Many maintenance tasks include precautions to minimize theses risks Always follow manufacturer s guidelines for safety precautions during specific tests Being aware of potential hazards will allow risks to be minimized Electrical hazards Electricity poses a significant hazard for biomedical personnel Not only are you exposed to electrical hazards during a repair but also while testing medical equipment for electrical safety Electrical safety testing requires the simulation of faults and extra caution should be taken Electrical safety testing should be done before performance testing The continuity between the chassis and the ground pin on the plug should be confirmed first this is the primary protection against electrical shock to equipment users Check the power cord for frayed instal lation or exposed wires Damaged power cords should be replaced immediately Testing should never be performed on equip ment that is in use on a patient As stated above electrical safety testing simulates electrical faults and can expose the patient to dangerous voltages and currents Work with clinical staff is necessary to either disconnect the equipment from the patient or to arrange a time to test the equipment when it is not in use The electrical safety analyzer should be plugged into a properly grounded outlet to prevent a shock haza
174. nical parts are in good condition Electrical safety analyzer ESA setup Place controls in startup mode e g ESA 620 function switch to OFF Insert measurement cables into the ESA Plug the ESA into the power receptacle and turn on Ensure the line voltage is appropriate as read from the ESA Note All tests below should be performed with the device OFF and ON The highest reading should be documented or used for exception reporting 30 uUniversity of Vermont Rev 2 Confidential Biomedical CURRENT SOURCE 1ADC RED TERMINAL DEVICE UNDER TEST wali annam CONDUCTIVE PART TEST LEAD Figure 10 Protective earth resistance test configuration Ground wire resistance Insert the medical equipment electrical power plug into the ESA power receptacle If this is a permanently wired device a ground connec tion at the same potential as the device under Switch Diagram Reference Action Sl Neutral S2 Polarity S3 Earth Open S5 test needs to be located A ground wire must be attached to the ESA ground input Devices that are located in rooms with isolated power should be tested on grounded distribution systems Zero the test lead resistance by connecting the RED lead to the ESA ground point e g ESA 601 PE TEST POINT and pressing the Zero button Attach the RED ground lead to the device under test DUT chassis grounding point
175. nits that apply the light radiation from a lamp Phototherapy units are also available as pad or blanket with a separate light source connected by a fiberoptic cable Recommended functional test frequency annual Weight Score 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 Device poses no appreciable risk due to failure O11 P W N e 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 Maintenance or inspection would not impact reliability of the device Blo N Common device failure modes are unpredictable or not very predictable testing frequently detects problems While common device failure modes are not very predictable device history indicates that TSP Common device failure is predictable and can be avoided by preventive maintenance No significant history Specific regulatory or manufacturers requirements dictate preventive maintenance or testing oje WwW N Re A significant history of incidents exists No requirements ja There are requirements for testing independent of a numerical rating system 2 Total Score Assig
176. nment 0 0x 0 5x 1x 2x 3x 4x times per year tested 116 OUniversity of Vermont Rev 2 Confidential 12 l EEE Biomedical oroceqdure Estimated time 20 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 DALE40 Phototherapy Radiometer or equivalent Stopwatch or watch with a second hand Test Result Pass Fail N A 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 and warnings present and legible Inlets and hoses Power cord accessory cables charger Filters and vents clean Ground wire resistance lt 0 3 Q Chassis leakage lt 100 pA NC lt 500 pA SFC Patient leakage current lt 100 pA B and BF lt 10 pA CF Patient lead leakage current isolation test lt 100 pA BF mains on patient applied part lt 10 pA CF Insulation test optional 500 V lt 2 MQ Inspect bulbs Complete model specific preventive maintenance Timer accuracy 0 5 Output accuracy gt 4 5 pW cm2 nm 198 pW cm2 44 nm bandwidth lt 40 pW cm2 nm lt 1760 pW cm2 44 nm bandwid
177. nosis or loss of monitoring Device failure could result in severe injury to or death of patient or user Maintenance or inspection would not impact reliability of the device AIIN 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 No significant history OJA Nj A significant history of incidents exists No requirements pas 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 University of Vermont Rev 2 Confidential 0 i 55 oroceqdure Estimated time 20 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 DPM 4 Pressure Meter or equivalent Stopwatch or watch with a second hand Tubing and connectors to connect to DPM 4 Compression set PVC pipe to attach compression set to Test Result Pass Fail N A De
178. nt Device is used for a life support Device poses no appreciable risk due to failure Ol P ds NI 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 Maintenance or inspection would not impact reliability of the device BlO DM e 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 No significant history No requirements A significant history of incidents exists Total Score 1 1 There are requirements for testing independent of a numerical rating system 2 Assignment 0 0x 0 5x 1x 2x 3x 4x times per year tested 59 University of Vermont Rev 2 Confidential orocequre Estimated time 30 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 Impulse 4000 Defibrillator and Pacer
179. nt Rev 2 Confidential completely drain the well Remove the drain tube from its storage clip Holding the tube end over a container pinch the tube just in front of the stopper with one hand while pulling the stopper out with the other Remove the stop per and allow the water to drain completely The UW5 should be fully drained before being stored This will prevent bacterial growth and other potential water related damage Return to service Before returning to use return any settings that were adjusted to their original settings Ensure the volume of the audible alarms is loud enough to be heard in normal operating conditions Ventilator Ventilators mechanically move air into and out of the lungs to provide respiration for a patient who is physically unable to breathe or is breathing insufficiently Most ventilators use positive pressure to gas to the lungs These Biomedical a control system monitors alarms and a source of gas either an internal compressor or external connections for compressed gas cylinders or the hospital gas wall outlets Recommended functional test frequency semiannual devices typically consist of a breathing circuit Sample risk assessment Criteria choose 1 rating from each category No patient contact Weight Score Device may make contact with patient but function is non critical Device is used for patient diagnosis or direct monitoring Device is use
180. ntenance per manufacturer s procedure Performance inspection Verify unit operates on battery Check that the ac power indicator is lit 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 Be sure to plug the power cord in at the conclusion of the test Pole clamp function Check the physical condition of the pole clamp The pole clamp should be securely fastened to the infusion pump The clamp mechanism should move freely The pole clamp should secure the infu sion pump to the IV pole 96 University of Vermont Rev 2 Confidential Flow rate accuracy Fill the infusion reser voir with a 1 detergent solution in de ionized water A 1 stock solution of detergent such as Cole Parmer Micro 90 should be prepared in volume using de ionized water this may be stored in a closed vessel for up to 6 months The solution should then be diluted 10 1 with de ionized water for daily use If the water used causes too much foaming a 20 1 dilution is recommended Do not use tap water or solutions intended for patient use as these may harm the transducers in the IDA 4 Plus Connect the infusion tubing to the reser voir Prime the set so that there is no air in the tubing With the tubing draining into a container or sink open the flow control
181. o bio medical equipment technicians This Chapter specifically covers the performance mainte nance and testing of electrical equipment used within the hospital Numerical criteria are given for electrical safety testing NFPA 99 section 8 4 states that the ground wire resistance of medical equipment should be less than 0 5 Q It goes on to say that the chassis leakage current should not exceed 300 pA The Joint Commission The Joint Commission is a regulatory body that evaluates and accredits health care organizations in the United States The Joint Commission s mission is to improve the safety and quality of healthcare provided to the public Currently a system of unannounced surveys is used to promote continued compliance of the Joint Commission s regulations The Joint Commission releases National Patient Safety Goals annually relating to per tinent healthcare quality issues The National Patient Safety Goals are eventually rolled into the Joint Commission s regulations The Joint Commission s regulations include a Chap ter on the Environment of Care This Chapter specifically deals with medical equipment its maintenance and how to minimize its risk One common benchmark that is used in the United States is the completion of scheduled mainte nance The Joint Commission requires that 100 of life support equipment receive its scheduled maintenance and that at least 90 of non life support equipment receive its sched
182. o failure Ol RP OW N e 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 Maintenance or inspection would not impact reliability of the device AIIN Common device failure modes are unpredictable or not very predictable testing frequently detects problems While common device failure modes are not very predictable device history indicates that TSP Common device failure is predictable and can be avoided by preventive maintenance No significant history Specific regulatory or manufacturers requirements dictate preventive maintenance or testing Oje N 1 A significant history of incidents exists No requirements p There are requirements for testing independent of a numerical rating system 2 Total Score Assignment 0 0x 0 5x 1x 2x 3x 4x times per year tested 134 OUniversity of Vermont Rev 2 Confidential 2 i procedure Estimated time 25 minutes Equipment information EEE Biomedical 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 Oscilloscope such as Fluke 199XRAY Stopwatch or watch with
183. objective test to determine if the risks have been acceptably minimized while avoiding requirements defining how to minimize risks This standard is not intended to be used alone as it addresses general safety issues applied broadly across medical equipment More specific standards need to be applied to specific types of medical equipment The 60601 family of standards contains collateral and particu lar standards Collateral standards contain Biomedical requirements in addition to the parent standard These standards are general in nature like the parent standard and are applicable to all medi cal equipment Particular standards contain requirements that are exceptions to the parent and collateral standards These types of stan dards are specific to a device type IEC 60601 is the parent standard Collateral standards are labeled as 60601 1 xx and particular standards are labeled as 60601 2 xx with xx represent ing a specific document IEC 60601 1 is mainly used by manufacturers of medical equipment Medical equipment that is manufactured to this standard has been sub jected to rigorous safety and performance tests and has met quality assurance specifications TEC 62353 IEC 62353 is an international standard pub lished by the International Electrotechnical Commission a worldwide organization that promotes global standardization in the elec tronics industry The standard deals with the testing of medical equip
184. of patient or user Maintenance or inspection would not impact reliability of the device Blw DO 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 No significant History oje WO N A significant history of incidents exists 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 13 l University of Vermont Rev 2 Confidential 41 orocequre 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 Stopwatch or watch with a second hand Test Result Pass Fail N A 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 fo
185. of gas cylinders and regulators Remove each cylinder and verify that the index pins are present on the cylinder yoke Verify that cylinders have the correct color coding and labeling and that the cylinders are within their expiration dates Replace the cylinders in their 144 9 University of Vermont Rev 2 Confidential yokes Disconnect hoses from the hospital s gas system With the ventilator turned off open each cylinder Note the pressure in each cylin der Replace any cylinders with less than 500 psi Close the cylinders The pressure should remain steady on the cylinder gauges Hoses tubing and connectors Check the condition of external hoses tubing and connectors Check for signs of wear such as cracking or dry rot Ensure all connectors are tight Volume accuracy Turn on the VT PLUS HF and allow it to warm up Ensure that all hoses are disconnected from the analyzer and then press the soft key to zero the pressure and flow Press 8 SETUP on the analyzer to enter the setup menu Use the arrow keys to highlight Gas Settings and then press the MODIFY soft key Use the arrow keys to highlight GAS TYPE and press the MODIFY soft key to select the gas used in the ventilator Most commonly air or O2 will be used Enter the gas temperature ambient temperature and relative humidity of the gas as necessary To change the settings highlight the parameter and then press the MO
186. olume of the audible alarms is loud enough to be heard in normal operating conditions Plug in the power cord to ensure the battery remains charged Biomedical Pulse oximeter hemoglobin HHb absorb red and infrared light differently The percent saturation of hemo A pulse oximeter non invasively measures the ee globin in arterial blood can be calculated by oxygen saturation of a patient s blood A pulse aon oximeter consists of a red and an infrared light measuring light abrorptioni changes Caused Dy source photo detectors and probe to transmit arterial blood flow pulsations light through a translucent pulsating arterial Recommended functional test frequency bed typically a fingertip or earlobe Oxygen annual ated hemoglobin O2Hb and deoxygenated Sample risk assessment Criteria choose 1 rating from each category Weight Score 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 O1 B W NM w 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 AIIN wo Maintenance or inspectio
187. on Complete model specific performance testing University of Vermont Rev 2 Confidential 105 Physical condition Check the physical condition of the device as described in the General Equipment Procedure Electrical safety Perform electrical safety checks as described in Chapter 5 Electrical Safety Check ground wire resistance and chassis leakage Preventive maintenance Check condition of tubing cuffs and hoses Inspect hoses and cuffs for signs of wear Look for holes cracks and dry rot Ensure that all connections are secure Clean recorder paper compartment roll ers and paper guides Inspect the rollers and paper guides and remove any debris Check for bits of torn paper caught in the rollers Lubricate motor and paper drive mecha nism Follow the manufacturer s instructions in the service manual for lubricating the motor and paper drive mechanism Not all motors will need to be lubricated Verify proper time and date Correct if nec essary Verify that the time and date displayed on the monitor is correct If the time and date is not displayed on the monitor print a strip from the recorder The time and date should appear on the printed strip Correct the time and date as necessary Replace battery The battery should be replaced every 24 months Replace if necessary Complete model specific preventive main tenance Refer to the monitor s service manual for preventive mainten
188. onnected to the MPS450 as above press 1 NSR on the MPS450 Set the heart rate to 60 bpm Initiate strip record on the central station Measure the distance between the peaks of the QRS complex With a recorder speed of 25 mm sec the QRS peaks should be between 24 mm and 26 mm apart Verify operation of alarms Check that all alarms are functional and that the volume is adequately loud Ensure that appropriate visual indicators are functioning Note the alarm settings on the central sta tion Press 1 NSR to enter the Normal Sinus Rhythm menu 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 Verify that the alarm sounds when the heart rate increases beyond the high alarm limit Set the heart rate back to 80 bpm and clear any alarms Complete model specific performance testing Refer to the service manual for perfor mance inspection tasks specific to the device Complete the performance inspection per manufacturer s procedure Return to service Discharge any test patients Return any alarms that were adjusted to their original settings Ensure the volume of the audible alarms is loud enough to be heard in normal operating conditions Compression unit Compression units are designed to apply and release pressure on a
189. orized suction pump creates a vacuum in the suction tubing When the tubing is inserted into a body cavity mate rial is sucked through the tubing and deposited into the collection container Recommended functional test frequency Score 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 Device poses no appreciable risk due to failure oc P O NI 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 Maintenance or inspection would not impact reliability of the device BLO NM No significant history Common device failure modes are unpredictable or not very predictable 2 2 While common device failure modes are not very predictable device history indicates that TSP 3 testing frequently detects problems Common device failure is predictable and can be avoided by preventive maintenance 4 Specific regulatory or manufacturers requirements dictate preventive maintenance or testing 5 A significant history of incidents exists No requirements There are requirements for testing independent of a numerical rating system Total Score Assignment 0 0x 0 5x 1x 2x
190. oth Most incubators also include humidity controls and a means for adjusting oxygen levels Recommended functional test frequency annual Weight Score 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 Device poses no appreciable risk due to failure Ol P ws NM 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 Maintenance or inspection would not impact reliability of the device B OO DO Common device failure modes are unpredictable or not very predictable testing frequently detects problems While common device failure modes are not very predictable device history indicates that TSP Common device failure is predictable and can be avoided by preventive maintenance No significant history Specific regulatory or manufacturers requirements dictate preventive maintenance or testing A significant history of incidents exists No requirements There are requirements for testing independent of a numerical rating system 2 Total Score Assignment 0 0x 0 5x 1x 2x 3x 4x times per year tested 88 University of Vermont Rev 2 Con
191. otor and paper drive mecha nism Follow the manufacturer s instructions in the service manual for lubricating the motor and paper drive mechanism Not all motors will need to be lubricated Verify proper time and date Correct if nec essary Verify that the time and date displayed on the monitor is correct If the time and date is not displayed on the monitor print a strip from the recorder The time and date should appear on the printed strip Correct the time and date as necessary Replace battery The battery should be replaced every 24 months Replace if necessary Biomedical Complete model specific preventive main tenance Refer to the monitor s service manual for preventive maintenance tasks specific to the device Complete the preventive maintenance per manufacturer s procedure Performance inspection Verify unit operates on battery Check that the ac power indicator is lit 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 Be sure to plug the power cord in at the conclusion of the test Leak test Connect a hose and cuff to the NIBP monitor Place the cuff around a piece of PVC pipe or other sturdy cylindrical object to simulate placement on a limb Connect a piece of tubing to the pressure port on the BP Pump 2
192. ould not exceed 80 dB Remove the INCU from the incubator and place it 3 m from the front of the incubator Activate an alarm on the incubator and mea sure the sound level with the INCU The alarm should be at least 80 dB at this distance Biomedical Alarm function Check that all alarms are functional and that the volume is adequately loud Ensure that appropriate visual indicators are functioning Unplug the temperature probe from the incu bator The disconnected probe alarm should activate If the incubator is equipped with alarms for an open or short circuited tempera ture probe use open and short circuited probe plugs to test these alarms Disconnect the skin temperature probe and connect the probe plugs The appropriate alarms should activate Unplug the incubator to simulate a power fail ure The power failure alarm should activate Complete model specific performance testing Refer to the service manual for perfor mance inspection tasks specific to the device Complete the performance inspection per manufacturer s procedure Return to service Before returning to use return any settings that were adjusted to their original settings Ensure the volume of the audible alarms is loud enough to be heard in normal operating conditions Plug in the power cord to ensure the battery remains charged 93 University of Vermont Rev 2 Confidential Infusion pump Infusion pumps deliver controlled and accu r
193. ound not to the patient or staff Figure 5 shows pictorially and sche matically the hazard current from the electrical failure being safety shunted to ground through this alternative pathway Effective grounding can only be achieved with very low resistance pathways to ground on the order of tenths of an ohm Grounding is another measurement speci fied in electrical safety standards for medical devices Biomedical The basic electrical safety tests are 1 Visual inspection of cables plugs and connectors 2 Measurement of ground wire resistance 3 Measurement of chassis and patient lead contact isolation Other tests may be required depending upon the country state province department or local codes 11 V 0 5 Q 22 A 0 5 to 200 kQ 055 to 22 mA Figure 5 Hazard current from electrical failure being safety shunted to ground through an alternative pathway 25 University of Vermont Rev 2 Confidential Electrical safety standards Electrical safety standards have been developed in the United States European countries and other parts of the world The standards differ in criteria measurements and protocol The International Organization for Stan dardization ISO and the International Electrotechnical Commission IEC based in Europe are organizations that provide standards worldwide in partnership with the World Trade Organization These standards include those for electrome
194. 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 Be sure to plug the power cord in at the conclusion of the test Vacuum gauge accuracy Turn on the DPM 4 The DPM 4 defaults to pressure units in mmHg If the pressure gauge is in another unit press the soft key labeled UNIT and then select the desired units Most aspirators measure vacuum in mmHg The DPM 4 should read 0 0 mmHg when the pressure port is open to atmosphere Connect the aspirator to the pressure port on the front of the DPM 4 This connector is a male leur lock connector The connection from the aspirator should come from the port intended for the patient tubing Turn on the aspirator and adjust the vacuum to a low setting Slowly increase the vacuum across its range up to the maximum setting Compare the vacuum gauge reading with the measured vacuum from the DPM 4 The gauge reading should be within 10 of the mea sured vacuum For a vacuum gauge reading of 300 mmHg the measured vacuum should be between 270 mmHg and 330 mmHg Maximum vacuum Disconnect the suction tubing from the DPM 4 and occlude the suction tubing The tubing can be occluded with a stop cock in the off position or by simply covering the tubing with your thumb Adjust the suction to its maximum setting The accuracy of the vacuum
195. ow temperature alarm set the temperature on the hypo hyperthermia unit to its lowest setting If the hypo hyperthermia unit is equipped with a patient temperature probe expose the temperature probe to room air The temperature of the circulating water should decrease until the hypo hyperthermia unit alarms low temper ature Note the temperature at which the alarm sounds on the DPM 4 Check the service manual for the specific low temperature limit and com pare this value with the measured temperature The measured temperature should be within 1 C of the low temperature limit Biomedical If the hypo hyperthermia is not equipped with a patient temperature probe follow the manufacturer s procedure for overriding the thermostat Temperature probe accuracy Fill a con tainer with warm water at about 30 C Insert the temperature probe from the hypo hyper thermia unit and the temperature probe from the DPM 4 into the water The temperature dis played on the hypo hyperthermia unit should be within 1 C of the temperature measured on the DPM 4 For a temperature of 30 C the displayed temperature should be between 29 C and 31 C Alarm function Check that all alarms are functional and that the volume is adequately loud Ensure that appropriate visual indicators are functioning If the hypo hyperthermia unit is equipped with a low reservoir alarm drain the reservoir to below the low water level Run the hypo hypert
196. ow temperature alarm sounds Close the incubator and allow the tem perature to stabilize at 36 C Use a heat gun to increase the air temperature Note the tempera ture at which the alarm sounds Placement of air flow sensor Skin temperature alarms Adjust the skin temperature set point on the incubator to 36 C Place the sensor in the incubator and allow the temperature to stabilize Remove the skin temperature sensor from the incubator and verify that the low temperature alarm sounds Place the skin temperature sensor in a cup of warm water Ensure the water is warm enough to activate the high temperature alarm High temperature protection Set the incu bator temperature to its maximum setting and allow the temperature to stabilize Use a heat gun to blow hot air into the incubator to raise the temperature above the maximum setting Note the temperature at which the over tem perature alarm activates Noise level With the incubator running and the INCU placed in the center of the incubator measure the sound level inside the incubator Press the SELECT button on the INCU to cycle through the measurements until the sound level is displayed All ports and doors should be closed for this measurement The sound level within the incubator should not exceed 60 dB The most common cause of high sound levels in the incubator is a noisy fan assembly Activate an alarm The sound level in the incubator with the alarm sounding sh
197. paper drive mechanism Not all motors will need to be lubricated Pulse oximeter connected to Index 2 SpO simulator FLUKE Biomedical Verify proper time and date Correct if nec essary Verify that the time and date displayed on the monitor is correct If the time and date is not displayed on the monitor print a strip from the recorder The time and date should appear on the printed strip Correct the time and date as necessary Replace battery The battery should be replaced every 24 months Replace if necessary Complete model specific preventive main tenance Refer to the monitor s service manual for preventive maintenance tasks specific to the device Complete the preventive maintenance per manufacturer s procedure Performance inspection Verify unit operates on battery Check that the ac power indicator is lit 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 Be sure to plug the power cord in at the conclusion of the test Heart rate accuracy Attach a finger probe to the pulse oximeter Place the finger sensor on the finger simulator of the Index 2 simulator From the main menu of the Index 2 press the soft key labeled MORE for the second menu and then press the soft key labeled MAKE Use the plus
198. pm Set the defibrillator output to the minimum setting and start pacing The ECG wave form should display pacing spikes at approximately the mid point between QRS peaks and on top of QRS peaks The impulse 4000 will display the pacer output amplitude in mA Measure the pacer output over its entire range The mea sured output should be within 10 of the set output For an amplitude setting of 100 mA the measured output should be between 90 mA and 110 mA MPORTANT DO NOT TOUCH THE PADDLE CONTACTS ON THE IMPULSE 4000 WHILE THE DEFIBRILLATOR PACER IS ON TURN THE PACER OFF BEFORE ADJUSTING OR REMOVING CONNECTIONS Pacer rate accuracy While measuring pacer output the Impulse 4000 also displays the pulse rate The measured pulse rate should be within 5 of the set rate For a rate of 120 ppm the pulse rate should be between 114 ppm and 126 ppm Set the heart rate on the MPS450 to 30 bpm Measure the pulse rate throughout its range Demand mode sensitivity Set the heart rate on the MPS450 to 60 bpm Turn on demand mode on the defibrillator pacer if necessary 64 University of Vermont Rev 2 Confidential Adjust the pulse rate on the pacer to just below 60 ppm The output should stop No output should be measured on the Impulse 4000 and pacing spikes should not appear on the ECG trace Adjust the pulse rate to just above 60 ppm Pacing should start again Connect the ECG leads to the Impulse 4000 From the
199. pressure lt 550 mmHg or manufacturer s specification Complete model specific performance testing 120 vUniversity of Vermont Rev 2 Confidential Physical condition Check the physical condition of the device as described in the General Equipment Procedure Electrical safety Perform electrical safety checks as described in Chapter 5 Electrical Safety Check ground wire resistance and chassis leakage Preventive maintenance Check condition of tubing cuffs and hoses Inspect hoses and cuffs for signs of wear Look for holes cracks and dry rot Ensure that all connections are secure Replace battery The battery should be replaced every 24 months Replace if necessary Complete model specific preventive main tenance Refer to the monitor s service manual for preventive maintenance tasks specific to the device Complete the preventive maintenance per manufacturer s procedure Performance inspection Verify unit operates on battery Check that the ac power indicator is lit 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 Be sure to plug the power cord in at the conclusion of the test Biomedical Verify function of control valve Connect hoses and cuffs to the pneumatic tourniquet
200. r Filters and vents clean Ground wire resistance lt 0 3 Q Chassis leakage lt 100 pA NC lt 500 pA SFC Patient leakage current lt 100 pA B and BF lt 10 pA CF Patient lead leakage current isolation test lt 100 pA BF mains on patient applied part lt 10 pA CF Insulation test optional 500 V lt 2 MQ Replace battery every 24 months Clean rollers and paper guides Lubricate motor and paper drive mechanism Verify proper time and date Correct if necessary Complete model specific preventive maintenance Verify unit operates on battery Heart rate accuracy 5 Amplitude accuracy 5 Recorder speed 4 Paper cue Alarm function Complete model specific performance testing 66 University of Vermont Rev 2 Confidential Physical condition Check the physical condition of the device as described in the General Equipment Procedure Electrical safety Perform electrical safety checks as described in Chapter 5 Electrical Safety Check ground wire resistance chassis leakage and lead leakage Preventive maintenance Replace battery The battery should be replaced every 24 months Replace if necessary Verify proper time and date Correct if nec essary Verify that the time and date displayed on the electrocardiograph is correct If the time and date is not displayed on the monitor print a strip from the recorder T
201. r Simulator or equivalent Cardiac output adapter box Cables to connect to cardiac output monitor 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 and warnings present and legible Inlets and hoses Power cord accessory cables charger Filters and vents clean Ground wire resistance lt 0 3 Q Chassis leakage lt 100 pA NC lt 500 pA SFC Patient leakage current lt 100 pA B and BF lt 10 pA CF Patient lead leakage current isolation test lt 100 pA BF mains on patient applied part lt 10 pA CF Insulation test optional 500 V lt 2 MQ Verify accuracy of blood temperature 37 C 0 2 C Verify cardiac output accuracy Complete model specific performance testing 50 uUniversity of Vermont Rev 2 Confidential Physical condition Check the physical condition of the device as described in the General Equipment Procedure Electrical safety Perform electrical safety checks as described in Chapter 5 Electrical Safety Check ground wire resistance and chassis leakage Performance inspection Verify accuracy of blood temperature Adjust the settings on the cardiac output monitor as follows Set the catheter type size to Baxter Edwards 93a 131 7f Set the calibration coef
202. r daytime use Control numbers labeling and warnings present and legible Inlets and hoses Power cord accessory cables charger Filters and vents clean Ground wire resistance lt 0 3 Q Chassis leakage lt 100 pA NC lt 500 pA SFC Patient leakage current lt 100 pA B and BF lt 10 pA CF Patient lead leakage current isolation test lt 100 pA BF mains on patient applied part lt 10 pA CF Insulation test optional 500 V lt 2 MQ Replace battery every 24 months Complete model specific preventive maintenance 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 42 University of Vermont Rev 2 Confidential Physical condition Check the physical condition of the device as described in the General Equipment Procedure Electrical safety Perform electrical safety checks as described in Chapter 5 Electrical Safety Check ground wire resistance chassis leakage and lead leakage Preventive maintenance Replace battery The battery should be replaced every 24 months Replace if necessary Complete model specific preventive main tenance Refer to the monitor s service manual for preventive maintenance tasks specific to the device Complete the preventive maintenance
203. rd while testing a piece of defective equipment Line voltage is used during lead isolation testing This test should only be performed with test equipment that has been designed for safe application of the voltage to the patient leads Do not touch the leads during lead isolation testing as this may cause a shock Biomedical In order to service equipment removing the cover is necessary This will expose more electrical hazards Jewelry such as rings and watches should be removed to avoid acciden tal contact with electrical components Power should be removed from the equipment during the repair process whenever possible As many tests as possible should be performed without power to the equipment for example using an ohmmeter to check semiconductors for a short circuit If you must test a live circuit be care ful not to accidentally cause a short with your test leads as this can cause damage to compo nents Also be aware that capacitors can store a charge even after the equipment has been unplugged for some time If a circuit board needs to be moved from their mountings insulating material should be placed between the board and anything that may cause a short Adjustments to potentiom eters should be made with insulated tools Use caution while handling static sensitive components as even small amounts of static electricity can cause damage to the compo nents Use an anti static wrist strap to avoid damage to sens
204. re injury to or death of patient or user Maintenance or inspection would not impact reliability of the device BlOw DO Common device failure modes are unpredictable or not very predictable testing frequently detects problems While common device failure modes are not very predictable device history indicates that TSP Common device failure is predictable and can be avoided by preventive maintenance No significant history Specific regulatory or manufacturers requirements dictate preventive maintenance or testing aje WO Ne A significant history of incidents exists 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 84 University of Vermont Rev 2 Confidential 1 EE Biomedical orocequre Estimated time 35 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 Test Result Pass Fail N A DPM 4 with temperature probe or equivalent Water flow meter Tubing and connectors to connect flow meter Device is clean and decontaminated No physical damage to case display mounts cart or components
205. re 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 No significant history aje WO N A significant history of incidents exists No requirements p 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 University of Vermont Rev 2 Confidential 13 i l 69 orocequre Estimated time 20 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 QA ES II Electrosurgery Analyzer or equivalent Cables and connectors to connect ESU to QA ES II Test Result Pass Fail N A 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 and warnings present and legible Inlets and hoses
206. re secure Complete model specific preventive main tenance Refer to the monitor s service manual for preventive maintenance tasks specific to the device Complete the preventive maintenance per manufacturer s procedure Performance inspection Gauge zero With no pressure in the cuff read the pressure on the gauge of the sphyg momanometer The gauge should read between 1 mmHg and 1 mmHg Discard aneroid gauges that cannot be reset to zero Leak test Place the cuff around a piece of PVC pipe or other sturdy cylindrical object to simulate placement on a limb Connect a piece of tubing to the pressure port on the DPM 4 Biomedical Connect a tee to this tubing and attach tubing and connectors Connect the two legs of the tee to between the hose and the cuff of the sphygmomanometer Close the bleed valve and use the cuff s squeeze ball to inflate the cuff to the maximum pressure indicated on the gauge After 1 minute read the pressure indicated on the gauge The pressure should not have dropped more than 15mmHg in 1 minute Pressure accuracy Inflate the cuff to until 200 mmHg is read on the DPM 4 Read the pressure on the sphygmomanometer gauge The pressure on the gauge should be within 3 mmHg of the true pressure measured on the DPM 4 For a pressure of 200 mmHg the gauge should read between 197 mmHg and 203 Hg Repeat the pressure measurement for 120 mmHg and 60 mmHg Complete model specific performance testing
207. re specifi cally mentioned as an at risk group due to their work on medical equipment that may be con taminated The regulation states Equipment which may become contaminated with blood or other potentially infectious materials shall be examined prior to servicing or shipping and shall be decontaminated as necessary Paragraph d 2 xiv The only exception in the standard is if decontamination of the equipment is not feasible In this case a biohazard label and a description of the contamination must be placed on the device At the University of Vermont all staff with occupational exposure to blood borne patho gens BBP receive initial training before exposure to the BBP environment and annual refresher training The hepatitis B vaccine is provided to staff upon completion of the initial BBP training Universal precautions a method of infection control in which all blood and body fluids are treated as if known to be infectious for HIV HBV and other blood borne pathogens and engineering work practice controls are used to limit occupational exposure to blood and other potentially infectious materials Tuberculosis is a serious bacterial infection that can spread from individual to individual through the air and may scar lungs kidneys bones or the brain Tuberculosis is highly contagious and can be fatal though it is usually curable with medication At the University of Vermont every staff member who performs work
208. return any controls that were adjusted to their original settings Plug in the power cord to ensure the battery remains charged CHAPTER 6 This section contains preventive maintenance and inspection procedures for common medi cal equipment Each procedure will list the necessary test equipment estimated time for inspection and an inspection check list that can be used for documentation The checklist is broken up into four categories physical condi tion electrical safety preventive maintenance and performance inspection A test form for general equipment is given for reference Biomedical University of Vermont Rev 2 Confidential 37 oroceqdure Estimated time 20 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 Other equipment as necessary Test Result Pass Fail N A 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 and warnings present and legible Inlets and hoses Power cord accessory cables charger Filters and vents clean Ground wire resistance lt 0 3 Q Ch
209. reventive maintenance or testing No significant history ajej wo ND A significant history of incidents exists 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 University of Vermont Rev 2 Confidential 0 l 99 orocequre 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 BP Pump2 NIBP Analyzer or equivalent Stopwatch or watch with a second hand PVC pipe to attach tourniquet cuff to Tubing and connectors to connect to DPM 4 Test Result Pass Fail N A 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 and warnings present and legible Inlets and hoses Power cord accessory cables charger Filters and vents clean Ground wire resistance lt 0 3 Q Chassis leakage lt 100 pA NC lt 500 pA SFC Patient leakage current lt 100 pA B and BF lt 10 pA CF Patient lead leakage current isolation test lt 1
210. rm function Complete model specific performance testing University of Vermont Rev 2 Confidential 143 Physical condition Check the physical condition of the device as described in the General Equipment Procedure Electrical safety Perform electrical safety checks as described in Chapter 5 Electrical Safety Check ground wire resistance and chassis leakage Preventive maintenance Clean vents and filters Inspect vents and air filters Clean or replace filters as necessary Ensure that filters are installed properly Replace tubing Replace internal tubing and filters as necessary Follow the manufacturer s guidelines for tubing replacement Replace battery The battery should be replaced every 24 months Replace if necessary Complete model specific preventive main tenance Refer to the monitor s service manual for preventive maintenance tasks specific to the device Complete the preventive maintenance per manufacturer s procedure Performance inspection Verify unit operates on battery Check that the ac power indicator is lit 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 Be sure to plug the power cord in at the conclusion of the test Gas cylinders and regulators Check the condition
211. rmance inspection but will not be added to the inventory 28 FT NO ADD F Device that will not be added to the inventory does not pass initial performance inspection 30 PROD ALERT A recall or alert has been issued for a device 33 RECALL MOD Work done in answer to a recall such as a software upgrade or parts replacement 37 INCIDENT INV Investigation of an incident involving the device 44 CALIBRATION Device requires calibration 59 INV DELETE Device is taken off of the inventory 12 University of Vermont Rev 2 Confidential Deciding which devices to put on the inventory The process to determine what devices will be managed as part of the equipment management system is crucial to the success of the system All devices must be evaluated to determine if they should be managed The University of Vermont uses three major classifications of devices clinical utilities and general Within the clinical classification two subgroups will be identified life support and non life support Other equipment may be inventoried and tracked for financial or other reasons but is not included in this process Clinical equipment is any equipment used for treatment monitoring or diagnosis of patients Life support equipment is clinical equipment that takes over a function of the body and will cause immediate within minutes death if removed Under this definition a ventilator will be considere
212. rs labeling and warnings present and legible Inlets and hoses Power cord accessory cables charger Filters and vents clean Ground wire resistance lt 0 3 Q Chassis leakage lt 100 pA NC lt 500 pA SFC Patient leakage current lt 100 pA B and BF lt 10 pA CF Patient lead leakage current isolation test lt 100 pA BF mains on patient applied part lt 10 pA CF Insulation test optional 500 V lt 2 MQ continued on page 105 104 9 OUniversity of Vermont Rev 2 Confidential EE Biomedical oroceqdure Estimated time 50 minutes continued from page 104 Test Result Pass Fail N A Check condition of tubing cuffs and hoses Clean recorder paper compartment rollers and paper guides Lubricate motor and paper drive mechanism Verify proper time and date correct if necessary Replace battery every 24 months Complete model specific preventive maintenance Verify unit operates on battery Heart rate accuracy 5 Amplitude accuracy 5 Recorder speed 4 Respiration rate accuracy 5 Leak test lt 15 mmHg min Static pressure accuracy 3 mmHg Pressure relief test lt 330 mmHg Dynamic pressure accuracy 10 mmHg Auto interval time 10 Stop Cancel Deflate lt 10 sec SpO2 accuracy 3 Invasive pressure accuracy 5 Temperature accuracy 0 3C Carbon dioxide concentration accuracy 0 4 vol Alarm functi
213. s 2 RESP to enter the Respiration menu on the MPS450 Set the respiration rate to 60 breaths min Press 1 NSR to enter the Normal Sinus Rhythm menu Set the heart rate to 60 bpm The monitor should alarm Set the heart rate back to 120 bpm Alarm function Check that all alarms are functional and that the volume is adequately loud Ensure appropriate visual indicators are functioning Check heart rate and respiration rate alarms separately Note the alarm settings on the moni tor Press 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 120 bpm and clear any alarms Press 2 RESP to enter the Respiration menu Repeat the process for the respiration rate as done for the heart rate above Ensure 44 OUniversity of Vermont Rev 2 Confidential the monitor alarms when the respiration rate falls below the set low respiration limit and above the high respiration limit Set the res piration rate to 60 breaths min and clear any alarms Check the function of the accidental power off alarm Apnea monitors used on infants
214. s The return electrode alarm should also sound if the dispersive cable is disconnected from the ESU The ESU should not activate when the return electrode monitor is alarming Verify operation of alarms Simulate any alarm conditions Check that all alarms are functional and that the volume is adequately loud Ensure that appropriate visual indicators are functioning Complete model specific performance testing Refer to the service manual for perfor mance inspection tasks specific to the device Complete the performance inspection per manufacturer s procedure Return to service Before returning to use return any settings that were adjusted to their original settings Enteral feeding pump Enteral feeding pumps are used in patients without gastrointestinal complications who are unable or unwilling to consume adequate nutrients Feeding solutions are delivered to the patient through temporary or surgically implanted feeding tubes The pumps accurately control the flow of liquid feeding solutions that are administered enterally through the malfunctions annual Sample risk assessment Criteria choose 1 rating from each category No patient contact Weight Biomedical digestive tract These pumps will utilize a pump mechanism such as a rotary peristaltic pump linear peristaltic pump or a volumetric pump Most pumps record the dose rate dose settings and infused volume in the memory Audib
215. sert the tubing set into the pump and restart the pump Simulate an empty container situation either by turning the reservoir upside down so that no fluid can get to the tubing or by removing the tubing from the reservoir The pump should alarm when no fluid flow is detected Complete model specific performance testing Refer to the service manual for perfor mance inspection tasks specific to the device Complete the performance inspection per manufacturer s procedure Return to service Before returning to use return any settings that were adjusted to their original settings Ensure the volume of the audible alarms is loud enough to be heard in normal operating conditions Plug in the power cord to ensure the battery remains charged 115 University of Vermont Rev 2 Confidential Phototherapy unit Phototherapy units irradiate patients with light to produce beneficial bioeffects Most commonly these devices are used to treat hyperbiliru binemia jaundice in newborns Phototherapy units for this purpose are sometimes referred to as bili lights Blue light typically with a wave length between 420 nm and 480 nm is used Sample risk assessment Criteria choose 1 rating from each category No patient contact to break down the bilirubin A photo oxidation process causes the converts water insoluble bilirubin to water soluble compounds that can be excreted Most commonly phototherapy units are seen as overhead u
216. shared service clinical engineering program serving Vermont upstate New York and northern New Hampshire He holds Certification as a Quality Manager from the American Society for Quality Michael is a member of the Vermont Council for Quality and serves as a state examiner for Performance Excellence Michael is a member of the Association for the Advancement of Medical Instrumentation and of the American Society for Field Service Managers Leah Rafuse BSME is a clinical engineer with Technical Services Program a 26 hospital shared service clinical engineering Program at the University of Vermont Leah is responsible for clinical engineering services for eight hospitals in upstate New York Leah is a graduate of the University of Vermont s engineering program Prior to taking over clinical engineering services in New York Leah worked with Technical Services Program as a biomedical equipment technician specializing in anesthesia equipment es Biomedical 2009 Fluke Biomedical 1 2009 3276553 C EN N Rev A
217. st frequency Score 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 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 Ol RW N e Device failure could result in severe injury to or death of patient or user Maintenance or inspection would not impact reliability of the device BB OW DM 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 No significant history Ol Pl wo N e A significant history of incidents exists 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 University of Vermont Rev 2 Confidential 14 l 119 orocequre Estimated time 35 minutes Equipment information Control number Hospital
218. st of electronic circuitry that controls the pulse rate and output current and a two lead cable used to connect it to disposable adhesive electrodes Electrical impulses are delivered Biomedical chambers of the heart are stimulated simul taneously External pacemakers are used to assist in resuscitation correct arrhythmias such as asystole or bradycardia or to temporarily pace during procedures that may induce these arrhythmias Recommended functional test frequency semiannual to the heart causing the heart to contract All Sample risk assessment Criteria choose 1 rating from each category Weight Score 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 ol P ws NM 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 Blo dM e 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 pro
219. sure the pulse width across its range The measured pulse width should be within 10 of the set width For a pulse width of 2 0 mSec the measured pulse width should be between 1 8 mSec and 2 2 msec Verify operation of alarms Simulate any alarm conditions Check that all alarms are functional and that the volume is adequately loud Ensure that appropriate visual indicators are functioning Complete model specific performance test ing Refer to the electrosurgical unit s service manual for performance inspection tasks spe cific to the device Complete the performance inspection per manufacturer s procedure Return to service Before returning to use return any settings that were adjusted to their original settings If equipped with a power cord or charger plug in to ensure the battery remains charged and ready for use 79 U niversity of Vermont Rev 2 Confidential Fetal monitor Fetal monitors measure fetal heart rate and maternal uterine contractions during labor to assess the progress of labor and the health of the mother and fetus Fetal monitors may use non invasive or invasive methods for monitor ing For non invasive monitoring measurements are taken from transducers placed on the moth er s abdomen An ultrasound transducer is used to measure the fetal heart rate Uterine contrac tions are measured using a tocodynamometer Sample risk assessment Criteria choose 1 rating from each category No patient
220. sure the temperature of the circulating water Set the temperature of the hypo hyperthermia unit to its lowest setting Allow the water temperature to stabilize Repeat the temperature measurement with a midrange temperature and the maximum temperature setting The measured temperature should be within 1 C of the set temperature For a set temperature of 42 C the measured temperature should be between 41 C and 43 C High temperature protection Connect a blanket to the hypo hyperthermia unit and insert the temperature probe into the water reservoir Set the temperature on the hypo hyperthermia unit to its maximum setting If the hypo hyperthermia unit is equipped with a patient temperature probe expose the temperature probe to room air The temperature of the circulating water should increase until the hypo hyperthermia unit alarms temperature Note the temperature at which the alarm sounds on the DPM 4 Check the service manual for the specific high temperature limit and compare this value with the measured temperature The mea sured temperature should be within 1 C of the high temperature limit For a high temperature limit of 44 C the measured high temperature should be between 43 C and 45 C If the hypo hyperthermia is not equipped with a patient temperature probe follow the manufacturer s procedure for overriding the thermostat Low temperature protection If the hypo hyperthermia unit is equipped with a l
221. sured in respect to ground Record the reading or docu ment by exception only University of Vermont Rev 2 Confidential 35 MAINS Ll L2 ISOLATION TRANSFORMER DEVICE UNDER TEST CONDUCTIVE PART RED TERMINAL Figure 15 Mains on applied parts leakage current test configuration Lead isolation test mains on applied parts leakage This test applies the power line or mains voltage to the patient applied parts so cau tion should be taken in not to come in contact with the patient applied parts during this test Ensure the Patient Applied Leads are attached to the appropriate connectors on the ESA e g see Figure 8 per the ESA manual Switch the function switch to Patient Lead Leakage or Applied Parts Leakage per the ESA instruc tions Make measurements with the RED lead attached to the device The measurement should be made under Normal and Reverse polarity Ensure the ESA is not quickly switched between Normal and Reverse polarity The test should be performed by selecting ALL leads connected together and individual leads mea sured in respect to ground Record the reading or document by exception only 36 University of Vermont Rev 2 Confidential LEAD SELECT Switch Diagram Reference Action S1 Neutral Closed S2 Polarity Variable S3 Earth Closed S4 M A P 500 V Variable S5 a se Aep Variante Return to service Before returning to use
222. te If the high heart rate alarm was unable to be set at a low enough value set the alarm for its lowest value Select PATIENT CONDITIONS on the BP Pump 2 Use the OPTIONS soft key to cycle through the available simulations until the heart rate is high enough The MILD EXERCISE simulation has a heart rate of 120 bpm Clear the alarms on the NIBP monitor and return the alarm limits to their original settings Select STANDARD BP on the BP Pump 2 and set the simulated blood pressure to 60 30 Set the low alarm limits on the NIBP monitor higher than the simulated pressures Set the low sys tolic alarm to 65 mmHg the low diastolic alarm to 35 mmHg the low mean pressure alarm to 45 mmHg and the low heart rate alarm to 85 bpm Initiate a blood pressure measurement on the NIBP monitor The high alarms should activate Complete model specific performance test ing 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 settings that were adjusted to their original settings Ensure the volume of the audible alarms is loud enough to be heard in normal operating conditions Plug in the power cord to ensure the battery remains charged Patient monitor Patient monitors measure and display physi ologic parameters reflecting a patient s clinical condition These mon
223. te Test type Incoming Post repair Test equipment needed ISA 601 Electrical Safety Analyzer 20 cc or larger syringe IDA4 Plus Infusion Device Analyzer 3 way stopcock Tubing set for infusion pump Tubing and connectors to connect to IDA 4 Plus Reservoir to connect to tubing set bag or bottle Test Result Pass Fail N A 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 and warnings present and legible Inlets and hoses Power cord accessory cables charger Filters and vents clean Ground wire resistance lt 0 3 Q Chassis leakage lt 100 pA NC lt 500 pA SFC Patient leakage current lt 100 pA B and BF lt 10 pA CF Patient lead leakage current isolation test lt 100 pA BF mains on patient applied part lt 10 pA CF Insulation test optional 500 V lt 2 MQ Clean flow detector Replace battery every 24 months Complete model specific preventive maintenance Verify unit operates on battery Pole clamp function Flow rate accuracy 10 Volume accuracy 10 Infusion complete KVO Occlusion detection pressure 1 psi Piggyback infusion Alarm function Complete model specific performance testing 20 uUniversity of Vermont Rev 2 Confidential Safety Maintaining a
224. teaepaaeenae 148 The Jomi COMMISSION or cocceccecs desveiee seeeeveoedesceeweteceteenedscesveree averted aa 148 FLUKE Biomedical University of Vermont Rev 2 Confidential 1 CHAPTER 1 The purpose of this document is to provide guidance in establishing and managing a medi cal equipment quality assurance QA program and to present detailed procedures for inspec tion preventive maintenance safety evaluation and performance testing The target audiences for this publication are those responsible for establishing and managing medical equipment QA program and staff performing inspections and device testing Readers should have a basic techni cal background and some exposure to medical equipment in healthcare The book does not provide background information on clinical or technical concepts or medical equipment prin ciples of operation Medical equipment QA is part of an over all medical equipment management program for a healthcare facility or system A complete program also includes corrective maintenance or repair equipment control asset management health care technology planning education and activities directed toward improving medi cal device related patient safety 2 University of Vermont Rev 2 Confidential The publication is organized into four primary sections e A glossary of terms e Background information on establishing and managing a program including goals meth ods
225. th Alarm function Complete model specific performance testing University of Vermont Rev 2 Confidential 117 Physical condition Check the physical condition of the device as described in the General Equipment Procedure Electrical safety Perform electrical safety checks as described in Chapter 5 Electrical Safety Check ground wire resistance and chassis leakage Preventive maintenance Inspect bulbs Inspect the phototherapy unit for broken or burned out bulbs Replace as necessary Complete model specific preventive main tenance Refer to the monitor s service manual for preventive maintenance tasks specific to the device Complete the preventive maintenance per manufacturer s procedure Performance inspection Timer accuracy Set the timer for 2 minutes Initiate treatment and begin timing with the stopwatch Initiate phototherapy treatment and begin timing with a stopwatch or a watch with a second hand The treatment timer should sound within 5 of the measured time For a 118 OUniversity of Vermont Rev 2 Confidential set time of 120 seconds the actual measured time should be between 114 seconds and 126 seconds Verify that treatment stops when the timer stops Output accuracy Initiate a phototherapy treatment Place the photodetector probe facing the light about 18 inches 45 7cm from the light source The irradiance will be displayed on the Dale40
226. the feed ing pump to the IV pole Biomedical Flow rate accuracy Fill the infusion reser voir with a 1 detergent solution in de ionized water Prepare a 1 stock solution of detergent such as Cole Parmer Micro 90 in volume using de ionized water The solution may be stored in a closed vessel for up to 6 months This solution should then be diluted 10 1 with de ionized water for daily use If the water used causes too much foaming a 20 1 dilution is recommended Do not use tap water or solutions intended for patient use as these may harm the transducers in the IDA 4 Plus Connect the feeding tubing to the reservoir Prime the set so there is no air in the tubing With the tubing draining into a container or sink open the flow control mechanism on the tubing set Hold the reservoir high enough above the tubing so that fluid flows through the tubing under the force of gravity Allow fluid to flow through the tubing until no air bubbles can be seen in the tubing Insert the set into the feeding pump Connect the three way stopcock to the channel 1 port on the IDA4 Plus Con nect the patient feeding tubing to one port of the stopcock Fill the syringe with the detergent solution and connect this to the other port of the stopcock Connect a piece of tubing to the drain port of channel 1 and run the tubing into a container to catch the used solution From the main menu of the IDA 4 Plus use the arrow keys to highlight SETUP
227. this part safe use and potential risks Note any special conditions This vendor certifies this device is provided to the facility in safe and useable condition and is FDA approved for the intended clinical procedure s This vendor has or will test the device for proper function prior to clinical use but after arrival at the facility Training will be provided to staff on This device is an investigational device for which FDA approval does not exist as of yet The device will not be used clinically until all hospital investigational review board approval is received Training will be provided on safe use and potential risks This equipment is provided repeatedly to the hospital and is maintained by the vendor It is checked between assignments to different facilities and records of maintenance are provided annually to the facility Ongoing performance and safety testing is provided and the vendor certifies that the device is safe for use as provided at delivery Non hospital employees who will be delivering and or operating the equipment are appropriately trained and qualified to be transporting setting up and operating the equipment Vendor Signature Date Facility Signature Date 16 uUniversity of Vermont Rev 2 Confidential Documentation Documentation is very important to any main tenance program Tracking what maintenance has been performed is impossible if there is no documentat
228. tional testing according to 5 4 department independent service organiza Concluding evaluation tion manufacturer e Date and signature of the individual who e Names of the persons who performed the performed the evaluation testing and evaluation s e Identification of the equipment system e g type serial number inventory number and the accessories tested Computerized record keeping systems are greatly preferred for data storage search review and analysis Note the device fields must be standardized To protective earth or enclosure Figure 8 General connections to an electrical safety analyzer 28 University of Vermont Rev 2 Confidential EEE Biomedical oroceqdure Estimated time 5 minutes Equipment information Control number Hospital Manufacturer Model Serial number Location Test information Technician Date Test type Incoming Post repair Test equipment needed Fluke Biomedical ESA620 or equivalent Test Result Pass Fail N A 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 and warnings present and legible Fuse rating is appropriate Power cord accessory cables charger patient cables connectors Integrity of mechanical parts
229. to deliver direct treatment to the patient 4 Device is used for a life support 5 Physical rise Device poses no appreciable risk due to failure 1 Device failure will result in low risk 2 Device failure will result in inappropriate therapy misdiagnosis or loss of monitoring 3 Device failure could result in severe injury to or death of patient or user 4 Maintenance or inspection would not impact reliability of the device 1 Common device failure modes are unpredictable or not very predictable 2 While common device failure modes are not very predictable device history indicates that 3 TSP testing frequently detects problems Common device failure is predictable and can be avoided by preventive maintenance 4 Specific regulatory or manufacturers requirements dictate preventive maintenance or testing 5 No significant history 1 A significant history of incidents exists 2 No requirements 1 There are requirements for testing independent of a numerical rating system 2 Total Score Assignment 0 0x 0 5x 1x 2x 3x 4x times per year tested A combined score of 13 or more is justification for semiannual testing A combined score of 9 12 is justification for annual testing A combined score of 8 or less is justification for less than annual testing either bi annual or no scheduled testing depending on clinical application Anesthesia machines and vaporizers are recommended for testing three times per year Some blood delivery devices such as warmers m
230. ty to the T2 sensor on the INCU Allow the incubator temperature to stabilize The measured temperature on the T2 sensor should be within 0 3 C of the displayed skin temperature on the incubator For a displayed skin temperature of 34 C the measured temperature should be between 33 7 C and 34 3 C Repeat the temperature measurements at 36 C and 38 C Temperature alarms Adjust the temperature set point on the warmer to its maximum set ting Place the sensor in the warmer and allow the temperature to stabilize Remove the skin temperature sensor from the warmer and allow it to cool Verify that the low temperature alarm activates Place the skin temperature sensor 130 University of Vermont Rev 2 Confidential back in the warmer and allow the tempera ture to stabilize Hold the sensor close to the heater Verify that the high temperature alarm activates Alarm function Check that all alarms are functional and that the volume is adequately loud Ensure that appropriate visual indicators are functioning Unplug the temperature probe from the incu bator The disconnected probe alarm should activate If the incubator is equipped with alarms for an open or short circuited tempera ture probe use open and short circuited probe plugs to test these alarms Disconnect the skin temperature probe and connect the probe plugs The appropriate alarms should activate Unplug the incubator to simulate a power fail
231. uled maintenance J Tobey Clark MSEE CCE is the Director Instrumentation and Technical Service at the University of Vermont He leads the Technical Services Program a 26 hospital shared service clinical engineering program serving Vermont upstate New York and northern New Hampshire Tobey also directs the Instrumentation amp Model Facility IMF which designs develops fabricates and services custom research instruments for the University of Vermont community He has a faculty appointment in the School of Engineering and the College of Nursing and Health Sciences where he teaches medical instrumentation courses Tobey is involved in a number of professional activities including serving as a board member of the ACCE Healthcare Technology Foundation and as an advisor to the World and Pan American Health Organizations He was the 2002 recipient of the Clinical Biomedical Engineering Career Achievement award from the Association for the Advancement of Medical Instrumentation and the 2008 Professional Achievement in Management award from the American College of Clinical Engineering Tobey is currently supported by several grants related to medical technology education and international clinical engineering exchange Biomedical Michael W Lane MBA is the Associate Director Instrumentation and Technical Services at the University of Vermont He manages the operations of Technical Services Program a 26 hospital
232. useful tool in keeping track of the device inventory and maintenance his tory There are several programs commercially available but whatever software is chosen the following information should be tracked Basic device information Any medical equipment management software should track basic device information At a minimum the device type manufacturer model and serial number should be tracked This information is essential to the maintenance program Clinical use The clinical use of a device should be documented Equipment used for life support needs to be given a higher priority for maintenance Additionally regulations on life support devices may be different In the United States the Joint Commission requires equipment used for life support to have a 100 completion rate for scheduled maintenance Biomedical Location This may be entered as the owner department or a physical location The equip ment location is used to find the equipment for maintenance Also the location is useful to break up the maintenance schedules by department Maintenance history A record should be kept of all maintenance performed on equip ment including scheduled maintenance repairs software upgrades and incident investigations Dates of service should be included in this history Work coding For benchmarking and trend ing the type of maintenance being performed on the equipment is required The University of Vermont uses a
233. vice 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 and warnings present and legible Inlets and hoses Power cord accessory cables charger Filters and vents clean Replace battery every 24 months Ground wire resistance lt 0 3 Q Chassis leakage lt 100 pA NC lt 500 pA SFC Patient leakage current lt 100 pA B and BF lt 10 pA CF Patient lead leakage current isolation test lt 100 pA BF mains on patient applied part lt 10 pA CF Insulation test optional 500 V lt 2 MQ Complete model specific preventive maintenance Verify unit operates on battery Pressure accuracy 2 Timing cycle accuracy 2 Alarm function Complete model specific performance testing 56 uUniversity of Vermont Rev 2 Confidential Physical condition Check the physical condition of the device as described in the General Equipment Procedure Electrical safety Perform electrical safety checks as described in Chapter 5 Electrical Safety Check ground wire resistance and chassis leakage Preventive maintenance Replace battery The battery should be replaced every 24 months Replace if necessary Complete model specific preventive main tenance Refer to the monitor s service manu
234. work order coding system where a work order is generated for each maintenance event and a work order type is assigned to each work order A sample of work order types are listed in the table on page 12 Work order coding is important in measuring the success of the maintenance program and for identifying areas that need to be addressed For example if there are a lot of work orders indicating use error for a device the trend may indicate the clinical staff needs to be trained in the proper use of the equipment Below is an example of the use of trending data to identify equipment with a high percentage of use error As a benchmark equipment with a use error per device of greater than 10 needs to be addressed In this example hypo hyperthermia units have a use error percentage of around 12 Further investigation will need to be done as to why the failures occur University of Vermont Rev 2 Confidential 11 Work order types for corrective maintenance Work Order Type Definition 08 REPR MAINT Device failure could have been prevented with maintenance such as replacing tubing O9 REPR RAND Device failure could not be prevented 10 REPR USR ERR Device failure was caused by improper clinical use 11 REPR DAMAGED Device failure was caused by abuse 12 REPR NO PROB Reported failure could not be reproduced 14 RE REPAIR Device failed for the same problem within 30 days of being repaired previously
235. y unit operates on battery Check that the ac power indicator is lit 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 Be sure to plug the power cord in at the conclusion of the test Fan operation Inspect the fan blades for damage Look for chips warping melting and missing blades Ensure there is adequate clear ance around the fan assembly Look for signs of rubbing around the fan housing Lubricate the fan motor per the manufacturer s specification Follow the manufacturer s instructions in the service manual for lubricating the pump motor Not all motors will need to be lubricated University of Vermont Rev 2 Confidential 129 Temperature accuracy Set the warmer tem perature to 34 C Place the INCU in the center of the incubator Place the T1 and T3 tempera ture probes so that they are placed vertically in opposite corners Clip the T2 probe to the underside of the radiant baby adapter Place the radiant baby adapter on top of the INCU and align it with the heater in the warmer Place the skin temperature probe from the warmer in close proximity to the T2 sensor Allow the temperature to stabilize Press the SELECT button on the INCU to cycle through the readings Place the skin temperature probe in close proximi
236. ypes of maintenance events to be identified University of Vermont Rev 2 Confidential 17 Labels Labels are an easy and effective way to com municate information about medical equipment The University of Vermont uses a variety of labels to indicate specific data necessary for technology management regulatory require ments and for safety Labels may be used for performance inspections bi annual annual semiannual and general battery installa tion specific calibration warranty hazards and warnings and upgrade or recall data In addition a unique identifier control number is placed on each piece of equipment for ease of device tracking The following are examples of these labels Control number tags are made of aluminum and attached with a permanent adhesive These tags need to be rugged in order to stand up to repeated cleaning and disinfecting of the equipment Other labels are made of a material that allows them to be peeled off and replaced Labels that require written information should be filled in using permanent marker to avoid fading of the ink Hospital XYZ Technical Services Program Inspection labels that include a next inspec tion due date are especially useful Clinical staff should be trained that if they find a piece of equipment with an outdated inspection sticker they should put the equipment aside if possible and contact biomedical personnel Care should be taken to ensure labels

Medical Equipment Quality Assurance: J. Tobey Clark

Contents

Download Pdf Manuals

Related Search

Related Contents