Chapter 4 Operational Verification and Start-up ‘This chapter covers the proper operational verification and ventilation start-up methods for the Model 31004 HFOV. ‘See Chapter 2 for instructions on unpacking, assembly, and installation ofthe Model 3100A HFOV prior to operational star-up and veriication. WARNING The operational verification and start-up procedure must be followed before ventilation ofa patient commences. I at any time during the operational verification and star-up procedure any abnormal function ofthe Mode! 3100 HFOV is nled, da nat proceed with patient ventilation as tis could cause inuty or death; contact SensorMedics “Technical Suppor before proceeding any futher. CAUTION Proper operaion of the venator must be vere prior to each use. The alarm function tested inthis procedure | very he capa ofthe device o detect and indicate condions which could havea harmful efeconthe | patient. } CAUTION Touch the outer metal cabinet of the instrument befote touching ny other component to evoit possible insument component damage from Electrostatic Discharge, WARNING ‘Do not operate radio transmitters within 20 fee of this insument. This may result in eroneous pressure readings leading to falso alarms and automatics shit down, Start-up Procedures ‘A“Quick-Checkist” label for pre-patient hookup verifcation is attached to the ventitator. Soo figure 4.1 below. 76r124 Revision K March 2002MODEL 31004 SensorMedics QUICK CHECK LIST LABEL, PRE PATIENT HOOKUP CHECK LIST (Refer to Verifeation Section in the Operators Manual) 1. Connact source gases to system. Connect power to 9 tem. Tum on power. Check source gas (Chock staristop let (Check alarm stent stem. ighis aro of. tis of. int Is on 10, Perform patient ecu cllbration 11. Perform vacation performance, 12, Petform alarm heck procedure. 13, Verily pressure monitor calibration, 14, Proset flo, frequency % Inspiratory tne fasway prossurs ard unning maar erway pressure Ink 415, Set Max Paw and Min Paw switches. 416, Set blender and humidifier controls for desired operation 47. Remove stopper from patient circuit. Connett to patont £T tube, Figu Start-up Procedure 1. Connect the source gases tothe Model 3100A HFOV System: ‘Oxygen ine tothe External Air/Oz Blender oxygen input fing © Airline tothe External AirfO2 Blender air input fiting and the oscillator “At Cooling” 761124 input connector. CCheck that patient circuit suppart is installed on system. Connect pation circuit ane humidor to eystem, Connect pation clrcuit control ond pressure sons tines to 5y5- owes, running mean 4.1 Quick Check Label ‘© Extemal irfOz Blender output to the Control Package rear panel oxygen DISS fiting labeled “inlet from Blender.” 2. Connect Patient Circuit and External Patient Humidifier tothe Model 3100 using the assembly procedures described in Chapter 2. WARNING Do rot attempt to substitute another cicult configuration as this coud result in injury tothe patient andlor operator ‘or cause equipment damage. The Patient Circuit described in this manual is specifically designed for patent use | with the Made! 31008 HFOV. Revision K ‘Merch 2002 e AADANAAAAAAIAAAANAAA AYA VAY AD VUE iOperator's Manual Chapter 4 Operational Vertical CAUTION ] ‘Wen connecting the Patent Circuit, make certain that its properly supported by the suppor: tm as described in Chapter 5, Assembly and installation, Falure todo so coud suk in inadvertent patient circuit disconnection ce {0 osiltory forces or could result n colton of humid condensate inthe paint aay 3. Connect all color-coded Patient Citcuit Control Lines and the clear Pressure Sense Line ‘o their proper locations on the Patient Circuit as described in Chapter 2 CAUTION. ate should be taken not to crimp oF perforate any ofthe control or sens lines (turning oor fom the Patient | RAD ding assemtiy or operation o the veniator as this wllause maluncten the Safely Aas, Waring | ‘Alans, Caution Alarms, andlor Pressure Limit conils, 4 Block off or obstruct the ET connection port on the Patent Circuit using the #1 rubber stopper accessory provided 5. Tun on the Main Power Switch (the green LED onthe StarvStop pushbulton should be cof). Some of the alarm LED's willbe lighted but the 3K-Hertz audible tone will be silenced ue to the automatic ination ofthe 45-Sec Silence function when power is fist turned on. This alarm silence feature can be retiggered during the verification and startup Procedure by pushing the 45-Sec Silence pushbutton, WARNING ‘An acter incates the extence ofa condton poeta hal tothe pain and should nt go tent Fale to respond to alarms coud rest nu, cling death cote patent ardor deme to tho vertatar | CAUTION ferme tat the stopcock is sed proto performing a Patent Circuit Calbraton, the Water Tap Stonackis te open, Patent Circuit Calboration (38-43 emH20) may not be achievable, and the dalwerale Paw wl be reduce Cy ‘alibrate the patient circuit to the system. Insttucions for this procedure are also located (on label onthe side of he Control Package. + Tumon source gas pressure and establish Bias Flow at 20LPM at the % oxygen level desired, Be sure to read the flow atthe center ofthe bal looking level atthe fowmoter * _Setboth Mean Pressure Adjust and Mean Pressure Limit contos ta Max (ull CW) * Push in and hold RESET while observing the Mean Pressure digital readout. tis normal ‘or the Battery Low LED to light when the resot button is pressed, * Adjust the Patient Cicuit Calibration on the righ sie ofthe contol package wo achieve a Pav of 39 0 43 emFz0. Do not overturn if the spectid pressure can not be achieved, locate the leak, * Release the RESET button; the Battery Low LED should tum off [ CAUTION : ce ] | Dovnot over tum the Patient Circuit Caltrationscrow as ths may cause ‘damage to the device, When itis nearing | its adjustment tii, it wil reach a mechanical stop. } @ Perform the Ventlator Performance Check ‘Off Patent Onl’ secon. {isucions for bis Procedure are also located on a label on the top of te Contol Package 767124 Revision K ‘March 200250 10, 11 2 8. 4, 15, 16. 11, 767124 31004 HFOV © Set Frequency to 15, % -Time to 33, and Power to 0.0. © Establish Bias Flow at 20 LPM, © Set the Mean Pressure Limit contol to Max (full CW), © Sel the "Set Max Paw" thumbwheel sich to 30 and the "Set Min snitch to 10, © Depress the RESET button long enough to allow PaW to increase above 6 cin}20. thumbwheel ‘* With the Mean Pressure Agjust control, establish a Paw of 190 21 cmH20, + Depress the START/STOP button ta cause the ascilatr to rn. Increase the POWER contol seting to 6.0 while simultaneousiy cen the Piston Centering contol © When a stable AP reading s obtained with the piston operating inthe center porton ofits range, vey that the AP and Pw readings are within the range spectled for your ‘corresponding altitude (see Figure 6.1. Depress the STARTISTOP button to stop the oscillator, With Mean Pressure Adjust andlor Bias Flow adjustment, achieve a mean airway pressure within 2 cmH20 ofthe desired level. Ensure thatthe Bias Flowis sufficient (see Chapter 6). Verify te function ofthe thumbwheel switches for “Sot Max Paw" and “Set Min Paw" alarms by setting the Max thumbwheel ust below the established mean airway pressure, and by seting the Min thumbwheel just above the estabished mean airway pressure. Set these thumbirhee! alarm switches to ther desitod sottings. Tis is gonerally 2-5 cmH20 above (Max thumbwheel) and below (Min thumbwhee) the established Mean away pressure. \With fingers and thumbs), squeeze closed the expired fb tubing onthe patient circult to verily operation ofthe "Paw > 50 cmH20" alarm. Depress the RESET button until the "Paw < 20% of Set Max Paw" LED is extinguished to reestablish mean aiway pressure. Rotate the Mean Pressure Limit control to approximately mid-scale. ‘Again, squeeze the expired tubing on the patient circuit and observe the pressure at which the Mean Pressure display limits, Rotate the Mean Pressure Limit contro in the appropriate direction to cause the Pa to iit at the desired point. he piston wath Position the ventilator for connection tothe patient, Loosen the Position Lock controt and adjust the angle of the Control Package for the best view and access relative to the patient, Retighten the Position Lock. Set the desired % oxygen, mean airway pressure, and AP forthe patient. AP will affect the Paw depending on ratio of Flow Rate/Paw. The lower the rai, the stronger the effect. Revision k ‘March 2002 ae RANA ANANAANAANAAAAAAAAA ELLE e eOperator's Manual Chapter 4 Operational Verification & Startup ca 51 PRECAUTION Fractional concentration of inspired oxygen should be vesfied wih en onygen moniter. Adinistaion of excessive oxygen toa patent may be harmful Its imperative that he prescribes gas mixture is devered by the ending syst i 18. Remove the Patent Circuit stopper. Adjust the Extemal Patient Huriifrto establish the desired gas temperature atthe patient away temperature port Connect the Patient Circuit to the patent ET tube WARNING Under no citcumstanees should proximal airway gas temporature of 41°C be exceeded. This could rest in injury to the patient's upper away membranes, CAUTION \When the ventilator fs connected to a pation, tis imperative that someone be in attendance at al times in order to react ta any alarms and to detect other indications ofa problem. | 49. Push the Reset pushbutton until the ‘Pad < 20% of Set Max Paw" LED is extinguished to reestablish mean airway pressure 20. Setthe Power control for the desired AP (see Chapter 8), 21. Adjust the Piston Centering control to keep the piston approximately centered and away from the mechanical stops at’Max Insp Limit and "Max Exp Limit’ as indicated on the Piston Postion and Displacement display. 22. Readjust the Frequency, % Inspiratory Time, Power, Mean Airway Pressure, Bias Flow, and Piston Centering controls as needed during patien ventilation. WARNING Under no circumstances should the ventilator be used inthe presence of flammable anesthetics cue tothe possiblity of explosion CAUTION Do not place on te Control Package of the ventilator any fud-containing accessories, accessories that weigh ‘more than 10 pounds, of accessories tha extend more than six inches above the ventilatr electronics package or bboyond is sides. This could cause the ventilator to tip ever, resulting in patient or user injuries andlor damage to the equipment 67124 Revision K March 209252 31008 HFOW Performance Verification Torta VENTILATOR PERFORMANCE CHECKS “hese ithe tal theyll peromanes tbe expec om he Mal 31005 fant SEAN se ost sien AP ve POWER ral © z | eet 3” 2° | A & e rr Cn Poon Seting iF OFF-PATIENT 4. let Sloper in Pa! Gait" and men both gasses 2, Sa"BAS FLOW for 20 LPM and tala an ess Lie a’ 5 Presta sta by pean an olng "RESET ane ADIUST fora Mem Presse 192 or20, 4 Sa FREQUENCY to 15% LTine" 0, ad press "STARTISTOP fe sate oslo, 5, Se"POWER" 60, ad ‘cena este 6; Oteerethe folowing parameters, athe elitude ene of ou ally, ad erty they al tin he ranges pacts _AuTETUDE (FT) MEAKL(emiig0) 4 Pemliz0) neo 182 675 eat Be 500 ‘oats ee tess agama sa as ‘oat-toote 8 a8 Figure 4.1, Ventilator Performance Checks, The two graphs shown in Figure 41 are intended to guide the operator in seting Power, Mean Pressure Adjust, and Bias Flow controls, and to help ascertain that the 3100A is performing ina typical fashion without problems. The left graph indicates the approximate setting of the Power control required to achieve a specific AP pressure, The right graph illustrates the Bias Flow required to achieve a range of Mean pressures with the single-turn Mean Pressure Adjust contol ‘When estabishing a specific mean airway pressure, you must find the required Bias Flow that wil allow the mean pressure to be adjusted above and below that desired, Set the Mean Pressure Adjust contol 10 approximately “twelve o'clock” and set the Bias Flow as indicated on the graph, toa level which puts the desired Pai level ints mid-range. When the system is operating, whether ON or OFF Patent, the settings of the controls relative tothe pressures being developed and displayed, will quickly give an indication thatthe system performance is nominal, Revision K ‘Masch 2002 A AAA RADAR OOOO OOO HAO