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Sensormedics-3100B-User-Manual

1. Outlet to Humidifier 3 8 Barbed Fittin Inlet From Blender DISS Fitting Pi nt Rdcord J COOLING AIR me Cooling Air DISS Fitting Figure 5 3 Rear Panel Connections 767164 0601G Chapter 5 Assembly and Installation 63 C Assembly Warning Do not shorten the 30 bias flow tube provided with the patient circuit as this may reduce the maximum AP by allowing the oscillatory pressures to be attenuated by closer proximity to the volume of the humidifier canister Precaution The inlet filter cartridges for the blended gas and the air inputs to the ventilator must be replaced at least every 500 hours of operation as described in Chapter 7 Maintenance and Troubleshooting Failure to replace a filter cartridge or substitution of an unauthorized cartridge could result in injury to the patient and or damage to the equipment Use only SensorMedics P N 463110 cartridges P N 767163 box of 10 Find a convenient power outlet for connection to the Model 3100B with a minimum rating compatible with the HFOV power ratings described in Chapter 2 The Model 3100B HFOV system is now ready for operational verification Warning Do not attempt to defeat the proper connection of the ground wire Improper grounding may cause damage to the device or interconnect
2. 1 Patient Circuit support arm and cradle 2 Two complete patient circuits packaged one to a box 3 Humidifier input and output hoses adapters 4 A box of ten spare Inlet Filter cartridges for blended gas and air inputs 5 Operator s Manual 6 Humidifier mounting bracket adapters Precaution Deviation from the assembly methods described here could damage the Model 3100B render it mechanically unstable or cause it to malfunction If any questions arise regarding the assembly procedure please contact SensorMedics Technical Support immediately before proceeding Place the pre assembled Control Package Column and Pedestal on a level floor and lock the locking wheels Assemble the Patient Circuit support arm prior to attempting to attach the Patient Circuit A flathead screwdriver will be necessary Precaution When connecting the Patient Circuit make certain that it is properly supported by the support arm Failure to do so could result in inadvertent Patient Circuit disconnection due to oscillatory forces or could result in collection of humidifier condensate in the patient airway 58 Chapter 5 Assembly and Installation C Assembly Attach the vertically adjustable rod to the end of the support arm so that it will cradle in its curved end the main tube of the Patient Circuit Tighten the thumbscrew crosspiece to secure it at the height desired The angle of the Patient Circuit can also be contro
3. 4 Block off or obstruct the ET connection port on the Patient Circuit using the 1 rubber stopper accessory provided 5 Turn on the Main Power Switch the green LED on the Start Stop pushbutton should be off Some of the alarm LED s will be lit when power is first turned on Warning An audible alarm indicates the existence of a condition potentially harmful to the patient and should not go unattended Failure to respond to alarms could result in injury including death to the patient and or damage to the ventilator Precaution Ensure that the stopcock is closed prior to performing a Patient Circuit Calibration If the Water Trap Stopcock is left open Patient Circuit Calibration 39 43 cmH20 may not be achievable and the deliverable Pa will be reduced Warning Ensure that the cooling fan at the rear of the driver enclosure is operational 6 Calibrate the patient circuit to the system These instructions are also located on a label on the side of the Control Package a Turn on source gas pressure and establish Bias Flow at 20LPM Be sure to read the flow at the center of the ball looking level at the flow meter b Set Max Pa Alarm to 59 cmH20 c Set Mean Pressure Adjust control to Max full CW d Push in and hold RESET while observing the Mean Pressure digital readout It is normal for the Battery Low LED to light when the reset button is pressed e Adjust the Patient Circuit Calibration on the right side o
4. 767164 0601G Chapter 7 Maintenance and Troubleshooting 79 E Other Scheduled Periodic Calibration oscillator If the oscillator is warm due to previous operation allow a non Operating cool down interval of at least one hour before commencing calibration Precaution The cover enclosing the Control Package Column or any other portion of the ventilator must not be removed by the user To avoid electrical shock hazard please refer all service requiring cover removal to a qualified biomedical equipment service technician Control Package DC Power The calibration procedure for the Control Package DC Power Supply is as Supply follows 1 Turn off Power to the 3100B HFOV and unplug unit from AC receptacle 2 Remove the rear column cover 3 Plug the 3100B HFOV back into receptacle and turn on Power 4 Refer to Figure 7 2 to locate screwdriver potentiometer settings R9 R57 and R82 for the DC Power Supply It is located immediately below the oscillator drive electronics 767164 0601G Chapter 7 Maintenance and Troubleshooting E Other Scheduled Periodic Calibration Figure 7 2 Power Supply Adjustment Potentiometers 5 Connect the negative lead of a digital voltmeter to the 5V Com terminal of the DC Power Supply 6 Connect the positive lead of the digital voltmeter to the 5V terminal of the DC Power Supply fadjustments are necessary remove the front column cover 7 If necessary adjus
5. 767164 0601G management of mean airway pressure is fundamental to controlling oxygenation Increases in mean airway pressure increase lung volume and therefore alveolar surface area At any given level of oscillatory pressure amplitude AP oxygenation is usually improved by increasing the mean airway pressure and vice versa Disease specific strategies for the manipulation of mean airway pressure will be described below Pa will show small fluctuations with temperature and humidity changes The operator should be ready to make minor adjustments to Pa as the circuit temperature rises and falls as it may for instance when a humidifier canister is filled with fresh water Changes in the oscillatory pressure amplitude AP are accomplished with the ten turn Power control which adjusts the electrical current level applied to the driving coil of the linear motor that displaces the diaphragm sealed piston As the piston is displaced rapidly forward and backward in a nearly square wave pattern by the square wave current in the driving coil high amplitude pressures fluctuations are symmetrically superimposed on the level of mean airway pressure previously established in the patient circuit as described above at a lnsp Time of 50 Although the 3100B is capable of generating oscillatory pressure higher than 90 cmH20 peak to peak at the proximal endotracheal tube attachment point of the patient circuit wye no such pressures are develope
6. RESET to establish Pa and then press Stop Start switch Internal power supply failure Call SensorMedics Service Failure During Checkout cont Condition Possible Causes Possible Remedies Failure to meet Patient Leak in patient circuit or humidifier Eliminate leak or replace patient circuit Circuit Calibration connections 767164 0601G Chapter 7 Maintenance and Troubleshooting 87 G Troubleshooting Failure of Ventilator Performance Check Pa out of range LOW Failure of Ventilator Performance Check Pa out of range HIGH Improper flow meter setting Open Water Trap Stopcock Internal leak or maladjustment Incorrect Patient Circuit Calibration Center of flow meter ball not used to make 20 LPM adjustment Incorrect altitude range being used Internal Failure Incorrect Patient Circuit Calibration Center of flow meter ball not used to make 20 LPM adjustment Incorrect altitude range being used Internal Failure Failure During Checkout cont Condition Possible Causes Set flow meter to 20 LPM sighting on center of ball Close Water Trap Stopcock Call SensorMedics Service Perform Patient Circuit Calibration Adjust flow to center of ball Use appropriate altitude range for your facility Call SensorMedics Service Perform Patient Circuit Calibration Adjust flow to center of ball Use appropriate altitude range for your facility Call SensorMedics
7. 0601G Chapter 2 Specifications H 3100B Performance Graphs 23 3 Ohm Driver Distal Tidal Volume vs Frequency at Maximum Power and 50 I Time e Three ET Tube Sizes e Single Compliance 19ml cm H20 767164 0601G Tidal Volume ml 300 Frequency Hz Figure 2 4 24 Chapter 2 Specifications H 3100B Performance Graphs 3 Ohm Driver Distal Tidal Volume vs Power Setting at 50 I Time e Three ET Tube Sizes e Single Compliance 19ml cm H20 Tidal Volume ml Power Setting Figure 2 5 767164 0601G Chapter 3 Description of System and Safety Features 25 A Introduction A Introduction Subsystems Provided by the User Subsystems Included with Ventilator B External Air Oz Blender C External Humidifier 767164 0601G The system consists of eight subsystems six included as part of the Model 3100B and two provided by the user 1 External Air O2 Blender and Oxygen Monitor 2 External Humidifier 3 Pneumatic Logic and Control 4 Patient Circuit 5 Oscillator Subsystem 6 Airway Pressure Monitor 7 Electronic Control and Alarm Subsystem 8 Electrical Power Supply Both oxygen and air pressure sources are required as specified in Chapter 2 These sources feed a user provided Air Oxygen Blender The air source also provides cooling to the Oscillator Subsyste
8. 14 27 48 Patient Circuit Calibration Failure 86 Patient Circuit Calibration Procedure Label 7 Patient Circuit Cradle 54 Patient Circuit Changing 75 Percent Inspiratory Time 91 Percent Inspiratory Time Control 43 Percent Inspiratory Time Indicator 15 Performance Check Ventilator 67 Performance Graphs 20 Performance Verification 70 Periodic Calibration Scheduled 77 Periodic Maintenance Scheduled 81 Pneumatic Connections 18 Pneumatic Logic and Control 27 pneumomediastinum 98 pneumonia 98 pneumopericardium 98 pneumoperitoneum 98 pneumothoraces severe recurrent 98 pneumothorax 98 Position Lock Control 50 Potentiometers Power Supply 79 Power Control 13 43 Power Failure Alarm 38 Power Failure Alarm Battery 50 Power Failure Alarm Battery Changing 74 Power Failure Indicator 14 46 Power Indicator 15 Power Requirements 17 Power Supply 36 Power Supply Calibration 78 Power Switch 53 Precautions 3 Pressure Limit Valve 29 Pressure Specifications 15 Pressure Transducer Span Adjustment 50 Pressure Transducer Zero Adjustment 50 Pre use Cleaning and Disinfection 63 proximal airway pressure sensing line 29 pulmonary interstitial emphysema PIE 98 R Radio Frequency Interference RFI Warning Label 11 radio transmitters 82 Rear Panel Connections 61 Rear Panel Control Package 49 Reset Power Failure 85 Reset Button 14 Reset Pushbutton
9. Battery Low LED 15 on front panel indicates when this battery needs to be changed It can be replaced by any high quality 9 volt alkaline battery Note remove the 9 volt battery if the instrument is not intended to be used for a lengthy period Locks the Control Package in the rotational position selected by the user When this lock is rotated counterclockwise it allows the rotation of the Control Package over an arc of nearly 360 This permits viewing of the Model 3100B front panel from an angle independent of the Patient Circuit outlet orientation After the desired position has been selected rotation of the knob in a clockwise direction will lock the enclosure in the selected position 52 Chapter 4 Location and Function of Controls Indicators and Connections C Rear Panel Control Package 27 Air Cooling Inlet 28 Blender Cooling Gas Filter Replacement Record 29 Driver Replacement Record Rotation of the knob slightly counterclockwise from fully locked will apply friction to prevent the enclosure from easily being rotated without actually fixing it in place More on the subject of positioning of controls is discussed in Chapter 5 Assembly An Air DISS fitting for connection through an in line Inlet Filter Cartridge to hospital air supply which provides the oscillator with cooling gas The nominal pressure of the hospital air should be 50 psig at the required 25 LPM rate The Source Gas Low yellow LED will ligh
10. C Adverse Effects C Adverse Effects High frequency ventilation as with conventional positive pressure ventilation has inherent risks These possible adverse effects include under over ventilation under over humidification chronic obstructive lung disease necrotizing tracheal bronchitis NTB atelectasis hypotension pneumothorax pneumopericardium pneumomediastinum pneumoperitoneum and pulmonary interstitial emphysema PIE The table below summarizes the adverse events reported during the MOAT II Clinical Trial and demonstrates that within this study there was no increase in the occurrence of the listed adverse effects with HFOV when compared to conventional mechanical ventilation Summary of reported adverse events during MOAT II Clinical Trial HFOV CMV Number of patients 15 73 Intractable hypotension failure 0 3 Oxygenation failure 5 8 Respiratory acidosis failure 5 8 Air leak developed or worsened 9 12 Mucous plugged ET Tube 5 4 Precaution Follow closely the recommendations contained in this Chapter regarding the use of chest radiographs to monitor patient condition During HFOV as with all ventilators the relationship between improvement in lung compliance inadvertent increases in lung volume increased pleural pressure and decreased venous return is a matter of concern since it may result in decreased cardiac output 767164 0601G 100 Chapter 8 Cli
11. 2001 Changed Frequency and Inspiratory Time 92 Added the section Mean and Range of 3100B Settings 92 Changed General Aspects of Clinical Strategy 95 Added the section Oxygenation 95 Changed Ventilation and Weaning 96 Removed Mean and Range of 3100B Settings and added Summary of MOAT II Clinical Management Strategies and Summary of Weaning Strategy from MOAT II Clinical Tria 97 Revision Changes Pages Date 767164 0601G vi Revisions 3100B High Frequency Oscillatory Ventilator G cont Removed Summary of HFOV Therapeutic Intervention June 2001 and Rationale 98 Changed C Adverse Effects 99 767164 0601G Company Addresses 3100B High Frequency Oscillatory Ventilator Vii Manufacturer SensorMedics Corporation 22705 Savi Ranch Parkway Yorba Linda California 92887 4645 Telephone 800 231 2466 714 283 2228 FAX 714 283 8493 Authorized European Representative SensorMedics BV Rembrandtlaan 1b 3723 BG Bilthoven The Netherlands Telephone 31 30 2289711 FAX 31 30 2286244 On the Internet at www sensormedics com 767164 0601G Precautions ix 3100B High Frequency Oscillatory Ventilator Caution Federal law restricts this device to sale by or on the order of a physician Caution Not suitable for use in the presence of flammable anesthetics Service of this instrumentation is restricted to factory trained personnel
12. 47 respiratory distress syndrome 98 S safety alarms 30 Safety Alarms 16 37 Safety and System Features Description 25 Safety Features 37 Safety Standards 17 767164 0601G Index 105 Scheduled Periodic Calibration 77 Scheduled Periodic Maintenance 81 Set Max Pa Alarm Thumbwheel 13 Set Max Pa Control 44 Set Max Pa Exceeded Indicator 14 Set Max Pa Thumbwheel 15 Set Min Pa 45 Set Min Pa Alarm Thumbwheel 14 Set Min Pa Exceeded Indicator 14 Set Min Pa Thumbwheel 15 Silence Control 45 Sec 14 Silence Indicator 45 SEC 14 Source Gas Low Alarm 85 Source Gas Low Indicator 14 47 Span Adjustment Pressure Transducer 80 Specifications 13 square wave driver 32 Standards Safety 17 Start Stop Control 13 44 Start up Procedures 64 65 Strap Hold Down 55 Strategies Treatment 90 Suctioning Guidelines 100 Supplies 88 System and Safety Features Description 25 767164 0601G System Column 52 T Technical Support Department 81 Temperature 19 Therapeutic Intervention and Rationale HFOV Summary 97 Therapeutic Objectives 94 thermal cutout circuit 34 thermal cutout safety system 39 Treatment Strategies 90 Troubleshooting 72 81 Troubleshooting Chart 83 tubes color coded 59 tubing connections 61 Tubing Humidifier 54 U Unpacking the Instrument 56 V Ventilation Management 94 Ventilator Performance Check 67 Ventilato
13. Features J Safety Features be necessary to press the Start Stop Switch It is normal for the Battery Low LED to light when the reset button is pressed The Caution Alarms activate a yellow LED only no audible alarm occurs The Caution Alarms are the following Battery Low Source Gas Low Oscillator Overheated and 45 Sec Silence The Battery Low or Source Gas Low and the Oscillator Overheated Caution Alarms are reset only by correction of the caution condition by the user The 45 Sec Silence caution indicator will be illuminated for the duration of the 45 second alarm silence duration During this 45 second period the audible alarm will be silenced regardless of the alarm condition All visual alarm indicators will operate normally The Oscillator Stopped Alarm will occur if AP is lt 5 to 7 cmH20 A red LED and audible 3K Hz indication occurs No action is taken by the machine and the alarm resets automatically upon correction of the alarm condition Note that the oscillator may in fact be operating but the resultant AP is below 5 to 7 cmH20 If the oscillator is disabled by pushing the Start Stop button the Oscillator Stopped alarm is disabled Warning An audible alarm indicates the existence of a condition potentially harmful to the patient and should not go unattended Failure to respond to alarms could result in injury including death to the patient and or damage to the ventilator Precaution When the ventilator is conn
14. Pa setting the Limit Valve will re pressurize to its normal operational state Should the high mean airway condition persist the alarm will repeat until the condition is resolved Once corrected the high Pa visual indicator will remain lit to notify the clinician that the alarm was violated Depress the Reset Power Failure button to reset the visual indicator 767164 0601G 46 Chapter 4 Location and Function of Controls Indicators and Connections B Front and Side Panel Control Package 10 Set Min Pa 11 Pa gt 60 cmH20 Operating the ventilator with low Bias Flow Rates lt 15 Ipm and Low Mean Airway Pressures lt 15 cmH20 with full power Maximum Amplitude may result in a low pressure dump upon activation of the Max Pa Alarm Determines the level in cmH20 at which the Min Pa Exceeded Warning Alarm will be indicated The Minimum Pa level is set by means of a thumb wheel switch covering the range of 0 to 59 cmH20 A mechanical stop has been inserted in the tens column of the thumb wheel switch to prevent the dial from being turned past the numeral 5 The activation of the alarm is indicated by a 3K Hertz modulated tone and a red LED which is adjacent to the thumb wheel switch The alarm will reset automatically after correction of the condition The audible indicator can be silenced for 45 seconds by pushing the 45 Sec Silence pushbutton This alarm does not initiate any machine response other than the
15. Please do not clean the driver diaphragm with cleaning solvents as it may degrade the materials causing premature wear of the driver diaphragm When connecting the Patient Circuit make certain that it is properly supported and oriented by the support arm as described in Chapter 5 Assembly and Installation Failure to do so could result in inadvertent Patient Circuit disconnection due to oscillatory forces or could result in collection of humidifier condensate in the patient airway If the temperature probe is wiped with alcohol allow the alcohol to evaporate completely before inserting it into the circuit A high residual of alcohol can weaken the acrylic adapter and cause fracturing Proper operation of the ventilator must be verified prior to each use Refer to Chapter 6 Operational Verification and Startup Procedures The alarm functions tested in this procedure verify the capability of the device to detect and indicate conditions which could have a harmful effect on the patient Touch the outer metal cabinet of the instrument before touching any other component to avoid possible instrument component damage from Electrostatic Discharge 767164 0601G Chapter 1 Introduction E Precautions 767164 0601G When the ventilator is connected to a patient it is imperative that someone be in attendance at all times in order to react to any alarms and to detect other indications of a problem The Inlet Filter Cartridges for the
16. Refer to Chapter 5 for assembly and adjustment instructions The external humidifier is connected between the Outlet To Humidifier on the rear of the Control Package and the Bias Flow Inlet on the Patient Circuit In Figure 4 3 the humidifier tubing is shown connected to the patient circuit without the humidifier inline Only the 3 8 tube supplied with the Patient Circuit should be used 56 Chapter 4 Location and Function of Controls Indicators and Connections D System Column and Patient Circuit 41 Bulkhead Luer Fittings There are four bulkhead luer fittings on the front of the oscillator compartment for connection to the three valve caps and pressure sense port on the patient circuit 42 Hold Down Strap Secures the patient circuit to the Patient Circuit Cradle This keeps the circuit in a stable position 767164 0601G Chapter 5 Assembly and Installation 57 A Introduction A Introduction B Unpacking C Assembly 767164 0601G This chapter covers the unpacking assembly and installation of the Model 3100B HFOV prior to operational verification The Control Package is shipped already attached to the Column The assembly of the Patient Circuit and its attachment to the rest of the ventilator is illustrated in Figures 5 1 and 5 2 The Model 3100B HFOV is shipped in one crate containing the instrument pre assembled control package column and pedestal and several smaller cartons containing
17. Service Possible Remedies Failure of Ventilator Bias Flow tubing from humidifier to circuit Performance Check has been cut to less than 30 or tubing not supplied with patient circuit being used 767164 0601G Use Bias Flow tubing supplied with circuit and do not shorten 88 Chapter 7 Maintenance and Troubleshooting G Troubleshooting AP out of range LOW Power not set at 6 Set Power to 6 Compression characteristics of humidifier Bypass humidifier for performance check allowing AP to drop then re attach Internal Failure Call SensorMedics Service Failure of Ventilator Oscillator not warmed up Allow Oscillator to warm up for 5 minutes Performance Check AP out of range Incorrect altitude range being used Use appropriate altitude range for your HIGH facility Internal Failure Call SensorMedics Service Unexplained Operation Condition Possible Causes Possible Remedies Oscillator shuts down Drastic change in Pa due to over Re establish Pa and make any small and Dump Valve aggressive control change using the Pa adjustments to Pa using Flow meter opens during operation Adjust Adjust Note see Clinical Guidelines chapter for minimum flow requirements ET Tube has become disconnected Reconnect ET Tube Radio Frequency Interference Locate and distance offending device Oscillator will not To restart oscillator Pa must first be gt 5 Reduce power and increase Pa to target restart
18. a ha atte a AA ae Sie ede ae 25 Cs Ext rnal TICLE sot Svante ie a eacea tno ede edeagnie ual a a E a A anette 25 D Pneumatic Logic and Control s c sc teesueisted Saha dled a io Ae nd ise 27 les HOW Sa sanexand EE css asvax aad cas senior AE EE A aust nasa A 27 Mean Pressure Adj sti 35 0 hes acest ea Gis lates esese bee win ide 27 Patient Circuit Calibration sisi ass aehia ay salen slelada Gaeta Seactn odicauasen crea tarpein Cad ais aa eeea eon 27 E Patient GlbChMiccava estate te Gata ar tale ane cent adele teste A a ahaa Ser ee tate A 28 Fy OSCINACOM Subsystem ise E E me tac CER 32 G Airway Pressure Monitor cies reed stdin raul ili rete echeeora alpha waadguteacieue ate Nixa aleded escola ood 34 H Electronic Control and Alarm SubSyStem c ccccccccessscsesesesesesececsseseececerensnscecensnsnsnseeeeeaeesetes 35 Electrical Power SUpply maere apesedaciasa cb boroieamcceseasaes 36 J Satety Features s a e a a a a a a aad a a Aah 37 4 Location and Function of Controls Indicators and Connections 20051111 41 Pe MIO CTR s easa a a oetiacaencetaaanan elon 41 B Front and Side Panel Control Package s sssesseesesessressressrsssressrnrresstesrrsstesrrsnresrenrrrstennrns 42 C Rear Patel Control Package ssesssesseesssessresssessrrssresrrsssresrrsriesnterrsnrennrnnnrenrnnrrentnrrr nsten 50 D System Column and Patient Circuit c cccscseccsesesesescseseseeeseescecesececececerenensneces
19. activation of the visual and audible indicators The red LED indicates activation of this preset Safety Alarm It is also indicated by a 3K Hertz modulated tone The alarm is reset only by pushing the Reset pushbutton after the alarm condition has been corrected The 45 Sec Silence pushbutton can be pushed to silence the audible indicator however the red LED indicator will still function and the Dump Valve will remain open When this alarm occurs the Model 3100B will automatically shut down the oscillator but bias flow will continue The Dump Valve will be open and will hold the airway pressure to near atmospheric This protects the patient from the elevated pressure and allows the patient to breathe spontaneously See the Patient Circuit section in Chapter 3 for further explanation of this feature Because of the Dump Valve activation the Pa lt 5 cmH20 Safety Alarm will also be activated After the correction of the condition that triggered the Safety Alarm the oscillator startup procedure must be followed for reset This is discussed in Chapter 6 767164 0601G Chapter 4 Location and Function of Controls Indicators 47 and Connections B Front and Side Panel Control Package 12 Pa lt 5 cmH20 The red LED indicates activation of this Safety Alarm It is also indicated by a 3K Hertz modulated tone This alarm triggers at a Pa lt 5 cmH20 The alarm will reset after the alarm condition has been corrected The 45 Sec
20. after temporary cmH20 but in order to achieve Pa gt 5 level using flow meter and Pa Adjust disconnection such as cmH20 oscillator must be on Control then increase power while for routine suctioning keeping Pa on target by adjusting flow meter or Pa control valve down Unexplained Operation cont Condition Possible Causes Possible Remedies Pa unstable jumps Water collecting at Pa Control Valve Adjust circuit height for better draining by 2 3 cmH20 Patient spontaneously breathing Bias Flow rate possibly insufficient re 767164 0601G Chapter 7 Maintenance and Troubleshooting 89 H Supplies and Replacement Parts adjust Pa using higher flow Also consider Clinical status of patient Worn or defective cap diaphragm Replace cap diaphragms Internal Failure Call SensorMedics Service Humidifier not Excessive heat from driver Ensure cooling gas is connected Try operating properly different source connection for cooling gas Room temperature gt 84 F Decrease room temperature Pa jumping by gt 5 Worn or improperly seated cap diaphragm Replace cap diaphragms cmH20 when trying to adjust with Pa Adjust Internal Failure Call SensorMedics Service Valve Oscillator making a Cap diaphragm defective Replace cap diaphragm squeaking sound H Supplies and Parts and Supplies can be ordered by calling the SensorMedics Customer Replacement Parts Service Department The Customer Service Representat
21. approved lubricant to the entire surface of the driver diaphragm Figure 7 1 4 Record the Elapsed Time Meter reading on the rear of the 3100B 767164 0601G Chapter 7 Maintenance and Troubleshooting TT C Operator Maintenance Procedures Apply a thin film of lubricant to the entire surface of the driver diaphragm only Figure 7 1 Driver Diaphragm Lubrication Warning Only SensorMedics approved lubricants should be used Use of any other lubricants could result in damage to the Driver Diaphragm or Bellows Water Trap Membrane causing ventilator failure or patient injury Precaution The Driver Diaphragm of the SensorMedics 3100B must be lubricated every 500 hours of use as described in this chapter Failure to lubricate the Driver Diaphragm may result in premature wear of the diaphragm which could result in failure of the driver mechanism 767164 0601G 78 Chapter 7 Maintenance and Troubleshooting D Patient Circuit Calibration D Patient Circuit Calibration E Other Scheduled Periodic Calibration Before use on a patient each patient circuit must be calibrated to the Model 3100B by following this procedure 1 Insert the stopper in the Patient Circuit Y and turn on the Bias Flow gas 2 Set Max Pa Alarm to 59 cmH20 3 Rotate the Mean Pressure ADJUST control to Max 4 Adjust the Bias Flow to 20 LPM 5 Depress and hold RESET Oscillator OFF 6 Observe the Mean Pressure
22. around the electrical coil A thermal cutout circuit has been incorporated into the oscillator to shut it down in case of overheating caused by a cooling system failure Such a failure if allowed to occur without oscillator shutdown could result in the destruction of the oscillator coil s support spiders The thermal cutout system utilizes a thermistor on the oscillator coil form to detect temperature rise Thermal shutdown will occur if coil temperature exceeds 175 C Prior to an oscillator thermal shutdown the operator is given an indication that the coil is overheating A yellow caution LED on the front panel of the Control Package lights when the coil temperature reaches approximately 150 C G Airway Pressure The Airway Pressure Monitor is a very key subsystem within the Model 3100B Monitor HFOV system The majority of the safety and warning alarms rely upon the mean airway pressure determinations of the Airway Pressure Monitor The Airway Pressure Monitor senses the pressure within the Patient Circuit through 1 8 tubing running from the Y coupler of the Patient Circuit to the airway pressure monitor transducer A 500 ml min trickle flow of dry gas from the blender flows constantly from the 3100B to the patient Y to keep water vapor from even partially obstructing this pressure sensing pathway Warning Failure to comply with the recommended maintenance procedures for the Airway Pressure Monitor as described in Chapte
23. battery Cleaning the Column Lint Filter Changing the Patient Circuit Lubricating the driver diaphragm 74 Chapter 7 Maintenance and Troubleshooting C Operator Maintenance Procedures Emptying the Water Trap Changing the Compressed gas Inlet Filter Cartridge Elements The Water Trap must be emptied as described below Precaution The Water Trap must be drained at intervals If the ventilator is operating leave a small amount of water at the bottom of the Water Trap container to act as a flow and pressure seal between the ventilator and the output of the drain Opening the stopcock on the bottom of the water trap will open the drain The contents of the water trap should be emptied into a disposable cup or a container which can be subsequently disinfected When the Model 3100B is not operational the Water Trap container can be completely emptied Precaution Ensure that the stopcock is closed prior to performing a Patient Circuit Calibration If the Water Trap Stopcock is left open Patient Circuit Calibration 39 43 cm H20 may not be achievable and the deliverable Pa will be reduced The 0 1 micron Inlet Filter Cartridges are placed at the input of both the Inlet From Blender DISS oxygen fitting and the Air Cooling Inlet DISS air fitting Their purpose is to capture any dirt particles or moisture before entry into the Model 3100B HFOV Precaution The Inlet Filter Cartridges for the blended gas an
24. before resetting the breaker This switch is a standard rocker switch which breaks both sides of the power line as does the built in circuit breaker Attaches to 1 1 4 I D inspiratory limb of patient circuit and is held in place by four quarter turn fasteners Green Luer bulkhead fitting for connection to green 1 16 1 D tubing that runs to the control input of the Pa Control Valve on the Patient Circuit Consult assembly procedure in Chapter 5 for details on attachment of this control line to its valve This line should be replaced periodically during scheduled preventive maintenance of the HFOV Red Luer bulkhead fitting for connection to red 1 16 1 D tubing that runs to control input of Dump Valve on Patient Circuit Consult assembly procedure in Chapter 5 for details on attachment of this control line to its valve This line should be replaced periodically during scheduled preventive maintenance of the HFOV White Luer bulkhead fitting for connection to clear 1 8 1 D tubing that runs to the Airway Pressure Port of the Patient Circuit for the purpose of transmitting the Pa signal to the pressure transducer within the Control Package Consult assembly procedure in Chapter 5 for details on attachment Blue Luer bulkhead fitting for connection to blue 1 16 1 D tubing that runs to control input of Pa Limit Valve on Patient Circuit Consult assembly procedure in 767164 0601G Chapter 4 Location and Function of Controls Indicator
25. blended gas and the air inputs to the ventilator must be changed at least every 500 hours of operation as described in Chapter 7 Maintenance and Troubleshooting Failure to replace a Filter Cartridge or substitution of an unauthorized cartridge could result in injury to the patient and or damage to the equipment Use only SensorMedics Inlet Filter Cartridges The filter cartridge body must be screwed back on securely Cross threaded or loose installation will result in leaks and possible dislodging of the cartridge body If the cartridge body is dislodged it will cause the ventilator to cease functioning The cover enclosing the Control Package Column or any other portion of the ventilator must not be removed by the user To avoid electrical shock hazard please refer all service requiring cover removal to a qualified biomedical equipment service technician Recheck and readjust alarm levels after any parameter change has been made Troubleshooting with the 3100B should be done OFF PATIENT to avoid any potentially dangerous situations such as abrupt changes in the Pa Do not use extraneous ventilator circuit attachments such as a suction port without a secondary external alarm capable of detecting ventilator disconnection Due to their inline pressure characteristics such attachments could possibly keep the Pa alarm from detecting an accidental ventilator circuit disconnection Fractional concentration of inspired oxygen should b
26. due to the possibility of explosion Precaution Do not place on the Control Package of the ventilator any fluid containing accessories accessories that weigh more than 10 pounds or accessories that extend more than six inches above the ventilator electronics package or beyond its sides This could cause the ventilator to tip over resulting in patient or user injuries and or damage to the equipment 767164 0601G Chapter 6 Operational Verification and Start up Procedures 71 C Performance Verification C Performance Verification 767164 0601G VENTILATOR PERFORMANCE CHECKS OFF PATIENT These graphs illustrate the typical performance to be expected from the Model 3100B Minimum AP vs POWER Range of Static MEAN Pressure vs BIAS FLOW PRESSURE cmH 0 0 5 10 15 20 25 30 35 40 45 50 55 60 S Bias Flow LPM OFF PATIENT Insert Stopper in Patient Circuit Y and turn on both gas sources Set BIAS FLOW for 30 LPM Set max Paw Alarm to 35 cmH0 Pressurize system by pressing and holding RESET and ADJUST for a Mean Pressure of 29 31 cmH20 Set FREQUENCY to 6 I Time to 33 and press START STOP to start the oscillator Set POWER to 6 0 7 Observe the following parameters using the appropriate altitude range and verify they fall within the ranges specified _ a GW DO oi for ALTITUDE FT MEAN cmH20 AP cmH20 0 2000 22 30 1
27. filter 3 Remove old cartridge 4 Install new cartridge A box of 10 spare cartridges part number 767163 is shipped with the Model 3100B as an accessory 5 Screw filter back together 6 Record the Elapsed Time Meter reading on the rear of the 3100B Precaution The filter cartridge body must be screwed back on securely Cross threaded or loose installation will result in leaks and possible dislodging of the cartridge body If the cartridge body is dislodged it will cause the ventilator to cease functioning When the yellow Battery Low LED Caution Alarm on the front panel of the Control Package is lighted the problem is the Power Failure Alarm battery It should be changed as soon as possible Access to this battery is gained through the access door on the rear panel A good quality 9 volt alkaline battery should be used After each patient inspect and clean the lint filter in the Column of the Model 3100B HFOV Remove the filter element from its holder on the column rear Shake dirt out wash it in warm sudsy water dry it out and replace it in the holder Failure to perform this procedure will eventually cause a significant restriction of air cooling flow to the oscillator square wave driver This could lead to overheating of the driver and eventual malfunction of the oscillator 76 Chapter 7 Maintenance and Troubleshooting C Operator Maintenance Procedures Changing the Patient Circuit Lubrication of the
28. frequency in Hertz The control knob is a 10 turn clockwise increasing electrical potentiometer covering the range of 3 to 15 Hertz The set frequency is displayed on the digital meter 7 Start Stop Manually toggles the oscillator between enabled and disabled If the green LED on this pushbutton is lit then the oscillator is enabled and pressing the pushbutton will disable the oscillator If the green LED is not lit then the oscillator is disabled and depressing the pushbutton will enable it to start oscillating assuming the start up procedure has been properly executed This start up procedure will be discussed in Chapter 6 If not done properly the system will not allow the oscillator to start This prevents the patient from experiencing too high or low a Pa 8 Mean Airway Pressure Displays the Pa on a digital meter in cmH20 9 Set Max Pa Determines the level in cmH20 at which the Max Pa Exceeded Warning Alarm will be indicated The Maximum Pa level is set by means of a thumb wheel switch covering the range of 0 to 59 cmH20 A mechanical stop has been inserted in the tens column of the thumb wheel switch to prevent the dial from being turned past the numeral 5 In the event that the proximal pressure meets or exceeds the set Max Pa alarm setting an audible and visual alarm will occur and the ventilator will depressurize the Limit Valve seat pressure Once the mean airway pressure falls to a level of 12 3 cm H20 below the Set Max
29. in the opposite direction expiration The distance the piston is driven in each direction is determined by the magnitude of the alternating polarity voltage applied to the electrical coil the Patient Circuit pressure encountered by the piston plate the piston coil counter force current and the frequency of the square wave The voltage of the square wave driver output is controlled by the Power Control of the Electronic Control and Alarm Subsystem There are two mechanical stops which determine the maximum piston displacement in the full inspiration and full expiration directions The maximum stroke of the piston defined by these stops is approximately 365 milliliters The inspiratory time is determined by another control on the Electronic Control and Alarms Subsystem This control sets the relative duration of the successive positive and negative polarity voltages from the square wave driver which is driving the electrical coil and piston This control also establishes the counter force current to overcome the tendency of the mean airway pressure to displace the piston off center As mentioned previously the displacement of the electrical coil and piston is determined by the magnitude of the voltage applied to the electrical coil The total transit time required for this displacement is only a matter of milliseconds Therefore at the lower oscillation frequencies the piston will remain stationery at its full travel position for the m
30. only 767164 0601G Table of Contents 3100B High Frequency Oscillatory Ventilator Ae introduction cagocccen tect encase ear te oce tess oes a uate cidaaetas 1 AOMA letio ERS A E EAE is a a he Re a a ad Ae Ae de oricaseaeeurcaane 1 BC Ota Ca MONS sudna a ely vcescueiiaulesteandudeam tne A ic auaneeaidae beadaeaentes 1 C Adverse Effects of the Device on Health ccccscssecscsscscscessssecsesscecsesesscsesacessesassesacassesavscsaees 1 PV AU UMN Sc nra cc n acea tina A esate E E Ren 1 E Precattions amene ees ctv coat ee hk eases aaa ee ued aa aaa a oi ae 3 F Explan tion f SyYmMDOl Se ea E a Ea a EE E 6 G Exterior Labelen at i E A A aa Ea CO ER 7 2 SPO CiG AG ONG enaa aa RE 13 Ac CONTOS neou a a E wae cata os ads E A ee 13 PAI E O EIA AE E EAA EA E AAA E E A PRE 14 C Pressure MOSUL STIG IL sucteca secs bevacasahaoscodnertgzaqinantaataaacneatidaaaraciocietunaiiaincaaaianaocsnaeueiees eave 15 Fe NS scence vag bacilli ia sa aes encloses eee 16 Px EVE CEA AE AEEA A E ane eos vote sues T AE 17 EP EUMAUC ORME CHON Si cacrise un aaea ea a leans a tm arauandunmeena 18 G gt Physical ch ras lyse eae cea vapid ca a ne AG Noack E aera OE 19 APA ETHIE AICE EATE AEE E A EAA cc ret aaa tices acta Re ae oe ae eo Seale fae 20 3 Description of System and Safety Features 0 0 ccs escsseeesssessssteessneeesneeeseen 25 yO 10 96 6 6 RNa ene PR aa Oe ter StS SEO RO ORR Nn Mm Pane oR 25 BAX CCIM AIC BICC Ok asteke chee ik tes
31. stopped and dump valve opened when limit exceeded Preset 2 of pressure monitor reading or 2 cmH20 whichever is greater Indicators activated oscillator stopped and dump valve opened when limit exceeded Preset to 5 cmH20 2 of pressure monitor reading or 2 cmH20 whichever is greater Audible and visual indicators operator intervention Indicators activated when set limit exceeded 0 59 cmH20 1 cmH20 2 of pressure monitor reading or 2 cmH20 whichever is greater Indicators activated when set limit exceeded 0 59 cmH20 1 cmH20 2 of pressure monitor reading or 2 cmH20 whichever is greater Visual alarm operator intervention Indicator activated when oscillator coil reaches a temperature of 150 C 15 767164 0601G Chapter 2 Specifications 17 E Electrical Battery Low Source Gas Low Accuracy 45 second Silence Accuracy Power Failure Oscillator Stopped E Electrical Power Requirements Leakage Current Overload Protection Power Line Connection Safety Standards 767164 0601G Indicator activated when battery which operates power failure alarm is low and must be replaced Indicator activated when blended gas or oscillator air cooling source pressure drops below 30 psig limit 5 in source gas mode Indicator Activated for 45 seconds when pushbutton pushed 5 seconds Audible and visual indicators activated when power switch turned off power plug unp
32. 08 130 2000 4000 22 30 98 120 4000 6000 22 30 90 110 6000 8000 22 30 81 100 767165 101F Figure 6 1 Ventilator Performance Checks 72 Chapter 6 Operational Verification and Start up Procedures C Performance Verification The two graphs shown in Figure 6 1 are intended to guide the operator in setting Power Mean Pressure Adjust and Bias Flow controls and to help ascertain that the 3100B is performing in a 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 control In establishing a specific Mean pressure find the required Bias Flow that will allow the Mean pressure to be adjusted above and below that desired Set the Mean Pressure Adjust control to approximately twelve o clock and set the Bias Flow as indicated on the graph to a level which puts the desired Pa level in its mid range When the system is operating whether ON or OFF Patient the settings of the controls relative to the pressures being developed and displayed will quickly give an indication that the system performance is nominal 767164 0601G Chapter 7 Maintenance and Troubleshooting 73 A Introduction A Introduction B Exterior Cleaning C Operator Maintenance Procedures 767164 0601G This c
33. 3100B High Frequency Oscillatory Ventilator Operator s Manual 767164 0601G Copyright 2001 SensorMedics Corporation Printed in U S A if SA SensorMepics aa a subsidiary of VIASYS Healthcare Revisions 3100B High Frequency Oscillatory Ventilator Revision Changes Pages Date A Original Release All January 1993 B Revisions to meet FDA requirements and All January 1996 3100B device specification changes C Performance Graphs updated 2 9 2 12 May 1998 Performance Check procedure updated 1 9 6 5 6 9 Piston Centering instructions removed 1 9 2 3 4 14 4 15 6 5 6 7 7 13 7 15 8 2 8 3 Warning re use in environments gt 28 C added 6 7 D Addresses and phone numbers updated Ad 1 October 1998 Indications for Use and Adverse Effects updated 1 2 Precautions updated 1 4 CE Mark information added 2 7 Tech Support phone numbers removed 7 9 7 11 Pa Control Valve changed to Pa Adjust Control Pa Adjust Valve changed to Pa Control Valve 7 16 Treatment Strategies updated 8 2 Bias Flow Frequency Inspiratory Time and Oscillatory Pressure Amplitude strategies updated 8 3 8 4 8 5 8 6 General Aspects of Clinical Strategy updated 8 6 8 7 8 8 Disease Specific Variations to General Clinical Strategies updated 8 10 Non Invasive Gas Monitoring recommendations updated 8 11 Suctioning Guidelines updated 8 13 767164 0601G iv Revisions 3100B High Frequency Oscillatory Ventilator Revision Ch
34. 5 92 Mean Airway Pressure Indicator 44 Mean and Range of 3100A Settings 96 Mean Pressure Adjust 13 27 42 Mean Pressure Limit 13 Mean Pressure Monitor 15 mechanical relief valves 39 Monitoring Frequency Recommended 99 Multi Center Controlled Trials 90 Multi Center Studies 100 N Name Rating Label 11 necrotizing tracheal bronchitis NTB 98 Non Homogeneous Lung Disease 98 O Operational and Environmental Conditions 19 Operational Verification 64 Operator Maintenance Procedures 72 Oscillator Compartment Bellows 53 Oscillator Enabled Indicator 14 Oscillator Overheated Alarm 85 Oscillator Overheated Indicator 14 48 Oscillator Stopped Alarm 38 Oscillator Stopped Indicator 14 48 Oscillator Subassembly Replacement 81 Oscillator Subsystem 32 Oscillatory Pressure Amplitude 92 Outlet Fitting to Humidifier 50 overhaul complete scheduled 81 Overload Protection 17 Oxygenation Management 95 P Pa lt 5 cmH20 Alarm 84 Pa lt 5 cmH20 Indicator 46 Pa lt Set Min Pa Thumbwheel Alarm 84 Pa lt 20 of 14 Pa gt 60 cmH20 Alarm 83 Pa gt 60 cmH20 Indicator 45 Pa gt Set Max Pa Thumbwheel Alarm 83 Pa gt 50 cmH20 Indicator 14 Pa Control Valve 29 Pa Control Valve Control 53 Pa Limit Valve Control 53 Pa Sense Fitting 53 Parts 88 Patient Circuit 28 52 patient circuit calibration 66 Patient Circuit Calibration 77 Patient Circuit Calibration Control
35. Driver Diaphragm Driver Lubrication Procedure Change the Patient Circuit with the same frequency as your institution s policy requires for conventionally ventilated patients Dispose of the three snap off Cap Diaphragms and the Bellows Water Trap Assembly these items absolutely cannot be reused The Patient Circuit Body is intended for single patient use Due to the high power settings which may be encountered the cap diaphragms of the patient circuit should be changed at least every three days Failure to do so may cause mean airway pressure instability Precaution The driver diaphragm of the 3100B has been coated with a special lubricant during assembly Please do not clean the driver diaphragm with cleaning solvents as it may degrade the materials causing premature wear of the driver diaphragm The oscillating mechanism of the 3100B ventilator consists of a linear motor which drives a piston assembly Due to the loads which can be placed on the piston assembly the driver diaphragm must be lubricated every 500 hours of operation This maintenance procedure will reduce wear on the driver diaphragm and prolong its operational life 1 Turn off the ventilator and remove the patient circuit 2 Utilizing a lint free cloth or towel wipe the surface of the driver diaphragm to remove any contaminants and any residual lubricant 3 Use a cotton tipped applicator or the finger of a gloved hand to apply a thin film of SensorMedics
36. Piston Centering from the fifth paragraph under Mean Pressure Adjustment 43 Changed the statement describing the affects of changing the Inspiratory Control 45 Revision Changes Pages Date 767164 0601G Revisions 3100B High Frequency Oscillatory Ventilator F cont Changed the warning alarm description 45 January 2001 Low Bias Flow Rates note added 46 Modified Figure 4 2 50 Changed the LPM value in item 27 of Chapter 4 52 Modified item 37 of Chapter 4 55 Modified item 42 of Chapter 4 56 Changed the patient circuit warning 61 Modified Figure 5 3 62 Changed the patient circuit warning 66 Changed step 6a of the Start up Procedures 67 Changed steps 7b 7c 9 and 10 of the Start up Procedures 68 Changed steps 13 14 16 and 17 of the Start up Procedures 69 Changed steps 18 and 20 of the Start up Procedures 70 Changed Emptying the Water Trap section 74 Changed Changing the Patient Circuit 76 Changed Patient Circuit Calibration 78 Changed F Scheduled Periodic Maintenance to indicated every 2 000 hours of operation 82 Updated the Visual Audible Alarm Occurring table 85 Changed the description of part number 771384 102 89 Changed the part number 463202 to 770566 and changed its description 90 Added part number 765298 90 Changed item 3 under Weaning 96 Removed the first paragraph of Section E 101 G Changed the section A Treatment Strategies 91 June
37. Silence pushbutton can be pushed to silence the audible indicator however the red LED indicator will still function When this alarm occurs the Model 3100B will automatically shut down the oscillator but bias flow will continue The Dump Valve will be activated and will hold the airway pressure to near atmospheric This allows the patient to breathe spontaneously See the Patient Circuit section in Chapter 3 for further explanation of this feature After the correction of the condition that triggered the Safety Alarm the oscillator startup procedure must be followed for reset This is discussed in Chapter 6 13 Power Failure The red LED indicates loss of electrical power or insufficient or inadequate electrical power supply It is accompanied by a 3K Hertz modulated audible tone The following conditions will cause this alarm to trigger a Tripping of Model 3100B System circuit breaker b Turning off Power Switch 29 c Power plug being pulled from wall socket d Loss of power to the hospital branch line to which the Model 3100B System is connected e A failure in the power supply internal to the Model 3100B System Once tripped the alarm indicators red LED and 3K Hz modulated tone can be reset only by pushing the Reset button 14 even if the power failure condition has been corrected Then the oscillator Start Stop Switch must also be pressed to restart the oscillator The Power Failure Alarm circuitry is powered by a
38. The AP is numerically displayed on the digital meter adjacent to the Power control At extremely high amplitudes power settings greater than 6 the oscillatory pressure may significantly contribute to the mean pressure Changes to the amplitude will result in changes to the mean airway pressure and should be compensated for to maintain an unchanged mean airway pressure Refer to Chapter 6 Operational Verification and Startup Procedures for a description of the adjustment technique for setting the Power control Determines the percent of the oscillator cycle time that the piston is traveling toward or is at its final inspiratory position The control is a 10 turn electrical potentiometer and covers the range of 30 to 50 The setting is numerically displayed on the digital meter adjacent to the control Changing the Inspiratory Time control could have an effect on the position of the oscillator piston At higher frequencies changing the Inspiratory Time from at or near 50 toward 30 may decrease the displacement This is due to the fact that the shorter inspiratory phase of the oscillation may not give the piston enough time to travel to its full deflection 767164 0601G Chapter 4 Location and Function of Controls Indicators 45 and Connections B Front and Side Panel Control Package Since this control affects the symmetry of the oscillatory waveform it may affect the Pa or the AP 6 Frequency Hz Sets the oscillator
39. Verification and Startup Procedures The alarm functions tested in this procedure verify the capability of the device to detect and indicate conditions which could have a harmful effect on the patient 767164 0601G 42 Chapter 4 Location and Function of Controls Indicators and Connections B Front and Side Panel Control Package B Front and Side Panel Control Package on side Bias Hew Bopondom MODEL 3100B OQCILLATORY VENTILATOR CERA Figure 4 1 Front Panel Controls and Indicators The numbers shown on Figure 4 1 correspond to the numbers on the following descriptions 1 Bias Flow Controls and indicates the rate of continuous flow of humidified blended gas through the Patient Circuit The control knob is a 15 turn pneumatic valve which increases flow as it is turned counterclockwise The rate of flow is indicated by a ball float within a rotameter glass tube graduated from 0 to 60 LPM in 5 LPM increments The flow is read by aligning the center of the ball float with the rotameter scale mark corresponding to the 767164 0601G Chapter 4 Location and Function of Controls Indicators 43 and Connections B Front and Side Panel Control Package 2 Mean Pressure Adjust 767164 0601G adjusted flow The maximum a
40. agm Remove source of interference Change setting Eliminate leak or replace circuit Replace cap diaphragm Remove source of interference Close Water Trap Stopcock Adjust setting for desired AP Call SensorMedics Service Possible Remedies 86 Chapter 7 Maintenance and Troubleshooting G Troubleshooting Source Gas Low Alarm Input pressure less than 30 psi either from Check input gas lines blender or cooling air Input filter needs replacement Replace filters Flow restriction in gas supply lines Replace supply lines Internal leak Call SensorMedics Service Battery Low Alarm Battery voltage less than optimal Replace battery Battery disconnected Properly reconnect battery Oscillator Overheated No cooling gas flow Assure cooling gas supply hose is Alarm attached Oscillator overheated due to poor cooling gas flow Check cooling gas flow for blocked filter element or restricted supply hose replace if necessary Oscillator overheated due to mechanical failure of oscillator subsystem Call SensorMedics Service Failure During Checkout Condition Possible Causes Possible Remedies Reset Power Failure AC power removed from system or main Check line cord If okay check other power interruption equipment on same outlet If other equipment okay possible internal fault Contact SensorMedics Service To start oscillator after correcting problem apply power to system press and hold
41. ajority of that particular respiration phase inspiratory or expiratory As the oscillation frequency increases the transit time of the electrical coil and piston to its set full displacement will become a larger percentage of the total respiratory phase duration Although exactly determined by conditions within the Patient Circuit as frequency is increased the electrical coil and piston are unable to complete full displacement before the square wave driver switches polarity requiring the travel direction to reverse Thus the displacement amplitude of the oscillator piston will decrease as the oscillation frequency is increased Refer to Chapter 2 Specifications for details on the range resolution and accuracy of the various control functions affecting the Oscillator Subsystem 34 Chapter 3 Description of System and Safety Features G Airway Pressure Monitor Refer to Chapter 4 Location and Function of Controls Indicators and Connections for a full description of the use of these controls Because the major portion of the Oscillator Subsystem is a linear motor some type of cooling mechanism must be provided for the electrical coil The cooling source used in the Model 3100B is air flow obtained from a standard 50 psig gas wall outlet A regulator within the Oscillator Subsystem meters the airflow to a Venturi type air cooler at 25 LPM which then entrains room air at approximately 75 LPM thus providing 100 LPM of cooling air
42. al Considerations Electrostatic Discharge There are two other scheduled maintenance intervals suggested by SensorMedics based on accelerated life testing data and clinical usage history These are x Every 2 000 operating hours have the Oscillator Subassembly Driver replaced with a new or rebuilt unit which has new diaphragms and support spiders the parts subject to flexure fatigue This replacement must be done by a factory trained technician Every 8 000 operating hours have the 3100B HFOV returned to a factory authorized service location for a complete overhaul This overhaul will include the scheduled Oscillator Subassembly replacement plus the replacement of all other parts subject to usage wear and aging e g solenoid valves regulators plastic tubing and cooling fans N This section is intended to assist the operator in identifying and correcting any apparent malfunctions of the 3100B System For assistance the SensorMedics Technical Support Department can be reached 24 hours a day 7 days a week Excessive amounts of dust and lint in the area around the 3100B can cause malfunctions due to blockage of the cooling fan input at the base of the instrument We recommend keeping the instrument environment as clean and well ventilated as possible along with the normal maintenance of the cooling fan filter as described earlier in this chapter The 3100B is designed and tested to withstand normal to high amounts
43. and occurrences of Electrostatic Discharge ESD Under certain circumstances however it is still possible for ESD to cause component damage to the 3100B ESD takes place when a person has built up enough static electricity on their body and clothing that a shock occurs when they touch something conductive like metal or another person This can damage instrument components if the charge is of sufficient strength To avoid this especially during conditions of extremely low humidity when the levels of ESD are generally high touch the outer metal cabinet of the instrument before touching any other component 767164 0601G Chapter 7 Maintenance and Troubleshooting 83 G Troubleshooting Electromagnetic The 3100B is also designed and tested to withstand normal amounts and Interference occurrences of Electromagnetic Interference EMI Under certain circumstances however it is possible for EMI to effect the components of the system EMI consists of electromagnetic waves from one electronic device interfering with the function of another electronic device These waves can be radiated through the air or conducted through electrical wiring Likely causes of troublesome EMI in the hospital setting include but are not limited to MRI systems lasers diathermy equipment cauterizers transmitting computers and hand held radio transmitters Operation of radio transmitters e g walkie talkies cellular phones etc within 20 feet of
44. anges Pages Date E Changed page numbering system All September 1999 Alarm levels readjust modified 5 Patient Circuit Calibration Procedure Label modified 7 Ventilator Performance Checks Label modified 8 Mean Pressure Limit specifications modified 13 Air Cooling Inlet Flow specifications modified 18 52 3100B HFOV Block Diagram removed 25 Mean Pressure Limit instructions removed 27 43 68 84 86 87 Oscillator Subsystem airflow specifications modified 35 Warning Alarms instructions modified 37 45 Set Max Pa Alarm instructions modified 44 Patient Circuit Calibration instructions modified 66 78 Ventilator Performance Check instructions modified 67 68 Driver Diaphragm Lubrication procedure added 19 F Corrected the company phone number vii January 2001 Indications of Use section removed the last sentence 1 Changed the patient circuit warning 2 Replaced the Patient Circuit Calibration Procedure label 7 Updated the Driver Replacement Record Label 10 Changed the driver replacement hours to 2000 10 Changed the Mean Pressure Limit to Automatic 13 Updated Figures 2 1 through Figure 2 4 20 23 Added Figure 2 5 24 Modified figure 3 2 changed the Y axis from 50 to 60 cm 31 Changed the oscillator system operational life to read more than 2 000 hours 32 Changed the LPM values in Section F 34 Changed the warning alarm description 37 Low bias flow rate note added 37 Changed the safety alarms description 37 38 Modified Figure 4 1 42 Removed
45. as pressure press reset until the Pa comes up and create a mean pressure of 40 45 cmH20 as read on the transducer meter by using the Mean Pressure and Bias Flow controls as explained in the Start Up Procedures section of Chapter 6 Remove the 1 stopper and adjust the ZERO control on the rear panel until the Mean Pressure Monitor digital readout matches the pressure transducer meter reading within 0 2 cmH20 This reading is typically between 0 2 and 0 3 cmH20 Replace the 1 stopper press reset until the Pa comes up and re establish the 40 45 cmH20 mean pressure reading on the transducer meter as explained in Step 3 above Adjust the rear panel SPAN control until the Mean Pressure Monitor reading matches the pressure transducer meter within 0 2 cmH20 If the SPAN control requires no adjustment the calibration procedure is now complete But if the SPAN control required readjustment steps 4 5 and 6 must be repeated typically twice until both the near zero level and the 40 45 cmH20 levels match within 0 2cmH20 The pressure transducer calibration procedure is now complete It has been adjusted finer than its 42 of reading or 2 0 cmH20 specification to allow for minor changes before the next required calibration in 2 000 operating hours 82 Chapter 7 Maintenance and Troubleshooting F Scheduled Periodic Maintenance F Scheduled Periodic Maintenance G Troubleshooting Special Environment
46. ate should be set at not less than 20 I min However the effect of increasing this control is relatively benign unless exceptionally high oscillatory amplitudes are required In these cases bias flow should be higher to insure that the patient circuit clearance flow is greater than the patient s oscillatory flow If the bias flow is inadequate the patient circuit s effective dead space will increase and diminish the ventilation affect being sought by increasing the oscillatory amplitude AP Additionally when operating the ventilator at high oscillatory amplitudes it may be necessary to increase the flow to maintain mean airway pressure Although changes in Bias Flow will cause changes in Pa in practice a flow rate of 20 40 I min is typical If signs of carbon dioxide retention persist increase the bias flow in increments of 5 l min as frequently as every 15 minutes Remember that the Pa Adjust 92 Chapter 8 Clinical Guidelines A Treatment Strategies Frequency Inspiratory Time Fl02 Mean Airway Pressure and Oscillatory Pressure Amplitude Mean and Range of 3100B Settings Mean Airway Pressure control will have to be turned counterclockwise to compensate for the increased flow and maintain the desired Pa For adult applications the typical starting frequency is 5Hz In patients who present with refractory hypercapnia with maximal oscillatory amplitude the frequency is then decreased incrementally to improve ven
47. ation Warning The operational verification and start up procedure must be followed before ventilation of a patient commences If at any time during the operational verification and start up procedure any abnormal function of the Model 3100B HFOV is noted do not proceed with patient ventilation as this could cause patient injury or death immediately contact SensorMedics Technical Support before proceeding any further Precaution Proper operation of the ventilator must be verified prior to each use The alarm functions tested in this procedure verify the capability of the device to detect and indicate conditions which could have a harmful effect on the patient Precaution Touch the outer metal cabinet of the instrument before touching any other component to avoid possible instrument component damage from Electrostatic Discharge Warning Do not operate radio transmitters within 20 feet of this instrument This may result in erroneous pressure readings leading to false alarms and automatic shut down 767164 0601G 66 Chapter 6 Operational Verification and Start up Procedures B Start up Procedures B Start up Procedures 1 Connect the source gases to the Model 3100B HFOV System a Oxygen line to the External Air O2 Blender oxygen input fitting b Air line to the External Air Oz Blender air input fitting and the oscillator Air Cooling input connector c External Air O2 Blender output to the Control Pa
48. ay membranes Do Not use the 3100B ventilator in environments where the ambient temperature is at or above 84 F 28 C Use of the ventilator in these environments will result in extreme reduction in relative humidity in the patient s airway and possible desiccation of the patient airways Failure to comply with the recommended maintenance procedures described in Chapter 7 could result in injury to the patient or operator or could result in damage to the equipment The following Precautions must be read and understood before an attempt is made to operate the Model 3100B HFOV Follow closely the recommendations contained in Chapter 8 Clinical Guidelines regarding the use of chest radiographs to monitor patient condition During HFOV as with all ventilators the relationship between improvement in lung compliance inadvertent increases in lung volume increased pleural pressure and decreased venous return is a matter of concern since it may result in decreased cardiac output Patient size is an important guideline as to lung volume and anatomical dead space as well as the metabolic demand placed on ventilation While the maximum displacement volume of the 3100B is approximately 365 ml the actual volume delivered to the patient is dependent on power setting frequency endotracheal tube size and patient respiratory system compliance It is recommended that the operator review Section 8 of this manual Clinical Guidelines The
49. battery 25 which will be discussed further in the next section covering operation of controls indicators and connections on the rear panel of the Control Package 14 Reset Pushbutton This momentary pushbutton resets all Safety Alarms and the Power Failure alarm The alarm conditions triggering the gt 60 cmH20 and lt 5 cmH20 Safety Alarms 11 and 12 must first be corrected before resetting will occur Since these 767164 0601G 48 Chapter 4 Location and Function of Controls Indicators and Connections B Front and Side Panel Control Package 15a Battery Low 15b Source Gas Low alarms cause the Dump Valve to open Reset must be held in with the Start Stop enabled until the Dump Valve closes and airway pressure builds above the 5 cmH20 Pa level The Power Failure alarm 13 will be reset regardless of whether the alarm condition has been corrected or still exists It is normal for the Battery Low LED to light when the reset button is pressed Indicates the Power Failure alarm battery 25 on the rear panel of the Control Package must be changed as soon as possible to ensure continued proper operation of the Power Failure alarm Indicates the gas pressure at the Inlet From Blender or Air Cooling connection has fallen below 30 psig Since the Battery Low and Source Gas Low are classified as caution alarms yellow LEDs are used and there is no audible indicator These alarms will reset only afte
50. c Control and Alarm Subsystem 1 Power 2 Inspiratory Time 3 Frequency Hz 4 Start Stop The operation and use of these controls is described in detail in Chapter 4 The subsystem also contains the following indicators for reporting on the Oscillator Subsystem status 1 Start Stop LED 2 AP digital meter 3 Inspiratory Time digital meter 36 Chapter 3 Description of System and Safety Features Electrical Power Supply Electrical Power Supply J Safety Features 4 Frequency digital meter The coordination of these indicators with the Oscillator Subsystem controls is described in detail in Chapter 4 The following alarm controls and indicators are part of this section 1 Max Pa exceeded thumb wheel and LED 2 Min Pa exceeded thumb wheel and LED 3 Pa gt 60 cmH20 LED 4 Pa lt 5 cmH20 5 45 Sec Silence pushbutton and LED 6 Reset pushbutton 7 Battery Low LED 8 Source Gas Low LED 9 Oscillator Overheated LED 10 Oscillator Stopped LED 11 Power Failure LED The range resolution and accuracy of these alarm functions are described in Chapter 2 A detailed description of the use of these alarms controls and indicators follows in Chapter 4 The function of the alarms is influenced by inputs from the Airway Pressure Monitor Oscillator Subsystem and Pneumatic Logic and Control Subsystem The Electrical Power Supply converts the AC line voltage to the DC voltages required to power
51. ceeded This could result in injury to the patient s airway membranes Warning Do Not use the 3100B ventilator in environments where the ambient temperature is at or above 84 F 28 C Use of the ventilator in these environments will result in extreme reduction in relative humidity in the patient s airway and possible desiccation of the patient airways Precaution To help prevent patient injury due to humidifier malfunction the use of a humidifier with the following characteristics is strongly recommended a Thermally protected heater b Alarms on overfilled water reservoir c Alarms on under filled water reservoir d Alarms when open or shorted temperature probe is detected e Alarms at probe temperatures gt 41 C f Alarms when dislodged temperature probe is detected The connection of the humidifier into the Model 3100B HFOV System will be further described in Chapter 5 Assembly and Installation Standard humidifier adapters are required and two are provided for connecting the 3 8 I D tubing to and from the humidifier D Pneumatic Logic The Blender feeds pressurized blended gas to the Mode 3100B Pneumatic and Control Logic and Control Subsystem through an oxygen DISS fitting Four pneumatic controls are part of this subsystem 767164 0601G Chapter 3 Description of System and Safety Features 27 E Patient Circuit Bias Flow Mean Pressure Adjust Patient Circuit Calibration E Patient Circu
52. chievable rate of flow is internally limited to 60 LPM Adjusts the mean airway pressure Pa by controlling the resistance of the Pa Control Valve This control is a clockwise increasing 1 turn pneumatic valve The adjustment affected by this control is read on the Mean Pressure Monitor 8 Since this control is not a closed loop control Pa will change if the bias flow setting is changed Increasing the bias flow will increase the Pa In addition since the oscillatory pressure waveform introduced by the Oscillator Subsystem is nonsymmetrical adjustment of the oscillator controls will also vary the Pa When adjusted this control fixes the mean pressure at the ET tube patient connection after about five system time constants have elapsed but only if set bias flow and oscillator characteristics remain unchanged for the same time period Five time constants will vary from about one second to as long as 30 seconds This time constant varies inversely with both Pa Control Valve resistance and bias flow setting Changes in the following oscillator controls may necessitate readjustment of the mean pressure to maintain a constant Pa Frequency Inspiratory Time Power and resultant AP change Frequency affects the Pa adjustment slightly but at higher frequencies the amplitude of the oscillator piston movement may be attenuated due to slew rate limiting The transit time of the piston is greater than the cycle time required by the Frequen
53. ckage rear panel oxygen DISS fitting labeled Inlet from Blender 2 Connect Patient Circuit and External Humidifier to the Model 3100B using the assembly procedures described in Chapter 5 Warning Do not attempt to substitute a circuit configuration from any other instrument Use of a non 3100A or a non 3100B circuit can result in injury to the patient or to the operator and it may cause damage to the equipment The Patient Circuit described in this manual is specifically designed for patient use with the Model 3100B HFOV Precaution When connecting the Patient Circuit make certain that it is properly supported by the support arm as described in Chapter 5 Assembly and Installation Failure to do so could result in inadvertent patient circuit disconnection due to oscillatory forces or could result in collection of humidifier condensate in the patient airway 3 Connect all color coded Patient Circuit Control Lines and the clear Pressure Sense Line to their proper locations on the Patient Circuit as described in Chapter 5 Precaution Care should be taken not to crimp or perforate any of the control or sense lines running to or from the Patient Circuit during assembly or operation of the ventilator as this will cause malfunction of the Safety Alarms Warning Alarms Caution Alarms and or Pressure Limit controls 767164 0601G Chapter 6 Operational Verification and Start up Procedures 67 B Start up Procedures
54. clude under over ventilation under over humidification chronic obstructive lung disease necrotizing tracheal bronchitis NTB atelectasis hypotension pneumothorax pneumopericardium pneumomediastinum pneumoperitoneum and pulmonary interstitial emphysema PIE The reported frequency of these occurrences are similar to conventional ventilation The following Warnings must be read and understood before an attempt is made to operate the Model 3100B HFOV Chapter 1 Introduction D Warnings Do not attempt to defeat the proper connection of the ground wire as it may cause damage to the device or interconnected equipment and could be injurious to the patient or to those associated with the device use This device is factory equipped with a hospital grade AC power plug Grounding reliability can only be assured when connected to a tested receptacle labeled Hospital Grade Do not operate radio transmitters within 20 feet of this instrument This may result in erroneous pressure readings leading to false alarms and automatic shutdown Do not shorten the 30 bias flow tube provided with the patient circuit as this may reduce the maximum AP by allowing the oscillatory pressures to be attenuated by closer proximity to the volume of the humidifier canister Do not attempt to substitute a circuit configuration from any other instrument Use of a non 3100A or a non 3100B circuit can result in injury to the patient or to the operato
55. corrected the high Pa visual indicator will remain lit to notify the clinician that the alarm was violated Depress the Reset Power Failure button to reset the visual indicator Should the proximal pressure meet or fall below the Min Pa setting an audible and visual alarm will occur which will automatically reset after correction of the alarm condition No machine action is taken Operating the ventilator with low Bias Flow Rates lt 15 Ipm and Low Mean Airway Pressures lt 15 cmH20 with full power Maximum Amplitude may result in a low pressure dump upon activation of the Max Pa Alarm The Safety Alarms consist of Pa gt 60 cmH20 and lt 5 cmH20 alarms They are indicated in the same manner as the Warning Alarms described above If either of these Pa alarms is activated the oscillator is stopped bias flow continues and the Dump Valve opens the Patient Circuit to atmospheric pressure Either of these alarms can be reset by pressing the Reset Button once the cause of the alarm condition has been corrected When the Power Failure Alarm is activated no other machine actions are taken other than the energizing of a red LED and a 3K Hertz modulated tone The Power Failure Alarm is reset by pushing the Reset button whether or not the alarm condition removal of or inadequate power supply to the Electronic Control and Alarms Subsystem has been corrected To restart the oscillator it will then Chapter 3 Description of System and Safety
56. ctors such as Electrostatic Discharge ESD and Electromagnetic Interference EMI require special consideration by the operator For an in depth discussion of these factors see the Troubleshooting section of Chapter 7 Maintenance and Troubleshooting 20 Chapter 2 Specifications H 3100B Performance Graphs H 3100B Performance Graphs 3 Ohm Driver Distal Tidal Volume vs Frequency at Maximum Power e Two l Time Settings e Single ET Tube Size 7mm e Single Compliance 19ml cmH20 E E gt T E Frequency H2 Figure 2 1 767164 0601G Chapter 2 Specifications H 3100B Performance Graphs 21 3 Ohm Driver Distal Tidal Volume vs Power 300 Setting at 33 I Time 280 e Three ET Tube Sizes 260 e Single Compliance A 0 0 ET ahn 49ml cm H20 240 220 4 T0 ETT 3 Hz 200 ak 2 E 180 d 160 4 3 5 5 0 ETT Hz F 120 4 100 9 0 ETT 15Hz 80 4 eo f 7 0 ETT 15Hz 20 Yor ETT 15Hz 0 x 10 8 7 6 5 4 1 Power Setting Figure 2 2 767164 0601G 22 Chapter 2 Specifications H 3100B Performance Graphs 3 Ohm Driver Distal Tidal Volume vs Frequency at Maximum Power and 33 I Time e Three ET Tube Sizes e Single Compliance 19ml cm H20 Tidal Volume ml Frequency Hz Figure 2 3 767164
57. cy adjustment Since the Inspiratory Time adjustment affects the symmetry of the oscillatory waveform it will directly cause a change in the Pa when readjusted A change in the AP will cause a change in the percent of the Pa contributed by any nonsymmetrical oscillatory waveform Thus Pa will change and will need to be readjusted if an unchanged Pa is desired 44 Chapter 4 Location and Function of Controls Indicators and Connections B Front and Side Panel Control Package 3 Not used 4 Power AP 5 Inspiratory Time With the oscillator off the Mean Pressure Adjust control is capable of achieving 41 cmH20 Pa ata Bias Flow of 20 LPM with the patient circuit calibrated to the system Pa will generally increase moderately with the oscillator running Refer to Chapter 6 Operational Verification and Startup Procedures for an explanation of the Mean pressure setup procedure Determines the amount of power that is driving the oscillator piston to and fro The Power control is a 10 turn electrical potentiometer covering the power range of 0 to 100 The knob scale is a 10 turn locking dial that is not calibrated in power but marked for purposes of establishing reference points The effect of this control is to change the displacement of the oscillator piston and hence the oscillatory pressure AP The Power setting interacts with the Pa conditions existing within the Patient Circuit to produce the resultant AP
58. d first The majority of devices used in a hospital environment have been checked for conducted emissions and only through a malfunction of the device is there likely to be an interference problem 767164 0601G 84 Chapter 7 Maintenance and Troubleshooting G Troubleshooting Troubleshooting Chart The following chart should be used as a guide in correcting problems that may arise in the use of the 3100B For problems not covered by this list or for any questions or concerns call the SensorMedics Technical Support Department Precaution Troubleshooting with the 3100B should be done OFF PATIENT to avoid any potentially dangerous situations such as abrupt changes in the Pa Visual Audible Alarm Occurring Condition Displayed Pa gt 60 cmH20 Alarm Displayed Pa gt Set Max Pa Thumbwheel Alarm Possible Causes Patient at high Pa and spontaneously breathing Obstruction in expiratory limb Obstruction in pressure sense line Interference from a radio transmitter Patient spontaneously breathing Improper setting of thumb wheel switch Obstruction in expiratory limb Obstruction in pressure sense line Patient circuit temperature rise Interference from a radio transmitter Possible Remedies Bias Flow rate possibly insufficient re adjust Pa using higher flow Also consider Clinical status of patient Replace patient circuit Replace patient circuit Remove source of interference Bias Flow
59. d Gases Arterial 99 Bulkhead Luer Fittings 55 767164 0601G C Calibration Airway Pressure Monitor Transducer 80 calibration patient circuit 66 Calibration Patient Circuit 77 Calibration Periodic Scheduled 77 Calibration Power Supply 78 Caution Alarms 16 38 Changing the Compressed gas Inlet Filter Cartridge Elements 73 Changing the Patient Circuit 75 Changing the Power Failure Alarm Battery 74 Chest X Ray 100 Children Large Adults Special Considerations 94 circuit breaker 53 Circuit Patient 28 Cleaning and Disinfection Pre use 63 Cleaning the Column Lint Filter 75 Cleaning Exterior 72 Clinical Guidelines 90 Clinical Strategy General Aspects 94 color coded tubes 59 Column Lint Filter Cleaning 75 Compartment Battery 50 Compressed gas Inlet Filter Cartridge Elements Changing 73 Connections Gas 18 Connections Location and Function 40 Connections Rear Panel 61 connections tubing 61 Contraindications 1 Controls 13 Controls Location and Function 40 Cradle Patient Circuit 54 D Delta P 35 Delta P Control 43 Delta P Indicator 15 Dimensions 19 Disconnection and Reconnection during Suctioning 100 Disease Specific Variations to General Clinical Strategies 98 Drain Valve Water Trap 54 Driver Diaphragm Lubrication 75 Driver Lubrication Record Label 9 Driver Replacement Record 51 Driver Replacement Record Label 10 Dump Val
60. d during the course of the Multicenter Oscillatory ARDS Trial MOAT II Prospective Randomized Control Trial A recently published trial by the National Institutes of Health ARDS network comparing a lung protective strategy of lower tidal volumes lt 6 ml kg and plateau pressures lt 30 cm H20 with a higher tidal volume strategy reported an absolute mortality reduction of 9 High frequency oscillatory ventilation HFOV is an alternative method of ventilation which theoretically achieves the goals of lung protective ventilation HFOV achieves gas exchange by applying a constant mean airway pressure higher than that usually applied during conventional ventilation Thus HFOV allows maintenance of alveolar recruitment while potentially avoiding both the cyclic closing and opening of alveolar units as well as the high peak airway pressures that occur with conventional ventilation techniques The strategies are easy to implement because for most clinical situations only two of the 3100B s five controls are employed mean airway pressure and oscillatory pressure amplitude AP The other three Bias Flow Frequency and Inspiratory Time are rarely changed during the course of treatment as explained below A continuous flow of fresh humidified gas from a standard humidifier and Air Oxygen blender is a fundamental requirement for replenishing oxygen and removing carbon dioxide from the patient circuit In most applications the flow r
61. d in the trachea This is because the respiratory system impedance of which the endotracheal tube is the dominant element greatly attenuates these high frequency pressure waves and at the same time distorts their wave shape into a nearly triangular pattern For instance at 3 Hz and a compliance of 19 ml cmH20 the losses are 95 5 0 mm ET tube 91 7 0 mm ET tube 84 9 0 mm ET tube Hence in the clinical setting a larger ET tube will result in greater distal pressure waveforms and a greater reduction in arterial PCO2 94 Chapter 8 Clinical Guidelines A Treatment Strategies Therapeutic Objectives To further clarify this oscillatory pressure amplitude phenomenon consider the following example A patient with a compliance of 19 ml cmH20 is attached to the 3100B s patient circuit with a 5 0 mm ET tube The 3100B is operating at 3 Hz 33 Inspiratory Time a mean airway pressure of 25 cmH20 and a AP of 90 cmHz20 Hence the peak proximal airway pressure has a peak of 70 cmH20 and a low of minus 20 cmH20 while the tracheal airway pressure has a peak of approximately 28 cmH20 and a low of 22 cmH20 because of the 95 attenuation caused by this size ET tube at 3 Hz With the 19 ml cmH20 compliance this distal AP of 6 cmH20 creates a high frequency tidal volume of 114 ml in a lung held at a nearly constant well inflated level by the 25 cmH20 mean airway pressure At a given mean airway pressure and frequency the sole mechanism by
62. d the air inputs to the ventilator must be replaced at least every 500 hours of operation as described in this chapter Failure to replace a Filter Cartridge or substitution of an unauthorized cartridge could result in injury to the patient and or damage to the equipment Use only SensorMedics cartridges P N 767163 box of 10 The recommended minimum change interval is every 500 hours of operation However the level of contaminants in the gas lines of your hospital may be higher than normal If the Model 3100B HFOV is used for the first time at a new location within your hospital Filter Cartridges should be checked for flow limiting 767164 0601G Chapter 7 Maintenance and Troubleshooting 75 C Operator Maintenance Procedures Cartridge Change Procedure Changing the Power Failure Alarm Battery Cleaning the Column Lint Filter 767164 0601G contaminants after 100 hours of operation and then after 300 hours of operation to determine whether or not a 500 hours of operation change interval is appropriate A Filter Cartridge which has been allowed to accumulate flow limiting contaminants will cause the gas supply pressure at the particular DISS fitting to drop Eventually the Source Gas Low alarm will trigger Refer to Chapter 4 for a description of this alarm indication The procedure for changing a cartridge is as follows 1 Turn off and disconnect both the air and oxygen source gas lines 2 Unscrew body of inlet
63. display and adjust the Patient Circuit Calibration screw for a reading of 39 43 cmH20 Precaution Do not over adjust the Patient Circuit Calibration screw Over adjustment may cause damage to the device The screw will reach a mechanical stop when it is at the adjustment limit DO NOT FORCE THE SCREW PAST THIS STOP There are two other functions within the Model 3100B HFOV which require periodic calibration 1 Control Package DC Power Supply 2 Airway Pressure Monitor Transducer Calibration Maintenance of accurate calibration of these functions is extremely important to the proper function of the Model 3100B HFOV If at any time a calibration discrepancy exists that cannot be solved by the normal calibration procedures described below do not attempt to treat a patient with the HFOV Call SensorMedics immediately for assistance The calibration interval for these functions is tracked on the Elapsed Time Meter 24 on the Rear Panel of the Control Package A calibration must be performed at least every 2 000 hours or when a discrepancy is noticed An National Bureau of Standards traceable digital voltmeter and a National Institute of Standards and Technology traceable pressure measurement transducer are required for proper calibration of the Power Supply and the Airway Pressure Monitor To assure accurate setup all periodic calibrations must be done with the Model 3100B HFOV at room temperature and prior to extensive operation of the
64. e The proper angle will allow condensate to run downward into the Water Trap mounted on the Column The 3100B High Frequency Oscillating Ventilator is now ready for Operational Verification and Start Up see Chapter 6 Warning Do not attempt to substitute a circuit configuration from any other instrument Use of a non 3100A or a non 3100B circuit can result in injury to the patient or to the operator and it may cause damage to the equipment The Patient Circuit described in this manual is specifically designed for patient use with the Model 3100B HFOV 767164 0601G 62 Chapter 5 Assembly and Installation C Assembly Obtain an External Air O2 Blender and an External Humidifier for incorporation into the system as described in Chapter 3 Attach these devices to the Patient Circuit using the attachment accessories supplied and using Figures 5 1 and 5 2 as a guide The following connections must be made Device Input Connection s From Air O2 Blender a Hospital Air DISS connection b Hospital Oxygen Humidifier DISS connection Control Package rear panel OUTLET TO HUMIDIFIER 3 8 barbed fitting Output Connection To Control Package rear panel INLET FROM BLENDER DISS fitting Patient Circuit Bias Flow Connection 3 8 nipple fitting There is an additional connection from the Hospital AIR DISS connection to the Column DISS Air fitting marked AIR COOLING r
65. e levels noted in step 1 If the oscillator does not restart or starts and then stops first turn the power down to a setting between 2 and 3 then while holding the reset switch adjust the Pa to the desired level using the flow meter Next while monitoring the Pa turn the power up to achieve the desired amplitude and adjust the flow meter as necessary to maintain the desired Pa Index 103 A Adverse Effects 1 Adverse Effects Potential 98 Air Cooling Inlet Fitting 51 Air Leak Syndromes 98 Airway Disease 98 Airway Pressure Monitor 34 Airway Pressure Monitor Transducer Calibration 80 Alarm 15 Alarm Battery Power Failure 50 Alarm Subsystem 35 Alarm Battery Low 85 Alarm Oscillator Overheated 85 Alarm Pa lt 5 cmH20 84 Alarm Pa lt Set Min Pa Thumbwheel 84 Alarm Pa gt 60 cmH20 83 Alarm Pa gt Set Max Pa Thumbwheel 83 Alarm Source Gas Low 85 Alarms 16 Arterial blood gases 95 Arterial Blood Gases 99 Assembly 56 atelectasis 98 B Battery Attachment Label 12 Battery Compartment 50 Battery Low Alarm 85 Battery Low Indicator 14 47 Battery Specification Label 12 Battery Power Failure Alarm Changing 74 Bellows Fasteners 54 Bias Flow 90 Bias Flow Control 13 27 Blender 61 Blender External Air O2 25 Blender Cooling Gas Filter Replacement Record 51 Blender Cooling Gas Filter Replacement Record Label 9 blood gases Arterial 95 Bloo
66. e verified with an oxygen monitor Administration of excessive oxygen to a patient may be harmful It is imperative that the prescribed gas mixture is delivered by the blending system The Water Trap must be drained at intervals as described in Chapter 7 Maintenance and Troubleshooting If the ventilator is operating leave a small amount of water at the bottom of the Water Trap container to act as a flow and pressure seal between the ventilator and the output of the drain Chapter 1 Introduction F Explanation of Symbols F Explanation of Symbols To help prevent patient injury due to humidifier malfunction the use of a humidifier with the following characteristics is strongly recommended Thermally protected heater Alarms on over filled water reservoir Alarms on under filled water reservoir Alarms when electrically open or shorted temperature probe detected Alarms at probe temperatures gt 41 C Alarms when dislodged temperature probe detected Do not place on the Control Package of the ventilator any fluid containing accessories accessories that weigh more than ten pounds or accessories that extend more than six inches above the ventilator electronics package or beyond its sides This could cause damage to the ventilator or could cause the ventilator to tip over resulting in patient or user injuries and or damage to the equipment Do not overturn the Patient Circuit Calibration screw as this may cause damage t
67. ected to a patient it is imperative that someone be in attendance at all times in order to react to any alarms and to detect other indications of a problem A thermal cutout safety feature has been incorporated into the Oscillator Subsystem This feature shuts down the oscillator if overheating occurs If the oscillator were not shut down such overheating could result in the destruction of the oscillator coil s support spiders The thermal cutout system utilizes a thermistor on the oscillator coil form to detect temperature rise Thermal shutdown will occur if coil temperature exceeds 175 C 767164 0601G Chapter 3 Description of System and Safety Features 39 J Safety Features Prior to an oscillator thermal shutdown the operator is given an indication that the coil is overheating A yellow caution LED on the front panel of the Control Package lights when the coil temperature reaches approximately 150 C A Water Trap is incorporated into the Oscillator subsystem as described in a previous section to help eliminate condensate from the Patient Circuit This is a safety feature not seen in many conventional ventilators with a similar water build up potential The Water Trap is easily emptied as described in Chapter 7 Maintenance and Troubleshooting Precaution The Water Trap must be drained at intervals as described in Chapter 7 Maintenance and Troubleshooting If the ventilator is operating leave a small amount of
68. ed equipment and could be injurious to the patient or to those associated with the device use This device is factory equipped with a hospital grade AC power plug Grounding reliability can only be assured when connected to a tested receptacle labeled Hospital Grade Precaution Proper operation of the ventilator must be verified prior to each use Refer to Chapter 6 Operational Verification and Start up Procedures 767164 0601G 64 Chapter 5 Assembly and Installation D Pre use Cleaning and Disinfection D Pre use Cleaning and Disinfection Warning Do not operate radio transmitters within 20 feet of this instrument This may result in erroneous pressure readings leading to false alarms and automatic shut down The 3100B requires no preliminary cleaning before initial use The Patient Breathing Circuit components though clean are not shipped sterile If desired the circuit body may be disinfected before using according to the instructions in the Changing the Patient Circuit section of Chapter 7 Maintenance and Troubleshooting 767164 0601G Chapter 6 Operational Verification and Start up Procedures 65 A Introduction A Introduction This chapter covers the proper operational verification and ventilation start up methods for the Model 3100B HFOV See Chapter 5 for instructions on unpacking assembly and installation of the Model 3100B HFOV prior to operational start up and verific
69. ensnsneeseeasasesetes 53 767164 0601G xii Table of Contents 3100B High Frequency Oscillatory Ventilator 5 Assembly and Installation 0 00 ccssssessssnsecssescssnseessnsessssessnseessneesssseesneessneeearenee 57 Ac MENON TO ne steht Dt a a alt Tak a aa ante ROEN 57 B Unpacking eiee a a e a ra cat A 57 C ASSeMDIV nea e a a a a a a e E E 57 D Pre use Cleaning and Disinfection sse sssesseeeesessresesessrtssressressrtssresrirsstetrrtnrensrnsnrtnsrntrnrasten nnns 64 6 Operational Verification and Start up Procedures 00 cccccccccssecsssesssecsseessecssees 65 VALEK eLo LE re iO DEAE AEE AAT E A teases 65 B Startup Proced re Sesti ia a a a a En 66 C Performance Verification ecard sascha are aceon alsa cg Scoot Weed sted aN ONS aa 71 7 Maintenance and Troubleshooting 0 cccccccccccsssessssesessneessseecssneecsnseesseecsseeesneeeareee 73 Fis ARNLFOCUC TON aja aster ceateriaasst ccceudene aaetiauteatidinatidutenbonstan ante a a A E 73 Bi Exterior Cleaning sae tase htc eget ca sates a ee cca tea haute sa eae ltd act tata Ata ab 73 C Operator Maintenance Procedures ccccccccssesscssssssscssesescscscassesseseesseesseeeseasaseeecseseaeasanaeesess 73 Emptying the Water Trap asa te a eal el gt ete il aa estas 74 Changing the Compressed gas Inlet Filter Cartridge Elements ccsscsccseseeeeeeeees 74 Changing the Power Failure Alarm Battery oc cccecessseseseetseseeseseeseesneeeneeesseeeeeneees 75 Clea
70. ent Figure 1 7 Battery Attachment Label The Battery Attachment Label indicates the correct position for the installed Power Failure Alarm Battery For directions on changing the battery see the Changing the Power Failure Alarm Battery Section of Chapter 7 Maintenance and Troubleshooting Battery Specification Figure 1 8 Battery Specification Label The Battery Specification Label indicates the type of Power Failure Alarm Battery 9V alkaline that must be used For directions on changing the battery see the Changing the Power Failure Alarm Battery Section of Chapter 7 Maintenance and Troubleshooting 767164 0601G Chapter 2 Specifications 13 A Controls A Controls Bias Flow 0 60 liters per minute LPM Continuous 15 turn control Resolution 2 5 LPM Accuracy 10 of full scale at the following conditions air or oxygen 70 F and 760 Mean Pressure Adjust Resolution Accuracy Mean Pressure Limit Power Resolution Frequency Hz Resolution Accuracy Inspiratory Time Resolution Accuracy Start Stop Set Max Pa Alarm Thumbwheel Resolution Accuracy 767164 0601G Torr Approximately 3 55 cmH20 minimum range Bias Flow dependent Refer to Ventilator Performance Checks in Chapter 6 0 1 cmH20 on airway pressure digital meter 1 turn control Non calibrated control knob Automatic At 100 power AP gt 90 cmH20 max amplitude of proximal airway pressure Graduated 10 turn locking dial not ca
71. f the control package to achieve a Pa of 39 to 43 cm H20 Do not overturn if the specified pressure can not be achieved locate the leak f Release the RESET button the Battery Low LED should turn off 767164 0601G 68 Chapter 6 Operational Verification and Start up Procedures B Start up Procedures Precaution Do not overturn the Patient Circuit Calibration as this may cause damage to the device When it is nearing its adjustment limit it will reach a mechanical stop 7 Perform the Ventilator Performance Check Off Patient Only section These instructions are also located on a label on the top of the Control Package a Insert stopper in Patient Circuit Y and turn on both gas sources b Set BIAS FLOW for 30 LPM c Set Max Pa Alarm to 35 cmH20 d Pressurize system by pressing and holding RESET and ADJUST for a mean Pressure of 29 31 cmH20 e Set FREQUENCY to 6 I Time to 33 and press START STOP to start the oscillator f Set POWER to 6 0 g When a stable AP reading is obtained verify that the AP and Pa readings are within the range specified for your corresponding altitude see Figure 6 1 8 Depress the START STOP button to stop the oscillator 9 With Mean Pressure Adjust and or Bias Flow adjustment achieve a mean airway pressure within 2 cmH20 of the desired level Ensure that the Bias Flow is sufficient see Chapter 8 10 Verify the function of the thumb wheel switches for Se
72. ge or a loose tube connection internal or external Refer to the Operator Maintenance Procedures section of Chapter 7 for instructions on changing the Inlet Filter Cartridges Indicates that the oscillator is enabled Start Stop pushbutton green LED lighted but AP lt 5 to 7 cmH20 A red LED indicator is accompanied by a 3K Hertz modulated tone No machine action is taken other than the indicators which automatically reset when the condition is corrected Activates and indicates the inhibiting of the audible alarm for a period of 45 seconds This control is a lighted pushbutton and indicates a caution with its yellow LED when pushed Once activated the 45 Sec Silence cannot be reset but must time out Adjusts the maximum mean pressure that can be obtained with a specific Patient Circuit This screwdriver adjustment is used to calibrate the maximum mean pressure after the Patient Circuit is changed or the Pa Control diaphragm is changed A full setup procedure is detailed in Chapter 7 Maintenance and Troubleshooting 50 Chapter 4 Location and Function of Controls Indicators and Connections C Rear Panel Control Package C Rear Panel Control Package lender Filter Rep Cooling Gals acement R cord S i 0 COOLING AIR Figure 4 2 Rear Panel Controls Indicators and Connections The numbers shown on Figure 4 2 correspond to the numbers on the following descripti
73. gths and color coding of the tubes and the physical arrangement of the valves within the Patient Circuit minimize any cross connection Precaution Care should be taken not to crimp or perforate any of the control or sensing lines running to or from the Patient Circuit during assembly or operation of the ventilator as this will cause malfunction of the Safety Alarms Warning Alarms Caution Alarms and or Pressure Limit controls Next attach the 1 8 Tygon pressure sense line captive to the Patient Circuit Y to the bulkhead Luer fitting marked Airway Pressure Finally insert the humidifier temperature probe in the tapered opening near the patient Y Note that an identical such port with a removable plug in it is located at the opposite end of the Patient Circuit Always insert the plug in the unused port 767164 0601G Chapter 5 Assembly and Installation 61 C Assembly Precaution If the temperature probe is wiped with alcohol allow the alcohol to evaporate completely before inserting it into the circuit A high residual of alcohol can weaken the acrylic adapter and cause fracturing Always insert the provided plug into the unused temperature probe port Failure to do so will allow a leak of sufficient magnitude that the minimum Pa necessary to allow the oscillator to start cannot be achieved Use the cradle rod adjustment already described to maintain the proper Patient Circuit height and angl
74. gure 1 2 Ventilator Performance Checks Label The Ventilator Performance Checks Label assists in setting Power Mean Pressure Adjust and Bias flow controls to achieve specific ranges of AP and Pa These procedures are explained in the Performance Verification Section of Chapter 6 Operational Verification and Start up Procedures 767164 0601G Chapter 1 Introduction G Exterior Labels Blender Cooling Gas Filter Replacement Record 767164 0601G BLENDER COOLING GAS FILTER REPLACEMENT RECORD Filters should be replaced every 500 hours of operation REPLACED REPLACED REPLACED REPLACED PIN 767159 A Figure 1 3 Blender Cooling Gas Filter Replacement Record Label The Blender Cooling Gas Filter Replacement Record Label provides a place to document the 500 hour gas filter changes For more information see the Operator Maintenance Procedures Section of Chapter 7 Maintenance and Troubleshooting 10 Chapter 1 Introduction G Exterior Labels Driver Replacement Record Driver Replacement Record Drivers should be replaced every 2000 hours of operation Replaced Driver S N Replaced By Date Hrs Hrs Hrs Hrs Hrs Hrs Hrs Hrs Hrs Hrs Hrs P N 773941A Figure 1 4 Driver Replacement Record Label The Driver Replacement Record Label provides a place to document the 2000
75. hapter covers the Model 3100B maintenance and troubleshooting procedures with which the operator and service technician should be acquainted SensorMedics or its official representative will make available upon request such circuit diagrams component part lists descriptions calibration instructions or other information which will assist factory qualified technical personnel to repair those parts of the equipment which are classified as repairable If you are interested in factory training please contact the SensorMedics Service Department for scheduling and pricing of our biomedical training classes Warning Failure to comply with the recommended maintenance procedures described in this chapter could result in injury to the patient or operator or could result in damage to the equipment When surface cleaning of the 3100B is desired we recommend using a weak disinfectant liquid to wipe down the exterior of the instrument Do not spray liquid cleaners directly on the exterior surface spray the cleaning cloth and wring it nearly dry before wiping Do not allow liquids to drip into the instrument Do not use alcohol or sterilization liquids on the exterior surface of the 3100B Do not use abrasive cleaners or solvents on the exterior surface of the 3100B The operator maintenance procedures are the following Emptying the Water Trap Changing the Compressed gas Inlet Filter Cartridge Elements Changing the Power Failure Alarm
76. hour replacement of the Oscillator Subassembly For more information see the Scheduled Periodic Maintenance Section of Chapter 7 Maintenance and Troubleshooting 767164 0601G Chapter 1 Introduction G Exterior Labels 11 Radio Frequency Interference RFI Warning Name Rating Label 767164 0601G WARNING DO NOT OPERATE RADIO TRANSMITTERS WITHIN 20 FEET OF THIS INSTRUMENT THIS MAY RESULT IN ERRONEOUS PRESSURE READINGS LEADING TO FALSE ALARMS AND AUTOMATIC SHUT DOWN SEE OPERATOR S MANUAL PIN 768559C Figure 1 5 Radio Frequency Interference Warning Label The Radio Frequency Interference RFI Warning Label refers to the possible problems caused by interference from hand held radio transmitters The RFI warning is also discussed in the Troubleshooting Section of Chapter 7 Maintenance and Troubleshooting 3100B OSCILLATORY VENTILATOR VOLTAGE 115V NY HERTZ 60 7 5A 31003 770155 SensorMedics Corporation SENSORMEDICS 22705 Savi Ranch Parkway MADE IN U S A Yorba Linda California 92687 Figure 1 6 Name Rating Label The Name Rating Label lists specific information on each individual instrument the Model Name and Number the Voltage and Current Rating the Serial Number and the instrument s Catalog Part Number The example shown is for the 115V 7 5A 60Hz model your instrument may have a different rating 12 Chapter 1 Introduction G Exterior Labels Battery Attachm
77. it 767164 0601G This control sets the flow of the blended gas that continuously moves past the patient airway This control adjusts the Mean pressure level on which the oscillatory waveform is superimposed This Mean pressure along with the oscillatory waveform characteristics determines the resultant Pa This control determines the level of Patient Circuit expiratory limb Control Valve restriction in the manner described in the Patient Circuit section below This control is a screwdriver adjustment used to set the maximum mean pressure that can be attained with a particular Patient Circuit under specified conditions see Chapter 7 Maintenance and Troubleshooting This control is used only when the Patient Circuit is replaced or the Pa control valve diaphragm of the existing Patient Circuit is changed The control is necessary because the individual elastic and dimensional characteristics of the Pa control valve diaphragm interact with the valve control line pressure to determine the control dial maximum setting Precaution Do not overturn the Patient Circuit Calibration as this may cause damage to the device When it is nearing its adjustment limit it will reach a mechanical stop The range resolution and accuracy of the pneumatic controls and the characteristics of the various pneumatic connections are described in Chapter 2 Chapter 4 provides a detailed description of the functions and use of each control Warning Do n
78. ive can answer questions concerning correct parts configurations and prices Part Number Description 771384 102 3100B Patient Circuit Body Flex Circuit with Heated Wire Box of 4 766895 3100A Patient Circuit Body Box of 4 766896 Cap Diaphragm Set Box of 4 766897 Bellows Watertrap Box of 4 767163 Gas Filter Cartridge Element Package of 10 765734 104 Connecting Tube Assembly 8 length blue 765734 105 Connecting Tube Assembly 8 length green 767164 0601G 90 Chapter 7 Maintenance and Troubleshooting H Supplies and Replacement Parts 765734 106 765734 107 766595 766798 765742 770566 768965 768968 765298 Connecting Tube Assembly 26 length red Connecting Tube Assembly 36 length red for use with 771384 102 patient circuit Humidifier Tubing Column Lint Filter Element Hold Down Strap Patient Circuit Adjustable Cradle with Collar Patient Circuit Mounting Bracket Humidifier 77mm RCI ConchaTherm Mounting Bracket Humidifier 30mm Fisher and Paykel Lubricant P N 766897 Bellows Watertrap Box of 4 P N 766895 Patient Circuit Body Box of 4 Figure 7 3 Patient Circuit Parts 767164 0601G Chapter 8 Clinical Guidelines 91 A Treatment Strategies A Treatment Strategies Adjusting the 3100B s Controls to Execute the Treatment Strategies Bias Flow 767164 0601G The clinical guidelines described below reflect the strategies and applications develope
79. lapsed Time Set Max Pa Set Min Pa Alarm audible AC Power C Pressure Measurement Range Resolution Accuracy Transducer Pressure Limit 767164 0601G Digital meter readout of AP to the nearest cmH20 Digital meter readout of set inspiratory time Digital meter readout of set oscillator frequency in Hertz Digital meter readout of mean airway pressure measurement to the nearest tenth of a cmH20 Digital readout of hours of power applied to the Model 3100B HFOV to nearest tenth of an hour Thumbwheel switch marked in cmH20 Thumbwheel switch marked in cmH20 3K Hertz modulated tone Visual indication of AC power applied 1 0 130 to 130 cmH20 airway pressure 0 1 cmH20 Within 2 of reading or 2 cmH20 whichever is greater assuming periodic calibration as described in Chapter 7 20 psig Warning Failure to comply with the recommended maintenance procedures for the Airway Pressure Monitor as described in Chapter 7 could result in injury to the patient or operator or could result in damage to the equipment 16 Chapter 2 Specifications D Alarms D Alarms Safety Pa gt 60 cmH20 Resolution Accuracy Pa lt 5 cmH20 Resolution Accuracy Warning Set Max Pa exceeded Range Resolution Accuracy Set Min Pa exceeded Range Resolution Accuracy Caution Oscillator Overheated Accuracy Audible and visual indicators machine intervention Indicators activated oscillator
80. librated in power 3 15 Hz oscillator frequency 0 1 Hz on digital meter 10 turn control 5 of full scale 30 50 of oscillatory cycle 1 as read on digital meter 5 of full scale Oscillator enable disable 0 59 cmH20 mean airway pressure 1 cmH20 Within 2 cmH20 14 Chapter 2 Specifications B Indicators Set Min Pa Alarm Thumbwheel Resolution Accuracy 45 Sec Silence Reset Patient Circuit Calibration AC Power B Indicators Oscillator Enabled Oscillator Stopped 45 SEC Silence Pa gt 60 cmH20 Pa lt 5 cmH20 Set Max Pa Exceeded Set Min Pa Exceeded Power Failure Oscillator Overheated Battery Low Source Gas Low 0 59 cmH20 mean airway pressure 1 cmH20 Within 2 cmH20 Inhibits audible alarm function for 45 seconds 5 seconds Resets Pa gt 60 cmH20 and lt 5 cmH20 alarms if condition has been corrected always resets power failure alarm Resets Max Pa visual alarm Adjusts maximum mean pressure that can be obtained with a specific Patient Circuit refer to Chapter 7 for setup procedure On off Green LED Light Emitting Diode on Start Stop pushbutton Red LED Yellow LED on pushbutton Red LED Red LED Red LED Red LED Red LED Power Failure Reset Pushbutton Yellow LED Yellow LED Yellow LED 767164 0601G Chapter 2 Specifications C Pressure Measurement 15 AP Inspiratory Time Frequency Hz Mean Pressure Monitor E
81. lled by loosening the thumbscrew on the cradle rod and sliding it either up or down Once again always be certain to retighten the thumbscrew Figure 5 1 Disassembled Patient Circuit 767164 0601G Chapter 5 Assembly and Installation 59 C Assembly Temperature Probe Ports Inspired Expired Y Coupler Tubes Bias Flow Input aes 3 8 Nipple Fitting Port Bias Flow Tube Water Trap Stopcock Figure 5 2 Details of Patient Circuit Assemble the Patient Circuit using Figures 5 1 and 5 2 as a guide Connect the Patient Circuit Body to the Bellows Water Trap Assembly and snap the three identical caps diaphragm assemblies onto the three valve bodies located on the Patient Circuit Body Next attach this assembled Patient Circuit to the face of the Oscillator Compartment using the four captive T handle quarter turn fasteners 767164 0601G Chapter 5 Assembly and Installation C Assembly Precaution The driver diaphragm of the 3100B has been coated with a special lubricant during assembly Please do not clean the driver diaphragm with cleaning solvents as it may degrade the materials causing premature wear of the driver diaphragm Attach the three color coded tubes to their corresponding valve caps using the following color coding scheme Color of Line Patient Circuit Attachment Point Blue Limit Valve Green Pa Control Valve Red Dump Valve Clear Pa Sensing Port Note that the differing len
82. lugged or insufficient supply voltage within the electronics package Audible and visual indicators activated when patient s airway AP falls below 5 to 7 cmH20 Warning An audible alarm indicates the existence of a condition potentially harmful to the patient and should not go unattended Failure to respond to alarms could result in injury including death to the patient and or damage to the ventilator 115 VAC 7 5A 60 Hz 100 VAC 7 5A 50 Hz 220 VAC 4 0A 50 Hz 240 VAC 4 0A 50 Hz lt 100 Microamperes Dual electromagnetic circuit breaker 3 wire grounded hospital grade plug Designed to CSA C22 2 No 125 and UL 544 Designed to IEC 601 1 18 Chapter 2 Specifications F Pneumatic Connections European Regulatory The 3100B Oscillatory Ventilator complies with the Medical Device Directive Approvals MDD 93 42 EEC and is labeled with the CE Mark as shown below 0050 Warning Do not attempt to defeat the proper connection of the ground wire Improper grounding may cause damage to the device or interconnected equipment and could be injurious to patient or to those associated with the device use This device is factory equipped with a hospital grade AC power plug Grounding reliability can only be assured when connected to a tested receptacle labeled Hospital Grade F Pneumatic Connections Inlet From Blender Air Oz DISS oxygen fitting Pressure Range 40 60 psig Maximum Flow 60 LPM 10 Overpress
83. m by means of a special pneumatic control system The flow requirements for both the blender and for the air cooling of the Oscillator Subsystem are described in Chapter 2 Precaution Fractional concentration of inspired oxygen should be verified with an oxygen monitor Administration of excessive oxygen to a patient may be harmful It is imperative that the prescribed gas mixture is delivered by the blending system It is the responsibility of the user to provide an Oxygen Air Blender and Oxygen Concentration Monitor The blender shall be capable of 60 L min flow When used in conjunction the accuracy shall be 3 Monitoring should be accomplished at an outlet of the blender in an unpressurized state Although functioning in harmony with the Patient Circuit Subsystem the External Humidifier is treated as a separate subsystem because it is provided by the user The humidifier that is used must be a heated humidifier specifically manufactured for pediatric adult use It must be capable of covering a flow range up to 60 LPM The temperature control can be either closed or open loop however proximal airway gas temperature must be monitored Two ports for the temperature probe are provided on the Patient Circuit These will be discussed in the next section 26 Chapter 3 Description of System and Safety Features D Pneumatic Logic and Control Warning Under no circumstances should a proximal airway gas temperature of 41 C be ex
84. n er feet ar E eee feet 103 767164 0601G Chapter 1 Introduction A Indications for Use A Indications for Use B Contraindications C Adverse Effects of the Device on Health D Warnings 767164 0601G The SensorMedics 3100B is indicated for use in the ventilatory support and treatment of selected patients 35 kilograms and greater with acute respiratory failure The SensorMedics 3100B Oscillatory Ventilator has no specific contraindications In the adult ARDS prospective non randomized trial adverse effects identified were hypotension and mucus plugging Significant adverse cardiovascular effects were rare in the 30 patients entered into the study with only one patient exited from the study for hypotension Only one patient required re intubation for narrowing of their endotracheal tube by mucus encrustment In the pediatric randomized trial of the 3100A ventilator adverse effects identified were lung overdistention air leak and hypotension There were no statistical differences in any of the adverse effects as compared to those reported in the conventionally treated patients with the exception of hypotension The HFOV treated group had few but statistically significant more frequent incidences of hypotension however without evidence of serious compromise of cardiovascular status High frequency ventilation as with conventional positive pressure ventilation has inherent risks These possible adverse effects in
85. n of inspired oxygen FiO2 lt 0 60 Once the patient was stabilized on HFOV the FiO2 was reduced to lt 0 60 as long as SpO2 was 88 An open lung strategy was used to optimize oxygenation on HFOV by increasing mean airway pressure If an FiO2 gt 0 60 was required to maintain SpO2 88 the Pa was increased in increments of 2 to 3 cm H20 every 20 to 30 minutes to a maximum of 45 cm H20 As oxygenation improved the FiO2 was reduced to maintain SpO2 88 Once FiO2 lt 0 50 Pa was decreased in en Pfation 0601G 96 Chapter 8 Clinical Guidelines A Treatment Strategies Weaning 1 to 2 cm H20 decrements at 4 to 6 hour intervals as long as SpO2 remained within the target range Initial oscillatory amplitude AP was titrated to chest wall vibration AP was subsequently titrated to achieve a PaCO 2 within the target range of 40 to 70 mm Hg and maintain pH gt 7 15 If the pH was lt 7 15 the power setting was increased up to a maximum of 10 in order to increase AP in increments of 10 cm H20 If adequate ventilation could not be achieved at maximum pressure amplitude the following interventions were used in sequence 1 Reduce respiratory frequency in 1 Hz steps to a minimum of 3 Hz 2 Deflate the endotracheal tube cuff followed by restoration of the Pa by adjusting the Pa controls or bias flow if Pa was already at maximum setting Patients were weaned from HFOV back to CMV when FiO lt 0 50 and Pa
86. nical Guidelines D Recommended Monitoring Frequency D Recommended Monitoring Frequency Arterial Blood Gases Non Invasive Gas Monitoring tcO2 teCO2 and SpO2 Chest X Ray Precaution The patient s tcPCO2 and tcPO2 or SpO2 should be monitored continuously to insure that blood gases are at the proper level It is important that an unrestricted and unobstructed patient airway be maintained during HFOV To insure a patent airway always maintain proper suctioning procedures as described in the Suctioning Guidelines Section of Chapter 8 Clinical Guidelines Since only proximal airway pressure is monitored no alarm will occur in the event of an obstruction or restriction The recommended minimum frequency for monitoring the key pulmonary status parameters is the following 1 45 60 minutes after initiation of HFOV therapy to correlate to transcutaneous values 2 Every 2 hours for 8 hours 3 Every 4 hours for 16 hours 4 Every 8 12 hours depending on institution policy during treatment 5 Within 1 hour after major setting change or as clinically indicated Continuously This may alert the clinician to subtle changes in the patients ventilatory status that may not be detectable by auscultation or physical exam Within 4 hours of start of use 2 Every 12 hours next 24 hours 3 Every 24 hours next 5 days 4 Every 48 hours next 8 days 5 Every week thereafter 6 Whenever lung over inflation is su
87. ning the Column Lint Filter 2 tet cteusetteic tae dace ren ela eae elute 76 Changing the Patient Circuit tovaesica estar ntiivieces een peeneiadl en ed oaheel ee 76 Lubrication of the Driver Diaphragm c csssssccsecsssesecessesecesesensesesesenereeseteneesesenesetenss 76 D Patient Circuit Calibration hes aiceiialst cose xsttasiesa lacs let is Beatin abdul ds apie Rett aie eeesse a nnn nnanne rennene 78 E Other Scheduled Periodic Calibration ss isstiisiats saritincoatadeadestouiccneyasv ayaa echabaaeadabionee 78 Control Package DC Power SUppIY 2 sess ecerelenveheoe eeaasceeitns a plocapdae inane ences 79 Airway Pressure Monitor Transducer cccccccccssesssesssesssssssssseeeecsescseeceseeseeseeseeseasacaceees 81 F Scheduled Periodic Mame ane iicssacantiutinans tasmay ateaistadentasa tea tnehuaane Mani racgeliiscaedaeaiaded eons 82 G Troubleshooting sienn aster putas uate at aidan enue e cere ternile lea A aed 82 Special Environmental Considerations ccccsscsssssssssessscssssseeseesessasaeeeeeeeasaeeseseeeees 82 Electrostatic DISCH ARGS neien ee eta cela EE taal E eta eae aay 82 Electromagnetic MMPS CS ce sesvertdese ilacteses ease tay t econdex hodesent und ayeteaacalerncvaeeneuede 83 Troubleshooting Chart 2 cs 2 Fett en att Eat aS Micaela area ecco ta Sater 84 H Supplies and Replacement Parts csssscsccsssssssssssessssessscssseseseeeeceessavseeseseeeeeeseeseasaseseres 89 8 Clinical Guideline airs Ae
88. o the device When it is nearing its adjustment limit it will reach a mechanical stop Do not allow liquids to penetrate the air vents of the ventilator as this may result in machine failure or malfunction Do not use a liquid sterilization agent on the outside of the ventilator as this may cause damage The following symbols are used on this device Circuit Breaker On C Circuit Breaker Off 7 Attention Consult Accompanying Documents Alternating Current Voltage 767164 0601G Chapter 1 Introduction G Exterior Labels G Exterior Labels Patient Circuit Calibration Procedure 767164 0601G Equipment of Type B Position Lock clockwise rotation locks instrument top Counter clockwise rotation unlocks instrument top allowing it to be swiveled for best view of front controls and displays This section identifies the labels attached to the exterior of the 3100B All labels are shown at approximately their actual size Your system may not have all of the labels listed PATIENT CIRCUIT CALIBRATION PROCEDURE OFF PATIENT IMPORTANT Before use on a patient each patient circuit must be calibrated to the Model 3100B by following this procedure 1 Insert stopper in Patient Circuit Y and turn on Bias Flow gas 2 Rotate Mean Pressure ADJUST control to Max Set Max Pa Alarm to 59 cm H20 Adjust Bias Flow to 20 LPM Depress and hold RESET Oscillator OFF Observe Mean Pressure display and adj
89. om valve that must be replaced at intervals as described in Chapter 7 Two ports are provided for inserting the temperature probe of the External Humidifier One is near the patient Y the other is near the Pressure Limit Valve The inspiratory limb acts as the propagation means for the pressure oscillations generated by the Oscillator Subsystem A typical airway pressure oscillatory waveform is illustrated in Figure 3 2 767164 0601G Chapter 3 Description of System and Safety Features 31 E Patient Circuit Figure 3 2 Typical Oscillatory Proximal Airway Pressure Waveforms With Dump Valve Activation This figure also illustrates the activation of the dump valve due to the Pa being less than the lt 5 cmH20 limit or greater than the 60cmH20 limit To prevent accumulation of water from condensate within the Patient Circuit and Oscillator Subsystems a Water Trap drains them through the Oscillator Compartment Consult Chapter 7 Maintenance and Troubleshooting for details on use of Water Trap Precaution The Water Trap must be drained at intervals as described in Chapter 7 Maintenance and Troubleshooting The function of the controls discussed in the paragraphs above as well as the function of the safety alarms are discussed further in Chapter 4 Location and Function of Controls Indicators and Connections The assembly of the Patient 767164 0601G 32 Chapter 3 Description of System and Safety Feature
90. omogeneous Lung Disease The primary pulmonary diagnoses which are associated with this pattern of lung Without Significant Air Leak disease are pneumonia and acute respiratory distress syndrome For these diagnoses follow the general strategies outlined previously in this chapter 767164 0601G 98 Chapter 8 Clinical Guidelines B Disease Specific Variations to General Clinical Strategies Non Homogeneous Lung The primary diagnoses in this group of illnesses are pulmonary interstitial Disease Air Leak Syndromes emphysema PIE and severe recurrent pneumothoraces The major and Airway Disease pathophysiologic processes are persistent leak of gas from the airways and alveoli into the interstitium of the lung or into the pleural space and trapping of gas within the lung For these diagnoses also follow the general strategies outlined above but with the following important changes in emphasis and pressure levels 1 When FIO is above 0 6 place equal emphasis on weaning mean airway pressure lower even if it means accepting higher PaCO2 levels and lower PaO levels in order to further reduce the peak inflation pressure and thus the risk of gas trapping and recurrent air leak 2 Initiate therapy at a lower frequency to provide a longer expiratory time and thus further reduce the risk of gas trapping 3 Following resolution of air leak revert to general strategies 767164 0601G Chapter 8 Clinical Guidelines 99
91. ons Details concerning specific design characteristics are discussed in Chapter 2 767164 0601G Chapter 4 Location and Function of Controls Indicators 51 and Connections C Rear Panel Control Package 20 Inlet From Blender 21 Outlet To Humidifier 22 Pressure Transducer Zero Adjustment 23 Pressure Transducer Span Adjustment 24 Elapsed Time Meter 25 Power Failure Alarm Battery And Battery Compartment 26 Position Lock 767164 0601G DISS oxygen fitting for connection to an inline Inlet Filter Cartridge and then to the External Air O2 Blender output The nominal pressure of the blender output gas should be 50 psig The Source Gas Low yellow LED will light if the pressure at the inlet drops below 30 psig 5 This input connection is protected from over pressure by a 75 psig mechanical relief valve More details regarding this protection are listed in Chapter 2 Connector which provides bias flow to the inlet of the External Humidifier This is a 3 8 barbed fitting which is over pressure protected by a 5 psig mechanical relief valve The Patient Circuit assembly procedures associated with this connector are discussed in Chapter 5 See Chapter 7 See Chapter 7 Indicates the total accumulated time in hours that power has been applied to the Model 3100B Detailed specifications of this meter are discussed in Chapter 2 A metal cover fastened by 2 screws behind which is a 9 volt alkaline battery
92. ot attempt to substitute another circuit configuration as this could result in injury to the patient and or the operator or cause equipment malfunction The Patient Circuit described in this manual is specifically designed for patient use with the Model 3100B HFOV Chapter 3 Description of System and Safety Features E Patient Circuit The Patient Circuit combines the three elements necessary for ventilation of the patient using HFOV techniques bias flow Mean pressure pressure oscillations and pressure limiting The Patient Circuit is illustrated in Figure 3 1 Temperature Probe Ports Inspired Expired Y Coupler Tubes ET Tube Connection Port Bias Flow Input 3 8 Nipple Fitting Bias Flow Tube Water Trap Stopcock Figure 3 1 Details of Patient Circuit During normal operation humidified blended bias gas flows into the continuous flow line from the External Humidifier This gas flows into and through the inspiratory limb of the Patient Circuit through the Y coupler and then into the expiratory limb of the Patient Circuit While passing through the Y coupler the fresh gas exchanges oxygen and carbon dioxide at the ET tube patient connection 767164 0601G Chapter 3 Description of System and Safety Features 29 E Patient Circuit 767164 0601G A proximal airway pressure sensing line made of 1 8 Tygon tubing runs from the Y coupler to the Airway Pressure Monitor
93. patient s tcPCO2 and tcPO2 or SpO2 should be monitored continuously to insure that blood gases are at the proper level It is important that an unrestricted and unobstructed patient airway be maintained during HFOV To insure a patent airway always maintain proper suctioning procedures as described in the Suctioning Guidelines Section of Chapter 8 Clinical Guidelines Since only proximal airway pressure is measured no alarm will occur in the event of an obstruction or restriction Chapter 1 Introduction E Precautions Ensure that the stopcock is closed prior to performing a Patient Circuit Calibration If the Water Trap Stopcock is left open Patient Circuit Calibration 39 43 cmH20 may not be achievable and the deliverable Pa will be reduced Deviation from the assembly methods described in Chapter 5 Assembly and Installation could damage the Model 3100B render it mechanically unstable or cause it to malfunction If any questions arise regarding the assembly procedure please contact SensorMedics Technical Support immediately before proceeding Care should be taken not to crimp or perforate any of the control or sensing lines running to or from the Patient Circuit during assembly operating or cleaning of the ventilator as this will cause malfunction of the Safety Alarms Warning Alarms Caution Alarms and or Pressure Limit Controls The driver diaphragm of the 3100B has been coated with a special lubricant during assembly
94. pressures than conventional ventilators This capability serves to improve oxygenation by increasing alveolar recruitment and reinflation of atelectatic lung spaces and thereby improving ventilation perfusion matching Hence the therapeutic objectives in using the 3100B are to take maximum advantage of these unique characteristics General Aspects of The strategy for the MOAT II clinical trial identified an oxygenation goal of a Clinical Strategy SpO2 88 with maintenance of mean airway pressure until FiO2 could be reduced to lt 0 60 The target PaCO2 expected was between 40 70 mm Hg although a higher PaCQ gt was tolerated providing the pH was gt 7 15 Special Considerations Precaution Patient size is an important guideline as to lung volume and anatomical dead space as well as the metabolic demand placed on ventilation While the maximum displacement of the 3100B is approximately 365 ml the actual volume delivered to the patient is dependent on power setting frequency endotracheal tube size and patient respiratory system compliance The performance charts in Section 2 of this manual can be used as a guide to these relationships but they may vary somewhat with individual patients and instruments Oxygenation Mean airway pressure Pa was set 5 cm H20 greater than the Pa during conventional ventilation CMV immediately prior to transition to HFOV Target oxygenation parameters were pulse oximetry SpO2 88 with fractio
95. r and it may cause damage to the equipment The Patient Circuit described in this manual is specifically designed for patient use with the Model 3100B HFOV Only SensorMedics approved lubricants should be used Use of any other lubricants could result in damage to the Driver Diaphragm or Bellows Water Trap Membrane causing ventilator failure or patient injury The operational verification and startup procedure Chapter 6 must be followed before ventilation of a patient commences If at any time during the operational verification and startup procedure any abnormal function of the Model 3100B HFOV is noted do not proceed with patient ventilation as this could cause patient injury or death immediately contact SensorMedics Technical Support before proceeding any further An audible alarm indicates the existence of a condition potentially harmful to the patient and should not go unattended Failure to respond to alarms could result in injury including death to the patient and or damage to the ventilator Ensure that the cooling fan at the rear of the driver enclosure is operational Under no circumstances should the ventilator be used in the presence of flammable anesthetics due to the possibility of explosion 767164 0601G Chapter 1 Introduction E Precautions E Precautions 767164 0601G Under no circumstances should a proximal airway gas temperature of 41 C be exceeded This could result in injury to the patient s airw
96. r 7 could result in injury to the patient or operator or could result in damage to the equipment The Airway Pressure Monitor processes the instantaneous airway pressure measurements of its pressure transducer to derive the following 1 Mean airway pressure Pa 767164 0601G Chapter 3 Description of System and Safety Features 35 H Electronic Control and Alarm Subsystem H Electronic Control and Alarm Subsystem 767164 0601G 2 Oscillatory peak minus oscillatory trough pressure AP Mean Airway Pressure is essentially an arithmetic mean of the airway pressure measurement It is obtained by filtering the instantaneous pressure signal with a DC to 0 5 Hz low pass filter The AP reading is obtained by subtracting the oscillatory trough pressure from the peak pressure A detailed list of specifications for the Airway Pressure Monitor is contained in Chapter 2 A detailed description of the use of its control and display is contained in Chapter 4 This subsystem contains the Oscillator Subsystem Controls and the alarm functions It consists of various electronic circuits and logic elements It integrates information received from the Airway Pressure Monitor to react in a fashion safest for the patient It utilizes this information to orchestrate the activity of the Oscillator Subsystem and the Pneumatic Logic and Control Subsystem The following are the Oscillator Subsystem controls which form a part of the Electroni
97. r Performance Check Failure 86 Ventilator Performance Checks Label 8 Verification Operational 64 W Warning Alarms 16 Warnings 1 Water Trap 31 39 54 Water Trap Drain Valve 54 Water Trap Emptying 73 Weaning 95 Wilford Hall Medical Center 90 X X Ray Chest 100 Z Zero Adjustment Pressure Transducer 80
98. r the battery has been replaced by a new one or the source gas pressure increases above 30 psig respectively The user should investigate the cause of the alarm If the problem is a loss in blender output pressure the Warning or Safety Alarms will soon be activated If the problem is a loss of oscillator cooling air the Oscillator Overheated alarm will soon activate This alarm can occur due to plugging of an Inlet Filter Cartridge with dirt Refer to the Operator Maintenance Procedures section of Chapter 7 for instructions on changing the Inlet Filter Cartridges The battery will be discussed further in the next section covering the operation and location of the rear panel controls indicators and connections 767164 0601G Chapter 4 Location and Function of Controls Indicators 49 and Connections B Front and Side Panel Control Package 16 Oscillator Overheated 17 Oscillator Stopped 18 45 Sec Silence Pushbutton 19 Patient Circuit Calibration 767164 0601G Indicates that the oscillator coil is overheated and has reached approximately 150 C Since this is a Caution Alarm a yellow LED is used and there is no audible indicator This alarm will reset only after the condition has been corrected The operator should determine if the problem is a loss of or decrease in cooling gas pressure This could be caused by low gas pressure at its source an occlusion such as a kinked tube or plugged Inlet Filter Cartrid
99. rate possibly insufficient re adjust Pa using higher flow Also consider Clinical status of patient Change setting Replace the patient circuit Replace the patient circuit Check and correct circuit temperature Remove the source of interference 767164 0601G Chapter 7 Maintenance and Troubleshooting G Troubleshooting 85 Visual Audible Alarm Occurring cont Possible Causes Patient spontaneously breathing Condition Displayed Pa lt Set Min Pa Thumbwheel Alarm Improper setting of thumb wheel switch Improper setting of Pa adjust or flow meter Patient circuit temperature drop Leak in patient circuit or humidifier Cap diaphragm leak Interference from a radio transmitter Improper setting of Pa adjust or flow meter Displayed Pa lt 5 cmH20 Alarm Leak in humidifier or patient circuit including patient disconnect Cap diaphragm leak Interference from a radio transmitter Open Water Trap Stopcock Power setting too low and AP is less than or equal to 7 cm H20 Oscillator Stopped with no other alarm occurring Oscillator Failure Visual Audible Alarm Occurring cont Condition Possible Causes 767164 0601G Possible Remedies Bias Flow rate possibly insufficient re adjust Pa using higher flow Also consider clinical status of patient Change setting Change setting Check and correct circuit temperature Eliminate leak or replace circuit Replace cap diaphr
100. s F Oscillator Subsystem Circuit onto its mounting arm and its connection to the rest of the HFOV system is discussed in Chapter 5 Assembly and Installation F Oscillator The components of the Oscillator Subsystem are illustrated in Figure 3 3 The Subsystem design incorporates an electronic control circuit square wave driver which drives a linear motor which in turn drives a piston assembly It is very similar to a permanent magnet speaker Pressure Compressed Air __ Regulator Air Amplifier Flexible Diaphragm Bellows Plastic Bellows Housing A Patient Circuit Port Diaphragm Condensate Drain Tube Water Trap Square Wave Driver Figure 3 3 Details of Oscillator Subsystems One of the major features of the design is that there is no physical contact between the permanent magnet and the electrical coil which is suspended by spiders within the permanent magnet This results in a very efficient frictionless oscillator system with an operational life of more than 2 000 hours 767164 0601G Chapter 3 Description of System and Safety Features 33 F Oscillator Subsystem 767164 0601G When the square wave driver is of positive polarity it drives the electrical coil and the attached piston forward in the direction of the patient inspiration When the polarity is negative it drives the electrical coil and the attached piston
101. s 55 and Connections D System Column and Patient Circuit 36 Water Trap 37 Water Trap Drain Valve 38 Bellows Fasteners 39 Patient Circuit Cradle 40 Humidifier Tubing 767164 0601G Chapter 5 for details on attachment of the control line to its valve This line should be replaced periodically during scheduled preventive maintenance of the HFOV Condensate should drain into the water trap if the Patient Circuit is positioned properly There is a small 025 diameter hole at the top of the water trap to allow air to escape as it fills Allows draining of water condensate Water is drained from the bottom when the stopcock is opened The contents of the water trap can be drained while the Model 3100B is still operating as long as the water seal between the ventilator and the bottom drain is not broken This can be accomplished by always leaving a small amount of water at the bottom of water trap after draining Follow the instructions in Chapter 7 regarding cleaning and disinfecting the water trap and valve mechanisms Precaution Ensure that the stopcock is closed prior to performing a Patient Circuit Calibration If the Water Trap Stopcock is left open Patient Circuit Calibration 39 43 cmH20 may not be achievable and the deliverable Pa will be reduced Four quarter turn fasteners that hold the bellows Oscillator Compartment in place in front of the oscillator piston For attachment of Patient Circuit
102. s imperative that the prescribed gas mixture is delivered by the blending system 17 Remove the Patient Circuit stopper Adjust the External Humidifier to establish the desired gas temperature at the patient airway temperature port Connect the Patient Circuit to the patient ET tube Warning Under no circumstances should proximal airway gas temperature of 41 C be exceeded This could result in injury to the patient s upper airway membranes Warning Do Not use the 3100B ventilator in environments where the ambient temperature is at or above 84 F 28 C Use of the ventilator in these environments will result in extreme reduction in relative humidity in the patient s airway and possible desiccation of the patient airways 767164 0601G 70 Chapter 6 Operational Verification and Start up Procedures B Start up Procedures Precaution When the ventilator is connected to a patient it is imperative that someone be in attendance at all times in order to react to any alarms and to detect other indications of a problem 18 Push the Reset pushbutton until the Pa lt 5 cmH20 LED is extinguished to reestablish Mean Pressure 19 Set the Power control for the desired AP see Chapter 8 20 Readjust the Frequency Inspiratory Time Power Mean Pressure and Bias Flow as needed during patient ventilation Warning Under no circumstances should the ventilator be used in the presence of flammable anesthetics
103. s Arata e Ea adbeast ee S 91 A Treatment Strategies act ees sect a aes A Oat et haat te ea tttael 91 Adjusting the 3100B s Controls to Execute the Treatment Strategies ccccseeeee 91 767164 0601G Table of Contents xiii 3100B High Frequency Oscillatory Ventilator Therapeutic Objectives csser a a cig a ds 95 General Aspects of Clinical Strategy ccccccsssssssssssssssssssssceceeeesescssasseeseeeeesananeceseeeees 95 Summary of MOAT II clinical management strategies ce ceeeeeeteeseeteeeeeeeeeeeeeeneees 97 Summary of weaning strategy from MOAT II Clinical Trail 98 B Disease Specific Variations to General Clinical Strategies eeteeeteeesesteeeetetseeteeeneees 98 Homogeneous Lung Disease Without Significant Air Leak 0 0 eee ceceeesteteeeeseeteneeteeees 98 Non Homogeneous Lung Disease Air Leak Syndromes and Airway Disease 98 C Adverse ENCCS 2 ts halantaveenuiat a teeta ni a pet anced lun dares ald 99 D Recommended Monitoring Frequency js tscajedccscia atid ede dtietle awa tatdaaiedantuaadaunee 100 Arterial BIOOd Gases icasi scum isonet eek cette ea ean hal ete aad ea 100 Non Invasive Blood Gases tcO2 tCCO2 and SpO2 cceeeseeeseeceeetetetseeeseetenenteetees 100 Chest AMY cee et el al tah ee Da E E tae teas 100 E Suctioning GUIDCIIN CS secs cecsses teasaczencetdavient tancess test ien ates gedsleecntincecuansesnaadinsieaioreuetesdetaedeeee 101 In index aneren er ea
104. spected 767164 0601G Chapter 8 Clinical Guidelines 101 E Suctioning Guidelines E Suctioning Guidelines Disconnection and Reconnection 767164 0601G The need to suction during HFOV use should be determined based on institution policy and clinical signs just as with CV The Multi Center Studies found no difference in the frequency of suctioning between the HFOV and CV patients However some have observed that more frequent suctioning becomes indicated during the treatment of the sickest patients especially after they have stabilized Precaution Do not use extraneous ventilator circuit attachments such as a suction port without a secondary external alarm capable of detecting ventilator disconnection Due to their inline pressure characteristics such attachments could possibly keep the Pa alarm from detecting an accidental ventilator circuit disconnection The correct steps for disconnection and reconnection of the patient are as follows 1 Press the Alarm Silence All the audio alarms will be inactive for 45 seconds Note the settings for Pa and Power setting 2 Disconnect patient This should allow the lt 5 cmH20 Pa alarm to open the dump valve and stop the oscillator 3 Perform suctioning using your institution s standard technique 4 Reconnect patient 5 Press and hold RESET Once the Pa rises above 5 cmH20 the oscillator will restart Readjust Power and Mean Pressure until Pa and AP are at th
105. sure that can be attained with a particular Patient Circuit under specified conditions This control is used only when the Patient Circuit is replaced or the Pa control valve diaphragm of the existing Patient Circuit is changed Refer to Chapter 7 Maintenance and Troubleshooting for the complete setup procedure The Pressure Limit Valve limits the Pa When an abnormal condition exists or when the system mean pressure increases due to an inadvertent or deliberate control setting change this valve acts to limit the mean proximal airway pressure Both the Pa Control Valve and the Pressure Limit Valve are mushroom valves that must be replaced periodically according to the procedures in Chapter 7 Maintenance and Troubleshooting Chapter 3 Description of System and Safety Features E Patient Circuit The Dump Valve is activated by the Electronic and Pneumatic Control Subsystems only when the safety alarms are activated The safety alarms are the following 1 Pa gt 60 cmH20 2 Pa lt 5 cmH20 The Dump Valve when activated will open the entire Patient Circuit to ambient air It allows the patient the opportunity to breathe spontaneously at normal atmospheric pressure when the safety alarms have been activated In an emergency situation the Dump Valve helps to prevent a decrease in cardiac output due to sustained elevated Patient Circuit pressure or atelectasis due to a negative Patient Circuit pressure The Dump Valve is a mushro
106. t Max Pa and Set Min Pa alarms by setting the Max thumb wheel just below the established Mean pressure and by setting the Min thumb wheel just above the established Mean pressure 11 Set these thumb wheel alarm switches to their desired settings This is generally 2 5 cmH20 above Max thumb wheel and below Min thumb wheel the established Mean pressure 12 With fingers and thumb s squeeze closed the 1 8 clear Pressure Sense tubing on the patient circuit to verify operation of the Pa gt 60 cmH20 alarm 767164 0601G Chapter 6 Operational Verification and Start up Procedures 69 B Start up Procedures 13 Depress the RESET button until the Pa lt 5 cmH20 LED is extinguished to reestablish the mean airway pressure 14 Again squeeze the pressure sense tubing on the patient circuit and observe the pressure at which the Mean Pressure display limits 15 Position the ventilator for connection to the patient Loosen the Position Lock control and adjust the angle of the Control Package for the best view and access relative to the patient Retighten the Position Lock 16 Set the desired oxygen Mean Pressure and AP for the patient AP will affect the Pa depending on ratio of Flow Rate Pa The lower the ratio the stronger the effect Precaution Fractional concentration of inspired oxygen should be verified with an oxygen monitor Administration of excessive oxygen to a patient may be harmful It i
107. t R9 for a reading of 5 volts 0 25 volts on the digital voltmeter 8 Connect the negative lead of the voltmeter to the 15V Com terminal 9 Connect the positive lead of the voltmeter to the 15V terminal 10 If necessary adjust R57 for a reading of 15 volts 0 75 volts 11 Connect the positive lead of the voltmeter to the 15V terminal 12 If necessary adjust R82 for a reading of 15 volts 0 75 volts 13 When calibration has been completed replace the column covers 767164 0601G Chapter 7 Maintenance and Troubleshooting 81 E Other Scheduled Periodic Calibration Airway Pressure Monitor Transducer 767164 0601G The calibration procedure for the Airway Pressure Monitor Transducer is as follows NO ow iN on 6 N foe Locate the pressure transducer ZERO and SPAN screwdriver adjustable controls on the rear panel of the Control Package below the battery compartment see Figure 4 2 Have a suitably small screwdriver available to make any necessary adjustments Attach a digital readout type pressure transducer meter to the bottom leg of a 1 8 T fitting Attach one of the arms of the T fitting directly to the pressure sense fitting of the patient Y Attach the 3100B s 1 8 Tygon pressure sense tubing directly to the other arm of the T fitting Plug the end of the patient circuit T with a 1 rubber stopper Turn on the bias flow g
108. t if the pressure at the inlet drops below 30 psig 5 During normal maintenance as described in Chapter 7 record the reading on the Elapsed Time Meter for quick reference During normal maintenance as described in Chapter 7 record the reading on the Elapsed Time Meter for quick reference 767164 0601G Chapter 4 Location and Function of Controls Indicators 53 and Connections D System Column and Patient Circuit D System Column and Patient Circuit Figure 4 3 System Column and Patient Circuit Controls and Connections The numbers shown on Figure 4 3 correspond to the numbers on the following descriptions 767164 0601G 54 Chapter 4 Location and Function of Controls Indicators and Connections D System Column and Patient Circuit 30 Power Switch 31 Oscillator Compartment Bellows 32 Pa Control Valve Control 33 Dump Valve Control 34 Pa Sense 35 Pa Limit Valve Control Precaution Care should be taken not to crimp or perforate any of the control or sensing lines running to or from the Patient Circuit during assembly or operation of the ventilator as this will cause malfunction of the Safety Alarms Warning Alarms Caution Alarms and or Pressure Limit controls Turns power to the Model 3100B System on and off This power switch also functions as a circuit breaker in case of a power overload If the circuit breaker trips be sure to locate the problem causing the power overload
109. the Electronic Control and Alarms Subsystem the Airway Pressure Monitor and the Oscillator Subsystem Detailed specifications are listed in Chapter 2 Maintenance procedures are covered in Chapter 7 The Model 3100B HFOV system has been designed with numerous safety features both to help avoid patient injury and to protect the equipment from damage These safety features are incorporated into the design of the various subsystems 1 Warning Alarms 2 Safety Alarms 767164 0601G Chapter 3 Description of System and Safety Features 37 J Safety Features 767164 0601G 3 Power Failure Alarm 4 Oscillator Stopped Alarm 5 Caution Alarms 6 Oscillator thermal cutout 7 Water trapping for condensate 8 Pressure relief valves to protect the equipment from over pressure damage 9 Oscillator startup logic to prevent application of excessively high or low oscillatory pressures to patient The Warning Alarms consist of the Max and Min Pa Exceeded settings and indicators In the event that the proximal pressure meets or exceeds the set Max Pa alarm setting an audible and visual alarm will occur and the ventilator will depressurize the Limit Valve seat pressure Once the mean airway pressure falls to a level of 12 3 cm H20 below the Set Max Pa setting the Limit Valve will re pressurize to its normal operational state Should the high mean airway condition persist the alarm will repeat until the condition is resolved Once
110. the instrument may cause erroneous pressure readings which can lead to false alarms and automatic shut down These erroneous pressure readings are not due to fluctuations in the actual pressure but are the effect of EMI on the components of the measurement circuits Once the disturbance stops the reading returns to normal If the condition of interference is strong enough and lasts long enough the gt 60cmH20 or the lt 5 cmH20 alarms may be triggered which will cause the dump valve to open and the oscillator to stop Once the EMI disturbance has stopped or has been removed press the reset switch to restart the oscillator The situation can generally be remedied by locating the offending device and then distancing it at least 20 feet away In addition to the radiated EMI described above conducted EMI can also cause the same problems by disturbing the AC power line Typical devices which can exhibit this phenomenon are personal computers and other devices that rely on high speed switching electronics This sort of interference can be difficult to locate if there are many such devices in the immediate vicinity Without expensive electronic detection equipment the only means available to locate the offending device is to power down the surrounding systems one at a time until the interference is removed It is important to note that radiated interference from hand held radio transmitters is the most common and sources such as these should be isolate
111. tilation For most therapeutic situations 33 has been found to be effective for most patients This control typically does not change during the course of treatment As for the adjustment of inspired oxygen concentration F102 the basic strategy employed with the 3100B is the same as in conventional ventilator strategy wean the concentration lower as tolerated Having addressed these seldom changed controls and the approach to FlO2 management it is time to turn attention to the two controls at the heart of the strategy for patient management with the 3100B mean airway pressure and oscillatory pressure amplitude AP The table below summarizes the ranges of control settings employed during the MOAT II Clinical Trial Mean and Standard Deviation of 3100B Settings from MOAT II Clinical Trial Mean Standard Deviation Patient Weight kg 78 25 24 hours 48 hours 72 hours FiO2 0 51 0 15 0 52 0 17 0 51 0 15 Mean Pa cm H20 29 6 28 6 28 6 Frequency Hz 4 7 0 7 4 7 0 7 4 5 0 9 Amplitude cm H20 66 14 65 13 66 17 Mean airway pressure changes are accomplished by a single turn control that varies the inflation of a mushroom valve which in turn increases the resistance to the exit of the bias flow from the expiratory limb of the patient circuit The 767164 0601G Chapter 8 Clinical Guidelines 93 A Treatment Strategies Oscillatory Pressure Amplitude
112. ure Protection 75 psig 15 relief valve Air Cooling Inlet DISS air fitting Pressure Range 40 60 psig Flow 25 LPM 10 Overpressure Protection 75 psig 15 relief valve Outlet to Humidifier 3 8 barbed fitting Overpressure Protection 5 psig 15 relief valve Pa Control Valve Coded green Luer bulkhead 767164 0601G Chapter 2 Specifications 19 G Physical Pa Limit Valve Coded blue Luer bulkhead Dump Valve Coded red Luer bulkhead Pa Sensing Coded white Luer bulkhead G Physical Materials All materials used in the construction of the 3100B instrument and its breathing Dimensions of Column and Control Package Pedestal Required Environmental and Operational Conditions 767164 0601G circuit are non toxic and pose no safety risk to the patient or operator Height 53 8 Width 18 6 Depth 11 4 Weight 143 Ibs 5 legs each with 4 diameter locking wheels 28 width across bottom of pedestal Precaution Do not place on the control package of the ventilator any fluid containing accessories accessories that weigh more than 10 pounds or accessories that extend more than six inches above the ventilator electronics package or beyond its sides This could cause damage to the ventilator or could cause the ventilator to tip over resulting in patient or user injuries and or damage to the equipment 1 Temperature 5 28 C 2 Humidity 15 95 non condensing 3 Certain specific environmental fa
113. ust Patient Circuit Calibration screw for a reading of 39 43 cm H20 P N 772754A Figure 1 1 Patient Circuit Calibration Procedure Label The Patient Circuit Calibration Procedure Label describes the steps necessary to calibrate the patient circuit to the 3100B This procedure is also explained in the Patient Circuit Calibration Section of Chapter 7 Maintenance and Troubleshooting 8 Chapter 1 Introduction G Exterior Labels erformance Checks OFF PATIENT These graphs illustrate the typical performance to be expected from the Model 3100B Minimum AP vs POWER Range of Static MEAN Pressure vs BIAS FLOW Paw cmH 0 PRESSURE cmH20 0 a R E 0 5 10 15 20 5 30 35 40 45 50 55 60 Power Setting Bias Flow LPM OFF PATIENT Insert Stopper in Patient Circuit Y and turn on both gas sources Set BIAS FLOW for 30 LPM Set max Paw Alarm to 35 cmH20 Pressurize system by pressing and holding RESET and ADJUST for a Mean Pressure of 29 31 cmH20 Set FREQUENCY to 6 l Time to 33 and press START STOP to start the oscillator Set POWER to 6 0 7 Observe the following parameters using the appropriate altitude range and verify they fall within the ranges specified Wh on lor ALTITUDE FT MEAN cmH20 AP cmH20 0 2000 22 30 108 130 2000 4000 22 30 99 120 4000 6000 22 30 90 110 6000 8000 22 30 81 100 767165 101F Fi
114. ve 30 Dump Valve Control 53 E Effects Adverse 1 Elapsed Time Indicator 15 Elapsed Time Meter 50 Electrical Power Supply 36 Electrical Specifications 17 Electromagnetic Interference EMI 82 Electronic Control and Alarm Subsystem 35 Electrostatic Discharge ESD 81 EMI Electromagnetic Interference 82 Emptying the Water Trap 73 Environmental and Operational Conditions 19 Environmental Considerations 81 Explanation of Symbols 6 Exterior Cleaning 72 F Filter Cartridge Elements Compressed gas Inlet Changing 73 FIO2 91 Flow Bias 90 Forty five Sec Silence Pushbutton 48 Frequency 91 Frequency Control 13 44 Frequency Indicator 15 G Gas Connections 18 General Clinical Strategies Disease Specific Variations 98 Graphs Performance 20 104 Index H Hold Down Strap 55 Homogeneous Lung Disease 98 Humidifier 61 Humidifier Tubing 54 Humidifier External 25 Humidity 19 hypotension 98 Indications for Use 1 Indicators 14 Indicators Location and Function 40 Inlet Fitting from Blender 50 Inspiratory Time Control 13 Inspiratory Time Percent 91 Installation 56 Interference Electromagnetic 82 Introduction 1 L Labels Exterior 7 Leakage Current 17 Lint Filter Column Cleaning 75 Lubrication Driver Diaphragm 75 Maintenance 72 Maintenance Procedures Operator 72 Maintenance Periodic Scheduled 81 Mean Airway Pressure 3
115. via a white Luer bulkhead fitting near the Patient Circuit connection The pressure signal is processed to determine various pressure measurements and alarm conditions The Airway Pressure Monitor and tubing are discussed in a following section The expiratory limb carries the exchanged gas to the Pa Control Valve This valve allows two expiratory flow paths One path is a variable restriction controlled by the Pa Control Valve control line extending from the Pneumatic Logic and Control Subsystem via a green Luer bulkhead fitting near the Patient Circuit connection The other flow path is a fixed orifice that requires a minimum bias flow be maintained through the Patient Circuit to ensure a flow of fresh Bias Gas regardless of the setting of the Pa Control Valve When the Pa Control Valve is changed it adjusts the mean airway pressure at the ET tube patient connection after about five system time constants have elapsed but only if the set bias flow and oscillator characteristics remain unchanged for the same time period Five time constants will vary from about one second to as long as 30 seconds This time constant varies directly with Pa and inversely with bias flow The individual elastic and dimensional characteristics of the Pa Control Valve diaphragm interact with the valve control line pressure to determine the control dial maximum setting The Patient Circuit Calibration control provides a screwdriver adjustment to set the maximum mean pres
116. was lt 24 cm H20 with SpO2 88 For transition back to CMV the conventional ventilator was set in the pressure control mode with peak inspiratory pressure adjusted to achieve a delivered tidal volume of 6 10 ml kg of actual body weight PEEP 10 cm H20 and 1 1 I E ratio These settings were designed to achieve a Pa of close to 20 cmH20 approximating the Pa on HFOV just prior to changing to CMV Summary of MOAT II Clinical Management Strategies Management Strategy 767164 0601G Chapter 8 Clinical Guidelines 97 B Disease Specific Variations to General Clinical Strategies Target SpO2 88 Target PaCOz 40 70 mm Hg Initial Setting Continued Management Pa CMV Pa 5 cm H20 Increase Pa to achieve the oxygenation goal 45 cm H20 maximum Amplitude Visible chest movement Adjust the amplitude to achieve the PCO2 goal If the amplitude is maximized decrease the frequency by 1Hz Frequency 5 Hz increments until the ventilation goal is reached If Frequency 3 Hz deflate ETT cuff FiO2 As Needed Maintain Pa until FiO2 lt 0 60 Sp02 gt 88 Insp Time 33 Summary of Weaning Strategy from MOAT II Clinical Trial Weaning from HFOV Transition to CMV when FiO2 lt 50 and Pa lt 24 cmH20 Tidal Volume LE Ratio PEEP Mode Initial CMV Settings 6 10 cc Kg 1 1 10 cmH20 Pressure Control B Disease Specific Variations to General Clinical Strategies H
117. water at the bottom of the Water Trap container to act as a flow and pressure seal between the ventilator and the output of the drain There are also mechanical pressure relief devices to protect the equipment from damage A 75 psig mechanical relief valve protects the Inlet from Blender and the Air Cooling Inlet connections The Outlet to Humidifier connection is protected by a 5 psig mechanical relief valve These devices function whether the Model 3100B HFOV is electrically energized or not The oscillator will not start unless the controls are used in the proper sequence and or set to the proper range The startup procedure is described in Chapter 6 Operational Verification and Startup Procedures 767164 0601G Chapter 4 Location and Function of Controls Indicators 41 and Connections A Introduction A Introduction This chapter describes the location function and use of each control indicator and connection on the Model 3100B HFOV They are illustrated with reference numbers on the illustrations contained within this chapter Detailed specifications of the resolution and accuracy of controls and indicators are contained in Chapter 2 The theory of operation of the overall Model 3100B system and each of its subsystems is explained in Chapter 3 Description of System and Safety Features Precaution Proper operation of the ventilator must be verified prior to each use Refer to Chapter 6 Operational
118. which ventilation carbon dioxide removal is achieved is the high frequency tidal volume created by the oscillatory pressure swings AP Hence as the Power control is increased the piston displacement increases the AP increases the tidal volume increases and ventilation increases Although the great majority of patients can be ventilated with this straightforward method of adjusting AP upwards to counter a high PaCOz level there are some patients who require an even larger AP When this is the case the strategy is to take advantage of the frequency dependent nature of the attenuation caused by the ET tube As the frequency is reduced the attenuation diminishes and a larger distal AP occurs resulting in an increase in delivered tidal volume Reducing the frequency in 1 Hz increments is generally sufficient to control persistently high PaCOQz levels In some patients the frequency may have to be reduced to 3Hz Assuming that peak alveolar pressure is the causative factor in airway rupture the principle advantage of HFOV over conventional ventilation is its ability to maintain adequate ventilation and oxygenation at lower peak alveolar pressures Because ventilation is so readily achieved with relatively low oscillatory pressure 767164 0601G Chapter 8 Clinical Guidelines 95 A Treatment Strategies amplitudes patients can be managed at higher mean airway pressures while simultaneously operating at lower peak alveolar

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