INFANT VENTILATOR MODEL IV-100B OPERATIONAL INSTRUCTIONS AND ROUTINE MAINTENANCEPee SELARIST Sr EC DECLARATION OF CONFORMGTY We, Sechrist Industries, Inc. Sechrist Industies GmbH 4225 East La Palma Avenue Frauholz-strasse 9B Anaheim, California 92807. CH-6422 Steinen U.S.A Switzerland (714) 579-8400 41-41-832-23-23 declare under sole responsibility that the Model IV-100B Infant Ventilator + Model 3200/3200R Hyperbaric Chamber Model IV-100B SAVI System Model 2500E/2500ER Hyperbaric Chamber Model TV-200 Infant Ventilator © Model 3200E/3200ER Hyperbaric Chamber Model IV-200 SAVI System to which this declaration relates, meets the essential health and safety requirements and is in confommity with the Council Directive No 89/336/BEC of 3 May 1989, as amended by Council Directive No 92/3 1/EEC and Council Directive No $3/S8/EEC, relating to electromagnetic compatibility and the following karmonized standard end other normative documents: EN 60601-12 "IEC 601-1-2: 1993 Medical electrical equipment Part 1: General requirements for safety - 2. Collateral standard: Electromagnetic compatibility - Requirements and tests” The conformity of these products was evaluated and confirmed by TUV Product Serv: GmbH. jevice in accordance to The following CE conformity marking has been affixed on th the directive requirements. Greg Godirey, Vice President Quality Assurance/Regulatory Afftirs Sechrist Industries, Inc., Anaheim September 1997 4208 £. ta rama Ave Telephone 714/579-8400 + FaxS ‘ WARRANTY SECHRIST INDUSTRIES, INC. warrants this product to meet the published specifications and "e free from detects in material and workmanship under normal use for a period of one (1) year from the date of purchase. THE FOREGOING IS IN LIEU OF ANY OTHER WAR- RANTY, EXPRESS, IMPLIED OR STATUTORY, INCLUDING WITHOUT LIMITATION ANY WARRANTY OF MERCHANTABILITY. The sole liability of SECHRIST under this warranty is limited to replacing, repairing, or issuing credit at the discretion of SECHRIST for the products, equipment or parts which fail to meet the published specifications or which be- come defective during the warranty period and which are upon examination by SECHRIST found not to meet the published specifications or to be defective in material or workman- ship. SECHRIST will not be liable under this warranty unless the following provisions are strictly complied with: (a) SECHRIST is promptly notified, in writing, upon discovery of the failure of said product or equipment to meet the published specifications or of defects in ma terial or workmanship, (b) the defective product, equipment or part thereof is returned to SE~ CHRIST, transportation charges prepaid by the buyer, (c) the defective part is received by SECHRIST for examination no later than one (1) month following the expiration of the war- ranty period and provided (¢) that examination by SECHRIST of said product, equipment or part shall disclose to SECHRIST'S satistaction that such defect has not been caused by improper usage, accident, neglect, alteration, abuse, improper installation or unauthorized repair. Products, equipment or parts replaced under this warranty are warranted only through the terms of the original warranty. SECHRIST neither assumes nor authorizes any other person or entity to assume for it any other warranty, obligation or liability in connec- tion with its products or equipment whatsoever, and this warranty can only be changed in writing by a duly authorized representative of SECHRIST. SECHRIST makes no represen- tations or warranties whatsoever as to the fitness or usefulness of the products or equip- ment manufactured by it for any medical treatment, physical condition or other purpose whatsoever. In no event shall SECHRIST be liable for personal injury, property damage or any special or consequential damage to any buyer, user or any other person whomsoever, including, but not limited to, loss of profits, loss of use of the product or equipment, or for damages of any other kind whatsoever based on a claim for breach of warranty other than a refund of the purchase price of any defective product or equipment. Any authorization for repair or alteration by buyer must be in writing from SECHRIST to prevent the voiding of this warranty. In the event SECHRIST or its representatives render any technical advice or service of any kind to buyer or anyone else in connection with the equipment or products covered by this warranty, the buyer hereby releases SECHRIST from all liability of any kind whatsoever as a result thereof; and the warranty as hereinbefore set forth shall not be enlarged or affected by said action by SECHRIST.KK KK KKK * sarery anert ¥ HK KKK KKK SECHRIST/HEALTHDYNE (INFRASONICS] INCOMPATIBILITY It has come to our attention at Sechrist Industries, that the diaphragm retaining cap of the Healthdyne (Infrasonics) Model 190 reusable exhalation valve is similar in appearance to the retaining cap (P/N IV- 305-02) provided with the Sechrist Model Iv-305 and IV-335 neonatal exhalation valve. In fact, the Healthdyne ( ‘asonics) component can be interchanged with the end cap provided with the Sechrist exhalation valve. When the Sechrist exhalation valve is assembled with the Healthdyne (Infrasonics) component, the inspiratory pressure control of the Sechrist Infant Ventilator (Models IV-100, IV-100B and/or IV-200) may be adversely affected. Our engineers have discovered that at certain ventilator control settings, patient circuit pressure will build uncontrollably (to the static safety pressure relief valve setting) when the Healthdyne (Infrasonics) component is used in the Sechrist exhalation valve. Sechrist Industries feels that such inter: lethal to the neonatal patient. Please take 4 following principle differences between the (Infrasonics) components. 2 HOLES © GT 1 HOLE SECHRIST HEALTHDYNE (INFRASONICS) ty is potentially oments to note the hrist and Healthdyne End view, Inside - Two holes are drilled into the Sechrist cap; = single hole is drilled into the Healthdyne (Infrasonics) cap. Side View - The Sechrist cap exhibits: a narrow O-ring retaining and a wider groove towards the inside end. The Hea. infrasonics) cap only exhibits a narrow O-ring retaining groove. sed tab on the outside end of the Sechrist cap is machined £1 raised tab of the Healthdyne (Infrasonics) cap has a curved surfa ease contact Technical Assistance, if you have any questi garding this. incompatibility.SECHRIST MODEL IV-100B INFANT VENTILATOR OPERATIONAL INSTRUCTION MANUAL OWNER/USER RESPONSIBILITY 1-2 SECTION 1. | INTRODUCTION A. SUMMARY OF WARNINGS AND CAUTIONS 3-6 2. OPERATING INSTRUCTIONS A. GENERAL DESCRIPTION 7-10 B. DESCRIPTION OF CONTROLS 11-18 C. PATIENT CIRCUIT 19 - 25 D. ‘SET-UP AND OPERATION 26 - 30 E. ACCESSORY APPLICATIONS 1. PEDIATRIC EXHALATION VALVE 31-34 2, ANESTHESIA EXHALATION VALVE 34 - 36 3. 12 V.D.c. OPERATION 36 . VARIATION OF THE AIRWAY PRESSURE WAVEFORM 38 3. SPECIFICATIONS 39 - 41 4. PERFORMANCE VERIFICATION PROCEDURE 42 - 46 5. SERVICE POLICY 47 6. | ROUTINE MAINTENANCE A. CLEANING & STERILIZATION 48 B. TROUBLESHOOTING 49 - 50 C. | ROUTINE MAINTENANCE PROCEDURES 51 - 55 D. REPLACEMENT PARTS LIST 56 - 63 7. UNDERSTANDING GUIDE A. UNDERSTANDING THE Iv-100 64 - 76 B. UNDERSTANDING THE SECHRIST AIR OXYGEN MIXER 77 - 82 P/N 100088 -Rev 4 08/24/94OWNER/USER RESPONSIBILITY Caution: Federal law restricts this device to sale by or on the order of a physician. The Sechrist Model IV-100B Infant Ventilator is a sophisticated instrument designed for use by qualified personnel under the direction of a qualified Physician. Before attempting to use this device in an actual life support situation, the operating personnel must become thoroughly familiar with the instructions in this manual. The Sechrist Model IV-100B Infant Ventilator will perform in conformance with the specifications and description contained in this instruction manual and other accompanying labeling when assembled, operated, maintained and repaired in accordance with the instructions contained in this manual. The ventilator must be checked periodically as specified in this manual. (See the Performance Verification Procedure.) A defective ventilator should not be used. Should repair be necessary, Sechrist Industries, Medical Products Division, recommends that a request for service be communicated to the Authorized Sechrist Distributor which originally effected delivery of the device. If a suitable response is not received within a reasonable tine, communicate directly with our home office in Anaheim, California. This product should not be repaired other than in accordance with written instructions from Sechrist, or modified in any way without written approval from Sechrist. The user of this product shall have the sole responsibility for any malfunction which results from improper use, faulty maintenance, improper repair, damage or alteration by anyone other than Sechrist Industries. TO PROPERLY IMPLEMENT THIS WARRANTY, THE END-USER MUST COMPLETE AND RETURN THE WARRANTY ENACTMENT FORM TO SECHRIST INDUSTRIES. A COMPLETED WARRANTY ENACTMENT FORM MUST BE ON FILE WITH SECHRIST INDUSTRIES BEFORE WARRANTY SERVICE CLAIMS WILL BE HONORED.WARNING It should be noted that whenever a patient is attached to a ventilator, constant attendance is required by qualified personnel. The use of a ventilator with built-in alarm systems or additional alarn systems does not give absolute assurance of warning for every type of malfunction that may occur with the ventilator/patient system. In addition, some problems may require immediate attention. WARNING only use replacement parts provided or approved by Sechrist Industries, Inc.INTRODUCTION You may be very anxious to put your new Sechrist Model IV-100B Infant Ventilator to use, but before you do, we ask you to thoroughly read through these instructions. Please follow all instructions to be sure that the unit has arrived safely and will perform its intended design functions. These instructions are intended to make operational personnel fully aware of the function and effect of the various controls, performance verification procedures and maintenance requirements of our device. First, determine that all the pieces have arrived. Compare the contents of the packages received with the shipping bill of materials. Second, determine that all the pieces have arrived without physical damage. visually inspect everything. Should any damage be found, it must be reported to the shipping carrier as soon as possible, otherwise it becomes difficult to make a claim. Finally, please take a moment to complete and return the Warranty Enactment Form in this manual or a facsimile thereof to effect the product warranty. A completed Warranty Enactment Form (signed and dated) must be in the possession of our home office before any claims for warranty parts or service will be honored. Please return the completed Warranty Enactment Form to: SECHRIST INDUSTRIES, INC. 4225 EB. La Palma Ave. Anaheim, CA 92807 PHONE: (714) 579-8400 A. SUMMARY OF WARNINGS AND CAUTIONS Caution: Federal law restricts this device to sale by or on the order of a physician. While operating personnel must become thoroughly familiar with all instructions in this manual, all statements preceded by the following words have special significance. WARNING Indicates that there is a possibility of personal injury to the operator and/or the patient. CAUTION | Indicates that there is a potential for) damage to the equipment and/or other | property if the precaution is ignored.NOTE: Indicates points of particular interest which are intended to supplement the basic instructions for more efficient and/or convenient operation. INFANT VENTILATOR WARNINGS SUMMARIZED Whenever a patient is connected to the ventilator, constant attendance is required by qualified personnel. The use of this ventilator with its built-in alarms and/or with additional alarm systems does not provide absolute assurance of warning for every type of malfunction that may occur in the patient/ventilator system. In addition, some problems may require immediate attention. Never use the Sechrist Infant Ventilator without the safety Pressure Relief Valve installed and adjusted to the patient's needs. Verify that the exposed valve stem is not obstructed in any way; do not tape or occlude the vent holes drilled through the valve body or the valve will be rendered inoperative. The Safety Pressure Relief Valve constitutes a back-up safety system intended to limit the pressure in the patient breathing circuit in the event that the patient circuit tubings become kinked or occluded. verify that all patient circuit tubings are free from kinks or obstructions and that the valve stem is not obstructed in any way before connecting the patient to the ventilator, and throughout operation to insure patient safety. only use replacement parts provided or approved by Sechrist Industries, Inc. The patient breathing circuit components provided with the Sechrist Infant Ventilator are shipped assembled, in clean but not sterile condition. Upon receipt, the patient breathing circuit should be completely disassembled and thoroughly cleaned and/or sterilized prior to use. oxygen vigorously accelerates combustion; do not use any service instruments or other equipment that may have been exposed to oil or grease contamination to avoid explosion hazard. The Main Power Switch is also a resettable 0.25 Amp circuit breaker. If the switch trips off during operation, the circuit breaker can be reset by manually depressing the switch to the "ON" position. If the switch continues to trip, the ventilator should be removed from service and referred to a qualified service technician. Always monitor oxygen concentrations with an accurate oxygen analyzer with high and low (F102) alarms to be assured that the desired FI02 is being delivered to the patient.Always mount the humidifier below the level of the patient and position the patient circuit so that condensate does not drain toward the patient or accumulate in the patient circuit. we recommend that the humidifier be located on the stand pole as low as possible. This position will allow the inspiratory patient hose to be draped in such a manner that the condensate in the hose will drain back to the humidifier. Routine maintenance procedures contained in this manual may involve opening the ventilator enclosure which constitutes an ELECTRICAL SHOCK HAZARD. These procedures must be performed by qualified personnel. INFANT VENTILATOR CAUTIONS SUMMARIZED Do not permit pressure to build on the ventilator manometer gauge beyond the indicated pressure range, as the gauge may be permanently damaged due to overpressure. Moving parts within the manometer gauge are subject to wear in normal use which may lead to inaccurate or erratic gauge performance over time. Periodic replacement of the manoneter is recommended for best performance. Ethylene oxide is toxic. Parts thus sterilized must be properly aerated to dissipate the residual toxic gas absorbed by the material. Follow the sterilizer manufacturer's recommendations for the specific aeration periods required. Verify that the Safety Pressure Relief valve operates freely after cleaning/sterilization by manually opening the valve. The competence of the Pediatric Exhalation Valve depends on the seal created by the metal-to-metal contact of a seat and poppet. These contacting surfaces should be handled carefully so they are not scratched or nicked in such a way as to cause leaks. It should also be noted that the diaphragm retaining cap of the Pediatric Exhalation Valve (blue) is not interchangeable with that of the standard exhalation valve (white). The Pediatric Valve Block is easily distinguished from the standard valve block by the letter “p" machined into the top surface. Do not subject clear plastic exhalation valve blocks to temperatures above 140'F or they will be damaged. Liguid water in the compressed air supply can cause malfunction of this equipment. If the ventilator is connected to A.C. power and a 12 volt battery at the same time, the internal 12 V.D.c. batteries (alarm backup) will NOT be charged. In fact, the battery will be used until its voltage drops to approximately 9.5 volts which will not provide sufficient backup power to sustain the alarm system in the event of total power failure. Therefore, we recommend that only one power source be connected at any time.zaunold G00L-Al JILVW3HS TWuaNID ANaLLVd J | uaiaiaiwaH viv ONINOLINOW aunssaad Wa1SAS OULNOD diainta JATWA NOUVIWHXa aINGOW ONIXIW MOoUsv. av “AKO WAlSAS TOULNOD wOssa20NdOUIIW atnaow TOYLNOD YOLVTILNSAThe mode switch must be turned off whenever the A.C. power is turned off or the alarm backup batteries will be discharged. Stretching the Smoothbor tubes may result in permanent damage to the tubing. Use care when disassembling the patient circuit. Do not attempt to push the diaphragm in place with the retaining cap. This will distort the seal ring. The retaining cap should have the o-ring seal in place before inserting. Do not stretch the diaphragm to test the competence of the diaphragm as it will tear; use the Performance Verification Procedure to functionally test the competence of the assembled exhalation valve. An active gas scavenging system should be tested with the ventilator before use to verify that it does not scavenge gas from within the patient circuit and create sub-ambient pressures.2 OPERATING INSTRUCTIONS A. GENERAL DESCRIPTION Sechrist Model IV-100B Infant Ventilator is a sophisticated instrument designed for use by properly trained and qualified personnel. It is restricted to use by or upon the direction of a physician. Before attempting to use this device in an actual life support situation, the operating personnel must become practiced in the function and effect of the various controls. The Sechrist Model IV-100B Infant Ventilator is a continuous flow, time cycled controller. The ventilator system is shown schematically in Figure 2. Sources of air and oxygen are supplied to the Air-Oxygen Mixer module where the desired FI02 and continuous flow rate are selected. The gas flow is typically directed from the gas mixing module through a humidifier (not included) where it is humidified and warmed to physiological values. The humidified mixed gas flows past the patient connection to ambient through an exhalation valve. Inflation of the patient's lungs is accomplished by closing the exhalation valve, thus creating a pressure increase at the patient connection. Exhalation occurs when the exhalation valve is opened. The exhalation valve is the principle active component which controls pressures created within the patient circuit. During the inspiratory phase, the ventilator generates a fluidic control pressure that closes the exhalation valve, thereby containing the flow of gas within the patient circuit. Pressure within the patient circuit increases resulting in the insufflation of the patient's lungs as pressure builds at the patient connection. During exhalation, the continuous flow of gas flushes carbon dioxide from the patient connection. Figure 5 illustrates the design of the Hi/Lo Exhalation valve in cross section. The gas flows into the exhalation valve from the "PATIENT CONNECTOR" as indicated in the figure. The gas flows through the "INJECTOR THROAT" and "VALVE SEAT" past the "CONTROL DIAPHRAGM" to ambient through holes drilled into the bottom of the valve block. The small space behind the control diaphragm (side opposite the valve seat) is sealed and connected directly to the fluidic control system in the ventilator. When a pressure signal is generated during the inspiratory phase, the diaphragm moves forward to occlude the valve seat. Pressure builds in the patient circuit until an equilibrium is reached between the forces created by the control pressure and the circuit pressure. The continuous flow will then be vented toambient at a specific pressure. A fluidic control system allows the operator to control the pressure of the gas signal applied to the diaphragm in the exhalation valve throughout the breath cycle, thereby establishing the inspiratory and expiratory pressures. The "INSP. PRESS" control establishes the control pressure corresponding to the peak inspiratory pressure (PIP) during the inspiratory phase and the "EXP. PRESS." control establishes the control pressure corresponding to the end expiratory pressure level during the expiratory phase. When it is desired ‘to have zero end expiratory pressure (ZEEP), the inherent resistance to gas flow of the expiratory limb of the patientcircuit must be eliminated. This is accomplished in the Sechrist Infant Ventilator by creating a slightly negative pressure at the patient side of the exhalation valve. The INJECTOR JET (refer to figure 5) directs high velocity gas through the INJECTOR THROAT which thereby generates a lower pressure on the patient side of the exhalation valve. The sub-ambient pressure produced is sufficient to eliminate inadvertent PEEP due to resistance to gas flow through the patient breathing circuit provided. A microprocessor-based control system allows the operator to select the duration of the inspiratory and expiratory periods using the INSP. TIME and EXP. TIME controls respectively. The times selected by the operator with the corresponding controls are displayed on the control panel. The microprocessor automatically calculates the I:E Ratio and Breath Rate which are also displayed above the inspiratory and expiratory times respectively. For a detailed explanation of the Air/oxygen Mixer, Fluidic Control System and Microprocessor Control circuit, refer to Section 7 - Understanding Guide. The "MANUAL" push button enables the operator to deliver a manual breath at the preset pressure limits whenever desired. The manual breath button is completely independent of the electronics and can be used to cycle the ventilator in the event of a power failure. The inspiratory phase will last as long as the button is depressed; releasing the button allows the exhalation valve to open. The Sechrist Infant ventilator incorporates a Digital Electronic Manometer which provides the following functions: Bar Graph Display of Airway Pressure Digital Display of Mean Airway Pressure Low Pressure Alarm High Pressure AlarmThe Bar Graph Display simulates the needle movement of a mechanical gauge to indicate the pressure being measured. Each segment of the display represents 1 cm H20. The Digital Display normally indicates the mean Airway Pressure. The display is updated on a breath by breath basis and the value shown is the average of the Mean Airway Pressure measured during the last four breaths. The Low Pressure Alarm Limit value may be set by the operator to provide audible and visible alarms for the following situations: Low Airway Pressure (leaks) Loss of Airway Pressure (patient disconnect) Failure to Cycle (microprocessor failure) Power Failure (AC or DC operation) Apnea (under certain CPAP conditions) Prolonged Inspiration Source Gas Failure (both gases lost) The High Pressure Alarm Limit value may be set by the operator to provide immediate audible and visible alarn indications whenever the High Pressure Limit value is reached by the measured pressure. The digital manometer/alarm system is operational in both the "VENT" and "CPAP" modes and is powered by Ni-Cad batteries incorporated in the ventilator in the event of a power failure. The Sechrist Infant Ventilator requires sources of Medical Breathing Air and USP oxygen (both at a nominal pressure of 50 PSI at 1.5 SCFM). The gas inlets conform to the Diameter Index Safety System (D.I.S.S.) as do the supply hoses provided with the ventilator. Both gas inlets incorporate 7 micron sintered stainless steel filters and a 0.1 micron filter/water trap assembly is provided for the air inlet. The Sechrist Infant Ventilator requires an AC power source at 115 VAC, 50 or 60 Hz (overseas power requirements available) and some types can be operated from a 12 VDC power supply using the accessory power cable provided. The main power switch on the back of the ventilator also serves as a resettable protection circuit breaker.B. DESCRIPTION OF CONTROLS 1. AIR-OXYGEN MIXER: This system consists of an air- oxygen proportioning device and flowmeter system. The supply gas hoses are used to connect Medical Breathing Air and Oxygen gas supplies to the D.I.S.S. connections on the rear of the gas mixing module. Gas supply pressures should be nominally 50 psi. Variations of + 20 psi between the gas supply pressures will not affect the accuracy of the Mixer by more than + 1%. FIO2 is selected with the proportioning valve control knob and flow of mixed gas into the patient circuit is controlled with the flowmeter. WARNING The Air-oxygen Mixer of the Sechrist Model IV-100B Infant Ventilator are designed to use Medical Breathing Air and oxygen only. Do not modify these inlets to use other breathing or anesthetic gases. WARNING Liquid water in the compressed air supply can cause malfunction of this equipment. Please consider the air supply a Medical Breathing Air rather than compressed air. In most cases, someone is forced to breathe what is entering the equipment! NOTE: Flowmeters provided are not back pressure compensated. WARNING Oxygen concentrations must be monitored at or near the proximal airway with an accurate oxygen analyzer with high and low (FI02) alarms to be assured that the desired FIO2 is being delivered to the patient.pres ekFETY PRESSURE RELIEF VALVE: The Sechrist safety Pressure Relief Valve is installed in the inspiratory limb SF tpe patient breathing circuit and is mounted in the back of the flowmeter assembly in all three gas mixing configurations. Relief pressures between 15 and’85 cm #20 can be obtained by adjusting the relief valve. Relics erasure is increased by rotating the white (delrin") adjuster (at the back of the valve) in a clockwise direction {viewed from rear) thereby increasing the compression on the internal spring which holds the valve closed. Rotating the adjuster in a counter-clockwise direction will decrease polief pressure. The valve stem is extended so that it can be grasped and the valve manually opened at any tine by the operator. The valve can be removed and disassembled for cleaning or sterilization as required. This valve muse be checked and adjusted for each patient. WARNING NEVER USE THE SECHRIST INFANT VENTILATOR WITHOUT THE SAFETY VERIFY THAT THE EXPOSED VALVE STEM FREELY AND IS NOT OBSTRUCTED IN Sen a POMER SWITCH: The A.C. power is switched on or off with a rocker switch located on the back panel. a.ce power Tust eon for the ventilator to operate. This will bs indicated by the lighting of one of the mode lights on the front panel. NOTE: When A.C. power is switched off, it may take several minutes for the mode lights to turn off. The a.c. Power switch can be off when a D.c. power source is used. WARNING The Main Power switch is also a resettable circuit breaker, If the switch trips off during operation, the circuit breaker can be reset by manually depressing the switchto the "ON" position. If the switch continues to trip, the ventilator should be removed from service and referred to a qualified service technician. 4. MODE SELECTOR: The mode selector is an electronic switch with three positions. The OFF position disables all electronic function. In the CPAP position, only the alarm system is functional. In the VENT mode, all alarms, displays and electronic contols are functional. The mode selector has no control over the gas supply (ie., will not turn the gas supply on or off). CAUTION The mode switch should always be turned off whenever the A.C. power is turned off or the alarm back-up batteries will be discharged. 5. MANUAL BREATH: The manual breath push button may be used to develop inspiratory pressure whenever the gas supply to the ventilator is present and there is flow through the patient circuit. The inspiratory pressure developed will be limited to the setting of the inspiratory pressure control. Inspiration will occur as long as the button is pushed. Use of the manual control will not synchronize the electronic timing circuit. 6. INSPIRATORY PRESSURE: The inspiratory pressure control is a single turn control which adjusts the signal pressure to the exhalation valve diaphragm, thereby controlling the maximum pressure attainable in the patient circuit. The nominal range of adjustment is from 5 to 70 cm H20. If necessary, the control can be internally recalibrated (QUALIFIED SERVICE PERSONNEL ONLY) to higher or lower values. The selected pressure is slightly flow-variable. Pressure may vary + 1 to 2 cm H20 as flow is increased or decreased.NOTE: Verify that the Safety Pressure Relief Valve is set correctly if it is not possible to achieve the desired inspiratory pressure. NOTE: Inspiratory and expiratory pressures obtainable with a particular ventilator/patient system are influenced by a number of factors including but not limited to the following: - Resistance and compliance of the patient and breathing circuit system Flow rate Waveform Adjustment (see part 2.F.) Inspiratory and expiratory time settings Safety pressure relief valve setting. Inspiratory and expiratory pressure ranges published in this manual only express the nominal performance of the ventilator under a particular set of controlled conditions. 7. EXPIRATORY PRESSURE: This control allows the operator to select a desired CPAP level whenever the ventilator is used as a CPAP-only device. In the VENT mode this control is used to select negative, zero or positive end expiratory pressure. The nominal control range is from -2 to 15 cm H20. This expiratory pressure is also slightly -dependent. It will vary + 1 to 2 cm H20 as flow is varied. Negative pressure cannot be obtained if the continuous flow in the patient circuit is greater than approximately 20 to 24 L.P.M. (when the standard Hi/Lo Flow Exhalation Valve/Patient Circuit are used; P/N IVv-335). 8. EXPIRATORY TIME: The expiratory time is selected with a ten-turn linear potentiometer. The total range of this control is from 0.30 sec. to 60.0 sec. The range of 0.30 sec. to 1.50 sec. is adjustable in 0.01 sec. increments. The range of 1.50 sec. to 10.0 sec. is adjustable in 0.1 sec. increments. The range of 10.0 sec. to 20.0 sec. is adjustable in 1.0 sec. increments and the range of 20.0 sec. to 60.0 sec. is adjustable in 5.0 sec. increments. The accuracy and repeatability of the selected time is within 0.05%. The expiratory time is displayed above the "EXP. TIME" control. 9. INSPIRATORY TIME: The inspiratory time is selected with a ten-turn linear potentiometer. The total range of this control is from 0.10 sec to 2.90 sec. The range of 0.10 15sec. to 1.00 sec. is adjustable in 0.01 sec. increments. The range of 1.00 sec. to 2.90 sec. is adjustable in 0.1 sec. increments. The accuracy and repeatability of the selected time is within 0.05%. The inspiratory time is displayed above the “INSP. TIME" control. 10. ALARM SELECT BUTTON: This button allows the operator to select either the LO LIMIT alarm pressure value or the HI LIMIT alarm pressure value for adjustment. Pressing the button once will change the digital display of the electronic manometer from MEAN to LO LIMIT, as indicated by lighting the appropriate annunciator. Pressing the button again will change the display to HI LIMIT as indicated by the annunciator. Whenever one of the annunciators has been selected, it is possible for the operator to adjust the selected value with the UP and DN buttons. The Select button is also used to cancel a HI LIMIT alarm when this alarm is activated. 11. ALARM UP/DN BUTTONS: These buttons will adust the alarm limit value for the parameter which has been selected by the SELECT button. If neither of the buttons are pressed within a 3 second’ period, the digital display reverts to the display of mean Airway Pressure. 12. LO LIMIT PRESSURE ALARM SETTING: This setting establishes the set point for the LO LIMIT alarm system. The alarm set point is indicated by the lighting the appropriate segment of the bar graph display whenever the measured pressure is less than the LO LIMIT value and blanking the segment whenever the measured pressure is greater than the limit value. In the VENT mode, the set point should be located 1 to 2 cm H20 below the maximum pressure reached during the inspiratory phase as indicated by the bar graph display. The measured pressure must pass the set point within the selected delay time (see item 11) to prevent an alarm indication. It may be possible to use the alarm system in the CPAP mode if the patient's spontaneous inspiratory breathing effort is sufficient to deflect the measured pressure approximately 1 to 2 cm H20. Position the set point 1 to 2 cm H20 below the CPAP baseline such that the patient‘s spontaneous effort will draw the measured pressure to or below the set point during inspiration. The LO LIMIT set point must be reached or passed by the measured pressure before the delay time is exceeded or the audible and visible alarms will be activated. 13. HI LIMIT PRESSURE ALARM SETTING: This setting establishes the set point for the HI LIMIT alarm system. 16The alarm set point is indicated by the lighting the appropriate segment of the bar graph display whenever the measured pressure is less than the HI LIMIT value and blanking the segment if the measured pressure is greater than the limit value. In the VENT mode, the set point should be located approximately 5 to 10 cm H20 above the peak measured pressure displayed on the bar graph. If the measured pressure reaches or exceeds the HI LIMIT value, an alarm situation is immediately indicated by the audible and visible indicators. 14. MEAN AIRWAY PRESSURE DISPLAY: This three digit numeric display normally displays the Mean Airway Pressure as measured in the patient circuit. The display is updated every breath and indicates the average Mean Pressure for the latest four breaths. When the Select button is pressed, this display will indicate the current numeric value for the LO LIMIT pressure value or the HI LIMIT pressure value. 15, ALARM DELAY TIME: This control sets the time delay before the LO LIMIT audible and visible alarms are activated. The delay time is actually the maximum time interval between subsequent interruptions of the LO LIMIT set point by the measured pressure. The time is adjustable from 3 to 60 seconds. The audible and visible alarms will activate at the end of the alarm delay tine if the measured pressure has not passed the alarm set point during the delay time. 16. ALARM VISIBLE INDICATOR: This light will flash red during an alarm situation. Simultaneously, an audible beep will be heard. Distinction between the type of alarm, either LO LIMIT or HI LIMIT can be determined by observing the lighted annunciator of the electronic manometer. 17. ALARM MUTE: Pushing this button will silence the audible alarm indicator for approximately 30 seconds. The audible indicator will automatically re-activate at the end of the mute period if an alarm condition continues to exist. It is intended for use during suctioning procedures so that the alarm delay time knob position need not be disturbed. 18. TEST: Pushing this button when the ventilator is operating in the "VENT" mode will initiate a self-test sequence. As the button is pressed, the audible and visible alarms are momentarily activated. The digital displays index collectively through a count sequence such that all display segments and the microprocessor programming are tested. Also, all segments and annunciators of the electronic manometer are lit. WFNOTE: The test sequence will not interrupt the ventilator's normal operation and can be performed while ventilating the patient. 19. TIME PRESET: Pushing this button when the mode selector is in the CPAP position allows the operator to observe the settings of the inspiratory and expiratory times before switching to the VENT mode and to make adjustments to the controls if desired. The ventilator will not cycle when this button is depressed. 20. INSPIRATORY PHASE LIGHT: This light (red LED) is illuminated for the duration of the inspiratory phase when the ventilator is used in the VENT mode. 21. ‘INVERSE I:E RATIO LIGHT: This light (red LED) indicates an inverse I:E ratio (inspiratory time greater than expiratory times) .c. PATIENT CIRCUIT The ventilator control system must interface with the patient. This is accomplished with the patient circuit. The primary components of the breathing circuit are: 1. Heated Humidifier 2. Patient connection 3. Water Traps 4. Exhalation valve 5. Associated Tubing WARNING The patient breathing circuit components provided with the Sechrist Infant Ventilator are shipped assembled in clean but not sterile condition. Upon receipt, the patient breathing circuit should be completely disassembled and thoroughly cleaned and/or sterilized prior to use. NOTE: As of December 1983, the Sechrist IV-100B Infant Ventilator is equipped with a IV-335 Hi/Lo Flow Exhalation valve/Patient Circuit as standard in place of the IV-305 Neonatal Exhalation Valve/Patient Circuit, This new systen is designed to minimize the need to use different exhalation valves and circuits for patients of various sizes. The IV-335 system can be used with flows of up to 24 L.P.M. (400 ml./sec.) without inadvertent P.E.E.P. To accommodate this system, the IV-100B control module has been calibrated with slight differences. It is possible to utilize the 1V-305 Neonatal Exhalation Valve/Patient Circuit and the IV-325 Pediatric Exhalation Valve/Patient Circuit with the later IV-100B control module as well as using the IV-335 Hi/Lo Flow Exhalation Valve/Patient Circuit with the earlier IV-100B control module. Only minor differences in performance will be noted unless it is necessary to use higher flows. In this situation, the IV-335 should be used with the later IV-100B control module; this will result in the best performance. It is possible to update earlier IV-100B control modules to the current specification. Check with your distributor for details. 1. HEATED HUMIDIFIER: (not provided) The gas being 19b Bunda GEE-Al LINowId LNALLYd MO14 O1/1H 3SOH NOLLWIWHX3 3NI7 aSNaS__—~ aunssaud YOL93NNOD ANAL Ld _% 3AWA NOILVWHX3delivered to the patient should be humidified and warmed to physiological values. Various humidifier systems will work with the Sechrist Infant Ventilator. Basically, any humidifier system which is capable of humidifying and heating a continuous flow of 3 to 40 liters per minute may be used if the resistance to flow is less than 2.0 cm H20 per liter per minute. WARNING Always mount the humidifier below the level of the patient and position the patient circuit so that condensate does not drain toward the patient or accumulate in the patient circuit. We recommend that the humidifier be located on the stand pole as low as possible. This position will allow the inspiratory patient hose to be draped in such a manner that the condensate in the hose will drain back to the humidifier. The compressible volume of the humidifier normally comprises the majority of the internal compliance of the patient circuit. The internal compliance of the patient circuit should be considered whenever the ventilator system is used. It is a factor in selecting the total flow through the patient circuit. Theoretically, if the compliance of the patient circuit were non-existent, the flow in the circuit would only need to be sufficient to deliver the desired tidal volume to the patient and overcome the inevitable leaks around the E.T. tube: probably somewhere in the range of 10 to 60 ml/second (0.6 to 3.6 liters/minute). However, if I.M.V. technigues are utilized, the primary determinant of the gas flow in the patient circuit is that it must be sufficient to satisfy the patient's peak inhalation demand. This peak flow probably normally ranges around 60 to 120 ml/second (3.6 to 7.2 liters/minute). If flows in this range are used in a patient circuit of very low internal compliance, the pressure rise time during the mechanically delivered breath will be very short (i.e., the pressure will rise very sharply to the inspiratory pressure limit). This may or may not be desirable and should be considered when the patient circuit is configured. It may be desirable to have enough patient circuit internal compliance to buffer the sharp rise in pressure. (Refer to the section 21concerning variation of the pressure waveform.) The total compressible volume of the patient circuit must also be considered when higher frequencies are used to deliver mechanical breaths. Pressure rise and decay times within the patient circuit must be short when higher frequencies are used if it is desired to reach peak inspiratory pressure during a short inspiratory time and to reach the desired expiratory pressure during a short expiratory time. This condition virtually necessitates the use of a patient circuit system with a minimal compressible volume. 2. PATIENT CONNECTOR: “The patient connector allows the inspiratory and expiratory tubing to be adapted to the patient airway, either a mask with a 22mm female connection or an endotracheal tube with a 15mm male adapter. An adapter allows the patient pressure to be monitored. NOTE: Use a push-twist action when assembling the various 1Smm and 22mm taper fittings to obtain a tight, secure connection. 3. WATER TRAPS: Accessory water traps may be located in the patient circuit in place of the double 15 mm female adapters (provided) which are used to connect the two 24" lengths of hose which make the inspiratory and expiratory limbs of the patient circuit. 4. EXHALATION VALVE: The exhalation valve is the principal active component which controls the pressures created within the patient circuit. A schematic cross section diagram of the exhalation valve is shown in Figure 5. The continuous flow of gas in the patient circuit must flow to ambient. It does this through a carefully designed valve seat located within the exhalation valve block. Positioned just above the valve seat is the control diaphragm. The space above the control diaphragm is sealed and connected to the fluidic control system within the ventilator. When pressure is created in the space above the diaphragm, it will move and occlude the valve seat. The flow of gas into the patient circuit will build up enough pressure within the patient circuit to oppose the closing movement of the diaphragn. The two opposing forces will reach an equilibrium venting flow to ambient at a specific pressure. Changing the control pressure above the diaphragm will result in a corresponding change in the pressure within the patient circuit. This is how the inspiratory and expiratory phases are created and controlled. The control pressure signal is 22saunold NOILD3S-SSOUD 3A1VA NOUV IVHXS WL BOND ONINIVLE aw i Was ONRI-O 4 Way ONINIVIaH a NN SY dV ONINIVITa WOVEHA WIC a b 4O1DINNOD ANalLVd a wous BNI7_38N3S 4 _.——_ BUNSS3Ud AVAUIV WOVUHdVIG TOMLNOD 13f SOLDAENI AVASJATVA AVOWHLYOIDIENIswitched from a relatively low pressure during the expiratory phase to a higher pressure during the inspiratory phase. When it is desired to have a zero end expiratory pressure, the resistance to flow caused by the exhalation hose must be eliminated. This is accomplished by creating a slight sub-ambient pressure in the exhalation valve. To do this, a reverse injector system is employed. Pressure in the injector jet creates a relatively high velocity of gas flow through the specially designed injector throat. This higher velocity translates to reduced relative pressure on the patient side of the injector throat. This pressure differential is sufficient to overcome the normal resistance of the exhalation tubing to the continuous gas flow thereby creating a zero (ambient) or slight negative (sub-ambient) pressure at the patient connection. Gas flow to the injector jet is interrupted during the inspiratory phase. Assembly of the exhalation valve should be done with care. The diaphragm must be located in its proper position with the convolution down. Its proper position is with the seal ring seated evenly on the ridge within the diaphragm cavity. Move the retaining arm in place and hand tighten the retaining knob. An even o-ring seal can be observed through the visible block. CAUTION Do not attempt to push the diaphragm in place with the retaining cap. This will distort the seal ring. The retaining cap should have the o-ring seal in place before inserting. Do not stretch the diaphragm to test the competence of the diaphragm as it will tear; use the Performance Verification procedure to functionally test the competence of the exhalation valve. Mounting the exhalation valve in place on the ventilator automatically makes the proper connections for the gas control signals. The retaining stud need only be hand tightened. 245. TUBING: The tubing provided for the patient circuit is a 1/2" I.D. Smoothbor” hose. The choice of tubing size is primarily predicated on the characteristics of light weight and flexibility. Standard 15mm taper fittings are used to terminate the tubing. The inspiratory and expiratory limbs are provided as two 24" lengths of hose with an adapter to connect them together or the adapters may be replaced with a water trap. Assembling the patient circuit is merely a matter of mounting the primary components and then adding the tubing. We recommend the system be assembled in the sequence of the gas flow from the source to the exhalation valve. see Figure 4. CAUTION Stretching the Smoothbor tubes may result is permanent damage to the tubing. Use care when disassembling the patient circuit or it will be permanently damaged. 25D. SET UP AND OPERATION Familiarization with the controls and functions can be accomp- lished by practicing the following procedures. Because of the internal compliance of the patient circuit, a test lung is not required. Merely plug the patient connector. If it is desired to evaluate the unit with a test lung, an inexpensive system may be constructed by adapting a 2.5 mm E.T. tube to a glass 1 liter 1.V. bottle. 1. Before connecting gas supply sources or power cord, adjust the controls to these settings: A. A.C. power OFF B, Mode selector switch OFF C. Alarm delay time switch at 3 seconds. D. Pressure controls to 12 o'clock position. 2. Assemble the complete patient circuit system as required and attach to the ventilator. 3. Connect air and oxygen supply hoses to suitable sources. NOTE: Verify that the water trap/filter assembly is connected to the air inlet. 4. Connect the electrical power cord to a suitable hospital grade, grounded receptacle (refer to the back panel for power requirements) . 5. Select desired oxygen mixture and flow. WARNING Always monitor oxygen concentrations with an accurate oxygen analyzer with appropriate alarms to be assured that the desired FIO2 is being delivered to the patient. WARNING If the air supply is 25 (or more) psi below the 02 supply pressure when the mixer FIO2 control is set at 1.0 resulting in an alarm/ bypass situation, the gas supply to the ventilator fluidics will be interrupted 26and the ventilator will stop cycling; audible and visible ventilator alarms and the audible mixer alarm will activate. To restore ventilator function, rotate the FIO2 control to the .90 setting. The patient will continue to receive 100% oxygen (FIO2 = 1.0) until the air supply is restored. 6. Select desired expiratory pressure level by observing manometer while occluding patient connection. 7. Check and adjust the Safety Pressure Relief valve to the patient's needs as follow: WARNING NEVER USE THE SECHRIST INFANT VENTILATOR WITHOUT THE SAFETY PRESSURE RELIEF VALVE INSTALLED AND ADJUSTED TO THE PATIENT'S NEEDS. VERIFY THAT THE EXPOSED VALVE STEM OPERATES FREELY AND IS NOT OBSTRUCTED IN ANY WAY; DO NOT TAPE OR OCCLUDE THE VENT HOLES DRILLED THROUGH THE VALVE BODY OR THE VALVE WILL BE RENDERED INOPERATIVE. NOTE: Simultaneously push and twist the relief valve when inserting into the flowmeter block to obtain a tight fit. Verify that the relief valve is securely inserted before each use and periodically during use to preclude inadvertant disconnection. CAUTION Verify that the valve operates freely after cleaning and/or sterilization by manually opening the valve. WARNING The Safety Pressure Relief Valve constitutes a back-up safety system intended to limit the pressure developed in 27the patient breathing circuit in the event that breathing circuit tubings become kinked or occluded. Verify that all patient circuit tubings are free from kinks or obstruction and that the valve stem is not obstructed in any way before connecting the patient to the ventilator and throughout operation to insure patient Safety. Verify that the holes in the side of the relief valve body are not taped closed or occluded in any way. Do not Substitute any other device for the relief valve provided. The Sechrist Safety Pressure Relief Valve is installed in the inspiratory limb of the patient breathing circuit and is mounted in the back of the flowmeter assembly in all three gas mixing configurations. Relief pressures between 15 and 85 cm H20 can be cbtained by adjusting the relief valve. Relief pressure is increased by rotating the white (Delrin-) adjuster (at the back of the valve) in a clockwise direction (viewed from rear) thereby increasing the compression on the internal spring which holds the valve closed. Rotating the adjuster in a counter-clockwise direction will decrease relief pressure. The valve stem is extended so that it can be grasped and the valve manually opened at any time by the operator. The valve can be removed and disassembled for Cleaning or sterilization as required. This valve must be checked and adjusted for each patient. VENT HOLES (Do Not Obstruct) VALVE HOUSING ZY? SAFETY PRESSURE RELIEF VALVE 8. If CPAP only is desired, connect the ventilator to the patient and select the CPAP mode. A relief valve setting of about 15 cm H20 may be appropriate for CPAP conditions. This can be set by rotating the white adjuster counter-clockwise until the larger diameter of the adjuster comes flush with the end of the aluminum valve housing (see 28illustration above). Verify that gas does not leak from the valve during operation. If gas is detected flowing from the valve, rotate the adjuster clockwise 1/4 turn to increase the relief pressure slightly. If gas is still detected flowing from the valve and it is apparant that the CPAP level is below 15 cm H20, examine the valve for competence as soon as possible. 9. If CPAP only is desired, set alarm to monitor patient spontaneous breathing, if possible. Patient breathing will cause a slight deflection to the manometer needle each breath. Adjust the alarm set point indicator to a value slightly less than the expiratory resting level but where it is passed by the manometer needle each breath. Select desired alarm delay time. A significant change in breathing pattern or expiratory resting level will cause alarm to activate. 10. If VENTILATION is desired, depress the time preset button (while in the CPAP mode) and select the desired inspiratory and expiratory times, then, select VENT position on mode switch. 11. %If VENTILATION is desired, occlude the patient connection and select the maximum inspiratory pressure. 12. Connect to patient and observe that the desired ventil- ation commences. Trim controls as necessary to achieve optimal ventilation. SAFETY PRESSURE RELIEF VALVE SET-UP AND OPERATION: Verify that the relief valve is set in accordance with the needs of the patient and is functioning correctly prior to connecting the patient to the ventilator and periodically during use. The following procedure can be used by qualified personnel to verify the correct setting and function of the valve and gan be performed with the patient connected to the ventilator. NOTE: It may be necessary to increase the relief pressure in order to obtain the desired inspiratory pressure setting depending upon the previous relief valve setting. The relief valve is currently factory set to relieve at 25 +2 cm H20. a) With the ventilator cycling in the "VENT" mode, note the peak inspiratory pressure indicated by the airway pressure manometer. b) Decrease the relief pressure (counterclockwise 29rotation of valve adjuster) until the relief valve is just beginning to relieve at or slightly below the peak inspiratory pressure. NOTE: It should be possible to hear the escape of gas from the relief valve and/or observe a slight decrease in the peak inspiratory pressure as indicated by the manometer during the inspiratory phase. c) Increase the relief pressure by rotating the valve adjuster in a clockwise direction 1/4 turn. This adjustment will achieve a relief pressure setting approximately 5 to 10 cm H20 above the peak inspiratory pressure. d) As adjustments are made to the inspiratory pressure control throughout the course of ventilatory support, reset the relief valve as described in steps a) through c) above. NOTE: When the ventilator is used to deliver constant volumes (ie. peak inspiratory pressure limited by the inspiratory time control setting), decreases in the patient compliance or increased resistance will result in increased peak inspiratory pressure to the extent that the relief pressure limit may be reached. 13. Set alarm to monitor ventilation as follows. Pressure breathing causes the manometer needle to deflect, reading maximum pressure. Set alarm set point indicator 1 to 2 cm H20 below the maximum pressure reached on each breath. Set the desired alarm delay time. If the manometer needle fails to reach the alarm set point before the delay time, an alarm will be indicated. 14. IMV is easily accomplished by increasing expiratory time to control the rate as desired. The standard clinical guidelines for the application of CPPS, CMV or IMV should be followed.E. ACCESSORY APPLICATIONS To enhance the versatility of the Sechrist IV-100B Infant Ventilator, various exhalation valves and patient circuits are available in addition to the system normally provided with the ventilator. The Sechrist Model Iv-1008 Infant ventilator is normally supplied with a patient circuit and exhalation valve designed to work best in a flow range of approximately 3 to 22 liters per minute. 1. PEDIATRIC EXHALATION VALVE/PATIENT CIRCUIT: For larger infants who require higher flows, a special exhalation valve and patient circuit should be used if inadvertent PEEP is to be avoided. ‘The Pediatric Exhalation Valve is designed to be used for flows up to approximately 40 liters per minute. To use this Pediatric Exhalation Valve, mount it on the IV-100B in place of the standard valve (see Figure 6) and operate the ventilator normally. If the IV-100B is calibrated to its standard inspiratory and expiratory pressure values, the Pediatric Exhalation Valve will produce the following values at a flow of 20 liters per minute: Inspiratory pressure 5 - 75 cm H20 Expiratory pressure 0 - 20 cm H20 The design of the Pediatric Exhalation Valve does not produce a significant amount of sub-ambient pressure. Use of the Pediatric Exhalation Valve requires use of the pediatric patient circuit as supplied by Sechrist to avoid "buzzing" of the valve and avoid excess expiratory resistance. CAUTION The competence of the Pediatric Exhalation Valve depends on the seal created by the metal-to-metal contact of a seat and poppet. These contacting surfaces should be handled carefully so they are not scratched or nicked in such a way as to cause leaks. It should also be noted that the diaphragm retaining cap of the Pediatric Exhalation Valve (colored blue) is not interchangeable with that of the 319 auNDId LINDUID LNALLVd DILWIGad aalaigIwn 3SOH NOLWIVHNI NIT 3SN3S 3NNSSIYd JY 3SOH NONVIVHXa WO1D3NNOD LNAlLVd BAIWA NOUWIVHX DIMVIGadv9 aUNDI JATVA NOILV TWHX4 DIMLVIGId 13f YOLOatNI BOND ONINIVERE ——~ ‘Was ONO way oNINIvisy —— dV ONINIVI34 WOVUHAVIG — Avawassv WOVUHdVIG/13ddOd AV3S IATA _— 4OIDINNOD LNIILVd WOMd 3NIT 3SN3S as BUNSSAU AVMUlYstandard exhalation valve (colored white). The Pediatric Valve Block is easily distinguished from the standard valve block by the letter "P" machined into the top surface. The Sechrist Pediatric Exhalation Valve is available in both clear plastic and metal configurations. The metal exhalation valve will withstand steam sterilization. CAUTION Do not subject the clear plastic exhalation valve block to temperatures above 140’F or it will be damaged. 2. ANESTHESIA APPLICATION: The Sechrist Model IV-100B Infant Ventilator was designed primarily to be used for newborn intensive care. However, with the use of the metal exhalation valve, (P/N 20084), it can be used as an infant anesthesia ventilator. To accomplish this, the IV-100B must be used in conjunction with a conventional anesthesia machine. The total system should be configured so that the continuous gas flow of the desired anesthetic agents is generated by the gas machine, routed to the patient connection and then to the IV-100B exhalation valve, see Figure 7. It will be necessary to locate a safety pressure relief valve near the origin of thegas from the anesthetic machine. This safety pressure relief valve should be capable of being adjusted within a range of 15 to 75 cm H20. Supply gases of air and oxygen at 50 psi are required for ventilator operation. However, in this application, the Air-oxygen Mixer will not be used to control the gas concentrations being delivered to the patient and the flowmeter may be turned off. Mechanical ventilation is accomplished with the IV-100B in a conventional manner. All anesthesia gases venting from the system may be collected with a gas scavenging system connected to the outlet port of the metal exhalation valve (30 mm taper fitting). 344 sano SOUJHISINY JTaVWWvTd AAIWA NOILWIWHX3 VISSHISINV 4O 3DN3S3¥d 3H NI-G3SN SI ANIWdINDA SIHI 41 GYVZVH NOISO1dX4 3181SSOd ‘AIONVG 3SOH NOUV IVHX3 —— INaliva Wous -—— AN3lLvd OL 3SOH AWaANTIG J —_ ANIHOVW SV Wous A7UNO SvO DUaHISANY WAISAS JONIAVIS SVD DUSHIS3NY O1 NOLD3NNOD ™, JATVA NOUVIVHX3 a LzUNO MO OL baeoog hs NOLLD3NNOD ON SOIGINTS TWNYJINI 31V¥IdO OL 001-Al OL N3DAXO GNV IY ATadnsCAUTION An active gas scavenging system should be tested with the ventilator before use to verify that it does not scavenge gas from within the patient circuit and create sub-ambient pressures. 3. 12_V.D.C. OPERATION: Some versions of the Sechrist Model IV-100B Infant Ventilator have a connector located on the back panel which will allow the unit to be operated from an external 12 V.D.C. power supply in lieu of the normal A.C, power requirements. However, operation from a 12 V.D.C. supply has several limitations. First, only the connector and cable supplied by Sechrist should be used to connect the 12 V.D.C. supply to the ventilator. During normal operation, the ventilator will draw approximately 1.3 Amps. Another operating limitation to consider is the status of the battery back-up system for the ventilator alarm system. This internal battery system is designed to support only the ventilator alarm system and is normally in a stand-by mode when the ventilator is operated from A.C. power and the batteries are kept at a float charge level. In the absence of A.C. power, the internal batteries will operate the alarm system until their voltage drops to the level of the 12 V.D.c. supply. At this point, they will be approximately 90% discharged. Therefore, the internal batteries will probably require recharging after operation of the ventilator on a D.C. supply for more than 10 to 20 minutes. These batteries are charged during normal A.C. power usage or may be recharged as specified in section 6.c.7. of this manual. CAUTION If the ventilator is connected to A.c. power and a 12 volt battery at the same time, the internal 12 v.D.c. batteries (alarm backup) will NOT be charged. In fact, the batteries will be used until its voltage drops to approximately 9.5 volts which will not provide sufficient back-up power to sustain the alarm system in the event of total power failure. Therefore, we recommend that only one power source be connected at any time. 36The connector and cable supplied by Sechrist does not have terminals at the battery end. They should be provided by the user to fit the battery being used. The red wire should be connected to positive and the black wire should be connected to negative. 4. AIRCRAFT OPERATION: Current Federal aviation Agency Regulations permit the operation of digital electronic equipment aboard an aircraft with the permission of the Pilot-in-command. The Sechrist IV-100B has been used for transport aboard aircraft. However, the high frequency digital circuitry emits small amounts of R.F.I. which may interfere with the sensitive navigation radio receivers used by the aircraft, and the pilot should be cautioned. Note: An IV-100B with Mixer will consume 14 L.P.M. from the air supply in addition to the flow into the patient circuit indicated on the Mixer flowmeter. This should be planned for when determining transport capabilities. 37F. VARIATION OF THE AIRWAY PRESSURE WAVEFORM The Sechrist Model IV-100B Infant ventilator incorporates a unique control which allows the user to vary the proximal airway pressure waveform. This control is located behind a button plug which is located immediately above the exhalation valve (right side viewed from front). When this control is rotated counter-clockwise, the gas pressure control signal to the exhalation valve diaphragm is unimpeded, therefore it is essentially a square pressure waveform. This square wave signal closes and opens the diaphragm valve quickly and imparts the potential for developing a square pressure waveform within the patient circuit. Rotation of this valve progressively clockwise dampens the gas pressure control signal to the diaphragm. This characteristically dampens the action of the diaphragm, thus prolonging slightly, the pressure rise and decay times in the patient circuit. With complete clockwise rotation, an approximate sine waveform may be simulated. We have incorporated this control because several practitioners have presented the hypothesis that different pressure waveforms may be more or less efficient in the ventilation of the infant lung. It may be that distribution of gas within the lung is improved or some other undetermined factor is effected. In any case, this control is available to the practitioner desiring its function. WARNING THIS CONTROL SHOULD ONLY BE USED BY QUALIFIED PERSONNEL IN CONJUNCTION WITH THE USE OF A PRESSURE RECORDER, OSCILLOSCOPE OR MODEL 600 AIRWAY PRESSURE MONITOR SO THAT THE EFFECT OF THE USAGE MAY BE ASCERTAINED AND JUDGED. The normal position of this control is 1 1/4 turns counter-clockwise from the fully clockwise position. It should be noted that there are several other factors . which contribute to the airway pressure waveform produced by the ventilator; the amount of flow into the patient circuit, the compliance of the patient circuit and humidifier system and the resistance and compliance of the patient and E. T. tube. The response time of the ventilator exhalation valve is only one factor to be considered in a complex equation when the airway pressure waveform pattern in considered. 38SPECIFICATIONS SECHRIST MODEL IV-100B INFANT VENTILATOR Recommended Application: Flot FIO2: Mode: Inspiratory Time: Expiratory Time: I:E Ratio: Rate: Expiratory Pressure: Inspiratory Pressure: Manual Breath: Alarm: Alarm Delay Time: Alarm Mute: Safety Pressure Relief valve: Indicators: Neonate, Pediatric Ventilation 0 to 32 LPM, Flush to 40 LPM +21 to 1.00 OFF, CPAP, VENT 0.10 to 2.90 sec. + .05% 0.30 to 60.0 sec. + .05% 10:1 to 1:600 (Readout 1:0.1 to 1.99) 1 to 150 BPM -2 to 20 cm H20 (@ 12 LPM flow) 5 to 70 cm H20 (@ 12 LPM flow) Yes (not electronics dependent) Independent from microprocessor Low Airway Pressure Peak Over-Pressure Patient Disconnect Fail to cycle Source Gas Failure Power Failure (Battery Back-up) Prolonged Inspiration 3 to 60 sec. 25 sec. + 5 sec. Yes (Inspiratory limb, adjustable from 15-85 cm H20) Inspiratory Time Display Expiratory Time Display I:E Ratio Display 39Manual Test: Safety Lock-out Circuit: Microprocessor Self-Test: Timing Pre-set: Dimensions: Weight: Gas Consumption: Power Requirements: Rate Display Inspiratory Phase Light Inverse Ratio Light Mode Selection Light Alarm Light Digital Electronic Manometer Flowmeter Mean Airway Pressure Display Checks microprocessor function, displays, alarm function Yes, Inspiratory Phase terminated at 4 sec. if microprocessor fails Yes Yes Height: 13" (33.02 cm) width 14" (35.56 cm) Depth 9" (23.00 cm) Model IV-100B-M Net 22 lbs. (10.0 Kg) Shipping 46 lbs. (20.9 Kg) 14 LPM above continuous flow (ventilator and gas mixer bleed) 117 VAC 50/60 Hz Circuit Breaker Protected 3 Wire SJT Power Cord Provided, Hospital Grade Plug Current leakage less than 20 microamps when tested per UL 544 Overseas Voltage Requirements Available 40SECHRIST AIR-OXYGEN MIXER FIO2 Selection Range: Accuracy? Maximum Inlet Pressure: Minimum Inlet Pressure: Required Matching of inlet Pressures: Alarm/Bypass System: Gas Consumption: at +21 to 1.0 (infinitely variable) + 3% of full scale 60 p.s.i. 30 p.s.i. Maintain inlet pressures within a differential of 20 p.s.i. Audible alarm activated and propor- tioning system is by-passed with the higher gas pressure if inlet pressure differential exceeds 25p: 3 to 4 LPM (not including ventilator gas consumption)PERFORMANCE VERIFICATION PROCEDURE This Performance Verification Procedure provides a means of determining whether the Sechrist Model IV-100B Infant Ventilator meets its design specifications. It is intended to be performed in the hospital by qualified technical personnel. This procedure should be performed prior to every time the ventilator is intended to be placed on a new patient or at least once a month or more frequently if desired. The check list should be followed exactly. If the ventilator fails to meet any design specification, it should be removed from use; service may be required. NOTE: It is recommended that hospital personnel responsible for the Performance Verification keep records documenting these activities and that all tested equipment be appropriately identified. WARNING Oxygen vigorously accelerates combustion: do not use any instruments or equipment that may have been exposed to oil or grease contamination to avoid EXPLOSION HAZARD! A. (TEST AIR SUPPLY FILTER: Because Medical Breathing Air is frequently not as clean as it should be, the air supply filters can become clogged relatively quickly. To test the restriction of the filters easily, a test port is provided. The test port is normally plugged with a 1/4" hex threaded plug. It is located as follows: on the mixer, on the rear immediately above the air inlet; on the dual or single flowmeter units, on the bottom of the mounting block. To test the filters, remove the plug and thread a.in a 10-32 threaded nipple in its place. Connect an accurate 0-60 psi pressure gauge to the nipple. Connect the IV-100B to clean dry sources of Medical Breathing Air and Oxygen, each with a nominal 50 psi pressure. Select a flow of 10°L.P.M. on the air flowmeter (with a mixer, select a FIO2 of .21). Observe the pressure indicated at the test port; it should not show a difference of more than 10 psi less than the air supply pressure. If the pressure drop is more than this, replace the air filter. B. FLOWMETER CALIBRATION: Connect the IV-100B to clean dry sources of Medical Breathing Air and Oxygen with a nominal 50 psi pressure. Select an FIO2 of .60 on the Mixer control knob. Connect the outlet of the Mixer flowmeter block to a TEST FLOWMETER with an appropriate hose. Select an 42indicated flow of 6 L.P.M. on the mixer flowmeter. Verity that the correct flow is indicated within + 10% relative to the TEST FLOWMETER. Repeat at 12, 20, and 28 L.P.M. C, MIXER CALIBRATION: Select a flow of 7 L.P.M. on the Mixer flowmeter. Using a calibrated + 1% oxygen analyzer. Verify that the oxygen concentration of the Mixer output flow is within + 3% of the selected value throughout the range of the control. Check at .21, 40, 60, 80, and 1.0 settings. NOTE: The mixer has a specified accuracy of + 3%. If the analyzer has a specified accuracy of + 1%, then the setting on the mixer and the reading on the analyzer should agree within + 4%. D. MIXER ALARM/BYPASS: verify that the alarm/bypass system of the mixer functions as it should. Disconnect the oxygen source from the inlet of the mixer. The audible alarm of the mixer should sound. A bypass should be indicated by continued flow from the mixer flowmeter. Note: the continued flow from the flowmeter during a bypass situation may be slightly lower than during normal operation with both gas sources present. Reconnect the oxygen supply. Disconnect the Medical Breathing Air source. The same conditions apply for normal bypass/alarm operation. E. MANOMETER ZERO SETTING: Disconnect any patient circuit or exhalation valve from the ventilator. Check the zero reading of the digital manometer. If necessary, calibrate the zero by pressing the UP and DN press buttons simultaneously for about 5 seconds until the "CAL" is indicated on the manometer digital display. F. SAFETY PRESSURE RELIEF VALVE SETTING: Connect a test exhalation valve and patient circuit to the ventilator. Select a flow of 5 L.P.M. Tee a TEST AIRWAY PRESSURE MANOMETER into the airway pressure sensing hose near the exhalation valve. Occlude the end of the exhalation hose and the patient connection simultaneously. Pressure in the patient circuit will increase to the relief valve setting. Compare the relief pressure indicated on the ventilator manometer to the TEST MANOMETER. The normal factory setting is 25 + 2 cm H20. Adjust, if necessary, to the valve desired. CAUTION Do not permit pressure to build on the ventilator manometer gauge beyond the indicated pressure range as the gauge may 43be permanently damaged due to overpressure. G. MANOMETER ACCURACY: Using the same set-up as above, connect the exhalation hose to the exhalation valve and plug patient connection. Create a machine inspiratory phase by depressing the ventilator manual button. Check the indicated airway pressure on the digital manometer against the reading on the TEST MANOMETER at various settings of the Inspiratory Pressure Control. The ventilator manometer should indicate within + 3 cm H20 of the TEST MANOMETER at all settings. CAUTION Moving parts within the manometer gauge are subject to wear in normal use which may lead to inaccurate or erratic gauge Performance over time. Periodic replacement of the manometer is recommended for best performance. H. EXPIRATORY PRESSURE CONTROL: With the same set-up as above but with a flow of 12 L.P.M., check the minimum and maximum values of the expiratory pressure generated by the ventilator. The normal minimum expiratory pressure should be -1.5 to -3.0 cm H20. The normal maximum expiratory Pressure should be 17 to 22 cm H20. I. INSPIRATORY PRESSURE CONTROL: Check the minimum and maximum values of the inspiratory pressure generated by the ventilator. The normal minimum value should be 5 + 2 cm H20, The normal maximum value should be 65 to 75 cm H20. Note: If the safety pressure relief valve is set to a lower value, it will have to be held closed during this test. J. MANUAL CONTROL: During the previous testing, depressing the manual button should create a machine inspiratory phase. Verify that the button does not stick in the depressed position and that it moves freely. K. A.C. POWER SWITCH: Place the mode switch in the OFF position. Plug the power cord into a grounded A.C. receptacle. Switch the A.C. power on; the switch should not trip off. The amber pilot light should light on the front panel. 44L. MODE SWITCH: S$ lect the CPAP position with the mode switch. The corresponding green pilot light should light. M. ALARM MUTE: Position the LO LIMIT set point at 30 cm H20 and select an alarm delay time of 3 seconds. When the alarm activates, depress the alarm mute button. The alarm system should be muted for approximately 25 seconds. As the alarm will be active for the remainder of the testing, depress the mute button whenever necessary to prevent distraction. N. INSPIRATORY TIME CONTROL:. Select the VENT position with the mode switch. The ventilator should begin cycling. Verify the inspiratory time control will smoothly adjust from 0.10 to 2.90 seconds and that various time displays remain stable when selected. ©, EXPIRATORY TIME CONTROL: Verify that the expiratory time control will smoothly adjust from 0.30 to 60.0 seconds and that various time displays remain stable when selected. P. TIMING TEST: Select an inspiratory time of 1.00 second and an expiratory time of 1.00 second. Using an accurate stopwatch, count the ventilator rate. It should be 30 per minute. Q. TEST: Depress the test button. The microprocessor should enter a test count subroutine as indicated by the displays. Depressing the test button should also activate all the segments of the digital manometer and the audible and visible alarm indicators. Note, the ventilator should continue to cycle during the 5 second test sequence. R. TIME PRESET: Select the CPAP position with the mode switch. The displays should turn off. Depress the tine Preset button. The displays should light, but the ventilator will not cycle. verify that it is possible to adjust the inspiratory and expiratory times and that the ventilator is not cycling. S. LO LIMIT ALARM ACTUATION - ALARM DELAY TIME: Leave the mede switch in the CPAP position. Allow the alarm to activate. Select an alarm delay time of 3 seconds. Generate a mechanical pressure breath with the Manual Breath Button which will allow the pressure to reach the LO LIMIT alarm set point. Start a stopwatch at the start of the expiratory phase. Stop the watch when the alarm activates. The time should be 3 + .3 seconds. Repeat the test at the 60 second position. The time should be 50 to 70 seconds. Verify that it is possible to adjust the LO LIMIT set poin 45up and down with the press buttons. T. HI LIMIT PRESSURE ALARM ACTUATION: Verify that it is possible to select the HI LIMIT adjustment mode and adjust the HI LIMIT set point up and down with the press buttons. Increase the delivered pressure until the HI LIMIT is reached. Verify that an alarm condition is indicated immediately. Verify that pressing the SELECT button will reset the alarms. U. ALARM BATTERY TEST: Select an alarm delay time of 3 seconds. Leave the mode switch in the CPAP position. Allow the alarm to activate. When the alarm activates, disconnect the A.C. power cord from the wall plug. The alarm systen should continue to sound or should sound after a 3 second delay if the disconnect resets it. If the alarm system does not activate on battery power, the batteries require charging. See Section 6.¢.7. If an Iv-100B Infant Ventilator system meets all the criteria of the above Performance Verification Procedure, it can be considered suitable for use. If the unit does not meet the criteria of this procedure, service is required. Certain service items can be performed by qualified personnel in the hospital (see Section 5). 46SERVICE POLICY A ventilator which does not meet the criteria of the Performance Verification Procedure should not be used until repairs have been made and the unit has been again checked using this procedure to determine that it is functioning according to specification. To ensure safety and reliability, we recommend that any service of the Sechrist Model IV-100B Infant Ventilator be accomplished by an Authorized Sechrist Service Representative. Authorized Service is available directly from or through many of our product distributors or directly from the home office of Sechrist Industries in Anaheim, California. Routine maintenance, as defined by this manual may be accomplished by competent individuals having experience in the maintenance and/or repair of devices of this nature. Parts designated in this manual should be replaced only with parts manufactured or sold by Sechrist Industries. If it is necessary to send a unit to the home office for service, it should be adequately packaged, preferably in the original shipping carton. Units returned to the home office for repair, (EXCEPT where our warranty applies), will be repaired at the current list price for replacement parts plus a reasonable labor charge. 47ROUTINE MAINTENANCE A. CLEANING AND STERILIZATION: This ventilator and the associated patient circuit are shipped in clean but not sterile condition. The patient circuit of the Sechrist Infant ventilator should be detached from the ventilator and completely disassembled to expose all surfaces prior to cleaning. Clean the components in a medical detergent solution. Thoroughly flush, preferably with distilled water. Sterilize using liquid chemicals or ethylene oxide. Use liquid chemical agents according to the manufacturer's recommendations. Be sure the agent is compatible with plastics. Ethylene oxide mixtures can be used at temperatures below 140 degrees F. Room temperature sterilization with 100% ethylene oxide can also be used. Ethylene oxide may cause superficial crazing of plastic components and will accelerate the aging of plastic components. CAUTION Ethylene oxide is toxic. Parts thus sterilized must be properly aerated to dissipate the residual toxic gas absorbed by the material. Follow the sterilizer manufacturer's recommendations for the specific aeration periods required. 48soatqyuyuesaa -day aopasag yetaysag oy yyun usngey wots -uurmuyuoo yao uBaTg aacqv oe oung aaoqu eu omug aaty ~quassaday aot Aras qerayoag paztaoyyny 04 3yun uangoy e104 {ty 908 [doy BxaT LoJ AD9yD syBaT 4OJ H9aUD eacqe su aung seq awousw aoatdoy worgeaqrtes pue @uruna[a 10J ato awoy 0} 4axpw uangoy TL#q pus eqny user NOTSOV GaTeOTNNOD 042 30 woTzo08 eyuTadoadde ayy 04 aesoa avtnorzaed @ 499m yOu seOP qOOI-AI Ue JT saayuarq qimoaro @ os{B BF WorTMs “aun UTYTIN | EMosT9-7L0yS orUOITDa TE Aqatp furs pawn? puw u0aynq uaanyaq aonds aouvanaty anoqu sv oung Atsodoad poyvsqrteo you ytuq pauymeyuos et Aaqymoayo oppyMta Teusey uy poy eurueyuos S107 TTS FOTUE TOF TA MOA @AT@A WOTRTeYXe UF SxvOq qimosto yuetied UT sxveT eacqe ae owes + peztanseoad -49A0 SKOTTAq 19} 0u0UsK soanjerow 40 94Ep UTA paquurmuzuog soangcqow 40 4ATP HVEA porwurueyuos TLeq puw e40q potadey [ousezuy asnvo §1a1Ssod uo kaye jou [LIM YortAs zemod -o°¥ exorys woyyng LenuOH e#upa aanegoad £10yvatdeur joeaa09 ayesoues oy atqeun oanssead £10, atdxg quepotsyne eyeseua® oy aTqoun eyvanooe you 10; am0UBq 40jeuousu osez 07 eTQeun poyerqETes you 19x1H peyesqy {vo you s949uMOTE waTdOwd seuop eq PINOYs 4eYA aUTULeZepP 03 aPTND FUTIoOUBaTANos, 9Ua UTTA PayeuTpsoos et aprn® Furzooysaiqnosy Stuy ‘uoyqeotstx9A aouswsosaad ayy Buranp uorqwors toads seanpadodg WOTy POTS TIAA aoUBULOSAAG ACID ONTLOONSSTaNONL ‘a *9Sets9338q ef1849 2aoqe cu omug anoqe sv aueg 92FF50 euoH 10 oATyS ~juoseadey eopareg yet ayoag paz yaoyyny 4oR4U09 aouenbes 49aq Buranp Aetderp sqraed qoetdey aaoqe oe ouvg aaoqe ao aueg eacqe eu owvg +a07JJO awoy 10 aaTyD -juesesdoy eopaseg yeTAyoeg pezrsoyyny y9u;U0D saca'T oqetadosdde aoxtdoy NOTLOV ~~ SATLORHHOD paduvyo you eeyaeq4eq waR[e [eusequy anoqe su owag eacqe cv ousg kaqqnoapo oyuorz 9919 o4y UF WaTQorg 4no pauang setdetp “aca anoqe cu owes anoqe av owug eacqu av ouug kay ynoapo, ofuoszoaT® ayy UF waTqord qno pousng 4u9TT 40Trd asnvo 41@1ss0od aemod *y*y yn0 -4}FM e3eredo you TTFA waeTy payeaqr {eo you our, Avyop wasTy eatyeaodour yasaad owry, £[ 4001109 aouenbas 4893 y8no1yy eTofo you seop aruq AToaasoo kvtdayp you soop 4ruq eyvanoow you Surury +eodued awyy £410jea¢dxe pus £10; easdeuy potstoads aaotyow you TTIa 4TUq oynw you eoop waeTy e38AT}0R you Ga0p mreTy [Busou UOTZoUNZ TOZBT TZ UIA usnoyz1e FFT FOU BINFEL FOLTd waldo HdC. ROUTINE MAINTENANCE PROCEDURES The following procedures are co-ordinated with the Performance Verification Procedure and the Troubleshooting Guide to permit competent individuals having experience in the maintenance or repair of devices of this nature to perform specified maintenance on the Sechrist Model IV-100B Infant Ventilator. WARNING Routine maintenance procedures contained in this manual may involve opening the ventilator enclosure which constitutes an ELECTRICAL SHOCK HAZARD. These procedures must be performed by qualified service personnel. 1. Cleaning the flowmeter. The calibration of the flowmeter depends upon the clearance between the’ internal tapered bore and the ball float. If the surface of the bore or the ball is dirty, the calibration of the flowmeter will not be correct. To clean the internal bore of the flowmeter, remove the hex plug on the top of the tube. Remove the ball carefully. Swab the internal bore with a suitable cleaner and swab dry. Wipe the ball clean, replace in bore. Replace the plug and flow Medical Breathing Air or Oxygen through the flowmeter for approximately ten minutes to evaporate any residual cleaner. 2. Replace the manometer. To replace the electronic manometer, the ventilator upper front panel subassembly must be removed from the unit. Disconnect the unit from AC power. Remove the four retaining screws from the lower front panel subassembly. Remove the two screws from the upper front panel subassembly. Tip the upper front panel subassembly forward at the top. Remove the ribbon cable connector from the top of the ventilator display circuit board. Carefully remove the small tubing from the transducer on the manometer circuit board. Pull the upper front panel subassembly forward and up. Tip the panel forward until horizontal. Desolder the wires which connect the electronic manometer circuit board to the display board. Remove the electronic circuit board by removing the three retaining screws. NOTE THE LOCATATION OF THE PLASTIC WASHER. Remove the ground wire from the panel. Remove the three screws holding the manometer circuit board to the 51Baunol ANAWSOV Ida HSaLSaWONVIA OINOYW193573 3M3H98 ONINIVLaY auvos ‘sa SS.LAWONVW SINOH.LD313 auvos ‘sd AVI1dS10 HOLY WLINaA SaHIM dW WHYfront panel. Replace the manometer circuit board with the new one. Reassemble by reversing the above procedure. 3. Check the exhalation valve. Remove the diaphragm cover cap and the diaphragm. Look down through the injector jet to be sure it is not occluded. Inspect the diaphragm for cuts or tears. Install the diaphragm in the block, be sure that the outer ring of the diaphragm is evenly seated on the ridge in the block completely around the edge. Inspect the o-ring on the diaphragm cover cap. Install the cover cap and visually inspect the seal it produces by the o-ring. Visually inspect the o-rings on the three nipples threaded into the exhalation mounting plate (right side of ventilator, viewing front). Mount the exhalation valve onto the ventilator and check its operation. 4. Replace inlet filters. The mixer incorporates filters in both the air and oxygen inlets. The air inlet incorporates a 0.1 micron filter element in an external water trap/filter housing and a 7 micron sintered stainless steel filter element within the mixer block. The oxygen inlet incorporates only the 7 micron sintered stainless filter element within the mixer oxygen block. On the air side, only the external 0.1 micron filter element should require replacement when dirty. Unscrew the water trap bowl, remove the old element and discard. Install a new element. To replace the oxygen inlet filter, remove the 3/4" hex brass bushing from the rear of the mixer. Remove and replace the element. Be sure the o-ring seals and tension spring are in place and install the adapter bushing. 5. Cleaning the Manual button. Remove the four screws holding the lower front panel. Tip the top of the panel forward. Remove the two tubes attached to the manual valve, note their location. Use a 9/16" wrench to loosen the valve from the guard ring. Remove the valve. Clean the push button and the inside of the guard ring. Reassemble. The button is a push fit on the valve shaft. 6. Replace the pilot L.E.D.‘s. Remove the four screws holding the lower front panel. Tip the top of the panel forward. Remove the wires from the defective L.E.D., push the L.E.D. out of the front panel. Note the polarity of the new L.E.D. before inserting into the panel. A 1/4" nut driver can be used to press it in place. Attach the wires to the L.E.D. terminals. Note, the black wire is ground. 7. Charge alarm batteries. The internal rechargeable batteries which provide a back up for the alarm system are charged whenever the AC power is on and the mode switch is 53 -OL aHnSS aNVd IO8LNOD LNOWS HaMo7 NK SHO.VDIONI Z00Win the CPAP or VENT position. To charge the batteries, operate the ventilator in the VENT mode on a test bench to keep the alarm from activating. To fully charge, the batteries require 12 to 14 hours of ventilator operation. Fully charged batteries will operate the electronic manometer and an activated alarm for more than 10 minutes without AC power. 556. D, REPLACEMENT PARTS The following drawings and lists delineate the Sechrist part numbers of the various parts which may be required for routine maintenance. Other replacement parts not illustrated are listed below. EMENT PARTS — NO’ D PART NO DESCRIPTION Iv 325 PEDIATRIC PATIENT CIRCUIT WITH EXHALATION VALVE (TRANSPARENT; COMPLETE) Iv 325A PEDIATRIC EXHALATION VALVE (TRANSPARENT) IV 3258 PEDIATRIC PATIENT CIRCUIT WITHOUT EXHALATION VALVE Iv 325M PEDIATRIC EXHALATION VALVE ASSY (METAL) Iv 335 HI/LO PATIENT CIRCUIT WITH EXHALATION VALVE (TRANSPARENT; COMPLETE) Iv 335A HI/LO EXHALATION VALVE ASSY (TRANSPARENT) IV-335B HI/LO PATIENT CIRCUIT WITHOUT EXHALATION VALVE Iv 302-01 MANUAL BUTTON VALVE IV 302-02 MANUAL BUTTON GUARD RING IV 302-03 MANUAL BUTTON IV 306-03 PRESSURE WAVEFORM CONTROL COVER PLUG Iv 412 12 V.D.C. CABLE ASSEMBLY Iv 408-01 NICAD ALARM BATTERY IV 408-03 ALARM SPEAKER 56REPLACEMENT PARTS - NOT ILLUSTRATED (continued) PART NO DESCRIPTION Iv 410 GREEN L.E.D. (MODE PILOT LIGHT) Iv 411 YELLOW L.E.D. (MODE PILOT LIGHT) Iv 407 POWER SWITCH/CIRCUIT BREAKER ASSEMBLY Iv 208-03D O-RING - EXHALATION VALVE MOUNTING NIPPLE Iv 208-02 EXHALATION VALVE MOUNT NIPPLE Iv 207-03 THUMB SCREW - POLE MOUNT BRACKET Iv 301-09 SOLENOID VALVE ASSEMBLY Iv 310 FITTING, 10-32 X 1/16" TUBE NIPPLE Iv 311 FITTING, 10-32 X 1/8" TUBE NIPPLE Iv 312 PLUG, 10-32 Iv 313 TEE, 1/16" TUBING Iv 308 AIR PRESSURE HOSE (D.I.S.S. F/F; 14 FT) Iv 309 OXYGEN PRESSURE HOSE (D.I.S. Iv 317 POP-OFF VALVE 25020 C.P.U. BOARD ASSEMBLY Iv 402 DISPLAY/ALARM BOARD ASSEMBLY Iv 403 POWER SUPPLY ASSEMBLY Iv 201 ENCLOSURE(see-aly SLUVd LNBW39V1daN LINDMIO MO14d O71/1H WHA 80H) = 0 -SEE-AL (ean) 81-SOE-AI (sunny ee? 2o-aee-al— Ojo@uUoD 4ue}}0d) vI-G0E-AT 91-Soe-Al (Asay 4901 9A}DA) vaee-Al(veee- Al) SLUVd LNSN390V1d3y SAIVA NOILVIVHX3 MO14S O7/1H (sa0vid € ) ONO oz-sor waHSVM TI-sOE > waNIVIay ose & oe 49078 sea! 4) OD. WOVaHdVIG so-so ONIN-O 90-1 at dV) ONINIVIAY WOVEHdVIC sos — Wav ONINIVI3S 80- anet i MAHSWAA ZL-SOt GON ONINIVITY 60-506(sze-al) SLUVd LNAW30V1d3y (ous) AINDHID LN3ILWd O1d.vidad €1-908-Al (8uratd) 22-eze-A (8ujqni) 81-90 -AI (Ould) 98-926-Al (6u0) 2! (2049euu09 yuelsog) 7 €2-sz2e-Al (heey yoog © veze-al )(veze-an) SLUVd LN3W3DV1d9a JATVA NOUV IVHX3 DIMLVIGId YO MBBS 13S 91-STE “A 13f 90-ste < ~~ ono rset © a — (spovu e) onn-o 02-908 ASSY WOVUHAVIG/13dd0d VLO-S7E (378) év> ONINIVIaY WoVUHavIa tse —~ 7 Wav ONINIVI3IY BO-90E: UIHSVM 21-908 GONM ONINIVI3Y 60-SOeE.L. BACK LITE P/N 39035 E.L. INVERTER P/N39034 ELECTRONIC MANOMETER REPLACEMENT PARTS3521 O-RING 3529T BODY QD ‘os 3520 O-RING 3530 FITTING —. 3519 BUSHING (3526 OXY NIPPLE 3529F O-RING ——O 3527 OXY NUT 3829G SHROUD —£ 3529E FILTER —__. i 3528A ADAPTER IG a ase SPRING 3873 ADAPTER ~~ 2 a 3522 FILTER 3829 RETAINER fi 35295 BOWL —_L. ——— 3529X WATER TRAP/ FILTER ASSEMBLY MIXER FILTER REPLACEMENT PARTSUNDERSTANDING GUIDE A. UNDERSTANDING THE SECHRIST IV-100B INFANT VENTILATOR In the early 1970's the use of continuous flow, time-cycled ventilator systems started to become the method of choice for the mechanical ventilation of infants. The subsequent success of this method has been widely reported. As a result, several models of this type of ventilator became available from various manufacturers. Schematically, this method of ventilation and the several model ventilators currently available can be described by the diagram shown in Figure 11. Oxygen and air sources are mixed to the desired oxygen concentration using flowmeters or gas mixing devices. A controlled continuous flow of mixed gas is passed through a humidifier thence to the patient connection via appropriate tubing. This continuous flow of gas vents to ambient through an exhalation valve. Closure of the exhalation valve will result in a pressure increase within the patient circuit and therefore, at the patient connection. This pressure increase causes insufflation of the patient's lungs. Opening the exhalation valve drops the pressure at the patient connection, thereby allowing exhalation to occur while the continuous flow of gas flushes carbon dioxide from the patient connection. A control timing system operates the exhalation valve. The various commercially available devices control the valve closed and valve open times by adjustment of inspiratory and expiratory times or adjustment of I:E ratio and rate per minute. In either case, the exhalation valve is cyclically closed and opened at predetermined intervals. The control timing system may be electronic or pneumatic and the associated exhalation valve may be an electronic solenoid or pneumatically operated valve. An appropriate pressure control system and a safety pressure relief valve is provided that control the maximum inflation pressure and end expiratory pressure in the patient breathing circuit. The Sechrist Model IV-100B Infant Ventilator is a continuous flow, time-cycled controller. The unit shown schematically in Figure 12. Sources of air and oxygen are supplied to the Air-Oxygen mixer and flowmeter where the desired FIO2 and continuous flow are selected. This flow passes through a humidifier where it is humidified and warmed to physiologic values. This flow passes the patient connection and flows to ambient through an exhalation valve. Inflation 64uaunold NOILWTILN3A G31DA2-aWIL MOTS-SNONNILNOD | ) waigiaIwoH | | 2 | ——== : Saunssaud aN ava 1OuINOD MoU ANY 3ATVA NOMWIWHXA | OU a1 “AWIL “'ASNNI ‘SWI "AX3 Onnxiwsvo :WAASAS ONIWIL TOMLNOD j a AXANIILWd SOOL-Al JILVW3HDS T1VuINIO walsas ‘TOULNOD drains aATWA NOMVIWHXa W31SAS TOULNOD wOssIIONdONDIW ancon JOULNOD YOLVTILNSA wana awn annaow oNDIW MOlSYSof the patient's lungs is accomplished by closing the exhalation valve, thus creating a pressure increase at the patient connection. Exhalation occurs when the exhalation valve is opened. A microprocessor based control system allows the operator to select the time intervals of the exhalation valve closing and opening, thereby controlling the inspiratory and expiratory times. A fluidic control system allows the operator to control the pressure of the gas signal closing and opening the diaphragm in the exhalation valve, thereby allowing control of the inspiratory and expiratory pressures. When the operator selects the desired inspiratory and expiratory times, the microprocessor based computer displays the times on the control panel. Simultaneously, the ventilator I:E ratio and rate are automatically calculated and displayed. A manual push button connected to the fluidic control systen allows a manual breath to be given whenever desired. A patient pressure alarm system is incorporated into the electronic manometer of the ventilator to warn of a loss of inspiratory pressure or warn of an overpressure condition. A loss of inspiratory pressure caused by loss of source gas supply, accidental extubation, patient circuit leaks, disconnects or failure of the ventilator to cycle would result in a decrease or loss of patient ventilation, an undesirable situation. To detect this condition, a Low Pressure Limit is selected by the operator at a value slightly less than the maximum pressure reached during inspiration. A delay time is then selected with the control knob. If the measured pressure does not reach, or exceed the low limit value before the delay time is reached, an alarm condition will be indicated. An overpressure condition will indicated whenever the measured pressure reaches the high limit value selected by the operator. Inlets for the supply gases, oxygen and air, conform to the Diameter Index Safety System (D.I.S.S.) as do the supply hoses. Sintered stainless filters are incorporated into the inlets. A high quality, low leakage power cord is utilized with a hospital grade plug. A 0.25 amp resettable circuit breaker is placed in series with A.c. Power. The exhalation valve is the principal active component which controls the pressures created within the patient circuit. A cross section diagram of the exhalation valve is shown in 67Figure 13. The continuous flow of gas in the patient circuit must flow to ambient. It does this through a carefully designed valve seat located within the exhalation valve block. Positioned just above the valve seat is the control diaphragm. The space above the control diaphragm is sealed and connected to the fluidic control system within the ventilator. When pressure is created in the space above the diaphragm it will move and occlude the valve seat. The flow of gas in the patient circuit will build up enough pressure within the patient circuit to oppose the closing movement of the diaphragm. The two opposing forces will reach an equilibrium venting the continuous flow to ambient at a specific pressure. Changing the control pressure above the diaphragm will result in a corresponding change in the maximum pressure developed within the patient circuit. This is how the inspiratory and expiratory phases are created and controlled. The control pressure signal is switched from a relatively low pressure during the expiratory phase to a higher pressure during the inspiratory phase. A reliable fluidic control circuit is utilized to control the signal pressure operating the exhalation valve. This control circuit is depicted in Figures 14 and 15. The function of this circuit is to allow the operator to control the signal pressure activating the exhalation diaphragm during the inspiratory and expiratory phases. Figure 14 depicts the circuit during the ventilator expiratory phase or CPAP mode. The nominal 50 psi to supply is filtered and regulated to approximately 20 psi to supply two fluidic gates, a back pressure sensing gate and an oR gate. If the gas flow from the signal port on the back pressure sensing gate is unimpeded the output flow of both gates is its respective outlet port 02. The outlet of the back pressure sensing gate flows to the negative injector jet. Simultaneously the outlet of the OR gate flows through the expiratory pressure calibration valve, a check valve and the waveform adjustment system to the exhalation valve diaphragm. The pressure generated on the control side of the exhalation valve diaphragm during this phase will be dependent upon the position of three valves in the system, the previously mentioned expiratory pressure calibration valve, the expiratory pressure control valve and the range calibration valve. The calibration valves are internal factory calibrations which adjust the maximum expiratcry pressure and the range of the externally accessible expiratory pressure control. It can be readily seen that if the expiratory pressure control is closed to the full clockwise position, the flow to ambient at that location is stopped and the maximum expiratory control pressure actinge:aunold NOILD3S-SSOUD JATVA NOILVIVHX SONY ONINIVIRY —~ L; 4O1D3NNOD INalVd wous Ws ONO way onintvisa INNS aanssaud dV2 ONINIVIIS WOVaHAVIG ae WovaHdvid 1OML a8 43f SOLD3FNI AVIS 3A1VA AVOYHL HOLD3FNIon the exhalation valve diaphragm is achieved. Counter-clockwise rotation of the control valve progressively decreases the control pressure acting upon the exhalation valve diaphragm, thereby decreasing the patient expiratory pressure. As previously discussed in the exhalation valve section, when pressure acting upon the diaphragm reaches a minimal value, the reverse injector will create a slight sub-ambient pressure in the exhalation valve. Thus a single control allows adjustment of the patient expiratory pressure from sub-ambient to the maximur calibrated positive pressure. The inspiratory phase is accomplished by blocking the outlet flow from the signal port of the fluidic back pressure sensing gate. This can be done by the operator depressing the manual button or electronically cycling a small solenoid valve with signals from the microprocessor circuit. In either case, when this signal flow is occluded, the back pressure sensing gate outlet flow switches from 02 to 01 thus turning off the negative pressure jet and concurrently switching the OR gate outlet from 02 to 01. The flow from outlet 01 passes through the inspiratory pressure ¢ calibration valve, a check valve, and the waveform adjustment system to the exhalation valve diaphragm. The function of this circuit in controlling the pressure on the exhalation valve diaphragm is identical to that described for the expiratory phase but the resulting control pressures are slightly higher, as they must be to create the peak patient circuit pressures required to inflate the patient. Check valves are located in each circuit so that the position of one pressure control valve will not affect the other, thus the independence of the pressure control setting. The Sechrist Model IV-100B Infant Ventilator incorporates a unique control which allows the user to vary the proximal airway pressure waveform. This control is located behind a button plug which is located immediately above the exhalation valve. When this control is rotated fully counter-clockwise, the gas pressure control signal to the exhalation valve diaphragm is unimpeded, therefore it is essentially a square waveform. This square wave signal closes and opens the diaphragm quickly and imparts the potential for developing a square waveform within the Patient circuit. Rotation of this valve progressively Clockwise dampens the gas pressure control signal to the diaphragm, prolonging somewhat the pressure rise time in the patient circuit and also the pressure decay time. With complete clockwise rotation, an approximate sine waveforn may be simulated.vi aunold JOuINOD JOULNOD aUNSSasd “ASHI qunssaud “axa 3SVHd ABOLVaIdXa JOIN? TWANYW NIBID TOALNOD JIGINAA TT Ct “WWD IONVE = Psa “W2"sSaud “dSNI “WO "SS3ud “Axa ft wOSsaudONDIW wous GION31OS ] | | BOLVINGIS «NALS aive uo” Je I PaO nn — — +] asnrav i] Vsaoz ) | W8OdIATM i! WOWaHaViG 3ATVA‘HXE 1ar 34NSS3ud IALLVOIN AVMIW TWWIXONd — = = eatstaunow JOULNOD JoUNOD aUNSS3Ud “dSNI waNSSaud “axa 3SVHd AYOLVUIdSNI LINDAID TOBLNOD JIGINId “WO 39NVE rr “TW2 "SSatid “aSNI pe------35 alive uo JOMLNOD TWANYW a3a7@ wOssadoUrIV wous aownos LS +A wolvinom = yan asnrav WuosaAVM WOVUHdVIG aATVA “HX Aaf aUNSS3Nd AALLVOAN avmulw WwWIxoud ~~~Fluidics were utilized in the design of the Sechrist Model IV-100B Infant Ventilator to actuate the exhalation valve because they provide a safer interface between the ventilator and patient and other inherent advantages. For control of ventilator cycling times, electronic technology was chosen for use because of its accuracy, repeatability and stability. Calibrated controls for inspiratory and expiratory times were considered mandatory and displays of the resulting I:E ratio and rate were desired. The microprocessor control circuit designed to accomplish this task is shown in Figure 16. The basic function of this circuit is to switch the solenoid valve of the fluidic control circuit on and off in response to operator selected inputs for inspiratory and expiratory times. Ten-turn potentiometers are used to create analog control signals which are presented to an analog-to- digital conversion circuit. The digital word created by the A-D converter is presented to the microprocessor through an input/output port, and the microprocessor interprets the meaning of this word by consulting its program memory. Depending upon what the program tells it, the microprocessor will send out a signal to the solenoid turning it on or off for a specific number of clock cycles of the time base generator circuit. This time base generator uses a 4.0 megahertz crystal for a precision reference oscillator. As the microprocessor is switching the solenoid on and off and as it samples the two analog input signals, it concurrently displays the on and off time via L.E.D. displays. Simultaneously, the microprocessor performs the necessary arithmetic to calculate the I:E ratio and number of breaths per minute and also displays these values via L.E.D. displays. In order to properly interpret the analog input signals and output to the solenoid correctly, the microprocessor must continuously run through its program loop sequentially. If any problem occurs which results in this not happening, an auto restart logic circuit will reset the microprocessor. If the problen is a failed component and the microproccesor cannot run properly, the circuit will turn the microprocessor off. A redundant and independent timing circuit is incorporated in the signal line to the solenoid which turns the solencid off, if on for more than 4.0 seconds. The function of the alarm system incorporated into the Sechrist Model IV-100B Infant Ventilator is based on the pressure that is achieved within the patient circuit during the inspiratory phase. The inspiratory pressure is necessary to insufflate the patient and the lack of pressure, for whatever reason, indicates that the ventilator is probably not accomplishing its task. To measure the 73sLaunols 1INDYID IOHLNOOS DINOH.LOSTS eanud w390930 HOW Anaino a one 3/1 “WI Wad Huvaua oosis0 za) +) SiNdNt oo a SOTWNY ane ¥300930 woWvT 09-060 anaino GIONaT0s OL (938) wantuo malt w3q0930 on anit o — 1uvis34 o1n Anaino (Ou) wouda gue ‘AMOWAW IVHDOUd ‘SAVIASIO wolvuaN39 Sve MILavaunor LnoHID WHIT SWI Av130 ainw 4sa..NG dn 193738 ySaLaWONTW YaAIHO WHIT 3INOH19373 YEMOd AHSLIVe waMod ‘ovpressure or lack of pressure in the patient circuit, a solid-state pressure transducer is used with an independent microprocessor system, the digital electronic manometer/alarm systen. The manometer measures and displays the pressure within the patient circuit. The alarm system allows the operator to select low pressure and high pressure alarm limit values. If the low limit pressure value is not reached by the measured pressure within a time period less than the time selected on the alarm delay tine control, audible and visual alarms will be activated. The delay time is adjustable from 3 to 60 seconds. If the measured pressure reaches the high limit pressure value, audible and visible alarms will be activated immediately. An alarm mute button will temporarily mute the alarm audible indicator for 20 to 30 seconds. The electronic manometer/alarm system is completely independent electrically from the main electronic control circuitry in the ventilator. This is to guarantee its operation even if the main microprocessor control systen is not operating. The electronic manometer/alarm systen also incorporates a battery power backup system to insure its function in the absence of normal 110 Volt A.C. power. The batteries are rechargeable ni-cads which are kept automatically charged during normal operation and should not require replacement for several years. 76B. UNDERSTANDING THE SECHRIST AIR-OXYGEN MIXER The Sechrist Air-oxygen Mixer is a device to proportion Medical Breathing Air and Medical Breathing oxygen at operator selected ratios for delivery to patients via respiratory care apparatus. To accomplish this task properly, several factors must be considered. First, the device must permit the operator to select a ratio of the flow of one gas vs. the other gas. This is typically done by using two variable restrictors, such as needle valves, which are linked together in such a way that the effective flow areas of the two variable restrictors are inversely proportional. These variable restrictors are positioned with a calibrated control knob. Movement of the control knob will increase the effective area for the flow of one gas while decreasing the effective area for the flow of the other gas. The ratio of the areas will determine the ratio of the two gas flows. If the two gases are air and oxygen, the percentage of oxygen in the mixed gas is determined by the formula: (1.0 X Qoxy) + (21 X Qair) Fl0g = -no--~--2ee at Where Qoxy = flow of oxygen air = flow of air in identical units Dimensioning for the effective areas is determined by the desired flow range of the device. A low flow system would have smaller effective flow areas than a device designed for the higher flows required for ventilator operation. A cross section schematic view of the proportioning valve module of the Sechrist Mixer is shown in Figure 18. The calibrated control knob is attached to a threaded positioning shaft. Positioned within two sharp edged orifice seats is a double-ended tapered needle valve. A spring loaded positioning device acts upon the end of the double-ended valve keeping it in contact with the threaded positioning shaft. Rotation of the control knob will move the location of the threaded positioning shaft thereby adjusting the location of the double-ended needle valve relative to the two orifice seats and defining the effective flow areas for both gases. This simple system would be all that is necessary toat aunolsproportion the flow of two gases. However, if it is desired to calibrate the control knob and to maintain the ratio of the two gas flows at a constant value, the pressure differential across both orifice areas must be identical. One can easily imagine what would happen to the gas flow ratio if the oxygen pressure increased from 50 psi, when the ratio was selected, to 100 psi. Some type of system must be used to regulate the gas pressure entering the proportioning device; preferably making both gas pressures equal. If the individual gas pressures entering the proportioning device are equal and the gases flow to a common outlet for mixing, the pressure differential across each of the orifice areas will be equal. If these conditions are maintained, the ratio of the two gas flows will remain constant. Various methods are used by different manufacturers to equalize the two gas supply pressures; precision regulators set to equal outlet pressures, dual regulators configured such that one gas pressure is slaved to the other and devices termed fulling regulators. Nulling regulators were conceived in the 1930's for welding and liquid mixing purposes. In principle, nulling regulators use one gas pressure to control the other, but either gas may be the controlling gas. A nulling regulator will reduce whichever gas pressure is higher to a value equal to the lower gas pressure. The Sechrist Air-Oxygen Mixer uses a nulling regulator t balance the two supply gas pressures before they enter t proportioning valve. This is shown schematically in Fig 19. Two identical needle valve/seat arrangements are configured on opposite sides of a central diaphragm. They are located so that both valve seats cannot be closed at the same time and they are designed so that the effective flow area for each gas is inversely proportional to the other. When one gas source is turned on, that gas pressure will act on the diaphragm pushing it away from the needle valve/seat until the valve closes and permits no flow of the gas. If the other gas source is turned on, it will find its needle valve/seat open and the gas pressure passing through this open seat will act upon the diaphragm. The diaphragm will then move to a position where the pressure acting upon each side of the diaphragm is equal. If the two pressures acting upon the diaphragm are not equal, the diaphragm will move away from the higher pressure. When the diaphragm moves in this way, the needle/seat which is the source of the higher gas pressure will close down, reducing pressure on the diaphragm. At the same time, the opposite needle valve/seat is opened. Thus, the system will null out differences in the gas pressures until they are equal. These equal gas pressures are then presented to the proportioning valve for mixing at the desired ratio. e565 ne r 79As stated previously, a characteristic of a nulling regulator is to create an outlet gas pressure equal to the lower of the two inlet gas pressures. In this case, if one of the inlet pressures is zero, the outlet pressure will be zero. It is desirable to keep pneumatic respiratory care equipment operating even with the inadvertent loss of one of the supply gases. Therefore, a device is required which will bypass the nulling regulator with the remaining supply gas and simultaneously activate an alarm to alert attending Personnel. Such a bypass/alarm system is incorporated in the Sechrist Air-oxygen Mixer. This device is depicted schematically in Figure 20. The supply pressures of air and oxygen are delivered to this module via internally drilled channels. Cross drilling within the module presents the air and oxygen pressures on opposing ends of two identical moveable pistons. These pistons are fitted with sealing o-rings and are nominally seated with the force of a compression spring. The sealing o-rings are of different diameter on the ends of the piston. Therefore, the forces generated by the inlet gas pressures keep the pistons seated as long as the inlet gas pressures are close to the same value. If, however, one of the gas pressures should drop in relation to the other, the resulting forces will cause the piston to move back from its seated position and in so doing open a flow channel from the higher of the two inlet pressures to the proportioning valve module outlet. when this occurs, the alarm reed will be activated and the higher gas pressure will enter the outlet manifold of the proportioning valve to supply gas pressure to the outlet port, bypassing its normal route. Restoring the lower gas pressure will reseat the moved piston. A one-way check valve is located in the bypass/alarm to prevent the normal gas mixture from activating the alarm reed. The pressure difference in the inlet gas pressures required to activate the alarm is determined by the dimensioning of the piston seal areas and the seating spring force. Filters are incorporated in both of the gas inlet connec- tions. One-way check valves are also located in both of the gas inlet connections to prevent the crossflow of one gas supply to the other's source. a1oz aunosoz aunols 4371N0 anon ONINOILYOdOYd OL 4371 437NI ui head [a VanY AAV eNiuds