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.