Uni-Vent 731 Series EMV+ Operation Manual Rev 6.0

EMV+ MAIN FEATURES: FIGURE 1

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TABLE OF CONTENTS LIST OF FIGURES ... 6 CONVENTIONS, TERMINOLOGY AND ABBREVIATIONS ... 7 INTENDED USE ... 8 ACCESSORIES LIST ... 9 LIMITED COPYRIGHT RELEASE ... 11 WARNINGS AND CAUTIONS REGARDING USE ... 12 EMV+ AND PULSE OXIMETER ... 12

SYMBOLS AND ICONS... 15 UNPACKING, ASSEMBLY AND CONNECTIONS... 16 SET-UP ... 17 EXTERNAL GAS SOURCES ... 18 VENTILATOR CIRCUIT CONNECTIONS ... 20 VENTILATOR CIRCUIT PATIENT CONNECTIONS ... 21 VENTILATOR CIRCUIT RESISTANCE AND COMPLIANCE ... 22 OPERATING POWER SELECTION & STOPPING ... 22 SELF CHECK ... 22 TRANSDUCER CALIBRATION ... 23

OPERATION OVERVIEW ... 24 INTRODUCTION ... 24

DESCRIPTION OF CONTROLS AND DISPLAY ... 27 CONTROLS ... 28 VISUAL INDICATORS ... 35

LCD ALARM INDICATORS ... 37 ALARM TURN OFF & CANCELLATION ... 38 POP UP MESSAGES ... 39 OPERATION ... 40 MODES OF OPERATION ... 40 ADJUNCTS TO MODES OF OPERATION ... 41 SPONTANEOUS/ ASSISTED BREATH TRIGGER... 42 OPERATIONAL TEST PROCEDURE ... 42 TO BEGIN VENTILATION ... 43 TO CHANGE SETTINGS ... 44 BACK UP VENTILATOR ... 45 PULSE OXIMETER ... 45 HUMIDIFICATION... 45

HAZARDOUS ENVIRONMENT FILTERS ... 47 BACTERIAL/ VIRAL FILTER USE ... 47 CHEMICAL/ BIOLOGICAL FILTER USE ... 47 CHECK VALVE ON BREATHING CIRCUIT WHEN IN HAZARDOUS ENVIRONMENT ... 48

HARSH ENVIRONMENT OPERATION ... 50 4

AIRBORNE PARTICULATES ... 50 EXTREME TEMPERATURE ENVIRONMENTS... 50 ALTITUDE ... 50 RAIN AND SNOW ... 51

ALARM FUNCTIONS ... 53 ALARM PRIORITIES ... 53 VENTILATOR ALARM CATEGORIES ... 54 PULSE OXIMETER ALARMS ... 57

ROUTINE CARE: CALIBRATION, CLEANING AND PREVENTATIVE MAINTENANCE ... 59 CALIBRATION CHECKS ... 59 GENERAL CLEANING ... 59 PREVENTATIVE MAINTENANCE ... 59 REMOVABLE FOAM FILTER REPLACEMENT ... 60 FRESH GAS/ EMERGENCY AIR INTAKE DISK FILTER REPLACEMENT ... 60 POST CONTAMINATED ENVIRONMENT CLEANING ... 60

BATTERY CAPACITY, CARE AND RECHARGING ... 62 BATTERY CAPACITY ... 62 BATTERY CARE AND CHARGING ... 62

IN CASE OF DIFFICULTY ... 63 OPERATOR CORRECTABLE PROBLEMS ... 63 OPERATING PROBLEMS REQUIRING SERVICE ... 63

STORAGE INFORMATION ... 63 LIMITED WARRANTY ... 67 APPENDIX 1: ALARMS ... 68 APPENDIX 2: PNEUMATIC DIAGRAM ... 87 APPENDIX 3: PULSE OXIMETER PRINCIPLES AND SPECIFICATION ... 88 APPENDIX 4: INTERNAL BATTERY CHANGE/ INSERTION ... 90 APPENDIX 5: INTERNAL FILTER CHANGE/ INSERTION ... 91 APPENDIX 6: USE OF LOW FLOW OXYGEN ... 93 APPENDIX 7: RECHARGING GUIDELINES ... 95 APPENDIX 8: POP UP MESSAGE LIST ... 96

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LIST OF FIGURES EMV+ MAIN FEATURES: FIGURE 1 ... 3 CONNECTOR PANEL: FIGURE 2 ... 17 EXTERNAL GAS SOURCES: FIGURE 3 ... 18 FRESH GAS/EMERGENCY AIR INTAKE: FIGURE 4 ... 19 VENTILATOR CIRCUIT, DEVICE CONNECTIONS: FIGURE 5 ... 20 VENTILATOR CIRCUIT, PATIENT CONNECTION: FIGURE 6... 21 CONTROLS AND INDICATORS: FIGURE 7 ... 26 EXAMPLE OUTLINED / NORMAL TEXT: FIGURE 8 ... 27 VISUAL INDICATORS: FIGURE 9 ... 34 ALARM & PLOT LIST: FIGURE 10 ... 37 POP UP MESSAGE EXAMPLE: FIGURE 11 ... 40 CHECK VALVE CONNECTION TO BREATHING CIRCUIT: FIGURE 12 ... 48 HAZARDOUS ENVIRONMENT FILTERS: FIGURE 13 ... 49 ALARM DISPLAY: FIGURE 14 ... 52 PNEUMATIC DIAGRAM : FIGURE 15 ... 87 PULSE OXIMETER DISCRETE SATURATION TRANSFORM: FIGURE 16 ... 89 BATTERY CHANGE INSTRUCTIONS: FIGURE 17 (A)-(E) ... 90 FILTER CHANGE INSTRUCTIONS: FIGURE 18 (A)-(I) ... 91 OXYGEN RESERVOIR BAG ASSEMBLY (PART #704-0004-00): FIGURE 19 ... 94 EMV+ STORAGE CASE (PART #703-0EMV-03): FIGURE 20 ... 95

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CONVENTIONS, TERMINOLOGY AND ABBREVIATIONS CONVENTIONS WARNING! A WARNING statement identifies conditions or information that could have an adverse effect upon the patient or operator which if not avoided, could result in death or serious injury.

CAUTION! A CAUTION statement provides important information about a potentially hazardous situation which if not avoided may result in minor or moderate injury to the patient, operator or damage to the equipment or other property.

NOTE: A NOTE provides additional information intended to avoid inconvenience during operation.

ABBREVIATIONS A/C- Assist/Control ACLS- Advanced Cardiac Life Support ALS- Advanced Life Support ATLS- Advanced Trauma Life Support ACV- Assist-Control Ventilation ATPD - Atmospheric Temperature and Pressure, Dry BPM - Breaths per Minute B/V - Bacterial/Viral Filter cm H2O - Centimeters of Water CPR - Cardiopulmonary Resuscitation DISS - Diameter Index Safety System FIO2 - Fraction of Inspired Oxygen HME - Heat and Moisture Exchanger HME/BV - Heat and Moisture Exchanger/Bacterial Viral filter combined Hz – Hertz (as in frequency, cycles per second) ID - Internal Diameter L - Liters

LED - Light Emitting Diode LPM - Liters per Minute ml - Milliliters mm - Millimeter NPPV – Noninvasive Positive Pressure Ventilation O2 - Oxygen Paw - Airway Pressure PEEP - Positive End Expiratory Pressure PIP - Peak Inspiratory Pressure psig - Pounds per Square Inch Gage USP - United States Pharmacopeia VAC - Volts AC VDC - Volts DC VT - Tidal Volume WOB – Work of Breathing

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INTENDED USE The Model 731EMV+ (EMV+) is indicated for use in the management of infant through adult patients weighing ≥5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. It is appropriate for use in hospitals, outside the hospital, during transport and in austere environments where it may be exposed to rain, dust, rough handling and extremes in temperature and humidity. With an appropriate third-party filter in place, it may be operated in environments where chemical and/or biological toxins are present (see External Filter Use). It is not intended to operate in explosive environments. The EMV+ is intended for use by skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation and by first responders under the direction of skilled medical care providers. The EMV+ ventilator is a small, extremely durable, full-featured portable mechanical ventilator designed to operate in hospitals or austere and under-resourced environments. It can be used in prehospital (ALS, ATLS, ACLS), field hospital and hospital settings. Easy-to-use, durable, lightweight and portable, the EMV+ ® is built with the same standard of quality, reliability and performance that all Impact products are known for.

FEATURES •

Portable critical care ventilator that can be used in the hospital, aeromedical and ground transport, mass casualty situations and extreme environments

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Multiple modes of ventilation for use with acute or chronic respiratory failure in both intubated and nonintubated patients.

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Intuitive operator interface minimizes operator training and protects existing settings from inadvertent contact and manipulation.

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Lightweight (9.7 lbs, 4.4 kg) provides for easy transport

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Rechargeable battery provides over 10 hours of operation (at factory default settings with pulse oximeter operating).

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Operating temperature range from -25° to 49°C (Impact Instrumentation validated testing) and from 10° to 40°C (SGS listed).

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Altitude compensation from -2000 to 25,000 feet

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Self-contained system that operates with or without external O2.

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Gas manifold design allows operation with both high and low-pressure O2 sources. . All O2 is delivered to the patient circuit, none vented or wasted to operate the device.

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Sealed gas path with chemical/biological filter connected to assure safe breathing gas supply.

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Sealed case and control panel protects components from weather and fluids.

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SHIPPING CONTENTS NOTE: Shipping contents may be different for military and government customers based on contract specifications. Please refer to the packing slip enclosed with your unit.

ACCESSORIES LIST The Accessories List contains common items, required from time to time, some of which are not provided with each EMV+ at the time of delivery. Each item is preceded by its part number. Accessories may be ordered direct from Impact or through your local distributor. When ordering, please include the part number, description and quantity required. Send purchase orders to: Impact Instrumentation, Inc. P.O. Box 508 West Caldwell, New Jersey 07007-0508

Telephone orders: 973/882-1212 Fax orders: 973/882-4993

Email: Government [email protected]

Non-Government [email protected]

PART NUMBER 024-0012-00 708-0042-00 402-0032-00 465-0024-00 465-0025-00 465-0027-00 465-0028-00 820-0108-00 820-0109-00 820-0110-00 704-0004-00 704-0EMV-05 704-0EMV-06 708-0036-00 708-0043-00 708-0037-00 708-0039-00 708-0047-00 820-0106-00 820-0106-15 820-0107-00 820-0107-20 825-0002-00 907-EMVP-01 906-EMVP-02 909-EMVP-02 703-0731-03 703-0731-11 703-0731-12 703-0731-13 703-0731-14

PART DESCRIPTION AC/DC Power Supply, 110-240 VAC, 100Watts 24 Volts 4.2A, IEC320 Plug AC Power line cord, 6’, (United States Version) Padded carry case, tan, material Filter, Bacterial/Viral (B/V) Filter, HME/ B/V, Heat and Moisture Exchanger Filter, Disk, B/V, Emergency Air Intake Removable foam compressor inlet filter Heat and Moisture Exchange (HME), Adult Heat and Moisture Exchange (HME), Pediatric Heat and Moisture Exchange (HME), Infant Assembly, Kit, O2 Reservoir, 3 Liter Assembly, Cable, DC, External Power, 28 V Assembly, Cable, DC, External Power, 12 V Pulse Oximeter Probe Sensor, Adult Reusable Pulse Oximeter Pediatric, Reusable Pulse Oximeter Patient Cable, Reusable Pulse Oximeter Adult - Ear, Reusable Pulse Oximeter Infant, Single Patient Use Circuit, Vent, Single Limb, Pediatric/Adult (disposable) Circuit, Vent, Single Limb, Pediatric/Adult (disposable) (case of 15) Circuit, Vent, Single Limb, Infant/Pediatric (disposable) Circuit, Vent, Single Limb, Infant/Pediatric (disposable) (case of 20) High pressure Oxygen Hose, DISS x DISS, oxygen, 6’ Quick Reference Guide, laminated Operation Manual (Commercial) CD format Operation Manual (Commercial) Carry-all Case with Foam Inserts, Rechargeable Assembly, Case, Transit Carry Assembly, Case, Transit Carry, w/ AC Bulkhead Connector Assembly, Case, Transit Carry, w/ AC Bulkhead & USB Connectors Assembly, Case, Transit Carry, w/ Wheels & Pull-Out Handle

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PART NUMBER 703-0731-15 703-0731-16 703-0731-01 704-0EMV-XX 708-0041-XX 704-0700-01 812-0011-00 812-0010-00 812-0009-00 812-0008-00 812-0007-00 812-0006-00 334-0125-00

PART DESCRIPTION Assembly, Case, Transit Carry, w/ Wheels & Pull-Out Handle, AC Bulkhead Connector Assembly, Case, Transit Carry, w/ Wheels & Pull-Out Handle, AC Bulkhead & USB Connectors Assembly, Battery Pack, Lithium-Ion, 6.6 Ah Extension Cord 8’ US Hospital Grade Female Plug to *** Cordset, 6’, IEC 60320-C5 Plug to *** Check Valve Kit Mask, CPAP, #6, Large Adult Mask, CPAP, #5, Adult Mask, CPAP, #4, Child Mask, CPAP, #3, Small Child Mask, CPAP, #2, Infant Mask, CPAP, #1, Small Infant Harness, Mask, Universal

*** Country Specific (Contact factory for complete part # for each country)

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LIMITED COPYRIGHT RELEASE Permission is hereby granted to any military/governmental agency to reproduce all materials furnished herein for use in a military/governmental service training program and/or other technical training program.

MASIMO PULSE OXIMETER This device uses Masimo SET® technology to provide continuous pulse oximeter and heart rate monitoring and is covered under one or more of the following U.S.A. patents: 5,758,644, 5,823,950, 6,011,986, 6,157,850, 6,263,222, 6,501,975 and other applicable patents listed at www.masimo.com/patents.htm.

QNET BV Hommerterweg 286 6436 AM Amstenrade The Netherlands

Manufactured by: IMPACT Instrumentation Inc. 27 Fairfield Place, West Caldwell, NJ 07006, U.S.A P.O Box 508, West Caldwell, NJ 07007-0508, U.S.A

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WARNINGS AND CAUTIONS REGARDING USE EMV+ AND PULSE OXIMETER WARNING! Electric shock hazard: Do not remove equipment covers except to replace batteries! An operator may only perform maintenance procedures specifically described in this manual. Refer servicing to Impact or an authorized Impact Service Center in the repair of this equipment. WARNING! The device is intended for use by qualified personnel only! The operator should read this manual, all precautionary information, and specifications before using the device! WARNING! Possible explosion hazard if used in the presence of flammable anesthetics or other flammable substances in combination with air, oxygen-enriched environments or nitrous oxide! WARNING! During operation the EMV+ unit should not be stacked on top of or under other medical equipment due to the possibility of electromagnetic interference between the EMV+ and other equipment. (The EMV+ was subjected to EMC testing in accordance with Military Mil-STD-461F and Commercial IEC 60601-1-2 and FDA Reviewers Guidance specifications.) WARNING! Grounding: • Connect the EMV+ only to a three-wire, grounded, hospital-grade receptacle! The three-conductor plug must be inserted into a properly wired three-wire receptacle; if a three-wire receptacle is not available, a qualified electrician must install one in accordance with the governing electrical code. • Do not under any circumstances remove the grounding conductor from the power plug! • Do not use extension cords or adapters of any type! The power cord and plug must be intact and undamaged. • If there is any doubt about the integrity of the protective earth conductor arrangement, operate the oximeter on internal battery power until the AC power supply protective conductor is fully functional! WARNING! To ensure patient electrical isolation, connect only to other equipment with electronically isolated circuits! WARNING! Do not use antistatic or conductive hoses or tubing with this device! WARNING! Do not connect to an electrical outlet controlled by a wall switch or dimmer! WARNING! As with all medical equipment, carefully route the ventilator circuit hose and tubing, patient cabling, and external power cables to reduce the possibility of patient entanglement or strangulation! WARNING! Do not place the EMV+ or external power supply in any position that might cause it to fall on the patient! Do not lift the EMV+ by the power supply cord, ventilator circuit or pulse oximeter patient cable! WARNING! Do not use the EMV+, its pulse oximeter or pulse oximetry sensors during magnetic resonance imaging (MRI) scanning! Induced current could potentially cause burns. The EMV+ and/or its pulse oximeter may affect the MRI image and the MRI unit may affect EMV+ operation or the accuracy of the oximetry measurements. WARNING! The EMV+ must be connected to a grounded AC power supply when connected to AC power. The EMV+ and its integrated pulse oximeter are referred to as an IEC 601/F device in the summary situation table contained in IEC-601-1-1. WARNING! USB Interconnection: Do not operate the device on a patient when the USB is connected to any other device. NOTE: The USB interconnection does not support automatic record keeping. WARNING! The Impact supplied ventilator circuit’s labeling provides the resistance and compliance values for the circuits under normal operating conditions. If added accessories are used (e.g. humidification, filters etc.), the operator should assure they do not degrade the performance of the device. If non-Impact circuits are used, the operator should assure these circuits do not affect the performance of the device. CAUTION! Federal law restricts this device to sale by or on the order of a physician. CAUTION! Service is to be performed by qualified biomedical equipment technicians only. CAUTION! Internal components are susceptible to damage from static discharge. Do not remove device covers.

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NOTE: This Operation Manual is not meant to supersede any controlling standard operating procedure regarding the safe use of assisted ventilation. NOTE: Follow all governing regulations regarding the disposal of any part of this medical device. NOTE: Follow all governing regulations regarding the handling of materials contaminated by body fluids. NOTE: Follow all governing regulations regarding shipment of the Li batteries.

PULSE OXIMETER SPECIFIC WARNINGS AND CAUTIONS WARNING! A pulse oximeter should not be used as an apnea monitor. WARNING! A pulse oximeter should be considered an early warning device. As a trend towards patient deoxygenation is indicated, blood samples should be analyzed by a laboratory co-oximeter to completely understand the patient’s condition. WARNING! MEASUREMENTS If the accuracy of any measurement does not seem reasonable, first check the patient’s vital signs by alternate means and then check the pulse oximeter for proper functioning. Inaccurate measurements may be caused by: • Incorrect sensor application or use • Significant levels of dysfunctional hemoglobin (e.g., carboxyhemoglobin or methemoglobin) • Intravascular dyes such as indocyanine green or methylene blue • Exposure to excessive illumination, such as surgical lamps (especially ones with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, or direct sunlight (exposure to excessive illumination can be corrected by covering the sensor with a dark or opaque material) • Excessive patient movement • Venous pulsations • Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line • The pulse oximeter can be used during defibrillation, but the readings may be inaccurate for a short time. WARNING! Interfering Substances: Carboxyhemoglobin may erroneously increase readings. The level of increase is approximately equal to the amount of carboxyhemoglobin present. Dyes, or any substance containing dyes, that change usual arterial pigmentation may cause erroneous readings. WARNING! ALARMS Check alarm limits each time the pulse oximeter is used to ensure that they are appropriate for the patient being monitored. WARNING! Loss of pulse signal can occur in any of the following situations: • The sensor is too tight • There is excessive illumination from light sources such as a surgical lamp, a bilirubin lamp, or sunlight • A blood pressure cuff is inflated on the same extremity as the one with a SpO2 sensor attached • The patient has hypotension, severe vasoconstriction, severe anemia, or hypothermia • There is arterial occlusion proximal to the sensor • The patient is in cardiac arrest or is in shock WARNING! Sensors: • • • •

•

®

Before use, carefully read the LNCS sensor directions for use. Use only Masimo oximetry sensors for SpO2 measurements. Other oxygen transducers (sensors) may cause improper performance. ® Tissue damage can be caused by incorrect application or use of an LNCS sensor, for example by wrapping the sensor too tightly. Inspect the sensor site as directed in the sensor Directions for Use to ensure skin integrity and correct positioning and adhesion of the sensor. ® ® Do not damage LNCS sensors. Do not use an LNCS sensor with exposed optical components. Do not immerse the sensor in water, solvents, or cleaning solutions (the sensors and connectors are not waterproof). Do not sterilize by irradiation, steam or ethylene oxide. See the cleaning instructions ® in the directions for reusable Masimo LNCS sensors. Do not use damaged patient cables. Do not immerse the patient cables in water, solvents or cleaning solutions (the patient cables are not waterproof). Do not sterilize by irradiation, steam or ethylene oxide. See the cleaning instructions in the directions for reusable Masimo patient cables.

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CAUTION! Possession or purchase of this device does not convey any expressed or implied license to use the device with unauthorized sensors or cables which would, alone, or in combination with this device fall within the scope of one or more of the patents relating to this device. Impact cannot assure the proper functioning of this device if it is used with unauthorized sensors or cables.

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SYMBOLS AND ICONS (Used with the EMV+ and this manual)

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UNPACKING, ASSEMBLY AND CONNECTIONS UNPACKING Compare shipping case contents against Shipping Contents list. Examine the device and accessories for any obvious signs of shipping damage. If there is no apparent sign of mechanical damage, read instructions contained within this manual before attempting operation.

ASSEMBLY The EMV+ only requires that the operator attach the breathing circuit to begin ventilation using either internal or external power. Both the ventilator and breathing circuit are supplied clean and are ready for use on a patient. The EMV+ batteries may not be installed within the unit (depending upon the contractual requirements or the storage environment as described in the Battery Care and Recharging section). Battery installation may be required prior to operation. (See Appendix 4 for Battery Installation.)

CONNECTIONS OXYGEN INPUT – connects the unit to the output of an appropriate O2 regulator attached to a medicalgrade (USP) O2 cylinder. The OXYGEN IN fitting has a male oxygen Diameter Index Safety System (D.I.S.S.) thread. It is located on the Connector Panel at the top of the unit (see Figure 2). A green (white for some installations), 6 foot long high-pressure oxygen hose with compatible fittings that provides for connection between the unit and the O2 source is required. (Also see Harsh Environment Operation section). NOTE: If external O2 is connected the gas pressure must be at least 41-psig (± 2 psig) when SELF-CHECK is performed. GAS OUTPUT - connects to the ventilator circuit 22 mm ID corrugated hose. The connector is a 22 mm male conical connection. It is located on the Connector Panel at the top of the unit (see Figure 2). FRESH GAS/EMERGENCY AIR INTAKE – allows ambient air into the EMV+’s internal compressor. The port also functions as the internal anti-asphyxia valve which allows the patient to breathe ambient air in the event of a ventilator failure. The intake contains a particulate filter and permits the operator to connect either a bacterial/viral or a chemical/biological filter depending on ambient conditions (see Figure 2). TRANSDUCER (Patient Airway Pressure) – connects to the ventilator circuit 3/16" ID transducer tubing. The barb-type connector is colored a green/blue to distinguish it from the other connectors (see Figure 2). NOTE: The 3/16" ID ventilator circuit transducer tubing is a green/blue (darker) color. It is located on the Connector Panel at the top of the unit. EXHALATION VALVE – connects to the ventilator circuit 1/4" ID exhalation valve tubing. The barb-type connector is clear anodized aluminum to distinguish it from the other connectors (see Figure 2). NOTE: The 1/4" ID ventilator circuit exhalation valve tubing is clear. It is located on the Connector Panel at the top of the unit. EXTERNAL POWER INPUT – The External Power Input connector is located on the top of the unit. It accepts DC voltages between 11 and 32 volts (negative ground). The input mates with the output connector plug of the AC/DC Power Supply, 12 and 28 VDC Power Cables (both are available as accessories) or the external battery (see Figure 2).

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HIGH PRESSURE OXYGEN INPUT

GAS OUTPUT

EXTERNAL POWER INPUT USB CONNECTOR

TRANSDUCER (PATIENT AIRWAY PRESSURE)

PULSE OXIMETER CONNECTOR

EXHALATION VALVE FRESH GAS/EMERGENCY AIR INTAKE

CONNECTOR PANEL: FIGURE 2

SET-UP The EMV+ can be configured to suit most applications. Additional hoses, fittings and adapters may be required for particular uses. 1. For use with external O2: connect a green (white for some installations) high-pressure O2 hose to the OXYGEN IN fitting and a 55 psig external source. NOTE: Use only with medical-grade (USP) oxygen. When using with an oxygen cylinder, the cylinder must be secured. 2.

3.

4.

5.

Connect the disposable ventilator circuit to the GAS OUTPUT, TRANSDUCER, and EXHALATION VALVE connectors on EMV+ Connector Panel. Follow the directions included with the disposable ventilator circuit. In a high-dust or biological environment, a bacterial/viral filter should be attached to the Fresh Gas/Emergency Air Intake to prevent entrainment of particulate or biological matter. (See section on Hazardous Environment Filters.) In toxic biological or chemical environments the user can attach a chemical/biological filter to the Fresh Gas/Emergency Air Intake. The threaded interface accommodates chemical/biological filters with an Rd 40 x 1/7 interface (see BS EN 148-1 1999 Respiratory protective devices – threads for face pieces). (See section on Hazardous Environment Filters.) For use with AC power: connect the AC/DC Power Supply (supplied) to the External Power Input (see Figure 2).

NOTE: The EMV+ can operate from internal battery or from external AC or DC power sources. See section entitled Operating Power Selection & Stopping for details. WARNING! Always assure that there is an alternate means of providing ventilation. A bag-valve resuscitator and an appropriate mask for the patient being ventilated should be immediately available. WARNING! This unit’s USB connection (unlabelled) does not provide any signal output or input to the Operator. It is for the use of Impact Instrumentation trained personnel only. The Operator should not connect anything to the USB connection.

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EXTERNAL GAS SOURCES The EMV+ can operate using high-pressure O2 from either bottled O2 or piped O2 sources, as illustrated in Figure 3.

EXTERNAL GAS SOURCES: FIGURE 3

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The duration of any given gas cylinder depends on the size & pressure of the cylinder, and the rate at which gas is being used to support the patient. The formula to calculate the operating duration of any cylinder (based on the Ideal Gas Law) is given below. An example is worked out for a typical large cylinder. It is recommended that the gas cylinder pressure not be allowed to fall below 300 psi. o

o

V start = 9540 liter at 1 atm/ 70 F (21 C) : from label on cylinder P start = 2640 psig : from label on cylinder P present in cylinder = 300 psig : from pressure gauge on cylinder o V present in cylinder = volume remaining in cylinder = (P present/ P start) V start = 1084 liter at 1 atm/ 70 F (21 o C) o o V delivered = 9540 – 1084 = 8456 liter at 1 atm/ 70 F (21 C) For a typical ventilator setting (20 BPM, Vt = 500 ml, FIO2 =100%, I time = 1 sec, I:E = 1:2.0), the gas consumption is 10 liter/min. NOTE: Whenever external high-pressure O2 is used, the EMV+ automatically determines the O2 usage and displays it in the FIO2 parameter window. (See O2 Use under FIO2 in Description of Controls and Display. Total duration of the gas cylinder in above example = Vdelivered/ (10 liter/min) = 8456/10 min = ~14 hours

FRESH GAS/EMERGENCY AIR INTAKE: FIGURE 4 WARNING! Never block the FRESH GAS/EMERGENCY AIR INTAKE. A free flow of air is required during compressor operation or in the event of a device failure to allow spontaneous breathing. The FRESH GAS/EMERGENCY AIR INTAKE also acts as an anti-asphyxia port in the event of a ventilator failure.

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VENTILATOR CIRCUIT CONNECTIONS The EMV+ is designed to operate using a standard disposable ventilator circuit. The circuit is attached to the ventilator as shown in Figure 5.

VENTILATOR CIRCUIT, DEVICE CONNECTIONS: FIGURE 5

CAUTION! Always dispose of the circuit after single patient use following the institutional guidelines for biologically contaminated material. Reusing the circuit can result in cross contamination between patients.

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VENTILATOR CIRCUIT, PATIENT CONNECTIONS The EMV+ uses two different single limb vent circuits to support patients from ≥5 kg through adult: Infant/ Pediatric (Part #820-0107-00) and Pediatric/Adult (Part #820-0106-00). These are illustrated in Figure 6.

VENTILATOR CIRCUIT, PATIENT CONNECTION: FIGURE 6

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