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... Copyright Information Copyright 2000 Mallinckrodt Inc. EasyCart, EasyNeb, 740, 760, and 700 Series are trademarks of Mallinckrodt Inc. All rights reserved. The 700 SeriesÔ Ventilator System (including the 740Ôand 760Ôventilators) are manufactured in accordance with Mallinckrodt proprietary information, covered by one or more of the following U.S. Patents and foreign equivalents: 5,524,615; 5,540,222; 5,596,984; 5,632,270; 5,664,560; and 5,673,689. The information contained in this manual is the sole property of Mallinckrodt Inc. and may not be duplicated without permission. This manual may be revised or replaced by Mallinckrodt Inc. at any time and without notice. You should ensure that you have the most current applicable version of this manual; if in doubt, contact the Technical Publications Department of Mallinckrodt Inc. While the information set forth herein is believed to be accurate, it is not a substitute for the exercise of professional judgment. The ventilator should be operated and serviced only by trained professionals. Mallinckrodt’s sole responsibility with respect to the ventilator, and its use, is as stated in the limited warranty provided. Nothing in this manual shall limit or restrict in any way Mallinckrodt’s right to revise or otherwise change or modify the equipment (including its software) described herein, without notice. In the absence of an express, written agreement to the contrary, Mallinckrodt Inc. has no obligation to furnish any such revisions, changes, or modifications to the owner or user of the equipment (including its software) described herein.

Definitions This manual uses these special indicators to convey information of a specific nature: Warning Indicates a condition that can endanger the patient or the ventilator operator.

Caution Indicates a condition that can damage the equipment.

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NOTE: Indicates points of particular emphasis that make operation of the ventilator more efficient or convenient.

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... Warnings, cautions, and notes Please take the time to familiarize yourself with the following safety considerations, special handling requirements, and regulations that govern the use of the 700 Series Ventilator System. Warning To avoid an electrical shock hazard while servicing the ventilator, be sure to remove all power to the ventilator by disconnecting the power source and turning off all ventilator power switches.

Warning To avoid a fire hazard, keep matches, lighted cigarettes, and all other sources of ignition (e.g., flammable anesthetics and/or heaters) away from the ventilator and oxygen hoses. Do not use oxygen hoses that are worn, frayed, or contaminated by combustible materials such as grease or oils. (Textiles, oils, and other combustibles are easily ignited and burn with great intensity in air enriched with oxygen.) In case of fire or a burning smell, immediately disconnect the ventilator from the oxygen supply and electrical power source.

Warning Patients on life-support equipment should be appropriately monitored by competent medical personnel and suitable monitoring devices. The 700 Series Ventilator is not intended to be a comprehensive monitoring device and does not activate alarms for all types of dangerous conditions for patients on life-support equipment.

Warning

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Check the ventilator periodically as outlined in the service manual; do not use if defective. Immediately replace parts that are broken, missing, obviously worn, distorted, or contaminated.

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... Warning An alternative source of ventilation should always be available when using the 700 Series Ventilator System.

Warning To ensure proper servicing and avoid the possibility of physical injury, only qualified personnel should attempt to service or make authorized modifications to the ventilator. The user of this product shall have sole responsibility for any ventilator malfunction due to operation or maintenance performed by anyone not trained by Mallinckrodt staff.

Warning For a thorough understanding of ventilator operations, be sure to read the 700 Series Ventilator System Operator's Manual in its entirety before attempting to use the system.

Warning Before activating any part of the ventilator, be sure to check the equipment for proper operation and, if appropriate, run the selfdiagnostic short self test (SST) program described in this manual.

Caution U.S. Federal law restricts this device to sale by or on the order of a physician.

Warranty

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The 700 Series Ventilator System is warranted against defects in material and workmanship in accordance with Mallinckrodt Medical Equipment Warranty for a period of one year from the time of sale. To ensure the validity of the warranty, be sure to keep a maintenance record.

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... Year of manufacture The 700 Series Ventilator System’s year of manufacture is indicated by the fifth and sixth digits of the serial number which is located at the lower edge of the ventilator front panel.

Manufacturer Manufactured by Nellcor Puritan Bennett Ireland A subsidiary of Mallinckrodt Inc. Mervue, Galway, Ireland

European Headquarters Mallinckrodt Europe BV Hambakenwetering 1 5231 DD ’s-Hertogenbosch The Netherlands

Phone: +353.91.753.771 Fax: +353.91.753.922

Phone: +31.73.6485200 Fax: +31.73.6410915

Electromagnetic susceptibility The 700 Series Ventilator System complies with the requirements of IEC 606011-2 (EMC Collateral Standard), which includes E-field susceptibility and ESD requirements. However, even though the device is compliant at the levels of immunity specified in the standard, certain transmitting devices (cellular phones, walkie-talkies, cordless phones, paging transmitters, etc.) emit radio frequencies that could interrupt ventilator operation if located in a range too close to the ventilator. It is difficult to determine when the field strength of these devices becomes excessive. Practitioners should be aware that radio frequency emissions are additive, and that the ventilator must be located a sufficient distance from transmitting devices to avoid interruption. Do not operate the ventilator in a magnetic resonance imaging (MRI) environment. The Alarm handling section of this manual describes possible ventilator alarms and what to do if they occur. Consult with your institution’s biomedical engineering department in case of interrupted ventilator operation, and before relocating any life support equipment.

Customer assistance

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For further assistance contact your local Mallinckrodt representative.

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Contents ... 1 Introduction 1.1 Functional description... 1-2 1.2 Symbols and labels... 1-8 1.3 Keyboard... 1-13 1.3.1 VENTILATOR SETTINGS... 1-14 1.3.2 PATIENT DATA... 1-24 1.3.3 VENTILATOR STATUS... 1-28

2 Setting up the ventilator 2.1 Connecting and using internal and external batteries... 2-2 2.2 Connecting the electrical supply... 2-6 2.3 Connecting the oxygen supply... 2-8 2.4 Connecting the ventilator breathing circuit... 2-10 2.5 Installing the collector vial... 2-13 2.6 Installing the flex arm... 2-14 2.7 Installing the humidifier... 2-16 2.8 Using the ventilator cart... 2-17

3 Getting started 3.1 Powering up the ventilator... 3-1 3.2 Selecting ventilator settings... 3-4 3.3 Viewing and changing alarm settings... 3-6 3.4 Entering and exiting standby mode... 3-8

4 Self tests (SST and EST) 4.1 Short self test (SST)... 4-3 4.2 Extended self test (EST)... 4-13

5 Once ventilation begins

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5.1 Changing settings: a quick review... 5-1 5.1.1 Changing settings... 5-1 5.1.2 Switching between VCV, PCV, and PSV... 5-2 5.1.3 Changing the mode... 5-2 5.2 Viewing and changing alarm settings: a quick review... 5-3 5.3 Adjusting apnea parameters... 5-4 5.3.1 Adjusting the apnea interval... 5-6 vii

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... 5.4 Viewing patient data... 5-6 5.5 The 100% O2 and MANUAL INSP keys... 5-10 5.6 The EXP PAUSE and INSP PAUSE keys (760 only)... 5-11

6 The MENU key 6.1 More active alarms... 6-5 6.2 Autoreset alarms... 6-6 6.3 Self tests... 6-7 6.4 User settings... 6-7 6.4.1 Endotracheal tube... 6-7 6.4.2 Humidifier type... 6-8 6.4.3 Date and time set... 6-8 6.4.4 Apnea interval (Ta)... 6-9 6.4.5 VCV flow pattern... 6-9 6.4.6 Speaking valve setup... 6-10 6.4.7 Alarm volume... 6-16 6.4.8 PCV timing setting... 6-16 6.4.9 Volume LED bar... 6-16 6.5 Oxygen sensor... 6-17 6.6 Standby mode... 6-19 6.7 Battery info... 6-20 6.8 Software revision... 6-20 6.9 Service summary... 6-21 6.10 Nebulizer... 6-21

7 Alarm handling 7.1 Autoreset alarms... 7-3 7.2 Alarm silence... 7-3 7.3 Alarm reset... 7-4 7.4 Clinical and technical alarms... 7-5 7.5 Power alarm... 7-17 7.5.1 Loss of AC Power... 7-17 7.5.2 Loss of Power... 7-18

Appendix A Maintenance

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A.1 Cleaning, disinfection, and sterilization... A-2 A.1.1 Cleaning: general guidelines... A-4 A.1.2 Disinfection and sterilization... A-4 A.2 Preventive maintenance... A-5

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... A.2.1 Daily or as required: inspiratory and expiratory bacteria filters... A-8 A.2.2 Daily or as required: collector vial... A-8 A.2.3 Daily or as required: in-line water traps... A-9 A.2.4 As necessary: oxygen sensor calibration... A-9 A.2.5 Every 250 hours (or 1 month of use): cooling fan filter . . . A-10 A.2.6 Every 1000 hours (or 3 months of use): air intake filter . . . A-11 A.2.7 Every 2 years: device checks... A-12 A.2.8 Storage... A-13 A.2.9 Repacking... A-13

Appendix B Part numbers Appendix C Specifications C.1 Physical... C.2 Environmental... C.3 Power... C.4 Compliance and approvals... C.5 Technical...

C-2 C-3 C-3 C-5 C-5

Appendix D Breath delivery D.1 A/C mode... D.2 SPONT mode... D.3 SIMV mode... D.3.1 Breath timing...

D-3 D-3 D-4 D-4

Appendix E Alarm testing Appendix F Pneumatic schematic Appendix G Glossary

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Index

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Figures ... Figure 1-1 Figure 1-2 Figure 1-3

Block diagram: 700 Series Ventilator function... 1-5 740 Ventilator System keyboard... 1-13 760 Ventilator System keyboard... 1-14

Figure 2-1 Figure 2-2 Figure 2-3 Figure 2-4 Figure 2-5 Figure 2-6 Figure 2-7 Figure 2-8 Figure 2-9 Figure 2-10 Figure 2-11 Figure 2-12 Figure 2-13

Lifting the ventilator... 2-2 Internal battery charge indicator... 2-3 Plugging the external battery into the ventilator... 2-5 Disconnecting the external battery... 2-6 Connecting the ventilator power cord... 2-7 Storing the power cord on the ventilator... 2-7 Connecting the oxygen supply... 2-9 Connecting the ventilator breathing circuit... 2-12 Installing the collector vial... 2-13 Installing the flex arm... 2-14 Shortening the flex arm... 2-15 Installing the humidifier... 2-16 Locking and unlocking the cart’s front wheels... 2-17

Figure 3-1

Turning the power switch on (the “I” position)... 3-2

Figure 5-1 Figure 5-2

Viewing patient data... 5-8 Volume bar graph (760 Ventilator only)... 5-9

Figure 6-1

Using the More active alarms menu function to view active alarms Using the Autoreset alarms menu function to view autoreset alarms

Figure 6-2

6-5 6-6

Viewing active alarms... 7-2

Figure A-1 Figure A-2 Figure A-3

Removing/replacing the collector vial... A-9 Cooling fan cover... A-10 Air intake filter... A-12

Figure B-1

Ventilator accessories... B-9

Figure C-1

Recommended ventilator breathing circuit configurations . . C-8

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Figure 7-1

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Figures

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Figure D-1 Figure D-2 Figure D-3 Figure D-4 Figure D-5 Figure D-6

Flow waveform... SIMV breath period intervals... Synchronizing breath intervals with patient effort... Spontaneous breaths during SIMV... Mandatory breaths during SIMV... Manual inspiration during SIMV...

D-2 D-4 D-5 D-5 D-5 D-6

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Tables ... Table 1-1 Table 1-2 Table 1-3 Table 1-4 Table 1-5

Mode/breath type availability on 740/760 Ventilators... 1-2 Changes to current settings in occlusion cycling mode... 1-7 700 Series Ventilator keyboards: VENTILATOR SETTINGS . 1-15 700 Series Ventilator keyboards: PATIENT DATA... 1-24 700 Series Ventilator keyboards: VENTILATOR STATUS . . . 1-29

Table 4-1 Table 4-2 Table 4-3 Table 4-4 Table 4-5 Table 4-6 Table 4-7 Table 4-8 Table 4-9

700 Series Ventilator self tests... 4-2 SST sequence of tests... 4-9 Overall SST results... 4-12 EST hardware requirements... 4-13 EST setup messages... 4-14 EST test sequence... 4-16 Key functions during EST... 4-21 Prompts during EST... 4-22 EST completion status... 4-23

Table 5-1

Breath type availability... 5-2

Table 6-1

Menu function summary... 6-2

Table 7-1 Table 7-2

Clinical alarms... 7-5 Technical alarms... 7-12

Table A-1 Table A-2

Cleaning, disinfection, and sterilization... A-3 Preventive maintenance schedule... A-7

Table B-1

Ventilator accessories... B-2

Table C-1 Table C-2 Table C-3 Table C-4 Table C-5

Physical specifications... Environmental specifications... Power specifications... Compliance and approvals... Technical specifications...

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C-2 C-3 C-3 C-5 C-5

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Tables

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SECTION

Introduction 1 1 ... The 700 Series Ventilator System (including the 740 and 760 Ventilators) provides respiratory support for a wide range of pediatric to adult patients for a wide variety of clinical conditions. The ventilator’s mixing technique allows it to ventilate critically ill patients at adjustable oxygen concentrations without the need for a blender, compressor, or hospital-grade wall air. The 700 Series Ventilator System can be mains- or battery-powered. Each ventilator includes two microcontrollers: one for breath delivery (which controls ventilation), and one for the user interface (which monitors ventilator and patient data). Each microcontroller verifies that the other is functioning properly. Using two independent microcontrollers in this fashion prevents a single fault from causing a simultaneous failure of controlling and monitoring functions. The 700 Series Ventilator System supplies mandatory or spontaneous breaths with a piston-based pneumatic system. Table 1-1 summarizes the modes and breath types offered by the 740 and 760 Ventilators. Mandatory breaths can be volume control ventilation (VCV, available on 740 and 760 Ventilators) or pressure control ventilation (PCV, available on the 760 Ventilator only). VCV delivers breaths to the patient at a preset tidal volume, peak flow, waveform, and oxygen concentration at a minimum respiratory rate. PCV delivers breaths to the patient at a preset inspiratory pressure, I:E ratio or inspiratory time, rise time factor (how quickly inspiratory pressure rises to achieve the set inspiratory pressure), and oxygen concentration at a minimum respiratory rate. A spontaneous breath allows the patient inspiratory flows of up to 300 L/min, with or without pressure support ventilation (PSV). On the 760 Ventilator, you can set the rise time factor and exhalation flow sensitivity (that is, the point at which the ventilator cycles from inspiration to exhalation) in PSV. The ventilator begins apnea ventilation if no breath (patient- , ventilator-, or operator-initiated) is delivered within the selected apnea interval. Apnea ventilation is active during all modes. On the 740 Ventilator, only VCV breaths are available in apnea ventilation. On the 760 Ventilator, VCV or PCV breaths are available in apnea ventilation.

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The 760 Ventilator also offers the ability to perform respiratory mechanics calculations and maneuvers as a standard feature using the EXP PAUSE (to

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Introduction

... calculate auto-PEEP) and INSP PAUSE (to calculate patient resistance and compliance) keys. Table 1-1: Mode/breath type availability on 740/760 Ventilators Mode/breath type VCV breath type

740 Ventilator

760 Ventilator

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PCV breath type PSV breath type (support pressure setting)

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PSV (rise time factor and exhalation sensitivity settings)

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SIMV mode

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Apnea ventilation (VCV breath type)

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Apnea ventilation (choice of VCV or PCV breath type)

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Respiratory mechanics (EXP PAUSE and INSP PAUSE)

•

This manual tells you how to operate and perform simple maintenance for the 700 Series Ventilator. Mallinckrodt recommends that you become familiar with this manual and accompanying labels before attempting to operate or maintain the ventilator. If you need additional copies of this manual, contact your Mallinckrodt representative. To ensure optimum performance of the 700 Series Ventilator System, Mallinckrodt recommends that a qualified service technician perform periodic maintenance on the ventilator. For more information, contact your Mallinckrodt representative.

1.1 Functional description

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By pressing keys and turning the knob on the ventilator keyboard, the operator gives initial instructions and data to the ventilator (Figure 1-1). The user interface microcontroller processes this information and

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... stores it in the ventilator’s memory. The breath delivery microcontroller uses this stored information to control and monitor the flow of gas to and from the patient. The 700 Series Ventilator uses a flow trigger to recognize patient effort. The trigger monitors flow from the piston during exhalation. When the patient inhales, patient circuit pressure drops very slightly below end-expiratory pressure. At the same time, the piston moves forward to deliver flow to the ventilator breathing circuit and maintain the preset PEEP/CPAP level. The level of flow depends on the patient’s effort. If this flow exceeds the user-set level, the ventilator triggers. By design, the ventilator attempts to maintain PEEP in the presence of a circuit leak. Since a leak drives the piston to deliver flow to make up for pressure losses, a circuit leak can require an increase in the flow trigger level to avoid autocycling. During exhalation, the ventilator’s piston retracts and draws air and oxygen into the cylinder. The ventilator uses room air, which means the ventilator can operate without a compressor or wall air source. Room air enters the ventilator through a protected user-replaceable air intake filter just inside the ventilator cabinet. This filter captures airborne particles. Oxygen from a cylinder or wall supply enters the ventilator through a hose and oxygen fitting (the fitting is available in several versions). Once inside the ventilator, the oxygen is regulated to a pressure the ventilator can use, then mixed with air, according to the selected % O2. The flow-triggered piston/cylinder system and motor controller circuit control the flow of gas to the patient. On the 760 Ventilator in PCV or PSV, the rate of flow is also determined by the preset rise time factor. This system is designed with a minute gap (about the size of a thin sheet of paper) between the piston and the cylinder wall. This design eliminates the friction between the piston and cylinder, allowing it to respond more rapidly than a “sealed” system. A small amount of gas leaks through the gap between the piston and cylinder. Ventilator software and a continuous forward motion of the piston compensate for this leak.

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The piston delivers the mixed air and oxygen through the inspiratory manifold system, and out to the patient. The oxygen concentration and temperature of the delivered gas are monitored here, using a galvanic oxygen sensor and a thermistor. The galvanic sensor generates a voltage proportional to the partial pressure of oxygen, from which the oxygen concentration is calculated. The ventilator alarms if the monitored oxygen concentration is more than ten percentage points above or below the % O2 setting. The inspiratory manifold

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... system also includes a safety valve to relieve patient pressure if necessary (for example, if the ventilator breathing circuit is kinked or occluded).

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The patient system includes the components external to the ventilator that route gas between the ventilator and the patient. These components include the inspiratory filter (which protects against contamination between the ventilator and patient), a humidification device, ventilator breathing circuit (the tubing through which the gas travels), collector vial (which protects the exhalation system from moisture in the exhaled gas, and can be emptied without losing circuit PEEP), and an expiratory filter (which limits the bacteria in the patient’s exhaled gas from escaping to room air or contaminating the ventilator).

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740 Ventilator

Keyboard

Regulator

Oxygen Filter

Piston/cylinder system

Room air

Gas intake system

Inspiration manifold

Exhalation/ PEEP/CPAP system

Inspiratory filter

Expiratory filter

Humidification device Collector vial Ventilator breathing circuit (inspiratory limb)

Patient Ventilator breathing circuit (expiratory limb) 7-00017

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Figure 1-1. Block diagram: 700 Series Ventilator function 1-5

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Introduction

... The heated exhalation system monitors the flow of the patient’s exhaled gas using a differential pressure transducer. The patient exhales through the exhalation valve. During exhalation, the PEEP/CPAP system maintains user-selected pressure in the ventilator breathing circuit. Throughout the respiratory cycle, pressure transducers monitor inspiratory, expiratory, and atmospheric pressures. The temperatures of the pneumatic compartment and inspiratory gas are also monitored. Information from these transducers is continuously used to update the calculations that control ventilation. (Appendix F provides a diagram of the ventilator’s pneumatic system and ventilator breathing circuit.) Power to operate the ventilator comes from ac mains (wall) or battery power. The power supply is designed to protect against excessive voltages, temperatures, or current draws. A power cord retainer prevents the cord from accidental disconnection. The ventilator includes an internal battery, and accommodates an optional external battery. Depending on the ventilator settings, battery backup power can be supplied for up to 2 ½ hours using the internal battery, and up to 7 hours using the external battery. Both batteries are recharged during operation from ac power. If both are installed, the external battery is used first when ac power is not present. If the external battery is depleted or not installed, the internal battery supplies power to the ventilator when ac power is not available. The keyboard indicates the source of power and battery charge level of the internal battery at all times. Emergency modes: The ventilator declares a ventilator inoperative (VENT INOP) condition if a hardware failure or critical software error that could compromise safe ventilation occurs. In case of a ventilator inoperative condition, the VENT INOP indicator lights and the ventilator enters the safety valve open (SVO) state. To correct a ventilator inoperative condition, the ventilator must be turned off, then powered on again; at power-on, the operator must run extended self-test (EST). The ventilator must pass EST before normal ventilation can resume. The safety valve allows the patient to breathe room air unassisted when the ventilator is in the SVO state. The ventilator remains in the SVO state until power-on self-test (POST) verifies that power levels to the ventilator are acceptable and that the motor controller and microcontrollers are functioning correctly, and until the user has confirmed ventilator settings.

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If the ventilator enters the SVO state and POST is not running, the SAFETY VALVE OPEN indicator lights and a high-priority alarm sounds. The ventilator enters the SVO state if it detects a hardware or software failure that could 700 Series Ventilator Operator’s Manual

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