Millennium Users Manual Rev 7

EC DECLARATION OF CONFORMITY Sechrist Industries, Inc. 4225 E. La Palma Anaheim, CA 92807 Declares that the medical device described hereafter: Model: Millennium Infant Ventilator is in conformity with the essential requirements and provisions of Council Directive 93/42/EEC, Annex II. Conformity has been achieved under the supervision of Notified Body Number 0120, SGS Yarsley Certification Services Ltd, Unit 202B Worle Parkway, Weston super Mare, North Sommerset BS22 0WA, United Kingdom.

__________________ Greg Godfrey Vice President Quality Assurance & Regulatory Affairs

______________

0120 93/42/EEC 4225 E La Palma Avenue Anaheim California 92807 Telephone 714 / 579-8400 Fax 714 / 579-8424 Website www.sechristUSA.com

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P/N 100236 Rev. 7

TABLE OF CONTENTS EC DECLARATION OF CONFORMITY ... 2 INTRODUCTION ... 4 OWNER / USER RESPONSIBILITY ... 4 INDICATIONS FOR USE ... 4 CONTRAINDICATIONS ... 6 SYMBOLS... 7 WARNINGS ... 9 WARRANTY ... 16 SPECIFICATIONS ... 17 GENERAL DESCRIPTION ... 20 STANDARD COMPONENTS ... 21 ASSEMBLY / SET-UP ... 21 OPTIONAL BATTERY BACK-UP... 24 SUPPLEMENTAL EQUIPMENT ... 29 PERFORMANCE VERIFICATION ... 31 CONTROLS ... 38 DISPLAYS ... 43 MODES OF OPERATION ... 44 ALARMS ... 57 ROUTINE MAINTENANCE... 67 6 month MAINTENANCE PROCEDURE ... 73 2 year MAINTENANCE ... 74 TROUBLESHOOTING ... 75 SERVICE POLICY ... 76 APPENDIX A Millennium Assembly ... 77 APPENDIX B Infant Exhalation Block Assembly ... 78 APPENDIX C Pediatric Exhalation Block Assembly ... 79 APPENDIX D Infant Breathing Circuit with Block Assembly ... 80 APPENDIX E Pediatric Breathing Circuit with Block Assembly ... 81 INDEX ... 82 3

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INTRODUCTION We at Sechrist Industries, Inc. thank you for choosing the Sechrist Millennium ventilator. We also caution you that before attempting to use the ventilator in a patient care setting, the operator must be thoroughly familiar with the instructions in this manual and any product labeling. Throughout this manual, warnings, cautions, and notes will be utilized to bring attention to particularly important matters. WARNINGS indicate the possibility of personal injury or death to the patient and/or operator of the device if the warning is ignored. CAUTIONS indicate the potential of damage to equipment and/or other property if the caution is ignored. NOTES indicate a call to attention to statements that are intended to supplement or emphasize basic instructions contained within this manual.

OWNER / USER RESPONSIBILITY If utilized and maintained properly, the Sechrist Millennium ventilator will perform in conformance with the specifications and descriptions contained within this manual and accompanying labeling. Do not attempt to operate this equipment without first thoroughly understanding the contents of this manual and any accompanying product labeling. The Sechrist Millennium should be periodically verified for functionality as outlined in this manual. A malfunctioning device should never be used in a clinical setting. All servicing of this ventilator must be accomplished by a Sechrist trained and authorized individual and must only involve parts designated by Sechrist Industries.

INDICATIONS FOR USE By definition, acute respiratory/ventilatory failure is the indication for mechanical ventilatory support 1. The Sechrist Millennium ventilator is intended to provide ventilatory support for the neonatal, infant or pediatric patient requiring mechanical ventilation. Many disorders or a combination of disorders may result in acute or impending ventilatory failure. Mechanical ventilatory support may be indicated due to existing or impending ventilatory failure as often occurs in the following disorders2.

1 The C.V. Mosby Company, Eagan’s Fundamental’s Of Respiratory Care, 1990 2 W.B. Saunders Company, Care Of The High-Risk Neonate, 1979

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Pulmonary Respiratory distress syndrome (RDS) Aspiration pneumonia Pneumonia Pulmonary hemorrhage Pulmonary edema Wilson-Mikity syndrome Bronchopulmonary dysplasia Pulmonary insufficiency or prematurity Loss of lung volume Pneumothorax Tumor Diaphragmatic hernia Airway Choanal atresia Pierre-Robin Micrognathia Nasopharyngeal tumor Abnormalities of muscles of respiration Phrenic nerve palsy Spinal cord injury Myasthenia gravis Central problems Apnea of prematurity Drugs; morphine, magnesium, mepivacaine Seizures Birth asphyxia Hypoxic encephalopathy CNS hemorrhage Ondine’s curse Miscellaneous Patent ductus arteriosus with congestive heart failure Post-operative Asphyxia neonatorum Tetanus neonatorum Extreme prematurity Shock Sepsis

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CONTRAINDICATIONS Mechanical ventilatory support may not be warranted when there is no reasonable chance of intact survival as in the following conditions;3 Anencephaly Trisomy 13-15 or 16-18 Werdnig-Hoffmann paralysis Potter’s syndrome Intracranial hemorrhage with cerebral involvement Hypoxic encephalopathy with absent reflexes or absent cerebral blood flow

3 W.B. Saunders Company, Care Of The High-Risk Neonate, 1979

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SYMBOLS The following symbols appear on the Millennium Infant Ventilator

Symbol

WARNING

~

Reference

IEC 60878 Symbol #03-02

This symbol indicates ATTENTION, consult the accompanying documents.

IEC 60417-1 Symbol #5009

This symbol indicates the ON and OFF condition for the part of the equipment

IEC 60417-1 Symbol #5021

This symbol indicates the POTENTIAL EQUILIZATON CONNECTOR used to connect the equipment to an electrical installation earth busbar.

IEC 60878-02 Symbol #02

This symbol indicates TYPE B applied part, which indicates equipment that provides a particular degree of protection against electrical shock, particularly with regards to allowable leakage current and of the protective earth connection.

IEC 60417-1 Symbol #5032

This symbol is located on the power supply. It indicates the equipment is SUITABLE FOR ALTERNATING CURRENT.

IEC 60417-1 Symbol #5031

This symbol indicates DC POWER CONNECTION.

IEC 60417-1 Symbol #5035

This symbol indicates an OUTPUT.

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Meaning

P/N 100236 Rev. 7

Symbol

Reference

Meaning

IEC 60417-1 Symbol #5034

This symbol indicates an INPUT.

IEC 60417-1 Symbol #5013

This symbol indicates the ALARM SILENCE key. (Silences alarm for 114 seconds (+ 5 seconds).

IEC 60417-1 Symbol #5056

This symbol indicates BRIGHTNESS ADJUSTMENT.

IEC 60417-1 Symbol #5057

This symbol indicates CONTRAST ADJUSTMENT.

This symbol indicates EUROPEAN CONFORMITY, to the European Medical Device Directive MDD 93/42/EEC and IEC 60601-1 and 60601-2-12.

This symbol indicates CANADIAN STANDARDS ASSOCIATION approval to CSA C22.2 No. 601.1, CSA C22.2 No. 601.2-12 and UL 2601

C

US 8

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WARNINGS

WARNING

WARNING Do not attempt to operate this ventilator before thoroughly reading and understanding the descriptions and instructions contained within this document.

WARNING Federal law restricts this device to sale by or on the order of a physician. The Sechrist Millennium is a sophisticated instrument designed for use by qualified personnel under the direction of a qualified physician.

WARNING The Sechrist Millennium should be maintained and serviced only by Sechrist Industries factory-trained personnel or by written instructions directly from Sechrist Industries.

WARNING A defective or malfunctioning ventilator must never be placed into clinical service.

WARNING The Sechrist Millennium will not be fully operational without the use of the SmartSync Patient Sensing Device.

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WARNING The SmartSync patient sensing device is intended FOR SINGLE PATIENT USE ONLY.

WARNING The Sechrist Millennium must be serviced and repaired only in accordance with the policies and instructions of Sechrist Industries. This product must not be modified in any fashion without written authorization from Sechrist Industries.

WARNING The user of the Sechrist Millennium shall have sole responsibility for any malfunction, which results from improper usage, faulty maintenance, improper and/or unauthorized repairs, damage or alteration performed by anyone other than Sechrist Industries.

WARNING Constant attendance by qualified personnel is required whenever this device is in clinical use. The use of this life support system, which incorporates built-in alarm systems, does not provide absolute assurance of warning for every type of malfunction or concern that may occur.

WARNING If the Sechrist Millennium fails to perform as described, remove the unit from service and refer it to a Sechrist authorized service technician. The unit should not be utilized until proper performance has been verified.

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WARNING The internal air-oxygen mixer is designed for use with medical air and oxygen only. Do not modify these inlets for use with other breathing or anesthetic gases.

WARNING DANGER: Explosion hazard. Do not use in the presence of flammable anesthetics.

WARNING Only parts approved by Sechrist Industries and provided by authorized distributors or Sechrist Industries are to be used as replacements.

WARNING Maintain inlet pressures within a differential of 20 psig (138 kPa) to ensure proper operation.

WARNING An independent device for manual ventilation must always be available when the Sechrist Millennium is in clinical use.

WARNING Never use the Sechrist Millennium ventilator without the safety pressure relief valve installed and appropriately adjusted. Verify that the exposed valve stem operates freely and is not obstructed in any manner. Do not tape or occlude the vent holes in the valve body or the valve will become inoperative.

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WARNING Always monitor oxygen concentrations with a calibrated oxygen analyzer equipped with high and low alarms to ensure that the desired oxygen concentration is being delivered to the patient. Oxygen concentrations must be analyzed at or near the patient airway.

WARNING - EXPLOSION HAZARD Oxygen vigorously accelerates combustion; do not use any instruments or equipment that may have been exposed to oil or grease contamination.

WARNING Liquid water in the compressed air supply can cause malfunction of this equipment. Use specified filter / water trap assembly.

WARNING Do not occlude or obstruct the orifices on the bottom of the exhalation block assembly. Obstruction of these ports will result in ventilator malfunction

WARNING The exhalation diaphragm, p/n IV 305-05, is a single use component. It should be discarded and replaced between patient use.

WARNING Do not attempt to use an A.C. power adapter other than the configuration provided with this ventilator.

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WARNING: ELECTRICAL SHOCK HAZARD This equipment must be properly grounded. The provided grounding stud shall be separately connected to the protective earth ground if required.

WARNING Fire may result if incorrect fuses are used. Replace fuses as marked.

WARNING The optional battery contains toxic materials. Avoid shorting. Use approved charging methods.

WARNING The batteries in the battery compartment are Nickel Metal Hydride (NiMH) type. Recycle or dispose of batteries properly.

WARNING Do not disconnect the DC power cord from the Backup Battery while the product is in operation. Always turn the Battery Power N/OFF switch to OFF when the unit is not in use

WARNING Battery operating life may be affected by battery age and the number of times it has been discharged and recharged. Over time the battery will degenerate and will not provide the same amount of operating time per charge that is available from a fully charged new battery. Only use Sechrist p/n 39064.

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WARNING Disposal of batteries in fire or disposal or use with other battery types, may result in expolosion or lead to and cause personal injury.

WARNING All alarms must be properly set when using the Sechrist Millennium. WARNING The Sechrist Millennium  is not recommended for use as a transport ventilator.

CAUTION Routine maintenance procedures contained within this manual may involve opening the ventilator enclosure, which constitutes an ELECTRICAL SHOCK HAZARD. Qualified service personnel must perform these procedures.

CAUTION Battery may explode or leak and cause burn injury if disposed of in fire, mixed with a different battery type, inserted backwards, or disassembled.

CAUTION The Backup Battery is designed to be charged by the Millennium infant ventilator only. Under no circumstances should an attempt be made to charge it in any other way.

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CAUTION The auxiliary flow meter outlet is an unregulated gas source with no relief valve.

CAUTION Electrically conductive hoses and/or tubing must not be used in conjunction with this device. NOTE: •

Activation of the high inspiratory pressure alarm will result in the following conditions; •

Pressure within the patient circuit will be vented to ambient.

•

Inspiratory and expiratory pressure controls will become temporarily inoperative.

•

The flow meter is not back-pressure compensated.

•

Follow institutional infection control guidelines when replacing inspiratory bacteria filter.

•

Disinfect/sterilize contaminated parts as defined in the routine maintenance section of this manual.

•

The Millennium infant ventilator should only be connected to appropriate medical grade gas sources capable of delivering a regulated 30 to 60 PSIG (207-414 kPa) at 40 LPM.

•

The Millennium infant ventilator is shipped with appropriate gas fittings and hoses for the intended environment, i.e., DISS (U.S.A., Canada, Germany), NIST (U.K.), Air Liquide (France), SIS (Australia).

•

The Millennium infant ventilator complies with the requirements of IEC 606011-2 (EMC collateral standard), including the E-field susceptibility requirements of 10 volts per meter. However, even at this level of immunity, certain transmitting devices (cellular phones, walkie-talkies, etc.) emit radio frequencies that could disrupt ventilator operation if operated in a range too close to the ventilator.

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WARRANTY Sechrist Industries warrants this product to meet the published specifications and to be free from defects 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 WARRANTY, EXPRESSED, IMPLIED, OR STATUTORY, INCLUDING, WITH OUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY. The sole liability of Sechrist Industries, under this warranty is limited to replacing or repairing, at the discretion of Sechrist Industries, equipment or parts which fail to meet the published specifications or which become defective during the warranty period and which, upon examination by Sechrist Industries are found not to meet the published specifications or to be defective in material or workmanship. Sechrist Industries will not be liable under this warranty unless the following provisions are strictly complied with: (a) Sechrist Industries is promptly notified, in writing, upon discovery of the failure of said product or equipment to meet the published specifications, or of defects in material or workmanship, (b) that examination by Sechrist Industries of said product, equipment, or part shall disclose to Sechrist Industries satisfaction 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 Industries neither assumes nor authorizes any other person or entity to assume for it any other warranty, obligation, or liability I connection with its products or equipment whatsoever, and this warranty can only be changed by a duly authorized representative of Sechrist Industries. Sechrist Industries makes no representations or warranties whatsoever as to the fitness or usefulness of the products or equipment manufactured by it for any medical treatment or physical condition whatsoever. In no event shall Sechrist Industries be liable for any special or consequential damages, or loss of uses of the machine, or loss of time, inconvenience, or any delay in the performance of this warranty. Any authorization for repair or alteration by the buyer must be in writing from Sechrist Industries to prevent the voiding of this warranty.

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SPECIFICATIONS Recommended Applications:

Neonatal, infant & pediatric patients < 50 Kg

Flow:

2-32 lpm; flush 40 lpm

FIO2

.21 to 1.0

Modes of operation:

Assist/Control (A/C), Intermittent Mandatory Ventilation (IMV), Synchronized Intermittent Mandatory Ventilation (SIMV), Continuous Positive Airway Pressure (CPAP) + backup ventilation, and Standby

Inspiratory Time:

0.1 to 3.0 seconds

I:E Ratio:

Normal Range: 1:1.0 to 1:10 (with Sensitivity @ OFF) 1:1.0 to 1:99 (with Sensitivity set) Inverse Range: 1.0:1 to 4.0:1

Rate:

2 to 150 breaths per minute

Expiratory Pressure:

0 to 20 cmH2O (0 to 2 kPa)

Inspiratory Pressure:

5 to 70 cmH2O (0.5 to 7 kPa)

Manual Breath:

Electronically controlled, based upon the inspiratory pressure, inspiratory time, FIO2, flow and waveform control settings

Waveform:

Adjustable from square to tapered.

Alarms:

High Inspiratory Pressure Low/Prolonged Inspiratory Pressure Low PEEP/Baseline Pressure Apnea/Circuit Disconnect Sense Line Disconnect High Respiratory Rate Loss/Low Electrical Power 17

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System Error/Vent Inop Low/Loss of Inlet Gas Internal Battery Power Prolonged Inspiratory Time Standby-Too-Long

Alarm Delay:

3 to 15 seconds

Alarm Mute:

114 seconds (+ 5 seconds)

Safety Pressure Relief Valve:

15 to 85 cmH2O (1.5 to 8.5 kPa) (factory set at 25 cmH2O +5 cmH2O)

Displays/Indicators:

DC Power Battery Power Alarm Alarm Mute Mode Message Peak Pressure PEEP/Baseline Pressure Calculated I:E Ratio / Inverse Status Mean Airway Pressure Proximal Airway Pressure Bar Graph Measured Respiratory Rate Set Respiratory Rate Set Inspiratory Time 18

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Dimensions:

13.5 H x 11W x 9.5D (in) 34.3H x 27.9W x 24.1D (cm)

Weight:

21 lbs. (9.5Kg)

Gas Consumption:

14 lpm above the continuous flow setting

Power Requirements:

AC Power Requirements: Voltage: 100-250 VAC, Frequency: 50-60 Hz, Current: 0.85 Amps.

DC Power Protection:

1 amp time delay fuse

Battery Backup (optional p/n 21513)

Provides a minimum of 2 hours of backup power

Data Transmission

Fiberoptic link

SmartSync Pressure Sensor

Maximum sensitivity: – 0.10 cm H2O Deadspace:

1.5 cc

Weight:

5 grams

Environmental Conditions: Normal Operation: +50 °F to +100 °F, 0 to 90% Relative Humidity, Noncondensing, at 8,000 ft maximum. Storage and Transportation: +40 °F to +120 °F, 0 to 90% Relative Humidity, Noncondensing, at 40,000 ft. maximum.

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GENERAL DESCRIPTION The Sechrist Millennium Infant/Pediatric ventilator is a sophisticated device designed for use by qualified and properly trained personnel. It is restricted to use by or upon the direction of a qualified physician. Before attempting to use this instrument in a patient care setting, operating personnel must become competent in the use of this device. The Sechrist Millennium is a continuous flow, time-cycled, pressure limited ventilator. The basic principle of the ventilator operation is as follows. Air and oxygen are supplied to the gas mixer where desired oxygen concentrations are established. A continuous gas flow rate is selected by the Flow control and indicated by the Flow meter. Gas flow is then directed from the flow meter through the patient circuit and generally through a humidification device (not included) where gas is warmed and humidified for delivery to the patient. At the patient connection, assisted and synchronized ventilation is accomplished by use of the SmartSync sensor, a patentpending sensor of patient effort that also provides for monitoring and display of certain settings or measurements. Gas then travels past the patient connection and to ambient through the exhalation valve assembly. Lung inflation occurs with the closing of the exhalation valve thereby creating a pressure increase in the patient circuit. The exhalation valve serves as the principle component controlling pressures within the patient circuit. Ventilator controls allow the operator to determine 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 inspiratory pressure control establishes the setting of the peak inspiratory pressure during the inspiratory phase and the expiratory pressure control determines the expiratory pressure setting during the expiratory phase of ventilation. A microprocessor-controlled system allows the user to select the inspiratory time and respiratory rate. From these control settings, expiratory time and I:E ratio are calculated, and I:E ratio is displayed on a continuous basis. Manual breaths can be delivered by the clinician and are based upon the settings of Inspiratory pressure, Inspiratory time, FIO2, Flow and Waveform controls Multiple manual breaths can be delivered by repeated depression of the Manual Breath button.

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STANDARD COMPONENTS Each Millennium Infant/Pediatric Ventilator ships ready to assemble and use. The following major components are standard equipment: Component

Reorder: Part Number

Stand and pole

21455

Oxygen/air supply hoses

IV308 (air), IV309 (oxygen)

Hose hanger and handle

43427 (hanger), 21509 (handle)

Reusable patient circuit – infant, with air inlet/water trap

21444-1

Reusable dual pressure sensing lines

21443

Exhalation valve block – infant

21436-1

SmartSync™ Patient Sensing Device (pkg. of 4)

20417 (pkg. of 12)

Power supply/power cable

Power Supply (40012), Cables 22188 (250V, 10A)/& 22189(100125V, 10A)

Power supply bracket

45306

User’s Manual

100236

User’s Quick Reference Manual

100246

ASSEMBLY / SET-UP After unpacking the ventilator, initial setup and verification of the ventilator is accomplished as outlined below. Please refer to Appendix A for a detailed assembly diagram. •

Attach the power supply bracket to the pole assembly and attach the Power Supply.

•

Attach the handle to the pole assembly.

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•

Attach the pole to the base assembly.

•

Attach the appropriate exhalation block, i.e. pediatric or neonatal, to the right side of the ventilator.

•

Set the ventilator atop the pole/stand assembly and secure it by tightening the pole mount securing knob.

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WARNING The safety pressure relief valve is a back-up safety system intended to limit the pressure developed in the patient breathing circuit. Do not obstruct or occlude the holes on relief valve in any fashion. Do not substitute any other device for the relief valve provided.

Air and oxygen hoses are provided in the basic accessory kit. Attach the DISS oxygen hose to the oxygen inlet fitting located on the back panel of the ventilator. Attach the air inlet water trap to the air inlet located on the ventilator back panel and then connect the DISS air hose to the water trap assembly. Tighten air and oxygen connections securely to avoid gas leakage.

Display brightness/ contrast controls

Handle Power supply connection Fuse holder Recess for optional battery backup Fiberoptic Link Air inlet

Oxygen inlet

Pole mount securing knob

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CAUTION Compressed air must be clean and dry to prevent a mixer malfunction, damage to the pneumatic components and unit malfunction. Whenever using compressed air an air inlet water trap is to be used.

OPTIONAL BATTERY BACK-UP INSTALLATION INSTRUCTIONS (p/n 21513)

WARNING 

Battery contains toxic materials. Avoid shorting. Use approved charging methods.



The batteries in the battery compartment are Nickel Metal Hydride type. Recycle or dispose of batteries properly.



As with all electrical devices, it is best not to disconnect the DC power cord from its power source while the product is functioning. Instead, always turn the Power On/Off switch ( ) to Off to discontinue power.



Disposal of batteries in fire or use with other battery types, may result in expolosion or lead to or cause personal injury.



Battery operating life may be affected by battery age and the number of times it has been discharged and recharged. Over time the battery will degenerate and will not provide the same amount of operating time per charge that is available from a fully charged, new battery. Replace the battery when it is fully charged but no longer able to operate the ventilator for at least 90 minutes. 24

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When replacing the battery, use only Sechrist p/n 39064.

CAUTION 

Battery may explode or leak and cause burn injury if recharged, disposed of in fire, mixed with a different battery type, inserted backwards, or disassembled.



The Backup Battery is designed to be charged only by the Millennium Infant Ventilator. Under no circumstances should an attempt be made to charge it in any other way.

Installation: •

Disconnect the power adapter from its power source and disconnect the power adapter from Power Input connector of the ventilator. WARNING

Screw the two stand-offs with lock washers into the threaded holes located in the battery pack recess of the ventilator back panel.

Fully loosen the pole-securing knob. Install the Battery Pack into the recess tilting the lower portion of the battery pack to clear the polesecuring knob.

Pole-securing knob.

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Secure the battery pack with the two screws provided.

Using the cable provided, connect it to the Power Input connector of the ventilator and to the Battery Pack Output connector.

Battery Pack Output Connection

Connect the Power supply to the Power Input connection of the battery pack.

Power Input Connection Operation: Note: The battery must be charged first (see below) before the ventilator is operated utilizing battery power. 26

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Connect the power supply to an appropriate source of electrical power, and switch the Battery Pack POWER switch to the ON position. Battery Pack Power Switch •

•

Observe that within a few moments that the green POWER and BATTERY indicators on the front panel of the ventilator are illuminated and that the ventilator functions normally. Allow the battery to fully charge (about 6 hours).

CAUTION 

• •

The battery pack may be damaged if the ventilator is not in use and disconnected from a primary power source and the battery power switch is left in the ON position. To prevent battery damage, turn the battery power switch OFF when the ventilator is disconnected from a primary power source and not in use. Testing: Disconnect the power adapter from its power source. Observe that the green POWER indicator is not illuminated, the green BATTERY indicator is illuminated and the ventilator functions normally (With the ventilator operating from the battery and when it is nearly discharged the BATTERY indicator turns amber).

•

Attach an appropriate patient circuit to the ventilator.

•

Attach the SmartSync sensor to the patient wye (proximal to the patient).

•

Attach the small bore sensing line to the SmartSync and to the exhalation block port labeled “proximal pressure” (see the diagram below).

•

Attach the small bore tubing to the patient wye and the exhalation block port labeled “reference pressure” (see the diagram below).

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Proximal (SmartSync) pressure line connection

Reference Pressure (wye) pressure line connection

•

Connect the electrical power cord to a suitable hospital grade, grounded receptacle.

•

Complete the performance verification procedure prior to initiating clinical use.

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SUPPLEMENTAL EQUIPMENT Some supplemental devices may and/or should be used with the Millennium. These devices should be used in accordance with the manufacturers instructions and with the following guidelines. FLOW METER An auxiliary flow meter, such as Sechrist p/n 1600, may be attached to the Millennium to provide for delivery of gas from the mixer to another device, e.g. a resuscitation bag or in-line nebulizers. Attachment of an auxiliary flowmeter will allow deliver of gas at the FIO2 set by the mixer. In accordance with the following caution, disconnect both gas sources prior to attaching an auxiliary flowmeter to the Millennium. CAUTION The auxiliary flow meter outlet is unregulated mixed gas source with no relief valve. NEBULIZER Nebulizer devices may be adapted to the inspiratory limb of the ventilator circuit in order to provide for the administration of nebulized medications. Care must be taken to make certain that leaks do not occur as a result of placing a nebulizer in-line and that the nebulizer driving gas does not affect the FIO2 delivered to the patient. Use the auxiliary flowmeter, or another mixer, to assure delivery of the desired FIO2. With the added flow from a nebulizer, the ventilator flow rate may need to be adjusted accordingly. OXYGEN ANALYZER WARNING Always monitor oxygen concentrations with a calibrated oxygen analyzer equipped with high and low alarms to assure that the desired oxygen concentration is being delivered to the patient. Oxygen concentrations must be analyzed at or near the patient airway. An analyzer should be placed into the inspiratory limb of the patient breathing circuit proximal to the patient wye. Care must be taken to assure that the analyzer connection is tight and that no circuit leaks occur. GRAPHIC MONITOR A pulmonary graphics monitor may be utilized in conjunction with the Millennium. The monitor should be used in accordance with the manufacturers guidelines and may require a ”tee” to be placed into the proximal pressure line of the patient circuit so that 29

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the monitor can read pressures. Any such “tee” should be placed proximal to the exhalation block assembly and care should be taken that all connections are tight fitting and that no leakage occurs. HUMIDIFIER Gases delivered from Millennium should be routed to the humidifier and then to the inspiratory limb of the patient circuit. Gases delivered directly from Millennium are dry and “cold”. Prior to patient delivery, inspired gases should be warmed and humidified. An appropriate humidifier for the specific patient type should be placed “in line” in the inspiratory limb of the patient circuit.

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PERFORMANCE VERIFICATION The performance verification procedure provides a means of determining whether the Sechrist Millennium meets its design specifications. The procedure should be performed by qualified technical personnel and should be conducted prior to each clinical application or at least once per month, whichever is soonest. The procedure can be conducted more frequently if desired. If the Sechrist Millennium fails any facet of the verification procedure, the ventilator should be removed from use pending further evaluation and possible service. It is recommended that hospital personnel maintain records documenting completion of the performance verification procedure. PRELIMINARY SETUP:

•

Connect the Sechrist Millennium to an appropriate power source. Note that the Visual Alarm may be lit. The Visual Alarm light will be extinguished once the System ON/OFF button is depressed.

•

Connect the ventilator to both oxygen and medical air sources. (Check that the inlet gas pressures are set at approximately 50 psi)

•

Connect an appropriate patient circuit to the ventilator, using a test lung, e.g. Sechrist Infant Test Lung p/n 20113.

•

Adjust the pressure relief valve to its maximum setting by turning the white adjuster fully clockwise.

•

Set the flow rate to 12 lpm

•

Set the FIO2 to 60%

VERIFY POWER ON AND CHARACTER DISPLAYS

•

Depress the System ON/OFF button.

•

Verify that the STBY mode is displayed.

•

Wait approximately 114 seconds (+ 5 seconds) and verify that the message “W03: Standby Too Long is displayed.

VERIFY OPERATION OF OPTIONAL BATTERY BACKUP: •

•

Disconnect the power adapter from its power source. Observe that both the audible and visual alarms are activated, and that “A02: Internal Battery Power” is displayed in the message window. Reset the alarm by depressing the Alarm Reset button. 31

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•

•

Observe that the green POWER indicator is not illuminated, the green BATTERY indicator is illuminated and the ventilator functions normally (With the ventilator operating from the battery and when it is nearly discharged the BATTERY indicator turns amber). Reconnect the power adapter to its power source.

VERIFY ALL DISPLAYS AND ALARMS

•

Depress and hold the TEST button

•

While holding Test button, verify that all displays, alarms (audible and visual) power indicators, and alarm silence indicator are activated.

•

Depress the Alarm Select control.

•

Using the Data Control knob adjust the ↑ Press alarm to 80 cmH2O (.8 kPa)

•

Depress the Alarm Select control again to confirm the alarm setting.

•

Depress the Mode selection control and using the Data Control knob; set the mode to A/C.

VERIFY BARGRAPH AND DIGITAL DISPLAYS OF PRESSURE

•

Tee a reference manometer into the proximal pressure sensing line near the SmartSync sensor.

•

Using various inspiratory and expiratory pressure settings, verify that the ventilator displays of pressure are accurate; + 3 cmH2O (+ 0.3 kPa)

VERIFY MAXIMUM AND MINIMUM INSPIRATORY PRESSURES

•

Turn the Inspiratory Pressure control fully clockwise.

•

Verify that the maximum inspiratory pressure is 70 cmH2O + 5 cmH2O (7 kPa + 0.5 kPa)

•

Turn the Inspiratory Pressure control knob fully counterclockwise.

•

Verify that the minimum inspiratory pressure is 5 cmH2O + 2 cmH2O ( 0.5 kPa + 0.2 kPa)

VERIFY MAXIMUM AND MINIMUM EXPIRATORY PRESSURES

•

Turn the Expiratory Pressure control fully clockwise.

•

Verify that the maximum expiratory pressure is 20 cmH2O + 2 cmH2O (2 kPa + 0.2kPa) 32

Industries, Inc.

P/N 100236 Rev. 7

•

Turn the Expiratory Pressure control fully counterclockwise.

•

Verify that the minimum expiratory pressure is 0 cmH2O + 0/-2 cmH2O (+0/-0.2 kPa)

•

Set an inspiratory time (Ti) of 0.40 seconds.

•

Set a respiratory rate (f) of 20 bpm.

•

Verify that the dump valve opens. Turn the Expiratory Pressure and Waveform controls fully counterclockwise. If necessary, reset alarms. Adjust the Inspiratory Pressure control to obtain a Peak pressure of 35 cmH2O (3.5 kPa). Set the ↑ Press alarm limit to 30 cmH2O (3 kPa ). Verify that the audible and visual alarms are activated. Verify that the“A03: High Inspiratory Pressure” is displayed. Verify that the displayed peak pressure is within the range of 30 –35 cmH2O (3-3.5 kPa).

•

Set the ↑ Press alarm limit to 80 cmH2O (8 kPa)

•

Verify that the audible alarm ceases.

•

Clear the alarm message by depressing the Alarm Reset button.

PEEP VERIFICATION

•

Set the inspiratory pressure to 30 cm H2O (3 kPa)

•

Place the ventilator in the A/C mode at the default Ti (0.5) and rate (40).

•

Set the expiratory pressure to each of the following settings allowing the ventilator to cycle for at least one minute at each expiratory pressure setting.

•

•

5 cm H2O (5 + 1 cm H2O) 0.5 kPa, (0.5 + 0.1 kPa)

•

10 cm H2O (10 + 1 cm H2O) 1 kPa (1.0 + 0.1 kPa)

•

15 cm H2O (15 + 1 cm H2O) 1.5 kPa (1.5 + 0.1 kPa)

Verify that there are no significant changes in inspiratory pressure with changes in expiratory pressure.

VERIFY MIXER ALARM/BYPASS

Verify that the alarm/bypass system functions, as it should. •

Disconnect the oxygen source from the gas inlet. 33

Industries, Inc.

P/N 100236 Rev. 7