E100m ventilator

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Contents of "E100m ventilator": operator’s responsibility; specifications; , buttons & indicators; theory of operation; operational verification procedure (ovp); overhaul procedure; electronic & pneumatic calibration; roubleshooting and error codes; electronic and pneumatic component removal and replacement procedures;...

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Newport Medical Instruments, Inc. NEWPORT E100M VENTILATOR Service Manual SER1500 Rev. D 01/07/05 NEWPORT MEDICAL INSTRUMENTS 1620 Sunflower Avenue Costa Mesa, CA 92626 Tel: 1.714.427.5811 1.800.451.3111 (USA only) Fax: 1.714.427.0489 Customer Service Ext. 282 0050 www.ventilators.com email: Info@NewportNMI.com
TABLE OF CONTENTS Section 1. . . . . . . . OPERATOR’S RESPONSIBILITY • Operator’s Responsibility for Patient Safety • Limitation of Liability • Warranty • Definitions • Warnings and Cautions Section 2. . . . . . . . SPECIFICATIONS • Ventilator Overview • Intended Use • Symbols/Labeling Table • Specifications Section 3. . . . . . . . DESCRIPTION OF CONTROLS, BUTTONS & INDICATORS • Front Panel Controls • Front Panel Buttons • Front Panel Indicators • Misc. Alarms • Left Side Controls • Rear Panel Controls/Switches • Rear Panel I/O Connectors • Right Side Labeling Section 4. . . . . . . . THEORY OF OPERATION • General System Overview • A/CMV (Assist /Control Mandatory Ventilation) • SIMV (Synchronized Intermittent Mandatory Ventilation) • SPONT + APNEA A/CMV (Spontaneous + APNEA A/CMV Ventilation) • SPONT (Spontaneous Ventilation) • Time-Limited Demand Flow • P limit (Pressure Limited Ventilation) • Advanced Trigger Control (ATC) • Auto-Set Alarms (AS) • ATC Target Trigger Look-up Table • Artifact Trigger Conditions Table • Auto-Set (AS) Alarm Tables • Low Baseline Alarm Table • RS-232 Specifications SER1500 D0105 i
Section 5 . . . . . OPERATIONAL VERIFICATION PROCEDURE (OVP) • Introduction • Set Up • Standard Test Settings • Pressure Gauge Verification • Alarm/LED Check • Mixer Alarm • FIO2 • ƒ (respiratory frequency) • tI (inspiratory time) • SPONT V1 ˙ • SPONT V2 ˙ • V (flow) ˙ • PEEP/CPAP • Low Baseline Alarm, RESET and Alarm Loudness Control • ▲Paw (High Pressure) Alarm • ▼Paw (Low Pressure) Alarm • Ptrig (trigger level) and MODE Select • Apnea Alarm • Manual Inflation Button • NEB (Nebulizer) • Internal Battery Back-Up • Control Monitor • Paw Monitor, (peak, mean, base) • Proximal Line Purge • Advanced Trigger Control (ATC) • Auto Set (AS) Alarms • Time-Limited Demand Flow • E100M Test Record Section 6 . . . . . PREVENTIVE MAINTENANCE PROCEDURE • Introduction • Tools Required • Parts Required • Maintenance Procedure Section 7 . . . . . OVERHAUL PROCEDURE • Introduction • Tools Required • Parts Required • Overhaul Procedure ii SER1500 D0105
Section 8 . . . . . ELECTRONIC & PNEUMATIC CALIBRATION • Introduction • Electronic Verification • Pressure Gauge Calibration • Front Panel Calibration • V (flow) ˙ • tI (inspiratory time) • ƒ (respiratory frequency) • Time-Limited Demand Flow • PEEP/CPAP • Battery Voltage Adjustment • Mixer Regulator Calibration Section 9 . . . . . TROUBLESHOOTING AND ERROR CODES • Introduction • Troubleshooting • Error Codes Section 10 . . . . ELECTRONIC AND PNEUMATIC COMPONENT REMOVAL AND REPLACEMENT PROCEDURES • Introduction • Tools Required • Open Front Panel • Remove Rear Panel • Mixer (MIX1725A) • Flow Control Assembly (FCL1500A) • Flow Block Assembly (BLK1500A) • Nebulizer and Prox/Machine Solenoids (SOL1503P and SOL1501P) • Internal Battery Back-Up (BAT1500A) • Main Board (PCB1550A) • Display Board (PCB1511A) • Electronic Pressure Gauge (MAN1540M) • Power Supply Board (PCB1530A) • Lower Display Board (PCB1520A) • Adapter Board (PCB1570A) SER1500 D0105 iii
Section 11 . . . . ELECTRONIC AND PNEUMATIC DIAGRAMS WITH PARTS LIST • PCB1511 Schematic • PCB1520 Schematic • PCB1530 Schematic • PCB1550 Schematic • PCB1570 Diagram • Pneumatic Diagram E100M • E100M System Pneumatic Diagram • E100M System Wiring Diagram Section 12 . . . . ASSEMBLY DRAWINGS WITH PARTS LIST • Final Assembly E100M • Box Assembly • Flow Block Assembly • Master Solenoid Assembly • Back Panel E100M • Front Panel E100M • Flow Controller Assembly • Mixer Assembly, E100M Calibrated • Needle Valve Assembly Section 13 . . . . REPACKAGING AND SHIPPING INSTRUCTIONS • Introduction • RGA (Return Goods Authorization) • Packaging: Complete Unit • Packaging: Parts or Accessories iv SER1500 D0105
1. OPERATOR’S RESPONSIBILITY Operator’s Responsibility for Patient Safety . . . . 1 - 1 Limitation of Liability . . . . . . . . . . . . . . . . . . . . . . 1 - 1 Warranty. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 2 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 3 Warnings and Cautions . . . . . . . . . . . . . 1 - 3 to 1 - 5 Factory Maintenance or Repair . . . . . . . . . . . . . . . 1-6 Contact Information . . . . . . . . . . . . . . . . . . . . . . . . 1-6 SER1500 D0105
SECTION 1 OPERATOR’S RESPONSIBILITY FOR PATIENT SAFETY For correct and effective use of the product and in order to avoid hazards, it is mandatory that you carefully read and observe all sections of this manual. The design of the E100M Ventilator, the Manuals, and the labeling on the ventilator take into consideration that the purchase and use of the equipment are restricted to trained professionals, and that certain inherent characteristics of the ventilator are known to the trained operator. Instructions, warnings and caution statements are limited therefore largely to the specifics of the Newport design. This manual excludes references to various hazards which are obvious to a medical professional and operator of this equipment, to the consequences of product misuse, and to potentially adverse effects in patients with abnormal conditions. Product modification or misuse can be dangerous. Newport Medical Instruments, Inc. disclaims all liability for the consequences of product alterations or modifications, as well as for the consequences which might result from the combination of this ventilator with other products whether supplied by Newport Medical Instruments, Inc. or by other manufacturers if such a combination is not endorsed by Newport Medical Instruments, Inc. Federal Law and Regulations in the United States and Canada restrict this device to sale by or on the order of a physician. The operators of the ventilator must recognize their responsibility for choosing appropriate safety monitoring that supplies adequate information on equipment performance and patient condition. Patient safety may be achieved through a wide variety of means such as electronic surveillance of equipment performance and patient condition, but surveillance equipment should not take the place of direct observation of clinical signs. The ventilator operator is solely responsible for the selection of the best level of patient monitoring. LIMITATION OF LIABILITY Newport Medical Instruments, Inc. liability, whether arising out of, or related to manufacture and sale of the goods, their installation, demonstration, sales representative, use, performance, or otherwise, including any liability based upon Newport Medical Instruments, Inc. product warranty, is subject to and limited to the exclusive terms and conditions as set forth, whether based upon breach of warranty or any other cause of action whatsoever, regardless of any fault attributable to Newport Medical Instruments, Inc. and regardless of the form of action (including, without limitation, breach of warranty, negligence, strict liability, or otherwise). The stated expressed warranties are in lieu of all other warranties, expressed or implied, including, without limitation, warranties of merchantability, fitness for any purpose, or noninfringement. SER1500 D0105 1-1
OPERATOR’S RESPONSIBILITY Newport Medical Instruments, Inc. shall not be liable for, nor shall the buyer be entitled to recover, any special incidental or consequential damages or for any liability incurred by buyer to any third party in any way arising out of or relating to the goods. WARRANTY The Newport E100M Ventilator is guaranteed to be free of defects for a period of 3 years from date of delivery or 12,000 hours of operation, whichever comes first. The following are exceptions to this warranty: 1. Defects caused by misuse, mishandling, tampering, or by modifications not authorized by Newport Medical Instruments, Inc. or its representatives are not covered. 2. Rubber and plastic components and materials are warranted to be free of defects at time of delivery. Any product which proves to be defective in workmanship or material will be replaced, credited, or repaired with Newport Medical Instruments, Inc. holding the option. Newport Medical Instruments, Inc. is not responsible for deterioration, wear, or abuse. In all cases, Newport Medical Instruments, Inc. will not be liable beyond the original selling price. Federal Law in the United States requires traceability of this equipment. Please return the self addressed Warranty Registration Card included with the product along with the required information. Application of this warranty is subject to the following conditions: 1 Newport Medical Instruments, Inc. or its authorized representatives must be promptly notified upon detection of the defective material or equipment. 2. Defective material or equipment must be returned to Newport Medical Instruments, Inc. or its authorized representative. 3. Examination by Newport Medical Instruments, Inc. or its authorized representatives must confirm that the defect is covered by the terms of this warranty. In order to assure complete protection under this warranty, the Warranty Registration Card must be returned to Newport Medical Instruments, Inc. within ten (10) days of receipt of the equipment. The above is the sole warranty provided by Newport Medical Instruments, Inc. No other warranty expressed or implied is intended. Representatives of Newport Medical Instruments, Inc. are not authorized to modify the terms of this warranty. 1-2 SER1500 D0105
SECTION 1 DEFINITIONS WARNING A WARNING statement refers to a condition with the possibility of personal injury if disregarded. Caution A Caution statement designates the possibility of minor or moderate injury to the user or patient or damage to equipment if disregarded. NOTE: A NOTE provides additional information intended to avoid inconveniences during operation or indicates important procedures to follow. Inspection: examination of actual condition Service: measures to maintain specified condition Repair: measures to restore specified condition Maintenance: inspection, service, repair, where necessary Preventive Maintenance: maintenance performed at regular intervals Typing Conventions Within the text of this manual, controls, alarms, buttons, etc. are designated by the labeling name as they appear on the ventilator, e.g.: P limit (pressure limit), P trig (pressure trigger), SPONT (spontaneous mode). Please review all warnings and cautions outlined in this manual before operating the ventilator. WARNINGS AND CAUTIONS Strictly follow this Manual. Any use of the product requires full understanding and strict observation of all sections of these instructions. The equipment is only to be used for the purpose specified under “Intended Use” (See Section 2) and in conjunction with appropriate airway monitoring. Observe all WARNINGS and Cautions as rendered throughout this manual and on labels on the equipment. General Warnings To maintain grounding integrity, connect only to a “hospital grade” receptacle. Always disconnect power supply before servicing. DANGER, there is a risk of explosion if used in the presence of flammable anesthetics. All settings and adjustments in the different modes of ventilation have to be made according to the therapy prescribed by a physician. Newport Medical Instruments, Inc. cannot warrant or endorse the safe performance of third party humidifiers for use with the E100M Ventilator. We recommend contacting the manufacturers/distributors of third party humidifiers about compliance of their products with the requested performance characteristics. SER1500 D0105 1-3
OPERATOR’S RESPONSIBILITY Do not use antistatic or electrically conductive patient circuits. Always use a clean, sterile breathing circuit. The ventilator is ready for operation only when: a) it is completely assembled and b) a “Quick Check” procedure has been performed successfully. Whenever a patient is connected to the ventilator, constant attention by qualified medical staff is recommended. If a fault is detected in the ventilator and its life support functions are in doubt, discontinue use and use an alternative method of ventilation. If the built-in monitoring malfunctions, provide a substitute in order to maintain an adequate level of monitoring. Failure to identify and correct alarm situations may result in patient injury. Use an external monitor to verify the accuracy of the oxygen concentration delivered to the patient at all times. When the Low Battery (▼ Battery ) audible alarm sounds continuously, only 10% of the internal battery charge remains and an alternate power source should be found immediately. Charge the battery for a minimum of 5 hours before again powering the ventilator from the internal battery. This will provide approximately 80% of the battery charge. If the battery is completely depleted, it will take approximately 14 to 16 hours to fully recharge. The internal battery should be fully charged at least once every 6 months to ensure that it remains functional. Water traps should be used in appropriate locations of the breathing circuit in order to prevent water that has accumulated in the circuit from being drained towards the patient’s airway. Newport Medical Instruments, Inc. cannot endorse or warrant the safe performance of nebulizers currently available when used with the E100M Ventilator. Specifically, some disposable nebulizer assemblies operate with flow rates different from the 10 L/min delivered by the ventilator at 28 psig. We recommend contacting the manufacturers/distributors selling nebulizing devices about compatibility of their products with the requested performance characteristics. The flow resistance of filters is liable to increase through use, due to both aerosol usage and humidification level. Make certain that filters are changed regularly (especially those in the expiratory limb of the breathing circuit). _ The P limit control should be set 4 to 10 cmH2O/mbar above the ▲Paw alarm limit as a safety pop-off when volume ventilating. In volume control ventilation, an incorrect setting of the P limit control could cause some volume to be “vented.” When pressure ventilating, the P limit control should be set to the plateau pressure level that is desired. 1-4 SER1500 D0105
SECTION 1 The E100M Ventilator is guaranteed to perform within specification when the Newport Medical permanent breathing circuit and the permanent exhalation valve are utilized. The Newport Medical permanent breathing circuit with proximal sensing line is available in infant or adult sizes. If an alternate circuit is used, the proximal pressure line must be a 1/8 in (3.2 mm) I.D. for proper ventilator performance. Only a Newport Medical permanent exhalation valve should be used with the E100M Ventilator. Cautions Use only dry, clean, compressed air and medical grade oxygen. Water in the air or oxygen supply can cause equipment malfunction and damage. Mains voltage must correspond to the voltage range selected on the power module of the ventilator. Always replace a blown fuse with one of proper rating for corresponding voltage range. Do not place containers of liquids in the immediate vicinity or on top of the E100M Ventilator. Liquids that get into the ventilator can cause equipment malfunction and damage. Periodically inspect the Air Inlet Water Trap. Drain water from the bowl when necessary by depressing the pin at the bottom of the bowl. SER1500 D0105 1-5
OPERATOR’S RESPONSIBILITY FACTORY MAINTENANCE OR REPAIR Scheduled maintenance or repair services are available from the Newport Technical Service Department. To send your ventilator in for service, see Section 13 for packaging and shipping instructions. Current pricing for scheduled maintenance and labor rates can be found in Newport Medical Instruments’ Annual Price List. To obtain a copy of the Price List, please contact your local Newport Medical Instruments Sales Representative or call/fax our Customer Service Department using the numbers that follow. CONTACT INFORMATION Address: Newport Medical Instruments, Inc. 1620 Sunflower Avenue Costa Mesa, CA 92626 Phone Numbers: 800.451.3111 Toll free within the United States 1.714.427.5811 Worldwide Fax Numbers: 1.714.427.0489 1.714.427.0572 Fax Direct Technical Service Dept. Web Site: www.ventilators.com email: Info@ventilators.com Department Extensions: Customer Service Department: 282 Technical Service Department: 500 (24 Hour pager activated after business hours) Clinical Support: 123 (24 Hour pager activated) Corporate Office Hours: Monday through Friday 8:00 am to 5:00 pm, Pacific Time, USA Technical Service Department Hours: Monday through Friday 7:00 am to 4:00 pm, Pacific Time, USA EU Representative: Newport Medical Instruments, Inc. Att: Robert Brink c/o Braun & Co. 19 Pasture Rd. Barton-on-Humber North Lincolnshire DN18 5HN, England tel: ++44.77 68 231311 fax: ++44.1652 633399 1-6 SER1500 D0105
2. SPECIFICATIONS Ventilator Overview . . . . . . . . . . . . . . . . . . . . . . 2 - 1 Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . 2 - 2 Symbols/Labeling Table . . . . . . . . . . . . . . . . . . 2 - 2 Specifications. . . . . . . . . . . . . . . . . . . . 2 - 5 to 2 - 9 SER1500 D0105
SECTION 2 VENTILATOR OVERVIEW The E100M ventilator provides the following features: Total patient range: Neonate, Infant Pediatric, and Adult Application delivered invasively (via ET tube) or noninvasively (via mask/mouthpiece) Full Mode Selection: Volume Controlled A/CMV Volume Controlled SIMV & DuoFlowPLUS • Pressure Limited A/CMV (adjust pressure slope w/V control) • Pressure Limited SIMV (adjust pressure slope w/V control) & DuoFlowPLUS* Spontaneous (CPAP) & DuoFlowPLUS Spontaneous w/APNEA A/CMV (Back-up) Ventilation & DuoFlowPLUS *DuoFlowPLUS (Intermittent Spontaneous Flow + Time-Limited Demand Flow) Good balance of simplicity and capability: • 21-100% Oxygen: Available from integrated high pressure air/oxygen precision mixer • Built-in PEEP/CPAP with Electronic Control for stability of baseline and ease of adjustment • Internal Battery 6-8 Hours: facilitates easy patient mobility • Monitors including Total Breath Rate, I:E Ratio, Peak, Mean and Baseline Pressure, and Set Tidal Volume • Real-time proximal airway or mainflow outlet pressure display with visual sensitivity Trigger setting indicator. • Logical Face Panel Layout With Color Coded Displays: Simplifies training and operation, with reduced confusion for home caregivers • Small Size And Footprint: Offer flexibility in mounting and carrying options • Inverse I:E 4:1 & APRV Capability: Advanced functions for advanced application • Graphics Display Monitor — Optional in countries where available SER1500 D0105 2-1
SPECIFICATIONS INTENDED USE Indications For Use: The Newport E100M is intended to provide positive pressure ventilation for neonatal, infant, pediatric and adult patients, for use in the hospital environment. The device is intended for use by or at the direction of a licensed practitioner. SYMBOLS / LABELING TABLE Reset Apnea (s) Alarm Silence/Reset Button Apnea Time Delay ▼Battery Select Button Low Battery Alarm Indicator ▼ ▲ Paw Alarm Spont Push to set only ▲ Paw Adjust High and Low Paw Alarm Spont (Patient Effort) Indicator — ▲ Paw ▲ Paw High Airway Set High Airway Pressure Alarm Indicator Pressure Alarm ▼ Paw ▼ Paw Low Airway Set Low Airway Pressure Alarm Indicator Pressure Alarm 2-2 SER1500 D0105
SECTION 2 SYMBOLS / LABELING TABLE AS ATC ! Automatic Control Buttons Refer to Operating Manual (see Paw Alarm and Ptrig) NEB EXH VLV Exhalation Valve Tubing Connection Nebulizer Tubing Connection PROX PATIENT Prox. Pressure Tubing Connection Ventilator Main Flow Outlet Connection for Patient Breathing Circuit/Humidifier • • SPONT V2 Tubing Connection SPONT V2 Flowmeter Connection ! Reservoir Bag Connection SER1500 D0105 2-3
SPECIFICATIONS SYMBOLS / LABELING TABLE Back Panel Labels Type B Alarm Loudness Control External Alarm Silence Connector REMOTE ALARM OUTPUT Remote Alarm Output Equipotentiality STDBY ON Main Power “Standby” Main Power “On” 2-4 SER1500 D0105
SECTION 2 E100M SPECIFICATIONS Control/Parameter/Indicator Range/Selection 1. MODE A/CMV Pressure or SIMV Volume SPONT + APNEA A/CMV SPONT 2. Tidal Volume 5 to 5000 mL • V (L/min) ( ) x TI 60 • 3. V (Mandatory Flow) 1 to 100 L/min 4. tI (Inspiratory Time) 0.1 to 3.0 sec 5. ƒ (Respiratory Frequency) 1 to 120 b/min 6. PEEP/CPAP 0 to ≥ 25 cmH2O/mbar 7. P limit (Pressure Limit) 0 to 120 cmH2O (0 to 118 mbar) (Use for Pressure Limited_ Ventilation and/or as a safety pop-off above the ▲Paw in Volume Control.) 8. Time-Limited Demand Flow Ø to 1.0 sec (Spont breath) 9. Manual Inflation 4 sec maximum (Pushing this button closes the exhalation valve and delivers mixed gas to the patient according • to the V setting.) 10. FIO2 .21 to 1.00 11. NEB Button Toggles nebulizer gas source on and off. (10 L/min mixed gas, inspiration only) 12. PROX Button Toggles proximal pressure monitoring on and off. (On: proximal pressure monitoring, Off: mainflow outlet pressure monitoring) 13. P trig (Sensitivity) –10 to ≥ +25 cmH2O/mbar 14. ATC Toggles ATC function on and off. (Advanced Trigger Control) (When on, automatically manages trigger level setting for patient.) 15. Spont (Patient Effort) Indicator Blinks once each time airway pressure drops below the P trig setting. SER1500 D0105 2-5
SPECIFICATIONS E100M SPECIFICATIONS Control/Parameter/Indicator Range/Selection 16. ▼▲ Paw Alarm _ high and low airway pressure alarms Set ▲Paw 5 to 120 cmH2O / 5 to 118 mbar ▼Paw 3 to 118 cmH2O / 3 to 116 mbar 17. AS (Auto-Set Alarms) Toggles AS alarms function on and off. (Automatically selects high and low pressure alarm settings each time button is pressed.) 18. Paw Selector Selects airway pressure parameter (peak, mean, base) to be displayed in the Paw Monitor window of pressure gauge. 19. Paw Monitor Display 0 to 99 cmH2O (0 to 97 mbar) (peak, mean, base pressure) 20. Pressure Gauge –10 to +120 cmH2O ( – 1 0 to +118 mbar) 21. Control Monitor Selector Selects parameter (I:E, ƒ tot, VT) which is displayed in the Control Monitor display. 22. Control Monitor Display I:E (ratio): 1:99 to 4:1 ƒ tot: 0 to 255 b/min VT: 0.00 to 5.00 L % Charge of Battery: 0 to 99 (Percent of charge displayed when “Internal Battery Test” button on rear panel is pressed and ventilator is running on battery power.) 23. Apnea Selector Selects time delay interval for the Apnea alarm, Ø (disable), 15, or 30 seconds. 24. Reset (Alarm Silence) Silences an alarm violation for 60 seconds, resets a “latched” alarm indicator and cancels Power Down alarm. 25. ALARMS Indicators Indicator for the alarm that is actively violated blinks red. When the alarm is no longer violated, the indicator latches (stays lit). Cancel a latched indicator by pressing the Reset button. 26. tI > tE Indicator A yellow indicator blinks any time the control settings result in an inverse I:E ratio. Provides 0 to 15+ L/min (uncalibrated up to 36 L/min) • 27. SPONT V2 Flowmeter mixed gas for spontaneous breathing. 2-6 SER1500 D0105
SECTION 2 E100M SPECIFICATIONS Control/Parameter/Indicator Range/Selection • 28. SPONT V 1 Switch Provides Ø or 8 L/min mixed gas for spontaneous breathing. 29. Alarm Loudness Control 74 dbA – 92 dbA. 30. External Alarm Silence Input Allows use of the NEWPORT External Alarm Silence cable which functions the same as the Reset button. Does not cancel the Power Down alarm. 31. RS-232C Interface Operates at 38,400 baud. Allows for interfacing with central monitoring and computer systems via 25 pin D type connector. 32. Remote Alarm Output Provides contact closure when alarming. Operates with most nurse call systems using a 1/4 in (0.64 cm) phone type connector. 33. Hour Meter Display Displays 0 to 199,999.9 hours 34. Internal Battery Test Button When pressed during battery power operation, % battery charge (0 to 99%) is displayed in Control Monitor window. 35. Power Switch This rocker type switch, (ON) or (STDBY) switches ventilator on and off. When the ventilator is connected to A.C. power, the internal battery charges regardless of switch position. 36. Loss of Gas Alarm Continuous audible alarm. Activated if air or oxygen supply pressures drop below 28 ± 3 psig. (No visual alarm indicator.) 37. Power Down Alarm Continuous audible alarm activated when the ventilator power switch is changed from (ON) to (STDBY). The alarm is silenced by pressing the Reset button. (No visual alarm indicator.) SER1500 D0105 2-7