Manual e100m Serman Rev d 2202

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: [email protected]

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

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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 V˙1 • SPONT V˙2 • 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

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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)

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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

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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

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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.

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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.

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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.

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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.

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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.

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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 1.714.427.5811

Toll free within the United States Worldwide

Fax Numbers:

1.714.427.0489 1.714.427.0572

Fax Direct Technical Service Dept.

Web Site:

www.ventilators.com email: [email protected]

Department Extensions: Customer Service Department: Technical Service Department:

282 500

Clinical Support:

123

(24 Hour pager activated after business hours) (24 Hour pager activated)

Corporate Office Hours: Monday through Friday

8:00 am to 5:00 pm, Pacific Time, USA

Technical Service Department Hours:

7:00 am to 4:00 pm, Pacific Time, USA

EU Representative:

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Monday through Friday

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

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2. SPECIFICATIONS

Ventilator Overview . . . . . . . . . . . . . . . . . . . . . . 2 Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Symbols/Labeling Table . . . . . . . . . . . . . . . . . . 2 Specifications. . . . . . . . . . . . . . . . . . . . 2 - 5 to 2

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1 2 2 9

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:

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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

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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 Alarm Silence/Reset Button

(s)

Apnea Time Delay

▼Battery Select Button

▼ ▲ Paw Alarm Push to set only ▲ Paw

Adjust High and Low Paw Alarm

▲

Paw

High Airway Pressure Alarm Indicator

▼

Paw

Low Airway Pressure Alarm Indicator

2-2

Low Battery Alarm Indicator

Spont

Spont (Patient Effort) Indicator

—

▲

Paw

Set High Airway Pressure Alarm

▼

Paw

Set Low Airway Pressure Alarm

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SECTION 2 SYMBOLS / LABELING TABLE

!

ATC

AS

Automatic Control Buttons (see Paw Alarm and Ptrig)

Refer to Operating Manual

NEB

EXH VLV

Exhalation Valve Tubing Connection

Nebulizer Tubing Connection

PATIENT

PROX

Prox. Pressure Tubing Connection

•

SPONT V2 Tubing Connection

Ventilator Main Flow Outlet Connection for Patient Breathing Circuit/Humidifier

•

SPONT V2 Flowmeter Connection

!

Reservoir Bag Connection SER1500 D0105

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SPECIFICATIONS SYMBOLS / LABELING TABLE

Back Panel Labels

Type B

Alarm Loudness Control

External Alarm Silence Connector

REMOTE ALARM OUTPUT

Remote Alarm Output

STDBY

Main Power “Standby”

2-4

Equipotentiality

ON

Main Power “On”

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SECTION 2 E100M SPECIFICATIONS Control/Parameter/Indicator 1. MODE

Pressure or Volume

2. Tidal Volume • V (L/min) ( ) x TI 60 •

Range/Selection A/CMV SIMV SPONT + APNEA A/CMV SPONT 5 to 5000 mL

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 (Advanced Trigger Control)

Toggles ATC function on and off. (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.

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SPECIFICATIONS E100M SPECIFICATIONS Control/Parameter/Indicator

Range/Selection

16.

Set high and low airway pressure alarms _ ▲Paw 5 to 120 cmH2O / 5 to 118 mbar ▼Paw 3 to 118 cmH2O / 3 to 116 mbar

▼▲

Paw Alarm

17. AS

(Auto-Set Alarms)

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.

•

27. SPONT V2 Flowmeter

2-6

Toggles AS alarms function on and off. (Automatically selects high and low pressure alarm settings each time button is pressed.)

Provides 0 to 15+ L/min (uncalibrated up to 36 L/min) mixed gas for spontaneous breathing.

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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.)

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SPECIFICATIONS E100M SPECIFICATIONS Control/Parameter Indicator

Range/Selection

38. Fault System Alarm

Continuous audible alarm. This alarm can not be silenced without first selecting the (STDBY) position on the power switch.

39. High Baseline Alarm (automatic)

▼Paw and ▲Paw alarm indicators blink red and the audible alarm sounds continually if Paw remains above ▼Paw alarm setting at end exhalation.

40. Low Baseline Alarm (automatic)

▼Paw alarm indicator blinks red and the audible alarm beeps intermittently if Paw remains below the Low Baseline alarm setting (see chart pg. 4-14) for > 3 seconds.

Hardware

Requirements

41. Electrical

100/120 VAC 0.14 A maximum 220/240 VAC 0.07 A maximum 50/60 Hz (0.25 A fuse type F for 100/120 VAC, 0.1 A fuse type F for 220/240 VAC line, NOTE: For 230 VAC use, select 220 VAC setting. WARNING If 230 VAC outlet is used with 220 VAC setting and actual voltage exceeds 242 VAC, damage to ventilator may occur.

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42. Pneumatic

35 to 90 psig Medical Air (2.4 to 6.2 Bar) 35 to 90 psig Medical Oxygen (2.4 to 6.2 Bar)

Miscellaneous

Description

43. Operating Temperature

0 to 40ºC

44. Operating Humidity

0 to 95% non-condensing

45. Operating Altitude

0 to 10,000 ft (0 to 3,000 m)

46. Regulatory and Agency Requirements

Designed to meet the applicable requirements of the FDA, CSA, JIS, IEC and TUV.

47. Storage Temperature

–20 to 60°C

48. Storage Humidity

0 to 95% non-condensing

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SECTION 2 E100M SPECIFICATIONS Miscellaneous

Description

49. Height

10.5 in (26.7 cm)

50. Width

9.5 in (24.1 cm)

51. Depth

6.5 in (16.5 cm)

52. Weight

18 lbs (8.2 kg)

53. Patient Range

Neonate – Pediatric – Adult

54. Internal Compressible Volume

29 mL

55. Flow Waveforms Available

Volume Control – square Pressure Limit – decelerating (with P limit set to limit pressure)

56. Patient Circuit

Reusable or disposable adult, pediatric or neonate circuits, with or without 1/8 in (3.2 mm) I.D. proximal pressure sensing lines. Main flow outlet and exhalation valve have a 22 mm standard taper.

57. Exhalation Valve

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NEWPORT’s exhalation valve is manufactured and designed specifically for NEWPORT Ventilators. NEWPORT does not recommend the use of any other type or brand of exhalation valve.

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3. DESCRIPTION OF CONTROLS, BUTTONS & INDICATORS

Front Panel Controls . . . . . . . . . . . . . . . . . . . . . . . 3 Front Panel Buttons . . . . . . . . . . . . . . . . . . . . . . . 3 Front Panel Indicators. . . . . . . . . . . . . . . . . . . . . . 3 Misc. Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Left Side Controls . . . . . . . . . . . . . . . . . . . . . . . . . 3 Rear Panel Controls/Switches . . . . . . . . . . . . . . . 3 Rear Panel I/O Connectors . . . . . . . . . . . . . . . . . . 3 Right Side Labeling. . . . . . . . . . . . . . . . . . . . . . . . 3

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23 73 12 13 15 17 17 21

SECTION 3

Reset

ALARMS

E100M V E N T I L A T O R

▲ Paw ▼ Paw

Apnea

(s) 15 30 0

▼ Battery

80

70

Apnea

90 100

60 50

110 120

40

MODE

30

SPONT

Paw (cmH20)

20 10

SPONT +APNEA A/CMV

0

-10

peak mean base

SIMV A/CMV ▼ ▲ Paw Alarm Push to set only ▲ Paw

Ptrig

Spont

ƒ tot

I:E

AS

ATC

V T (L) •

.50 .40

.60

30

20

.70 .80

tI

40

1.5

.21

.90 1.00

20

40 60

2.5

80

10

100

70 MAX

30 2.0

60 0.5

MIN

.30

> tE

1.0

50

10 5

ƒ (b/min)

tI (s)

V (L/min)

F IO 2

0.1

1

3.0

120

80 100

90

Time-Limited Demand Flow (s)

Manual Inflation

0.3

Pbase

Plimit

0.7

0.1 0

1.0

PROX

NEB

EXH VLV

PEEP/CPAP

0.5

NEB

PROX

PATIENT

Figure 3-1 E100M FRONT PANEL

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DESCRIPTION OF CONTROLS, BUTTONS & INDICATORS FRONT PANEL CONTROLS Front panel controls that have corresponding indicators (i.e. Paw Alarm control with ▼Paw/▲Paw indicators) are included with the description of the control. The E100M front panel is shown in Figure 1.

MODE Control A/CMV (Assist/Control Mandatory Ventilation) MODE SPONT SPONT +APNEA A/CMV SIMV A/CMV

The minimum number of time triggered mandatory breaths is determined by the ƒ control. The total number of mandatory breaths is a result of the ƒ setting and patient triggers. Set the P trig as close to baseline pressure as possible so that all patient efforts are recognized as patient triggers. The indicator for A/CMV is lit green while operating in this mode. NOTE: If the P trig setting is not adjusted to a level that allows the patient’s inspiratory effort to be detected, the A/CMV mode resembles Control mode.

SIMV (Synchronized Intermittent Mandatory Ventilation) MODE SPONT SPONT +APNEA A/CMV SIMV A/CMV

The number of time triggered mandatory breaths is determined by the ƒ control. The patient can take spontaneous breaths between the delivery of the mandatory breaths. Set the P trig as close to baseline as possible so that all patient efforts are recognized as patient triggers. This allows the E100M to synchronize the mandatory breaths and spontaneous Time-Limited Demand Flow breaths with patient effort. Time-Limited Demand Flow may be used to support spontaneous efforts with a higher initial flow which then drops to the lower Spont Flow. The indicator for SIMV is lit green while operating in this mode.

SPONT + APNEA A/CMV (Spontaneous Ventilation + Apnea A/CMV) MODE SPONT SPONT +APNEA A/CMV SIMV A/CMV

3-2

All breaths are spontaneous. Set the P trig as close to baseline as possible so that all patient efforts are recognized as patient triggers. Time-Limited Demand Flow may be used to support spontaneous efforts with a higher initial flow which then drops to the lower Spont Flow. If the patient stops breathing and it results in an Apnea alarm violation, A/CMV breaths are delivered at the face panel control settings until the patient effort results in four consecutive patient triggered breaths. The indicator for SPONT + APNEA A/CMV is lit green while operating in this mode.

SER1500 D0105

SECTION 3 SPONT (Spontaneous Ventilation) MODE SPONT SPONT +APNEA A/CMV SIMV A/CMV

All breaths are spontaneous. Set the P trig as close to baseline as possible so that all patient efforts are recognized as patient triggers. Time-Limited Demand Flow may be used to support spontaneous efforts with a higher initial flow which then drops to the lower Spont Flow. The indicator for SPONT is lit green while operating in this mode.

Ventilation Controls FIO2 Determines the air/oxygen mixture for all gas delivery to the patient.

FIO2 .60

Range: .21 to 1.00

.70

.50

.80

.40 .30

.90

.21

1.00

NOTE: When the FIO2 is readjusted, the oxygen concentration will stabilize in the Reservoir Bag in approximately 30 seconds (depending on SPONT V˙1 and V˙ 2 settings).

V˙ (mandatory flow) •

V (L/min) 20

30

40

10 5

50 60

MIN

70 MAX

80 100

90

Sets the flow delivered to the patient during mandatory breaths (volume or pressure), APNEA A/CMV breaths, Time-Limited Demand Flow, and Manual Inflation. Volume Ventilation: Adjust V˙ and tI to set VT (tidal volume). Pressure Ventilation: Adjust V˙ to achieve desired inspiratory pressure rise/slope. Normal flow ranges for neonatal, pediatric, and adult patients are indicated by the three different green lines around the dial. Range: 1 to 100 L/min

tI (inspiratory time-mandatory) tI

> tE

Sets the inspiratory time for mandatory breaths (volume or pressure).

tI (s) 1.5

1.0

Volume Ventilation: Adjust V˙ and tI to set VT (tidal volume).

2.0

0.5 0.1

SER1500 D0105

2.5 3.0

Pressure Ventilation: Adjust tI and ƒ to set appropriate I:E ratio. Range: 0.1 to 3.0 sec

3-3

DESCRIPTION OF CONTROLS, BUTTONS & INDICATORS ƒ (respiratory frequency) ƒ (b/min) 30 40

20

60

Sets the number of time triggered breaths delivered to the patient in the A/CMV and SIMV modes, and in the event of an Apnea alarm violation in the SPONT + APNEA A/CMV mode.

80

10

100 1

Range: 1 to 120 b/min

120

Time-Limited Demand Flow Time-Limited Demand Flow (s)

0.5 0.3

0.7

0.1 0

1.0

Determines the duration of time flow support is provided for spontaneous breaths in SIMV or either SPONT mode. The amount of flow support is determined by the V˙ setting. The exhalation valve remains at the PEEP/CPAP level during Time-Limited Demand Flow breaths. A patient can ˙ 1 and/or continue spontaneous inspiration from gas provided by SPONT V ˙ 2 and draw gas from the reservoir bag after Time-Limited SPONT V Demand Flow ends. The indicator for Time-Limited Demand Flow is lit green while in use. Range: Ø to 1.0 sec

P limit (pressure limit) Plimit

P limit determines the maximum pressure for all breaths. If airway pressure reaches the P limit setting, flow vents to prevent airway pressure from going higher. Clockwise rotation increases the maximum P limit level. Pressure Ventilation: Use the P limit control to set the peak inspiratory pressure for all mandatory breaths. The inspiratory pressure rise/slope is determined by the V˙ setting. Volume Ventilation: Use the P limit control to set a safe pressure pop-off _ above the ▲Paw alarm setting. Range: 0 to 120 cmH2O (0 to 118 mbar) _ NOTE: P limit must be set lower than the ▲Paw alarm when pressure ventilating. If V˙ and tI are not set appropriately, P limit may not be achieved during mandatory breaths. WARNING When volume ventilating, P limit must be set higher than _ the ▲Paw alarm, otherwise volume may be vented.

PEEP/CPAP PEEP/CPAP Pbase

Establishes the pressure in the patient circuit from end exhalation to the start of the next inspiration. Also referred to as base or baseline pressure. Range: 0 to ≥ +25 cmH2O/mbar

3-4

SER1500 D0105

SECTION 3 P trig Control and SPONT Indicator (sensitivity) Ptrig

Spont

ATC

The Ptrig control knob adjusts the patient trigger sensitivity setting on the E100M. The trigger sensitivity setting determines the amount of negative pressure (inspiratory effort) the patient must generate in the breathing circuit in order for the E100M to detect the effort (trigger). On "power up" of the ventilator, the trigger is set at –5 cmH2O/mbar. When you rotate the knob, you will feel it click slightly. Each click represents a trigger sensitivity level change of ~0.14 cmH2O/mbar. Rotating it through seven clicks changes the trigger sensitivity by one cmH2O/mbar, i.e., one pressure gauge segment. (The selected segment blinks on the electronic pressure gauge.) Rotate the Ptrig control counter-clockwise to increase the patient effort required to trigger and clockwise to decrease the effort required. Spont

The Spont indicator blinks when the E100M detects a trigger. The Apnea alarm time delay interval (Apnea ) is reset at the same time. See Theory of Operation, Section 4, for more details on adjusting Ptrig. Spont indicator blinks yellow: Indicates a spontaneous effort is detected by the Ptrig.

Spont

Spont indicator doesn’t blink: Indicates no spontaneous effort is detected by the Ptrig. NOTE: Each time the Spont indicator blinks or a mandatory breath is delivered, the Apnea alarm delay is reset. Range: –10 to ≥ +25 cmH2O/mbar ▼▲

Paw Alarm Control and Indicators (Adjust ▲Paw and ▼Paw alarms) ▼ ▲ Paw Alarm Push to set only ▲ Paw

AS

_ The ▲Paw (high) and ▼Paw (low) pressure alarm settings are adjusted by rotating the ▼ ▲ Paw Alarm knob. Settings are displayed on the pressure gauge as non-blinking bars. _ Default settings: ▲Paw 30 cmH2O/mbar ▼Paw 10 cmH2O/mbar _ Range: ▲Paw 5 to 120 cmH2O / 5 to 118 mbar ▼Paw 3 to 118 cmH2O / 3 to 116 mbar

• Adjusting ▼Paw: Rotate the ▼ ▲ Paw Alarm knob clockwise to increase, counter-clockwise to decrease the alarm setting. _ NOTE: Adjusting the ▼Paw alarm setting also adjusts the ▲Paw alarm setting. _ • Adjusting ▲Paw: Push ▼ ▲ Paw Alarm knob in, then rotate clockwise to increase, counter-clockwise to decrease the alarm setting. _ NOTE: Adjusting the ▲Paw alarm setting does not adjust the ▼Paw setting. SER1500 D0105

3-5

DESCRIPTION OF CONTROLS, BUTTONS & INDICATORS ▲Paw Alarm (user adjustable) ALARMS ▲ Paw ▼ Paw ▼ Battery

_ If airway pressure reaches the ▲Paw (high pressure) alarm setting a ▲Paw alarm violation occurs, and any breath in progress cycles to exhalation. The alarm resets when airway pressure drops below the _ ▲Paw setting.

Apnea

Audible Alarm: intermittent beep Visual Alarm: ▲Paw indicator blinks red

▼Paw Alarm (user adjustable) ALARMS ▲ Paw ▼ Paw ▼ Battery

Apnea

If airway pressure does not rise above the ▼Paw (low pressure) alarm setting during inspiration, then drop below the ▼Paw alarm setting during exhalation, a ▼Paw alarm violation will occur on mandatory breaths. The alarm is reset when one mandatory breath is delivered without a ▼Paw alarm violation. Audible Alarm: intermittent beep Visual Alarm: ▼Paw indicator blinks red

Low Baseline Alarm – ▼Paw (automatic) ALARMS ▲ Paw ▼ Paw ▼ Battery

Apnea

A Low Baseline violation indicates an unstable baseline (leak in the breathing circuit) or that baseline has decreased, possibly due to a • • SPONT V1 or SPONT V2 adjustment, since the last PEEP/CPAP control change. In all modes, if airway pressure drops below the Low Baseline alarm default selection for 3 sec, a Low Baseline violation occurs. This alarm is indicated the same as a ▼Paw violation. The alarm resets when airway pressure rises to the alarm table default setting. Audible Alarm: intermittent beep Visual Alarm: ▼Paw indicator blinks red NOTE: The Low Baseline alarm default settings are defined in Section 4, Theory of Operation, Low Baseline Alarm Table, Table 4-4.

High Baseline Alarm – ▲Paw/▼Paw (automatic) ALARMS ▲ Paw ▼ Paw ▼ Battery

Apnea

3-6

A High Baseline violation alerts the user to a potential blockage or occlusion in the breathing circuit. During mandatory breaths, a High Baseline violation occurs if airway pressure does not drop lower than the ▼Paw alarm setting before the start of the next mandatory breath. Audible Alarm: continuous beep Visual Alarm: ▲Paw and ▼Paw indicators blink red

SER1500 D0105

SECTION 3 FRONT PANEL BUTTONS Front panel buttons that have corresponding indicators (i.e. Apnea button and indicators) are included with the description of the control. The E100M Front Panel is shown in Figure 3-1, Page 3-1.

Manual Inflaton Manual Inflation

Used to deliver a single, operator controlled manual inflation. Inspiration is terminated if the button is released, the ▲Paw alarm is violated, or 4 seconds have elapsed. Flow is determined by the V˙ control setting. Manual Inflation is available in all modes but will not function in the event of a Fault System Alarm condition. Range: 0 to 4 sec

NEB (nebulizer gas source) NEB

NEB On/Off Button NEB

NEB Connection

Activates a 28 psig (1.9 Bar) mixed gas source for powering a low volume nebulizer. NEB function is available during all mandatory, TimeLimited Demand Flow, and Manual Inflation breaths. Push button to toggle on/off. When in use the indicator is lit green. NOTE: The NEB gas source provides an unrestricted flow of 10 L/min. When using the Newport Nebulizer Kit (p/n PNK502A) the actual flow to the patient breathing circuit is 8 L/min. The additional 8 L/min flow is reflected in the VT calculation displayed in the Control Monitor. You can compensate for the additional flow by reducing the V˙ control setting by 8 L/min when the NEB indicator is lit.

PROX (proximal mainflow pressure monitoring) PROX

PROX On/Off Button

Selects the location for monitoring airway pressure and patient efforts (triggering). Monitoring location is at the main flow outlet of the ventilator or at the proximal monitoring line of the breathing circuit. PROX Button Indicator unlit: PATIENT main flow outlet monitoring PROX Button Indicator lit: PROX monitoring

PROX

PROX Connection

SER1500 D0105

NOTE: Proximal pressure monitoring may enhance recognition of the patient’s inspiratory efforts. A breathing circuit with a proximal pressure monitoring line is required for proximal pressure monitoring.

3-7

DESCRIPTION OF CONTROLS, BUTTONS & INDICATORS Control Monitor Selector

& Display

I:E (Inspiration to Exhalation ratio) I:E

ƒ tot

. 1.2.0

V T (L)

A/CMV mode: I:E calculated from ƒ total and tI setting. SIMV mode: I:E calculated from ƒ and tI setting. SPONT modes: same as SIMV mode. If the ƒ and tI control settings result in an I:E that is not allowable, the display flashes and the tI is shortened in order to stay within an allowable range. Range: 1:99 to 4:1 WARNING Although the E100M allows the user to set an inverse I:E ratio of up to 4:1, ventilating a patient at a ratio of greater than 1:1.0 is unusual. Care should be taken to ensure that each patient is being ventilated at an appropriate I:E ratio.

ƒ tot (total frequency) ƒ tot

I:E

18 V T (L)

ƒ tot is the total number of time triggered and patient triggered breaths detected in the last 60 seconds. Range: 0 to 255 b/min

VT (L) (calculated tidal volume) ƒ tot

I:E

.6 5 V T (L)

Set VT is calculated from the V˙ and tI control settings and is displayed in liters (L). Increasing either control increases tidal volume. Range: 0 to 5 L NOTE: When pressure ventilating a patient, the VT display may not accurately reflect the tidal volume delivered to the patient.

Battery in Use and % Charge I:E

V T (L)

3-8

ƒ tot

The Control Monitor displays -b- anytime the ventilator is powered by the internal battery. You can select I:E, VT or ƒ tot, but after 30 seconds the display reverts back to -b-.

SER1500 D0105

SECTION 3 When switching from A.C. power to internal battery power and every 30 minutes of battery power thereafter, the Control Monitor displays the % charge remaining in the battery, and sounds an audible Battery In Use alert for two seconds.

ƒ tot

I:E

75P V T (L)

NOTE: When the ventilator is powered by internal battery power and the Internal Battery Test button on the rear panel is pressed, the % of battery charge remaining is displayed in the Control Monitor. The ventilator must be running on battery power for a minimum of 5 minutes prior to checking the % charge. WARNING When the ▼ Battery audible alarm sounds continuously, only 10% internal battery charge remains. Find an alternate power source immediately. Charge the battery for a minimum of 5 hours before again powering the ventilator from the internal battery. This charges the battery to approximately 80% charge level. If the battery is completely depleted, it takes approximately 14 to 16 hours to fully recharge.

P aw Button & Display Range: 0 to 99 cmH2O (0 to 97 mbar) 70

80

90 100

60 50

110 120

40 30

Paw

20

(cmH20)

10

0

-10

peak mean base

NOTE: Automatic selection of monitored values occurs with certain control changes or specific conditions. Certain conditions do not allow display of some values. When the display shows “- - ”, the measured value is out of the monitor’s range.

peak Paw (cmH20)

peak mean base

In A/CMV and SIMV mode, peak pressure is updated at the end of each mandatory breath or manual inflation. In either SPONT mode, peak pressure is not displayed unless APNEA A/CMV is activated or a Manual Inflation is delivered.

mean Paw (cmH20)

peak mean base

In all modes, mean pressure is averaged over the last 30 seconds. It is updated every 3.75 seconds.

base Paw (cmH20)

peak mean base

SER1500 D0105

In all modes, base (PEEP/CPAP) pressure displays the airway pressure at end exhalation of the previous breath. It is updated every 10 seconds or at the beginning of inspiration, whichever occurs first.

3-9

DESCRIPTION OF CONTROLS, BUTTONS & INDICATORS Auto-Set Alarm (AS

)

_ Range: ▲Paw Alarm 5 to 115 cmH2O / 5 to 113 mbar ▼Paw Alarm 15 to 120 cmH2O / 15 to 118 mbar

AS

The Auto-Set (AS ) alarm button activates a function that automatically _ selects ▲Paw and ▼Paw alarm settings. The settings are based on the current peak airway pressure for mandatory breaths at the time the button is pressed. Any time a change is made to a primary ventilator control, the AS button must be pressed again in order to select new _ ▲Paw/▼Paw alarm settings. Primary controls include Mode, Inspiratory Time (tI), Flow (V· ), Frequency (ƒ) and PEEP/CPAP. The AS function can move the ▼Paw alarm setting anywhere within its _ specified range. The ▲Paw alarm setting will increase a maximum of 10 cmH2O from its prior setting with each activation of the AS button. If the ▲Paw alarm is still being violated after the 10 cmH2O increase, the AS function turns off (unlit). This alerts you to the fact that the changes made to the ventilator controls or changes in the patient condition have resulted in a significant increase in peak pressure. Press the AS button again to reactivate the AS function. WARNING Make certain the patient is being ventilated at an appropriate peak airway pressure before pressing the AS alarm button.

▼ ▲ Paw Alarm Push to set only ▲ Paw

AS

NOTE: For a detailed description of the Auto-Set alarm function, see Auto-Set Alarms in Section 4, Theory of Operation, Page 4-10. _ AS alarm indicator lit green: ▲Paw and ▼Paw alarm levels have been selected by the AS function. AS alarm indicator unlit: Alarms set manually by the ▼ ▲ Paw Alarm control knob, a primary control has been changed since pressing AS or a 10 cmH2O increase occurs during the initiation of AS function while the ▲Paw alarm is still being violated. NOTE: Alarms may be manually selected at any time by rotating the Paw Alarm control. This turns off the AS alarm indicator. NOTE: During AS alarm selection, the pressure alarm bars on the pressure gauge blink.

Advanced Trigger Control (ATC

)

The ATC button activates a function that keeps the P trig setting as sensitive as possible within a specified range, with the goal of preventing artifact triggering. The most sensitive trigger level adjustment that the ATC targets is determined by the ATC Target Trigger Look-up Table, (see Section 4, Theory of Operation, Figure 4-1). The least sensitive position is 2 cmH2O/mbar less than the assessed baseline pressure. The P trig setting is displayed on the pressure gauge as a blinking bar.

3-10

SER1500 D0105

SECTION 3 NOTE: For a detailed description of ATC, see Advanced Trigger Control in Section 4, Theory of Operation, Page 4-9. NOTE: When ATC is first activated, self triggering of the ventilator may occur for a number of breaths until the ideal trigger setting is determined. Ptrig

ATC indicator lit green: P trig level managed by the ATC function. P trig follows baseline changes automatically and ATC re-evaluates the current P trig setting every 30 minutes if self triggering does not occur.

Spont

ATC

ATC

indicator unlit: P trig level set manually by P trig control.

NOTE: Always re-activate the ATC function to readjust trigger setting when SPONT V˙1 or V˙2 is changed, since a shift of the baseline pressure may occur.

Apnea Apnea

and Apnea Alarm The Apnea selector determines the time interval before an apnea alarm violation occurs if no time or patient triggers occur. The selections are 30 seconds, 15 seconds, and Ø (disabled). A detected patient effort (trigger) is indicated by a lit Spont detect indicator. To select Ø (disabled Apnea alarm), press Apnea button until a beep is heard (approximately 1 second).

(s) 15 30 0

Spont

Ø selection is available if:

A/CMV or SIMV: ƒ > 2 b/min SPONT: CPAP > +3 cmH2O/mbar

WARNING The Ø (disabled) position should not be selected unless another apnea monitor is in use. NOTE: The Ø selection is not available in SPONT + APNEA A/CMV. Reset

ALARMS ▲ Paw

Apnea alarm indicator blinks red: Indicates an Apnea alarm violation. An audible alarm beeps.

▼ Paw

Apnea

(s) 15 30 0

Reset

▼ Battery

Apnea

(alarm silence)

Reset

ALARMS ▲ Paw ▼ Paw

Apnea

Apnea alarm indicator latches (stays lit): After one breath (patient or time triggered) is detected (mandatory or spontaneous) in A/CMV, SIMV, or SPONT. After 4 consecutive patient triggered breaths are detected in SPONT + APNEA A / CMV . The audible alarm deactivates.

(s) 15 30 0

▼ Battery

Apnea

The Reset

button has three functions.

1. Silencing alarms: Press the Reset button to silence all front panel alarms for 60 seconds. When the Reset button indicator is lit, all front panel alarms are silenced. Press the button again to cancel the silence period. NOTE: The Loss of Gas alarm (pneumatic) and Fault System alarm are non-silencable.

SER1500 D0105

3-11

DESCRIPTION OF CONTROLS, BUTTONS & INDICATORS 2. Resetting latched indicators: Press the Reset button to cancel latched alarms when an alarm indicator is no longer blinking but is latched (continuously lit). 3. Resetting Power Down alarm: Press the Reset button to reset (silence) the continuous audible alarm that sounds when the power switch on the E100M is changed from (ON) to (STDBY).

FRONT PANEL INDICATORS ▼ Battery ALARMS ▲ Paw ▼ Paw ▼ Battery

Apnea

▼Battery (low battery) indicator blinks red/no audible alarm: Indicates 20% charge remaining on internal battery. ▼Battery indicator blinks red/continuous audible alarm: Indicates 10% charge remaining on internal battery. When the ventilator is switched back to A.C. power, the Low Battery indicator latches (stays lit). Press Reset to cancel latched alarm indicator. WARNING When the ▼Battery audible alarm sounds continuously, only 10% internal battery charge remains. Find an alternate power source immediately. Charge the battery for a minimum of 5 hours before again powering the ventilator from the internal battery. This charges the battery to approximately 80% charge level. If the battery is completely depleted, it takes approximately 14 to 16 hours to fully recharge.

Pressure Gauge E100M VENTILATOR

70

80

90 100

60 50

110 120

40 30 20 10

0

-10

The pressure gauge displays proximal airway pressure if PROX is activated, or PATIENT mainflow outlet pressure if PROX is not activated. _ Non-blinking segments: ▲Paw and ▼Paw alarm settings are displayed as single non-blinking segments. P base is displayed as the appropriate range of non-blinking segments. Blinking segments: The P trig indicator is the only bar displayed as a blinking segment. NOTE: If the P trig indicator is set at the same level as P base, the segment which indicates both blinks. Range: –10 to +120 cmH2O / –10 to +118 mbar

3-12

SER1500 D0105

SECTION 3 tI > tE Indicator (inverse ratio) tI

> tE

Any time the ƒ and tI settings cause an inspiratory time that is longer than expiratory time (I >E), the tI > tE indicator blinks yellow.

tI (s) 1.5

1.0 0.5 0.1

2.0 2.5 3.0

Range: 4:1 max WARNING Although the E100M allows the user to set an inverse I:E ratio of up to 4:1, ventilating a patient at a ratio of greater than 1:1.0 is unusual. Care should be taken to ensure that each patient is being ventilated at an appropriate I:E ratio.

MISC. ALARMS (NO VISUAL INDICATORS) Power Down Alarm When the power switch on the E100M is changed from (ON) to (STDBY), a continuous audible (no visual) alarm sounds, indicating the ventilator is no longer in operation. This alarm is reset (silenced) by pressing the Reset button. NOTE: The Power Down Alarm cannot be silenced with the External Alarm Silence Cable.

Fault System Alarm A Fault System Alarm occurs when the microprocessor detects a functional problem with the ventilator. When this occurs the ventilator cannot be used for patient care. DO NOT use the ventilator until the cause of alarm has been determined and corrected. Audible Alarm: continuous beep Visual Alarm: error code displayed in Control Monitor (see Section 9, Page 9-4). This alarm cannot be silenced without first selecting the position on the Power Switch.

(STDBY)

WARNING If a Fault System Alarm occurs, immediately disconnect the patient from the ventilator and provide an alternate method of ventilation for patient.

Loss of Inlet Gas Pressure Alarm The Loss of Inlet Gas Pressure Alarm is a pneumatic alarm which sounds when one or both of the supply gas (air or oxygen) pressures are outside the operating range of the ventilator. Audible Alarm: continuous reed (pneumatic) alarm Visual Alarm: none Range: ≤ 28 psig SER1500 D0105

3-13

DESCRIPTION OF CONTROLS, BUTTONS & INDICATORS

•

SPONT V1 8 L/min

0 L/min

!

•

SPONT V2 •

SPONT V2

Figure 3-2 E100M LEFT SIDE PANEL

3-14

SER1500 D0105

SECTION 3 WARNING If Loss of Inlet Gas Pressure Alarm occurs, delivered oxygen concentrations may vary and the ventilator may not be able to function properly. Corrective action should be taken in order to ensure that the patient is not injured.

LEFT SIDE CONTROLS The E100M Left Side Panel is shown in Figure 3-2, Page 3-14.

SPONT V˙ 1 •

SPONT V1 8 L/min

This control provides a fixed amount of mixed gas for patient spontaneous breathing.

0 L/min

8 L/min position: Approximately 8 L/min of mixed gas is available to the patient for spontaneous breathing. The gas is sent to the Reservoir Bag, then enters the breathing circuit through the PATIENT outlet. Ø L/min position: No gas (Ø L/min) is provided for spontaneous breathing from this control. WARNING Time-Limited Demand Flow, SPONT V˙ 1 and SPONT V˙ 2 provide the only source of mixed gas for patient spontaneous breaths.

SPONT V˙ 2 This control provides a user-adjustable amount of mixed gas for patient spontaneous breathing. It can be used in place of Time-Limited Demand Flow, or in addition to the SPONT V˙1 gas source. Range: 0 to +15 L/min calibrated 36 L/min flush WARNING Time-Limited Demand Flow, SPONT V˙ 1 and SPONT V˙ 2 provide the only source of mixed gas for patient spontaneous breaths. NOTE: When SPONT V˙ 1 and SPONT V˙ 2 are adjusted, a change in the baseline pressure may occur. Manually adjust the P trig control or (re)activate the ATC button to re-optimize the trigger setting.

SER1500 D0105

3-15

DESCRIPTION OF CONTROLS, BUTTONS & INDICATORS

NEWPORT MODEL E100M NEWPORT MEDICAL INSTRUMENTS, INC. COSTA MESA, CALIFORNIA USA MADE IN USA

INTERNAL BATTERY TEST

CAUTION: USA FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN

TYPE 'B'

SERIAL NO.

RS-232C WARNING: ALARM LOUDNESS

100/120 V ~ .14A 220/240 V ~ .07A 50/60 HZ

EXTERNAL ALARM SILENCE

!

FUSE

Condensed water in the air supply can cause malfunction of this device.

MEDICAL AIR

02 OXYGEN

REMOTE ALARM OUTPUT

100/120 V ~ .25A, F 220/240 V ~ .10A, F

Certified to the requirements of the Canadian Electrical Code. CSA has not investigated other physiological effects. DANGER-Explosion Hazard. Do not use in presence of flammable anaesthetics. Total system chassis risk current should not exceed 100uA. Certifié seion les exigences du code Canadian de l'Ajectrioité LACNOR n'apas otudiolles aulres effects physiologiques possibles, DANGER-RISQUE D'EXPLOSION, Ne pas emplyer en presence d'anésthaeiques inflamables, La courant de risque total adisaible au chassis ne noit pas depaesar 100uA.

ON LR51420 NRTL/C

0050

STDBY

Figure 3-3 E100M REAR PANEL

3-16

SER1500 D0105

SECTION 3 REAR PANEL CONTROLS/SWITCHES The E100M Rear Panel is shown in Figure 3-3, Page 3-16.

Power Switch To power the E100M on, push the rocker switch up ( ON). To power the E100M off, push the rocker switch down ( STDBY). The internal battery charges when the power switch is in either position and the ventilator is plugged into an A.C. power source.

ON

STDBY

The audible Power Down alarm is activated when the ventilator main power is switched from (ON) to (STDBY) position. Press the Reset button to cancel the audible alarm.

ALARM LOUDNESS Control Rotate the control clockwise to increase the volume of electronic audible alarms. Alarm loudness is adjustable from minimum 74 dbA to maximum 92 dbA. ALARM LOUDNESS

INTERNAL BATTERY TEST Button (% charge of battery) INTERNAL BATTERY TEST

ƒ tot

I:E

75P V T (L)

Press the Internal Battery Test button to display the internal battery’s % charge remaining in the Control Monitor window (i.e. = 75%). When the battery is fully charged, approximately 6 to 8 hours of battery operation is possible, with a minimum of 4 hours at maximum load. NOTE: The E100M must be unplugged from A.C. power and running on internal battery for a minimum of 5 minutes before testing the % charge. NOTE: If the ventilator is not being powered by the internal battery and the Internal Battery Test button is pressed, dashes (---) are displayed instead of the % charge.

REAR PANEL I/O CONNECTORS REMOTE ALARM OUTPUT REMOTE ALARM OUTPUT

The REMOTE ALARM OUTPUT connector is designed to work with most nurse call systems. It is a contact closure switch with a .25 inch (0.64 cm) phone-type connector. When an alarm violation occurs on the E100M it also triggers the remote alarm system which informs the remote location that the ventilator is alarming. The REMOTE ALARM OUTPUT does not indicate which alarm on the ventilator is being violated.

SER1500 D0105

3-17

DESCRIPTION OF CONTROLS, BUTTONS & INDICATORS Recognized alarm violations: • • • •

▼Paw ▲Paw ▲Paw/▼Paw – High Baseline Alarm ▼Paw – Low Baseline Alarm

• ▼ Battery • Apnea • Fault System Alarm (audible, plus visual error code in Control Monitor window) • Power Down Alarm (audible, no visual indicator) The REMOTE ALARM OUTPUT continues to send the ventilator alarm message to the remote station until the alarm is no longer violated. Unrecognized Alarm Violations: • Loss of Inlet Gas Pressure Alarm (pneumatic)

EXTERNAL ALARM SILENCE Input EXTERNAL ALARM SILENCE

(Requires Optional Ext. Alarm Silence Cable) When the NEWPORT External Alarm Silence Cable is connected to the EXTERNAL ALARM SILENCE input, you can silence violated alarms and reset latched alarm indicators by pressing the button on the cable instead of the Reset button on the front panel of the ventilator. Silencing alarms: Press the External Alarm Silence Cable button to cause the Reset button to light and silence all front panel alarms for 60 seconds. Press the button again during the silence period to cancel the alarm silence. Resetting latched indicators: Press the External Alarm Silence Cable button to cancel the latched alarms when an alarm indicator is no longer blinking but is latched (steadily lit). Alarms that the External Alarm Silence Cable button will not cancel: • Loss of Inlet Gas Pressure (pneumatic) • Fault System • Power Down Use only the NEWPORT External Alarm Silence Cable with this connector. It is available as an optional accessory.

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SECTION 3 RS-232C Interface RS-232C

The RS-232C interface is a 25 pin D-type connector, operating at 38,400 baud. It allows you to interface with central monitoring and computer systems. NOTE: Contact your Newport Medical representative for more information regarding the interface with specific monitoring systems. NOTE: See Theory of Operation, Page 4-15 for additional information.

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DESCRIPTION OF CONTROLS, BUTTONS & INDICATORS

!

Figure 3-4 E100M RIGHT SIDE PANEL

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SECTION 3 RIGHT SIDE LABELING The E100M Right Side Panel is shown in Figure 3-4, Page 3-20.

Reservoir Bag Connection

!

The two liter Reservoir Bag provides a reservoir of gas which is available to meet the peak flow needs of a spontaneously breathing patient. Mixed gas from the SPONT V˙ 1 switch and/or SPONT V˙ 2 flowmeter enters the Reservoir Bag prior to entering the patient circuit. The patient can draw gas from the Reservoir Bag during peak need. Adjust the spontaneous flow (SPONT V˙ 1 and SPONT V˙ 2) to meet average spontaneous flow needs of the patient rather than peak spontaneous flow needs. This helps to conserve gas supplies. Caution If the patient’s effort empties the Reservoir Bag, it is possible for the patient to pull ambient gas in through the Emergency Intake Valve. Make sure that SPONT V˙1 and SPONT V˙ 2 are adjusted so that the patient does not empty the Reservoir Bag during spontaneous breathing. NOTE: Time-Limited Demand Flow may be set to meet the patient’s peak flow needs. In this case the patient breathes from SPONT V˙1 and SPONT V˙ 2 and the reservoir bag at end exhalation only.

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4. THEORY OF OPERATION

General System Overview . . . . . . . . . . . . . . . . . 4 - 13 A/CMV (Assist/Control Mandatory Ventilation) . . . . . . . . . . . . . . . . . 4 - 13 SIMV (Synchronized Intermittent Mandatory Ventilation) . . . . . . . . . . . . . . . . . 4 - 13 SPONT + APNEA A/CMV (Spontaneous + APNEA A/CMV Ventilation) . . 4 - 23 SPONT (Spontaneous Ventilation) . . . . . . . . . . 4 - 33 Time-Limited Demand Flow . . . . . . . . . . . . . . . 4 - 43 P limit (Pressure Limited Ventilation) . . . . . . . . . 4 - 53 P trig Control . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 83 Advanced Trigger Control (ATC) . . . . . . . . . . . . 4 - 93 Auto-Set Alarm (AS) . . . . . . . . . . . . . . . . . . . . . 4 - 10 ATC Target Trigger Look-up Table. . . . . . . . . . . 4 - 13 Artifact Trigger Conditions Table . . . . . . . . . . . . 4 - 13 Auto-Set (AS) Alarm Tables . . . . . . . . . . . . . . . . 4 - 14 Low Baseline Alarm Table . . . . . . . . . . . . . . . . . 4 - 14 RS-232 Specifications . . . . . . . . . . . . 4 - 15 to 4 - 18

SER1500 D0105

SECTION 4 GENERAL SYSTEMS OVERVIEW The Newport Ventilator Model E100M is a pneumatically powered, microprocessor controlled, pressure, time or manually triggered, time cycled, flow or pressure limited ventilator, with Time-Limited Demand Flow and continuous flow for spontaneous breathing. It is capable of ventilating neonate through adult patients. An internal lead acid battery powers the ventilator for approximately 6 to 8 hours when fully charged. The electronic control system incorporates two microprocessors on the main board. The control microprocessor is responsible for all electrically activated mechanical components. The monitor processor is responsible for the electronic pressure gauge and all displays. The main component of the pneumatic system is a pneumatic interface valve activated by an electrically controlled pilot valve. These two valves are responsible for initiating gas delivery during mandatory breath and Time-Limited Demand Flow inspiration. A separate valve controls gas delivery the rest of the time. An emergency intake valve allows the patient to pull ambient air into the breathing circuit in the event of a complete loss of supply gas pressure. Opening pressure is approximately –2 cmH2O/mbar in this condition.

A/CMV (Assist/Control Mandatory Ventilation) In A/CMV, mandatory breaths are time triggered at the ƒ setting. A patient can trigger mandatory breaths in addition to, or in place of, the time triggered breaths if the effort they generate causes airway pressure to meet the Ptrig setting. Every patient effort that causes airway pressure to meet the Ptrig setting results in a mandatory breath. Tidal volume is determined by the V˙ and tI settings in volume control, and determined by V˙, tI and P limit settings in pressure limited ventilation. WARNING A leak in the breathing circuit can cause the ventilator to auto-trigger. Monitoring, including high and low minute volume alarms, should be used to detect this condition, and the clinician should frequently check the ventilator to verify baseline stability.

SIMV (Synchronized Intermittent Mandatory Ventilation) In SIMV, the patient receives a fixed number of time/patient triggered mandatory breaths and may breathe spontaneously from the ventilator’s Time-Limited Demand Flow and/or spontaneous flow. See Figure 4-1.

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4-1

THEORY OF OPERATION The first breath the patient triggers in any mandatory breath interval is the patient triggered mandatory breath. The patient has the rest of the interval to breathe spontaneously. If the patient stops triggering breaths and one complete mandatory breath interval has elapsed without a trigger, a time triggered mandatory breath is delivered. A mandatory breath lockout interval is activated whenever the patient triggers a mandaory breath. This limits the number of mandatory breaths the patient receives in 60 seconds to the ƒ (b/min) setting. TIME TRIGGERED MANDATORY BREATH

PATIENT TRIGGERED MANDATORY BREATH

PRESSURE

SPONTANEOUS BREATH

A

B

C

C

100%

A

MANDATORY BREATH INTERVAL

MANDATORY BREATH INTERVAL

A: B: C: ---:

A

MANDATORY BREATH LOCKOUT INTERVAL

Time Triggered Mandatory Breath Patient Triggered Mandatory Breath Spontaneous Breath "Scheduled" Mandatory Breath not delivered because of the patient triggered mandatory breath in the last interval

Figure 4-1 100% SIMV WINDOW

WARNING The SPONT V˙1 switch and/or SPONT V˙ 2 flowmeter must be turned “on” in SIMV and SPONT modes to provide gas for patient spontaneous breathing even if Time-Limited Demand Flow is enabled.

SPONT + APNEA A/CMV (SPONTANEOUS + APNEA A/CMV VENTILATION) If the Apnea alarm is not violated in SPONT + APNEA A/CMV, this mode performs the same as SPONT mode. Please review SPONT in this section. If no patient triggers occur during the apnea alarm delay interval selected, back-up breaths are delivered according to the A/CMV settings (V˙, ƒ, tI, Plimit). The Apnea alarm indicator blinks and the audible alarm activates. If four consecutive patient triggered breaths are detected, the Apnea alarm indicator latches, the audible alarm is silenced, and back-up breaths cease. Press Reset to cancel the latched indicator.

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SECTION 4 WARNING Before switching to the SPONT + APNEA A/CMV mode, always make sure the Plimit, ƒ, tI, and V˙ controls are set appropriately for the patient. WARNING The SPONT V˙1 switch and/or SPONT V˙2 flowmeter must be turned “on” in SIMV and SPONT modes to provide gas for patient spontaneous breathing even if Time-Limited Demand Flow is enabled.

SPONT (SPONTANEOUS VENTILATION) In SPONT, the patient may trigger Time-Limited Demand Flow and/or may breathe exclusively from the spontaneous flow through the breathing circuit and reservoir bag at the selected FIO2. The patient has control over each breath. CPAP may be added using the PEEP/CPAP control. Adjust the P trig control or enable ATC so that the E100M can detect the patient’s spontaneous efforts. If detected, the Spont indicator blinks yellow, and the apnea alarm delay interval is reset. WARNING The SPONT V˙1 switch and/or SPONT V˙2 flowmeter must be turned “on” in SIMV and SPONT modes to provide gas for patient spontaneous breathing even if Time-Limited Demand Flow is enabled. DuoFlow The DuoFlow system allows the user to control mandatory and spontaneous flow separately. The V˙ control determines the flow for mandatory breaths, manual inflations, and Time-Limited Demand Flow. The SPONT V˙1 (toggle switch) and V˙2 (flowmeter) determine the flow available for spontaneous breathing either exclusively or after the TimeLimited Demand Flow duration elapses. The reservoir bag provides additional gas in the event that patient spontaneous flow exceeds the SPONT V˙1 and V˙2 setting. The patient breathes from mandatory flow during mandatory and TimeLimited Demand Flow breaths, and from SPONT V˙1 and V˙2 flow during spontaneous breathing. When mandatory flow is delivered to the patient, SPONT V˙1 and V˙2 are switched off (electronically), and vice-versa. See Figure 4-2.

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THEORY OF OPERATION

Flow

Time

Mand. Breath

Mandatory Flow

Spont Breathing

Mand. Breath

Spont Breathing

Mand. Breath

Spontaneous Flow

Figure 4-2 DuoFlow SYSTEM

TIME-LIMITED DEMAND FLOW Time-Limited Demand Flow provides flow support for a patient's peak spontaneous breathing flow needs. The Time-Limited Demand Flow control determines the duration of time that the mandatory flow rate will be delivered at the onset of a patient triggered spontaneous breath. When the Time-Limited Demand Flow time elapses, the spontaneous flow (determined by the SPONT V˙1 and V˙2 settings) is delivered for the remainder of the exhalation period. Time-Limited Demand Flow can provide a higher level (V˙ setting) of flow to the patient at the onset of a patient triggered spontaneous breath, after which the patient completes inspiration from the SPONT V˙1 and V˙2 flow. Providing the patient with a higher level of flow during the time they have the highest demand can decrease imposed work of breathing. Use of Time-Limited Demand Flow can allow the caregiver to set a lower level of SPONT V˙1 and V˙2 since the spontaneous flow no longer needs to meet the patient’s spontaneous peak flow needs. Setting a lower level of SPONT V˙1 and V˙2 helps to decrease expiratory resistance for patient exhalation and decrease gas consumption. The V˙, Time-Limited Demand Flow, and SPONT V˙1 and V˙2 controls should be adjusted to maximize the patient's comfort during spontaneous breathing. The Time-Limited Demand Flow control is adjustable from Ø-1.0 second and functions in SIMV, SPONT + APNEA A/CMV, and SPONT modes. The Time-Limited Demand Flow indicator lights any time the Time-Limited Demand Flow control is set above “Ø,” except when the mode is set to A/CMV. The exhalation valve remains at the PEEP/CPAP setting level during the Time-Limited Demand Flow portion of a spontaneous breath.

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SECTION 4 Figure 4-3 provides an example of what occurs in SIMV when TimeLimited Demand Flow is activated. The V˙ control determines the flow delivered during mandatory breaths and Time-Limited Demand Flow portion of spontaneous breaths. The tI control determines the inspiratory time that mandatory flow is delivered for mandatory breaths. Time-Limited Demand Flow control determines the time that mandatory flow will be delivered prior to switching back to the spont flow at the onset of each spontaneous breath. In between the mandatory breaths and Time-Limited Demand Flow, spontaneous flow is delivered according to the SPONT V˙1 and V˙2 setting. .

P R E S S U R E

Breath A = Mandatory Breath (exhalation valve closed)

. V (Mandatory Flow)

Breath B = Time-Limited Demand Flow (exhalation valve open)

A

F L O W

.

SPONT V1 + V2

B

B

A TIME

A

B

B

A TIME

Open

Closed

Open

Closed

Open

Exhalation Valve

Figure 4-3 DuoFlow Plus System SIMV with Time-Limited Demand Flow

At the onset of each spontaneous breath, flow enters the patient breathing circuit at the mandatory flow setting. When the Time-Limited Demand Flow setting time elapses, the flow entering the circuit switches to the SPONT V˙1 and V˙2 level.

P limit (Pressure Limited Ventilation) Range: 0 to 120 cmH2O / 0 to 118 mbar Pressure Limited Ventilation has been used for neonatal / pediatric ventilation for many years. In recent years it has gained popularity for adult patients. The proposed benefit of Pressure Limited Ventilation in adults with obstructive disease is that gas distribution may be enhanced while ventilating at lower airway pressures. The Plimit control determines the maximum pressure in the patient circuit during a spontaneous, mandatory, or manual breath. Clockwise rotation of the knob increases the maximum pressure (pop-off) setting, and counter-clockwise rotation decreases the maximum pressure. The Plimit control works in all modes and can be adjusted from 0 to 120 cmH2O / 0 to118 mbar. SER1500 D0105

4-5

THEORY OF OPERATION Pressure Limited Ventilation differs from Volume Control Ventilation in that each breath is pressure limited, and volume variable. A mandatory breath becomes pressure limited when airway pressure is equal to the Plimit control setting. When this occurs, the Plimit control vents flow as needed to prevent pressure from rising above the pressure limit selected by the caregiver. With adequate flow, airway pressure rises to the Plimit then flattens or plateaus for the remainder of the set inspiratory time (tI). The volume delivered during a pressure limited breath varies, depending on the V˙ setting, the duration of the inspiratory time and the patient’s time constant. As demonstrated in Figure 4-4, physiologic changes such as a change in the patient's resistance or compliance, or changes within the gas delivery system such as leaks or obstructed filters, can all affect the duration of the pressure plateau and consequently the tidal volume delivered to the patient. NOTE: Exhaled volume monitoring can be very useful and is recommended when using pressure limited ventilation.

Flow resistance and compliance affect how fast airway pressure rises.

Flow delivered from the ventilator does not necessarily enter the patient airway. This Flow escapes from the P limit valve after the P limit level is achieved at the airway. VENTED FLOW DOES NOT contribute to the delivered tidal volume. P limit

Airway Pressure cmH2O

Delivered volume will vary as patient effort, compliance and resistance varies.

tI (Inspiratory Time) This Flow enters the airway and results in the VT (tidal volume) that is delivered.

This whole box represents Flow leaving the ventilator.

Flow

This striped area represents the Flow that vents from the P limit valve without entering the airway. tI (Inspiratory Time)

Figure 4-4 Pressure Limited Ventilation Open Circuit

Changing the V˙ (mandatory flow) or tI (inspiratory time) setting affects the duration of the airway opening pressure plateau for mandatory breaths. The V˙ determines the inspiratory pressure slope/rise for mandatory breaths.

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SECTION 4 Figure 4-5 shows an example of how the V˙ setting affects the inspiratory pressure slope/rise and pressure plateau. The V˙ setting for breath #1 is 45 L/min and for breath #2 is 30 L/min. The tI and Plimit settings are the same for both breaths. Breath #1 has a much faster pressure rise due to the higher flow (50 L/min). As a result, the pressure plateau level (Plimit setting) for breath #1 is reached rapidly, causing flow entering the airway to begin to decrease quickly. With breath #2, flow entering the airway does not begin to decrease until approximately 75% of the elapsed inspiratory time. 1

L/s

#1 . V = 50 L/min

#2 . V = 25 L/min

. V

1

60

P a w

cm H 2O -20

Figure 4-5 MANDATORY FLOW V˙ SETTING

NOTE: Always verify the Plimit setting after a change is made to the V˙ or tI controls. NOTE: The Plimit control is factory preset at its minimum setting (fully counter-clockwise). _ NOTE: The purpose of setting the ▲Paw alarm when pressure ventilating a patient is to have a secondary safety back-up in the event of a Plimit valve failure. WARNING When volume ventilating a patient, make certain the Plimit control is set higher than the pressure required to deliver the set VT, since volume will be vented to the atmosphere when the Plimit is reached. WARNING Make certain that appropriate monitoring is in place when ventilating a patient with pressure targeted ventilation. An occlusion of the patient circuit or ET tube may not result in a ▲Paw (high pressure) alarm violation.

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THEORY OF OPERATION Ptrig CONTROL Range: –10 to ≥ 25 cmH20 The Ptrig control knob adjusts the patient trigger sensitivity setting on the E100M. The trigger sensitivity setting determines the amount of negative pressure (inspiratory effort) the patient must generate in the breathing circuit in order for the E100M to detect the effort (trigger). On “power up” of the ventilator, the trigger is set at –5 cmH2O/mbar. When you rotate the knob, you will feel it click slightly. Each click represents a trigger sensitivity level change of ~0.14 cmH2O/mbar. Rotating it through seven clicks changes the trigger sensitivity by one cmH2O/mbar, i.e., one pressure gauge segment. (The selected segment blinks on the electronic pressure gauge.) Rotate the Ptrig control counter-clockwise to increase the patient effort required to trigger and clockwise to decrease the effort required. The Spont indicator blinks when the E100M detects a trigger. The Apnea time delay interval is reset at the same time. Adjusting the Ptrig control: Adjust the Ptrig control until you reach a setting at which it is easy for the patient to trigger the ventilator but not likely that the ventilator will trigger from non-patient generated circuit pressure fluctuations. From this point, non-patient generated triggers will be refered to as "artifact triggers". When you adjust the PEEP/CPAP control the trigger level automatically moves in conjunction with the change in baseline pressure. If baseline pressure changes as a result of adjusting you need to re-adjust the trigger sensitivity manually. If Time-Limited Demand Flow is enabled for spontaneous breathing, a spontaneous breath trigger is followed by a trigger lock-out period until baseline pressure stabilizes or until 1.5 seconds elapse, whichever is shorter. This lock-out helps to prevent multiple augmented flow triggering during a single spontaneous patient effort. If it appears that the E100M is not detecting patient efforts (Spont indicator not "blinking") with the trigger level set to within one or two cmH2O/mbar of baseline, you may want to reassess the SPONT V˙1 and V˙2 settings.

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SECTION 4 ADVANCED TRIGGER CONTROL (ATC

)

The Advanced Trigger Control (ATC ) button activates a function that automatically manages the Ptrig setting in any mode. The ATC function manages the trigger sensitivity setting within an allowable range (between the target trigger as defined in the ATC Target Trigger Look Up Table and 2 cmH2O/mbar below baseline pressure) with the goal of making it easy for the patient to trigger the ventilator while keeping the ventilator from artifact triggering. (See description of artifact triggering in the Ptrig Control section and definitions/conditions in the table on Page 4-13.) There are two fundamental aspects of automatic trigger management, (1) optimization, which includes baseline assessment and attempting to set trigger at an optimized value, and (2) basic trigger adjustment up or down. (1) Optimization of the trigger level and reassessment of baseline pressure occurs: •

when the ATC function is activated by pushing the button;

•

when 30 minutes of operation has elapsed since the last assessment;

•

each time the PEEP/CPAP control is adjusted.

How the ATC trigger setting is determined during assessment and optimization: The microprocessor assesses baseline pressure and then selects a target setting for the trigger level according to the ATC Target Trigger Look Up Table. If the E100M does not artifact trigger at the target trigger setting, as determined by the definitions listed in the Artifact Trigger Conditions on page 4-13, the trigger setting remains at the target value. If an artifact trigger condition is identified, ATC backs off on the trigger setting (becomes less sensitive) by 0.14 cmH2O/mbar until the artifact trigger condition is eliminated or until the trigger is 2 cmH2O/mbar below the assessed baseline. (2) In between optimization events, ATC provides basic adjustment of the trigger setting, either up or down. Trigger is never adjusted closer to baseline than the target trigger level defined in the ATC Target Trigger Look Up Table and it is never adjusted to a position further than 2 cmH2O/mbar below the most recently assessed baseline.

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THEORY OF OPERATION If no patient efforts have been detected in the last 15 seconds in A/CMV or SIMV mode (SPONT indicator not “blinking”), the trigger level will move 0.28 cmH2O/mbar closer to the baseline. If the patient effort still goes undetected for another 15 seconds, the trigger will again move 0.28 cmH2O/mbar closer to the baseline. This will continue until a patient breath is detected or until the trigger reaches the target trigger defined in the ATC look-up table. For both SPONT modes, the time criteria is 32 seconds rather than 15 seconds. Each time an artifact trigger condition is identified in any mode, ATC will move the trigger level down (more negative) by 0.14 cmH2O/mbar but it will never move the trigger more than 2 cmH2O/mbar below baseline. NOTE: For information on manually adjusting the trigger level, see previous section, Ptrig Control. NOTE: When ATC is first activated, self-triggering of the ventilator may occur until the “ideal” trigger setting is determined. NOTE: When SPONT V˙1 or V˙2 is changed, a shift of the P base may occur. Press the ATC button to deactivate and press it again to reactivate the ATC function so that trigger is immediately adjusted to the new P base.

AUTO-SET ALARM (AS

)

_ Range: ▲Paw Alarm 15 to 120 cmH2O /15 to 118 mbar ▼Paw Alarm 5 to 115 cmH2O / 5 to 113 mbar The Auto-Set (AS ) alarm button activates a function that automatically _ selects ▲Paw (high pressure) and ▼Paw (low pressure) alarm settings. The settings are selected according to the current peak airway pressure for mandatory breaths at the time the button is pressed. _ The AS button must be pressed again in order to select new ▲Paw and ▼Paw alarm settings after any change is made to a primary ventilator control. Primary controls include Mode, Inspiratory Time (tI), Flow (V· ), Frequency (ƒ) and PEEP/CPAP. _ The ▲Paw alarm setting will increase a maximum of 10 cmH2O from its prior setting with each _activation of the AS button. With the exception of an increase to the ▲Paw alarm setting, the AS function can move the _ ▼Paw and ▲Paw alarm settings anywhere within their specified ranges. If the ▲Paw alarm continues to be violated after the 10 cmH2O increase, the AS function turns off. This helps alert the user to the fact that the changes made to the ventilator or changes in the patient condition have resulted in a significant increase in peak pressure. Press the AS button again to reactivate the AS function after verifying that all primary controls are set at a safe level. Primary controls include Mode, Inspiratory Time (tI), Flow (V· ), Frequency (ƒ) and PEEP/CPAP.

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SECTION 4 NOTE: The peak airway pressure for the AS function is determined by averaging the peak pressure for two consecutive mandatory breaths without a ▲Paw alarm violation.

▼ ▲ Paw Alarm Push to set only ▲ Paw

NOTE: The minimum alarm setting for ▼Paw is 5 cmH2O above baseline. ▲Paw must be 2 cmH2O above ▼Paw. If the minimum criteria is not met, the alarm bars remain at the current settings and the AS function and indicator turns off. _ AS alarm indicator lit green: ▲Paw and ▼Paw alarm levels selected by the AS function.

AS

▼ ▲ Paw Alarm Push to set only ▲ Paw

AS

AS alarm indicator unlit: Alarms set manually with the Paw Alarm control knob or a primary control has been changed since pressing AS button. Press the AS button once to cause the high and low pressure alarm settings to be evaluated and adjusted for the current peak airway pressure. Activating the AS alarm function after power up: After the MODE, ƒ, V˙, tI, PEEP/CPAP and P limit controls are adjusted to the appropriate settings and the patient is connected to the ventilator, press the AS alarm button to set the alarms. The indicator on the AS button will light indicating AS is on, and the ▲Paw and ▼P_ aw alarm bars on the pressure gauge will blink until the selection of ▲Paw and ▼Paw settings are establised. WARNING Make certain the patient is being ventilated at an appropriate peak airway pressure before pressing the AS alarm button. If a ▲Paw violation occurs during the AS alarm selection process: _ After the AS function is selected, the ▲Paw alarm setting can increase up to 10 cmH2O above the existing setting. If peak pressure reaches 10 cmH2O above the alarm's previous setting (i.e. 40 cmH2O/mbar), the breath is pressure cycled to exhalation, the ▲Paw alarm indicator blinks, the audible alarm activates, and the AS indicator turns off. Each time the AS button is pressed (re-activating the AS function), the _ ▲Paw alarm bar can increase an additional 10 cmH2O/mbar. If a ▲Paw alarm violation occurs during the AS alarm setting, the AS indicator turns off. You may continue this sequence until the breaths are no longer pressure cycling (max. 120 cmH2O/mbar).

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THEORY OF OPERATION During the AS alarm selection process, the ▼Paw setting alarm increases from the default setting of 10 cmH2O/mbar, to a setting that is appropriate according to the published table. If a low rate is set in A/CMV or SIMV during the alarm selection process: If the AS function does not detect a mandatory breath within 30 seconds after the AS button is pressed, a preliminary peak pressure reading on the first mandatory breath is taken, and the pressure alarms are temporarily set according to the preliminary peak pressure reading. The pressure alarm bars continue to blink as the normal process of selecting the alarm settings continues. If a ▼Paw violation occurs during the AS alarm selection process: If peak pressure is less than the ▼Paw alarm setting during the first mandatory breath after activating the AS function, the ▼Paw alarm is violated and an audible and visual alarm is activated. If baseline pressure is above the ▼Paw alarm setting when the AS alarm function is activated, the ▼Paw alarm setting is moved to 5 cmH2O/mbar above the baseline pressure. The alarm bar continues to blink until the alarm selection process is completed.

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SECTION 4

Table 4-1: ATC Target Trigger Look-Up Table •

•

•

A/C & SIMV Modes

V Control ≤ 10 L/min

V Control >10-30 L/min

V Control > 30 L/min

tI Control 0.1-0.54 sec

Neonate (–0.14 cmH2O)

Neonate (–0.14 cmH2O)

Ped (–0.27 cmH2O)

tI Control 0.55-1.04

Neonate (–0.14 cmH2O)

Pediatric (–0.27 cmH2O)

Adult (–0.54 cmH2O)

tI Control 1.05-3.0 sec

Neonate (–0.14 cmH2O)

Pediatric (–0.27 cmH2O)

Adult (–0.54 cmH2O)

Table 4-2: Artifact Trigger Conditions Table Artifact triggering is defined as: 1. The time between trigger events is < the following time criteria for 3 consecutive triggers. • Neonate:

0.3 seconds (200 b/min)

• Pediatric:

0.4 seconds (150 b/min)

• Adult:

0.8 seconds (75 b/min)

2. For three consecutive breaths, the time duration of patient inhalation versus the time duration of patient exhalation calculates out to an I:E ratio which exceeds the following limits: • Neonate:

I:E > 5:1

• Pediatric:

I:E > 4:1

• Adult:

I:E > 3:1

3. If the sensitivity trigger level setting is above current baseline and current baseline is within 2 cmH2O/mbar of the baseline that was assessed during the last trigger optimization process. 4. For Pediatric and Adult categories only, baseline pressure isn’t stable (no flat spot) between triggers. 5. If the rate of pressure drop in the patient circuit that causes the E100M to trigger is less than 0.28 cmH2O/mbar per 100 ms.

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THEORY OF OPERATION Table 4-3: AS Alarm Look-up Table Default Settings (A/CMV or SIMV) Peak Pressure

120 110 100 90 80 70 60 50 40 30 25 20 10 9 8 7 6 5

▼Paw Alarm (Adult)

_ ▲Paw Alarm (Adult)

▼Paw Alarm (Neo/Ped)

_ ▲PawAlarm (Neo/Ped)

A/CMV & SIMV

A/CMV & SIMV

A/CMV & SIMV

A/CMV & SIMV

105 95 85 75 65 55 45 35 30 20 20 15 5 5 5 5 5 AS off

120 120 115 105 95 85 75 65 55 45 40 35 25 25 25 25 25 AS off

115 105 95 85 75 65 55 45 35 25 20 15 7 6 5 5 5 AS off

120 115 105 95 85 75 65 55 45 35 30 25 15 15 15 15 15 AS off

Table 4-4: Low Baseline Alarm Table PEEP/CPAP Level 4-5 cmH2O/mbar 6-11 cmH2O/mbar ≥ 12 cmH2O/mbar

4-14

Alarm Default 3 cmH2O/mbar below baseline pressure 4 cmH2O/mbar below baseline pressure 5 cmH2O/mbar below baseline pressure

SER1500 D0105

SECTION 4 RS-232C SPECIFICATIONS Scope This section defines both the hardware and software protocol for the RS-232 port on the Newport E100M Ventilator.

Hardware Protocol Hardware specifications: Connector: Protocol: Encoding: Baud rate: Mode: Format: Data bits: Stop bits: Start bits: Parity:

Female 25 pin connector (DB25S) ASYNC ASCII 38.4 K Full duplex 8 1 1 None

Pin Assignment Pin Number 2 3 7

Assignment Transmitted Data Received Data Ground

Software Protocol The E100M Ventilator has the ability to interface with external devices by transmitting and receiving messages in variable length data packets. All packets are preceded by an SYN character, and ended by a checksum. The purpose of the SYN character is to enable the receiver to detect the start of a message. Following the SYN character is the identification character. The identification character consists of a message ID and a message length. Checksum is the one’s complement of the sum of all data bytes contained in the package, excluding the SYN character. Format: [SYN][ID][Data #1] ........................[Data #n][Checksum] SYN: ID: Checksum:

SER1500 D0105

16H Bit 5-7: identification Bit 0-4: n number of data bytes in the packets One’s complement of [ID + Data #1 +......+ Data #n]

4-15

THEORY OF OPERATION Every 10 ms, the E100M outputs the real time packet. If a request is made by an external device for a control or monitor data packet, the E100M will transmit the requested packet after the real time packet. An external device can request a packet from the E100M by sending a message that follows the above format: the identification of the data packet it is requesting, and no data bytes (i.e. bit 0-4 of ID are 0).

Message Transmitted by the E100M Real time data

4-16

Format: ID:

[SYN][ID][Data #1].....[Data #3][Checksum] 23h Identification: Bit 5-7: 001 = 1 Length: Bit 0-4: 00011 = 3 data bytes

Data# Bit

Parameter

Range –10...120 cmH2O

0...950

0 1 0 1 0

0...1

#1 #2 #3

0-7 0-7 0

Airway Pressure MSB Airway Pressure LSB ▲Paw

#3

1

▼Paw

#3

2

#3

3

#3

4

#3

5-7

Apnea 1 = Active Inverse I:E Ratio Display 0 1 Mechanical Inspiration 0 1 Reserved

= = = = =

Not Active Active Not Active Active Not Active

= = = =

Not Active Active Not Active Active

Binary Range#

0...1 0...1 0...1

SER1500 D0105

SECTION 4 Control data Format: ID:

[SYN][ID][Data #1].....[Data #8][Checksum] 48h Identification: Bit 5-7: 010 = 2 Length: Bit 0-4: 01000 = 8 data bytes

Data #1 Bit Bit Bit Bit Bit Bit Bit Bit

0 1 2 3 4 5 6 7

General Status ....................0 = Not Active, 1 = Active – Spontaneous Mode – SIMV Mode – Spontaneous + Apnea A/CMV Mode – Apnea On – Apnea 15 secs – tI >tE – Reserved – Reserved

0 1 2 3 4 5 6 7

Switch Status ......................0 = Not Active, 1 = Active – Proximal – Nebulizer – Silence – Manual Inflation – Advanced Trigger Control – Auto Set Alarm – Reserved – Reserved

Data #2 Bit Bit Bit Bit Bit Bit Bit Bit

SER1500 D0105

Data#

Bit

#3 #4 #5 #6 #7 #8

0-7 0-7 0-7 0-7 0-7 0-7

Parameter Flow Inspiratory Time Frequency Time-Limited Demand Flow Set Tidal Volume MSB Set Tidal Volume LSB

Range 0...100 L/min 0...3 secs 0...120 b/min 0...1 sec 0...5.40 L

Binary Range# 0...100 0...30 0...120 0...10 0...540

4-17

THEORY OF OPERATION Monitor data Format: ID:

4-18

[SYN][ID][Data #1].....[Data #7][Checksum] 67h Identification: Bit 5-7: 011 = 3 Length: Bit 0-4: 00111 = 7 data bytes

Data#

Bit

Parameter

Range

Binary Range#

#1 #2 #3 #4

0-7 0-7 0-7 0-7

I:E Ratio MSB I:E Ratio LSB Total Rate Peak Pressure

1...100

10...1000

0...255 b/min 0...120 cmH2O/mbar

#5 #6 #7

0-7 0-7 0-7

Mean Pressure Base Pressure Battery Power

0...120 cmH2O/mbar 0...120 cmH2O/mbar 0...100%

0...255 0...120 and 255 = out of range 0...120 0...120 0...100

SER1500 D0105

5. OPERATIONAL VERIFICATION PROCEDURE (OVP)

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 1 Set-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 1 Standard Test Settings. . . . . . . . . . . . . . . . . . . . . . . . 5 - 2 Pressure Gauge Verification. . . . . . . . . . . . . . . . . . . . 5 - 3 Alarm/LED Check. . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 3 Mixer Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 4 FIO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 4 ƒ (respiratory frequency) . . . . . . . . . . . . . . . . . . . . . . 5 - 4 tI (inspiratory time) . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 4 SPONT V˙ 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 5 SPONT V˙ 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 5 V˙ (flow) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 6 PEEP/CPAP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 6 Low Baseline Alarm, Reset and Alarm Loudness. . . 5 - 6 ▼P aw Alarm (low pressure) . . . . . . . . . . . . . . . . . . . . 5 - 7 ▲P aw Alarm (high pressure) . . . . . . . . . . . . . . . . . . . 5 - 7 P trig (pressure trigger level) and MODE Select . . . . 5 - 8 Apnea Alarm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 8 Manual Inflation Button . . . . . . . . . . . . . . . . . . . . . . . 5 - 8 NEB (nebulizer). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 9 Internal Battery Back-Up . . . . . . . . . . . . . . . . . . . . . 5 - 10 Control Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 10 P aw Monitor (peak, mean, base) . . . . . . . . . . . . . . 5 - 10 Proximal Line Purge . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 11 Advanced Trigger Control (ATC) . . . . . . . . . . . . . . . 5 - 11 Auto-Set Alarms (AS) . . . . . . . . . . . . . . . . . . . . . . . 5 - 11 Time-Limited Demand Flow . . . . . . . . . . . . . . . . . . 5 - 12 E100M Test Record . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 13

SER1500 D0105

SECTION 5 INTRODUCTION This procedure is intended to assist a qualified hospital technician or NEWPORT factory authorized service technician establish a routine verification program to ensure proper operation of the Newport E100M Ventilator. An Operational Verification Procedure (OVP) must be performed each time the E100M is serviced or a minimum of once a year with the Preventive Maintenance. WARNING Do not use the E100M unless it passes the OVP. Test Equipment Required: • • • •

RT-200 Calibration Analyzer, or equivalent TSK1500A, E100M Test Kit (NMI) Oxygen Analyzer Adjustable 0-60 psig medical grade air and oxygen supplies, set to 50 psig

Caution The accuracy of any test equipment (electronic or pneumatic) should be annually certified by a testing laboratory before use. NOTE: The Calibration Analyzer, RT-200, manufactured by Allied Health Care Products (Timeter Instrument Corporation) has been used for flow, inspiratory time, tidal volume, I:E ratio and pressure measurements. Any equivalent measuring instrument may be used.

SET-UP 1. Connect a reusable adult breathing circuit with proximal line and a test lung to the Newport E100M to be tested. See Figure 5-1. 2. Connect 50 psig air and 50 psig oxygen supplies to the ventilator gas inlets. 3. Connect the power cord to an appropriate hospital grade electrical outlet. 4. Set controls to STANDARD TEST SETTINGS. 5. Install the Reservoir Bag Cap (CAP100A) on the Reservoir Bag Connection . 6. Make a copy of the Test Record at the end of this section and check off each test as it is performed. NOTE: Audible alarms will activate periodically while performing some tests. You may silence the alarm by pushing the Reset button. NOTE: When zeroing the RT-200, be sure to disconnect any inputs to the analyzer. Verify the RT-200 is reading zero before reinstalling any hoses. NOTE: When turning power back on to E100M or when changing from SPONT or SPONT + APNEA A/CMV modes back to SIMV or A/CMV, you _ may need to reset your ▼Paw and ▲Paw alarm settings. SER1500 D0105

5-1

OPERATIONAL VERIFICATION PROCEDURE (OVP)

ALARMS

Reset

E100 M

V ENTILATOR

Paw P aw (s) 15 30 0/

Apnea

Battery Apnea

MODE

Paw

SPONT

(cmH 2O)

peak mean base

SPONT +APNEA A/CMV SIMV A/CMV

P trig

Paw Alarm

Push to set only

I:E

P aw

AS

VT

V 30 20

20

40

80 100

1

30

tI

40

tE

tI

(s)

(b/min)

1.5

1.0

50

30 2.0

20

40 60

5 60

MIN

120

70 MAX

Calibration Analyzer

ATC

(L)

(L/min)

10

60 10

Spont

tot

2.5

0.5

80

10

100 0.1

1

3.0

120

80 100 90 Manual Inflation

Time-Limited Demand Flow (s) 0.5 0.7 0.3

PEEP/CPAP

Pbase

Plimit

0.1 0/

1.0

NEB

PROX

Figure 5-1

STANDARD TEST SETTINGS A.C. power ........................................... (on) FIO2 ....................................................0.60 MODE ..................................................SPONT V˙ (mandatory flow)................................40 L/min tI (inspiratory time) ..............................1.0 sec ƒ (respiratory frequency) ......................10 b/min ATC ................................................off P trig (trigger level) ..............................–5 cmH2O/mbar AS Alarm ........................................off Plimit (pressure relief valve) ................80 cmH2O/mbar ▼Paw (low pressure alarm)..................N/A ▲Paw (high pressure alarm) ................75 cmH2O/mbar PEEP/CPAP (P base) ............................minimum NEB ......................................................off PROX ....................................................off Apnea ............................................30 sec SPONT V˙2 ............................................minimum SPONT V˙1 ................................................Ø NOTE: To set Plimit, press and hold the Manual Inflation button. Turn Plimit knob clockwise to increase pressure and counter-clockwise to decrease pressure.

5-2

SER1500 D0105

SECTION 5 PRESSURE GAUGE VERIFICATION 1. Remove test lung from circuit and reservoir bag cap from reservoir outlet and verify pressure gauge is at zero. 2. Re-attach test lung and reservoir bag cap. 3. Set Plimit to achieve 10 cmH2O/mbar on the pressure gauge. 4. Set RT-200 to Function 12 cmH2O/mbar, press Enter and press Zero. 5. Tee small hose from patient outlet to the RT-200 low pressure inlet. See Figure 5-2. 6. Set t I to 2 sec, set MODE to SIMV and verify the pressure on the pressure gauge is at 10 cmH2O. 7. Verify RT-200 reads 8 to 12 cmH2O/mbar. 8. Set Plimit to achieve 60 cmH2O/mbar on the pressure gauge and repeat step 6 at 60 cmH2O/mbar. 9. Verify RT-200 reads 58 to 62 cmH2O/mbar.

ALARMS

Reset

E100 M

V ENTILATOR

P trig

Spont

Paw P aw (s) 15 30 0/

Apnea

Battery Apnea

MODE

Paw SPONT

(cmH 2O)

peak mean base

SPONT +APNEA A/CMV SIMV A/CMV

Paw Alarm

Push to set only

I:E

P aw

AS

VT

V 30 20

20

40

80 100

1

30

ATC

(L)

tI

(L/min) tI

40

tE

(s)

(b/min)

1.5

1.0

50

10

60 10

30 2.0

20

60

120

40 60

5 MIN

70 MAX

Calibration Analyzer

tot

2.5

0.5

80

10

100 0.1

1

3.0

120

80 100 90 Manual Inflation

Time-Limited Demand Flow (s) 0.5 0.7 0.3

PEEP/CPAP

Pbase

Plimit

0.1 0/

1.0

NEB

PROX

Figure 5-2

ALARM / LED CHECK 1. Switch Power to standby( ) then on ( ), verify operation of all LED indicators and audible alarm.

SER1500 D0105

5-3

OPERATIONAL VERIFICATION PROCEDURE (OVP) MIXER ALARM 1. Reduce O2 supply pressure to 28 psig ± 3 psig, verify that the mixer audible alarm sounds. 2. Increase O2 supply pressure to 44 psig, verify that the mixer audible alarm ceases. 3. Return O2 supply pressure to 50 psig. 4. Repeat steps 1 thru 3 for air supply. 5. Remove adult breathing circuit from the E100M.

FIO2 1. Set SPONT V˙ 2 to 15 L/min. 2. Connect standard oxygen analyzer to PATIENT

outlet.

3. Set FIO2 control to .21, verify O2% per tolerance on Test Record. 4. Repeat step 3 for settings of .40, .60, .80 and 1.0. 5. Set SPONT V˙ 2 to minimum. 6. Set FIO2 to .60.

ƒ (respiratory frequency) 1. Set RT-200 to Function 45 (Rate bpm), and press Enter key, then press Zero key. 2. Remove a section of large bore tubing from the breathing circuit and connect one end to the PATIENT outlet of the ventilator and the other end to the High Flow Range of the RT-200. See Figure 5-3. 3. Set t I to 0.2 sec. 4. Set MODE to SIMV. 5. Remove reservoir bag cap from reservoir outlet. 6. Set ƒ to 1, verify RT-200 reading per tolerance on Test Record. 7. Repeat step 6 for settings of 10, 20, 30, 60, 90 and 120. 8. Set ƒ to 10.

t I (inspiratory time) 1. Set RT-200 to Function 46 (Inspiratory) then press Enter key. 2. Set t I to 0.1, verify RT-200 reading per tolerance on Test Record. 3. Repeat step 2 for setting of 1.0, 2.0 and 3.0. 4. Press and hold the Manual Inflation button and verify inspiration ends per tolerance on Test Record. 5. Release Manual Inflation button. 6. Set MODE to SPONT.

5-4

SER1500 D0105

SECTION 5

ALARMS

Reset

E100 M

V ENTILATOR

P aw P aw (s) 15 30 0/

Apnea

Battery Apnea

MODE

Paw

SPONT

(cmH 2O)

peak mean base

SPONT +APNEA A/CMV SIMV A/CMV

P trig

Paw Alarm

Push to set only

I:E

P aw

AS

VT

V 30 20

20

40

80 100

1

30

ATC

(L)

tI

(L/min) tI

40

tE

(s)

(b/min)

1.5

30 2.0

1.0

50

10

60 10

20

60

MIN

120

40 60

5 2.5

0.5

80

10

100

70 MAX

Calibration Analyzer

Spont

tot

0.1

1

3.0

120

80 100 90 Manual Inflation

Time-Limited Demand Flow (s) 0.5 0.7

PEEP/CPAP

Pbase

Plimit

0.3 0.1 0/

1.0

NEB

PROX

Figure 5-3

SPONT V˙ 1 1. Set RT-200 to Function 35 (180 lpm O2 (%)/N2), press Enter, press F1, then 0-6-0, then press Zero. 2. Install reservoir bag cap on reservoir outlet. 3. Flip up the SPONT V˙1 switch (8 L/min) on the left side of the E100M. 4. Verify that the RT-200 reads 7 to 9 L/min. 5. Flip down the SPONT V˙1 switch (Ø L/min). 6. Verify that the RT-200 reads less than 1 L/min.

SPONT V˙ 2 1. Set SPONT V˙2 to maximum. 2. Verify that the RT-200 reads a minimum of 36 L/min. 3. Set SPONT V˙2 to minimum. 4. Verify that the RT-200 reads less than 1 L/min. 5. Remove reservoir bag cap from reservoir outlet.

SER1500 D0105

5-5

OPERATIONAL VERIFICATION PROCEDURE (OVP) V˙ (flow) 1. Set MODE to SIMV. 2. Set V˙ to 5 L/min. and verify RT-200 reading per tolerance on Test Record. 3. Repeat step 2 for settings of 10, 20, 40, 70 and 100 L/min. 4. Set V˙ to 40 L/min. 5. Set SPONT V˙2 to 10 L/min. 6. During mechanical inspiration, verify RT-200 reading (40 L/min) still meets tolerance on Test Record. 7. Disconnect tube from the RT-200 and the PATIENT

outlet.

8. Reassemble the breathing circuit, then reconnect the circuit and test lung. See Figure 5-1.

PEEP/CPAP 1. Set MODE to SPONT. 2. Install the reservoir bag cap on the reservoir outlet. 3. Set PEEP/CPAP to maximum. 4. Select base by pressing the Paw selector button. Confirm that the base LED is lit. 5. Confirm that the Electronic Pressure Gauge display and digital pressure readout exceed 25 cmH2O/mbar. 6. Slowly reduce PEEP/CPAP to minimum and verify PEEP/CPAP can be set to any value between 25 and 1 cmH2O/mbar.

LOW BASELINE ALARM, RESET AND ALARM LOUDNESS CONTROL 1. Set PEEP/CPAP to 5 cmH2O/mbar. 2. Remove the test lung from the patient wye connector. 3. Verify that the ▼Paw indicator and audible alarm activate after three (3) seconds. NOTE: The Apnea alarm LED indicator will also activate after 30 seconds. 4. PressReset . Confirm that the audible alarm is silenced and ▼Paw and Apnea (if activated) LEDs continue to blink. 5. Verify that the audible alarm resumes normal operation after 55 to 65 seconds. 6. Turn Alarm Loudness Control (on rear panel) from minimum to maximum and back to minimum. Verify that alarm volume can be adjusted.

5-6

SER1500 D0105

SECTION 5 7. Briefly press and release the Manual Inflation button to reset Apnea alarm. The Apnea alarm LED changes from flashing to latched (steadily lit). 8. Re-attacj test lung, verify that the audible alarm is silenced and ▼Paw LED changes from flashing to latched (steadily lit) after pressure rises above 3 cmH2O/mbar. 9. Press Reset extinguish.

and verify that the Apnea and ▼Paw LED indicators

10. Set PEEP/CPAP to minimum. 11. Set SPONT V˙2 to minimum.

▼Paw ALARM (low pressure) 1. Set MODE to SIMV. 2. Set ▼Paw to 10 cmH2O. 3. Adjust V˙ and t I to achieve a peak pressure of approximately 40 cmH2O/mbar during inspiration. 4. Disconnect the test lung from the patient wye connector. 5. Verify ▼Paw LED and audible alarm activate on next inspiration. 6. Reconnect the test lung to the patient wye connector. 7. Verify that the audible alarm is silenced when the Pressure Gauge reading exceeds the set ▼Paw alarm level. 8. Verify that the ▼Paw alarm LED changes from flashing to latched. 9. Press Reset

and verify that the ▼Paw alarm LED extinguishes.

▲Paw ALARM (high pressure)

_ 1. Create a high pressure alarm condition by lowering the ▲Paw alarm level below the peak pressure reading. 2. Verify that the ▲Paw alarm LED and audible_ alarm activate and inspiration ends when pressure reaches the ▲Paw alarm setting. _ 3. Reset ▲Paw alarm setting to 75 cmH2O. 4. Verify that the ▲Paw alarm changes from flashing to latched. 5. Press Reset extinguishes.

SER1500 D0105

and verify that the ▲Paw alarm LED indicator

5-7

OPERATIONAL VERIFICATION PROCEDURE (OVP) P trig (pressure trigger level) AND MODE SELECT 1. Set MODE to SPONT. 2. Set ƒ to 5. 3. Set SPONT V˙2 to 15 L/min. 4. Set PEEP to 5 cmH2O/mbar. 5. Set P trig to 3 cmH2O/mbar below baseline (PEEP/CPAP). 6. Gently squeeze and slowly release the test lung to create a dip in pressure. 7. Verify when the pressure drops to the set Ptrig level, Spont indicator LED is momentarily lit. 8. Verify that no mandatory breaths are delivered. 9. Set MODE to SIMV and repeat step 6. 10. Verify mandatory breath is triggered on first breath. 11. Repeat step 6 and 7 several times and verify that spontaneous breaths can be drawn from the Reservoir Bag, and only one (1) mandatory breath is delivered for each twelve (12) second period. 12. Set MODE to A/CMV and repeat step 6. 13. Verify that when pressure drops to set Ptrig level, the Spont LED is momentarily activated and the ventilator delivers a mandatory breath each time a dip in pressure reaches set Ptrig level.

APNEA ALARM 1. Set MODE to SPONT. 2. Gently squeeze and slowly release test lung to cause pressure to meet Ptrig, simulating one spontaneous effort. Make sure Spont LED blinks. Verify Apnea alarm LED and audible alarm are activated 30 seconds after the Spont indicator LED blinks. 3. Create another spontaneous effort simulation and verify Apnea alarm LED latches (steadily lit) and audible alarm is silenced. 4. Set Apnea

to 15 sec selection and repeat step 2 and 3.

MANUAL INFLATION BUTTON 1. Press and release the Manual Inflation button. 2. Verify a manual inflation occurs each time the Manual Inflation button is pressed. 3. Set PEEP to 0 cmH2O/mbar. 4. Set SPONT V˙2 to minimum.

5-8

SER1500 D0105

SECTION 5 NEB (Nebulizer) 1. Set MODE to SIMV. 2. Set V˙ (flow) to 30. 3. Set t I to 3.0. 4. Set Plimit to 40 cmH2O. 5. Remove test lung from circuit. 6. Set the RT-200 to Function 36. 7. Connect the NEB outlet to the RT-200 High Flow Range inlet. See Figure 5-4. 8. Press the NEB button, verify that the NEB LED indicator activates. 9. Press and hold Manual Inflation button until inspiration is terminated. 10. Verify flow from NEB outlet is 10 –2/+1 L/min during each manual inspiration. 11. Press NEB button and verify NEB LED indicator extinguishes. 12. Repeat step 8 and verify that no gas is delivered from NEB outlet. (NEB indicator should be off (unlit).)

ALARMS

Reset

E100 M

V ENTILATOR

P trig

Spont

Paw P aw (s) 15 30 0/

Apnea

Battery Apnea

MODE

Paw

SPONT

(cmH 2O)

peak mean base

SPONT +APNEA A/CMV SIMV A/CMV

Paw Alarm

Push to set only

I:E

P aw

AS

VT

V 30 20

20

40

80 100

1

30

ATC

(L)

tI

(L/min) tI

40

tE

(s)

(b/min)

1.5

30 2.0

1.0

50

10

60 10

20

60

120

40 60

5 MIN

70 MAX

Calibration Analyzer

tot

2.5

0.5

80

10

100 0.1

1

3.0

120

80 100 90 Manual Inflation

Time-Limited Demand Flow (s) 0.5 0.7 0.3

PEEP/CPAP

Pbase

Plimit

0.1 0/

1.0

NEB

PROX

Figure 5-4

SER1500 D0105

5-9

OPERATIONAL VERIFICATION PROCEDURE (OVP) INTERNAL BATTERY BACK-UP 1. Disconnect the A.C. power. 2. Verify that the % Battery Charge is indicated in the Control Monitor window momentarily (ie. 70P), then -b- is displayed to indicate battery is in use. 3. Verify that the audible alert activates momentarily to signify “Battery in Use”. 4. Verify that normal ventilation continues. 5. Momentarily press the Internal Battery Test button on the back panel and verify that the Control Monitor displays the % Battery Charge. 6. Reconnect the A.C. power and verify that the Control Monitor window no longer displays -b-.

CONTROL MONITOR 1. Set tI to 1.0, ƒ to 10 and set V˙ to 30. 2. Set MODE to A/CMV. 3. Select VT on the Control Monitor and verify LED activates. 4. Verify that the Control Monitor displays 0.45 to 0.55. 5. Set tI to 2.0 and set V˙ to 60. 6. Verify that the Control Monitor displays 1.8 to 2.20. 7. Select I:E and verify that the LED activates. 8. Verify that the Control Monitor displays 1:1.9 to 1:2.1. 9. Set ƒ to 60. 10. Verify that the Control Monitor displays 4.0:1 and the tI > tE LED activates. 11. Set ƒ to 10, set tI to 1.0. 12. Verify that the Control Monitor displays 1:4.5 to 1:5.5. 13. Select ƒ tot and verify LED activates. 14. Verify that the Control Monitor displays 9 to 11. (Allow up to 60 seconds for reading to stabilize.)

Paw MONITOR (peak, mean, base) 1. Select peak, verify that the LED activates and the P aw Monitor displays peak pressure. 2. Select mean, verify that the LED activates and the P aw Monitor displays mean pressure. 3. Set MODE to SPONT and set SPONT V˙2 to 10 L/min. 4. Select base, verify that the LED activates and the P aw Monitor displays baseline pressure.

5-10

SER1500 D0105

SECTION 5 5. Set the PEEP/CPAP control to various settings and verify P aw Monitor displays the changing baseline pressure. 6. Set the PEEP/CPAP control to minimum and SPONT V˙2 flowmeter to minimum.

PROXIMAL LINE PURGE 1. Occlude the PROX connection or pinch proximal tubing. 2. Verify that the Pressure Gauge does not rise. 3. Press PROX button, verify that the LED activates. 4. Verify that pressure is greater than 40 cmH2O/mbar and less than 115 cmH2O/mbar on the Pressure Gauge. 5. Release occlusion, verify that pressure returns to zero.

ADVANCED TRIGGER CONTROL (ATC) 1. Return to standard settings. 2. Press the ATC button and verify that the ATC LED activates and that the Ptrig level indicator on the Pressure Gauge moves from –5 cmH2O/mbar to approximately –1 cmH2O/mbar. 3. Adjust SPONT V˙2 to 10 L/min. 4. Adjust PEEP/CPAP to 10 cmH2O/mbar and verify that the Ptrig level indicator follows the baseline pressure, staying approximately 1 cmH2O/mbar below baseline. 5. Press the ATC button and verify that the ATC LED is extinguished. 6. Adjust Ptrig to –5 cmH2O/mbar. 7. Adjust PEEP/CPAP and SPONT V˙2 to minimum.

AUTO-SET (AS) ALARMS 1. Turn MODE to A/CMV. 2. Set ▼Paw to 10 cmH2O/mbar. 3. Set ▲Paw to 100 cmH2O/mbar. 4. Set P limit to 40 cmH2O/mbar. 5. Adjust V˙ to 25 L/min and adjust tI to whatever is needed to obtain 40 cmH2O/mbar on the Pressure Gauge during inspiration. 6. Press AS Alarm button and verify that the LED activates and the ▲Paw alarm setting changes to about 5 cmH2O/mbar above peak pressure and the ▼Paw alarm setting changes to about 5 cmH2O/mbar below peak pressure.

SER1500 D0105

5-11

OPERATIONAL VERIFICATION PROCEDURE (OVP) TIME-LIMITED DEMAND FLOW 1. Set MODE to SPONT. 2. Set SPONT V˙2 to 10 L/min. 3. Set PEEP to 5 cmH2O/mbar. 4. Set Ptrig to 3 cmH2O/mbar (2 cmH2O/mbar below baseline [PEEP/CPAP]). 5. Set Time-Limited Demand Flow to Ø, gently squeeze and slowly release the test lung to create a dip in pressure. 6. Verify when pressure drops to the set Ptrig level, the Spont indicator LED momentarily activates and no change in flow delivery occurs. 7. Set Time-Limited Demand Flow to 0.5. Gently squeeze and slowly release the test lung to create a dip in pressure. 8. Verify when pressure drops to the set Ptrig level, the Spont indicator LED momentarily lights and gas is delivered at the mandatory V˙ setting for approximately 0.5 seconds. 9. Switch Power to silence alarm.

(standby) on E100M and press Reset

to

Record serial number and hour meter reading on Test Record. If all procedures and tests have been successfully completed, clean ventilator using a cloth dampened with mild detergent and return to patient care use. If any procedures or tests have not been successfully completed, contact your NEWPORT Technical Service representative for assistance.

5-12

SER1500 D0105

SECTION 5

E100M Test Record Hospital/Organization Serial # Ventilator:

Mixer:

Today’s date OVP Tests Pressure Gauge Verification Alarm/LED check Mixer Alarm FIO2 ƒ (respiratory frequency) tI (inspiratory time) SPONT V˙1 SPONT V˙2 V˙ (flow) PEEP/CPAP Low Baseline Alarm Reset Button Alarm Loudness Control Low Pressure Alarm ( ▼Paw) High Pressure Alarm (▲Paw)

Hour meter Tested by

Pass

Set .21 .40 .60 .80 1.00

Set 1 10 20 30 60 90 120

FIO2 Tolerance 20.9 37.0 57.0 77.0 97.0

to to to to to

Actual Value

24.0 43.0 63.0 83.0 100

ƒ (respiratory frequency) Tolerance Actual Value 1 to 2 9 to 11 19 to 21 28 to 32 57 to 63 85 to 95 114 to 126

Ptrig (trigger level) and MODE Select

Set

tI (inspiratory time) Tolerance Actual Value

Apnea Alarm

0.1 1.0 2.0 3.0 Manual

0.10 0.90 1.90 2.90 3.90

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) Alarm Time-Limited Demand Flow

SER1500 D0105

Set 5 10 20 40 70 100

to to to to to

0.20 1.10 2.10 3.10 4.10

V˙ (flow) Tolerance

Actual Value

2 to 8 L/min 7 to 13 L/min 17 to 23 L/min 36 to 44 L/min 63 to 77 L/min 90 to 110 L/min

5-13

6. PREVENTIVE MAINTENANCE

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 1 Tools Required . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 1 Parts Required . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 1 Maintenance Procedure . . . . . . . . . . . . . . . . . . . 6 - 1

SER1500 D0105

SECTION 6 INTRODUCTION Preventive Maintenance should be performed every 3000 hours or one time per year, whichever comes first. WARNING After every Preventive Maintenance, an Operational Verification Procedure (Section 5) must be performed successfully before returning the E100M ventilator for patient use. WARNING Lethal voltages are present inside the ventilator. To prevent electrical shock, use extreme caution when working on the ventilator with front and/or rear panel opened.

TOOLS REQUIRED • • • • •

3/4 inch open end wrench Diagonal pliers Diagonal cutters T25 torx driver T15 torx driver

PARTS REQUIRED PMK1500A (Preventive Maintenance Kit) Kit Includes: Qty. Part # 2 FTR1700P 1 JFK100P 1 DIA200P 1 FRK1545A

Description Mixer Inlet Filter Water Trap Filter Kit Exhalation Valve Diaphragm Filter Restrictor Kit

MAINTENANCE PROCEDURE Open Front Panel Refer to Section 12, Final Assembly drawing, #E100MB-X, item #6 for location of SCT0408P and item #32 for location of SCT0408M. 1. Remove the two (2) screws (SCT0408P) from Reservoir Outlet on bottom of ventilator and remove the Outlet. 2. Remove the two (2) screws (SCT0408M) from each side of the front panel. 3. Open front panel by pulling from the top. The retaining strap (SST1500P) will limit how far the panel will open.

FTR1700P Replacement Refer to Section 12, Box Assembly drawing, #BOX1550A, item #33 for location of MIX1725A. 1. Remove the air inlet fitting from MIX1725A using a 3/4 inch wrench. 2. Remove the filter. 3. Insert the new filter. 4. Reinstall the air inlet fitting. 5. Repeat steps 1-4 for removal of the O2 side of mixer. NOTE: The O2 side of the mixer is left handed thread.

SER1500 D0105

6-1

PREVENTIVE MAINTENANCE PROCEDURE JFK100P Replacement Refer to Section 12, Final Assembly drawing, #E100MB-X, item #25, for location of water trap (WTR305A). 1. Unscrew the bowl from the water trap (WTR305A). 2. Unscrew the filter holder. 3. Remove and replace the filter. 4. Remove and replace O-ring. 5. Reinstall the filter holder. 6. Reinstall the bowl.

DIA200P Replacement 1. Remove the exhalation valve located under MIX1725A from the ventilator. 2. Unscrew the exhalation valve cap assembly. 3. Remove the knurled plastic nut from the diaphragm stem. 4. Remove and replace the diaphragm. 5. Install and tighten the knurled plastic nut. 6. Reinstall the cap assembly on the exhalation valve.

FRK1545A Replacement Refer to Section 11, E100M System Pneumatic Diagram, #SPD1550A, for tube locations. 1. Remove tube #

24

from 3-way toggle desig #10.

2. From the 3 way toggle, remove the desig #11 restrictor and tube # 42 . 3. Remove tube #

13

from TEE1551P desig #6.

4. Remove tube #

17

from mixer outlet port desig #4.

5. Remove tube #

43

from exhaust port desig #6.

6. Remove tube #

50

from prox fitting desig #3.

7. Remove tube #

49

from prox solenoid desig #3.

8. To intall new FRK1545A, reverse steps 1-7.

Close Front Panel 1. Close front panel by pushing from the top. 2. Insert the two (2) screws (SCT0408P) on each side of the front panel and tighten. 3. Replace the Reservoir Outlet on the bottom of the ventilator. Insert the two (2) screws (SCT0508P) and tighten.

6-2

SER1500 D0105

7. OVERHAUL PROCEDURE

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 - 1 Tools Required . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 - 1 Parts Required . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 - 1 Overhaul Procedure. . . . . . . . . . . . . . . . . . . . . . . 7 - 2

SER1500 D0105

SECTION 7 INTRODUCTION An overhaul should be performed every 12,000 hours or one time every 5 years, whichever occurs first. WARNING After every overhaul, an Electronic and Pneumatic Calibration (Section 8) and an Operational Verification Procedure (Section 5) must be performed successfully before returning the E100M Ventilator to patient use. WARNING Lethal voltages are present inside the ventilator. To prevent electrical shock, use extreme caution when working on the ventilator with front and/or rear panel opened.

TOOLS REQUIRED Diagonal pliers Diagonal cutters T25 torx driver T15 torx driver #2 Philips screwdriver 1/4 inch open end wrench 5/16 inch open end wrench 3/8 inch open end wrench 7/16 inch open end wrench 1/2 inch open end wrench 9/16 inch open end wrench

PARTS REQUIRED OVL1500A & MIX1725E Overhaul Kit and Mixer for E100M (must order both part #s) Kit Includes: Qty. 1 1 1 1 1 1 1 1 1 1 1 2 1

SER1500 D0105

Part #

Description

MIX1725E JFK100P DIA200P FRK1545A VLV150P VLV900M SOL200P BAT1500A CM1270 ORG1500P ORG1003P ORG400P GKT1500M

Rebuilt Exchange Mixer Water Trap Filter Kit Exh. Valve Diaphragm Filter Restrictor Kit Spont Flow Valve Umbrella Valve Master Solenoid Valve Internal Battery Back-Up One Way Valve O-ring O-ring O-ring Gasket

7-1

OVERHAUL PROCEDURE 10 1 ft 3 ft 3 ft 1 ft 2 ft 1 ft 2 ft 2 ft 3 3

TYR100P TUB106P TUB105P TUB600P TUB103P TUB100P TUB102P TUB104P TUB202P TEE1550P TEE1551P

Small tywrap 1/16 in Blue Tubing 1/16 in Green Tubing 3/16 in Clear Tubing 1/16 in Orange Tubing 1/16 in Clear Tubing 1/16 in Red Tubing 1/16 in Yellow Tubing 1/8 in Red Tubing 1/16 in Tee 1/8 x 1/8 x 1/16 in Tee

OVERHAUL PROCEDURE Open Front Panel Refer to Section 12, Final Assembly drawing, #E100MB-X, item #6 for location of SCT0408P and item #32 for location of SCT0408M. 1. Remove two (2) screws (SCT0408P) from Reservoir Outlet on bottom of ventilator and remove the Outlet. 2. Remove two (2) screws (SCT0408M) from each side of the front panel. 3. Open front panel by pulling from the top of panel. The retaining strap (SST1500P) will limit how far the panel will open.

Remove Rear Panel 1. Disconnect cable from JP5 on main circuit board (PCB1550A) inside front panel. 2. Remove the nine (9) screws (SCT0408P) on the rear panel of the ventilator. 3. Remove rear panel and disconnect cable from JP2 on circuit board (PCB1530A) mounted to back panel. 4. Disconnect the two (2) wires from master solenoid mounted inside of main box.

MIX1725A Replacement 1. Disconnect the three (3) tubes from mixer. 2. Remove the four (4) nuts from left side of box and remove mixer. 3. To install new mixer, reverse steps 1 and 2.

JFK100P Replacement

7-2

SER1500 D0105

SECTION 7 Refer to Section 12, Final Assembly drawing, #E100MB-X, item #25 for location of the water trap (WTR305A). 1. Unscrew bowl from water trap (WTR305A). 2. Unscrew filter holder. 3. Remove and replace filter. 4. Remove and replace O-ring. 5. Reinstall filter holder. 6. Reinstall bowl.

DIA200P Replacement 1. Remove exhalation valve, located under MIX1725A, from ventilator. 2. Unscrew exhalation valve cap assembly. 3. Remove knurled plastic nut from diaphragm stem. 4. Remove and replace diaphragm. 5. Install and tighten knurled plastic nut. 6. Reinstall cap assembly on exhalation valve.

FRK1545A Replacement Refer to Section 11, E100M System Pneumatic Diagram, #SPD1550A, for tube locations. 1. Remove tube #

24

from 3-way toggle desig #10.

2. From the 3 way toggle, remove the desig #11 restrictor and tube # 42 . 3. Remove tube #

13

from TEE1551P desig #6.

4. Remove tube #

17

from mixer outlet port desig #4.

5. Remove tube #

43

from exhaust port desig #6.

6. Remove tube #

50

from prox fitting desig #3.

7. Remove tube #

49

from prox solenoid desig #3.

8. To intall new FRK1545A, reverse steps 1-7.

VLV150P Replacement Refer to Section 12, Box Assembly drawing, #BOX1550A, for part location and assembly details. Be sure to apply ADH222P and PPS1000P per details # 2 and 5 . 1. Disconnect the four (4) tubes from valve. 2. Remove the two (2) nuts holding mounting plate to the side of ventilator box. 3. Remove the two (2) screws holding valve to mounting plate. 4. Remove the four (4) brass fittings from valve. 5. To install new valve, reverse steps 1-4.

SER1500 D0105

7-3

OVERHAUL PROCEDURE VLV900M, ORG1003P, ORG1500P, CM1270 and GKT1500M Replacement Refer to Section 12, Flow Block Assembly drawing, #BLK1545A, for part location and assembly details. Be sure to apply GRS129P to all O-rings per detail # 2 . 1. Remove tube from side of Flow Block (BLK1500M). 2. Remove Carrier (CRV1002M) from top of Flow Block. 3. Remove VLV900M and ORG1003P from Carrier. 4. To install new VLV900M and ORG1003P, reverse steps 1-4. 5. Remove Block Plug (PLG1500M) from side of Flow Block. 6. Remove and replace ORG1500P. 7. Reinstall Block Plug to Flow Block. 8. Remove the two (2) screws (SCR6150P) from back of Flow Block. 9. Remove the Flow Block from Outlet Block (BLK1501M). 10. Remove and replace CM1270 and GKT1500M. 11. Reinstall Flow Block to Outlet Block by reversing steps 8 and 9.

SOL200P Replacement Refer to Section 12, Master Solenoid Assembly drawing, #SOL1500A, for part location and assembly details. Be sure to apply PPS1000P to all pipe thread per detail # 1 . 1. Disconnect the six (6) tubes from Master Solenoid Assembly (SOL1500A). 2. Disconnect the two (2) wires from VLV1501P. 3. Loosen or remove the four (4) screws from the Master Solenoid Base (BMS820P). 4. Remove SOL200P from Base. 5. Remove Manifold (MFD1500M) from SOL200P (do not remove any parts from Manifold). 6. Remove the three (3) brass fittings from SOL200P. 7. To install new SOL200P, reverse steps 1-6.

BAT1500A Replacement Refer to Section 12, Back Panel E100M drawing, #PNL1550A, for part location and assembly details. 1. Disconnect the positive and negative battery cables. 2. Remove the battery by pulling it from the top of the rear panel. 3. To reinstall the battery, reverse steps 1 and 2.

7-4

SER1500 D0105

SECTION 7 ORG400P Replacement Refer to Section 12, Front Panel E100M drawing, #BZL1550A, for part location and assembly details. 1. Remove caps from tI and ƒ knobs, loosen nuts on knobs and remove knobs. 2. Remove and replace O-rings (ORG400P) from pointers. 3. Reinstall knobs, tighten nuts and reinstall caps.

Tubing, Restrictors and Tee Assembly Replacement Refer to Section 11, E100M System Pneumatic diagram, #SPD1550A, for part location and assembly details. NOTE: Do not replace any tubing or tees that are a part of FRK1545A filter restrictor kit. 1. Cut tubing per tubing list on System Pneumatic diagram. 2. Start with tube #1 at the top of tubing list and replace tubing (one tube at a time) per diagram. Replace plastic Tee’s as needed. 3. Install the directional restrictor RES1525P (item #7 on SPD1550A) between tubes # 34 and # 54 before the nebulizer solenoid. 4. Replace Tywraps (TYR100P) as required per diagram.

FINAL PROCEDURE Verify Electronic and Pneumatic Calibration by following the procedures outlined in Section 8 (Electronic and Pneumatic Calibration). Once calibration has been verified and meets all requirements as described in Section 6, reinstall rear panel, close front bezel and perform the Operational Verification Procedure (OVP) in Section 5. If the ventilator successfully passes the OVP, the ventilator can be returned to patient use.

SER1500 D0105

7-5

8. ELECTRONIC AND PNEUMATIC CALIBRATION

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Electronic Verification . . . . . . . . . . . . . . . . . . . . 8 Pressure Gauge Calibration . . . . . . . . . . . . . . . 8 Front Panel Calibration . . . . . . . . . . . . . . . . . . . 8 V˙ (flow) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 tI (inspiratory time) . . . . . . . . . . . . . . . . . . . . . . 8 ƒ (respiratory frequency) . . . . . . . . . . . . . . . . . . 8 Time-Limited Demand Flow . . . . . . . . . . . . . . . 8 PEEP/CPAP. . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Battery Voltage Adjustment . . . . . . . . . . . . . . . 8 Mixer Regulator Calibration . . . . . . . . . . . . . . . 8

SER1500 D0105

-

1 1 3 3 3 4 4 4 5 5 5

SECTION 8 INTRODUCTION This procedure is intended to assist a qualified NEWPORT factory authorized service technician in troubleshooting electronic failures and calibration errors. Equipment Required: • Air supply (50 psig) • Oxygen supply (50 psig) • 680 ohm resistor • Digital multimeter (DMM) Fluke 87 or equivalent • T25 torx driver • T15 torx driver • 5/64 inch hex key • RT-200 Calibration Analyzer or 0-60 psig gauge or equivalent • 50 mL syringe or equivalent • Container of water (for bubble test) WARNING Lethal voltages are present inside the ventilator. To prevent electrical shock, use extreme caution when working on the ventilator with front and/or rear panel opened. Caution Before removing and/or installing any circuit boards, make sure power is switched to standby ( ). Failure to do so could cause failure of the ventilator. To prevent damage from ESD (electro static discharge) and possible failure of the ventilator, please use standard antistatic techniques when handling circuit boards or other electronic components.

ELECTRONIC VERIFICATION PROCEDURE Refer to Section 12, Final Assembly drawing, #E100MB-X, item #7 for location of SCT0508P, item #32 for location of SCT0408M and Front Panel E100m drawing, #BZL1550A, item #2 for location of PCB1550A. 1. Remove the two (2) screws (SCT0408P) from the Reservoir Outlet located on the bottom of the unit, then remove the Outlet. 2. Remove the two (2) screws (SCT0408M) from each side of the front panel. 3. Open the front panel by pulling the top. The retaining strap (SST1500P) will limit how far the panel will open. 4. Turn the Power to on ( ). 5. Connect the black (ground) lead of the DMM to the common ground (TP2 is used as common ground unless otherwise stated). 6. TP1, TP2, TP5 and TP6 are located on PCB1550A. 7. Measure the voltage across TP1 and TP2 and verify that it is 5 volts ± 250 mVolts. There is no adjustment. 8. Using the DMM, verify that the voltage at TP5 is 4.7 volts ± 470 mVolts. There is no voltage adjustment. 9. Verify that the voltage at TP6 is 4.1 volts ± 140 mVolts. There is no voltage adjustment.

SER1500 D0105

8-1

ELECTRONIC & PNEUMATIC CALIBRATION

Reset

ALARMS

E100M V E N T I L A T O R

▲ Paw ▼ Paw

Apnea

(s) 15 30 0

▼ Battery

80

70

90 100

60

Apnea

50

110 120

40

MODE

30

SPONT

Paw (cmH20)

20 10

SPONT +APNEA A/CMV

0

-10

peak mean base

SIMV A/CMV ▼ ▲ Paw Alarm Push to set only ▲ Paw

Ptrig

Spont

ƒ tot

I:E

AS

ATC

V T (L) •

F IO 2 .50 .40

.60

30

20

.70 .80

tI

40

1.5

.21

.90 1.00

20

40 60

2.5

80

10

100

70 MAX

30 2.0

60 0.5

MIN

.30

> tE

1.0

50

10 5

ƒ (b/min)

tI (s)

V (L/min)

0.1

1

3.0

120

80 100

90

Time-Limited Demand Flow (s)

Manual Inflation

0.3

Pbase

Plimit

0.7

0.1 0

1.0

PROX

NEB

EXH VLV

PEEP/CPAP

0.5

NEB

PROX

PATIENT

Figure 8-1

8-2

SER1500 D0105

SECTION 8 PRESSURE GAUGE CALIBRATION 1. Disconnect the tubing from XD1 2. NOTE: XD1, RV1, RV2, S1 and TP4 are located on PCB1550A. Refer to Section 12, Front Panel drawing, #BZL1550A for location of PCB1550A. 3. With no pressure applied to XD1, adjust RV1 so the Electronic Pressure Gauge display reads 0 cmH2O/mbar. 4. Press switch (S1). While the pressure gauge display zero bar is blinking, adjust RV1 for 0 cmH2O/mbar. NOTE: It may be necessary to repeat step 3 to zero the display. 5. With a 50 mL syringe, tee in XD1 and the RT-200 set at function 12, apply 60 cmH2O/mbar to XD1 and the RT-200. Adjust RV2 until the electronic pressure gauge display reads 60. 6. Disconnect tubing from XD1 and recheck zero reading again at 0 cmH2O/mbar. NOTE: If adjustment is needed in step 5, repeat steps 3 and 4. 7. Turn the unit to standby ( ) and close the front panel (reverse steps 1 thru 3 of the Electronic Verification Procedure).

FRONT PANEL CALIBRATION Press and hold the Control Monitor Selector button and power On ( ) the unit. Verify "d1A" is displayed in the Control Monitor window. This indicates the ventilator is in diagnostic mode. The calibration mode cannot be canceled until the ventilator is powered off/standby ( ). The ventilator will not ventilate in this mode. While in diagnostic mode, the Control Monitor will automatically display the potentiometer readings of V˙, tI, or ƒ when you turn the corresponding knob on the front panel. The Paw display will automatically display the potentiometer readings of TimeLimited Demand Flow or PEEP/CPAP when you turn the corresponding knob on the front panel.

V˙ (flow) Potentiometer scaled readings for V˙ (flow) will be displayed in the Control Monitor when VT has been selected and the VT indicator is lit. 1. Turn V˙ knob until the Control Monitor reads 30. 2. Verify that the V˙ knob reads 30 on the front panel scale. 3. To adjust the V˙ knob to 30 on the front panel scale, remove the cap from the V˙ knob and loosen the locking nut. 4. Adjust the V˙ knob so that the Control Monitor and the V˙ knob read 30. 5. Retighten the locking nut and reinstall cap. 6. Rotate the V˙ knob to minimum and verify that the value reads 0 or 1. Rotate the knob to 100 and verify the value reads 99 or 100. Rotate the knob to maximum and verify that the value reads 100. If needed, adjust RV6 on PCB1550A board to bring the values into specification.

SER1500 D0105

8-3

ELECTRONIC & PNEUMATIC CALIBRATION tI (inspiratory time) The potentiometer scaled reading for tI will be displayed in the Control Monitor when I:E ratio has been selected and the indicator is lit. 1. Turn tI knob until the Control Monitor reads 1.00. 2. Verify that the tI knob reads 1.0 on the front panel scale. 3. To adjust the tI knob to 1.0 on the front panel scale, remove the cap from the tI knob and loosen the locking nut. 4. Adjust the tI knob so that the Control Monitor reads 1.00 and the tI knob reads 1.0. 5. Retighten locking nut and reinstall the cap.

ƒ (respiratory frequency) The potentiometer scaled readings for ƒ will be displayed in the Control Monitor when ƒ tot has been selected and the indicator is lit. 1. Turn ƒ knob until the Control Monitor reads 30. 2. Verify that the ƒ knob reads 30 on the front panel scale. 3. To adjust the ƒ knob to 30 on the front panel scale, remove the cap from the ƒ knob and loosen the locking nut. 4. Adjust the ƒ knob so that the Control Monitor and the ƒ knob read 30. 5. Retighten the locking nut and reinstall cap.

TIME-LIMITED DEMAND FLOW The potentiometer scaled readings for Time-Limited Demand Flow will be displayed in the Paw display when peak has been selected and the peak indicator is lit. 1. Turn the Time-Limited Demand Flow knob until the Paw display reads 0.5. 2. Verify that the Time-Limited Demand Flow knob reads 0.5 on the front panel scale. 3. To adjust the Time-Limited Demand Flow knob to 0.5 on the front panel scale, remove the cap from the Time-Limited Demand Flow knob and loosen the locking nut. 4. Adjust the Time-Limited Demand Flow knob so that Paw display and the Time-Limited Demand Flow knob read 0.5. 5

8-4

Retighten the locking nut and reinstall the cap.

SER1500 D0105

SECTION 8 PEEP/CPAP The potentiometer scaled readings for PEEP/CPAP will be displayed in the Paw display when base has been selected and the base indicator is lit. Verify PEEP/CPAP: 1. Turn the PEEP/CPAP knob to minimum. 2. Verify that the Paw display reads 0. 3. Turn PEEP/CPAP to maximum. 4. Verify that the Paw display reads a minimum of 30. 5. Return PEEP/CPAP knob to minimum. If display at minimum setting is not 0, or display at maximum setting is not > 30 then you must calibrate the PEEP/CPAP control according to the following directions. Calibration of PEEP/CPAP: 1. Remove the two screws securing the reservoir outlet on the bottom of the ventilator and remove the outlet. 2. Remove the two screws from each side of the front panel and open the front panel. 3. Remove the cap from the PEEP control knob, loosen the nut on the knob and remove the knob. 4. Remove the two screws securing the BKT1504M with the PEEP needle valve and potentiometer to the front bezel. 5. Carefully pull the needle valve assembly out of the ventilator so you can loosen the gears. NOTE: Do not unsolder the wires on the potentiometer from the PEEP needle valve assembly. 6. Disconnect the tube from the outlet of the needle valve assembly. (The outlet is the stem that comes out at a 90° angle to the needle valve.) 7. Connect a tube long enough to go from the outlet of the needle valve to a cup of water on the workbench. (Water is used to check for bubbles.) 8. Loosen the set screw securing the gear to the shaft of the potentiometer. Rotate the shaft of the potentiometer fully clockwise. 9. Connect the 50 psig gas source to the ventilator, verify that flow comes out of the needle valve outlet by the presence of bubbles in the water. 10. Slowly rotate the shaft of the PEEP needle valve until no bubbles are present in the cup of water. Rotate the shaft an additional 1/3 turn. 11. Secure the gear to the shaft of the potentiometer with the set screw. 12. Rotate the shaft of the needle valve fully clockwise and fully counter clockwise. Verify the gears on the PEEP needle valve and the potentiometer align properly throughout the rotation and the potentiometer creates the minimum and maximum stops for the needle valve. (Repeat steps 8 through 11 if these conditions are not met.) 13. Remove the tube from the outlet of the PEEP needle valve and reconnect the tube from the ventilator to the PEEP needle valve. SER1500 D0105

8-5

ELECTRONIC & PNEUMATIC CALIBRATION 14. Secure the bracket BKT1504M with the PEEP needle valve and potentiometer to the ventilator with two screws. 15. Close and secure the front panel with two screws. 16. Reconnect the reservoir outlet to the bottom of the vent and secure with two screws. 17. Perform steps 1 through 5 in Verify PEEP/CPAP above.

BATTERY VOLTAGE ADJUSTMENT 1.

Switch POWER to standby ( ).

2. NOTE: Refer to Section 12, Front Panel drawing, #BZL1550A, item #2 for location of PCB1550A, Final Assembly drawing, #E100MB-X, item #6 for location of SCT0408P, Back Panel drawing, #PNL1550A, item #6 for location of PCB1530A. 3. Disconnect the cable from JP5 on PCB1550A inside the front panel (to open front panel, follow steps 1-3 of the Electronic Verification Procedure). 4. Remove the nine (9) screws (SCT0408P) from the rear panel. 5. Remove rear panel and disconnect the positive terminal of the battery. 6. Without disconnecting JP1 from PCB1530A, connect a 680 ohm resistor across Pin 1 and Pin 2 on JP1. 7. Verify with the DMM that the voltage across Pin 1 and Pin 2 is between 6.89 and 6.91 volts. 8. Adjust RV5 (PCB1530A) to obtain correct voltage. 9. Remove resistor and reverse steps 2-4 for reassembly.

MIXER REGULATOR CALIBRATION 1.

Connect 50 psig air and oxygen sources to the ventilator.

2. Connect a piece of tubing from the P+ port (high pressure range) of the RT-200 to the barbed connection on the outlet of the flowmeter (SPONT V˙2). 3.

Select Function 22 on the RT-200.

4. Rotate the flowmeter knob approximately 2 full turns counterclockwise. NOTE: The ball inside the flowmeter may not register any flow during this test. 5. Remove the small cap located on the upper rear panel of the mixer. 6. Using a 5/64 hex key, adjust the mixer regulator screw, now visible since the removal of the small cap, until the RT-200 reads 28.0 to 28.5 psig. 7. Disconnect the tubing from the RT-200 then reconnect. Verify that the pressure remains 28.0 to 28.5 psig. 8. Remove tubing, then reinsert the small cap back into the upper rear panel of the mixer.

8-6

SER1500 D0105

9. TROUBLESHOOTING AND ERROR CODES

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 - 1 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . 9 - 1 Error Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 - 4

SER1500 D0105

SECTION 9 INTRODUCTION The following information is intended to assist a qualified hospital technician or NEWPORT factory authorized service technician to determine the cause of functional failures. NEWPORT does not guarantee that the suggested corrective action will rectify the problem. NOTE: Refer to the E100M Operating Manual, Section 7, for assistance with troubleshooting common user problems.

TROUBLESHOOTING Problem

Potential Cause

Suggested Corrective Action

Continuous low gas pressure/ gas failure alarm from mixer.

Gas supplies did not exceed 40 psig upon initial application of pressure.

Ensure both gas supplies exceed 40 psig at mixer inlet upon initial application of pressure.

Gas supplies dropped below 35 psig during use.

Ensure both gas supplies are within 35 to 90 psig at mixer inlet.

Mixer inlet filter (FTR1700P) is occluded.

Check inlet filter and replace if necessary.

Alarm module in mixer is sticking.

Turn gas supplies on and off in different sequences. If alarm continues, replace mixer (MIX1725A).

Internal by-pass system in mixer failed.

Replace mixer.

No gas to either side of mixer gas inputs.

Ensure gas pressure is applied to one side of the mixer.

Mixer does not alarm when gas pressure drops below 25 psig.

Mixer inlet filter (FTR1700P) Check inlet filter and replace is occluded. if necessary.

SER1500 D0105

Alarm reed (ALM1725S) failure.

Replace alarm reed.

Bleed from mixer into alarm reed occluded.

Remove occlusion or replace mixer if necessary.

9-1

TROUBLESHOOTING AND ERROR CODES Problem No flow (V˙) from patient outlet during inspiration of mandatory breath.

Main inspiratory flow from patient outlet does not meet tolerance on test record.

Can't achieve or maintain 25 cmH2O/mbar of PEEP/CPAP.

9-2

Potential Cause

Suggested Corrective Action

V˙ set to minimum.

Adjust V˙.

No voltage signal to solenoid (VLV1501P) on master solenoid assembly (SOL1500A) during inspiration.

Failure on PCB1550A or bad electrical connection between VLV1501P and PCB1550A. Replace PCB1550A if necessary.

VLV1501P does not open when voltage signal is applied.

Replace VLV1501P.

Mixer outlet pressure is not set between 28.0 and 28.5 psig.

Adjust regulator on MIX1725A to 28 psig.

Leak in flow block assembly (BLK1545A).

Check VLV900M, CM1270 ORG1500P, GKT1500M and tubing for leaks. Replace parts if necessary.

Leak in Plimit (pop off valve) or Plimit valve block.

Check block and valve for leaks. Replace parts if necessary.

Leak in patient/test circuit.

Check circuit for leaks. Replace circuit if necessary.

No Spont V˙1 or V˙2 flow through circuit to build or maintain PEEP.

Turn on Spont V˙1, or adjust Spont V˙2 to a minimum of 4 L/min.

Leak in exhalation valve.

Check valve and diaphragm for leaks. Replace valve or diaphragm if necessary.

No Reservoir Outlet Cap (CAP100A) or Reservoir Bag attached to Reservoir Outlet.

Attach Cap or Reservoir Bag.

Restrictor on outlet of PEEP valve occluded.

Check restrictor for occlusion. Replace restrictor if necessary.

SER1500 D0105

SECTION 9 Problem No NEB flow during inspiration when NEB is selected (lit).

NEB flow during inspiration when NEB has not been selected (unlit).

SPONT V˙1 or V˙2 flow does not shut off during inspiration of a mandatory breath.

No proximal purge from Prox outlet when Prox is selected.

SER1500 D0105

Potential Cause

Suggested Corrective Action

No voltage signal to NEB solenoid (SOL1503P).

Failure on PCB1550A or bad electrical connection between SOL1503P and PCB1550A. Replace PCB1550A if necessary.

NEB solenoid does not open when voltage signal is applied.

Replace NEB solenoid.

Constant voltage signal from PCB1550A.

Failure on PCB1550A. Replace PCB1550A.

NEB solenoid stays open when no voltage signal is applied.

Replace NEB solenoid.

Tube #11 between spont flow valve (VLV150P) and master solenoid assembly (SOL1500A) occluded.

Remove occlusion or replace tube if necessary.

Spont flow valve does not close when pressure is applied to pilot input during inspiration.

Flow valve failure. Replace flow valve VLV150P.

Internal proximal circuit occluded.

Check all restrictors, hoses and filter in prox circuit for occlusion. Replace any necessary parts.

Prox solenoid does not activate when voltage signal is applied.

Replace Prox solenoid.

9-3

TROUBLESHOOTING AND ERROR CODES ERROR CODES The ventilator will not cycle, a constant audible alarm is activated and an error code is displayed in the Control Monitor window.

9-4

ERROR “E01”

Read only memory error. Replace PCB1550A.

ERROR “E02”

Random access memory error. Replace PCB1550A.

ERROR “E03”

Sum check or program error. Replace E-prom or PCB1550A if necessary.

ERROR “E04”

Time out/communication error on controller processor. Replace PCB1550A.

ERROR “E05”

Time out/communication error on monitor processor. Replace PCB1550A.

SER1500 D0105

10. ELECTRONIC & PNEUMATIC COMPONENT REMOVAL & REPLACEMENT PROCEDURES

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 - 1 Tools Required . . . . . . . . . . . . . . . . . . . . . . . . . . 10 - 1 Open Front Panel. . . . . . . . . . . . . . . . . . . . . . . . 10 - 1 Remove Rear Panel. . . . . . . . . . . . . . . . . . . . . . 10 - 1 Mixer (MIX1725A) . . . . . . . . . . . . . . . . . . . . . . . 10 - 1 Flow Control Assembly (FCL1500A) . . . . . . . . . 10 - 2 Flow Block Assembly (BLK1545A) . . . . . . . . . . 10 - 2 Nebulizer and Prox/Machine Solenoids (SOL1503P and SOL1501P). . . . . . . . . . . . . 10 - 2 Internal Battery Back-up (BAT1500A) . . . . . . . . 10 - 2 Main Board (PCB1550A) . . . . . . . . . . . . . . . . . . 10 - 3 Display Board (PCB1511A) . . . . . . . . . . . . . . . . 10 - 3 Electronic Pressure Gauge (MAN1540M) . . . . . 10 - 3 Power Supply Board (PCB1530A) . . . . . . . . . . 10 - 4 Lower Display Board (PCB1520A) . . . . . . . . . . 10 - 4 Adapter Board (PCB1570A) . . . . . . . . . . . . . . . 10 - 4

SER1500 D0105

SECTION 10 INTRODUCTION This section will assist you in the removal and replacement of electronic and pneumatic components.

TOOLS REQUIRED Small #1 phillips screwdriver Medium #2 phillips screwdriver TOL001P (special NEWPORT tool to loosen nuts on knobs) 7/16 inch open end wrench 1/4 inch nut driver T25 torx driver T15 torx driver WARNING Lethal voltages are present inside the ventilator. To prevent electrical shock, use extreme caution when working on the ventilator with front and/or rear panel open.

OPEN FRONT PANEL Refer to Section 12, Final Assembly drawing, #E100MB-X, item #6 for location of SCT0408P and item #32 for location of SCT0408M. 1. Remove the two (2) screws (SCT0408P) from Reservoir Outlet on bottom of ventilator and remove the Outlet. 2. Remove the two (2) screws (SCT0408M) from each side of the front panel. 3. Open front panel by pulling from the top of panel. The retaining strap (SST1500P) will limit how far the panel will open.

REMOVE REAR PANEL 1. Disconnect cable from JP5 on main circuit board (PCB1550A) inside front panel. 2. Remove the nine (9) rear screws (SCT0408P). 3. Remove rear panel and disconnect cable from JP2 on circuit board (PCB1530A) mounted to back panel. 4. Disconnect the two (2) wires from master solenoid mounted inside of main box.

MIXER (MIX1725A) 1. Disconnect the three (3) tubes from the mixer. 2. Remove the four (4) nuts from the left side of the box and remove the mixer. 3. To reinstall the mixer, reverse steps 1 and 2.

SER1500 D0105

10-1

ELECTRONIC & PNEUMATIC COMPONENT REMOVAL & REPLACEMENT PROCEDURES FLOW CONTROL ASSEMBLY (FCL1500A) 1. Disconnect the two (2) tubes from the flow valve. 2. Remove the two (2) screws from the potentiometer bracket and remove the bracket from the flow valve (leaving pot attached to bracket). 3. Remove the cap from the flow knob, loosen the nut from the knob and remove knob. 4. Remove the two (2) screws from the pointer, then remove pointer. 5. Remove the three (3) screws holding the flow valve to the front panel and remove the flow valve. 6. To reinstall the flow valve, reverse steps 1 through 5.

FLOW BLOCK ASSEMBLY (BLK1545A) 1. Disconnect the three (3) tubes from the flow block. 2. Remove the two (2) screws from the patient outlet. 3. Remove the patient outlet and flow block. 4. To reinstall the flow block, reverse steps 1 thru 3.

NEBULIZER AND PROX/MACHINE SOLENOIDS (SOL1503P and SOL1501P ) 1. Remove the solenoid tubes. 2. Disconnect the cable. 3. Remove the two (2) screws from the bracket, then remove the valve. 4. To reinstall valve, reverse steps 1 thru 3.

INTERNAL BATTERY BACK-UP (BAT1500A) 1. Disconnect the positive and negative battery cables. 2. Remove the battery by pulling it from the top of the rear panel. 3. To re-install the battery, reverse steps 1 and 2.

10-2

SER1500 D0105

SECTION 10 Caution Before removing and/or installing any circuit boards, make sure power is switched to standby ( ). Failure to do so could cause failure of the ventilator. To prevent damage from ESD (electro static discharge) and possible failure of the ventilator, please use standard antistatic techniques when handling circuit boards or other electronic components.

MAIN BOARD (PCB1550A) 1. Remove the six (6) cables from PCB1550A. 2. Remove the caps from Paw Alarm and Ptrig knobs, loosen the nuts on the knobs, then remove knobs. 3. Remove nuts from the Paw Alarm and Ptrig potentiometer shafts. 4. Remove the tube from the transducer. 5. Remove the six (6) screws from PCB1550A, then remove board. 6. To reinstall the board, reverse steps 1-5.

DISPLAY BOARD (PCB1511A) NOTE: PCB1511A and MAN1540M are connected by ribbon cables. Use caution when removing them. 1. Remove PCB1550A. 2. Disconnect cable from J2 on PCB1511A. 3. Remove the cap from the MODE knob, then loosen the nut on the knob, remove knob. 4

Remove the nut and washer from MODE control shaft.

5. Remove the two (2) standoffs (STO1500P) and the four (4) standoffs (STO1505P). 6. For ease of removal, gently push on the manometer display while pulling on the PCB1511A board. 7. To reinstall the PCB1511A board, reverse steps 1-6.

ELECTRONIC PRESSURE GAUGE (MAN1540M) Refer to Section 12, Front Panel E100M drawing, #BZL1550A, for part location and assembly details. 1. Remove PCB1550A. 1.1 Remove the six (6) cables from PCB1550A. 1.2 Remove caps from Paw Alarm and Ptrig knobs, loosen nuts on knobs and remove knobs. 1.3 Remove nuts from potentiometer shafts. 1.4 Remove the tube from the transducer. 1.5 Remove the six (6) screws from PCB1550A and remove board.

SER1500 D0105

10-3

ELECTRONIC & PNEUMATIC COMPONENT REMOVAL & REPLACEMENT PROCEDURES 2. Remove PCB1511A. NOTE: PCB1511A and MAN1540A are connected by ribbon cables. Use caution when removing. 2.1 Disconnect cable from J2 on PCB1511A board. 2.2 Remove cap from MODE control knob, loosen nut on knob and remove knob. 2.3 Remove nut and washer from MODE control shaft. 2.4 Remove the two (2) standoffs (STO1500) and the four (4) standoffs (STO1505P). 3. For ease of removal, gently push on the pressure gauge display while pulling on the PCB1511A board. 4. Remove the four (4) display ribbon cables from the connectors on PCB1511A. 5. To install new MAN1540M, reverse steps 1-4.

POWER SUPPLY BOARD (PCB1530A) 1. Remove the two (2) cables from PCB1530A. 2. Remove the four (4) screws from PCB1530A, then remove board. 3. To reinstall the board, reverse steps 1 and 2.

LOWER DISPLAY BOARD (PCB1520A) 1. Remove cap from PEEP/CPAP knob, loosen nut on the knob, remove knob. 2. Remove the two (2) screws holding needle valve assembly (NDL1500A) to front panel. Be careful not to pull on the wires when moving NDL1500A. 3. Remove the two (2) screws holding PCB1520A to front panel. 4. Remove cable from JP1 on PCB1520A. 5. Remove PCB1520A. 6. To reinstall PCB1520A, reverse steps 1-5.

ADAPTER BOARD (PCB1570A) 1. Remove ribbon cable from Front Panel Membrane Switch to PCB1570A. 2. Remove PCB1570A from PCB1550A. 3. To reinstall PCB1570A board, reverse steps 1-2.

10-4

SER1500 D0105

11. ELECTRONIC AND PNEUMATIC DIAGRAMS WITH PARTS LIST

PCB1511A Schematic #SCH1511 PCB1520A Schmetic #SCH1520 PCB1530A Schematic #SCH1530 PCB1550A Schematic #SCH1550 PCB1570A #PCB1570A Pnuematic Diagram #PNU1550A E100M System Pnuematic Diagram #SPD1550A E100M System Wiring Diagram #SWD1545A

SER1500 D0105

ELECTRONIC AND PNEUMATIC DIAGRAMS WITH PARTS LIST

SER1500 D0105

SECTION 11

PCB1511 SCHEMATIC SCH1511 11-1

SECTION 11

PCB1520 SCHEMATIC SCH1520

SER1500 D0105

11-2

ELECTRONIC AND PNEUMATIC DIAGRAMS WITH PARTS LIST

SER1500 D0105

SECTION 11

PCB1530 SCHEMATIC SCH1530

11-3

ELECTRONIC AND PNEUMATIC DIAGRAMS WITH PARTS LIST

C25 15pF Y1 24MHz 35 34 15

C24 15pF RST

GAIN = 100K / 523 = 191.2 C17

FLOW ASST POT PEEP POT IT POT RATE POT

.15uF

ASUP

VCC ASUP

10 HZ LOPASS R8 523

C15 .1uF

VS

+OUT

GND

-OUT

C19 .1uF

+OUT

3

3

-OUT

2

U3 +

6

U4A

3

+ -

C20 .1uF

R33

1

11

SDX01G2

C71 .1uF

4.7K 5%

LMC660

3

.1uF 1 68 67 66 65 64 63 62

BATT SENSE

2

AMP04

C21

0cm H2O = 0.433V 120cm H2O = 3.94V

TP3 PRESSURE1

4

1

4

2

C18 .1uF

7 8 1

XD1 5

5

ASUP

ASUP

C16 .1uF

1%

ANASPARE1 ANASPARE2 C22

cw

4 5

C23 .1uF

.1uF ASUP

7 8 9 10 11 12 13 14

FLOW GAIN

R9 47.5K 1%

RV2

ASUP

R11 33.2K 1%

U4D

4 12

0.433V

+

5K

LMC660

11

R10 3.92K 1%

5

R12 3.92K 1%

6

+

14

13

100K C70

\ALARMSW

.01uF

0.433V

U4B

R13 47.5K 1%

6

S1

7

11

RV1

4

cw

61 60 59 58

ZERO LMC660 VCC

RN1 \ALRM \TRIG \PRESSURE

1 2 3 4 5 6 7

SCL SDA

R1 R2 R3 R4 R5 R6 R7

14 13 12 11 10 9 8

COM R13 R12 R11 R10 R9 R8

10K JMP1

JMP2

\SILENCE \APNEATIME

\PRESSURE \TRIG \ALRM

\SELECT \PROX \NEB

MEMBRAN CONNECTO

TP1 VCC

VDD

C64

.1uF

C61 .1uF

C26 .1uF

C27 .1uF

ASUP

VCC

C29

C28

TP2 DGND

.1uF

.1uF

DIGITAL GND PLANE

4

ANALOG GND PLANE

U4C

10

+

8

9 11

-

U21 U8 U7 U6 U5 REF

SER1500 D0105

74HC14 62256 27C256 74HC573 80C552 PART NO. POWER CONNECTION

14 28 32 20 2 VCC

7 14 16 10 36,37 GND

LMC660

FLOW ASST POT RATE POT FLOW POT IT POT

PEEP POT ANASPARE1

SECTION 11

U21D 8

9

VCC 74HC14 U21C 6

5

R29

R30

R31

4.7K

4.7K

4.7K 5%

5%

5%

R32 4.7K 5%

74HC14 U5 XTAL1 XTAL2 RST

P1.0/CT0I P1.1/CT1I P1.2/CT2I P1.3/CT3I P1.4/T2 P1.5/RT2 P1.6/SCL P1.7/SDA

AVDD AVSS AVREF+ AVREFSTADC

P3.0/RXD P3.1/TXD P3.2/INT0 P3.3/INT1 P3.4/T0 P3.5/T1 P3.6/WR P3.7/RD

P5.0/ADC0 P5.1/ADC1 P5.2/ADC2 P5.3/ADC3 P5.4/ADC4 P5.5/ADC5 P5.6/ADC6 P5.7/ADC7

P0.0/AD0 P0.1/AD1 P0.2/AD2 P0.3/AD3 P0.4/AD4 P0.5/AD5 P0.6/AD6 P0.7/AD7

PWM0 PWM1 P4.0/CSMR0 P4.1/CSMR1 P4.2/CSMR2 P4.3/CSMR3 P4.4/CSMR4 P4.5/CSMR5 P4.6/CMT0 P4.7/CMT1

P2.0/A08 P2.1/A09 P2.2/A10 P2.3/A11 P2.4/A12 P2.5/A13 P2.6/A14 P2.7/A15

EW

PSEN ALE EA

16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

TRIGGERA TRIGGERB ALARMA ALARMB

U21B 4

TRIGGER INOP1

3

74HC14

SCL SDA

U21A DATA CLOCK LATCH POL

2

\HI VOLT ON

1

74HC14 HIPRESS

\WR \RD

AD[0..7] U6

57 56 55 54 53 52 51 50

AD0 AD1 AD2 AD3 AD4 AD5 AD6 AD7

39 40 41 42 43 44 45 46

A8 A9 A10 A11 A12 A13 A14 A15

AD0 AD1 AD2 AD3 AD4 AD5 AD6 AD7

2 3 4 5 6 7 8 9 11 1

D1 D2 D3 D4 D5 D6 D7 D8

U7 Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8

A0 A1 A2 A3 A4 A5 A6 A7

19 18 17 16 15 14 13 12

C OC

74HC573

47 48 49

A0 A1 A2 A3 A4 A5 A6 A7 A8 A9 A10 A11 A12 A13 A14

VCC

11 10 9 8 7 6 5 4 29 28 24 27 3 30 31 23 25 2

U22

A0 A1 A2 A3 A4 A5 A6 A7 A8 A9 A10 A11 A12 A13 A14

O0 O1 O2 O3 O4 O5 O6 O7 NC NC DU DU

AD0 AD1 AD2 AD3 AD4 AD5 AD6 AD7

13 14 15 18 19 20 21 22 12 26 1 17

CE OE VPP

A0 A1 A2 A3 A4 A5 A6 A7 A8 A9 A10 A11 A12 A13 A14

10 9 8 7 6 5 4 3 25 24 21 23 2 26 1

\RD \WR

20 22 27

27C256

D0 D1 D2 D3 D4 D5 D6 D7

11 12 13 15 16 17 18 19

AD0 AD1 AD2 AD3 AD4 AD5 AD6 AD7

CS OE WE

62256

A[0..15]

80C552

A0 A1 A2 A3 A4 A5 A6 A7 A8 A9 A10 A11 A12 A13 A14

RAM ADDRESS 8000-FFFF U21F A15

13

12

74HC14 MONITOR MICROPROCESSOR

JP2 JP3 1 2 3 4 5 6 7 8 9

POL LATCH CLOCK DATA \HI VOLT ON

1 3 5 7 9 11 13 15 17 19 21 23

DIN CLK LOAD

\SPONT \SPONTBKUP

2 4 6 8 10 12 14 16 18 20 22 24

S2 1 2 3 4 5 6

\ALARMSW ALARMB ALARMA VCC

ENCODER \A/C \SIMV

S3 VCC

NE SWITCH OR

1 2 3 4 5 6

TRIGGERB TRIGGERA

DISPLAY PCB CONNECTOR

VCC

ENCODER

JP1 1 2 3 4 5 6 7 8 9 10

VCC JP4 1 2 3 4 5 6

NEB SOLN PROX SOLN EXH SOLN EXH SOLN SOURCE

|LINK |PCB15502.SCH |PCB15503.SCH

SOLENOID CONNECTOR

SCH1550

Sheet

1 of

3

FRONT PANEL CONTROL CONNECTOR

PCB1550 SCHEMATIC SCH1550 (1 of 3) 11-4

ELECTRONIC AND PNEUMATIC DIAGRAMS WITH PARTS LIST

ASUP cw SPARE FOR FUTURE USE FLOW TRIM

RV6

5K

GAIN = 100K / 523 = 191.2 C45

.15uF 10 Hz LOPASS

ASUP

ASUP R14 523

C43 .1uF

2

7 8 1

XD2 VS

+OUT

GND

-OUT

+OUT

1

U15

3

+ -OUT

3

6

3

4

1

2

-

AMP04

R15 47.5K 1%

C32

4.7K 5%

LMC660

11

SDX01G2

C66 .1uF

.1uF

cw ASUP

cw

+

R17 33.2K 1%

14

13

-

R19 47.5K 1%

U16B

+

7

5

0.433V LMC660

11

C33 .1uF

C34

\SPONT \SIMV \A/C \SPONTBKUP EXHSOL

NEB SOL

INOP2

REMALARM

C65

C59 .1uF

.1uF

.01uF

6

R18 3.92K 1%

1

LMC660

14

COM

R1

R16 3.92K 1%

4

12

5K

RV4 100K

11

0.433V

GAIN

U16D

4

RV3

IT POT RATE POT

R34

+

2

ASUP

FLOW POT

TP4 PRESSURE2

U16A

4

5

0cm H2O = 0.433 120cm H2O = 3.94

C44 .1uF

1%

5

ASUP

VCC \NEB \PROX \SIL \BATTEST \SELECT \APNEATIME

VCC TP6 ASUP

6 2

C68 1uF 16V

ASUP

4.1V

U23 8 7 3

VIN FDBK SHTDN

VOUT ERR

1 5

R36 110K 1%

TAP SENS

+ C69 .01uF

C55 1uF 16V

LP2951

R35 47.5K 1%

ANALOG SUPPLY TP5 VCAP D7

R20 VCAP

MBRS130LT3

10 5%

C56 1F SUPERCAP

VCAP POWER

5 6 7 8

D1 1N4001

Q S

VDD

VCC

VCC C67

C46

C47

C48

C49

C50

C51

C52

C53

.1uF

.1uF

.1uF

.1uF

.1uF

.1uF

.1uF

.1uF

.1uF

1 2 3 4

POWER CONNECTOR

SPARE 4

U16C

10

+

8

9

11

LMC660

REF # U9 U8 U14 U13 U19 U11 U22 U12

SER1500 D0105

POWER CONNECTION PART # 74HC573 S80C552 MAX232A MAX693A X2402 62256 27C256 SCC2692

VCC 20 2 16 3 8 28 32 44

GND 10 36,37 15 4 4 14 16 22

\EXHSOL

4

2 3

JP7 BATT SENSE

SECTION 11

C35 15pF Y2 24MHz

JP6 C36 15pF

1 2 3 4 5 6

R2I T2O VCC

U8 35 34 15

RST

61 60 59 58

VCC ASUP

3 1 68 67 66 65 64 63 62

BATT SENSE ANASPARE3 ANASPARE4 C62

4 5

C63 .1uF

.1uF

7 8 9 10 11 12 13 14

P1.0/CT0I P1.1/CT1I P1.2/CT2I P1.3/CT3I P1.4/T2 P1.5/RT2 P1.6/SCL P1.7/SDA

AVDD AVSS AVREF+ AVREFSTADC

P3.0/RXD P3.1/TXD P3.2/INT0 P3.3/INT1 P3.4/T0 P3.5/T1 P3.6/WR P3.7/RD

P5.0/ADC0 P5.1/ADC1 P5.2/ADC2 P5.3/ADC3 P5.4/ADC4 P5.5/ADC5 P5.6/ADC6 P5.7/ADC7

P0.0/AD0 P0.1/AD1 P0.2/AD2 P0.3/AD3 P0.4/AD4 P0.5/AD5 P0.6/AD6 P0.7/AD7

PWM0 PWM1 P4.0/CSMR0 P4.1/CSMR1 P4.2/CSMR2 P4.3/CSMR3 P4.4/CSMR4 P4.5/CSMR5 P4.6/CMT0 P4.7/CMT1

P2.0/A08 P2.1/A09 P2.2/A10 P2.3/A11 P2.4/A12 P2.5/A13 P2.6/A14 P2.7/A15

EW

RN2 10K

PSEN ALE EA

R13 R12 R11 R10 R9 R8

R2 R3 R4 R5 R6 R7

2 3 4 5 6 7

6

U19

XTAL1 XTAL2 RST

PROX SOL

16 17 18 19 20 21 22 23

1 2 3 7

FLOW

REMSIL

TRIGGER ALARM LOAD

VCC

A0 A1 A2 WP

SCL SDA

SCL SDA

OPTION CONNECTOR

6 5

X2402 SCL SDA

24 25 26 27 28 29 30 31

DIN CLK HIPRESS

UART INT WDI

SOLENOID

\WR \RD

AD[0..7] U10

U9 57 56 55 54 53 52 51 50

AD0 AD1 AD2 AD3 AD4 AD5 AD6 AD7

39 40 41 42 43 44 45 46

A8 A9 A10 A11 A12 A13 A14 A15

AD0 AD1 AD2 AD3 AD4 AD5 AD6 AD7

2 3 4 5 6 7 8 9 11 1

D1 D2 D3 D4 D5 D6 D7 D8

Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8

19 18 17 16 15 14 13 12

C OC

74HC573

47 48 49

A0 A1 A2 A3 A4 A5 A6 A7

A0 A1 A2 A3 A4 A5 A6 A7 A8 A9 A10 A11 A12 A13 A14

VCC

11 10 9 8 7 6 5 4 29 28 24 27 3 30 31 23 25 2

A0 A1 A2 A3 A4 A5 A6 A7 A8 A9 A10 A11 A12 A13 A14

U11 O0 O1 O2 O3 O4 O5 O6 O7 NC NC DU DU

AD0 AD1 AD2 AD3 AD4 AD5 AD6 AD7

13 14 15 18 19 20 21 22 12 26 1 17

U21E A15

CE OE VPP

11

A0 A1 A2 A3 A4 A5 A6 A7 A8 A9 A10 A11 A12 A13 A14

10 9 8 7 6 5 4 3 25 24 21 23 2 26 1

\RD \WR

20 22 27

10

74HC14 TI SN74HC14D

27C256

A0 A1 A2 A3 A4 A5 A6 A7 A8 A9 A10 A11 A12 A13 A14

D0 D1 D2 D3 D4 D5 D6 D7

11 12 13 15 16 17 18 19

AD0 AD1 AD2 AD3 AD4 AD5 AD6 AD7

CS OE WE

62256 RAM ADDR 8000-FFFF

(PRM1501A)

80C552

SO14

U12

13 12 11 10 9 8

A0 A1 A2 A3 A15 \WR \RD

CONTROLLER MICORPROCESSOR A[0..15] UART INT

RST VCC

R21 32 14 31 15 30 16 29 17

4.7K 5%

22pF

C41 Y3 3.686MHz

VCC C42

2 4 6 7 39 9 10 24 38

36 37

A0 A1 A2 A3 CEN WRN RDN INT RST OP0 OP1 OP2 OP3 OP4 OP5 OP6 OP7 X1 X2

D0 D1 D2 D3 D4 D5 D6 D7 RXDA TXDA RXDB TXDB IP0 IP1 IP2 IP3 IP4 IP5 IP6

28 18 27 19 26 20 25 21

AD0 AD1 AD2 AD3 AD4 AD5 AD6 AD7 U14

35 33 11 13 8 5 40 3 43 42 41

12 11 9 10

C37 \PROX \NEB \SIL

.1uF

1 3 4 5

C38

\BATTEST

R1I T1O R2I T2O

C1+ C1C2+ C2-

V+ V-

MAX232A

.1uF

\SELECT \APNEATIME

R1O T1I R2O T2I

13 14 8 7

R1I T1O R2I T2O

C39 2 6

VCC .1uF C40 .1uF

SCC2692 D12 1N4001

22pF UART ADDR 0

PROX SOLN 5 6 7 8

Q7 SI9410

PROX SOL

2 3

4

VCC

D13 1N4001 VCC NEB SOLN R22 3.3K 5%

NEB SOL

5 6 7 8

Q8 SI9410

RST R23 20K 5%

MBRS130LT3 2 3

VCC

4

1 2

Q2 SI9400

5

EXH SOLN SOURCE 5 6 7 8

6 7 8

VBATT VOUT BAT ON LOWLN OSC IN OSCSEL

RST RST WDO CEI CEO WDI PFO PFI

16 15 14 13 12 11 10 9

VCC

R24 10K 5%

U13

2 3

INOP

TP7 RST

D9

4

\PWROFF \WDO WDI

MAX691A D10 1N4001

JP5

VCAP 5 6 7 8

EXH SOLN

Q1 I9410

\BATTEST

Q3

4

REMSIL R1I T1O SCL SDA

2 3

SI9410

1 2 3 4 5 6 7 8 9 10 11 12 13 14

REAR PANEL CONNECTOR

MAIN SOLN 1,2 ALARM XDUCER 3,4 REMOTE ALARM 5,6 BATTEST 7,8 REMOTE SIL. 9,10 RS-232 11,12 I2C 13,14

\SOLENOID

R26

ALRMON

Q5 BSS138

47 5%

VCC REMALARM

K1 N.C.

Q6 BSS84

D14 SG051B00 1N4001

PCB1550 SCHEMATIC SCH1550 (2 of 3) 11-5

SER1500 D0105

INOP2

INOP1

3

2

\WDO

74HC02

U17A

1

2

1

EXHSOL

SOLENOID

\SILLOCK

74HC00

U20A 3

13

12

6

VCAP

12

11

10

9

74HC00

U20C

74HC02

U17D

11

VCC

13

8

C57 .1uF

\EXHSOL

\SOLENOID

VCAP BACKUP ALARM/VENT INOP CIRCUIT

74HC00

U20D

74HC00

U20B

SOLENOID DRIVE INVERSION

5

4

INOP

ALARM

C60 .1uF

6

5

C58 .1uF

74HC02

U17B 4

\SILENCE

9

8

SCH1550

74HC02

U17C

Sheet

\SIL

D8 MBRS130LT3

3

of

3

R25 10K 5%

VCAP

\PWROFF

10

74HC153

A B 1G 2G

2C0 2C1 2C2 2C3

1C0 1C1 1C2 1C3

U18

\SILLOCK

14 2 1 15

10 11 12 13

6 5 4 3

2Y

1Y

9

7

ALRMON

SECTION 11

PCB1550 SCHEMATIC SCH1550 (3 of 3)

11-6

SECTION 11

PCB1570A

SER1500 D0105

11-7

ELECTRONIC AND PNEUMATIC DIAGRAMS WITH PARTS LIST

MUFFLER*

73 MICRON .030

.025

RESTRICTOR

FILTER

73 MICRON

8L

SPONT V QUICK CONNECT

FILTER

.012 5 MICRON FILTER

MIXER .004 .004

.005

RESTRICTORS

.004 LINE AIR

MIXED GAS PRESSURE TRANSDUCER PROX PURGE

MIXED GAS FLOW METER

AIR

PROXIMAL MACHINE SOLENOID

02

P REGUL

PROXIMAL CONNECTOR

SER1500 D0105

/

LPM

SECTION 11

MUFFLER*

8LPM

EXHAUST

SPONT V

.0228 RESTRICTOR

EMERGENCY VALVE

RESERVOIR BAG

IN

CYL

EXH

PILOT VALVE FLAPPER VALVE

MAIN FLOW VALVE

CYL

FLOW CONTROL

MUFFLER

IN RESTRICTOR .025

.0189

RESTRICTOR

NEB SOLENOID

.26mm (.102) RESTRICTOR

EXHALATION SOLENOID

PEEP LATOR

NEBULIZER CONNECTOR

PATIENT OUTLET

EXHALATION VALVE

MUFFLER* TO PATIENT CIRCUIT

POP-OFF VALVE

PNEUMATIC DIAGRAM PNU1550A

11-8

ELECTRONIC AND PNEUMATIC DIAGRAMS WITH PARTS LIST

3

3-WAY TOGGLE 2 24 10

12

11

1 46

18

13

2

2

14

3

3

4

42

19

6 3

4

5

4

12

13

SPONT VALVE

9 11 31

14

15

3 2

2

1

1

16 30 5 6

2

4

XD1 1 2 IN

CYL

MASTER SOLENOID ASSY.

3 40

32 1

6

FLOW CONTROLLER ASSY.

18 17

34

16

39

2 36

1 2

EXH

3

49

1

(IN)

7

1 2

2

(OUT)

20

1 (IN)

27 33

6

2

7 1

3

50

23

24 22

5

4

FLOW BLOCK ASSY.

3 3 48

PROX

SER1500 D0105

N

SECTION 11

1

19

7

18 4

4

4

17 1

41

2

6

5

2

1

15

5

48

19

3 6

18

2

2

1

53

20

45 4

6

2

1 52

21

2

1

51

2

1

47

16

3

44

3

6

4

7

2

7

9 26

8 2

1

43

9

7

EXHAUST PORTS

6 5

8 17

6

5 4

11 10

12

MIXER OUTLET PORTS

3

37

28

2

3 29

. SPONT V2 FLOW

21

1

2

OUT 1 IN

21

6 55

5 4

20

PROX

3

1 2

2

54 2

2

OUT

FLOW

IN

1

NEEDLE VALVE ASSY

1

2

(OUT)

20

38

6

NEB SOLENOID

25

(IN)

(OUT) FLOW

10

PEEP REGULATOR

35

2

NEB.

1

EXH-VALVE

E100M SYSTEM PNEUMATIC DIAGRAM SPD1550A

11-9

ELECTRONIC AND PNEUMATIC DIAGRAMS WITH PARTS LIST

JP1

(PCB1550A)

6 1

2

3

4

5

6

7

8

9

10

JP3

N\C

PEEP CPAP 2

1

1

T.L. DEMAND FLOW 3

B

A 2

MANUAL INFLATION

(PCB1550A) JP6

3

1

2 FLOW CONTRL

RATE

2

1

JP2

3

1 3

2

INSP TIME 1

JP5

JP7

2

JP4

JP1

JP2

IN

RATE 1

2

3

3

1

2

2

1 FLOW CONTROL

2 PEEP P CAP

S E E DETA IL A

OUT

1 3

3

EXH SOL.

3

INSP TIME

D E T A I L "A"

PROX SOL.

3

NE SO

1

2

1 2

T.L. DEMAND FLOW JP1 PCB1520A

1 2

1 2

1 A

2 MA INFL

G3

7

S E E DETA IL A

SER1500 D0105

SECTION 11

1 REF FUSE HOLDER

J3

+ BATTERY

1 2 PUSH BUTTON 1

3 1

2

2

EXTERNA L BATTERY

-

SPEAKER

17 REF

_

4

+

ME

AN TR

2

1 2 3

R

OR

SF

REF

7

RS232

ALARM

1 2 3

REF

A

C

E

D

F

2

REMOTE SILENCE

1

4

2

3

B

1

NURSE CALL INP

G

POWER ENTRY MODULE

2 3

5

G1

EB OL.

2

HOUR METER

MASTER SOLENOID

1

H

3

1 2 3

B G2

2 ANUAL LATION

3

CYL

2 1

IN

EXH

3

EXH

MAIN SWITCH

13 J1 J2

G4

E100M SYSTEM WIRING DIAGRAM SWD1545A

11-10

12. ASSEMBLY DRAWINGS WITH PARTS LIST

Final Assembly E100M #E100MB-X Box Assembly #BOX1550A Flow Block Assembly #BLK1545A Master Solenoid Assembly #SOL1500A Back Panel E100M #PNL1550A Front Panel E100M #BZL1550A Flow Controller Assembly #FCL1500A Mixer Assembly, E100M Calibrated #MIX1725A PEEP Needle Valve Assembly #NDL1500A

SER1500 D0105

ASSEMBLY DRAWINGS WITH PARTS LIST

2

32

1

1

2 PLCS

SHOWN 47 OPPOSITE SIDE 46 10

28

4

8

35 36

33

7

2

4 PLCS

SER1500 D0105

8

SECTION 12

6

1 9 PLCS

NEWPORT MODEL E100M NEWPORT MEDICAL INSTRUMENTS, INC. NEWPORT BEACH, CALIFORNIA U.S.A. MADE IN U.S.A.

3

INTERNAL BATTERY TEST

CAUTION: U.S.A. FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR O N T HE O RDER O F A P HYSICIAN

15

14

37

TYPE 'B'

11

16

SERIAL # :

34

RS- 232C

18 ALARM LOUDNESS 10 0 / 120 V 220/240 V 50 / 60 HZ

.14A .07A

100/ 120 V 220/ 240 V

.25A, F .10A, F

EXTERNAL ALARM SILENCE

! REMOTE ALARM OUTPUT

6

Cer tifie d t o the r equiremen ts o f the C ana dian Ele ctrical Co de. C SA has no t i nvestig ated o ther ph ysiolo gical e ff ects. D ANGER-Explo sion Haz ard. D o no t us e i n pr esenc e o f F lam mable ana esthe tics. Total s ystem cha ssisrisk cu rrent shou ld no t e xc eed 100uA. Cer tifie s elon le s e xig enc es d u c ode C ana dian de l'ele ctricit e. L'A CNOR n'a p as e tud ie le s a utr es e ff ects ph ysiolo gique s p ossi ble s. DANGER-RI SQUE D'EXP LOSION. Nep as em ployer en pr esenc e d'ane sthe siq ue s i nflamable s. L e c ou rant de ris que t otal admissi ble a u cha ssis ne noit p as dep assar 100uA.

ON

LR51420

R

NRT L/C

0050

STDBY

44

25

12 13 19

11

1

49

2 PLCS

8

30

17

20

E100M Final Assembly E100MB-X

12-1

SECTION 12

E100MB-X (120V) Part List Part Number ADH1200P ADP1500M BKT147M BOX1550A BZL1550A CAP100A CAP1013P CAP1503P FUS1504P GRS129P HIN1545M NUT600P NUT832P ORG1001P PLG1201P PNL1550A POP1500A PRM1550A-A PRM1551A-A PWR1500P SCK5150P SCT0408M SCT0408P SCT0412P SCT0508P SHM1500M SHM1501M TOL1500P TOL1501P TOL1515P TYR100P WTR305A

SER1500 D0105

Description INSTANT ADHESIVE, LOCTITE 411 FLOW BLOCK ADAPTOR POWER CORD BRACKET BOX ASSY - E100M FRONT BEZEL ASSY CAP ASSY, RESERVOIR OUTLET CAP- 25 PIN SOCKET CAP, REMOTE ALARM SILENCE, E100M FUSE, 250 mA, E100M GREASE - MCG129 CHRISTO-LUBE HINGE, BOX E100M #6-32 LOCKWASHER NUT 8-32 NYLON INSERT NUTS S/S O-RING CAPLUG-OUTLET- COMPASS ASSY, BACK PANEL - E100M POP-OFF VALVE ASSY, E100M EPROM ASSY, MONITOR E100M EPROM ASSEMBLY, CONTROLLER, E100M POWER CORD, E100M SCREW, KNOB 516-18 X 1.5 LONG SCREW, M4 - POWDERCOATED SCREW, METRIC - M4 X 8MM SCREW, METRIC - M4 X 12MM SCREW, METRIC - M5 X 8MM Left Shim, Front Panel Right Shim, Front Panel TORX L-KEY, T-20 TORX L-KEY, T-25 TORX L-KEY, T-15 TYWRAP SMALL WATER TRAP ASSY

Quantity 0.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 2.00 0.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 2.00 10.00 2.00 4.00 1.00 1.00 1.00 1.00 1.00 0.00 1.00

Item Number 37 11 18 01 02 30 16 34 22 13 33 36 28 12 35 03 41 24 23 17 08 32 06 49 07 46 47 48 27 26 10 25

12-2

ASSEMBLY DRAWINGS WITH PARTS LIST

29

3 PL

31 39 33

2

18

4 PLCS 19 N

13

EW

P

N MO R T I

5

50

51

5

30 .50 .40

F 1O 2 .60 .70

.80 1.0

0

SEE DE TAIL A

17 30 2 PLCS

35 25

26

52 37

2

9

2 PLCS

4P LC S

34 36 2 PLCS

3

16

2 PLCS

39 2

15

2 PLCS

14

9

12

13

10

5

11 42

SER1500 D0105

13

2 PLCS

5

SECTION 12

21

LCS 39

43

6

20

24

4

4 PLCS 28 23 40

46 24

7

28

3

8 26 REF

46 22

44

7

7 PLCS 47

44

2 PLCS 41

1

10 G

38

39 4

4 PLCS

W

B

R

1

1

32

13

5

REF

6

1 5

24

4

3 PLCS

7 12

12

2 PLCS

4 49

DETAIL A SCALE = NON E

8 2 PLCS

E100M Box Assembly BOX1550A

12-3

SECTION 12

BOX1550A Part List Part Number Description HNG100P SHF500M PST100M SCP4031P WSH700P VLV150P ELB400P FTG880P ELB908P PPS1000P BKT1503M SCF8025P NUT600P SCP8037P SOL1500A BOX1525M STO1525P BLK1555M SCT0408P CON200P GKT1501M CON100P MUF160P CON1525P BKT1501M CLP1500P SCF8087P ADH222P GRM1500P CBL1500A SST1500A ADH108P WSH001P ADP1540M NUTL832P ADH1225P NUTLM04P CPL1501P CPL1500P ADH290P

SER1500 D0105

HINGE 333 TOGGLE SWITCH SHAFT DELRIN POST SCREW, PHILLIPS PAN HEAD 440 X .312 LONG #4 INT TOOTH LOCKWASHER ELECT. INTERFACE VLV CLIPPARD ELBOW DYNAMCO 1/16T X 1/8M FITTING BRASS 1/8 NPT/#3 BARB ELBOW- 1/8T X 1/8M PIPE PASTE- LOX 8 BRACKET, SPONT. VALVE SCREW, 8-32 X .25 FLAT HEAD PHILLIPS SS #6-32 LOCKWASHER NUT SCREW, PHILLIPS PAN HEAD MASTER SOLENOID ASSY, E100M POWER BOX, E100M STANDOFF, M4 X 63M EXTENSION ARM BLOCK SCREW, METRIC - M4 X 8MM CONNECTOR 1/8T X 10-32M BLEED FITTING GASKET CONNECTOR 1/16T X 10-32M MUFFLER CLIPPARD CONNECTOR, PWR CABLE EXH. VALVE, BRACKET SPRING CLIP, EXH VLV SCREW, PHILLIPS FLATHEAD 832 X .875 LONG LOCTITE, SMALL SCREW THREADLOCKER GROMMET, POWER BOX POWER CABLE STRAP, RETAINER, E100M ADHESIVE- SEALANT #8 FLATWASHER .174X.375X.032 S POLE MOUNT BLOCK Lockwasher Nut #832 ADHESIVE LOCTITE 425 Locknut - M4 Demand Coupling Insert Demand Coupling ADHESIVE- THREADLOCKER

Quantity 1.00 1.00 1.00 2.00 4.00 1.00 1.00 2.00 1.00 0.00 1.00 2.00 2.00 4.00 1.00 1.00 7.00 1.00 8.00 3.00 1.00 3.00 3.00 1.00 1.00 1.00 2.00 0.00 1.00 1.00 1.00 0.00 9.00 1.00 4.00 0.00 2.00 1.00 1.00 0.00

Item Number 04 05 06 07 08 09 10 11 12 13 14 15 16 18 19 20 22 23 24 28 29 30 31 32 34 35 36 39 40 41 42 43 44 17 38 46 47 25 26 48

12-4

ASSEMBLY DRAWINGS WITH PARTS LIST BOX1550A Part List - continued Part Number Description

Quantity Item Number

WSH1504P

Washer - #4 SST

1.00

49

VLV1506A

Valve Assy - Spont V.

1.00

03

BOX1550M

MAIN BOX, E100M

1.00

01

MIX1725A

MIXER ASSY

1.00

33

ELB300M

MODIFIED ELBOW

1.00

50

DCV1700P

DEMAND CHECK VALVE 1/8" NPT TO OXYGEN

1.00

51

WSH650P

#6 INT TOOTH LOCKWASHER 410SS

2.00

52

SCR620P

SCREW 6-32 X 3/16 BUTT SOC SS

2.00

37

GKT1526P

Gasket, Extruded, Neoprene Rubber, Black, 40 +/-5 Durometer

2.50

21

12-5

SER1500 D0105

ASSEMBLY DRAWINGS WITH PARTS LIST

SER1500 D0105

SECTION 12

Flow Block Assembly BLK1545A

12-6

SECTION 12

BLK1545A Parts List Part Number Description

Quantity

Item Number

BLK1500M

MAIN FLOW BLOCK

1.00

01

BLK1501M

OUTLET FLOW BLOCK, E100M

1.00

02

FTG1545M

FLOW BLOCK FITTING

1.00

03

CON100P

CONNECTOR 1/16T X 10-32M

1.00

05

GKT1500M

FLOW BLOCK GASKET

1.00

06

PLG1500M

MAIN FLOW BLOCK, PLUG

1.00

08

ORG1500P

O-RING, .55 ID x .070

1.00

09

SCP6150P

SCREW, 6-32 X 1.5 PHILLIPS

2.00

10

MUF160P

MUFFLER CLIPPARD

1.00

11

CON200P

CONNECTOR 1/8T X 10-32M

1.00

12

ORG1003P

O-RING- SILICONE

1.00

13

VLV900M

INTAKE UMBRELLA VALVE

1.00

14

CRV1002M

CARRIER FLOW

1.00

15

SCP2025P

SCREW PH PAN HEAD 256 X .250 LONG

4.00

16

GRS129P

GREASE - MCG129 CHRISTO-LUBE

0.00

17

PPS1000P

PIPE PASTE- LOX 8

0.00

18

CM1270

ONE WAY VALVE

1.00

07

MUF1502M

MUFFLER/FILTER (MODIFIED) E100

1.00

04

SER1500 D0105

12-7

SECTION 12

9

12∞±5∞

6

A

A 8

10

TOP VIEW

7

SCALE: NONE

3

6 45∞±5∞

60∞±5∞

REF

VIEW A-A SCALE : NONE

2

6 5

EXH

IN

EXH

CYL

10

1

3 10

4 10

PART OF ITEM 1 4 PLCS

FRONT VIEW

Master Solenoid Assembly SOL1500A

SCALE: NONE

SER1500 D0105

12-8

SECTION 12

SOL1500A Parts List Part Number Description

Quantity

Item Number

BMS820P

BASE MASTER SOLENOID

1.00

1

SOL200P

HUMPHREY VALVE

1.00

2

FTG125M

MDFY BARB FITTING

1.00

3

PLG500P

PLUG- HEX PARKER

1.00

4

ELB200P

ELBOW 3/8 TUBE X 1/4 NPT

1.00

5

CON100P

CONNECTOR 1/16T X 10-32M

3.00

6

VLV1501P

VALVE, SOLENOID

1.00

7

MFD1500M

MANIFOLD MFD100P MDFY

1.00

8

ELB500P

DYNAMCO ELBOW 1/16T X 10-32M

1.00

9

PPS1000P

PIPE PASTE- LOX 8

0.00

10

SER1500 D0105

12-9

ASSEMBLY DRAWINGS WITH PARTS LIST

27 4

5

2 PLCS

(+)

D

RE

CK L BA NE PA (-)

CK BLA

25

CA

U

RE TIO N S TO TRIC : U .S T S OF ALE S TH .A. F A P BY IS D ED HY OR EV ERA SIC ON IC LL AW IAN TH E EO . RD ER

10

26

TY

PE

"B

"

28 REF

17 16

15 REF

4

19

29

21

11

13 32 12 23 23 REF

SER1500 D0105

SECTION 12

5

6

7

4

3

4 PLCS

6 2

3

2 PLCS

9

2

4 PLCS

1

30

26 REF

2

28

15

IN TE BA RNA TT L TE ERY ST

8

19

REF

2 PLCS

18

21

2

REF

33

22

29 REF

14

1

4

E100M Back Panel PNL1550A

12-10

SECTION 12 PNL1550A Parts List Part Number Description

Quantity

Item Number

NUT600P

#6-32 LOCKWASHER NUT

3.00

02

XFM1500P

TRANSFORMER

1.00

03

BAT1500A

BATTERY AND LABEL

1.00

04

GKT1502P

GASKET, CLOSED CELL FOAM

0.50

05

PCB1530A

POWER PCB, E100M

1.00

06

SCP4019P

SCREW, PHILLIPS PAN HEAD 440 X .187 LONG

4.00

07

MOD1500P

POWER ENTRY MODULE/FUSE

1.00

08

NUT440P

#4-40 LOCKWASHER NUT

4.00

09

CAP1500P

VENT, CAP

1.00

10

SWI1500P

SWITCH, SINGLE POLE

1.00

11

SWI1501P

SWITCH, ROCKER COVER

1.00

12

PSP100M

POWER SWITCH PROTECTOR

1.00

13

SCP2019P

SCREW, PHILLIPS PAN HEAD 256 X .187 LONG

2.00

14

RVP1005M

POT- CLAROSTAT

1.00

15

CAP1200P

KNOB CAP- GRAY

1.00

16

KNB1200P

KNOB- 1/8'- GRAY

1.00

17

CON1500P

RS232 CONNECTOR

1.00

18

SLK1001P

FEM SCREW LOCK (PKG OF 2)

1.00

19

CON1002P

RECEPTACLE

1.00

21

CON1503P

CONNECTOR, NURSE CALL

1.00

22

CAP1501P

CAP, NURSE CALL

1.00

23

HND1500P

POCKET PULL FLUSH HANDLE

1.00

25

SWI1510P

SWITCH, PUSHBUTTON

1.00

26

SCP0037P

SCREW, PHILLIPS PAN HEAD 1032 X .375 LONG

2.00

27

BZR1001P

BUZZER

1.00

28

MTR1501P

HOUR METER, SHIELDED

1.00

29

PPR1500M

AC MODULE INSULATOR

1.00

30

ADH222P

LOCTITE, SMALL SCREW THREADLOCKER

0.00

31

GND001P

STUD, GROUNDING

1.00

32

NUT006P

bUT, 6MM W/LOCKWASHER

1.00

33

PNL1518M

BACK PANEL, E100M

1.00

01

SER1500 D0105

12-11

SECTION 12

24 26

2 PLCS

31 7 PLCS

IN

IN

3

6 PLCS

45

IN

39 25 53 52

1

13 66 49 PIN 1

41 41 REF 63 4 PLCS 33 5

10 21 23 30

MO

DE

54

SP

ON

T

SP

ON

T

10 21

+A

PN

SIM

V

EA

A/C

A/C

64 13

23

8 3 PLCS

REF

30

V (l 10

/m

20

in)

30

40

5 MIN

13

50 60

MA

REF

X

11

80

0

T I (se c) 1.5

1.0

70 10

0.5

90

12

2.0 (b/m

0.1

14

MA

NU AL

E-L

DE

IM

MA

0.3 0.1

8

2.5

TIM

0.5

ND

ITE

3.0

20

30

in)

40

10

D LFO W

60 80

1

10

0.7

0

12

0

0

9

1.0

10 30

12

3 PLCS

58

17 18 28

9 23

27

40 42 58

46 23

29

36

37 2 PLCS

SER1500 D0105

4

SECTION 12

J3 ON COMPONENT SID E

2

16 3 15 1

11

10 35

3

9

6 PLCS

4 PLCS

3 56

2 PLCS 65 12 62 4

2 PLCS

7

IN

80

13

90 10

70

0 11

50

0

12

40 30

0

10 0

OUT

-10

6

30 31

68

FLOW

67

6 21

69

30

3 16

3

9

2 PLCS

3

26

3

43

2 PLCS

17 44

REF

55

32

34 33 2 PLCS

21 30

3 PLCS

31

50 2 PLCS

NOTE 5 DETAIL

1

E100M Front Panel BZL1550A

REF

SCALE: 2=1

12-12

SECTION 12 BZL1550A Parts List Part Number

Description

PCB1550A PCB1520A MAN1540M

1.00 1.00 1.00

02 03 04

GKT1503M RVP310P

Main PCB, E100MB LOWER DISPLAY PCB, E100M DISPLAY DIGITAL MANOMETER W/EL BACKLIGHT GASKET, MANOMETER E100M POT 1% LINEAR

1.00 3.00

05 06

NUT200M ORG400P KNB1550P

FRICTION POT MTG NUT O-RING BUNA .014 KNOB POINTER COMBO.

2.00 3.00 2.00

08 09 10

KNB210P CAP210P FCL1500A PTR1001M

SELCO-KNOB 21MM PLAIN SELCO CAP PLAIN- LARGE- GRAY FLOW CONTROLLER ASSY, E100M POINTER MOLDED

1.00 3.00 1.00 1.00

11 12 13 14

STO1505P GRD1500M NUT300P CAP150P SOL1501P SCP6025P OUT345M

STANDOFF, 4-40 GUARD, MANUAL BUTTON HEX PANEL NUTS 3/8-32 SELCO CAP PLAIN- SMALL- GRAY SOLENOID - PROX SCREW, PHILLIPS PAN HEAD 632 X .25 LONG OUTLET NEB (PROX)

4.00 1.00 7.00 5.00 2.00 8.00 1.00

15 18 21 23 24 26 27

OUT335M OUT360M WSH500P CON100P BLK1502M

EXP OUTLET OUTLET PROX 3/8 WASHER SHAKEPROOF CONNECTOR 1/16T X 10-32M BLOCK, POP OFF

1.00 1.00 12.00 10.00 1.00

28 29 30 31 32

NUT600P

#6-32 LOCKWASHER NUT

3.00

33

BLK1545A STO1510P BLK1504M SCT0412P WSH1510P NUT150M KNB1500P STO1501P RES148P KNB1501P GKT1505P

FLOW BLOCK ASSY STANDOFF, DISPLAY BRD FLOW BLOCK BEZEL, E100M SCREW, METRIC - M4 X 12MM WASHER, MODE SWITCH SMALL FRICTION NUT KNOB, 15MM WITH LINE STAND OFF, PEEP RESTRICTOR- RF148 KNOB 15MM 3/16" GRAY, E100M GASKET, UPPER BOX

1.00 2.00 1.00 2.00 1.00 1.00 1.00 2.00 1.00 1.00 0.56

34 35 36 37 39 40 42 43 45 46 49

SER1500 D0105

Quantity Item Number

12-13

ASSEMBLY DRAWINGS WITH PARTS LIST BZL1550A Parts List- continued Part Number

Description

LBL1500P GKT1502P ADH290P SAD200M KNB1100P TUB1500P STO1500P ADH222P

LABEL, DISPLAY BOARD - E100M GASKET, CLOSED CELL FOAM ADHESIVE- THREADLOCKER MODE SW ADAPTOR KNOB 1/8' TUBING, SILICONE STANDOFF, PCB LOCTITE, SMALL SCREW THREADLOCKER GREASE - MCG129 CHRISTO-LUBE WASHER Washer - Nylon .050 Thick Display PCB, E100M Screw, Fillister Phillips 440x.156 Knob, 15mm w/skirt Guideplate, LED Adaptor PCB - E100M Solenoid, Nebulizer, Hi-Flow BEZEL PANEL SUB-ASSY E100M Peep Regulator Bracket Regulator, 60 psi RESTRICTOR 1/16 X 10-32 .44MM Needle Valve Assy SWITCH ASSY, PUSHBUTTON

GRS129P WSH1020P WSH1511P PCB1511A SCP4015P KNB155P GID1500M PCB1570A SOL1503P BZL1549A BKT1513M REG1504P RES144P NDL1500A SWI1502A

12-14

Quantity

Item Number

2.00 0.08 0.00 1.00 1.00 0.70 2.00 0.00

50 51 52 53 54 55 56 57

0.00 2.00 4.00 1.00 8.00 2.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00

58 62 63 01 16 64 65 66 25 41 67 68 69 44 17

SER1500 D0105

SECTION 12

SEE DE TAIL A

B

1

2

IN

B

3 4

1

OUT

4

2

4 VIEW

8

3

1

3

2

6

4

B-B

2

NUT

3

9

5

7

5

6

7

3

2

BRACKET MOUNTIN G SCR EWS (2 P LCS)

2

DETAIL "A"

Flow Controller Assembly FCL1500A

SER1500 D0105

12-15

SECTION 12 FCL1500A Parts List Part Number

Description

BKT550M

FLOW CONTROLLER POT BKT

1.00

07

RVP410M

POT 6637S-445-502

1.00

06

GRS129P

GREASE - MCG129 CHRISTO-LUBE

0.00

04

ORG150P

METRIC O-RING 7.5MM X 2MM

2.00

03

FTG300M

FITTING FCL

2.00

02

FCL250P

FLOW CONTROL W/POT IND.

1.00

01

SCP02505P

Screw M2.5 X 5mm Flathead Phillips

0.00

08

WSH500P

3/8 WASHER SHAKEPROOF

1.00

09

WSH1210M

Washer, Pot Mounting

1.00

10

SER1500 D0105

Quantity

Item Number

12-16

ASSEMBLY DRAWINGS WITH PARTS LIST

4X 84

REGULATOR BLOCK ASSEMBLY SEE DETAIL FOR ASSEMBLY

2X

3

103

62 62 60

65 99

3

102

DETAIL E PROPORTIONAL BLOCK ASSEMBLY 2X 70 70 2X 105 2X 105

87

INCLUDES: PROPORTIONAL VALVE ASS

ALARM PISTON ASSEMBLIE

SER1500 D0105

SECTION 12

A 64

66 91

(58)

1

58

A

106 2x 76 2X

59

79 2x (4 1/4" LG)

REGULATOR ASSEMBLY DETAIL 15

4 104 2X 80 2X 54

MIXER ALARM DETAIL

SEMBLIES

ES

MIXER ASSEMBLY MIX1725A

12-17

SECTION 12 MIX1725A Parts List Part Number

Description

CON100P REG1700P BKT1726M HSG1726M TUB100P HSG1725A SCR1725P LBL1701P SCR1707P PLG1725P SCR1728P SCR1726P NUT832P CAP210P KNB1550P PNL1725A WSH1705Q ALM1725S GLP100P ADH222P

CONNECTOR 1/16T X 10-32M REGULATOR, MINI REGULATOR MOUNTING BRACKET FRONT HOUSING CLEAR URE TUBING 1/16 X 1/8 BACK HOUSING ASSY SCREW, 8-32 X .25 LG POWDERCOATED Label, Serial Number CAP SCREW, M5 X 55mm PLUG, 5/8" NICKEL PLATED SCREW, BTN HD M3 X .5 X 8 MM LG SCREW, FL HD M5 X .08 X 10 MM LG 8-32 NYLON INSERT NUTS S/S SELCO CAP PLAIN- LARGE- GRAY KNOB POINTER COMBO. ASSEMBLY, FRONT PANEL OVERLAY Washer, #10 Countersunk ALARM REPLACEMENT INSULATING VARNISH- GLYPTOL LOCTITE, SMALL SCREW THREADLOCKER ELBOW

ELB152P

SER1500 D0105

Quantity

Item Number

3.00 1.00 1.00 1.00 1.00 1.00 2.00 2.00 4.00 1.00 2.00 2.00 2.00 1.00 1.00 1.00 2.00 1.00 0.00 0.00

15 58 59 62 79 64 76 91 84 66 70 80 87 102 65 60 104 54 99 105

2.00

106

12-18

ASSEMBLY DRAWINGS WITH PARTS LIST

12-19

SER1500 D0105

SECTION 12

1

2

3

A

B

4

1

A

1

5

2

B

PART OF ITEM 1

2

REF

2 REF

VIEW B-B

VIEW A-A

1 REF

1

REF

PEEP NEEDLE VALVE ASSEMBLY NDL1500A SER1500 D0105

12-20

SECTION 12

NDL1500A Parts List Part Number

Description

NDL1500P

Needle Valve

1.00

1

RVP1500P

10 TURN POTENTIOMETER

1.00

2

BKT1504M

Bracket, Peep Valve

1.00

3

GER1510P

Gear,Peep, !/4 " hub

1.00

4

GER1511P

Gear,Peep, 3/16" hub

1.00

5

SER1500 D0105

Quantity

Item Number

12-21

13. REPACKING AND SHIPPING INSTRUCTIONS

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 RGA (Return Goods Authorization) . . . . . . . . . . . 13 Packaging: Complete Unit . . . . . . . . . . . . . . . . . 13 Packaging: Parts or Accessories . . . . . . . . . . . . 13

SER1500 D0105

-

1 1 1 1

SECTION 13 INTRODUCTION This section will help ensure that returns are properly packaged, the risk of shipping damage is reduced and that the return is delivered to the correct Department within Newport Medical Instruments. Please follow the instructions below. This will help you avoid any inconveniences or delays when returning merchandise.

RGA (Return Goods Authorization) 1. All returns to Newport Medical Instruments must have an RGA number assigned. Returning goods without an RGA number could delay service, replacement or credit issues. 2. To obtain an RGA number please call Newport Medical Instruments during business hours (800.451.3111 or 714.427.5811). Dial extension 500 for any parts or products being returned to the Technical Service Department for maintenance, warranty or non-warranty repairs. Dial extension 282 (Customer Service Department) for all other returns or FAX your request to 714.427.0489, attention Customer Service.

PACKAGING: COMPLETE UNIT 1. When returning an E100M Ventilator, the original box and packaging must be used. If you do not have the original box and packaging, please contact the Technical Service Department at extension 500 to have one shipped to you. 2. Remove all accessories from the ventilator except for the air inlet water trap. 3. Do not ship any accessories unless they are requested by a Technician. 4. Once the ventilator is sealed in the box, write the RGA number on the shipping label. 5. When addressing the shipping label, use the following address: Newport Medical Instruments, Attention: Receiving Dept., 1620 Sunflower Avenue, Costa Mesa, California, USA 92626.

PACKAGING: PARTS OR ACCESSORIES 1. When returning any parts or accessories, please package them in a large enough box that the parts or accessories can be wrapped in a sufficient amount of packaging material. 2. Once the parts or accessories are sealed in the box, write the RGA number on the shipping label. 3. When addressing the shipping label, use the following address: Newport Medical Instruments, Attention: Receiving Dept., 1620 Sunflower Avenue, Costa Mesa, California, USA 92626. NOTE: When calling Newport Medical Instruments regarding a return, please have your assigned RGA number available to avoid any delays in answering your inquiry. SER1500 D1104

13-1