Manual e100m Serman Rev d 2202

Service ManualSER1500 Rev. D

01/07/05

NEWPORT MEDICAL INSTRUMENTS1620 Sunflower Avenue

Costa Mesa, CA 92626Tel: 1.714.427.5811

1.800.451.3111 (USA only)Fax: 1.714.427.0489

Customer Service Ext. 282

www.ventilators.comemail: [email protected]

0050

Newport Medical Instruments, Inc.NEWPORT E100M VENTILATOR

SER1500 D0105 i

TABLE OF CONTENTSSection 1. . . . . . . . OPERATORS RESPONSIBILITY

Operators 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

ii SER1500 D0105

Section 5 . . . . . OPERATIONAL VERIFICATION PROCEDURE (OVP) Introduction Set Up Standard Test Settings Pressure Gauge Verification Alarm/LED Check Mixer Alarm FIO2 (respiratory frequency) tI (inspiratory time) SPONT V1 SPONT V2 V (flow) PEEP/CPAP Low Baseline Alarm, RESET and

Alarm Loudness Control Paw (High Pressure) Alarm Paw (Low Pressure) Alarm Ptrig (trigger level) and MODE Select Apnea Alarm Manual Inflation Button NEB (Nebulizer) Internal Battery Back-Up Control Monitor Paw Monitor, (peak, mean, base) Proximal Line Purge Advanced Trigger Control (ATC) Auto Set (AS) Alarms Time-Limited Demand Flow E100M Test Record

Section 6 . . . . . PREVENTIVE MAINTENANCE PROCEDURE

Introduction Tools Required Parts Required Maintenance Procedure

Section 7 . . . . . OVERHAUL PROCEDURE

Introduction Tools Required Parts Required Overhaul Procedure

SER1500 D0105 iii

Section 8 . . . . . ELECTRONIC & PNEUMATIC CALIBRATION

Introduction Electronic Verification Pressure Gauge Calibration Front Panel Calibration V (flow) tI (inspiratory time) (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)

iv SER1500 D0105

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

SER1500 D0105

1. OPERATORS RESPONSIBILITY

Operators Responsibility for Patient Safety. . . . 1 - 1Limitation of Liability . . . . . . . . . . . . . . . . . . . . . . 1 - 1Warranty. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 2Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 3Warnings and Cautions . . . . . . . . . . . . . 1 - 3 to 1 - 5Factory Maintenance or Repair . . . . . . . . . . . . . . . 1-6Contact Information. . . . . . . . . . . . . . . . . . . . . . . . 1-6

SECTION 1

SER1500 D0105 1-1

OPERATORS RESPONSIBILITY FOR PATIENT SAFETY

For correct and effective use of the product and in order to avoidhazards, it is mandatory that you carefully read and observe allsections of this manual.

The design of the E100M Ventilator, the Manuals, and the labeling on theventilator take into consideration that the purchase and use of theequipment are restricted to trained professionals, and that certaininherent characteristics of the ventilator are known to the trainedoperator. Instructions, warnings and caution statements are limitedtherefore largely to the specifics of the Newport design. This manualexcludes references to various hazards which are obvious to a medicalprofessional and operator of this equipment, to the consequences ofproduct misuse, and to potentially adverse effects in patients withabnormal conditions. Product modification or misuse can be dangerous.Newport Medical Instruments, Inc. disclaims all liability for theconsequences of product alterations or modifications, as well as for theconsequences which might result from the combination of this ventilatorwith other products whether supplied by Newport Medical Instruments,Inc. or by other manufacturers if such a combination is not endorsed byNewport Medical Instruments, Inc.

Federal Law and Regulations in the United States and Canadarestrict this device to sale by or on the order of a physician.

The operators of the ventilator must recognize their responsibility forchoosing appropriate safety monitoring that supplies adequateinformation on equipment performance and patient condition. Patientsafety may be achieved through a wide variety of means such aselectronic surveillance of equipment performance and patient condition,but surveillance equipment should not take the place of directobservation of clinical signs. The ventilator operator is solely responsiblefor the selection of the best level of patient monitoring.

LIMITATION OF LIABILITY

Newport Medical Instruments, Inc. liability, whether arising out of, orrelated 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 andconditions as set forth, whether based upon breach of warranty or anyother cause of action whatsoever, regardless of any fault attributable toNewport Medical Instruments, Inc. and regardless of the form of action(including, without limitation, breach of warranty, negligence, strictliability, or otherwise).

The stated expressed warranties are in lieu of all other warranties,expressed or implied, including, without limitation, warranties ofmerchantability, fitness for any purpose, or noninfringement.

OPERATORS RESPONSIBILITY

1-2 SER1500 D0105

Newport Medical Instruments, Inc. shall not be liable for, nor shall thebuyer be entitled to recover, any special incidental or consequentialdamages or for any liability incurred by buyer to any third party in anyway 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 bymodifications not authorized by Newport Medical Instruments, Inc.or its representatives are not covered.

2. Rubber and plastic components and materials are warranted to befree of defects at time of delivery.

Any product which proves to be defective in workmanship or materialwill be replaced, credited, or repaired with Newport Medical Instruments,Inc. holding the option. Newport Medical Instruments, Inc. is notresponsible for deterioration, wear, or abuse. In all cases, NewportMedical Instruments, Inc. will not be liable beyond the original sellingprice.

Federal Law in the United States requires traceability of thisequipment. Please return the self addressed Warranty RegistrationCard 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 representativesmust be promptly notified upon detection of the defective material orequipment.

2. Defective material or equipment must be returned to NewportMedical Instruments, Inc. or its authorized representative.

3. Examination by Newport Medical Instruments, Inc. or its authorizedrepresentatives must confirm that the defect is covered by the termsof this warranty.

In order to assure complete protection under this warranty, theWarranty Registration Card must be returned to Newport MedicalInstruments, Inc. within ten (10) days of receipt of the equipment.

The above is the sole warranty provided by Newport MedicalInstruments, Inc. No other warranty expressed or implied is intended.Representatives of Newport Medical Instruments, Inc. are not authorizedto modify the terms of this warranty.

SECTION 1

SER1500 D0105 1-3

WARNING A WARNING statement refers to a condition with thepossibility of personal injury if disregarded.

Caution A Caution statement designates the possibility of minor ormoderate injury to the user or patient or damage to equipment ifdisregarded.

NOTE: A NOTE provides additional information intended to avoidinconveniences during operation or indicates important procedures tofollow.

Inspection: examination of actual condition

Service: measures to maintain specified condition

Repair: measures to restore specified condition

Maintenance: inspection, service, repair, where necessary

PreventiveMaintenance: maintenance performed at regular intervals

Within the text of this manual, controls, alarms, buttons, etc. aredesignated by the labeling name as they appear on the ventilator, e.g.:Plimit (pressure limit), Ptrig (pressure trigger), SPONT (spontaneousmode).

Please review all warnings and cautions outlined in this manualbefore operating the ventilator.

WARNINGS AND CAUTIONS

Strictly follow this Manual. Any use of the product requires fullunderstanding and strict observation of all sections of these instructions.The equipment is only to be used for the purpose specified underIntended Use (See Section 2) and in conjunction with appropriateairway monitoring. Observe all WARNINGS and Cautions as renderedthroughout this manual and on labels on the equipment.

To maintain grounding integrity, connect only to a hospital gradereceptacle. Always disconnect power supply before servicing.

DANGER, there is a risk of explosion if used in the presence offlammable anesthetics.

All settings and adjustments in the different modes of ventilation have tobe made according to the therapy prescribed by a physician.

Newport Medical Instruments, Inc. cannot warrant or endorse the safeperformance of third party humidifiers for use with the E100M Ventilator.

We recommend contacting the manufacturers/distributors of third partyhumidifiers about compliance of their products with the requestedperformance characteristics.

General Warnings

Typing Conventions

DEFINITIONS


1-4 SER1500 D0105

Do not use antistatic or electrically conductive patient circuits. Alwaysuse a clean, sterile breathing circuit.

The ventilator is ready for operation only when:a) it is completely assembled andb) a Quick Check procedure has been performed successfully.

Whenever a patient is connected to the ventilator, constant attention byqualified medical staff is recommended.

If a fault is detected in the ventilator and its life support functions are indoubt, discontinue use and use an alternative method of ventilation.

If the built-in monitoring malfunctions, provide a substitute in order tomaintain an adequate level of monitoring.

Failure to identify and correct alarm situations may result in patientinjury.

Use an external monitor to verify the accuracy of the oxygenconcentration delivered to the patient at all times.

When the Low Battery ( Battery ) audible alarm soundscontinuously, only 10% of the internal battery charge remains and analternate power source should be found immediately. Charge the batteryfor a minimum of 5 hours before again powering the ventilator from theinternal battery. This will provide approximately 80% of the batterycharge. If the battery is completely depleted, it will take approximately14 to 16 hours to fully recharge.

The internal battery should be fully charged at least once every 6months to ensure that it remains functional.

Water traps should be used in appropriate locations of the breathingcircuit in order to prevent water that has accumulated in the circuit frombeing drained towards the patients airway.

Newport Medical Instruments, Inc. cannot endorse or warrant the safeperformance of nebulizers currently available when used with the E100MVentilator. Specifically, some disposable nebulizer assemblies operatewith flow rates different from the 10 L/min delivered by the ventilator at28 psig. We recommend contacting the manufacturers/distributorsselling nebulizing devices about compatibility of their products with therequested performance characteristics.

The flow resistance of filters is liable to increase through use, due toboth aerosol usage and humidification level. Make certain that filters arechanged regularly (especially those in the expiratory limb of thebreathing circuit).

The Plimit control should be set 4 to10 cmH2O/mbar above the _

Pawalarm limit as a safety pop-off when volume ventilating. In volumecontrol ventilation, an incorrect setting of the Plimit control could causesome volume to be vented. When pressure ventilating, the Plimitcontrol should be set to the plateau pressure level that is desired.

SECTION 1

SER1500 D0105 1-5

The E100M Ventilator is guaranteed to perform within specification whenthe Newport Medical permanent breathing circuit and the permanentexhalation valve are utilized. The Newport Medical permanent breathingcircuit with proximal sensing line is available in infant or adult sizes. If analternate circuit is used, the proximal pressure line must be a 1/8 in (3.2mm) I.D. for proper ventilator performance.

Only a Newport Medical permanent exhalation valve should be usedwith the E100M Ventilator.

Use only dry, clean, compressed air and medical grade oxygen. Water inthe air or oxygen supply can cause equipment malfunction and damage.

Mains voltage must correspond to the voltage range selected on thepower module of the ventilator. Always replace a blown fuse with one ofproper rating for corresponding voltage range.

Do not place containers of liquids in the immediate vicinity or on top ofthe E100M Ventilator. Liquids that get into the ventilator can causeequipment malfunction and damage.

Periodically inspect the Air Inlet Water Trap. Drain water from the bowlwhen necessary by depressing the pin at the bottom of the bowl.

Cautions


1-6 SER1500 D0105

FACTORY MAINTENANCE OR REPAIR

Scheduled maintenance or repair services are available from theNewport Technical Service Department. To send your ventilator in forservice, see Section 13 for packaging and shipping instructions. Currentpricing for scheduled maintenance and labor rates can be found inNewport Medical Instruments Annual Price List. To obtain a copy of thePrice List, please contact your local Newport Medical Instruments SalesRepresentative or call/fax our Customer Service Department using thenumbers that follow.

CONTACT INFORMATION

Address: Newport Medical Instruments, Inc.1620 Sunflower AvenueCosta Mesa, CA 92626

Phone Numbers: 800.451.3111 Toll free within the United States1.714.427.5811 Worldwide

Fax Numbers: 1.714.427.04891.714.427.0572 Fax Direct Technical Service Dept.

Web Site: www.ventilators.com email: [email protected]

Department Extensions: Customer Service Department: 282Technical Service Department: 500 (24 Hour pager activated

after business hours)Clinical Support: 123 (24 Hour pager activated)

Corporate Office Hours: Monday through Friday 8:00 am to 5:00 pm, Pacific Time, USA

Technical Service Department Hours: Monday through Friday 7:00 am to 4:00 pm, Pacific Time, USA

EU Representative: Newport Medical Instruments, Inc.Att: Robert Brinkc/o Braun & Co.19 Pasture Rd.Barton-on-HumberNorth LincolnshireDN18 5HN, Englandtel: ++44.77 68 231311fax: ++44.1652 633399

SER1500 D0105

2. SPECIFICATIONS

Ventilator Overview . . . . . . . . . . . . . . . . . . . . . . 2 - 1Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . 2 - 2Symbols/Labeling Table . . . . . . . . . . . . . . . . . . 2 - 2Specifications. . . . . . . . . . . . . . . . . . . . 2 - 5 to 2 - 9

SECTION 2

SER1500 D0105 2-1

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 DemandFlow)

Good balance of simplicity and capability:

21-100% Oxygen: Available from integrated high pressure air/oxygenprecision mixer

Built-in PEEP/CPAP with Electronic Control for stability of baseline andease of adjustment

Internal Battery 6-8 Hours: facilitates easy patient mobility

Monitors including Total Breath Rate, I:E Ratio, Peak, Mean andBaseline Pressure, and Set Tidal Volume

Real-time proximal airway or mainflow outlet pressure display withvisual sensitivity Trigger setting indicator.

Logical Face Panel Layout With Color Coded Displays: Simplifiestraining and operation, with reduced confusion for home caregivers

Small Size And Footprint: Offer flexibility in mounting and carryingoptions

Inverse I:E 4:1 & APRV Capability: Advanced functions for advancedapplication

Graphics Display Monitor Optional in countries where available

SPECIFICATIONS

2-2 SER1500 D0105

Indications For Use: The Newport E100M is intended to provide positivepressure ventilation for neonatal, infant, pediatric and adult patients, foruse in the hospital environment. The device is intended for use by or atthe direction of a licensed practitioner.

SYMBOLS/LABELING TABLE

INTENDED USE

Alarm Silence/Reset Button

Reset

Apnea Time Delay

Apnea (s)

Select Button Low Battery Alarm Indicator

Battery

Adjust High and Low Paw Alarm

Paw Alarm Push to set only Paw

Spont

Spont (Patient Effort) Indicator

Paw

Paw

High Airway Set High AirwayPressure Alarm Indicator Pressure Alarm

Paw PawLow Airway Set Low Airway

Pressure Alarm Indicator Pressure Alarm

SECTION 2

SER1500 D0105 2-3


Automatic Control Buttons(see Paw Alarm and Ptrig)

AS

Exhalation Valve Tubing Connection

EXH VLVNEB

Nebulizer Tubing Connection

PROX

Prox. Pressure Tubing Connection Ventilator Main Flow OutletConnection for Patient Breathing

Circuit/Humidifier

PATIENT

Refer to Operating Manual

!

SPONT V

2 Tubing Connection SPONT V

2 Flowmeter Connection

Reservoir Bag Connection

!

ATC

SPECIFICATIONS

2-4 SER1500 D0105


Type B

External Alarm Silence ConnectorAlarm Loudness Control

REMOTEALARMOUTPUT

Remote Alarm Output

Main Power On

Equipotentiality

Main Power Standby

Back Panel Labels

STDBY ON

SECTION 2

SER1500 D0105 2-5

E100M SPECIFICATIONS

1. MODE

2. Tidal Volume

( ) x TI

3. V (Mandatory Flow)

4. tI (Inspiratory Time)

5. (Respiratory Frequency)

6. PEEP/CPAP

7. Plimit (Pressure Limit)

8. Time-Limited Demand Flow

9. Manual Inflation

10. FIO2

11. NEB Button

12. PROX Button

13. Ptrig (Sensitivity)

14. ATC (Advanced Trigger Control)

15. Spont (Patient Effort) Indicator

V (L/min)60

A/CMVSIMVSPONT + APNEA A/CMVSPONT

5 to 5000 mL

1 to 100 L/min

0.1 to 3.0 sec

1 to 120 b/min

0 to 25 cmH2O/mbar

0 to 120 cmH2O (0 to 118 mbar)(Use for Pressure Limited Ventilation and/or as asafety pop-off above the

_Paw in Volume

Control.)

to 1.0 sec (Spont breath)

4 sec maximum(Pushing this button closes the exhalation valveand delivers mixed gas to the patient accordingto the V setting.)

.21 to 1.00

Toggles nebulizer gas source on and off.(10 L/min mixed gas, inspiration only)

Toggles proximal pressure monitoring on and off.(On: proximal pressure monitoring,Off: mainflow outlet pressure monitoring)

10 to +25 cmH2O/mbar

Toggles ATC function on and off.(When on, automatically manages trigger levelsetting for patient.)

Blinks once each time airway pressure drops belowthe Ptrig setting.

Control/Parameter/Indicator Range/Selection

Pressureor

Volume

SPECIFICATIONS

2-6 SER1500 D0105


16. Paw Alarm

17. AS (Auto-Set Alarms)

18. Paw Selector

19. Paw Monitor Display

20. Pressure Gauge

21. Control Monitor Selector

22. Control Monitor Display

23. Apnea Selector

24. Reset (Alarm Silence)

25. ALARMS Indicators

26. tI > tE Indicator

27. SPONT V 2 Flowmeter

Set high and low airway pressure alarms_

Paw 5 to 120 cmH2O / 5 to 118 mbarPaw 3 to 118 cmH2O / 3 to 116 mbar

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

Selects airway pressure parameter (peak, mean,base) to be displayed in the Paw Monitor window ofpressure gauge.

0 to 99 cmH2O (0 to 97 mbar)(peak, mean, base pressure)

10 to +120 cmH2O (10 to +118 mbar)

Selects parameter (I:E, tot, VT) which is displayedin the Control Monitor display.

I:E (ratio): 1:99 to 4:1 tot: 0 to 255 b/min VT: 0.00 to 5.00 L% Charge of Battery: 0 to 99

(Percent of charge displayed when InternalBattery Test button on rear panel is pressed andventilator is running on battery power.)

Selects time delay interval for the Apnea alarm, (disable), 15, or 30 seconds.

Silences an alarm violation for 60 seconds, resets alatched alarm indicator and cancels Power Downalarm.

Indicator for the alarm that is actively violated blinksred. When the alarm is no longer violated, theindicator latches (stays lit). Cancel a latched indicatorby pressing the Reset button.

A yellow indicator blinks any time the control settingsresult in an inverse I:E ratio.

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


SECTION 2

SER1500 D0105 2-7


28. SPONT V

1 Switch

29. Alarm Loudness Control

30. External Alarm Silence Input

31. RS-232C Interface

32. Remote Alarm Output

33. Hour Meter Display

34. Internal Battery Test Button

35. Power Switch

36. Loss of Gas Alarm

37. Power Down Alarm

Provides or 8 L/min mixed gas for spontaneousbreathing.

74 dbA 92 dbA.

Allows use of the NEWPORT External Alarm Silencecable which functions the same as the Resetbutton. Does not cancel the Power Down alarm.

Operates at 38,400 baud. Allows for interfacing withcentral monitoring and computer systems via 25 pinD type connector.

Provides contact closure when alarming. Operateswith most nurse call systems using a 1/4 in (0.64 cm)phone type connector.

Displays 0 to 199,999.9 hours

When pressed during battery power operation, %battery charge (0 to 99%) is displayed in ControlMonitor window.

This rocker type switch, (ON) or (STDBY) switchesventilator on and off. When the ventilator isconnected to A.C. power, the internal batterycharges regardless of switch position.

Continuous audible alarm. Activated if air or oxygensupply pressures drop below 28 3 psig.(No visual alarm indicator.)

Continuous audible alarm activated when the ventilatorpower switch is changed from (ON) to (STDBY).The alarm is silenced by pressing the Reset button.(No visual alarm indicator.)


SPECIFICATIONS

2-8 SER1500 D0105


38. Fault System Alarm

39. High Baseline Alarm(automatic)

40. Low Baseline Alarm(automatic)

Hardware

41. Electrical

42. Pneumatic

Miscellaneous

43. Operating Temperature

44. Operating Humidity

45. Operating Altitude

46. Regulatory and AgencyRequirements

47. Storage Temperature

48. Storage Humidity

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

Paw and Paw alarm indicators blink red and theaudible alarm sounds continually if Paw remainsabove Paw alarm setting at end exhalation.

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

Requirements

100/120 VAC 0.14 A maximum220/240 VAC 0.07 A maximum50/60 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 VACsetting and actual voltage exceeds 242 VAC,damage to ventilator may occur.

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

Description

0 to 40C

0 to 95% non-condensing

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

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

20 to 60C

0 to 95% non-condensing

Control/Parameter Indicator Range/Selection

SECTION 2

SER1500 D0105 2-9


49. Height

50. Width

51. Depth

52. Weight

53. Patient Range

54. Internal Compressible Volume

55. Flow Waveforms Available

56. Patient Circuit

57. Exhalation Valve

10.5 in (26.7 cm)

9.5 in (24.1 cm)

6.5 in (16.5 cm)

18 lbs (8.2 kg)

Neonate Pediatric Adult

29 mL

Volume Control square Pressure Limit decelerating

(with P limit set to limit pressure)

Reusable or disposable adult, pediatric or neonatecircuits, with or without 1/8 in (3.2 mm) I.D. proximalpressure sensing lines. Main flow outlet andexhalation valve have a 22 mm standard taper.

NEWPORTs exhalation valve is manufactured anddesigned specifically for NEWPORT Ventilators.NEWPORT does not recommend the use of any othertype or brand of exhalation valve.

Miscellaneous Description

SER1500 D0105

3. DESCRIPTION OF CONTROLS,BUTTONS & INDICATORS

Front Panel Controls . . . . . . . . . . . . . . . . . . . . . . . 3 - 23Front Panel Buttons . . . . . . . . . . . . . . . . . . . . . . . 3 - 73Front Panel Indicators. . . . . . . . . . . . . . . . . . . . . . 3 - 12Misc. Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 13Left Side Controls . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 15Rear Panel Controls/Switches . . . . . . . . . . . . . . . 3 - 17Rear Panel I/O Connectors . . . . . . . . . . . . . . . . . . 3 - 17Right Side Labeling. . . . . . . . . . . . . . . . . . . . . . . . 3 - 21

SECTION 3

SER1500 D0105 3-1

.21

.30

.40

.50.60

.70

.80

.90

1.00

-10010

20

30

40

50

6070 80 90

100

110

120

E100M

0.7

1.0

0.3

0.1

0.5

Apnea

Paw

Paw

ALARMSReset

(cmH20)

peakmeanbase

Ptrig Paw Alarm

Apnea (s)15300

MODESPONT

SPONT+APNEA A/CMV

SIMV

A/CMV

I:E tot

FIO2

VT (L)

V (L/min)

20

105

MIN

MAX

3040

50

60

70

8090100

1.0

0.5

0.1

1.52.0

2.5

3.0

tI > tEtI (s)

1

10

2030

40

60

80

100

120

(b/min)

Spont

PlimitPEEP/CPAPPbase

Demand Flow (s) ManualInflation

EXH VLV NEB PROX PATIENT

0

A S ATC

NEB PROX

V ENTILATOR

Push to set only Paw

Battery

Time-Limited

Paw

Figure 3-1E100M FRONT PANEL

DESCRIPTION OF CONTROLS, BUTTONS & INDICATORS

3-2 SER1500 D0105

FRONT PANEL CONTROLS

Front panel controls that have corresponding indicators (i.e. Paw Alarmcontrol with Paw/Paw indicators) are included with the description ofthe control. The E100M front panel is shown in Figure 1.

MODE Control

A/CMV(Assist/Control Mandatory Ventilation)

The minimum number of time triggered mandatory breaths is determinedby the control. The total number of mandatory breaths is a result ofthe setting and patient triggers. Set the Ptrig as close to baselinepressure as possible so that all patient efforts are recognized as patienttriggers. The indicator for A/CMV is lit green while operating in thismode.

NOTE: If the Ptrig setting is not adjusted to a level that allows thepatients inspiratory effort to be detected, the A/CMV mode resemblesControl mode.

SIMV(Synchronized Intermittent Mandatory Ventilation)

The number of time triggered mandatory breaths is determined by the control. The patient can take spontaneous breaths between the deliveryof the mandatory breaths. Set the Ptrig as close to baseline as possibleso that all patient efforts are recognized as patient triggers. This allowsthe E100M to synchronize the mandatory breaths and spontaneousTime-Limited Demand Flow breaths with patient effort. Time-LimitedDemand Flow may be used to support spontaneous efforts with a higherinitial flow which then drops to the lower Spont Flow. The indicator forSIMV is lit green while operating in this mode.

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

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

MODESPONT

SPONT+APNEA A/CMV

SIMV

A/CMV

MODESPONT

SPONT+APNEA A/CMV

SIMV

A/CMV

MODESPONT

SPONT+APNEA A/CMV

SIMV

A/CMV

SECTION 3

SER1500 D0105 3-3

SPONT(Spontaneous Ventilation)

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

Ventilation Controls

FIO2Determines the air/oxygen mixture for all gas delivery to the patient.

Range: .21 to 1.00

NOTE: When the FIO2 is readjusted, the oxygen concentration willstabilize in the Reservoir Bag in approximately 30 seconds (dependingon SPONT V1 and V2 settings).

V(mandatory flow)

Sets the flow delivered to the patient during mandatory breaths (volumeor pressure), APNEA A/CMV breaths, Time-Limited Demand Flow, andManual Inflation.

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

Pressure Ventilation: Adjust V to achieve desired inspiratory pressurerise/slope.

Normal flow ranges for neonatal, pediatric, and adult patients areindicated by the three different green lines around the dial.

Range: 1 to 100 L/min

tI(inspiratory time-mandatory)

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

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

Pressure Ventilation: Adjust tI and to set appropriate I:E ratio.

Range: 0.1 to 3.0 sec

1.0

0.5

0.1

1.52.0

2.5

3.0

tI > tEtI (s)

V (L/min)

20

105

MIN

MAX

3040

50

60

70

8090100

.21

.30

.40

.50.60

.70

.80

.90

1.00

FIO2

MODESPONT

SPONT+APNEA A/CMV

SIMV

A/CMV


3-4 SER1500 D0105

(respiratory frequency)

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

Range: 1 to 120 b/min

Time-Limited Demand FlowDetermines the duration of time flow support is provided for spontaneousbreaths in SIMV or either SPONT mode. The amount of flow support isdetermined by the V setting. The exhalation valve remains at thePEEP/CPAP level during Time-Limited Demand Flow breaths. A patient cancontinue spontaneous inspiration from gas provided by SPONT V1 and/orSPONT V2 and draw gas from the reservoir bag after Time-LimitedDemand Flow ends. The indicator for Time-Limited Demand Flow is litgreen while in use.

Range: to 1.0 sec

P limit(pressure limit)

Plimit determines the maximum pressure for all breaths. If airwaypressure reaches the P limit setting, flow vents to prevent airwaypressure from going higher. Clockwise rotation increases the maximumPlimit level.

Pressure Ventilation: Use the P limit control to set the peak inspiratorypressure for all mandatory breaths. The inspiratory pressure rise/slope isdetermined by the V setting.

Volume Ventilation: Use the Plimit control to set a safe pressure pop-offabove the

_Paw alarm setting.

Range: 0 to 120 cmH2O (0 to 118 mbar)

NOTE: Plimit must be set lower than the _

Paw alarm when pressureventilating. If Vand tI are not set appropriately, P limit may not beachieved during mandatory breaths.

WARNING When volume ventilating, P limit must be set higher thanthe

_Paw alarm, otherwise volume may be vented.

PEEP/CPAPEstablishes the pressure in the patient circuit from end exhalation to thestart of the next inspiration. Also referred to as base or baselinepressure.

Range: 0 to +25 cmH2O/mbar

PEEP/CPAPPbase

Plimit

0.7

1.0

0.3

0.1

0.5 Demand Flow (s)

0

Time-Limited

1

10

2030

4060

80

100

120

(b/min)

SECTION 3

SER1500 D0105 3-5

P trig Control and SPONT Indicator (sensitivity)

The Ptrig control knob adjusts the patient trigger sensitivity setting onthe E100M. The trigger sensitivity setting determines the amount ofnegative pressure (inspiratory effort) the patient must generate in thebreathing 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 clickrepresents a trigger sensitivity level change of ~0.14 cmH2O/mbar.Rotating it through seven clicks changes the trigger sensitivity by onecmH2O/mbar, i.e., one pressure gauge segment. (The selected segmentblinks on the electronic pressure gauge.) Rotate the Ptrig controlcounter-clockwise to increase the patient effort required to trigger andclockwise to decrease the effort required.

The Spont indicator blinks when the E100M detects a trigger. TheApnea 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 detectedby the Ptrig.

Spont indicator doesnt blink: Indicates no spontaneous effort is detectedby the Ptrig.

NOTE: Each time the Spont indicator blinks or a mandatory breath isdelivered, the Apnea alarm delay is reset.

Range: 10 to +25 cmH2O/mbar

PawAlarm Control and Indicators (Adjust Paw and Paw alarms)

The _

Paw (high) and Paw (low) pressure alarm settings are adjustedby rotating the Paw Alarm knob. Settings are displayed on thepressure gauge as non-blinking bars.

Default settings: _

Paw 30 cmH2O/mbarPaw 10 cmH2O/mbar

Range: _

Paw 5 to 120 cmH2O / 5 to 118 mbarPaw 3 to 118 cmH2O / 3 to 116 mbar

Adjusting Paw: Rotate the Paw Alarm knob clockwise toincrease, counter-clockwise to decrease the alarm setting.

NOTE: Adjusting the Paw alarm setting also adjusts the _

Paw alarmsetting.

Adjusting _

Paw: Push Paw Alarm knob in, then rotateclockwise to increase, counter-clockwise to decrease the alarm setting.

NOTE: Adjusting the _

Paw alarm setting does not adjust the Pawsetting.

Paw Alarm

A S


Spont

Spont

Ptrig Spont

ATC


3-6 SER1500 D0105

Paw Alarm (user adjustable)

If airway pressure reaches the _

Paw (high pressure) alarm setting aPaw alarm violation occurs, and any breath in progress cycles toexhalation. The alarm resets when airway pressure drops below the_

Paw setting.

Audible Alarm: intermittent beepVisual Alarm: Paw indicator blinks red

Paw Alarm (user adjustable)

If airway pressure does not rise above the Paw (low pressure) alarmsetting during inspiration, then drop below the Paw alarm settingduring exhalation, a Paw alarm violation will occur on mandatorybreaths. The alarm is reset when one mandatory breath is deliveredwithout a Paw alarm violation.


Low Baseline Alarm Paw(automatic)

A Low Baseline violation indicates an unstable baseline (leak in thebreathing circuit) or that baseline has decreased, possibly due to aSPONT V 1 or SPONT V

2 adjustment, since the last PEEP/CPAP controlchange. In all modes, if airway pressure drops below the Low Baselinealarm default selection for 3 sec, a Low Baseline violation occurs. Thisalarm is indicated the same as a Paw violation. The alarm resets whenairway pressure rises to the alarm table default setting.


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)

A High Baseline violation alerts the user to a potential blockage orocclusion in the breathing circuit. During mandatory breaths, a HighBaseline violation occurs if airway pressure does not drop lower than thePaw alarm setting before the start of the next mandatory breath.

Audible Alarm: continuous beepVisual Alarm: Paw and Paw indicators blink red

Apnea

Paw

Paw

ALARMS

Battery

Apnea

Paw

Paw

ALARMS

Battery

Apnea

Paw

Paw

ALARMS

Battery

Apnea

Paw

Paw

ALARMS

Battery

SECTION 3

SER1500 D0105 3-7

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 InflatonUsed to deliver a single, operator controlled manual inflation. Inspirationis terminated if the button is released, the Paw alarm is violated, or 4seconds have elapsed. Flow is determined by the Vcontrol setting.Manual Inflation is available in all modes but will not function in theevent of a Fault System Alarm condition.

Range: 0 to 4 sec

NEB(nebulizer gas source)

Activates a 28 psig (1.9 Bar) mixed gas source for powering a lowvolume nebulizer. NEB function is available during all mandatory, Time-Limited Demand Flow, and Manual Inflation breaths. Push button totoggle 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 tothe patient breathing circuit is 8 L/min. The additional 8 L/min flow isreflected in the VT calculation displayed in the Control Monitor. You cancompensate for the additional flow by reducing the Vcontrol setting by 8L/min when the NEB indicator is lit.

PROX(proximal mainflow pressure monitoring)

Selects the location for monitoring airway pressure and patient efforts(triggering). Monitoring location is at the main flow outlet of the ventilatoror at the proximal monitoring line of the breathing circuit.

PROX Button Indicator unlit: PATIENT main flow outlet monitoring

PROX Button Indicator lit: PROX monitoring

NOTE: Proximal pressure monitoring may enhance recognition of thepatients inspiratory efforts. A breathing circuit with a proximal pressuremonitoring line is required for proximal pressure monitoring.

PROX

PROX

NEB

NEB

ManualInflation

NEB On/Off Button

NEB Connection

PROX On/Off Button

PROX Connection


3-8 SER1500 D0105

Control Monitor Selector & Display

I:E (Inspiration to Exhalation ratio)

A/CMV mode: I:E calculated from total and tI setting.

SIMV mode: I:E calculated from and tI setting.

SPONT modes: same as SIMV mode.

If the and tI control settings result in an I:E that is not allowable, thedisplay flashes and the tI is shortened in order to stay within anallowable range.

Range: 1:99 to 4:1

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

tot(total frequency)

tot is the total number of time triggered and patient triggered breathsdetected in the last 60 seconds.

Range: 0 to 255 b/min

VT (L)(calculated tidal volume)

Set VT is calculated from the Vand tI control settings and is displayed inliters (L). Increasing either control increases tidal volume.

Range: 0 to 5 L

NOTE: When pressure ventilating a patient, the VT display may notaccurately reflect the tidal volume delivered to the patient.

Battery in Use and % ChargeThe Control Monitor displays -b- anytime the ventilator is powered bythe internal battery. You can select I:E, VT or tot, but after 30 secondsthe display reverts back to -b-.

I:E tot

VT (L)

I:E tot

VT (L)

.6 5

I:E tot

VT (L)

1 8

I:E tot

VT (L)

1.2.0.

SECTION 3

SER1500 D0105 3-9

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

NOTE: When the ventilator is powered by internal battery power and theInternal Battery Test button on the rear panel is pressed, the % ofbattery charge remaining is displayed in the Control Monitor. Theventilator must be running on battery power for a minimum of 5 minutesprior 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.

Paw Button & DisplayRange: 0 to 99 cmH2O (0 to 97 mbar)

NOTE: Automatic selection of monitored values occurs with certaincontrol changes or specific conditions. Certain conditions do not allowdisplay of some values. When the display shows --, the measuredvalue is out of the monitors range.

peakIn A/CMV and SIMV mode, peak pressure is updated at the end of eachmandatory breath or manual inflation.

In either SPONT mode, peak pressure is not displayed unless APNEAA/CMV is activated or a Manual Inflation is delivered.

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

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

Paw(cmH20)

peakmeanbase

Paw(cmH20)

peakmeanbase

Paw(cmH20)

peakmeanbase

-1001020

30

40

50

6070 80 90

100

110

120

Paw(cmH20)

peakmeanbase

I:E tot

VT (L)

7 5 P


3-10 SER1500 D0105

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

The Auto-Set (AS ) alarm button activates a function that automaticallyselects

_Paw and Paw alarm settings. The settings are based on the

current peak airway pressure for mandatory breaths at the time thebutton is pressed. Any time a change is made to a primary ventilatorcontrol, the AS button must be pressed again in order to select new_

Paw/Paw alarm settings. Primary controls include Mode, InspiratoryTime (tI), Flow (V

), Frequency () and PEEP/CPAP.

The AS function can move the Paw alarm setting anywhere within itsspecified range. The

_Paw alarm setting will increase a maximum of 10

cmH2O from its prior setting with each activation of the AS button. If thePaw alarm is still being violated after the 10 cmH2O increase, the ASfunction turns off (unlit). This alerts you to the fact that the changesmade to the ventilator controls or changes in the patient condition haveresulted in a significant increase in peak pressure. Press the AS buttonagain to reactivate the AS function.

WARNING Make certain the patient is being ventilated at anappropriate peak airway pressure before pressing the AS alarm button.

NOTE: For a detailed description of the Auto-Set alarm function, seeAuto-Set Alarms in Section 4, Theory of Operation, Page 4-10.

AS alarm indicator lit green: _

Paw and Paw alarm levels have beenselected by the AS function.

AS alarm indicator unlit: Alarms set manually by the Paw Alarmcontrol knob, a primary control has been changed since pressing ASor a 10 cmH2O increase occurs during the initiation of AS function whilethe 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 thepressure gauge blink.

Advanced Trigger Control (ATC )

The ATC button activates a function that keeps the Ptrig setting assensitive as possible within a specified range, with the goal ofpreventing artifact triggering. The most sensitive trigger level adjustmentthat the ATC targets is determined by the ATC Target Trigger Look-upTable, (see Section 4, Theory of Operation, Figure 4-1). The leastsensitive position is 2 cmH2O/mbar less than the assessed baselinepressure. The Ptrig setting is displayed on the pressure gauge as ablinking bar.

Paw Alarm

A S


AS

SECTION 3

SER1500 D0105 3-11

NOTE: For a detailed description of ATC, see Advanced Trigger Controlin Section 4, Theory of Operation, Page 4-9.

NOTE: When ATC is first activated, self triggering of the ventilator mayoccur for a number of breaths until the ideal trigger setting isdetermined.

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

ATC indicator unlit: Ptrig level set manually by Ptrig control.

NOTE: Always re-activate the ATC function to readjust trigger settingwhen SPONT V1 or V2 is changed, since a shift of the baseline pressuremay occur.

Apnea and Apnea Alarm

The Apnea selector determines the time interval before an apneaalarm violation occurs if no time or patient triggers occur. Theselections are 30 seconds, 15 seconds, and (disabled). A detectedpatient effort (trigger) is indicated by a lit Spont detect indicator. Toselect (disabled Apnea alarm), press Apnea button until a beepis heard (approximately 1 second).

selection is available if: A/CMV or SIMV: > 2 b/minSPONT: CPAP > +3 cmH2O/mbar

WARNING The (disabled) position should not be selected unlessanother apnea monitor is in use.

NOTE: The selection is not available in SPONT + APNEA A/CMV.

Apnea alarm indicator blinks red: Indicates an Apnea alarm violation. Anaudible alarm beeps.

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

Reset (alarm silence)

The Reset button has three functions.

1. Silencing alarms: Press the Reset button to silence all front panelalarms for 60 seconds. When the Reset button indicator is lit, allfront panel alarms are silenced. Press the button again to cancel thesilence period.

NOTE: The Loss of Gas alarm (pneumatic) and Fault System alarm arenon-silencable.

Apnea

Paw

Paw

ALARMSReset

Apnea (s)15300

Battery

Apnea

Paw

Paw

ALARMSReset

Apnea (s)15300

Battery

Spont

Apnea (s)15300

Ptrig Spont

ATC


3-12 SER1500 D0105

2. Resetting latched indicators: Press the Reset button to cancellatched alarms when an alarm indicator is no longer blinking but islatched (continuously lit).

3. Resetting Power Down alarm: Press the Reset button to reset(silence) the continuous audible alarm that sounds when the powerswitch on the E100M is changed from (ON) to (STDBY).

FRONT PANEL INDICATORS

BatteryBattery (low battery) indicator blinks red/no audible alarm: Indicates20% charge remaining on internal battery.

Battery indicator blinks red/continuous audible alarm: Indicates10% charge remaining on internal battery.

When the ventilator is switched back to A.C. power, the Low Batteryindicator latches (stays lit). Press Reset to cancel latched alarmindicator.

WARNING When the Battery audible alarm sounds continuously,only 10% internal battery charge remains. Find an alternate powersource immediately. Charge the battery for a minimum of 5 hoursbefore again powering the ventilator from the internal battery. Thischarges the battery to approximately 80% charge level. If the batteryis completely depleted, it takes approximately 14 to 16 hours to fullyrecharge.

Pressure GaugeThe pressure gauge displays proximal airway pressure if PROX isactivated, or PATIENT mainflow outlet pressure if PROX is notactivated.

Non-blinking segments: _

Paw and Paw alarm settings are displayedas single non-blinking segments. Pbase is displayed as the appropriaterange of non-blinking segments.

Blinking segments: The Ptrig indicator is the only bar displayed as ablinking segment.

NOTE: If the Ptrig indicator is set at the same level as Pbase, thesegment which indicates both blinks.

Range: 10 to +120 cmH2O / 10 to +118 mbar

-1001020

30

40

50

6070 80 90

100

110

120

E100M VENTILATOR

Apnea

Paw

Paw

ALARMS

Battery

SECTION 3

SER1500 D0105 3-13

tI > tE Indicator(inverse ratio)

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

Range: 4:1 max

WARNING Although the E100M allows the user to set an inverse I:Eratio of up to 4:1, ventilating a patient at a ratio of greater than 1:1.0is unusual. Care should be taken to ensure that each patient is beingventilated 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 theventilator is no longer in operation. This alarm is reset (silenced) bypressing the Reset button.

NOTE: The Power Down Alarm cannot be silenced with the ExternalAlarm Silence Cable.

Fault System AlarmA Fault System Alarm occurs when the microprocessor detects afunctional problem with the ventilator. When this occurs the ventilatorcannot be used for patient care. DO NOT use the ventilator until thecause 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 (STDBY)position on the Power Switch.

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

Loss of Inlet Gas Pressure Alarm

The Loss of Inlet Gas Pressure Alarm is a pneumatic alarm whichsounds when one or both of the supply gas (air or oxygen) pressures areoutside the operating range of the ventilator.

Audible Alarm: continuous reed (pneumatic) alarm

Visual Alarm: none

Range: 28 psig

1.0

0.5

0.1

1.52.0

2.5

3.0

tI > tEtI (s)


3-14 SER1500 D0105

!

1SPONT V

8 L/min

0 L/min

2SPONT V

2 SPONT V

Figure 3-2E100M LEFT SIDE PANEL

SECTION 3

SER1500 D0105 3-15

WARNING If Loss of Inlet Gas Pressure Alarm occurs, deliveredoxygen concentrations may vary and the ventilator may not be ableto function properly. Corrective action should be taken in order toensure that the patient is not injured.

LEFT SIDE CONTROLS

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

SPONT V1This control provides a fixed amount of mixed gas for patientspontaneous breathing.

8 L/min position: Approximately 8 L/min of mixed gas is available to thepatient for spontaneous breathing. The gas is sent to the Reservoir Bag,then enters the breathing circuit through the PATIENT outlet.

L/min position: No gas ( L/min) is provided for spontaneousbreathing from this control.

WARNING Time-Limited Demand Flow, SPONT V1 and SPONT V2provide the only source of mixed gas for patient spontaneous breaths.

SPONT V2This control provides a user-adjustable amount of mixed gas for patientspontaneous breathing. It can be used in place of Time-Limited DemandFlow, or in addition to the SPONT V1 gas source.

Range: 0 to +15 L/min calibrated36 L/min flush

WARNING Time-Limited Demand Flow, SPONT V1 and SPONT V2provide the only source of mixed gas for patient spontaneous breaths.

NOTE: When SPONT V1 and SPONT V 2 are adjusted, a change in thebaseline pressure may occur. Manually adjust the Ptrig control or(re)activate the ATC button to re-optimize the trigger setting.

1SPONT V

8 L/min

0 L/min


3-16 SER1500 D0105

NEWPORT MODEL E100MNEWPORT MEDICAL INSTRUMENTS, INC.COSTA MESA, CALIFORNIA USAMADE IN USA

CAUTION: USA FEDERAL LAWRESTRICTS THIS DEVICE TO SALE BYOR ON THE ORDER OF A PHYSICIAN

TYPE 'B'

SERIAL NO.

100/120 V ~ .14A220/240 V ~ .07A50/60 HZ

100/120 V ~ .25A, F220/240 V ~ .10A, F

RS-232C

WARNING:Condensed water in the air

supply can cause malfunctionof this device.

MEDICALAIR

02OXYGEN

Certified to the requirements of the Canadian Electrical Code. CSAhas 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.Certifi seion les exigences du code Canadian de l'Ajectrioit

LACNOR n'apas otudiolles aulres effects physiologiques possibles,DANGER-RISQUE D'EXPLOSION, Ne pas emplyer en presence

d'ansthaeiques inflamables, La courant de risque totaladisaible au chassis ne noit pas depaesar 100uA.

LR51420

NRTL/C

ON

STDBY

FUSE

REMOTEALARMOUTPUT

EXTERNALALARMSILENCE

ALARMLOUDNESS

!

0050

INTERNAL BATTERY TEST

Figure 3-3E100M REAR PANEL

SECTION 3

SER1500 D0105 3-17

REAR PANEL CONTROLS/SWITCHES

The E100M Rear Panel is shown in Figure 3-3, Page 3-16.

Power SwitchTo power the E100M on, push the rocker switch up ( ON). To power theE100M off, push the rocker switch down ( STDBY). The internal batterycharges when the power switch is in either position and the ventilator isplugged into an A.C. power source.

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

button to cancel the audible alarm.

ALARM LOUDNESS ControlRotate the control clockwise to increase the volume of electronic audiblealarms. Alarm loudness is adjustable from minimum 74 dbAto maximum 92 dbA.

INTERNAL BATTERY TEST Button(% charge of battery)

Press the Internal Battery Test button to display the internal batterys %charge remaining in the Control Monitor window (i.e. = 75%). Whenthe battery is fully charged, approximately 6 to 8 hours of batteryoperation is possible, with a minimum of 4 hours at maximum load.

NOTE: The E100M must be unplugged from A.C. power and running oninternal battery for a minimum of 5 minutes before testing the % charge.

NOTE: If the ventilator is not being powered by the internal battery andthe Internal Battery Test button is pressed, dashes (---) are displayedinstead of the % charge.

REAR PANEL I/O CONNECTORS

REMOTE ALARM OUTPUTThe REMOTE ALARM OUTPUT connector is designed to work withmost 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 remotealarm system which informs the remote location that the ventilator isalarming. The REMOTE ALARM OUTPUT does not indicate which alarmon the ventilator is being violated.

REMOTEALARMOUTPUT

I:E tot

VT (L)

7 5 P

INTERNALBATTERYTEST

ALARMLOUDNESS

ON

STDBY


3-18 SER1500 D0105

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 alarmmessage 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(Requires Optional Ext. Alarm Silence Cable)

When the NEWPORT External Alarm Silence Cable is connected to theEXTERNAL ALARM SILENCE input, you can silence violated alarms andreset latched alarm indicators by pressing the button on the cableinstead of the Reset button on the front panel of the ventilator.

Silencing alarms: Press the External Alarm Silence Cable button tocause the Reset button to light and silence all front panel alarms for60 seconds. Press the button again during the silence period to cancelthe alarm silence.

Resetting latched indicators: Press the External Alarm Silence Cablebutton to cancel the latched alarms when an alarm indicator is no longerblinking 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.

EXTERNALALARMSILENCE

SECTION 3

SER1500 D0105 3-19

RS-232C InterfaceThe RS-232C interface is a 25 pin D-type connector, operating at 38,400baud. It allows you to interface with central monitoring and computersystems.

NOTE: Contact your Newport Medical representative for moreinformation regarding the interface with specific monitoring systems.

NOTE: See Theory of Operation, Page 4-15 for additional information.

RS-232C


3-20 SER1500 D0105

Figure 3-4E100M RIGHT SIDE PANEL

!

SECTION 3

SER1500 D0105 3-21

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 availableto meet the peak flow needs of a spontaneously breathing patient.Mixed gas from the SPONT V1 switch and/or SPONT V2 flowmeterenters the Reservoir Bag prior to entering the patient circuit. The patientcan draw gas from the Reservoir Bag during peak need. Adjust thespontaneous flow (SPONT V1 and SPONT V2) to meet averagespontaneous flow needs of the patient rather than peak spontaneousflow needs. This helps to conserve gas supplies.

Caution If the patients effort empties the Reservoir Bag, it is possiblefor the patient to pull ambient gas in through the Emergency IntakeValve. Make sure that SPONT V1 and SPONT V2 are adjusted so thatthe patient does not empty the Reservoir Bag during spontaneousbreathing.

NOTE: Time-Limited Demand Flow may be set to meet the patientspeak flow needs. In this case the patient breathes from SPONT V1 andSPONT V2 and the reservoir bag at end exhalation only.

!

SER1500 D0105

4. THEORY OF OPERATION

General System Overview. . . . . . . . . . . . . . . . . 4 - 13A/CMV (Assist/Control

Mandatory Ventilation) . . . . . . . . . . . . . . . . . 4 - 13SIMV (Synchronized Intermittent

Mandatory Ventilation) . . . . . . . . . . . . . . . . . 4 - 13SPONT + APNEA A/CMV

(Spontaneous + APNEA A/CMV Ventilation) . . 4 - 23SPONT (Spontaneous Ventilation) . . . . . . . . . . 4 - 33Time-Limited Demand Flow . . . . . . . . . . . . . . . 4 - 43Plimit (Pressure Limited Ventilation) . . . . . . . . . 4 - 53Ptrig Control . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 83Advanced Trigger Control (ATC) . . . . . . . . . . . . 4 - 93Auto-Set Alarm (AS) . . . . . . . . . . . . . . . . . . . . . 4 - 10ATC Target Trigger Look-up Table. . . . . . . . . . . 4 - 13Artifact Trigger Conditions Table . . . . . . . . . . . . 4 - 13Auto-Set (AS) Alarm Tables . . . . . . . . . . . . . . . . 4 - 14Low Baseline Alarm Table . . . . . . . . . . . . . . . . . 4 - 14RS-232 Specifications . . . . . . . . . . . . 4 - 15 to 4 - 18

SECTION 4

SER1500 D0105 4-1

GENERAL SYSTEMS OVERVIEW

The Newport Ventilator Model E100M is a pneumatically powered,microprocessor controlled, pressure, time or manually triggered, timecycled, flow or pressure limited ventilator, with Time-Limited DemandFlow and continuous flow for spontaneous breathing. It is capable ofventilating neonate through adult patients. An internal lead acid batterypowers the ventilator for approximately 6 to 8 hours when fully charged.

The electronic control system incorporates two microprocessors on themain board. The control microprocessor is responsible for all electricallyactivated mechanical components. The monitor processor is responsiblefor the electronic pressure gauge and all displays. The main componentof the pneumatic system is a pneumatic interface valve activated by anelectrically controlled pilot valve. These two valves are responsible forinitiating gas delivery during mandatory breath and Time-LimitedDemand Flow inspiration. A separate valve controls gas delivery the restof the time.

An emergency intake valve allows the patient to pull ambient air into thebreathing 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 setting. Apatient can trigger mandatory breaths in addition to, or in place of, thetime triggered breaths if the effort they generate causes airway pressureto meet the Ptrig setting. Every patient effort that causes airwaypressure to meet the Ptrig setting results in a mandatory breath. Tidalvolume is determined by the V and tI settings in volume control, anddetermined by V, tI and Plimit settings in pressure limited ventilation.

WARNING A leak in the breathing circuit can cause the ventilator toauto-trigger. Monitoring, including high and low minute volumealarms, should be used to detect this condition, and the clinicianshould frequently check the ventilator to verify baseline stability.

SIMV(Synchronized Intermittent Mandatory Ventilation)

In SIMV, the patient receives a fixed number of time/patient triggeredmandatory breaths and may breathe spontaneously from the ventilatorsTime-Limited Demand Flow and/or spontaneous flow. See Figure 4-1.

THEORY OF OPERATION

4-2 SER1500 D0105

The first breath the patient triggers in any mandatory breath interval isthe patient triggered mandatory breath. The patient has the rest of theinterval to breathe spontaneously. If the patient stops triggering breathsand one complete mandatory breath interval has elapsed without atrigger, a time triggered mandatory breath is delivered.

A mandatory breath lockout interval is activated whenever the patienttriggers a mandaory breath. This limits the number of mandatory breathsthe patient receives in 60 seconds to the (b/min) setting.

WARNING The SPONT V1 switch and/or SPONT V2 flowmetermust be turned on in SIMV and SPONT modes to provide gas forpatient spontaneous breathing even if Time-Limited Demand Flow isenabled.

SPONT + APNEA A/CMV(SPONTANEOUS + APNEA A/CMV VENTILATION)

If the Apnea alarm is not violated in SPONT + APNEA A/CMV, this modeperforms the same as SPONT mode. Please review SPONT in thissection.

If no patient triggers occur during the apnea alarm delay intervalselected, back-up breaths are delivered according to the A/CMVsettings (V, , tI, Plimit). The Apnea alarm indicator blinks and the audiblealarm activates. If four consecutive patient triggered breaths aredetected, the Apnea alarm indicator latches, the audible alarm issilenced, and back-up breaths cease. Press Reset to cancel thelatched indicator.

Figure 4-1100% SIMV WINDOW

TIME TRIGGEREDMANDATORY BREATH

PATIENT TRIGGEREDMANDATORY BREATH

SPONTANEOUS BREATH

PR

ES

SU

RE

100%

A B C C A A

MANDATORY BREATHINTERVAL

MANDATORY BREATHINTERVAL

MANDATORYBREATH

LOCKOUTINTERVAL

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

SECTION 4

SER1500 D0105 4-3

WARNING Before switching to the SPONT + APNEA A/CMV mode,always make sure the Plimit, , tI, and Vcontrols are setappropriately for the patient.

WARNING The SPONT V1 switch and/or SPONT V2 flowmeter mustbe turned on in SIMV and SPONT modes to provide gas for patientspontaneous breathing even if Time-Limited Demand Flow isenabled.

SPONT (SPONTANEOUS VENTILATION)

In SPONT, the patient may trigger Time-Limited Demand Flow and/ormay breathe exclusively from the spontaneous flow through thebreathing circuit and reservoir bag at the selected FIO2. The patient hascontrol over each breath. CPAP may be added using the PEEP/CPAPcontrol. Adjust the Ptrig control or enable ATC so that the E100M candetect the patients spontaneous efforts. If detected, the Spont indicatorblinks yellow, and the apnea alarm delay interval is reset.

WARNING The SPONT V1 switch and/or SPONT V2 flowmetermust be turned on in SIMV and SPONT modes to provide gas forpatient spontaneous breathing even if Time-Limited Demand Flowis enabled.

DuoFlow

The DuoFlow system allows the user to control mandatory andspontaneous flow separately. The V control determines the flow formandatory breaths, manual inflations, and Time-Limited Demand Flow.The SPONT V1 (toggle switch) and V2 (flowmeter) determine the flowavailable for spontaneous breathing either exclusively or after the Time-Limited Demand Flow duration elapses. The reservoir bag providesadditional gas in the event that patient spontaneous flow exceeds theSPONT V1 and V2 setting.

The patient breathes from mandatory flow during mandatory and Time-Limited Demand Flow breaths, and from SPONT V1 and V2 flow duringspontaneous breathing. When mandatory flow is delivered to the patient,SPONT V1 and V2 are switched off (electronically), and vice-versa. SeeFigure 4-2.

THEORY OF OPERATION

4-4 SER1500 D0105

Figure 4-2DuoFlow SYSTEM

Time-Limited Demand Flow provides flow support for a patient's peakspontaneous breathing flow needs. The Time-Limited Demand Flowcontrol determines the duration of time that the mandatory flow rate willbe delivered at the onset of a patient triggered spontaneous breath.When the Time-Limited Demand Flow time elapses, the spontaneousflow (determined by the SPONT V1 and V2 settings) is delivered for theremainder of the exhalation period.

Time-Limited Demand Flow can provide a higher level (V setting) of flowto the patient at the onset of a patient triggered spontaneous breath,after which the patient completes inspiration from the SPONT V1 and V2flow. Providing the patient with a higher level of flow during the time theyhave the highest demand can decrease imposed work of breathing.

Use of Time-Limited Demand Flow can allow the caregiver to set a lowerlevel of SPONT V1 and V2 since the spontaneous flow no longer needsto meet the patients spontaneous peak flow needs. Setting a lower levelof SPONT V1 and V2 helps to decrease expiratory resistance for patientexhalation and decrease gas consumption. The V, Time-LimitedDemand Flow, and SPONT V1 and V2 controls should be adjusted tomaximize the patient's comfort during spontaneous breathing.

The Time-Limited Demand Flow control is adjustable from -1.0 secondand functions in SIMV, SPONT + APNEA A/CMV, and SPONT modes. TheTime-Limited Demand Flow indicator lights any time the Time-LimitedDemand Flow control is set above , except when the mode is set toA/CMV. The exhalation valve remains at the PEEP/CPAP setting levelduring the Time-Limited Demand Flow portion of a spontaneous breath.

TIME-LIMITED DEMAND FLOW

Time Mand.Breath

SpontBreathing

Mand.Breath

SpontBreathing

Mand.Breath

Mandatory Flow Spontaneous Flow

Flow

SECTION 4

SER1500 D0105 4-5

Figure 4-3 provides an example of what occurs in SIMV when Time-Limited Demand Flow is activated. The V control determines the flowdelivered during mandatory breaths and Time-Limited Demand Flowportion of spontaneous breaths.

The tI control determines the inspiratory time that mandatory flow isdelivered for mandatory breaths. Time-Limited Demand Flow controldetermines the time that mandatory flow will be delivered prior toswitching back to the spont flow at the onset of each spontaneousbreath. In between the mandatory breaths and Time-Limited DemandFlow, spontaneous flow is delivered according to the SPONT V1 and V2setting.

Figure 4-3DuoFlow Plus System

SIMV with Time-Limited Demand Flow

At the onset of each spontaneous breath, flow enters the patientbreathing circuit at the mandatory flow setting. When the Time-LimitedDemand Flow setting time elapses, the flow entering the circuit switchesto the SPONT V1 and V2 level.

P limit(Pressure Limited Ventilation)

Range: 0 to 120 cmH2O / 0 to 118 mbar

Pressure Limited Ventilation has been used for neonatal / pediatricventilation for many years. In recent years it has gained popularity foradult patients. The proposed benefit of Pressure Limited Ventilation inadults with obstructive disease is that gas distribution may be enhancedwhile ventilating at lower airway pressures.

The Plimit control determines the maximum pressure in the patientcircuit during a spontaneous, mandatory, or manual breath. Clockwiserotation of the knob increases the maximum pressure (pop-off) setting,and counter-clockwise rotation decreases the maximum pressure. ThePlimit control works in all modes and can be adjusted from 0 to 120cmH2O / 0 to118 mbar.

A B B AFLOW TIME

SPONT V1 + V2. .

Breath A = Mandatory Breath (exhalation valve closed)

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

A B B A

PRESSURE

TIME

Exhalation Valve

Closed ClosedOpen OpenOpen

THEORY OF OPERATION

4-6 SER1500 D0105

Pressure Limited Ventilation differs from Volume Control Ventilation inthat each breath is pressure limited, and volume variable. A mandatorybreath becomes pressure limited when airway pressure is equal to thePlimit control setting. When this occurs, the Plimit control vents flow asneeded to prevent pressure from rising above the pressure limit selectedby the caregiver. With adequate flow, airway pressure rises to the Plimitthen flattens or plateaus for the remainder of the set inspiratory time (tI).

The volume delivered during a pressure limited breath varies, dependingon the V setting, the duration of the inspiratory time and the patientstime constant. As demonstrated in Figure 4-4, physiologic changes suchas a change in the patient's resistance or compliance, or changes withinthe gas delivery system such as leaks or obstructed filters, can all affectthe duration of the pressure plateau and consequently the tidal volumedelivered to the patient.

NOTE: Exhaled volume monitoring can be very useful and isrecommended when using pressure limited ventilation.

Figure 4-4Pressure Limited Ventilation Open Circuit

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

Flow resistance and compliance affecthow fast airway pressure rises.

Flow delivered from the ventilator does not necessarily enterthe 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.

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

P limit

tI (Inspiratory Time)

Airw

ayP

ress

ure

cmH

2O

This Flow enters the airway and results in the VT (tidal volume) that is delivered. This whole box

represents Flowleaving the ventilator.

This striped arearepresents the Flow thatvents from the P limit valvewithout entering the airway.Fl

ow

tI (Inspiratory Time)

SECTION 4

SER1500 D0105 4-7

Figure 4-5 shows an example of how the V setting affects the inspiratorypressure slope/rise and pressure plateau. The V setting for breath #1 is45 L/min and for breath #2 is 30 L/min. The tI and Plimit settings are thesame for both breaths.

Breath #1 has a much faster pressure rise due to the higher flow (50L/min). As a result, the pressure plateau level (Plimit setting) for breath#1 is reached rapidly, causing flow entering the airway to begin todecrease quickly. With breath #2, flow entering the airway does notbegin to decrease until approximately 75% of the elapsed inspiratorytime.

Figure 4-5MANDATORY FLOW V SETTING

NOTE: Always verify the Plimit setting after a change is made to the V ortI controls.

NOTE: The Plimit control is factory preset at its minimum setting (fullycounter-clockwise).

NOTE: The purpose of setting the _

Paw alarm when pressureventilating a patient is to have a secondary safety back-up in the eventof a Plimit valve failure.

WARNING When volume ventilating a patient, make certain thePlimit control is set higher than the pressure required to deliver theset VT, since volume will be vented to the atmosphere when thePlimit is reached.

WARNING Make certain that appropriate monitoring is in placewhen ventilating a patient with pressure targeted ventilation. Anocclusion of the patient circuit or ET tube may not result in a Paw(high pressure) alarm violation.

1

L/s

160

-20

cmH2O

V.

Pa w

V = 50 L/min.

#1

V = 25 L/min.

#2

THEORY OF OPERATION

4-8 SER1500 D0105

Ptrig CONTROLRange: 10 to 25 cmH20

The Ptrig control knob adjusts the patient trigger sensitivity setting onthe E100M. The trigger sensitivity setting determines the amount ofnegative pressure (inspiratory effort) the patient must generate in thebreathing circuit in order for the E100M to detect the effort (trigger). Onpower up of the ventilator, the trigger is set at 5 cmH2O/mbar.

When you rotate the knob, you will feel it click slightly. Each clickrepresents a trigger sensitivity level change of ~0.14 cmH2O/mbar.Rotating it through seven clicks changes the trigger sensitivity by onecmH2O/mbar, i.e., one pressure gauge segment. (The selected segmentblinks on the electronic pressure gauge.) Rotate the Ptrig controlcounter-clockwise to increase the patient effort required to trigger andclockwise to decrease the effort required.

The Spont indicator blinks when the E100M detects a trigger. The Apneatime delay interval is reset at the same time.

Adjusting the Ptrig control: Adjust the Ptrig control until you reach asetting at which it is easy for the patient to trigger the ventilator but notlikely that the ventilator will trigger from non-patient generated circuitpressure fluctuations. From this point, non-patient generated triggerswill be refered to as "artifact triggers".

When you adjust the PEEP/CPAP control the trigger level automaticallymoves in conjunction with the change in baseline pressure. If baselinepressure changes as a result of adjusting you need to re-adjust thetrigger sensitivity manually.

If Time-Limited Demand Flow is enabled for spontaneous breathing, aspontaneous breath trigger is followed by a trigger lock-out period untilbaseline pressure stabilizes or until 1.5 seconds elapse, whichever isshorter. This lock-out helps to prevent multiple augmented flowtriggering during a single spontaneous patient effort.

If it appears that the E100M is not detecting patient efforts (Spontindicator not "blinking") with the trigger level set to within one or twocmH2O/mbar of baseline, you may want to reassess the SPONT V1 andV2 settings.

SECTION 4

SER1500 D0105 4-9

ADVANCED TRIGGER CONTROL (ATC )The Advanced Trigger Control (ATC ) button activates a function thatautomatically manages the Ptrig setting in any mode. The ATC functionmanages the trigger sensitivity setting within an allowable range (betweenthe target trigger as defined in the ATC Target Trigger Look Up Table and2 cmH2O/mbar below baseline pressure) with the goal of making it easyfor the patient to trigger the ventilator while keeping the ventilator fromartifact triggering. (See description of artifact triggering in the Ptrig Controlsection 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 toset trigger at an optimized value, and (2) basic trigger adjustment up ordown.

(1) Optimization of the trigger level and reassessment of baselinepressure 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 andoptimization:

The microprocessor assesses baseline pressure and then selects atarget setting for the trigger level according to the ATC Target TriggerLook Up Table.

If the E100M does not artifact trigger at the target trigger setting, asdetermined by the definitions listed in the Artifact Trigger Conditions onpage 4-13, the trigger setting remains at the target value.

If an artifact trigger condition is identified, ATC backs off on the triggersetting (becomes less sensitive) by 0.14 cmH2O/mbar until the artifacttrigger condition is eliminated or until the trigger is 2 cmH2O/mbarbelow the assessed baseline.

(2) In between optimization events, ATC provides basic adjustmentof the trigger setting, either up or down.

Trigger is never adjusted closer to baseline than the target trigger leveldefined in the ATC Target Trigger Look Up Table and it is never adjustedto a position further than 2 cmH2O/mbar below the most recentlyassessed baseline.

THEORY OF OPERATION

4-10 SER1500 D0105

If no patient efforts have been detected in the last 15 seconds in A/CMVor SIMV mode (SPONT indicator not blinking), the trigger level willmove 0.28 cmH2O/mbar closer to the baseline. If the patient effort stillgoes undetected for another 15 seconds, the trigger will again move0.28 cmH2O/mbar closer to the baseline. This will continue until apatient breath is detected or until the trigger reaches the target triggerdefined in the ATC look-up table. For both SPONT modes, the timecriteria is 32 seconds rather than 15 seconds.

Each time an artifact trigger condition is identified in any mode, ATC willmove the trigger level down (more negative) by 0.14 cmH2O/mbar but itwill never move the trigger more than 2 cmH2O/mbar below baseline.

NOTE: For information on manually adjusting the trigger level, seeprevious section, Ptrig Control.

NOTE: When ATC is first activated, self-triggering of the ventilator mayoccur until the ideal trigger setting is determined.

NOTE: When SPONT V1 or V2 is changed, a shift of the Pbase mayoccur. Press the ATC button to deactivate and press it again toreactivate the ATC function so that trigger is immediately adjusted to thenew Pbase.

AUTO-SET ALARM (AS )

Range: _

Paw Alarm 15 to 120 cmH2O /15 to 118 mbarPaw Alarm 5 to 115 cmH2O / 5 to 113 mbar

The Auto-Set (AS ) alarm button activates a function that automaticallyselects

_Paw (high pressure) and Paw (low pressure) alarm settings.

The settings are selected according to the current peak airway pressurefor mandatory breaths at the time the button is pressed. The ASbutton 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() and PEEP/CPAP.

The _

Paw alarm setting will increase a maximum of 10 cmH2O from itsprior setting with each activation of the AS button. With the exceptionof 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 thechanges made to the ventilator or changes in the patient condition haveresulted in a significant increase in peak pressure. Press the AS buttonagain to reactivate the AS function after verifying that all primarycontrols are set at a safe level. Primary controls include Mode,Inspiratory Time (tI), Flow (V

), Frequency () and PEEP/CPAP.

SECTION 4

SER1500 D0105 4-11

NOTE: The peak airway pressure for the AS function is determined byaveraging the peak pressure for two consecutive mandatory breathswithout a Paw alarm violation.

NOTE: The minimum alarm setting for Paw is 5 cmH2O abovebaseline. Paw must be 2 cmH2O above Paw. If the minimum criteriais not met, the alarm bars remain at the current settings and the ASfunction and indicator turns off.

AS alarm indicator lit green: _

Paw and Paw alarm levels selectedby the AS function.

AS alarm indicator unlit: Alarms set manually with the Paw Alarmcontrol knob or a primary control has been changed since pressing AS

button.

Press the AS button once to cause the high and low pressure alarmsettings to be evaluated and adjusted for the current peak airwaypressure.

Activating the AS alarm function after power up:

After the MODE, , V, tI, PEEP/CPAP and Plimit controls are adjusted tothe appropriate settings and the patient is connected to the ventilator,press theAS alarm button to set the alarms. The indicator on the ASbutton will light indicating AS is on, and the Paw and Paw alarmbars 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 anappropriate peak airway pressure before pressing the AS alarmbutton.

If a Paw violation occurs during the AS alarm selection process:

After the AS function is selected, the _

Paw alarm setting can increaseup to 10 cmH2O above the existing setting. If peak pressure reaches 10cmH2O above the alarm's previous setting (i.e. 40 cmH2O/mbar), thebreath 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 Pawalarm violation occurs during the AS alarm setting, the AS indicatorturns off. You may continue this sequence until the breaths are no longerpressure cycling (max. 120 cmH2O/mbar).

Paw Alarm

A S


Paw Alarm

A S


THEORY OF OPERATION

4-12 SER1500 D0105

During the AS alarm selection process, t

Manual e100m Serman Rev d 2202

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