Operating Manual
Newport Medical Instruments, Inc.
Newport e360 Ventilator
Operating Manual
For Model e360S-US
OPR360US Rev. H
07/11
Newport Medical Instruments, Inc.
1620 Sunflower Ave.
Costa Mesa, CA 92626
Tel: 1.714.427.5811
Tel: 1.800.451.3111 (USA Only)
Fax: 1.714.427.0489
Customer Service ext. 282
0344
www.ventilators.com
email: Info@ventilators.com
Manual Revision History
Rev A
April 2004
New release
Rev B
July 2006
Update to software USR1.1
5-1
OPR360U A0509
5-1
Rev C
February 2008
Update company logo and remove
CE/EU representative information
Rev D
March 2008
Update manual to include Addendum
Document (DOC360-ADD-4-US) for
software release USR3.1
Rev E
May 2008
Update manual to replace Addendum
Document (DOC360-ADD-4-US)
Revision A with Revision B for
software release USR3.1B, which also
includes any updated information
before the USR3.1B
Rev F
December 2009
Updated manual to incorporate
DOC360-ADD-4-US, reformatted
to new compact size, added
drawings and streamlined
content. Current to software USR3.8
Rev G
June 2011
Operating Manual Revision Notice included for update to internal battery recharge schedule, added patent number and update to warranty for O2 sensor.
Rev H
July 2011
Update manual to include Software version 7.0 new features: NIF & P0.1 maneuvers, O2 sensor disable & FlexCycle feature. Correction to O2 sensor warranty.
OPR360U A0509
OPR360US H0711
Contact Information
Telephone: +1.714.427.5811 or 1.800.451.3111 (US only)
Fax: +1.714.427.0489
Customer Service: ext: 282
5-1
OPR360U A0509
Hours: Monday through Friday, 8:00 am to 5:00 pm (PST)
24 hour Support:
Technical Support: ext. 500
Clinical Support: ext. 123
Email:
Customer Service Department: customers@ventilators.com
Clinical Education and Support: clinical@ventilators.com
Technical Service and Support: techservice@ventilators.com
Internet: www.ventilators.com
Shipping Address:
Attn: Receiving Dept.
1620 Sunflower Avenue, Costa Mesa, CA 92626 USA
EC Representative: EC REP
Newport Medical Instruments, Inc.
Attn: Robert Brink
C/O Braun & Co.
11B/11C Harrier Road
Humber Bridge Industrial Estate
Barton-on-Humber, North Lincolnshire
DN18 5RP, England
Tel: +44.1652.632273
Fax: +44.1652.633399
Copyright Information
© Copyright 2011 Newport Medical Instruments, Inc. All rights
reserved. The Newport e360 Ventilator system is manufactured in
accordance with Newport Medical Instruments, Inc. proprietary
information. The Newport e360 is covered under patent # 6,439,229.
OPR360U A0509
5-1The information in this manual is the sole property of Newport
Medical Instruments, Inc. and may not be duplicated without
permission. This manual may be revised or replaced by Newport
Medical Instruments, Inc. at any time and without notice.
OPR360US H0711
1 Oxygen Inlet
8
VGA Connection
2 Air Inlet
9
USB Connection
3 Remote Alarm Connection
10 Cooling Fan
4 Alarm Speaker
11 Equipotential Ground Stud
5 External Alarm Silence
12 AC Power Connection
6 On/Off Power Switch
13 Fuse Drawer
7 RS232 Connection
14 External Battery Connection
Figure F-2: Newport e360 Rear Panel
Figure F-3: GUI Navigation Map
OPR360US H0711
ADULT
VTPC-SPONT
05-01-2008 15:30
Int
Bat
Hours
999999.7
*
Check
power on). Do not use a test lung to block the patient wye for the circuit check
test.
OPR360US H0711
Table of Contents
1Introduction
Device Description
Intended Use Information
About this Manual
Typing Conventions
Software Versions
Service Guidelines
Regular Service
Complete Service Records
Disclaimers
Warnings
General Warnings
Filter Warnings
Power Supply Warnings
Gas Warnings
Auxiliary Equipment Warnings
Cautions
Warranty Information
Responsibility for Patient Safety
Limitation of Liability
5-1
OPR360U A0509
2Overview
5-1
Ventilator System Overview
Control Panel Layout and Labeling
Graphical User Interface (GUI) and Controls
Navigation Map for GUI Menus
Lower Front Panel Layout
Rear Panel Layout
Navigating the Control Panel
Using Touch-Turn-Accept
Selecting Mandatory Breath Type and Mode
Non Invasive Function
Patient Triggering Methods
Basic Ventilation Controls
Flow or Insp Time in Volume Control
Manual Inflation Button
O2 3 Minute Button
Alarm Silence Button
Suction Disconnect Function
Alarm Reset
Graphical User Interface (GUI) Screens
Alarms Screen
Main Screen
Extended Functions Screen
Setup & Calibration Screen
GUI Miscellaneous Indicators
Internal Battery
OPR360US H0711
OPR360U A0509
Table of Contents
3Unpacking, Assembly, and Safety Check
5-1
Unpack the Ventilator
List of Package Contents
Assembly
Exhalation Valve Compartment
Connect Air, Oxygen and AC Power
Install the Breathing Circuit System
Safety Check Procedure
Setup and Inspection
Emergency Intake Valve
Circuit Check
Gas Supply Alarms
AC Power Loss/Battery Backup Alarm
High/Low Airway Pressure Alarm/Circuit Disconnect Alarm/ Alarm Silence
Minute Volume/Back Up Ventilation/Apnea Alarms
Trigger/Pressure Support
Volume/Flow/Rate Accuracy Test
Shut Down Alarm
Safety Check Record Sheet
OPR360U A0509
4Setting Up for Patient Use
Power Conditions
Shutdown Alarm
Overview: Preparing for Patient Ventilation
Setup & Calibration Menu
Circuit Check
Oxygen and Flow Sensors
Exhalation Flow Sensor, Calibration
Oxygen Sensor, Calibration
Oxygen Sensor, Disable
Patient Setup
Patient Category
Weight Units
Ideal Weight
Volume Units
Sigh
Circuit Type
Leak Comp (Leak Compensation)
Compl Comp (Compliance Compensation)
Technical
5-1Comm (Communications) Protocol
Display Brightness
Regional Settings
Altitude
Date Format
Date and Time
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OPR360US H0711
Table of Contents
Screen Files
Event History Files
Ventilator Controls Guide
Ventilator Settings in Advanced Data Set
Slope/Rise
Expiratory Threshold
Pause
Flow Waveform
Volume Target
Open Exhalation Valve
Inspiratory and Expiratory Hold Maneuvers
P0.1 Measurement Function
Negative Inspiratory Force (NIF) Maneuver
Waves and Loops Display
Adjusting Scale
Auto Scale
Using the Freeze Function
Using the Cursor in Freeze
Event History Screen
Numerics Screen
Trends Screen
Data Sets
Save Feature
Download Feature
5-1
OPR360U A0509
5Alarms
5-1
Introduction
Visual Alarm Displays
360° Alarm Lamp
Alarm and Message Display
Device Alert LED
GUI Alarm Screen Environment
Alarm Settings Screen
Saving the Alarm Settings Screen
Adjustable Alarms
Alarm History
Saving the Alarm History Log
Alarm Loudness
Alarm Tones
Exiting Alarm Screens
Front Panel Alarm Interface Environment
Alarm Silence Button
Suction Disconnect Feature
Alarm Reset Button
Non-Adjustable Alarms
Alarm Violation and Remedy Guide
OPR360US H0711
OPR360U A0509
Table of Contents
6Cleaning and Maintenance
Introduction
Use of Filters
Inspiratory (To Patient) Port
Expiratory (From Patient) Port
Disassembly and Reassembly Procedures
Rear Panel Fan Filter
Exhalation Manifold
Exhalation Flow Sensor
Exhalation Valve
Inspiratory Manifold
Oxygen Sensor
Fuses
Cleaning
Sterilizing
Autoclave Sterilization
EtO Sterilization
Guide to Cleaning and Sterilizing
Guide to Preventive Maintenance
Storing the Ventilator
Repackaging the Ventilator
5-1
OPR360U A0509
7Explanation of Modes, Breath Types and Special Functions
Introduction
Settings Functions
Timing Limitations to Ventilation Controls
Control Retention
Control Range
Mandatory Breath Types
Volume Control
Pressure Control
Biphasic Pressure Release Ventilation
Volume Targeted Pressure Control
Spontaneous Breath Management in SIMV and SPONT
Pressure Support
Volume Targeted Pressure Support
Ventilation Modes
A/CMV
SIMV
SPONT (Spontaneous)
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5-1
Advanced Features and Special Functions
Bias Flow
Slope/Rise
Expiratory Threshold and FlexCycle
Leak Compensation
OPR360US H0711
Table of Contents
Compliance Compensation
Non-Invasive Ventilation-NIV
Leak Compensation in NIV
Alarms Settings in NIV
5-1
OPR360U A0509
8Specifications
Alarms, Controls, Monitored Data, Setup & Calibration
Physical Specifications
Foldout Diagrams
ront F
F-1e360 Ventilator System and Accessories
F-2e360 Rear Panel
F-3Graphical User Interface (GUI) Navigation Map
F-4Control (Front) Panel
F-5Circuit Check Screen
Rear F-6Main Screen
F-7Extended Functions Screen
F-8Alarms Screen
F-9Event History Screen
F-10Technical Screen
F-11Patient Setup Screen
5-1
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OPR360U A0509
Introduction
Introduction
Section 1:
OPR360U A0509
Device Description . ...............................................1-1
Intended Use Information.............................1-2
About this Manual...................................................1-2
Typing Conventions.................................................1-3
Software Versions.................................................. 1-4
Service Guidelines ................................................ 1-4
Regular Service . .......................................... 1-4
Complete Service Records ......................... 1-4
Disclaimers ............................................................ 1-4
Warnings.........................................................1-5
General Warnings..........................................1-5
Filter Warnings.............................................. 1-6
Power Supply Warnings................................1-7
Gas Warnings................................................ 1-8
Auxiliary Equipment Warnings.................... 1-8
Cautions.................................................................. 1-8
Warranty...................................................................1-9
Responsibility for Patient Safety......................... 1-10
Limitation of Liability............................................ 1-11
5-1
OPR360U A0509
5-1
Introduction
Section 1:
1
Introduction
Device Description
The e360 Ventilator is a high performance ventilator that is easy to use
and maintain. The e360 features a dual servo gas delivery system, a
servo controlled active exhalation valve, a simple to use interface and
a touch screen graphics monitor. The electronically-controlled inlet gas
mixing system is superior to traditional pneumatic mixers that must
exhaust gas from the system to consistently deliver precise oxygen
concentrations. The dual servos respond immediately to changes in
the set FIO2. Approximately 60 minutes of operational backup power
is available when the ventilator’s internal battery is fully charged.
In addition, the e360 has remote alarm (nurse call) and external
alarm silence connections, an RS232 interface to connect to central
monitoring systems, a VGA port to connect to an external monitor, and
USB port for uploading software and downloading saved files.
5-1
OPR360U A0509
When the e360 is turned on, the power on self-test (POST) verifies
the integrity of the software and hardware of the ventilator. During
operation, the ventilator performs regular pressure transducer
calibrations and software tests to ensure accuracy of monitored and
displayed data. A user initiated Circuit Check ensures that there are
no leaks in the breathing circuit system, measures circuit compliance
and resistance, and calibrates the exhalation flow sensor. User
initiated sensor calibration tests allow for calibration of the Oxygen
and Exhalation Flow Sensors.
All breath types and modes include a range of ventilation and alarm
settings appropriate for adult or pediatric/infant patients. The e360
has settable alarm limits for High and Low Peak Airway Pressure,
High and Low Expiratory Minute Ventilation/ Back Up Ventilation,
High Respiratory rate, disconnect threshold and Apnea. There are
built-in alarms for O2 monitoring, O2 and Flow Sensors, Low Baseline
Pressure, High Baseline Pressure, Sustained High Baseline Pressure,
Ventilator settings violations, Low Battery, Gas Supply Failure, Device
Alert, and Power Switchover.
5-1
The ventilator monitors and displays the power source, exhaled
volumes, peak flows, breath timing parameters (I:E ratio, respiratory
rate, and inspiratory time), delivered oxygen concentration, patient
pressures (peak, plateau, mean airway, and baseline), and pulmonary
mechanics.
OPR360U A0509
During exhalation, the e360 uses a bias flow to flush exhaled CO2
and stabilize temperature, humidity, and baseline pressure in the
patient breathing circuit. A stable baseline pressure between breaths
helps to minimize auto-triggering.
OPR360US H0711
1-1
1 Introduction
The heated exhalation system features an active exhalation valve with
a low exhaled flow resistance for rapid return of circuit pressure to
baseline and decreased potential for auto-PEEP.
5-1
OPR360U A0509
Figure 1-1 Newport e360 Ventilator
Intended Use Information
The e360 Ventilator System is intended to provide invasive or
noninvasive ventilatory support and monitoring for infant, pediatric,
and adult patients with respiratory failure or respiratory insufficiency.
The e360 Ventilator System is for use by prescription only. Only those
who are professional healthcare providers with training in the use
of this ventilator system and experience with providing ventilator
support should use it.
The e360 Ventilator System is for use in hospitals, healthcare
facilities, or during intra-hospital transport.
Specific details about the intended use environment are available in
Section 8 Specifications.
About this Manual
Foldout Drawings
Foldout pages containing frequently referenced diagrams are placed
OPR360U A0509
5-1in the front and rear of this manual. These foldouts are designed
for easy reference while reading the manual and are designated as
Foldout F-X. Foldouts F-1 to F-5 are located on the front foldout
page and Foldouts F-6 to F-11 are located on the rear foldout page.
1-2
OPR360US H0711
1
Introduction
Section 1- Introduction
This section contains information about the safe use of the e360
Ventilator system, information about this manual, general warnings
and cautions, and warranty information.
5-1
OPR360U A0509
Section 2- Ventilator Overview
This is the road map and directions for getting where you need to
go. This section summarizes the elements of the ventilator system,
controls, and functions.
Section 3- Unpacking, Assembly and Safety Check
This is the “putting it together/setting it up” section-use this as a
guide to setting up the ventilator for the first time and performing a
safety check. A sample record sheet is provided for documenting the
results of the safety check.
Section 4- Setting Up for Patient Use
This is the “how to use” section. It will guide you through setting up
the ventilator for patient use and managing commonly used features
during ventilation.
Section 5- Alarms
This contains information related to the alarm systems and alarm
troubleshooting.
Section 6- Cleaning and Maintenance
Make sure to follow these guidelines for cleaning, reprocessing,
keeping the ventilator system in working order, storing, and
packaging for shipment.
Section 7- Explanation of Modes, Breath Types and Special Functions
This is the “how does it work” reference section of the manual to
give you a general description of the e360 breath types, modes and
special functions.
Section 8- Specifications
This is where you will find ranges, physical dimensions, and
information about settings, controls, alarms, and displays.
Typing Conventions
5-1
Controls, buttons, and alarms are shown in this manual as italicized
OPR360U A0509
text, written as they appear on the ventilator (for example, SPONT for
spontaneous mode).
WARNING! A Warning describes a condition that can cause personal
injury.
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1-3
1 Introduction
Caution A Caution describes a condition that can cause damage to
equipment.
5-1
NOTE: A Note emphasizes information that is important or adds
convenience.
OPR360U A0509
Software Version
This manual applies to software version 7.0 and later for the e360
Ventilator System. The software version is listed at the top of the
Event History Log, i.e. USR7.0.
Service Guidelines
Regular Service
Service must be provided at regular intervals by professionals who
have received training specific to the maintenance and repair of the
Newport e360 Ventilator.
Complete Service Records
All service performed on the e360 Ventilator System must be
recorded in a service log in accordance with hospital procedures and
local and national regulations.
Disclaimers
Newport Medical has no responsibility for the safe operation of
the e360 Ventilator System if the intended use, intended user, and
intended use environment requirements specified in this document
are not followed.
Newport Medical has no responsibility for the safe operation of the
e360 Ventilator System if operating instructions and maintenance
specified in this document are not followed or if service maintenance
or repairs are performed by persons who have not received the
appropriate professional training.
Newport Medical disclaims all liability for the consequences of product
alterations or modifications, as well as for the consequences that
might result from the combination of this ventilator with other products,
OPR360UifA0509
5-1whether supplied by Newport Medical or by other manufacturers,
such a combination is not endorsed by Newport Medical.
1-4
OPR360US H0711
1
Introduction
Warnings
OPR360U A0509
General Warnings
All ventilator controls and alarm limits must be appropriate for the
patient’s condition, according to the therapy prescribed by a physician.
5-1
Follow these safety guidelines. Additional warnings appear in context
throughout this document.
A patient connected to a ventilator requires the constant attention
of medical staff to the patient’s condition and to any significant
difference between monitored and set values that may indicate a fault
in ventilator operation.
Have an alternate method of ventilation available for use when
using the e360 Ventilator. If the ventilator’s operation or monitoring
functions are in doubt, discontinue ventilator use and employ an
alternate method of ventilation.
Always use appropriate monitors to ensure sufficient oxygenation
and ventilation (such as a pulse oximeter and capnograph) when the
e360 Ventilator is in use on a patient.
Have an alternate method of oxygen monitoring with high and low
alarms available for use when using the e360, in the event the built-in
oxygen monitor is unavailable due to a disabled, defective or missing
oxygen sensor.
Always ensure that the caregiver can hear the audible alert when
the alarm sounds. Do not use the ventilator in an environment where
audible alarms cannot be heard by the caregivers.
Before and during the use of the e360 Ventilator, make sure that all
connections in the patient circuit are secure. Ensure the integrity of
each part of the patient circuit, humidifier connections and humidifier
chamber.
Always use clean breathing circuits.
5-1
Dispose of waste products, residue, etc., in accordance with the
appropriate regulatory requirements and facility policy.
OPR360U A0509
Follow your institutions infection control policy.
Unqualified personnel must not attempt to service the ventilator
OPR360US H0711
1-5
1 Introduction
system. Improper repair or unauthorized modification can
compromise safety and result in patient injury. The regularly
scheduled maintenance should only be done by a qualified service
technician using the e360 Ventilator Service Manual.
OPR360U A0509
1.
2.
5-1
Filter Warnings
At all times during patient use, keep clean, dry filters in the following
locations to protect the patient and the ventilator:
Between the Inspiratory (To Patient) Port and the inspiratory limb of the circuit.
Between the expiratory limb of the circuit and the Expiratory (From Patient) Port.
If a clean, dry filter is not used on the Expiratory (From Patient) Port,
sterilize the exhalation valve and the expiratory flow sensor between
every patient use.
If a clean, dry filter is not used on the Inspiratory (To Patient) Port,
sterilize the inspiratory manifold between patients should any of the
following occur during patient ventilation:
• Device Alert Alarm
• Both Air/ O2 Supply Loss Alarm
• Sustained High Baseline Pressure Alarm
(These are alarms which cause the emergency intake relief valve and
exhalation valve to open.)
Active humidification, nebulization or instillation of medications or
liquids could result in moisture accumulation in the expiratory (From
Patient) filter. This could result in the following:
•
•
•
•
•
Ineffective filtration
Expiratory volume monitoring inaccuracies
Damage to the Expiratory Flow Sensor
Increased resistance to patient exhalation
Exhalation system obstruction
Change/discard dirty or wet filters in accordance with the
recommendations of the filter manufacturer as well as the policy of
OPR360U A0509
5-1your facility.
Handle filters carefully to minimize the risk of infection as well as
damage to filters.
1-6
OPR360US H0711
1
Introduction
Do not submerge filters in liquids of any kind.
Between uses, reusable filters must be steam autoclaved and then
checked for resistance, according to the manufacturer’s instructions.
5-1
OPR360U A0509
Power Supply Warnings
To maintain grounding integrity, connect the ventilator only to a
hospital-grade receptacle.
Always disconnect the ventilator from power before servicing.
Do not use electrically conductive breathing circuit tubing.
Make sure the internal battery is fully charged to assure battery
operation in case of AC power failure.
To ensure that the internal battery remains functional, fully recharge
the battery at least every 2 months when the ventilator is not in use.
This equipment has been tested and found to comply with the EMC
limits for the Medical Device Directive 93/42/EEC (EN 55011 Class 1
and EN 60601-1-2). These limits are designed to provide reasonable
protection against harmful interference in a typical medical
installation. The equipment generates, uses, and can radiate radio
frequency energy and, if not installed and used in accordance with
these instructions, may cause harmful interference to other devices in
the vicinity. However, there is no guarantee that interference will not
occur in a particular installation. If this equipment does cause harmful
interference with other devices, which can be determined by turning
the equipment off and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
•
•
•
•
5-1
Reorient or relocate the receiving device.
Increase the separation between the equipment.
Connect the equipment into an outlet on a circuit different from that to which the other device(s) is connected.
Consult the manufacturer or field service technician for help.
Accessory equipment connected to the analog and digital interfaces
must be certified according to the respective IEC standards (e.g.
IEC 60950 for data processing equipment and IEC 60601 for
medical equipment). Furthermore, all configurations shall comply
with the system standard IEC 60601-1-1. Any person whoOPR360U
connects
A0509
additional equipment to the signal input or output parts “configures”
a medical system, and is therefore responsible for ensuring that the
system complies with the requirements of the system standard IEC
60601-1-1. If in doubt, consult the Technical Service department or
your local representative.
OPR360US H0711
1-7
1 Introduction
Gas Warnings
Danger: There is a risk of explosion if used in the presence of
flammable anesthetics. The system is not intended for use with
anesthetic gases.
5-1
OPR360U A0509
Use only dry clean, particle-free compressed air.
Oxygen source gas must be medical grade, 100% oxygen.
Auxiliary Equipment Warnings
Newport Medical cannot warrant or endorse the safe performance
of third party humidifiers for use with the e360 Ventilator. Contact
the manufacturers/distributors of third party humidifiers about the
compliance and performance characteristics of their products.
Cautions
Follow these safety guidelines. Additional cautions appear in context
throughout this document.
Use only fuses with the correct rating.
Do not immerse the ventilator in liquid sterilizing agents or liquids of
any kind.
Do not spray cleaning solutions directly onto the front or rear panels
of the ventilator.
Do not allow cleaning solutions to pool on the ventilator control panel
or top of ventilator.
Do not place liquids on or near the ventilator.
Check with the manufacturer of all cleaning chemicals and sterilizing
equipment to ensure safe handling procedures are followed.
The Exhalation Flow Sensor is a precise and delicate instrument.
Take care when handling not to disturb the measuring wires. Do not
insert any object into the flow sensor, nor direct pressurized flows of
liquids or gases through the sensor during cleaning and reprocessing.
life cycle of the sensor is limited and will depend on observance
OPR360U A0509
5-1The
of safe handling precautions and the ability to calibrate the sensor.
Always make sure that the flow sensor is completely dry before
installation.
1-8
OPR360US H0711
1
Introduction
Federal law in the United States requires traceability of this
equipment. Please register your ventilator online at
www.ventilators.com.
5-1
OPR360U A0509
Warranty
The Newport e360 Ventilator System is warranted to be free of
defects for a period of two (2) years from invoice date of purchase.
The following are exceptions to this warranty:
•
•
•
•
•
•
Defects caused by misuse, mishandling, tampering, or by modifications not authorized by Newport Medical or its representatives are not covered.
Rubber and plastic components and materials are warranted to be free of defects at time of delivery.
The exhalation flow sensor is warranted to be free of defects at time of delivery. After initial use, the flow sensor is not covered by this warranty.
The O2 sensor is covered for a period of six months from the invoice date of the e360 purchase.
The internal battery is covered for a period of of six months from theinvoice date of the e360 purchase.
Accessory items, not manufactured by Newport Medical, supplied with the ventilator are warranted in accordance with the original manufacturer’s warranty. These include (but are not limited to) items such as humidifiers, nebulizers, monitors, and patient circuits.
Any product which proves to be defective in workmanship or material
will be replaced, credited, or repaired with Newport Medical holding
the option. Newport Medical is not responsible for wear, or abuse.
In all cases, Newport Medical will not be liable beyond the original
selling price.
Application of this warranty is subject to the following conditions:
5-1
•
•
•
Newport Medical or its authorized representatives must be promptly notified upon detection of the defective material or equipment. This can be accomplished by filling out the online complaint form at www.ventilators.com.
Defective material or equipment must be returned to Newport OPR360U A0509
Medical or its authorized representative.
Examination by Newport Medical or its authorized representatives must confirm that the defect is covered by the terms of this warranty.
OPR360US H0711
1-9
1 Introduction
This warranty is applicable to the original purchaser/facility and is non-transferable.
Repairs, maintenance or servicing of the Newport e360 Ventilator by personnel other than Newport Factory Trained Technicians or authorized representatives will void this warranty.
5-1
•
•
OPR360U A0509
In order to assure complete protection under this warranty the
customer must register the product within ten (10) days of receipt of
the equipment by visiting the Newport Medical website and filling out
the product registration form at www.ventilators.com.
The above is the sole warranty provided by Newport Medical. No
other warranty expressed or implied is intended. Representatives
of Newport Medical are not authorized to modify the terms of this
warranty.
Federal Law and Regulations in the United States and Canada
restrict this device to sale by or on the order of a physician.
Responsibility for Patient Safety
To use this product correctly and effectively and to avoid hazards,
carefully read and observe all sections of this manual prior to use.
Because the operating manual and labeling of the e360 Ventilator
System assume that its sale and use are restricted to qualified,
trained professionals under the direction of a physician who
understand the general operating characteristics of ventilators, this
manual includes instructions, warnings, and cautions that are specific
to the design of this ventilator. This manual excludes references to
hazards that are obvious to medical professionals, the consequences
of product misuse, or to potentially adverse effects in patients with
abnormal conditions.
Product modification or misuse can be dangerous. Newport Medical
disclaims all liability for the consequences of product alterations
or modifications, as well as for the consequences that might result
from the combination of this ventilator with other products, whether
supplied by Newport Medical or by other manufacturers, if such a
combination is not endorsed by Newport Medical.
It is the responsibility of the ventilator operator to choose appropriate
5-1monitoring of equipment performance and patient condition.OPR360U A0509
Electronic surveillance of equipment performance and patient
condition cannot take the place of directly observing clinical signs.
The ventilator operator is solely responsible for selecting the optimum
level of patient monitoring.
1-10
OPR360US H0711
1
Introduction
Limitation of Liability
5-1
The liability of Newport Medical, whether arising out of, or related to
manufacture and sale of the goods, their installation, demonstration,
sales representation, use, performance, or otherwise, including any
liability based upon Newport Medical’s 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
and regardless of the form of action (including, without limitation,
breach of warranty, negligence, strict liability, or otherwise).
OPR360U A0509
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 non-infringement.
Newport Medical shall not be liable for, nor shall the buyer be entitled
to recover, any special incidental or consequential damages or any
liability incurred by buyer to any third party in any way arising out of
or relating to the goods.
5-1
OPR360US H0711
OPR360U A0509
1-11
Overview
Section 2:
Overview
OPR360U A0509
Ventilator System Overview...................................2-1
Control Panel Layout and Labeling.......................2-1
Graphical User Interface Display (GUI) and
Controls....................................................................2-1
Navigation Map for GUI Menus.........................2-1
Lower Front Panel Layout......................................2-1
Rear Panel Layout...................................................2-2
Navigating the Control Panel.................................2-2
Using Touch - Turn - Accept..............................2-2
Selecting Mandatory Breath Type & Mode..... 2-3
Non Invasive (Ventilation) (NIV) Function............ 2-3
Patient Triggering Methods................................... 2-4
Basic Ventilation Controls..................................... 2-4
Flow or Inspiratory Time in Volume Control........ 2-4
Manual Inflation Button......................................... 2-4
O2 (3 min) Button................................................... 2-5
Alarm Silence Button............................................. 2-5
Suction Disconnect Function .............................. 2-5
Alarm Reset............................................................ 2-5
Graphical User Interface (GUI) Screens ............. 2-5
Alarms Screen .................................................. 2-5
Main Screen....................................................... 2-6
Extended Functions Screen............................. 2-6
2-6
OPR360U A0509
5-1 Setup & Calibration Screen..............................
GUI Miscellaneous Indicators............................... 2-6
Internal Battery........................................................2-7
5-1
Overview
Section 2:
2
Overview
Ventilator System Overview
The user controls the ventilator settings by using the graphical user
interface, membrane buttons and rotary adjustment knob. Ventilation
delivery is continuously monitored and controlled by a servo-controlled
feedback system. When there is a difference between the measured
value and the target value, e360 adjusts gas delivery so that the target
value is achieved. The system uses two gas modules. When air and
O2 are both connected to the ventilator, the system mixes the gases
according to the user adjustment for FIO2. Gases may be supplied by
a medical pipeline system, a compressor, or by gas cylinders.
5-1
OPR360U A0509
Control Panel Layout and Labeling
Please refer to Foldout F-4 for a sample of the e360 English language
control panel.
The e360 Ventilator Control Panel is made up of a Graphical User
Interface (GUI) touch screen, membrane buttons, rotary dial, and
indicator LEDs/lights. The panel may be ordered with different
labeling options which include various languages or an all symbols
panel.
Graphical User Interface Display (GUI) and
Controls
The e360 Graphical User Interface allows the user to quickly navigate
through a number of screens to access monitoring, custom set-up,
automated calibrations, numerics, waveforms and loops.
Please refer to Foldout F-4 for a sample of the GUI screen and
description of its controls.
Navigation Map for GUI Menus
Please refer to Foldout F-3 for a flow chart of the GUI menu
navigation.
Lower Front Panel Layout
5-1
The lower panel area on the front of the e360 contains patient
OPR360Uvalve
A0509
connection ports and provides easy access to the exhalation
and flow sensor. See Figure 2-1.
OPR360US H0711
2-1
2 Overview
5-1
OPR360U A0509
1. Inspiratory (To Patient) Port 22 mm OD
2. Expiratory (From Patient) Port 22 mm OD
3. Exhalation Valve
4. Exhalation Flow Sensor
5. Flow Sensor Cable connection
Figure 2-1 Lower Front Panel Layout
Rear Panel Layout
The e360 rear panel contains the On/Off power switch, Air/Oxygen
inlets, and other connections for various external devices.
Refer to Foldout F-2 for rear panel view and description of connections.
NOTE: Make sure that the e360 is completely shutdown before the
power switch is turned on again. If the power switch is turned off and
then on too quickly and the screen does not load correctly, turn the
power off and wait 15 seconds before powering ON the ventilator.
Navigating the Control Panel
Refer to Foldout F-4 for a full view of the e360 Control Panel
OPR360U A0509
5-1functions described here.
Using Touch - Turn - Accept
Most ventilation and alarm controls on the Control Panel and the GUI
are adjusted with the Touch-Turn-Accept method. There are a few
exceptions which are noted with the description of the control.
2-2
OPR360US H0711
2
Overview
Touch a parameter control on the GUI or press a parameter
membrane button on the Control Panel; then,
Turn the Adjustment knob (Foldout F-4, Item 9) to make a change;
and,
5-1
OPR360U A0509
Press the Accept button (Foldout F-4, Item 10) to confirm and invoke
the change.
If the Accept button is not pressed within 10 seconds, the setting will
not be changed and will revert to the previous condition/value.
Selecting Mandatory Breath Type and Mode
Refer to Foldout F-4, item 12.
NOTE: More specific information on modes and breath types is
available in Section 7.
The mandatory breath type and mode are displayed in the upper left
corner of the GUI. Spontaneous breath type is pre-selected based
on the mandatory breath type.
Modes are selected by pressing the Volume Control or Pressure
Control breath type buttons repeatedly until the desired mode is
highlighted.
Biphasic Pressure Release Ventilation (BPRV) is selected by choosing
Pressure Control A/CMV or SIMV mode and then selecting Open
Exhalation Valve from the Advanced Data Set GUI screen. See Data
Sets, Section 4, for more information.
Volume Target Pressure Control (VTPC) is selected by choosing a
Volume Control or Pressure Control A/CMV or SIMV mode and then
selecting Volume Target ON from the Advanced Data Set GUI screen.
See Advanced Data Sets in Section 4 for more information.
See the Ventilation Controls Guide in Section 4 for a full list of breath
type and mode combinations.
Non Invasive (Ventilation) (NIV) Function
Refer to Foldout F-4, item 11.
5-1
OPR360U A0509
To activate the NIV function in any mode or breath type, press the
Non Invasive button (the indicator will light) and then press Accept.
Non Invasive always reverts to OFF when e360 is powered down (the
setting is not retained). See Section 7 for more information on Non
Invasive function.
OPR360US H0711
2-3
2 Overview
Patient Triggering Methods
Refer to Foldout F-4, item 8.
5-1
The ventilator offers the clinician the choice of flow or pressure (P)
triggering for patient-initiated breaths in all modes of ventilation. To
select Flow or P, press the Trig button (LED lights) and then press
Accept.
OPR360U A0509
Basic Ventilation Controls
Refer to Foldout F-4, item 8.
To set FIO2, Tidal Volume, Flow, Inspiratory Time (t Insp), Respiratory
Rate (Resp Rate), Pressure Support, Pressure Limit, PEEP/CPAP and
Trigger (flow or pressure (P)):
1. Press the button below the corresponding display to select a parameter.
2. Rotate the Adjustment knob to adjust the setting while it is flashing.
3. Press the Accept button to invoke the change.
Or
Select and adjust multiple basic ventilation controls within 10
seconds of the last change and then press the Accept button to
invoke all of the changes. The display(s) will stop flashing and the
setting(s) will take effect.
Flow or Inspiratory Time in Volume Control
When ventilating in Volume Control, you can choose to set either
Flow or Inspiratory Time (t Insp) for mandatory breaths. For all other
mandatory breath types, only t Insp can be adjusted. Press the Select
button to toggle between Flow and t insp.
Manual Inflation Button
Refer to Foldout F-4, item 11.
Press and hold the Manual Inflation button to deliver a manual
OPR360U A0509
The inflation ends when the user releases the button,
five
seconds elapses, or a High Paw alarm is violated, whichever occurs
first.
5-1inspiration.
2-4
OPR360US H0711
2
Overview
O2 (3 min) Button
Refer to Foldout F-4, item 11.
5-1
Press the O2 (3 min) button to start a timed delivery of 100% oxygen,
regardless of the current FIO2 setting. The indicator on the O2 (3
min) button lights when this function is activated. FIO2 returns to the
set value and the indicator turns off after three minutes or when the
button is pushed a second time, whichever comes first.
OPR360U A0509
Alarm Silence Button
Refer to Foldout F-4, item 1.
Press the Alarm Silence
button (LED lights) to mute silenceable
audible alarms for two (2) minutes or to cancel the Shutdown alarm
after the power is switched to OFF. Press again to cancel alarm
silence.
Suction Disconnect Function
Prior to a planned circuit disconnect, press and hold Alarm Silence
button for one second until a second tone sounds to activate the
Suction Disconnect function. See Section 5, Alarms, for more details.
Alarm Reset
Refer to Foldout F-4, item 2.
Press the Reset button to clear visual indicators for alarms that are
no longer violated.
Graphical User Interface (GUI) Screens
Refer to rear Foldout F-6 - F-8 for samples of these screens.
Alarms Screen
Refer to Foldout F-4, item 5.
5-1
Press the Alarms Screen menu button on the Control Panel to open
OPR360U A0509
the Alarm Settings screen on the GUI. From this screen the user
can modify all adjustable alarm settings, view Alarm History, adjust
Alarm Loudness and Alarm Tones and Save the screen image for later
downloading. See Section 5, Alarms, for more details.
OPR360US H0711
2-5
2 Overview
Main Screen
Refer to Foldout F-4, item 6.
5-1
Press the Main Screen menu button on the Control Panel to reveal
five GUI menu buttons: Waves, Loops, Numeric, Trends and Freeze.
When Freeze is selected the Adjustment knob will move a cursor
across the screen and display data and time relevant to the point the
cursor is crossing. The user can choose to “Save” the current screen
or touch “Start” to deactivate the Freeze function. See Section 4 for
more details.
OPR360U A0509
Extended Functions Screen
Refer to Foldout F-4, item 6.
Press the Extended Functions menu button on the Control Panel to
reveal five GUI menu buttons: Insp Hold, Exp Hold, Event History,
Save and Freeze. Touch and hold Insp Hold or Exp Hold to start the
maneuver for the current or following mandatory breath (the Accept
button is not needed). Touch the Event History button to access the
Event History log that records up to 1000 events. See Section 4 for
more details.
Setup & Calibration Screen
Refer to Foldout F-4, item 6.
Press the Setup & Calibration menu button on the Control Panel to
reveal four GUI menu buttons: Circuit Check, Sensors, Patient Setup
and Technical. See Section 4 for more details.
GUI (Graphical User Interface) Miscellaneous
Indicators
Refer to Foldout F-4, item A.
The top area of the GUI provides useful information and icons that
relate to ventilator settings and conditions. This is referred to as the
Status Bar area.
5-1
OPR360U
A0509
05-01-2008
15:30
ADULT
Int
Bat
VTPC-SPONT
Ho u r s
999999.7
Figure 2-2 GUI Status Bar
2-6
OPR360US H0711
2
Overview
Patient and Breath Type/Mode Selection
At the far left of the Status Bar an icon is displayed that represents
which Patient Category and which mandatory Breath Type/Mode are
selected. See Section 4 for more details.
5-1
OPR360U A0509
Patient Trigger Indicator
While ventilating, the Patient Category and mandatory Breath Type/
Mode selection area flashes green each time the patient triggers the
ventilator.
Int. Battery Charge Level
When the ventilator is powered by the internal battery an icon at the
far right of the Status Bar shows the remaining battery power. Each lit
bar represents approximately 25% of the total battery capacity.
Ext. Battery Indicator
When the ventilator is powered by an external battery “Ext Bat” is
displayed on the far right of the status bar.
Date/Time
Date and time are displayed in the far right corner of the display. The
date, time, and preferred format can be set in the Technical screen.
See Section 4 for more details.
Hour Meter
Touch the area just below the Date/Time to display the total
working hours of the ventilator. After 10 seconds the hour meter will
disappear.
Internal Battery
The e360 Ventilator is equipped with an internal battery that when
fully charged can support approximately one hour of ventilator
function at the following settings: Adult, SIMV with RR 15, VT 500,
t insp 1.0 seconds, FIO2 .30, PS 0, PEEP +5, Pause OFF, Sigh OFF,
Square wave form.
5-1
When the ventilator is operating on the internal battery:
o the Int Battery LED on the front panel lights and an audible alarm sounds every 5 minutes
o the Battery Charge Level icon indicates the relative charge level of OPR360U A0509
the internal battery
The internal battery recharges whenever the ventilator is connected
to AC power, regardless of whether the power switch is ON or OFF.
OPR360US H0711
2-7
2 Overview
The internal battery requires up to 5 hours recharge from AC power
to obtain an 80% charge and is fully charged after 14-16 hours.
Recharge interval should not exceed 2 months.
OPR360U A0509
5-1
2-8
5-1
If the internal battery voltage remains low (a Low Battery alarm
sounds after disconnecting from AC power) after a 5 hour charge on
AC power, the internal battery may need to be replaced. The standard
replacement schedule for the e360 internal battery is every 24
months. Refer to the e360 Ventilator Service Manual for replacement
procedure.
OPR360U A0509
OPR360US H0711
Unpacking,
Section 3:
Assembly, and
Safety Check
Unpacking, Assembly, and
Safety Check
OPR360U A0509
Assembly, and
Safety Check
Unpack the Ventilator and Accessories................3-1
List of Package Contents..............................3-1
Assembly..................................................................3-1
Exhalation Valve Compartment . ................ 3-5
Connect Air, Oxygen and AC Power........... 3-5
Install the Breathing Circuit System .......... 3-6
Safety Check Procedure....................................... 3-8
Setup and Inspection................................... 3-8
Emergency Intake Valve............................... 3-8
Circuit Check................................................. 3-9
Gas Supply Alarms....................................... 3-9
AC Power Loss/Battery Backup Alarm.....3-10
High/ Low Airway Pressure Alarms / Circuit
Disconnect Alarm/ Alarm Silence..............3-10
Minute Volume / Back Up Ventilation / Apnea
Alarms........................................................... 3-11
Trigger/Pressure Support...........................
3-11
OPR360U A0509
5-1 Volume/Flow/Rate Accuracy Test.............. 3-11
Shut Down Alarm.........................................3-12
Safety Check Record............................................3-13
5-1
Unpacking,
Section 3:
3
Unpacking, Assembly, and Safety Check
Unpack the Ventilator and Accessories
Make note of and photograph if possible any shipping damage to the
boxes. Compare the contents you received with the e360 package
contents listed below. Contact Newport Customer Service to resolve
any discrepancies.
5-1
OPR360U A0509
Register your ventilator for warranty protection by submitting the
Product Registration form online at www.ventilators.com.
List of Package Contents
• e360 Ventilator, model S
• Power Cord: NA (North American standard)
• Built-in heated reusable exhalation valve
• Two (2) Exhalation Flow Sensors – one installed and one spare
• Operating Manual
• Accessory Package
• Air and O2 hoses
• Extension arm with circuit hanger and rail mount extension arm bracket
• Two (2) disposable breathing circuit filters
•
Optional Accessories
• External Monitor
• Humidifier
• Expiratory Filter Heater Kit and Reusable or Disposable Expiratory Filter
• e360 Cart
• AC Power Strip (120 VAC) for Cart
• Dual Cylinder Holder for Cart
• Accessory Basket for Cart
Assembly
Refer to Foldout F-1 or Figure 3-1 for complete view of e360
assembled on the cart.
5-1
1.
2.
3.
4.
Set aside the disposable breathing circuit filters and store the spare exhalation flow sensor in a convenient location.
Optional: Mount the e360 to the CRT360A Cart (assembly instructions are provided with the cart.) See Figure 3-1, A.
OPR360U A0509
Install the extension arm bracket and extension arm on either of the side rails. See Figure 3-1, B.
Optional: Install a third-party humidifier. See Figure 3-1, C.
OPR360US H0711
3-1
3 Unpacking, Assembly, and Safety Check
5-1
OPR360U A0509
B
C
A
5-1
OPR360U A0509
Figure 3-1 Mounting Accessories to Cart
3-2
OPR360US H0711
3
Unpacking, Assembly, and Safety Check
5-1
OPR360U A0509
Figure 3-2 External Monitor
5-1
OPR360U A0509
5. Optional: Install External Monitor (instructions are provided with the monitor). See Figure 3-2.
OPR360US H0711
3-3
3 Unpacking, Assembly, and Safety Check
5-1
OPR360U A0509
Main
Screen
Extended
Functions
Setup &
Calibration
Fl O2
Tidal Volume
Flow
I Insp
Resp Rate
A/CMV
A/CMV
A/CMV
Pressure Support
Pressure Limit
PEEP/CPAP
Flow
P
Manual
Inflation
Mon
Inactive
Manual
Inflation
O2
Accept
Figure 3-3 Mounting Expiratory Filter Heater
6. Optional: Install Expiratory Filter Heater Kit (instructions are provided with the heater kit). See Figure 3-3.
willA0509
OPR360U
5-1NOTE: To install both a humidifier and heater on the cart, you
need to order a Dual Mounting Bar. The straight bar, p/n BAR1820A,
mounts the filter heater next to the humidifier. The L-shape bar, p/n
BAR2101A, mounts the filter heater next to and higher than the
humidifier so that a shorter tubing can be used between the heater
and the patient port.
3-4
OPR360US H0711
3
Unpacking, Assembly, and Safety Check
Exhalation Valve Compartment
Open the Exhalation Valve Compartment and check to make sure
that the exhalation valve and flow sensor are fitted securely. See
Figure 3-4. Close the compartment door. Refer to Section 6 for
removal and cleaning instructions.
5-1
OPR360U A0509
Exhalation Valve
Plug
Flow sensor
Figure 3-4 Exhalation Valve Compartment
Figure 3-5 Fitting Flow Sensor Cable
NOTE: When fitting the flow sensor cable to the flow sensor, ensure
that the pins in the cable are properly aligned with the flow sensor
during insertion. Do not twist either assembly while inserting the flow
sensor cable or damage to the cable may result. See Figure 3-5.
5-1
Connect Air, Oxygen and AC Power
Refer to Foldout F-2, items 3 and 4, or Figure 3-6.
OPR360U A0509
Connect Air and Oxygen Hoses to their proper fittings on the back of
the ventilator. See Figure 3-6, A.
OPR360US H0711
3-5
3 Unpacking, Assembly, and Safety Check
A
5-1
OPR360U A0509
B
Figure 3-6 Air, O2 and AC Power Connections
Ensure that the AC power cord is connected to the fitting on the back
of the ventilator. Tighten the retaining clamp as needed to secure the
cord. See Figure 3-6, B.
Caution Periodically inspect the air and oxygen inlet water traps and
drain water from the bowls as necessary by pressing the pin at the
bottom of the bowl.
Install the Breathing Circuit System
1. Firmly install the disposable filters on the To Patient port and the From Patient port.
Optional: If the Expiratory Filter Heater is in use, install a filter into
the heated system instead of on the From Patient port.
5-1
OPR360U A0509
2. Install a two-limb breathing circuit and humidification system according to patient requirements. See Figure 3-7, 3-8 and 3-9 for setup options.
3-6
OPR360US H0711
3
Unpacking, Assembly, and Safety Check
Filter
Ventilator
From patient
5-1
OPR360U A0509
Patient connection
To patient
Filter
Figure 3-7 Heated Wire Breathing Circuit with Humidifier
Filter
Ventilator
From patient
To patient
Patient connection
Filter
Figure 3-8: Non-Heated Breathing Circuit with Humdifier
Filter
Ventilator
From patient
To patient
Patient connection
Filter
Figure 3-9 Non-heated Breathing Circuit with HME
5-1
OPR360U A0509
NOTE: The e360 can be used with a reusable or disposable two
limb breathing circuit. No proximal line or external exhalation valve is
required.
WARNING! Do not use electronically conductive breathing circuits.
OPR360US H0711
3-7
3 Unpacking, Assembly, and Safety Check
5-1
WARNING! Use water traps or heated wires in appropriate locations
in the breathing circuit to prevent water from pooling in the circuit
tubing, draining into the patient airway or draining into the ventilator.
Empty and clean water traps as necessary. Never drain the water
back into the humidifier water chamber.
OPR360U A0509
Caution The ventilator is ready for operation only when it is
completely assembled and has successfully completed the Safety
Check and Circuit Check procedures.
Safety Check Procedure
The e360 does a self-diagnostics test when powered ON which
verifies the operation of internal electronics. Newport Medical
recommends that you perform a complete Safety Check prior to
the initial use of the ventilator and at least with every preventative
maintenance interval. Use the e360 Safety Check Record at the end
of this section to record the results of each check.
Do not use the e360 ventilator if it does not pass the Safety Check
Procedure.
Setup and Inspection
1. Assemble the ventilator system.
2. Inspect the Newport e360 ventilator, Newport air compressor (if used), AC power cords, and verify that there is no evidence of wear or damage which might contribute to a malfunction.
3. Connect AC power cord(s) to properly grounded wall receptacles.
4. Inspect the high pressure air and oxygen inlet water traps on the
back of the e360 to ensure that there is no water or debris present.
5. Ensure that the high pressure air and oxygen hoses are firmly secured onto the ventilator inlet fittings.
6. Attach a recommended two-limb 22 mm breathing circuit and filters. Have a 500 mL (or 1L enclosed) test lung available.
7. Inspect the patient breathing circuit and all connections to verify that there is no evidence of wear or damage which might result in leaks and/or contribute to ventilator malfunction.
Emergency Intake Valve
1. Make sure the e360 power is turned OFF on the back of the ventilator.
OPR360U A0509
5-12. Verify that air can be drawn into the patient breathing circuit
through the emergency intake valve. You may create a negative effort on the inspiratory limb of the patient breathing circuit by (1) using a “bellows” type test lung, or (2) inspiring through a barrier filter on the inspiratory limb of the patient circuit.
3-8
OPR360US H0711
3
Unpacking, Assembly, and Safety Check
WARNING! Newport Medical strongly recommends that you use a
clean/disinfected circuit and filters on the ventilator before breathing
through the circuit.
Circuit Check
1. Connect the high pressure oxygen and air hoses from the oxygen and air inlet water traps on the back of the Newport e360 to 50 ± 10 psig gas sources provided by gas cylinders, wall outlets or air compressor.
2. If an air compressor is the compressed air gas source, connect the high pressure air hose from the air inlet water trap on the back of the Newport e360 to the outlet of the air compressor. Otherwise go to #4.
3. Toggle the compressor power switch to the ON position and verify its function.
4. Switch the Power Switch (on the back of the ventilator) to the ON position.
5. When the Graphical User Interface (GUI) powers on, the ventilator will be ready to start a Circuit Check test. Follow the on-screen instructions. Do not use a test lung to occlude the circuit for
the Circuit Check. Following the completion of the two-step test,
a message will show that the test has passed or failed. If the
circuit test failed, resolve all circuit tubing connections and] exhalation valve leaks and repeat test.
6. Touch the Patient Setup button and select the ADULT patient category.
5-1
OPR360U A0509
Gas Supply Alarms
Set ventilator to standard test settings:
5-1
Volume Control
Mode: A/CMV
Waveform: Square
Resp Rate: 10
Flow: 30 L/min or t Insp = 1.0 sec
Tidal Volume: 500 mL
FiO2: .21
Pressure Trig: 5.0 cmH2O/mbar
PEEP: 0 cmH2O/mbar
High/Low Paw Alarms: 70/5
High/Low MVE Alarms: 6.0/2.0
Apnea: 20 seconds
Disconnect Alarm: 75%
OPR360U A0509
1. Attach a 500 mL (or 1L enclosed) test lung.
2. Touch the “Start Ventilating” button on the GUI.
OPR360US H0711
3-9
3 Unpacking, Assembly, and Safety Check
3. Adjust the FIO2 to .23. Disconnect the high pressure oxygen hose from the gas source. Verify that e360 provides an audible alarm and visual O2 Supply Loss alarm message.
4. Reconnect the high pressure oxygen hose to the gas source. Verify that the alarm is no longer violated. Push Reset to clear visual message and indicator. Return the FIO2 to .21.
5. Disconnect the high pressure air hose from the gas source. Verify that e360 provides an audible alarm and visual Air Supply Loss alarm message.
6. Reconnect the high pressure air hose to the gas source. Verify that the alarm is no longer violated. Push Reset to clear visual message and indicator.
5-1
OPR360U A0509
AC Power Loss/Battery Backup Alarm
1. While the ventilator is operating, unplug the AC power cord from the wall outlet. Verify that the ventilator continues functioning and provides an audible and a visual alarm, the Int Battery (Internal Battery) indicator lights and the message AC Power Loss Battery Back Up appears in the window. The e360 issues a short beep every five (5) minutes while running on internal battery.
2. Plug the AC power cord back into the wall outlet. Verify that the ventilator continues functioning, the Internal Battery indicator goes out and the Mains (Battery Charging) indicator lights.
3. Push Reset to clear visual messages and indicator.
High/ Low Airway Pressure Alarms / Circuit Disconnect Alarm/
Alarm Silence
1. Remove the test lung. Verify that both visual and audible indicators for the Low Paw (low airway pressure) alarm are activated after two mandatory breaths and after three breaths the Circuit Disconnect alarm message is displayed.
2. Press the Alarm Silence button and verify that the audible alarm is muted but the alarm lamp continues to blink and the alarm message remains displayed.
3. Press the Alarm Silence button again and verify that the audible alarm resumes beeping.
4. Re-attach the test lung. Verify that the audible alarm stops and the 360° alarm lamp is steadily lit (latched).
5. Press the Reset button to clear all visual alarm indicators (lamp and messages).
6. Remove the test lung and occlude the patient wye connector OPR360U A0509
5-1 of the breathing circuit. Verify that both the visual and audible
indicators for High Paw (high airway pressure) alarm are activated.
7. Re-attach the test lung to the wye connector. Verify that the audible alarm stops and the alarm indicator is steadily lit.
3-10
OPR360US H0711
3
Unpacking, Assembly, and Safety Check
8. Press the Reset button to clear the High Paw alarm message and visual indicators.
5-1
Minute Volume / Back Up Ventilation / Apnea Alarms
1. Adjust the Resp Rate to 20 b/min. Verify that both audible and visual indicators for High MVE (Exhaled Minute Volume) alarms are activated within 30 seconds.
2. Adjust the Resp Rate back to 10 b/min. Verify that within 30 seconds the audible alarm stops and the visual alarm indicator is steadily lit. Press the Reset button to clear the High MVE alarm message and indicator.
3. Adjust the Resp Rate to 1 b/min. Verify that within 30 seconds the audible and visual alarm indicators for APNEA and the Low MVE alarm are activated. Verify that after 65 seconds, Back Up Ventilation begins and is indicated with a Back Up Ventilation message on the Alarms and Messages display.
4. Verify that within 30 seconds following the start of Back Up Ventilation the alarm indicators are steadily lit signifying the end of Back Up Ventilation. Adjust the Resp Rate to 10 b/min. Press the Reset button to clear the alarm messages and indicators.
OPR360U A0509
Trigger/Pressure Support
1. Set High MVE alarm to 12 L, Mode to SPONT, Pressure Support to 10 cmH2O/mbar, PEEP to 3 cmH2O/mbar, P Trig to 2.0 cmH2O/mbar.
2. Briefly squeeze the test lung to create a negative pressure in the breathing circuit. Verify that the green patient effort indicator “blinks”, and that a pressure support breath is delivered.
3. Select Flow Trig and set to 2.0 L/min and repeat step 2.
4. Set Mode to A/CMV, PEEP to 0 cmH2O/mbar and Trig to P = 5.0 cmH2O/mbar. All other controls should still be at standard settings.
5-1
Volume/Flow/Rate Accuracy Test
1. Change the GUI to the Numeric screen (via Main Screen button) to see the monitored exhaled tidal volume (VTE). Verify that the monitored value is within ± 20% of the Tidal Volume setting on the front panel.
2. Observe the Insp Flow display on the Numeric screen and verify that the measured value is within ± 5 L/min of the Flow setting on the front panel.
3. Observe RRtot (monitored total breath rate) on the Numeric
OPR360U A0509
screen and verify that after 30 seconds the monitored value is within ± 1 b/min of the Resp Rate setting on the front panel.
OPR360US H0711
3-11
3 Unpacking, Assembly, and Safety Check
OPR360U A0509
Shut Down Alarm
1. Switch the e360 power to OFF. Verify that the audible Shut Down alarm activates.
2. Press the Alarm Silence button. Verify that the alarm is silenced.
5-1
3-12
OPR360U A0509
OPR360US H0711
5-1
NOTE: The flow sensor should be calibrated whenever you suspect
that the expiratory tidal/minute volumes are significantly different
than expected (such as ± 25%). If the sensor fails to calibrate, even
after it has been cleaned and sterilized, inspect it for broken wires. If
damaged, discard it in accordance with local regulations and replace
with a new sensor.
3
Unpacking, Assembly, and Safety Check
NOTE: Make copies of this form to record the results of safety checks.
Newport e360 Ventilator
Safety Check Record
5-1
OPR360U A0509
Newport Medical recommends that you perform a complete Safety
Check prior to A) The initial use of the ventilator; and, B) At least at
every Preventative Maintenance interval.
Unit Serial Number:
Item
Pass
Fail
Setup and Inspection
Emergency Intake Valve
Circuit Check
Gas Supply Alarms
AC Power Loss/Battery Backup Alarm
Pressure Alarms/Circuit Disconnect
Alarm/Alarm Silence
Minute Volume/Back up Ventilation/
Apnea Alarms
Trigger/Pressure Support
Volume/Flow/Rate Accuracy Test
Shut Down Alarm
Comments:
5-1
OPR360U A0509
Performed by:
OPR360US H0711
Date:
Unit Hours:
3-13
Setting Up For
Section 4:
Patient Use
Setting Up For Patient Use
5-1
OPR360U A0509
Setting Up For
Section 4:
Patient Use
Power Conditions.................................................................. 4-1
Shutdown Alarm......................................................... 4-1
Overview: Preparing For Patient Ventilation..................... 4-1
Setup & Calibration Menu.................................................... 4-2
Circuit Check ............................................................. 4-2
Oxygen and Flow Sensors.........................................4-3
Exhalation Flow Sensor, Calibration...................4-3
O2 (Oxygen) Sensor, Calibration.........................4-4
O2 Sensor, Disable................................................4-4
Patient Setup..............................................................4-5
Patient Category...................................................4-5
Weight Units..........................................................4-5
Ideal Weight...........................................................4-5
Volume Units.........................................................4-5
Sigh.........................................................................4-5
Circuit Type............................................................4-6
Leak Comp (Leak Compensation)......................4-6
Compliance Compensation.................................4-6
Technical .................................................................... 4-7
Comm (Communication) Protocol...................... 4-7
Display Brightness................................................ 4-7
Regional Settings.................................................. 4-7
OPR360U A05094-7
5-1 Altitude.............................................................
Date Format........................................................... 4-7
Date and Time....................................................... 4-7
Screen Files........................................................... 4-7
Event History Files................................................ 4-7
5-1
OPR360U A0509
Ventilation Controls Guide...................................................4-8
Ventilation Settings in Advanced Data Set....................... 4-10
Slope/Rise................................................................. 4-10
Expiratory Threshold............................................... 4-10
Pause......................................................................... 4-10
Flow Waveform......................................................... 4-10
Volume Target........................................................... 4-10
Open Exhalation Valve............................................. 4-10
Inspiratory and Expiratory Hold Maneuvers.................... 4-10
P0.1 Measurement.............................................................. 4-10
Negative Inspiratory Force (NIF)....................................... 4-10
Waves and Loops Displays................................................ 4-14
Adjusting Scale......................................................... 4-14
Auto-scale................................................................. 4-14
Using the Freeze Function....................................... 4-14
Using the Cursor in Freeze...................................... 4-14
Event History Screen.......................................................... 4-16
Numeric Screen................................................................... 4-17
Trends Screen..................................................................... 4-17
Data Sets ......................................................................... 4-18
Save Feature........................................................................ 4-19
Download Feature............................................................... 4-21
5-1
OPR360U A0509
4
Setting Up For Patient Use
Power Conditions
Power switch is in the OFF position.
Power switch is in the ON position but the ventilator is not yet in the ventilating condition.
Power switch is in the ON position and the user has touched the Start Ventilating button.
5-1
Off: Ventilation Standby: Ventilating: OPR360U A0509
WARNING! Never connect the patient breathing circuit to the patient
while the ventilator is in ventilation standby condition. Always touch
the “Start Ventilating” button on the GUI prior to connecting the
breathing circuit to the patient.
Shutdown Alarm
After powering off the ventilator it will initiate a Shutdown alarm as
confirmation that the ventilator has been powered OFF. Cancel the
Shutdown alarm by pressing the Alarm Silence button.
NOTE: Make sure that the e360 is completely shutdown before the
power switch is turned on again. If the power switch is turned off and
then on too quickly and the screen does not load correctly, turn the
power off and wait 15 seconds before powering ON the ventilator.
Overview: Preparing For Patient Ventilation
1.
2.
3.
4.
5.
Attach the breathing circuit and humidifier. Fill the humidifier water chamber.
Connect the air and oxygen hoses to the appropriate source gas supplies.
Plug the ventilator power cord into AC power.
Turn the ventilator ON. It will be in the standby condition.
While in standby:
a. Perform a Circuit Check (follow the on-screen instructions).
b. Touch Sensors and perform the O2 Sensor calibration.
WARNING! Newport Medical recommends that you perform the
Circuit Check (which includes an Exhalation Flow Sensor Calibration)
and O2 Sensor Calibration procedures before connecting the
ventilator to a patient.
5-1
c. Touch Patient Setup and enter selections for:
Patient Category
Ideal Weight and Units of Measure
Circuit Type
A0509
Leak Compensation (Newport recommends thatOPR360U
you always
keep Leak Compensation turned ON)
Compliance Compensation (ON or OFF)
Sigh (ON or OFF)
d. Verify that ventilation parameters settings, including Advanced settings are appropriate.
OPR360US H0711
4-1
4 Setting Up For Patient Use
e. Activate the Non-invasive button when using a noninvasive (e.g., mask) patient interface, or when ventilating with a large
airway leak.
f. Verify safe alarm limits.
6. Touch the Start Ventilating button to enter ventilating condition and begin breath delivery.
7. Connect the breathing circuit to the patient.
8. Observe the patient’s condition and make sure the ventilation and alarm settings are appropriate.
5-1
OPR360U A0509
Setup & Calibration Menu
Refer to Foldout F-3 for a navigation map of GUI menus, including
Setup & Calibration Menu. See Foldout F-10 and F-11 to reference
the Setup & Calibration menu screens.
Circuit Check
Refer to Foldout F-5.
The Circuit Check is available in Standby condition after the e360 is
turned ON. It requires that the e360 be connected to a compressed
air gas source.
Perform the Circuit Check:
• Each time you set up the e360 on a patient;
• With each breathing circuit or circuit component installation;
• Any time breathing circuit/filter integrity or resistance is suspect.
The check is performed in two steps. The results of the Circuit Check
are logged in the Event History. Follow these instructions to perform a
Circuit Check:
1.
2.
3.
4.
5.
5-1
6.
4-2
Set up the breathing circuit and humidifier (including water) as it will be used on the patient. The breathing circuit system compliance that is measured will determine the Compliance Compensation factor used during ventilation.
Cap off/occlude the patient connection of the circuit (don’t use a test lung).
Touch the Circuit Check button to initiate the first step.
When the first step is complete, remove everything distal to the circuit wye connector, then touch the Circuit Check button again to complete the test.
When the Circuit Check is successfully completed, the screen will OPR360U
A0509
show “Passed” and Compl Comp, Insp and Exp Resistance
values will be displayed.
If the Circuit Check is not successful, the screen will show “Failed”.
OPR360US H0711
4
Setting Up For Patient Use
a. Confirm the integrity and tightness of connections for all breathing circuit components such as tubing, filters and humidifier chamber, as well as the exhalation valve components.
b. Repeat the test.
7. The results of the Circuit Check are logged in the Event History.
5-1
OPR360U A0509
NOTE: Circuit Check function is only available in the standby
condition. If the ventilator is in use, ensure that an alternate method of
ventilation is available if you want to perform a Circuit Check. You must
power OFF the ventilator and power back ON to access Circuit Check.
Oxygen and Flow Sensors
Refer to Figure 4-1.
Press the Setup & Calibration menu button, then touch the Sensors
button to access the screen which allows you to calibrate the Oxygen
(O2) and Exhalation Flow sensors and to disable the O2 sensor.
Exhalation Flow Sensor, Calibration
Refer to Figure 4-1.
The Exhalation Flow Sensor calibration requires that the ventilator be
connected to a compressed air gas service.
Perform an Exhalation Flow Sensor calibration each time you change
the sensor and anytime there are suspected volume/monitoring
inaccuracies. To calibrate the sensor:
5-1
OPR360U A0509
Figure 4-1 Sensors Screen
OPR360US H0711
4-3
4 Setting Up For Patient Use
Touch the Sensors button and then touch the Flow Sensor button.
Touch Calibrate to start the calibration procedure or touch Exit to terminate the process.
Upon successful calibration, touch Exit.
OPR360U A0509
The message display will indicate if the sensor passed or failed
the calibration. If the calibration fails or shows an error message,
the sensor may need to be cleaned or replaced. See Section 7 for
instructions. The results of the Flow Sensor Calibration are logged in
the Event History.
NOTE: The Exhalation Flow Sensor Calibration is automatically
performed as part of the Circuit Check. Make sure to perform the
Circuit Check each time you set up the e360 Ventilator for patient use.
O2 (Oxygen) Sensor, Calibration
Refer to Figure 4-1.
The O2 Sensor Calibration requires that the e360 be connected to
a medical grade, 100% oxygen gas source. Perform an O2 Sensor
Calibration before each patient use and regularly while ventilating,
according to hospital policy. Pressing the O2 3 min button also
initiates an O2 sensor calibration. To calibrate the O2 sensor:
1. Touch the Sensors button and then touch the O2 Sensor button.
2. Touch Calibrate to initiate the automatic calibration, or touch Exit to terminate the process.
The message display will indicate if the sensor passed or failed
the calibration. If the calibration fails or shows an error message,
the sensor may need to be replaced. The results of the O2 Sensor
Calibration are logged in the Event History.
Newport Medical recommends that the O2 sensor be replaced every
two years or sooner if it is not able to pass a calibration. See Section
6 for instructions.
NOTE: Gas delivery to the breathing circuit is at 100% O2 during O2
Sensor calibration.
O2 (Oxygen) Sensor, Disable
Disabling the O2 sensor causes the FIO2 monitoring and FIO2 alarms
be disabled and places an alarm-disabled icon in place of the
OPR360U A0509
5-1to
monitored FIO2 value on the Basic Data Set Bar. (See Figure 4-2)
WARNING While this function is disabled, use an external device for
FIO2 monitoring and alarms.
Ensure that an O2 sensor remains in place even while disabled.
4-4
OPR360US H0711
5-1
1.
2.
3.
4
Setting Up For Patient Use
To Disable the O2 Sensor
1. Touch the Sensors button, then touch the O2 Sensor button.
2. Touch Disable to disable the O2 sensor, then touch Yes to confirm.
3. Touch Exit.
5-1
OPR360U A0509
Figure 4-2. Basic Data Set Bar indicating that the O2 sensor
and FIO2 alarms are disabled
To Enable the O2 Sensor
1. Touch the Sensors button, then touch the O2 Sensor button.
2. Touch Enable to enable the O2 sensor.
3. Touch Exit.
Patient Setup
Refer to Foldout F-11.
Press the Setup & Calibration menu button, then touch the Patient
Setup button to access this screen.
Patient Category
Choose between Adult and Ped/Infant patient category. The setting
impacts ventilation and alarm settings ranges and ventilation
management algorithms. If any alarm or ventilator setting is out of
range after changing the Patient Category, the Alarms and Messages
display shows “[Setting] Out of Range” and the LED display for the
parameter(s) that are out of range flashes and an audible alarm sounds.
NOTE: Always select Ped/Infant category when using a pediatric or
infant breathing circuit.
Weight Units
Select either Lb or kg for the unit of measure for weight.
Ideal Weight
Enter the ideal patient weight value, between 1 – 999 kg/ 2 - 2202 lb.
The ideal weight must be entered before you can choose to display
exhaled volume measurements in mL/lb or mL/kg.
5-1
Volume Units
OPR360U A0509You
Choose mL or mL/kg for the unit of measure for the VTE display.
must enter an ideal weight before selecting mL/Kg.
NOTE: Selecting the volume unit affects the numeric data display for
VTE only.
OPR360US H0711
4-5
4 Setting Up For Patient Use
Sigh
Turn the Sigh feature ON or OFF. When turned on, the ventilator will
give a sigh breath every 100 breaths at 1.5 times the set Tidal Volume
for Volume Controlled breaths only.
5-1
OPR360U A0509
Circuit Type
Select from the following four choices:
1. Heated Exp Limb = heated humidifier with dual heated wire breathing circuit.
2. Heated Insp Limb = heated humidifier with no heated wire on the expiratory limb of a breathing circuit.
3. HME = unheated circuit with heat moisture exchanger.
4. Test Lung = no humidification, no heat (for testing and demonstration purposes)
Monitored expiratory flow and volumes are adjusted appropriately for
Body Temperature Pressure Saturated (BTPS). Circuit Type selection
affects the monitored values. Selecting the Circuit Type that matches
the humidifier and circuit in use will ensure accuracy of monitored
expiratory flow and volumes.
Leak Comp (Leak Compensation)
Select Leak Comp ON or OFF. When Leak Compensation is
turned ON, the e360 automatically adjusts the bias flow between
3 and 8 L/min for Ped/Infant selection and 3 and 15 L/min for
Adult, in order to maintain an end expiratory base flow of 3 L/min.
When Leak Compensation is OFF, the ventilator always provides
a leak compensation flow of 3 L/min during the expiratory phase
of each breath cycle. Leak Compensation flow may increase to
a maximum of 25 L/min with Non Invasive ON. See Section 7 for
more information on Non Invasive Ventilation. Flow Triggering is
automatically compensated for Leak Compensation flow.
Compl Comp (Compliance Compensation)
Select Compl Comp ON or OFF. When Compl Comp is turned
ON, the ventilator automatically compensates for delivered volume
loss due to breathing circuit compressibility during every volume
controlled mandatory breath, using the Compl Comp factor that was
measured during the most recent Circuit Check (the factor is stored
at power down).
OPR360U A0509
5-1The Compl Comp factor is measured during the Circuit Check.
Always perform the circuit check with the breathing circuit system
and humidifier (including water), set up exactly as they will be used
on the patient in order to ensure that the volume delivery/monitoring
adjustment is accurate.
4-6
OPR360US H0711
4
Technical
The Technical Screen is accessed from the Setup & Calibration
screen. Refer to Foldout F-10 for a sample of the Technical screen.
Set ventilator specific technical settings that are appropriate for your
hospital or patient.
5-1
Setting Up For Patient Use
OPR360U A0509
Comm (Communication) Protocol
Select the RS232 communication protocol that corresponds with the
monitoring system that is connected to the e360 Ventilator. Touch
the button to select from Newport, Newport 2, and Vuelink.
Contact Newport Technical Service for more details regarding the
communication port protocol.
Display Brightness
Adjust the built-in GUI display brightness.
Regional Settings
• Altitude
Adjust the altitude setting in 200-meter increments so that it
corresponds with your local ambient altitude. The altitude setting may
be adjusted up to 4,000 meters (13,124 feet).
Date Format
Select from three (3) date formats: month–day–year, day-month-year
or year-month-day.
Date and Time
Set the Month, Day, Year and Time.
Screen Files
Touch this button to open the Screen Files List window which
contains the last 200 saved screen images (.bmp files). Ensure that a
flash drive is properly inserted into the USB port. Use the Adjustment
knob to scroll to a .bmp file, then touch Download button to download
the file to the flash drive. A File Storing Successful message will
appear with a short two-toned beep when the download to the flash
drive is complete. Repeat the process for each file to be downloaded.
5-1
Event History Files
Touch this button to open the Event History Files List window which
contains the last 200 Event and Alarm History Logs (.csv files).
Ensure that a flash drive is properly inserted into the USB OPR360U
port.A0509
Use
the Adjustment knob to scroll to a file, and then touch Download
button to save the file to the flash drive. A File Storing Successful
message will appear with a short two-toned beep when the download
to the flash drive is complete. Repeat the process for each file to be
downloaded.
OPR360US H0711
4-7
4 Setting Up For Patient Use
NOTE: See “Save Feature” and “Download Feature” on following pages
in this section for details on saving Screen and Event History files.
OPR360U A0509
The following table shows the ventilation parameters that are active
in each mode/breath type.
X = active, D =dimmed (not active but still adjustable)
Control
Display
VC/
ACMV
VC/
SIMV
VC/
SPONT
PC/
ACMV
PC/
SIMV
PC/
SPONT
FIO2
X
X
X
X
X
X
Tidal
Volume
X
X
D
D
D
D
Flow
X
X
D
D
D
D
t Insp
X
X
D
X
X
D
Resp. Rate
X
X
D
X
X
D
Pressure
Support
D
X
X
D
X
X
Pressure
Limit
D
D
D
X
X
D
PEEP/CPAP
X
X
X
X
X
X
Trig
X
X
X
X
X
X
Slope/Rise
D
X
X
X
X
X
Exp. Thresh
D
X
X
D
X
X
Pause
X
X
D
D
D
D
X
X
ON =
BPRV
ON =
BPRV
Open Exh
(ON/OFF)
D
D
D
Flow Wave
X
X
D
D
D
D
X
X
X
X
X
X
ON =
VTPC
ON =
VTPC
ON =
VTPC
ON =
VTPC
ON =
VTPC
ON =
VTPC
Volume
Target (ON /
OFF)
5-1
Mode LEDs
Volume Volume Volume
Control Control Control
and
and
and
ACMV
SIMV SPONT
Pressure
Control
and
ACMV
D
Pressure Pressure
A0509
Control OPR360U
Control
and
and
SIMV
SPONT
Table 4-1: Ventilation Controls Guide
4-8
OPR360US H0711
5-1
Ventilation Controls Guide
4
Setting Up For Patient Use
WARNING! Always ensure that ventilator settings that are not in use
(their displays are dimmed) are set at appropriate, safe levels in case
of accidental breath type or mode changes.
OPR360U A0509
5-1
BPRV/
ACMV
BPRV/
SIMV
VTPC/
ACMV
VTPC/
SIMV
VTPC/
SPONT
X
X
X
X
X
FIO2
D
D
X
X
X
Tidal
Volume
D
D
D
D
D
Flow
X
X
X
X
D
t Insp
X
X
X
X
D
Resp. Rate
D
X
D
D
D
Pressure
Support
X
X
X
X
X
Pressure
Limit
X
X
X
X
X
PEEP/CPAP
X
X
X
X
X
Trig
X
X
X
X
X
Slope/Rise
D
X
D
X
X
Exp. Thresh
D
D
D
D
D
Pause
X
X
D
D
D
Open Exh
(ON/OFF)
Flow Wave
5-1
NOTE: When Freeze is activated, the Freeze button turns to “Start”
and all other menu buttons are dimmed and not functional until Start
is pressed.
Control
Display
ON
ON
D
D
D
D
D
Must be
OFF
Must be
OFF
X
ON
X
ON
X
ON
Volume
Target (ON /
OFF)
Pressure
Control
and ACMV
Pressure
Control
and
SIMV
Volume
Control,
Pressure
Control
ACMV
Volume
Control,
Pressure
Control
SIMV
Volume
Control,
Pressure
Control
SPONT
OPR360U A0509
Mode LEDs
Table 4-1: Ventilation Controls Guide (cont.)
OPR360US H0711
4-9
4 Setting Up For Patient Use
Ventilation Settings in Advanced Data Set
OPR360U A0509
Figure 4-3 Advanced Data Set Options
Slope/Rise: 1 (slowest) – 19 (fastest) (active for all pressure based
breaths).
Exp Thresh: 5 – 55% or AUTO (FlexCycle) (active for Pressure
Support and Volume Target Pressure Support breaths).
Pause: 0.1 to 2.0 seconds or OFF (active for Volume Control breaths).
Flow Wave: Square or Descending Ramp (active for Volume Control
breaths).
Volume Target: ON (enables Volume Target Pressure Control and
Volume Target Pressure Support breaths) or OFF.
Open Exhalation Valve: ON (enables Biphasic Pressure Control
breaths) or OFF.
Inspiratory and Expiratory Hold Maneuvers
Refer to Foldout F-7 for a sample of the Extended Functions screen.
During ventilation, you may perform “end-inspiratory” and “endexpiratory” mandatory breath hold maneuvers in order to obtain
ventilatory mechanics measurements. Follow these instructions:
1.
2.
5-13.
4-10
Press the Extended Functions menu button.
Touch and hold the Insp Hold button on the right of the display. The e360 will perform the hold and measure the static pressure. The maneuver is terminated by releasing your finger from the button or when 15 seconds elapse.
Touch and hold the Exp Hold button on the right of the display.
OPR360U A0509
The e360 will perform the hold and measure the static pressure. The maneuver is terminated by releasing your finger from the button or when 20 seconds elapse.
OPR360US H0711
5-1
Touch the Data Sets button in the lower right corner of the GUI to
scroll to the Advanced data set.
4
Setting Up For Patient Use
The Mechanics data set will show Plateau Pressure, Total PEEP,
Static Compliance, Inspiratory and Expiratory Resistance. If the
maneuver does not succeed in providing a stable static pressure
(patient effort is present) or other exclusion criteria is not met, the
related calculated values will not be displayed.
5-1
OPR360U A0509
See “Save Feature” and “Download Feature” on following pages for
details on saving Extended Function screen files.
P0.1 Measurement
While ventilating, the P0.1 measurement function is available for
assessing the patient’s respiratory drive. This measurement can be
used as one of the tools to predict weaning success from ventilatory
support.
This function is enabled via the P0.1 button on the Technical Screen. It
is available in all modes and breath types. It is not available when Non
Invasive Ventilation (NIV) is activated.
Ensure that the trigger setting is optimized before performing this
function. The P0.1 measurement is the difference between the
pressure at which a patient effort (trigger) is detected and the pressure
100 milliseconds later.
To Perform a P0.1 Measurement
Refer to Fold-out drawing F10 for a sample of Technical Screens.
1. Press the Setup & Calibration menu button on the control panel.
2. Touch TECHNICAL.
3. Touch P0.1 to enable the function. The screen will change to the Main Screen.
4. Touch START P0.1 to initiate the measurement. (Figure 4-4)
The measurement result will be displayed after the first patient
trigger is detected.
5. Touch SAVE to store the measurement result and the screen image. The measurement will be logged in the Event History and the screen image will be stored in the Screen Files List.
6. Touch START to resume normal plotting on the screen.
5-1
OPR360U A0509
OPR360US H0711
4-11
4 Setting Up For Patient Use
5-1
OPR360U A0509
Figure 4-4. Main screen showing the location of the
START P0.1 button
Explanation of P0.1 Measurement Function Conditions
After the P0.1 Measurement Function is activated the following
condition occurs:
• Ventilation continues according to user settings but a 3-minute timing window opens within which the user may touch START P0.1. The function times out if the measurement is not started within this time frame.
After START P0.1 is touched the following conditions occur:
• Ventilation continues per user settings.
• Backup ventilation is disabled for one minute.
• When the e360 detects a patient trigger, it imposes a 100 millisecond delay before delivering inspiratory flow to the patient.
• Normal operation resumes after the first patient trigger
or after one minute if no trigger is detected.
Negative Inspiratory Force (NIF) Maneuver
(also referred to as Maximum Inspiratory Pressure (MIP) or PIMAX)
While ventilating, the Negative Inspiratory Force (NIF) Maneuver is
OPR360U A0509
5-1available for measuring airway pressure during a maximum inspiratory
effort. This measurement is used to assess the patient’s inspiratory
muscle strength.
This function is enabled via the NIF button on the Technical Screen.
4-12
OPR360US H0711
4
Setting Up For Patient Use
The NIF Maneuver is available in all modes, with and without Non
Invasive Ventilation (NIV) activated.
To Perform a NIF Maneuver
5-1
OPR360U A0509
Refer to Foldout drawing F-10 for a sample Technical Screen.
1.
2.
3.
4.
5.
6.
7.
Press the Setup & Calibration menu button on the control panel.
Touch TECHNICAL.
Touch NIF to enable the function. The screen will change to the main screen with a pressure waveform displayed.
(See Figure 4-5)
Touch and hold the NIF (menu button) to perform the maneuver. The e360 will temporarily cease all flow delivery while the button
is being touched.
Upon release of the NIF button, choose the ideal NIF value by
using the adjustment knob to move the cursor to the appropriate point on the pressure waveform. The NIF value
displayed is the measured value at the selected pressure point.
Touch the SAVE button to store the measurement result and
the screen image. The measurement will be logged in the Event History and the screen image will be stored in the Screen Files List.
Touch START to resume normal plotting on the screen.
5-1
OPR360U A0509
Figure 4-5. Main screen showing the location of the NIF button
OPR360US H0711
4-13
4 Setting Up For Patient Use
OPR360U A0509
While a NIF maneuver is in progress (while NIF button is being
touched), the following conditions occur:
• PEEP is automatically set at ≤1 cmH2O.
• No flow is delivered from the ventilator.
• Expiratory minute volume (MVE) monitoring is paused.
• Backup ventilation and apnea alarms are disabled.
Normal operation resumes after the NIF button is released or 30 seconds elapse.
Waves and Loops Displays
Refer to Foldout F-6 for a sample of the Main Screen.
From the Main Screen menu on the GUI, repeatedly touching the
Waves button will allow the user to scroll through the following
waveform displays:
• Pressure/Time
• Flow/Time
• Volume/Time
• Pressure/Time and Flow/Time
• Pressure/Time and Volume/Time
When the waveform reaches the right end of the time scale, it wraps
from right to left and continues to plot, erasing a small section of the
old graph as it goes. Changing the time scale causes the waveform
to restart from the left.
Touch the Loops button to display either a Flow-Volume Loop,
Volume-Pressure Loop or both. Each loop clears before a new one is
plotted. Spontaneous breath Loops are displayed in a separate color
from mandatory breaths.
OPR360U for
A0509
5-1See “Save Feature” and “Download Feature” on following pages
details on saving Waves and Loops screen files.
NOTE: The Accept button is not needed to change the display from
waveforms to loops, trends or numerics.
4-14
OPR360US H0711
5-1
Explanation of NIF Maneuver Function Conditions
After the NIF Measurement is turned ON the following condition occurs;
• Ventilation continues according to user settings but a 3-minute timing window opens within which the user may touch the NIF button. The function times out if the measurement is not started within this time frame.
4
Setting Up For Patient Use
Adjusting Scale
To adjust scales: Touch the GUI screen at the X or Y axis of the
desired scale to be adjusted. A blue indicator bar appears on the
screen to identify the parameter selected for scale change. Use the
Adjustment knob to increase or decrease the scale and press the
Accept button to confirm the change. While in Waves or Loops,
pressure, volume and flow scales may be adjusted independently.
The time scale applies to all displayed parameters.
5-1
OPR360U A0509
Each turn of the Adjustment Knob steps to the next scale, with the
Auto-scale option between the highest and lowest scales choice
for parameters other than time. Scale adjustments are not saved at
power-off.
Auto-scale
When Auto-scale is active, the automatic control icon appears on the
automatically scaled vertical axis. Auto-scale automatically selects
one of the four pre-defined manual scales that allows the best view
(highest resolution) of the parameter.
Using the Freeze Function
Touch the Freeze button to suspend plotting of graphs (waveforms,
loops, or trends) and hold the current display for extended viewing.
Touch the Start button to resume plotting. Only the graphic display is
suspended, numeric values continue to update.
Using the Cursor in Freeze
When Freeze is on, a green, vertical-dashed line (the cursor)
appears at the center of the screen. The Adjustment knob is used to
reposition the cursor.
Numerical values are displayed for each point on a waveform, loop
or trend intersected by the cursor. Where the cursor intersects a time
axis for a waveform or trend, the numerical value of the time axis is
displayed once the cursor stops moving. Where the cursor intersects
a loop, the values of the loop at the top and bottom intersect points
are displayed.
Freeze is also available from the Main Screen and Extended Function
menus.
5-1
OPR360U A0509
OPR360US H0711
4-15
4 Setting Up For Patient Use
Event History Screen
Refer to Foldout F-9
OPR360U A0509
The software version (i.e. USR7.0) and the serial number (i.e. NXXX...)
are listed at the top of the Event History Log.
See “Save Feature” and “Download Feature” on following pages in
this section for details on saving Event History files.
Numeric Screen
Refer to Figure 4-6
5-1
Figure 4-6 Numeric Screen
OPR360U A0509
Touching the Numeric button from the Main Screen menu displays
the following information:
4-16
OPR360US H0711
5-1
From the Extended Functions menu touch the Event History button
to access the Event History Log. This log records the 1000 most
recent occurrences of alarm violations and settings, ventilator setting
changes, sensor calibration results and power On/Off sequences with
the date and time of each event. Recorded events are
color-coded - alarm violations and power OFF are red, setting
changes and calibration results are blue, and power ON and Start
Ventilating are in green. The Event History is retained after shutdown.
4
Setting Up For Patient Use
All monitored data (except P0.1 and NIF)
All calculated data
Settings for Advanced controls (except Vol Target)
See Section 8, Specifications, for a details about the data displayed
on this screen.
5-1
o
o
o
OPR360U A0509
See “Save Feature” and “Download Feature” on following pages in
this section for details on saving Numeric screen files.
Trends Screen
The e360 ventilator can display two trends screens, each screen
displays four trended parameters containing up to 24 hours of
trended data. Touch the Trends button from the Main Screen menu to
choose between the two trend screens.
The following data is displayed on the trends screens:
Screen 1
Screen 2
VTE/Time
Ppeak/Time
Minute Volume/Time
Pmean/Time
RRtot/Time
Pbase/Time
VTE % Variance/Time
RSBI/Time
Table 4-2 Trends Screens
See “Save Feature” and “Download Feature” on following pages for
details on saving Trends screen files.
5-1
OPR360U A0509
OPR360US H0711
4-17
4 Setting Up For Patient Use
Data Sets
Refer to Figure 4-7
5-1
OPR360U A0509
Figure 4-7 Data Sets
Selected sets of data may be viewed on the GUI during ventilation
utilizing the Data Sets button at the bottom of the GUI screen.
Three different monitored data subsets and one settings subset are
accessed by touching the tabs at lower right corner of the display. The
Data Sets are labeled: Basic, Mechanic, Weaning, and Advanced. The
following table lists the parameters displayed in each data set. For
information on a specific parameter, refer to Section 8, Specifications.
5-1
4-18
OPR360U A0509
OPR360US H0711
4
Setting Up For Patient Use
Data Sets
Mechanics
Ppeak (Peak
Pressure)
Time Constant
RR Spont
(Respiratory Rate
Spontaneous)
Slope/Rise
PEEP
Pplat
(Plateau
Pressure)
P0.1
Exp. Thresh
(Expiratory
Threshold)
FiO2
Total PEEP
MVE Spont
(Minute Ventilation
Exhaled
Spontaneous)
Pause
MVE (Minute
Volume
Exhaled)
Cstat
(Static
Compliance)
RSBI
(Rapid Shallow
Breathing Index)
Open Exh.
(Open
Exhalation
Valve)
VTE
RI
(Tidal Volume (Inspiratory
Exhaled)
Resistance)
NIF
Flow
Waveform
(Shape)
RRtot
(Total
Respiratory
Rate)
I:E
(I:E Ratio)
Volume
Target
RE (Expiratory
Resistance)
Weaning
Advanced
(settings)
5-1
Basic
OPR360U A0509
Save Feature
The Save Feature is available from these screens: Waves, Loops,
Trends, Numeric, Extended Functions, P0.1, NIF, Alarms setting,
Alarm History and Event History. Screens that have been saved can
be accessed from the Technical screen for download.
5-1
Screen image files are saved in .bmp format and Event History files
are saved in .csv format. To make them easier to identify, each saved
file is assigned an 8-digit file name which includes a letter indicating
the type of file (i.e., W for wave, L for loop, H for history, etc.), the
last four digits of the ventilator’s serial number, and a three digit
sequential number. A maximum of 200 Screen or Event (and Alarm)
History files can be saved. After 200 of either type are saved,
OPR360Uthe
A0509
oldest file is deleted.
When the Save function is complete, e360 emits a short, two-tone
beep.
OPR360US H0711
4-19
4 Setting Up For Patient Use
Waves, Loops, Trends, Numeric and Extended Functions Screens
(see Figure 4-7)
Touch the “Freeze” button. “Save” and “Start” buttons will appear.
OPR360U A0509
Figure 4-7 Waveform Save and Start Buttons
Alarm Setting Screen
Touch the Save button to store a screen image of the current alarm settings.
Alarm History Screen
Touch the Save Alarm History button to store the Alarm/ Event
History Log as a spreadsheet file.
Event History Screen
Touch the Save Event History button to store the Event History Log
as a spreadsheet file.
P0.1 Screen
screen
A0509
5-1Touch the Save button to store a screen image of the currentOPR360U
and also log the P0.1 measurement to the Event History.
NIF Screen
Touch the Save button to store a screen image of the current screen
and also log the NIF measurement to the Event History.
4-20
OPR360US H0711
5-1
Touch the “Save” button to store the screen image or touch the
“Start” button to exit the Freeze screen and resume normal plotting.
4
Setting Up For Patient Use
Download Feature
Touching Screen Files and Event History Files buttons on the
Technical screen allows retrieval and downloading of the stored
images and spreadsheet files to an external flash drive via the USB
port on the rear of the ventilator (See Figure 4-8).
5-1
OPR360U A0509
1.
2.
3.
Press the Setup & Calibration button on the control panel.
Touch the Technical button on the GUI.
Touch the Screen Files (for screen image files) or the Event History Files (for Event/Alarm History files) button.
A scrollable table of the corresponding saved files will appear.
4.
5.
6.
7.
Install a USB compatible flash drive (level 2.0 or later) into the USB port on the back of the ventilator (located below the power switch). Ensure that the flash drive is installed securely.
Using the Adjustment knob, highlight a file to be downloaded.
Touch the Download button.
When the download to the flash drive is complete, a “File storing successful” message will appear with a short, two-tone beep.
5-1
OPR360U A0509
Figure 4-8 Screen and Event History Files List screens
(for download)
OPR360US H0711
4-21
Alarms
Alarms
Section 5:
5-1
OPR360U A0509
Alarms
Section 5:
Introduction.............................................................5-1
Visual Alarm Displays.............................................5-1
360˚ Alarm Lamp.................................................5-1
Alarm and Message Display..............................5-1
Device Alert LED................................................ 5-2
GUI Alarms Screen Environment.......................... 5-3
Alarm Settings Screen...................................... 5-3
Saving the Alarm Settings Screen.............. 5-3
Ajustable Alarms.......................................... 5-3
Alarm History..................................................... 5-3
Saving the Alarm History Log .................... 5-4
Alarm Loudness................................................. 5-4
Alarm Tones....................................................... 5-5
Exiting Alarm Screens....................................... 5-5
Front Panel Alarm Interface Environment........... 5-5
Alarm Silence Button........................................ 5-5
Suction Disconnect Feature............................. 5-6
Alarm Reset Button........................................... 5-6
Non-Adjustable Alarms......................................... 5-6
Alarm Violation and Remedy Guide......................5-7
5-1
OPR360U A0509
5
Alarms
Introduction
The e360 Ventilator is equipped with an audible and visual alarm
system to help ensure patient safety. This section describes the
procedure for setting alarm limits, lists all alarms and includes a
Violation and Remedy Guide in Table 5-1. Alarm specifications are
located in Section 8 of this manual.
5-1
OPR360U A0509
Visual and audible alarms warn about:
• Patient breathing problems such as apnea or high and low airway
pressure.
• Power problems such as a loss of AC power.
• Problems with gases such as low supply pressure of oxygen.
• Hardware problems such as overheating or memory failure.
NOTE: The e360 Ventilator powers up using the most recently
selected alarm limits. The MVE and Disconnect Threshold alarms may
be set to OFF in NIV. Those settings are not retained. See Section 7,
Non Invasive Ventilation for details.
WARNING: Failure to identify and correct alarm conditions can result
in patient injury. To ensure continued operation of the ventilator when
a Low Battery Alarm occurs, substitute an alternate power source
immediately. AC Power is always the preferred power source.
WARNING: Always ensure that the caregiver can hear the audible
alert when the alarm sounds. Do not use the ventilator in an
environment where audible alarms cannot be heard by the caregivers.
Visual Alarm Displays
The e360 displays the following visual information when an alarm is
violated:
The 360˚ Alarm Lamp
Refer to Foldout F-4, item 4.
5-1
Located at the top center of the e360 front panel, the 360˚ Alarm
Lamp flashes yellow and/or red when an alarm is violated. The lamp
remains lit in a steady state to show a latched alarm until the Reset
button is pressed.
OPR360U A0509
Alarm and Message Display
Refer to Figure 5-1.
Descriptions of violated alarms such as Low Paw or Circuit
OPR360US H0711
5-1
5 Alarms
Disconnect as well as all messages are displayed in the center
section of the status bar in the Graphical User Interface (GUI).
5-1
These messages flash while active then remain in a steady state
(latched) after the alarm violation has been corrected until the Reset
button is used to clear the alarm. Alarm messages are color-coded
and listed in order of priority. Red messages are alarms of high
priority such as Low MVE or High Paw. Messages displayed in yellow
are medium priority warnings such as Back-up ventilation. Green
Messages are low priority informational messages such as Ventilation
Suspended or Low Paw Below PEEP setting violation.
OPR360U A0509
Device Alert LED
Refer to Figure 5-1.
Located on the left side of the control panel, the Device Alert LED
lights and a non-silenceable alarm sounds when there is a device
alert condition such as an empty battery or device malfunction. Refer
to table 5-2 for more information on device alert conditions.
4
5
1
6
2
7
3
Figure 5-1 Alarms Screen Environment
1. Alarm Silence/Suction Disconnect button and indicator
2. Alarm Reset button
3. Mains Power, Internal Battery, and Device Alert indicators
4. Alarm Messages display area
5. Alarms Screen button
Touch buttons:
OPR360U A0509
5-16.
Alarm History button
Alarm Loudness button
Alarm Tones button
Save button
7. Setting adjustable alarms area
5-2
OPR360US H0711
5
Alarms
WARNING! If a Device Alert alarm occurs, ventilation ceases and the
emergency intake relief valve and exhalation valve opens.
GUI Alarms Screen Environment
5-1
OPR360U A0509
Alarm Settings Screen
See Figure 5-1 or Foldout F-8.
Press the Alarms Screen menu button to open the Alarm Settings
screen on the GUI. From this screen you may modify all adjustable
alarm settings, view Alarm History, adjust Alarm Loudness and Alarm
Tones, and Save the screen for download.
Saving the Alarm Settings Screen
Touch the Save button to capture an image of the Alarm Setting
screen for later download. Refer to Section 4 for instructions on
downloading files that are saved to memory.
Adjustable Alarms
The Alarm Setting screen allows you to adjust the following settings:
• High and Low Paw • High and Low MVE
• Apnea delay time
• High Respiratory Rate (RR tot)
• Disconnect Threshold %
To change an alarm setting touch the displayed value you want to
change. The value will begin to flash. Rotate the Adjustment knob
and press either the Accept button or the displayed value. The
display will stop flashing and the new alarm setting will be in effect.
You may change multiple alarms before touching the Accept button
as long as inputs occur within 10 seconds of each other. If the
Accept button or displayed value are not pressed within 10 seconds
of the last change all adjusted alarms will revert to the original values.
Alarm History
See Figure 5-2.
5-1
Touch the Alarm History button to open a log of the last 1000 alarms
and events including:
• Alarm Violations
• Setting Changes
OPR360U A0509
results
• Circuit Check
• O2 Sensor
Calibration results
• Flow Sensor
Calibration results
• Power On/Off
Sequences
The ventilator settings at the time of the highlighted event are displayed.
OPR360US H0711
5-3
5 Alarms
5-1
OPR360U A0509
Figure 5-2 Alarm History Log
Saving the Alarm History Log
See Figure 5-2.
Touch the Save Alarm History button to save the Alarm History Log
for later download as a spreadsheet file in comma-separated format
(.csv). Refer to Section 4 for instructions on downloading files that are
saved to memory.
Alarm Loudness
See Figure 5-3.
Press the Alarm Loudness button to open a new screen. Use the
Adjustment knob to change the value from 1 (Quiet) to 10 (Loud).
Press the Accept button to confirm the change.
5-1
OPR360U A0509
Figure 5-3 Alarm Loudness
5-4
OPR360US H0711
5
Alarms
Alarm Tones
See Figure 5-4.
5-1
Touch the Alarm Tones button to open the screen. Use the Adjustment
knob to select one of three unique sets of sounds that will be activated
when an alarm is violated. Press Accept to confirm the change.
OPR360U A0509
Figure 5-4 Alarm Tones
Exiting Alarm Screens
Touch any menu button on the control panel to exit any alarm screen.
See Figure 5-1
Front Panel Alarm Interface Environment
Alarm Silence Button
See Figure 5-1
Press the Alarm Silence button to mute silenceable alarms for two
(2) minutes and also to cancel the Shutdown Alarm after powering
down the ventilator. The indicator lamp on the Alarm Silence button is
lit when alarms are silenced. To cancel Alarm Silence press the Alarm
Silence button again.
Press the Alarm Silence for one (1) second or longer to enable the
Suction Disconnect feature.
5-1
NOTE: Pressing the Alarm Silence button does not mute OPR360U
a Device
A0509
Alert until the ventilator is powered down.
NOTE: The optional External Alarm Silence cable provides the same
function as the button except that it does not silence a the Shutdown
Alarm.
OPR360US H0711
5-5
5 Alarms
5-1
Suction Disconnect Feature
Press and hold the Alarm Silence button for one second or longer
(until the ventilator sounds a short tone) to enable the Suction
Disconnect feature. With this feature enabled the ventilator will
automatically silence all patient and disconnect alarms, display
the message Ventilation Suspended, disable automatic leak
compensation, and deliver a bias flow of 10 L/min for Adult or 5 L/
min for Ped/Infant patient types if the ventilator senses that the
patient circuit has been disconnected. The ventilator will not deliver
breaths until the breathing circuit is reconnected or three minutes has
elapsed. When the ventilator detects reconnection or three minutes
has elapsed the ventilator will resume normal function.
OPR360U A0509
NOTE: The ventilator recognizes the reconnection of the circuit
by reading the expiratory flow. Do not use the Suction Disconnect
feature if the flow sensor on the ventilator is defective, failing
calibration or disconnected.
Alarm Reset Button
See Figure 5-1
Audible alarms are automatically silenced when the alarm violation no
longer exists; however, visual alarm indicators do not automatically
reset. When an alarm violation is no longer active the alarm indicator
stops flashing and remains steadily lit to signal a latched alarm.
Press the Reset button to individually clear these alarm indicators.
Non-Adjustable Alarms
The following alarms may occur during ventilator operation and are
non-adjustable:
(Priority, violation criteria, and remedies are listed in Table 5-1)
• High FIO2
• O2 Sensor Error
• Low FIO2
• Flow Sensor Error
• Low Baseline (PEEP) Pressure
• Insp. Time Too Long
• High Baseline (PEEP) Pressure
• Insp. Time Too Short
• Volume Target Not Met
• Sustained High Baseline (PEEP
Pressure
• Low Paw Below PEEP
• Setting Out of Range
• Pressure Limit Below PEEP
• Check Vent Fan
5-1 • Gas Supply Alarm
5-6
OPR360U A0509
• AC Power Loss/Battery Backup
• Both Air/O2 Supply Loss
• Low Battery
• Power Shutdown
• Device Alert
• Data Read Failure
• Check Flow Sensor Board
OPR360US H0711
5
Alarms
Alarm Violation and Remedy Guide
5-1
The following table lists alarm and informational messages
alphabetically. The alarm priority, type (ventilator/patient problem
differentiation), violation message or criteria (what causes the alarm
to be activated) and remedy (possible corrective actions) are included
in this guide. Alarm specification ranges are listed in Section 8.
OPR360U A0509
Table 5-1 Alarm Violation and Remedy Guide
Alarm or
• Priority
Description
Device Alert • Type
and/or
Message
• Lamp Color Criteria
5-1
Remedy
{Any
• High
Message not • Ventilator
listed here}
• Red
Check patient and provide
Ventilator failure an alternate source of
that requires
ventilation.
service
Contact a qualified service
representative.
AC Power
• High
Loss-Battery • Ventilator
Back Up
• Red
No action required if AC
power is deliberately
Loss of main
disconnected.
power-may be
Verify that AC power
due to failed AC
source is securely
power source,
connected and functional.
a blown fuse, or
disconnected
Prepare alternate
power cord.
ventilation source if
needed.
Air Supply
Loss
(< 30 psig)
• High
• Ventilator
• Red
Check patient and provide
an alternate source of
ventilation.
Check that air supply is
connected and providing
equal to or greater than
Air gas inlet
supply pressure 30 psig at inlet, especially
has dropped to during inspiration.
< 30 psig.
NOTE: If the oxygen
supply is connected, the
ventilator continues breath
delivery using 100%
oxygen.
• High
• Patient/
Ventilator
• Red
Ventilator has
not detected
a mandatory
breath or
spontaneous
effort during the
set interval.
Apnea
(5-60
seconds)
OPR360US H0711
Check patient.
Evaluate settings/readjust
OPR360U A0509
as necessary. Check
trigger sensitivity.
Check that the breathing
circuit is intact and
securely connected.
5-7
5 Alarms
Check patient.
Evaluate settings/readjust
as necessary. Check
trigger sensitivity.
Check that the breathing
circuit is intact and
securely connected.
OPR360U A0509
Back Up
Ventilation
Remedy
• Medium
• Patient
• Yellow
Monitored MVE
</= Low MVE
alarm limit.
5-1
Alarm or
• Priority
Description
Device Alert • Type
and/or
Message
• Lamp Color Criteria
The alarm is recovered
when MVE rises to 10%
above the Low MVE alarm
limit.
NOTE: Back up ventilation
is suspended for 60
seconds after changing
any ventilator settings and
following circuit reconnect
after the Suction
Disconnect feature is
used.
Both Air/O2
Supply Loss
Check Flow
Sensor
5-1 Board
5-8
• High
• Ventilator
• Red
Restore both gas supplies
and/or provide alternate
ventilation immediately.
Check that air and oxygen
Inlet pressure
for both air and supplies are connected
oxygen supplies and providing >/= 30 psig
at ventilator inlet.
has dropped
below minimum
supply pressure The ventilator opens the
emergency intake and
required.
exhalation valves to allow
the patient to breathe
room air.
• Medium
• Ventilator
• Yellow
The flow
sensor cable
on the flow
sensor board is
disconnected
from the main
board. The
ventilator can
only detect the
flow sensor
cable during
ventilation.
The flow sensor cable
must be re-connected
to the Main Board by
a qualified service
representative.
OPR360U A0509
NOTE: Message cannot
be cleared with the Reset
button.
OPR360US H0711
5
Alarms
OPR360U A0509
Check Vent
Fan
• Medium
• Ventilator
• Yellow
Fan inside of
the unit fails.
Remedy
Contact a qualified service
representative to replace
vent fan.
5-1
Alarm or
• Priority
Description
Device Alert • Type
and/or
Message
• Lamp Color Criteria
NOTE: Message cannot
be cleared with the Reset
button.
Monitor
Exception
Failure
C Internal
System
The monitor
processor
has detected
• High
an abnormal
• Device Alert
operation
• Red
such as illegal
instruction or
division by
zero that was
generated by
the monitor
software.
Check patient and provide
an alternate source of
ventilation.
Contact a qualified service
representative
Disconnect
Threshold %
alarm level met.
Reconnect circuit or check
In A/C or SIMV- for leaks in the breathing
VTE % variance circuit, ET tube or mask (if
> Disconnect
mask ventilating).
Threshold.
Circuit
Disconnect
5-1
OPR360US H0711
• High
• Patient/
Ventilator
• Red
In SPONTExpiratory flow
reading is less
than 1 L/min for
greater than 5
seconds.
Reduce or eliminate leak
as much as possible.
May be caused
by large leak or
disconnection
of the patient
circuit from the
ventilator or
High Pressure
Alarm.
Clean or replace sensor if
necessary.
Check that the exhalation
flow sensor is calibrated
and installed correctly.
OPR360U
A0509
Re-adjust alarm
limit
to
clinically appropriate level.
5-9
5 Alarms
OPR360U A0509
Control CPU
Failed
• High
Control CPU
• Device Alert
Failure
• Red
Remedy
Check patient and provide
an alternate source of
ventilation.
5-1
Alarm or
• Priority
Description
Device Alert • Type
and/or
Message
• Lamp Color Criteria
Contact a qualified service
representative.
Monitor
Communications Failure
Control uP
Failed
The control
• High
processor does
• Device Alert not respond to
• Red
a request from
the monitor
processor.
The control
processor is not
running.
Check patient and provide
an alternate source of
ventilation.
Contact a qualified service
representative
Control RAM
Failure
• High
Random access
Control RAM • Device Alert memory that
Failed
• Red
is used by
the control
processor on
the main PCB is
damaged.
Control Task
Continuity
Failure
Control
Tasks Failed
Data Read
5-1Failure
5-10
• High
• Device Alert
Software tasks
• Red
of the control
processor have
operated out of
sequence.
• High
• Ventilator
• Red
Error is
detected during
the reading of
stored data at
power up.
Check patient and provide
an alternate source of
ventilation.
Contact a qualified service
representative.
Check patient and provide
an alternate source of
ventilation.
Contact a qualified service
representative.
Contact a qualified service
representative. OPR360U A0509
OPR360US H0711
5
Alarms
Device Alert
(If message
display is
possible)
Unsilenceable audible
alarm.
Device Alert
indicator
flashes if
possible.
Ventilator
malfunction.
Also activated
if less than
10% of the
• High
internal battery
• Device Alert
operation time
• Red
remains when
ventilator is
operating on
the internal
battery.
Remedy
Check patient and provide
an alternate source of
ventilation.
5-1
Alarm or
• Priority
Description
Device Alert • Type
and/or
Message
• Lamp Color Criteria
If the alarm is due to
battery depletion, plug the
ventilator into an alternate
power source to allow
charging.
If not a result of a low
battery, contact a qualified
service representative.
OPR360U A0509
Dual RAM
Failure
Dual RAM
Failed
EEPROM
Read Error
Random access
• High
• Device Alert memory that
is shared by
• Red
the control
and monitor
processors has
failed.
• Low
• Ventilator
• None
This error is
logged into the
Event History
Log when the
software type
read from the
EEPROM on the
main board is
invalid.
No audible or
visual alarm is
displayed, and
no message
appears on the
GUI.
5-1
FIO2 High
• Medium
• Ventilator
• Yellow
Measured FIO2
is more than
0.07 above the
FIO2 setting for
30 seconds.
(cont. next
page)
OPR360US H0711
Check patient and provide
an alternate source of
ventilation.
Contact a qualified service
representative.
EEPROM Read Error
is a Technical Service
Message that does not
affect functionality of
the ventilator. Contact
a qualified service
representative.
Verify that the source
gases and connections
are secure and functional.
OPR360U A0509
Verify that the oxygen
source gas is providing
100% oxygen.
(cont. next page)
5-11
5 Alarms
OPR360U A0509
FIO2 High
(cont.)
• Medium
• Ventilator
• Yellow
NOTE: This
alarm is
inactive if the
e360 detects
a disabled
or defective
oxygen sensor,
or oxygen
supply pressure
is below 30
psig.
Remedy
Calibrate the O2 sensor
by pressing the O2 3 min.
button or by accessing O2
Sensor calibration button
in Setup & Calibration/
Sensors.
5-1
Alarm or
• Priority
Description
Device Alert • Type
and/or
Message
• Lamp Color Criteria
Replace O2 sensor if
necessary.
NOTE: Insufficient supply
inlet pressure of air may
cause ventilator to be
unable to deliver required
high flow rate, resulting in
FIO2 alarm.
Verify that the source
gas and connections are
secure and functional.
Measured FIO2
is more than
0.07 below the
FIO2 setting for
more than 30
seconds.
FIO2 Low
5-1
5-12
• High
• Ventilator
• Red
NOTE: This
alarm is
inactive if the
e360 detects a
disabled or
defective
oxygen sensor,
or oxygen
supply pressure
is below 30
psig.
Verify that the oxygen
source gas is providing
100% oxygen.
Verify that ventilator
flow and trigger settings
are adequate to meet
patient’s needs.
Calibrate the O2 sensor
by pressing the O2 3 min
button or by accessing O2
Sensor calibration button
in Setup & Calibration.
Replace O2 sensor if
necessary.
NOTE: Insufficient supply
inlet pressure of O2 may
cause ventilator to be
unable to deliverOPR360U
required
A0509
high flow rate, resulting in
FIO2 alarm.
OPR360US H0711
5
Alarms
Sensor is
disconnected
from cable.
OPR360U A0509
Flow Sensor
Error
High
Baseline
Pressure
High MVE
5-1
High PAW
• High
• Ventilator
• Red
• Medium
• Ventilator
• Yellow
• High
• Patient
• Red
• High
• Patient/
Ventilator
• Red
Ventilator is
unable to
calibrate the
exhalation
flow sensor
or a sensor
malfunction is
detected.
At the start of a
time triggered
mandatory
breath
monitored
baseline
pressure (PEEP/
CPAP) has been
5 cmH2O/
mbar above the
PEEP/CPAP
setting for two
consecutive
breaths.
Monitored
exhaled minute
volume (MVE)
is >/= set High
MVE.
Monitored
breathing circuit
pressure is >/=
set High Paw
alarm limit for
one breath.
(cont. next
page)
OPR360US H0711
Remedy
5-1
Alarm or
• Priority
Description
Device Alert • Type
and/or
Message
• Lamp Color Criteria
Check flow sensor
connection and
recalibrate.
Clean or replace sensor
and calibrate.
Contact qualified technical
service representative.
Check breathing circuit
tubing and From Patient
port filter for kinks or
obstructions. Change
the filter if resistance is
suspected.
Evaluate ventilator
settings and readjust if
necessary to allow for
adequate exhalation time.
The alarm is recovered
when monitored baseline
pressure (PEEP/CPAP) is
less than set PEEP/CPAP +
5 cmH2O/mbar at the start
of a time triggered breath.
Check patient, evaluate
ventilator settings, check
for leaks and autotriggering
and readjust if necessary.
The alarm is recovered
when the monitored MVE is
below the High MVE alarm
limit.
Check patient.
Check the endotracheal
tube.
Check breathing circuit
OPR360U A0509
tubing and From Patient
port filter for kinks or
obstructions.
(cont. next page)
5-13
5 Alarms
OPR360U A0509
High PAW
(cont.)
High RR Tot
• High
• Patient/
Ventilator
• Red
• Medium
• Patient/
Ventilator
• Yellow
A High Paw
alarm violation
terminates the
current breath
and cycles to
exhalation.
This alarm is
applicable for
all breaths,
including
manual
inflations.
When alarm is
ON, monitored
total breathing
frequency is
>/= set alarm
level. This
may indicate
a change
in patient
condition or
autotriggering.
Remedy
Make sure exhalation
valve is functioning
correctly.
Evaluate ventilator settings
and readjust if necessary.
5-1
Alarm or
• Priority
Description
Device Alert • Type
and/or
Message
• Lamp Color Criteria
The alarm is recovered
when patient breathing
circuit pressure drops 5
cmH2O/mbar below the
High Paw alarm limit.
Check patient for change
in status or need for
increased ventilatory
support.
If due to autotrigger, check
breathing circuit for leaks.
If due to autotrigger, turn
Leak Compensation ON (if
it has been turned to OFF).
If due to airway/mask
leak, turn ON Noninvasive
Ventilation..
Evaluate trigger setting/
method (Flow vs. Pressure).
I:E Ratio
Inverse
Violation
• Medium
• Ventilator
• Yellow
5-1
Insp Time
Too Long
5-14
• Medium
• Ventilator
• Yellow
Ventilator
settings would
result in an
inverse I:E
ratio greater
than 4:1, so
ventilation is
not delivered
according to
settings.
Ventilator
settings result
(cont. next
page)
Check patient.
Evaluate inspiratory time,
frequency, and trigger
settings and readjust as
necessary.
OPR360U A0509
Evaluate Tidal Volume,
Flow, Respiratory Rate,
Inspiratory Time,
(cont. next page)
OPR360US H0711
5
Alarms
• Medium
• Ventilator
• Yellow
in an inspiratory
time greater
than 5 seconds,
including any
and Pause settings and
pause time, so
readjust as necessary.
ventilation is not
delivered
according to
settings.
• Medium
• Ventilator
• Yellow
Ventilator
settings or
alarm limit
violation
results in an
inspiratory time
< 0.1 seconds
for adult or <
0.05 seconds
for pediatric
patients,
excluding
any pause or
inspiratory hold.
While in VC,
an Insp. Time
setting that
cannot deliver
the set Tidal
Volume.
OPR360U A0509
Insp Time
Too Long
(cont.)
Insp Time
Too Short
Low
Baseline
Pressure
• High
• Patient/
Ventilator
• Red
5-1
Low Battery
OPR360US H0711
Remedy
• High
• Ventilator
• Red
Monitored
airway pressure
has been below
the PEEP/CPAP
setting for
more than 0.5
seconds for two
consecutive
breaths.
Internal battery
operating
(cont. next
page)
5-1
Alarm or
• Priority
Description
Device Alert • Type
and/or
Message
• Lamp Color Criteria
Evaluate Tidal Volume and
Flow settings and readjust
as necessary.
Potential cause may be
High Paw alarm violation.
Resolve as needed.
Turn Leak Compensation
ON.
Check breathing circuit for
leaks or disconnects.
If there is an airway/mask
leak, turn ON Noninvasive
Ventilation..
The alarm is inactive when
PEEP/CPAP is set below
4 cmH2O/mbar.
OPR360U A0509
Connect the ventilator to
any AC power source to
allow the internal battery
to recharge.
(cont. next page)
5-15
5 Alarms
OPR360U A0509
Low Battery
(cont.)
• High
• Ventilator
• Red
capacity has
dropped
to 25% of
capacity.
Remedy
NOTE: The ventilator
continues to operate
normally until the battery is
depleted, at which time a
Device Alert alarm occurs.
5-1
Alarm or
• Priority
Description
Device Alert • Type
and/or
Message
• Lamp Color Criteria
WARNING! To ensure
continued ventilator
operation, substitute an
alternate power source,
such as AC power,
immediately when a Low
Battery alarm occurs.
Check patient, evaluate
ventilation and alarm
settings and readjust if
necessary.
Low MVE
• High
• Patient
• Red
Monitored MVE
< set
Low MVE alarm
limit.
Check breathing circuit for
leaks or disconnects.
Check that the exhalation
flow sensor is installed
correctly.
The ventilator provides
back up ventilation while
this alarm limit is violated.
Low Paw
5-1
5-16
• High
• Patient/
Ventilator
• Red
Monitored
airway pressure
does not
reach the Low
Paw alarm
limit during
a mandatory
inspiration for
two breaths
(does not apply
to manual,
spontaneous
or pressure
supported
breaths).
Check breathing circuit for
leaks or disconnects.
Evaluate ventilation
and alarm settings and
readjust if necessary.
The alarm is recovered
when Ppeak for a
mandatory breath
(including Back Up
Ventilation) is greater than
OPR360U A0509
Low Paw alarm limit.
OPR360US H0711
5
Alarms
OPR360U A0509
Low Paw
Below PEEP
Informational
Message
Set Low Paw
Alarm level is
less than set
PEEP
Remedy
Change alarm limit to
greater than the set PEEP
level.
5-1
Alarm or
• Priority
Description
Device Alert • Type
and/or
Message
• Lamp Color Criteria
Control
Exception
Failure
M Internal
System
Monitor uP
Failed
The Control
processor
has detected
• High
an abnormal
• Device Alert
operation
• Red
such as illegal
instruction
or divide by
zero that was
generated by
the control
software.
Control
Communications Failure
The monitor
processor does
• High
not respond
• Device Alert to a request
• Red
from the control
processor.
The monitor
processor is not
running.
Monitor CPU
Failure
• High
Monitor CPU
The monitor
• Device Alert
Failed
processor on
• Red
the main PCB is
bad.
5-1
Monitor RAM
• High
Failure
Monitor RAM • Device Alert
Failed
• Red
(cont. next
page)
OPR360US H0711
Check patient and provide
an alternate source of
ventilation.
Contact a qualified service
representative.
Check patient and provide
an alternate source of
ventilation.
Contact a qualified service
representative.
Check patient and provide
an alternate source of
ventilation.
Contact a qualified service
representative.
Check patientOPR360U
and provide
A0509
an alternate source of
ventilation.
Contact a qualified service
representative.
5-17
5 Alarms
Alarm or
• Priority
Description
Device Alert • Type
and/or
Message
• Lamp Color Criteria
Remedy
Random
Access Memory
• High
that is used
Monitor RAM
• Device Alert by the monitor
Failed (cont.)
• Red
processor on
the main PCB is
damaged.
5-1
OPR360U A0509
Monitor ROM
Failure
Monitor
ROM Failed
Read only
• High
memory that
• Device Alert stores the code
• Red
of the monitor
processor
has detected
an illegal
checksum.
Monitor Task
Continuity
Failure
Mon Task
Failed
No
Communication
5-1
5-18
• High
• Device Alert Software tasks
• Red
of the monitor
processor have
operated out of
sequence.
• High
• Ventilator
• none
Continuous
audible alert.
This message
is recorded
into the Event
History Log
when there is a
communication
failure to the
touch screen.
No visual alarm
displayed, and
no message
appears on the
GUI.
Check patient and provide
an alternate source of
ventilation.
Contact a qualified service
representative.
Check patient and provide
an alternate source of
ventilation.
Contact a qualified service
representative.
If the communication is
reestablished the alert will
automatically reset.
No Communication
is a Technical Service
Message that does not
affect functionality of
the ventilator. Contact
a qualified service
representative if the alert
does not reset.
OPR360U A0509
OPR360US H0711
5
Alarms
Reconnect the O2 sensor.
OPR360U A0509
O2 Sensor
Disconnect
Remedy
Informational
Message
The O2
Sensor is
disconnected.
NOTE: Always use an
external O2 monitor with
alarms while ventilating
with this message.
5-1
Alarm or
• Priority
Description
Device Alert • Type
and/or
Message
• Lamp Color Criteria
Change the sensor as
soon as possible.
O2 Sensor
Error
O2 Supply
Loss
Out of
Range
• Medium
• Ventilator
• Red
Ventilator
cannot calibrate
NOTE: Always use an
the O2 sensor
external O2 monitor with
correctly.
alarms while ventilating
with this message.
• High
• Ventilator
• Red
Oxygen supply
inlet pressure is
below minimum
supply
pressure
required.
Informational
Message
A setting
adjustment is
out of range
for the patient
category
selected.
Check that oxygen supply
is connected and providing
>/= 30 psig at the
ventilator inlet, especially
during inspiration.
Provide alternate
ventilation if necessary.
The ventilator continues
breath delivery using the
remaining air gas supply,
and does not calibrate the
O2 sensor.
Re-adjust the setting to
within range or change the
patient category.
Power Failure
Power
Failure
5-1
OPR360US H0711
DC power out
of tolerance.
• High
Check +12
• Device Alert
VDC, -12 VDC,
• Red
and +5 VDC.
(cont. next
page)
Check patient and provide
an alternate source of
ventilation.
Contact a qualified service
representative.
OPR360U A0509
5-19
5 Alarms
Alarm or
• Priority
Description
Device Alert • Type
and/or
Message
• Lamp Color Criteria
Power
Failure
(cont.)
(The e360 may
have been
powered by the
• High
internal battery
• Device Alert
until it was
• Red
depleted and
a Device Alert
resulted.)
Pressure
Limit Below
PEEP
Informational
Message
The set
pressure limit
is less than the
set PEEP.
Adjust either set Pressure
Limit or set PEEP so
that the Pressure Limit is
above the PEEP level.
Informational
Message
The sum of
Pressure
Support plus
the PEEP
Settings is
greater than 60
cmH2O/mbar.
Adjust either Pressure
Support or PEEP level to
less than a combined total
of 60 cmH2O/mbar.
No Indicator
No message
is associated
with this alarm.
The Shutdown
Press the Alarm Silence
alarm provides
button to cancel the
confirmation that
Shutdown alarm.
the ventilator
power state has
been switched
to OFF.
OPR360U A0509
Shutdown
Alarm
Sustained
High
Baseline
Pressure
• High
• Ventilator
• Red
Monitored
PEEP pressure
has been >/=
8 cmH2O/
mbar above set
PEEP/CPAP for
over 6 seconds
in Ped/Infant or
10 seconds for
Adult.
(cont. next
page)
5-20
5-1
Pressure
Support +
PEEP > 60
5-1
Remedy
Check circuit tubing for
occlusions and/or fluids.
Check expiratory filter
for increased resistance/
blockage, replace if
necessary.
Evaluate ventilator settings
and readjust if necessary.
Check to verify that the
A0509
Exhalation Valve OPR360U
is clean/
free of debris. Replace if
necessary.
If not resolved, use
alternate means of
ventilation.
OPR360US H0711
5
Alarms
Sustained
High
Baseline
Pressure
(cont.)
• High
• Ventilator
• Red
WARNING!
Ventilation and
triggering are
suspended,
the exhalation
valve and the
emergency
relief valve open
as needed for
a minimum of
5 seconds to
relieve pressure
and no flow is
delivered until
the condition is
resolved.
Ventilation
Suspended
Informational
Message
The Suction
Disconnect
feature is
enabled.
OPR360U A0509
Volume
Target Not
Met
5-1
OPR360US H0711
• Medium
• Patient/
Ventilator
• Yellow
In Volume
Target
Pressure
Control or
Volume Target
Pressure
Support breath
type, the set
tidal volume
cannot be
delivered within
the set Pressure
Limit for two
consecutive
breaths.
Remedy
5-1
Alarm or
• Priority
Description
Device Alert • Type
and/or
Message
• Lamp Color Criteria
Informational only.
Check patient condition
for reversible cause.
Increase t Insp, reduce
Resp Rate, increase
Slope/Rise, adjust Exp.
Threshold, increase
Pressure Limit or reduce
Tidal Volume if necessary.
Factors that could trigger
the alarm: agitation, biting
of ET tube, coughing,
increase in expiratory filter
or patient resistance or
drop in compliance (e.g.
secretions,
pneumothorax).
OPR360U A0509
5-21
Cleaning and
Section 6:
Cleaning and Maintenance
Maintenance
OPR360U A0509
Maintenance
Introduction........................................................................... 6-1
Use of Filters.......................................................................... 6-1
Inspiratory (To Patient) Port...................................... 6-1
Expiratory (From Patient) Port.................................. 6-1
Disassembly and Reassembly Procedures........................ 6-2
Rear Panel Fan Filter.................................................. 6-2
Exhalation Manifold...................................................6-3
Exhalation Flow Sensor........................................6-3
Exhalation Valve....................................................6-5
Inspiratory Manifold................................................... 6-7
Oxygen Sensor...........................................................6-8
Fuses............................................................................6-8
Cleaning................................................................................6-9
Sterilizing...............................................................................6-9
Autoclave Sterilization ............................................ 6-10
EtO (Ethylene Oxide) Sterilization ......................... 6-10
Guide to Cleaning and Sterilizing ..................................... 6-10
Guide to Preventive Maintenance..................................... 6-12
Storing the Ventilator.......................................................... 6-14
Repackaging the Ventilator................................................ 6-14
5-1
OPR360U A0509
5-1
Cleaning and
Section 6:
6
Cleaning and Maintenance
Introduction
5-1
To ensure proper ventilator operation and minimize risk of cross
contamination, perform the following cleaning and maintenance
procedures at the recommended intervals. All procedures should be
adapted to your institution’s policies and procedures. All personnel
should use precautions to minimize the risk of spreading infection
when disassembling, cleaning and performing maintenance
procedures on the ventilator system.
OPR360U A0509
Use of Filters
Inspiratory (To Patient) Port
The gas that enters the breathing circuit through the Inspiratory
(To Patient) Port of the ventilator is usually clean and dry; however,
Newport Medical strongly recommends using a filter at this port for
two reasons:
1.
2.
To protect the inspiratory manifold from potential contaminants in patient gases, and
To protect the patient from potential contaminant in the delivered gas.
By using the filter, the need for regular cleaning and sterilization of
the inspiratory manifold is reduced. By replacing the filter between
each patient use, the risk of infection being spread between patients
is reduced.
Expiratory (From Patient) Port
Gas that enters the Expiratory (From Patient) Port on the ventilator
from the breathing circuit may be moist and contain pathogens.
Newport Medical strongly recommends the use of a dry, clean filter in
this location for three reasons:
5-1
1. To protect the expiratory manifold from potential contaminants in exhaled gases;
2. To protect the patient from potential contaminants in the exhalation system should the patient pull gas in through the expiratory limb of the circuit;
3. To protect the staff from potential contaminants in the patient gases.
OPR360U A0509
When a filter placed on the From Patient port gets wet, filtration
capabilities are diminished and resistance to patient exhalation
increases. By keeping a clean, dry filter in this location, the need for
regular cleaning of the exhalation valve and flow sensor is reduced,
OPR360US H0711
6-1
6 Cleaning and Maintenance
the lifetime of the flow sensor is maintained, the risk of cross
contamination between patients is reduced, the risk of infection being
spread to the staff is reduced and expiratory resistance is kept to a
minimum.
5-1
OPR360U A0509
NOTE: Any practice that adds moisture to the exhaled gas will cause
the filter on the From Patient port to get wet more quickly and require
that it be changed more often.
Caution For cleaning/disinfecting the exterior surface of the
ventilator system, use a soft cloth that is moistened with a cleaning/
disinfecting agent. Do not use harsh abrasives, hard brushes,
or cleaning/disinfecting agents that contain phenols, ammonium
chloride, chloride compounds, or more than 2.4% glutaraldehyde.
Caution Plastic components should not come in contact with the
following solutions because they may cause disintegration of the
component:
1.
2.
3.
4.
5.
6.
7.
Hypochlorite
Phenol (> 5%)
Inorganic Acids
Formaldehyde
Ketone
Chlorinated Hydrocarbons
Aromatic Hydrocarbon
Caution Use only the cleaning and sterilization methods
specifically listed for each ventilator component. Consult accessory
manufacturer’s guidelines for specific cleaning, disinfecting, and
sterilizing guidelines.
Disassembly and Reassembly Procedures
Rear Panel Fan Filter
The following diagram and instructions are for removal and
reinstallation of the fan filter.
1.
5-12.
3.
4.
6-2
Gently pry the fan cover from the back panel of the e360 (a coin can be used).
Remove the fan filter from the cover.
OPR360U A0509
Vacuum dust from filter or clean with soap and water, dry and replace.
Reinstall the cover by pressing it onto the back panel until it snaps into place.
OPR360US H0711
6
Cleaning and Maintenance
5-1
OPR360U A0509
Figure 6-1 Fan Filter
Exhalation Manifold
Exhalation Flow Sensor
The following diagram and instructions are for the removal and
reinstallation of the exhalation flow sensor.
1. Open the front panel door on the lower left front of the ventilator to expose exhalation valve and flow sensor. See Figure 6-2
5-1
OPR360U A0509
Figure 6-2 Exhalation Valve and Flow Sensor
2. With a gentle twisting motion, pull the plastic flow sensor away from the outlet of the exhalation valve. See Figure 6-3.
OPR360US H0711
6-3
6 Cleaning and Maintenance
5-1
OPR360U A0509
Figure 6-3 Remove Flow Sensor
3. Disconnect the flow sensor cable from the plastic body of the sensor by pulling the cable connector straight out. Do not twist.
4.
To reconnect the cable connector to the sensor body: Take care to line up the notch in the cable connector with the notch in the connector on the sensor body. Press together. Do not twist. See Figure 6-4.
Figure 6-4 Connect Cable to Sensor
5.
6.
7.
To reconnect the flow sensor to the exhalation valve: Push the flow sensor into the outlet port of the exhalation valve, carefully tucking the cable into the compartment behind it.
Close the front panel door.
Calibrate the sensor as described in Section 4.
5-1Caution
OPR360U A0509
The exhalation flow sensor is a precise and delicate
instrument. Take care when handling not to disturb the measuring
wires. Do not insert any object into the flow sensor, nor direct
pressurized flows of liquids or gases through the sensor during
cleaning and reprocessing. The life cycle of the sensor is limited
6-4
OPR360US H0711
6
Cleaning and Maintenance
and will depend on observance of safe handling precautions and the
ability to calibrate the sensor. Always make sure that the flow sensor
is completely dry before installation.
Exhalation Valve
The following diagram and instructions are for removal and
reinstallation of the exhalation valve.
5-1
OPR360U A0509
1.
2.
3.
Open the front panel door to expose the exhalation valve.
Remove the exhalation valve by releasing the latch at the top of the panel and pulling the valve away from the ventilator. Refer to Figure 6-5.
With a twisting motion, pull the plastic flow sensor away from the outlet of the exhalation valve.
Figure 6-5 Remove Exhalation Valve
4.
5.
6.
While holding exhalation valve body securely, turn the retaining ring counter clockwise and remove it. See Figure 6-6.
Separate the exhalation valve cap from the valve body.
Remove diaphragm poppet assembly from the valve cap (do not disassemble the diaphragm poppet assembly).
5-1
OPR360US H0711
OPR360U A0509
6-5
6 Cleaning and Maintenance
5-1
OPR360U A0509
Figure 6-6 Exhalation Valve Assembly
Caution Proper orientation of the various components is critical.
Failure to reassemble the exhalation valve correctly will result in leaks
in the exhalation system.
7. To re-assemble and reinstall the valve, reverse these steps taking care to align the guide pin on the valve cap with the slot in the valve body See Figure 6-7.
5-1
OPR360U A0509
Figure 6-7 Align Exhalation Valve Cap and Body During
Reassembly
6-6
OPR360US H0711
6
Cleaning and Maintenance
Inspiratory Manifold
The following diagram and instructions are for removal and
reinstallation of the inspiratory manifold.
Using a flat screwdriver or a coin, unscrew the two screws on the lower right front panel section and remove it to expose the inspiratory manifold. See Figure 6-8.
Use a Philips screwdriver to remove the upper and lower manifold retaining screws and pull the manifold away from the ventilator.
5-1
1.
2.
OPR360U A0509
Figure 6-8 Remove Panel Section
3.
4.
5.
Remove the manifold cap by removing the four screws to expose the diaphragm. Handle with care. See Figure 6-9.
Remove the inspiratory port from the block by turning it counterclockwise.
To reassemble and reinstall, reverse the above steps.
5-1
OPR360U A0509
Figure 6-9 Inspiratory Manifold Block
OPR360US H0711
6-7
6 Cleaning and Maintenance
Oxygen Sensor
The following diagram and instructions are for the removal and
reinstallation of the oxygen sensor.
1. Set the power switch to the OFF position and disconnect the ventilator from AC power and gas supplies.
2. Using a screwdriver or a coin, unscrew the two screws on the lower right front panel section and remove it to expose the oxygen sensor. See Figure 6-11.
3. Locate the sensor cable and turn the twist collar counter clockwise to remove the cable from the sensor.
4. Pull the sensor straight out to remove it. Discard oxygen sensor in accordance with local regulations.
NOTE: The Inspiratory Manifold may need to be removed to aid in
sensor removal.
5-1
OPR360U A0509
Figure 6-11 Remove Panel Section
5. To install a new sensor, reverse the steps.
6. Calibrate the sensor as described in section 4.
NOTE: Before calibrating a new oxygen sensor, open the package
and allow the sensor to be exposed to room air for 20 minutes.
Fuses
The following diagram and instructions are for the removal and
reinstallation of fuses.
The fuses are located in the top of the AC power module on the rear
of the e360.
1. Set the power switch to the OFF position and disconnect the OPR360U A0509
ventilator from AC power and gas supplies.
2. Using a small flathead screwdriver, squeeze the tabs on the fuse drawer to loosen it; then pull it from the AC power module. See Figure 6-10.
3. Inspect and replace the fuses only if they are blown.
5-1
6-8
OPR360US H0711
6
Cleaning and Maintenance
5-1
OPR360U A0509
Figure 6-10 Remove Fuses
4. Reinstall the fuse drawer.
NOTE: Refer to the e360 Ventilator Service Manual for fuse
specifications.
Cleaning
Definition of clean: the removal of all foreign material (for example,
soil or organic matter) from objects. Cleaning is normally
accomplished by washing with running water, mechanical action, or
enzymatic products.
Follow these steps to clean a part before sterilization:
1.
2.
3.
4.
Disassemble (separate all components).
Wash part in water and mild soap solution or enzymatic cleaner.
Rinse part thoroughly in clean running water for at least two minutes and wipe dry or allow to air dry thoroughly.
Inspect part after every cleaning. Replace damaged or worn parts.
Caution Always follow soap manufacturer’s instructions. Exposure
to a highly concentrated soap solution can shorten the useful life of
a part. Soap residue can cause blemishes or cracks, particularly on
parts exposed to elevated temperatures during sterilization.
Sterilizing
5-1
Definition of sterilize: The complete elimination or destruction of
all forms of microbial life. Sterilization is accomplished by physical
OPR360U
A0509
or chemical processes. Steam under pressure, dry heat, and
low
temperature sterilization processes (such as ethylene oxide [EtO],
gas, or plasma sterilization) and liquid chemicals are the principal
sterilizing methods used.
OPR360US H0711
6-9
6 Cleaning and Maintenance
Caution Do not sterilize the entire ventilator. Standard sterilization
techniques, including EtO and formalin, may cause damage.
NOTE: Follow the cleaning and sterilization instructions provided by
the manufacturer of each assembly as well as your facility’s policy.
5-1
OPR360U A0509
Autoclave Sterilization:
1. Clean/Inspect
2. Sterilize
3. Dry
4. Reassemble
5. Perform Circuit Check on fully assembled breathing circuit after
installation.
EtO (Ethylene Oxide) Sterilization:
1. Clean/Inspect
2. Sterilize
3. Aerate (to dissipate residual gas absorbed by the part)
4. Reassemble
5. Perform Circuit Check on fully assembled breathing circuit after
installation.
Guide to Cleaning and Sterilizing
Table 6-1
Ventilator/
Component
Accessory
Ventilator
exterior,
including
control panel,
cart, support
arm, humidifier,
and exhalation
filter heater
5-1
Cleaning and Sterilization
Methods
Clean and disinfect with a
cloth dampened with a surface
disinfectant cleaner, according
to your facility’s infection control
policy.
Environments that have resistant
strains of bacteria may require
the use of a buffered bleach
solution to clean the surfaces
between patients (consult your
facility’s cleaning procedures).
After cleaning, wipe off all
cleaning agent residues to
prevent buildup.
Additional
Information
Do not allow liquids
into components or
cable connections.
Do not attempt to
EtO sterilize or use
pressurized air to
clean or dry.
OPR360U A0509
Vacuum rear vents to remove
dust.
6-10
OPR360US H0711
6
Cleaning and Maintenance
Ventilator/
Component
Accessory
Cleaning and Sterilization
Methods
Additional
Information
e360 fan filter
Wash filter in mild detergent
solution, rinse thoroughly, allow
to air dry.
Replace if
damaged.
Inspiratory filter
Expiratory filter
Single patient use: discard.
Reusable: dry, then autoclave.
Replace with each
patient set up and
sooner if expiratory
resistance through
the expiratory filter
is increased or if
visibly wet, soiled,
or contaminated
or as per the filter
manufacturer’s
recommendation.
Exhalation Valve
Inspiratory
Manifold
If filters are not used during
ventilation: disassemble and
clean, then autoclave to sterilize.
If filters are used: clean and
sterilize only as needed.
After sterilization,
perform the
Circuit Check on
the fully
assembled circuit.
Exhalation Flow
Sensor
Remove, Clean, Sterilize.
After sterilization,
perform the
Circuit Check on
the fully
assembled circuit.
If replaced during
use on a patient,
perform the Flow
Sensor Calibration.
OPR360U A0509
Cleaning: Soak the Sensor
in 70% alcohol solution for
approximately one hour then
gently agitate the sensor while
submerged. When visibly clean,
remove from alcohol and fully air
dry for at least 30 minutes.
Sterilization: Sterilize by EtO. The
sensor cannot be sterilized in an
autoclave.
Exhalation Flow
Sensor Cable
5-1
OPR360US H0711
Clean/disinfect the Flow Sensor
Cable with a cloth dampened
with an appropriate disinfectant
cleaner (do not soak) between
patients and when visibly soiled.
5-1
Approved cleaning and
sterilization methods:
NOTE: Newport
Medical
recommends that
the flow sensor
be replaced after
5 cleaning or
sterilizing cycles.
OPR360U A0509
6-11
6 Cleaning and Maintenance
Guide to Preventive Maintenance
5-1
CAUTION: Perform preventive maintenance and replace
components at recommended intervals to avoid component damage
from excessive wear.
OPR360U A0509
Table 6-2
Frequency
Ventilator
Component
Several times
a day or as
Expiratory
required
filter,
by your
disposable
institution’s
policy
Daily or as
necessary
e360 rear
panel air and
oxygen high
pressure inlet
water traps
Recommended Maintenance
Replace with each patient set up and
sooner if expiratory resistance through
the filter is increased or if visibly wet,
soiled, or contaminated or as per the filter
manufacturer’s recommendation.
Monitor for water accumulation, drain and
clean as necessary. Replace the bowl if
there is any sign of wear/damage. If inlet
water trap fills, remove ventilator from use
and contact an authorized service agent.
e360 rear
Check and clean as required.
panel fan filter
Ventilator
exterior (body,
control panel,
cart, and
support arm)
Wipe to clean/disinfect with soft cloth
dampened with a surface disinfectant
cleaner. Vacuum dust from the vents on
the rear panel. Wipe off all residues after
cleaning.
Inspiratory
filter,
disposable
Discard and replace.
As necessary
and between Inspiratory
filter, reusable
patient use
Expiratory
filter, reusable
heated
5-1
Exhalation
Flow Sensor
Sterilize and replace with each patient
setup.
Reusable: sterilize and replace with each
patient set up and sooner if expiratory
resistance through the filter is increased
or if visibly wet, soiled, or contaminated
or as per the filter manufacturer’s
recommendation.
Calibrate:
Calibrate the Flow Sensor (see Section
4) after cleaning and/or sterilizing, before
OPR360U
A0509
every patient use and any time you
suspect
that the expiratory tidal/ minute volumes
are significantly different than expected
(example: at least 25% higher or lower).
(continued on next page)
6-12
OPR360US H0711
6
Cleaning and Maintenance
Ventilator
Component
Recommended Maintenance
If the Sensor fails to calibrate, even after
it has been cleaned and sterilized, discard
the sensor in accordance with local
regulations and replace with a new sensor.
5-1
Frequency
OPR360U A0509
Clean/sterilize:
With no expiratory filter: clean and
sterilize between patients and also when
it malfunctions or is visibly contaminated
during use. With exp. filter in use: clean
and sterilize when it malfunctions or is
visibly contaminated during use.
Replace sensor when it cannot pass
calibration after cleaning/sterilization.
Between
patient use
Exhalation
Valve/
Inspiratory
Manifold
With no filter in use: disassemble, clean
and sterilize.
At least every
Internal battery Fully recharge the internal battery.
2 months
Install Level 1 Preventative Maintenance
Kit (PMK360A). Preventive maintenance
must be performed by a Newport
authorized service technician following
the instructions found in the e360
Ventilator Service Manual.
Every year or
5,000 hours,
whichever
comes first
e360 various
parts
Every 2
years or as
required
Discard and replace the Oxygen (O2)
Sensor every two years or when the
Oxygen sensor sensor cannot be calibrated (the ventilator
will display the message O2 Sensor Error
or O2 Sensor Calibration Failed).
Internal battery Discard and replace.
Every 5 years
or 25,000
e360 various
hours of
parts
operation
5-1
OPR360US H0711
Perform a Level 2 Preventative
Maintenance (OVL360A) according to
instructions in the e360 Ventilator Service
Manual. This must be performed by a
Newport Medical authorized service
technician.
OPR360U A0509
6-13
6 Cleaning and Maintenance
Storing the Ventilator
OPR360U A0509
Caution To ensure that the internal battery remains functional, fully
recharge the battery at least every 2 months when the ventilator is
not in use.
5-1
Caution Disconnect gas supplies from the ventilator for storage or if
the ventilator will not be used for an extended period of time.
Caution Do not store the ventilator on its side or back.
Repackaging the Ventilator
Use the original packing carton and material to ship the ventilator, or
contact your Newport representative to order replacement packing
material. See Contact Information at the front of this manual.
5-1
6-14
OPR360U A0509
OPR360US H0711
Section 7:
Explanation of
Modes, Breath
Types and
Special Functions
Explanation of Modes,
Breath Types and Functions
Explanation of
Section 7:
OPR360U A0509
Introduction....................................................................... 7-1
Settings Functions............................................................ 7-1
Timing Limitations to Ventilation Controls . ............. 7-1
Control Retention......................................................... 7-1
Control Range.............................................................. 7-1
Mandatory Breath Types.................................................. 7-1
Volume Control............................................................. 7-2
Pressure Control.......................................................... 7-3
Biphasic Pressure Release Ventilation...................... 7-3
Volume Target Pressure Control................................ 7-4
Spontaneous Breath Management (SIMV/SPONT)....... 7-4
Pressure Support......................................................... 7-4
Volume Target Pressure Support............................... 7-5
Ventilation Modes............................................................. 7-6
A/CMV........................................................................... 7-7
SIMV.............................................................................. 7-8
SPONT (Spontaneous)................................................. 7-8
Advanced Features & Special Functions........................ 7-9
Bias Flow....................................................................... 7-9
Slope/Rise.................................................................... 7-9
Expiratory Threshold and FlexCycle.......................... 7-9
OPR360U A0509
5-1 Leak Compensation (Leak Comp)............................7-10
Compliance Compensation (Compl Comp).............7-10
Non Invasive Ventilation (NIV).........................................7-11
Leak Compensation in NIV.........................................7-11
Alarm Settings in NIV..................................................7-11
5-1
Modes, Breath
Types and
Special Functions
7
Explanation of Modes, Breath Types and Special Functions
Introduction
The e360 offers a comprehensive selection of breath types and
modes. This section describes each form of mandatory and
spontaneous breath available within these selections as well as
descriptions of the operation of special functions.
5-1
OPR360U A0509
Settings Functions
Timing Limitations to Ventilation Controls
While in A/CMV, SIMV, and SPONT modes, the ventilator limits the
setting of any ventilation parameter so that inspiratory time and I:E
ratio cannot exceed the following limits.
• Inspiratory time cannot be less than 0.01 seconds.
• Inspiratory time cannot exceed 5.0 seconds for adult and 3.0 seconds for Infant/Pediatric patients (not counting an Inspiratory
Hold).
• I:E ratio cannot exceed an inverse ratio of 4:1.
Control Retention
All ventilation control settings, except Noninvasive and Scale setting,
are retained when e360 is powered OFF. When the ventilator is
powered ON, the control settings that are retained in memory are the
initial Start Ventilating ventilation and alarm settings unless the user
selects new settings.
Control Range
All variable ventilation controls are limited to a specified range.
For some controls, the range is dependent on the selected patient
category. When the patient category is changed, the selection for a
variable ventilation control may be out of range.
Mandatory Breath Types
The e360 offers these breath types:
• Volume Control
• Pressure Control
• Biphasic Pressure Release Ventilation
• Volume Target Pressure Control
5-1
Mandatory
Control Panel Advanced
Breath Type Selection
SelectionOpen Exhalation
Advanced
OPR360U A0509
SelectionVolume Target
Volume
Control
Off
OPR360US H0711
Volume
Control
Not available
7-1
7
Explanation of Modes, Breath Types and Special Functions
Mandatory
Control Panel Advanced
Breath Type Selection
SelectionOpen Exhalation
Advanced
SelectionVolume Target
Pressure
Control
Pressure
Control
Off
Off
Volume
Target
Pressure
Control
(VPTC)
Volume
Control or
Pressure
Control
Off
On
Biphasic
Pressure
Release
(BPRV)
Pressure
Control
On
Off
5-1
OPR360U A0509
Table 7-1 Control Selections for Mandatory Breaths
Volume Control
Volume Control ventilation provides time-cycled, volume limited
mandatory breaths. Volume and flow (or inspiratory time) are user-set
parameters and pressure is allowed to vary. The user has the option
to select between two Flow Wave patterns for breath delivery in
volume ventilation. The Flow Wave pattern function is accessed via
the Advanced Data Set.
A square flow wave pattern delivers the set flow constantly until
the set tidal volume is delivered. See figure 7-1A. A descending
ramp flow wave pattern delivers the set flow initially, decreases flow
rate at a constant rate until 50% of the initial flow is reached and
then terminates flow delivery when the set Tidal Volume has been
delivered. See Figure 7-1B.
5-1
OPR360U A0509
Figure 7-1A Square Waveform in VCV
7-2
OPR360US H0711
7
Explanation of Modes, Breath Types and Special Functions
5-1
OPR360U A0509
Figure 7-1B Decelerating Flow Waveform in VCV
Pressure Control
Pressure Control Ventilation provides time-cycled, pressure limited
mandatory breaths. Inspiratory Pressure Limit and t Insp (inspiratory
time) are set parameters with tidal volume and flow allowed to vary
to meet the set parameters. The Slope/Rise may be adjusted via the
Advanced Data Set. A pressure control inspiration terminates when
the set inspiratory time has elapsed.
NOTE: If the Slope/Rise control is set too low, breathing circuit
pressure may not reach the pressure limit value by end inspiration.
Biphasic Pressure Release Ventilation
(Open Exhalation Valve On)
Biphasic Pressure Release mandatory breaths are similar to Pressure
Control mandatory breaths except that the exhalation valve remains
open during the inspiratory time. This allows the patient the option
of unrestricted spontaneous breathing even while pressure in the
circuit is elevated to the Pressure Limit level. This type of ventilation
is referred to as “Biphasic Pressure Release Ventilation” (BPRV).
It is considered to be more comfortable for patients with an active
respiratory drive who are ventilated with Pressure Control. Open
Exhalation Valve is turned ON via the Advanced Data Set to achieve
BRPV breaths.
5-1
If a patient makes an expiratory effort, such as a cough, against a
closed exhalation system (i.e., Open Exhalation Valve OFF) during the
inspiratory phase of a pressure-controlled mandatory breath, airway
pressure will rise above the target pressure. When Open Exhalation
Valve is ON, the e360 Ventilator actively controls the exhalation
OPR360U A0509
valve so that excess pressure is vented out, the degree of pressure
overshoot is minimized and airway pressure is maintained close to
the target pressure.
OPR360US H0711
7-3
7
Explanation of Modes, Breath Types and Special Functions
5-1
Volume Target (Volume Target Pressure Control - VTPC)
Volume Targeted Pressure Control is a hybrid pressure control breath
type where the ventilator attempts to achieve (target) a user-set tidal
volume using the lowest pressure control level. These are much like
pressure control mandatory breaths except that the pressure control
level is managed breath-by-breath by the ventilator in steps of up to
3 cmH2O/mbar. The pressure change in VTPC is limited to a level
that is between 5 cmH2O/mbar above PEEP and the Pressure limit
setting in order to try to achieve the targeted (user set) tidal volume
within the (user set) inspiratory time. The set tidal volume is not
guaranteed for each breath, it is a target.
OPR360U A0509
The first VTPC mandatory breath delivered after Volume Target is
turned ON is at a pressure control level equal to PEEP/CPAP+ 5
cmH2O/mbar.
Spontaneous breaths in VTPC/SIMV mode are Volume Target
Pressure Support (VTPS) breaths.
NOTE: If the Slope/Rise control is set too low, breathing circuit
pressure may not reach the target pressure by the end of inspiration.
Spontaneous Breath Management in SIMV and
SPONT Modes
There are two forms of spontaneous breath assistance on the e360
ventilator in SIMV and SPONT modes, Pressure Support and Volume
Target Pressure Support.
In Volume Control, Biphasic Pressure Release and Pressure Control
SIMV, spontaneous breaths with Pressure Support are available.
In Volume Target Pressure Control SIMV, spontaneous breaths are
Volume Target Pressure Support breaths.
In SPONT, when Volume, BPRV or Pressure Control mandatory
breath type is selected spontaneous breaths with Pressure Support
are available.
In SPONT, when Volume Target Pressure Control mandatory breath
type is selected (Volume Target is ON in Advanced Data Set), all
spontaneous efforts are assisted by Volume Target Pressure Support.
5-1
OPR360U A0509
Pressure Support
Pressure Support is available in SIMV and SPONT - Volume Control,
BPRV and Pressure Control mandatory breath types only. For
7-4
OPR360US H0711
7
patient spontaneous efforts that trigger the ventilator, e360 delivers
breaths with a constant pressure equal to PEEP/CPAP + Pressure
Support until the end of patient inspiration which is determined by
the attainment of one of the three cycling off thresholds. The breaths
are delivered according to the user-selected settings for Pressure
Support, Slope/Rise, and PEEP/CPAP.
5-1
Explanation of Modes, Breath Types and Special Functions
OPR360U A0509
Pressure Support breaths are cycled off based on attaining one of
three thresholds: a percent (%) of peak flow (user set via Expiratory
Threshold in Advanced Data Set), maximum inspiratory time (2.0
seconds for Adult, 1.2 seconds for Ped/Infant) or pressure overshoot,
whichever comes first.
NOTE: See Figure 7-2 for a graphical representation of the pressure
overshoot cycling off threshold for Pressure Support and Volume
Target Pressure Support breaths.
Figure 7-2 Pressure Overshoot Cycling Off
5-1
NOTE: If Pressure Support is set to zero, the ventilator raises the
pressure in the patient circuit to a target pressure of 1.5 cmH2O/mbar
OPR360U A0509
above the set PEEP/CPAP until the end of inspiration.
Volume Target Pressure Support (VTPS)
Volume Target Pressure Support is available in SIMV and SPONT
- Volume Target Pressure Control breath type only. For patient
OPR360US H0711
7-5
7
Explanation of Modes, Breath Types and Special Functions
5-1
spontaneous breaths in the Volume Targeted Pressure Control
SPONT and SIMV modes, the ventilator delivers breaths with a
constant pressure in the breathing circuit at a pressure equal to a
ventilator selected level between PEEP/CPAP + 5 cmH2O/mbar
and the pressure limit, until the end of patient inspiration which
is determined by the attainment of one of the three cycling off
thresholds.
OPR360U A0509
Each VTPS spontaneous breath is delivered according to the
user-selected Tidal Volume and Pressure Limit, Slope/Rise and
PEEP/CPAP settings. These are very much like pressure support
spontaneous breaths but unlike the pressure support spontaneous
breaths delivered when Pressure Control, BPRV or Volume Control
breath type are selected, the pressure support level is managed
breath-by-breath by the ventilator the lowest level possible between
5 cmH2O/mbar above PEEP/CPAP and the Pressure Limit setting in
order to try to achieve the set tidal volume. The set tidal volume is not
guaranteed for each breath, it is a target.
The target pressure of the first breath, when no target pressure has
been established is PEEP/CPAP + 5 cmH2O/mbar.
Volume Target Pressure Support (VTPS) breaths are cycled off based
on attaining one of three thresholds: a percent (%) of peak flow
(user set via Expiratory Threshold in Advanced Data Set), maximum
inspiratory time (2.0 seconds for Adult, 1.2 seconds for Ped/Infant)
or pressure overshoot, whichever comes first. See Figure 7-2 for an
illustration of the pressure overshoot cycling off function.
Ventilation Modes
There are three modes of ventilation available:
• Assist/Control Mandatory Ventilation (A/CMV)
• Synchronized Intermittent Mandatory Ventilation (SIMV)
• Spontaneous (SPONT)
5-1
7-6
OPR360U A0509
OPR360US H0711
7
Explanation of Modes, Breath Types and Special Functions
A/CMV
5-1
OPR360U A0509
Figure 7-3 A/CMV
In A/CMV, all breaths delivered to the patient are delivered according
to the parameters set by the user. These are called mandatory
breaths. The user may choose to Pressure Control, Volume Control,
Biphasic Pressure Release or Volume Target Pressure Control the
mandatory breaths. All breaths may be time (ventilator-triggered) or
patient-triggered.
The Resp Rate (respiratory rate) setting determines the minimum
number of time-triggered or patient triggered mandatory breaths
delivered each minute. The Trig setting determines the airway
pressure or airway flow threshold that the patient’s effort must reach
in order to trigger these and additional mandatory breaths.
If the patient doesn’t breathe or if the patient’s efforts don’t cause
airway pressure or airway flow to reach the Trig threshold, the e360
Ventilator delivers the number of time-triggered breaths each minute
selected via the Resp Rate setting.
SIMV
5-1
OPR360U A0509
Figure 7-4 SIMV
OPR360US H0711
7-7
7
Explanation of Modes, Breath Types and Special Functions
5-1
In SIMV, mandatory and spontaneous breaths may be delivered
to the patient. The user may choose to Pressure Control, Volume
Control, Biphasic Pressure Release or Volume Target Pressure
Control the mandatory breaths. Mandatory breaths may be time or
patient-triggered. In Volume Control, Pressure Control or Biphasic
Pressure Release, the user may choose Pressure Support to augment
the spontaneous breaths.
OPR360U A0509
When Volume Target Pressure Control mandatory breath type is
selected, all spontaneous breaths are Volume Target Pressure
Support breaths.
The Resp Rate setting determines the total number of mandatory
breaths delivered each minute and establishes a timing window that
determines whether a patient trigger results in a mandatory breath or
a spontaneous breath.
The Trig setting determines the airway pressure or airway flow
threshold that the patient’s effort must reach in order to trigger
mandatory breaths and also to trigger spontaneous breaths in
between mandatory breaths.
If there are no patient breathing efforts or if patient efforts fail to
cause enough airway pressure or airway flow change to meet the
set Trig threshold, the patient receives the number of time-triggered
breaths each minute selected via the Resp Rate setting.
SPONT (Spontaneous)
In SPONT, all breaths delivered to the patient are spontaneous
breaths. When Volume Control or Pressure Control breath types
are selected, the user may choose to add Pressure Support to
assist spontaneous efforts. When Volume Target Pressure Control
mandatory breath type is selected, all spontaneous efforts are
assisted by Volume Target Pressure Support.
The Trig setting determines the airway pressure or airway flow
threshold that the patient’s effort must reach in order to trigger
spontaneous breathing assistance from the ventilator.
If there are no patient efforts or if the patient efforts fail to cause
enough airway pressure or airway flow change to meet the set Trig
5-1threshold, no spontaneous breathing assistance is provided.OPR360U A0509
7-8
OPR360US H0711
7
Explanation of Modes, Breath Types and Special Functions
Advanced Features & Special Functions
5-1
Bias Flow
When e360 is in standby or ventilating condition, it provides 3 L/
min of mixed-gas (when both air and oxygen source gases are
connected) Bias Flow during the exhalation period. Exceptions to this
Bias Flow level are described below.
OPR360U A0509
Bias Flow is at a Different Level When:
•
•
•
Ventilation Suspended due to Circuit Disconnect alarm or other condition: Bias Flow 10 L/min for Adult and 5 L/min for Ped /Infant patient type;
(Automatic) Leak Compensation is turned ON and there is a leak:
Bias Flow 3-15 L/min for Adult and 3-8 L/min for Ped /Infant patient type;
Noninvasive Ventilation is turned ON and there is a leak:
3-25 L/min for all patient types.
Bias Flow is OFF When:
•
•
e360 is powered OFF;
During a pause, an inspiratory hold, an expiratory hold, any alarm related to an elevated pressure, and during a Loss of Both Gas Supplies alarm.
Slope/Rise
Slope/Rise is the term used to describe the e360 pressurization
gain for Pressure Control, Volume Target Pressure Control, Biphasic
Pressure Release, Pressure Support and Volume Target Pressure
Support* breaths.
The user can choose a Slope/Rise value between 1 and 19 (resolution
1, where 1 is the slowest pressurization and 19 is the fastest). This
function is accessed via the Advanced Data Set at the bottom of the
GUI screen.
The Slope/Rise selection is retained after power down.
5-1
Expiratory Threshold and FlexCycle
(Automatic Expiratory Threshold Management)
A0509 off
Expiratory Threshold is the term used to describe the flowOPR360U
cycling
threshold for Pressure Support and Volume Target Pressure Support
breaths. Expiratory Threshold is expressed as a percent (%) of peak
flow.
OPR360US H0711
7-9
7
Explanation of Modes, Breath Types and Special Functions
The user can choose an Expiratory Threshold value between 5 and
55% of peak flow. This function is accessed via the Advanced Data
Set at the bottom of the GUI screen.
5-1
In addition to the manual selection for Expiratory Threshold, an
AUTO option is also available. When Auto is selected, the ventilator
automatically adjusts the Expiratory Threshold setting on a breathby-breath basis within the established range in order to end the
breath when the patient stops inhaling and prevent early or late
cycling off. We refer to this automated option as FlexCycle.
OPR360U A0509
The Expiratory Threshold selection is retained after power down.
Leak Compensation (Leak Comp)
The e360 provides 3 L/min of bias flow through the breathing
circuit in between breaths (i.e. during the exhalation period). This
flow facilitates both flow triggering and the stabilization of baseline
pressure and flow in order to minimize auto-triggering of breaths.
The Leak Comp (Automatic Leak Compensation/ Baseline Pressure
Management) function allows the user to select whether or not they
want the e360 to compensate for leaks over and above the 3 L/min
bias flow. Leak Comp is factory preset to ON and the selection is
retained after power down.
When Leak Comp is ON, the e360 automatically adjusts the bias flow
between 3 and 8 L/min for Ped/Infant selection and between 3 and
15 L/min for Adult selection, in order to maintain an end expiratory
base flow of 3 L/min. Flow triggering is automatically compensated
for changes in bias flow delivery. When Leak Comp is OFF, bias flow
is 3 L/min regardless of leaks. If there is no leak, bias flow remains at
3 L/min whether Leak Comp is ON or OFF.
Compliance Compensation (Compl Comp)
Compliance Compensation (Compl Comp) for Volume Control
mandatory breaths can be selected ON or OFF from the Patient
Setup screen.
When Compl Comp is ON, displayed VTI and VTE represent volume
as if it were being monitored at the patient’s airway. When Compl
Comp is OFF, VTI and VTE represent volume monitored at the main
flow outlet and exhalation valve.
5-1
OPR360U A0509
VTI and VTE displayed values will not look any different with Compl
Comp ON or OFF even though VTI and VTE monitored values are
different. Actual delivered/monitored values will be bigger with Compl
Comp ON. But you will not see it in the displayed value. The extra
7-10
OPR360US H0711
7
Explanation of Modes, Breath Types and Special Functions
flow/volume that is added in and delivered to the patient in order to
compensate for the volume that is “lost” in the tubing is subtracted
from both the displayed values.
5-1
Caution The e360 Circuit Check determines how much the e360
compensates for circuit compliance. If you have a bigger circuit
and humidifier in place when you do the test it will result in more
adjustment. A smaller circuit/humidifier will result in less adjustment.
Make certain that the ventilator is set up exactly like it will be on the
patient (including filters and water in the humidifier) when you do
these tests or the delivered and displayed volumes will be incorrect
during ventilation.
OPR360U A0509
Non Invasive Ventilation (NIV)
The e360 Ventilator can be used for invasive (intubated patient) or
noninvasive (mask) ventilation. When the Non Invasive button is
activated on the front panel (LED lights), e360 tailors the ventilator’s
performance (described below) to meet the needs of a patient who is
breathing from a mask rather than an invasive artificial airway or an
uncuffed/deflated cuff trach tube. Non Invasive can be used with any
mode of ventilation. It is factory preset to OFF and the setting returns
to OFF after power down.
Leak Compensation in NIV
The Non Invasive function automatically provides leak compensation/
baseline pressure management with a bias flow range of 3 to 25 L/min
in order to accommodate the potential for bigger airway leaks around
the non-vented mask or uncuffed/deflated cuff trach tube. (When Non
Invasive is not activated and Leak Comp is ON bias flow is only 3-8 L/
min Ped/Infant and 3-15 L/min Adult.)
Alarm Settings in NIV
The Low MVE and the Disconnect Threshold alarms, can be set to
OFF while Non Invasive is activated. All other alarms are functional.
If the Low MVE or Disconnect Threshold alarm is OFF when Non
Invasive is deactivated, the alarms are automatically turned back
on and the Low MVE alarm is set to the lowest value while the
Disconnect Threshold alarm is set to the highest value.
5-1
NOTE: To minimize the chances of auto-triggering due to leaks,
Newport Medical recommends using Pressure trigger (start at 2
A0509
when
cmH2O/mbar for Adult and 1 cmH2O/mbar for Ped/Infant)OPR360U
using the e360 for noninvasive mask ventilation. Use a nonvented
mask to ensure proper patient-ventilator synchrony.
OPR360US H0711
7-11
Specifications
Section 8:
Specifications
OPR360U A0509
Alarms, Controls, Monitored Data, Setup & Calibration... 8-1
Physical Specifications...................................................... 8-18
5-1
OPR360U A0509
5-1
Specifications
Section 8:
8
Specifications
Alarms, Controls, Monitored Data, Setup & Calibration
Table 8-1
OPR360U A0509
Location and/or
Function
All Other
Messages
GUIInformational
Message
For any message not shown here
refer to Section 5, Alarms for more
information.
Alarm History
GUI-Alarms
See Event History
Alarm
Loudness
GUI-Alarms
Range: 1 to 10 (55 - 75 dbA)
Default : 5
Accuracy: +/- 5 dbA
(Alarm) Reset
Control Panel
Clears visual indicators and messages
for alarms that are no longer violated.
Alarm Silence
Control Panel
Mutes silenceable, audible alarms for
two (2) minutes. Pressing the Alarm
Silence button again turns off the
alarm silence function. This button
will not silence a Device Alert alarm
without first powering the ventilator
OFF.
Alarm Tones
GUI-Alarms
Range: 1-3
Default: 1
GUI-AlarmsAdjustable
Alarm is violated when no breath or
effort is detected within the set apnea
interval.
Range: 5 to 60 seconds
Accuracy: ±1 second
Apnea
Range and Resolution or
Description
5-1
Item
If the current mode is A/CMV or SIMV,
Back Up Ventilation employs the
current Control Panel settings except
for Respiratory Rate which increases
to 1.5 times the current setting (15 b/
min minimum, 100 b/min maximum).
Back Up
Ventilation
(BUV)
Alarms-Non(Results from
Adjustable
low MVE Alarm
Violation)
5-1
If the current mode is SPONT, the
ventilator delivers pressure control
mandatory breaths with the following
settings:
• Plimit 15 cmH2O/mbar above PEEP
setting
• t Insp 0.6 seconds Ped/Infant,
1.0
OPR360U A0509
seconds Adult
• Resp Rate 20 b/min Ped/Infant,
12 b/min Adult
(Cont. next page)
OPR360US H0711
8-1
8 Specifications
Location and/or
Function
Changing any ventilation setting that
affects mode, breath timing,
flow/volume, pressure, or trigger
sensitivity suspends back up
ventilation for 60 seconds. It is also
suspended for 60 seconds following
Suction Disconnect function with
breathing circuit disconnect then
reconnect.
OPR360U A0509
Back Up
Ventilation
(BUV)
(Results from
low MVE Alarm
Violation)
(cont.)
Breath Type/
Mode
Setting
Range and Resolution or
Description
5-1
Item
Back Up Ventilation terminates when
MVE exceeds the Low MVE Alarm
setting by 10%
Control Panel/
GUI
Breath Type:
Volume Control, Pressure Control or
Volume Target Pressure Control and
Biphasic Pressure Release Ventilation
(BPRV)
Mode:
A/CMV (assist/control mandatory
ventilation),
SIMV (synchronized intermittent
mandatory ventilation), or
SPONT (spontaneous ventilation)
Monitored
GUI-Monitored
Data
Cdyn effective
(mL/ cmH2O/
GUI-Monitored
mbar) (Effective
Data
dynamic
compliance)
5-1
8-2
Circuit
Disconnect
Alarms- Non
adjustable
Circuit Type
GUI-Patient
Setup
Selected breath type and mode is
displayed below the Patient Category
icon on the upper left side of GUI.
Displayed range:
0 to 999.9 mL/ cmH2O/mbar
Accuracy:
± 1 mL/ cmH2O/mbar
Cdyn effective = VTE/ (Ppeak – Pbase)
NOTE: Calculated for time triggered
breaths only. VTE, Ppeak, and Pbase
must be valid to calculate Cdyn
effective.
Indicates that the Disconnect
Threshold % is greater than or equal
to the set value.
OPR360U A0509
Range: Heated Expiratory Limb,
Heated Inspiratory Limb, Heat
Moisture Exchanger (HME), and Test
Lung.
(Cont. next page)
OPR360US H0711
8
Specifications
Location and/or
Function
OPR360U A0509
Circuit Type
(cont.)
GUI-Patient
Setup
Range and Resolution or
Description
1. Heated Exp. Limb = heated
humidifier with dual heated wire
breathing circuit.
2. Heated Insp. Limb = heated
humidifier with no heated wires in the
circuit or heated wire in the inspiratory
limb of the breathing circuit only.
3. HME = no heated humidifier,
unheated breathing circuit with
passive humidification (heat moisture
exchanger [HME] or hydroscopic
condensing humidifier [HCH]).
4. Test Lung = no humidification, no
heat.
5-1
Item
NOTE: Circuit Type selection affects
the accuracy of monitored values
for expiratory flow, expiratory tidal
volume and expiratory minute volume.
Comm.
Protocol
GUI-Technical
Compl Comp
GUI-Patient
(Compliance
Sertup
Compensation)
5-1
Cstat
(mL/cmH2O/
mbar)
(Static
compliance)
OPR360US H0711
GUI-Monitored
Data
Range: Newport, Newport 2, Vuelink
Allows user to select protocol to
communicate with patient monitoring
systems via the RS232 port.
Range: ON or OFF
Volume Control mandatory
breaths: flow delivery is adjusted
to compensate for the effects of
breathing circuit compliance and
the display of monitored flows and
volumes approximate effective
delivered flows and volumes.
Displayed range: 0 to 999.9 mL/
cmH2O/mbar
Accuracy: ± 1 mL/ cmH2O/mbar
Cstat = VTE/ (Pplat – PEEP)
Maneuver based with time stamp for
up to 24 hrs.
NOTE: Calculated for time-triggered
breaths only.
Cstat is updated immediately
following an update of Pplat (Insp
Hold Maneuver). It is also updated
OPR360U A0509
following an update of Total-PEEP (Exp
Hold Maneuver) if this maneuver is
performed within 5 min. following Pplat
update. In this case, the Auto-PEEP
measurement is substituted for the
PEEP measurement in the equation.
8-3
8 Specifications
Location and/or
Function
Data Read
Alarms-Non
Failure Contact
Adjustable
Service Alarm
OPR360U A0509
Device Alert
Disconnect
Threshold
(VTE Var %)
Display
Brightness
EEPROM
Read Error
Event History
(Alarm History)
5-1
8-4
Range and Resolution or
Description
Software type is read invalid from both
the EEPROM on the main board and a
stored file on the compact flash card.
Control PanelAlarms-Non
Adjustable
LED on Control Panel lights (if possible).
Unsilenceable audible alarm sounds
if there is a ventilator malfunction
(messages associated with a device
alert are described in Section 5). Also
activated if less than 10% of internal
battery operation time remains.
WARNING! If a Device Alert occurs,
ventilation ceases and the emergency
intake valve and exhalation valve
opens.
GUI-AlarmsAdjustable
Percent of difference between
inspiratory and expiratory tidal
volumes.
Range: 20 to 95%
Accuracy: +/- 10%
NOTE: When Non Invasive is activated
this alarm may be set to OFF.
GUI-Technical
Range: 0-100%
Default: 50%
Allows user to adjust display
brightness of GUI.
Alarms-Non
Adjustable
Software type is read invalid from
the EEPROM on the main board. It
is logged in the event history page,
but no audible alarm and alarm LED
indicator will be activated. No error
message will be displayed on the
alarm/message bar on the screen.
GUI-Extended
Functions (and
Alarms)
5-1
Item
A log of the past 1000 events. Events
are color coded:
Green: Power ON and Start
Ventilating.
Blue: Control settings and changes,
calibration results and Circuit Checks.
Red: Alarm violations and messages
and Power OFF
A0509
Event History is retained afterOPR360U
Power
shutdown. Save Event History button
allows user to capture current event
log for later downloading in .csv
format.
OPR360US H0711
8
Specifications
Range and Resolution or
Description
GUI-Technical
Contains a list of the last 200 saved
Event and Alarm History logs (.csv
files). Files are assigned an 8-digit file
name that includes a letter for file type
(H for history, etc), the last 4 digits
of the serial number, and a 3 digit
sequential number.
GUI-Extended
Functions
Range: Up to 20 seconds
Generates an Expiratory Hold
maneuver at the end of a mandatory
breath exhalation for as long as the
button is pushed.
Expiratory
Threshold
GUI-Advanced
Data Set
Range: AUTO 5 – 55%, (resolution
1%) of peak flow.
Manually or automatically sets the
flow cycling-off threshold for Pressure
Support and Volume Target Pressure
Support breaths
FIO2 (Set)
Control Panel
Range: 0.21 to 1.00 (resolution 0.01)
Accuracy: ±.03
FIO2
(Monitored)
GUI-Monitored
Data
Displayed range: 0.21 to 1.00
(resolution 0.01)
Accuracy: ±0.03 (“—-” displayed if
sensor is disconnected)
FIO2 High
Alarms-Non
Adjustable
Monitored FIO2 is more than 0.07
above the set FIO2 for 30 seconds.
Accuracy: ±0.03
FIO2 Low
Alarms-Non
Adjustable
Monitored FIO2 is more than 0.07
below the set FiO2 for 30 seconds.
Accuracy: ±0.03
Flow Sensor
Error
Alarms-Non
Adjustable
Flow sensor cannot calibrate or the
internal wire is damaged or sensor is
disconnected.
Flow Inspiratory
Setting
Control Panel
Range: Ped/Infant: 1 to 100 L/min
(resolution 1 L/min)
Adult: 1 to 180 L/min (resolution 1 L/min)
Accuracy: ±10% or ± 0.3 L/min,
whichever is greater
Flow Inspiratory
Monitored
GUI-Monitored
Data
Displayed range: 0 to 200 L/min
(resolution 1 L/min)
FlowExpiratory
GUI Monitored
Data
OPR360U A0509
Displayed range: 0 to 200 L/min
(resolution 1 L/min)
Flow
Waveform
GUI-Advanced
Data Set
Range: Square or Descending Ramp
Selects flow waveform for Volume
Control mandatory breaths.
OPR360U A0509
Event History
Files
Expiratory
Hold
5-1
Location and/or
Function
OPR360US H0711
5-1
Item
8-5
8 Specifications
Location and/or
Function
Range and Resolution or
Description
Freeze/Start/
Save
GUI-Main
and Extended
Functions
Freeze: Suspends plotting of graphs
(waveforms, loops, or trends) and
holds the current display for extended
viewing.
Start: Resumes plotting of graphs.
Save: Captures current screen image
for later downloading.
Gas Supply
Alarms-Non
Adjustable
If one or both gas supplies are below
30 psi.
Alarms-Non
Adjustable
Monitored PEEP (Pbase) is greater
than set PEEP level by 5 cmH2O/mbar
for two consecutive breaths.
OPR360U A0509
High Baseline
Pressure
5-1
Item
Accuracy: ±1 cmH2O/mbar
High MVE
High Paw
GUI-AlarmsAdjustable
GUI-AlarmsAdjustable
Range:
Ped/Infant: 0.02 to 9.99 L (resolution
0.01 L)
10.0 to 60.0 L (resolution 0.1 L)
Adult: 2.00 to 9.99 L (resolution
0.01 L)
Range:
Ped/Infant: 5 to 100 cmH2O/mbar
(resolution 1 cmH2O/mbar)
Adult: 5 to 120 cmH2O/mbar
(resolution 1 cmH2O/mbar)
Accuracy: ±3% or ±2 cmH2O/mbar,
whichever is greater
NOTE: A High Paw alarm violation
terminates the current breath and
cycles to exhalation. This alarm is
applicable for all breaths, including
manual inflations.
Total respiratory rate including
mandatory and spontaneous breaths.
High RRtot
5-1 I:E Inverse
8-6
GUI-AlarmsAdjustable
Range:
10-120 b/min or OFF
Accuracy: +3% or +2 b/min,
whichever is greater
Violation
Alarms-Non
Adjustable
Ventilator settings result in anOPR360U
I:E ratio
A0509
greater than 4:1
I:E Ratio
(Monitored)
GUI-Monitored
Data
Displayed range:
From 99:1 to 10:1 (resolution 1)
From 9.9:1 to 1:9.9 (resolution 0.1)
From 1:10 to 1:99 (resolution 1)
OPR360US H0711
8
Specifications
Ideal Body
Weight
Range and Resolution or
Description
GUI-Patient
Setup
Range: 2-2202 lb (1-999 kg)
Inspiratory
Hold
GUI-Extended
Functions
Range: Up to 15 seconds
Generates an Inspiratory Hold
maneuver at the end of a mandatory
breath inspiration for as long as the
button is pushed.
Insp time too
long
Alarms-Non
Adjustable
Ventilator settings result in an
Inspiratory Time greater than 5
seconds
Insp time too
short
Ventilator settings result in an
GUI-Alarms-Non Inspiratory Time less than:
Adjustable
Adult: 0.1 Seconds
Infant/Peds: 0.05 seconds
OPR360U A0509
Internal
Battery
Indicators
5-1
Location and/or
Function
Control Panel
5-1
Item
Internal Battery LED on the Control
Panel lights and an audible signal
sounds every five minutes to indicate
that the ventilator is operating on
internal battery power. The Battery
Charge Level icon (located in the
top right area of the GUI) shows
the relative level of internal battery
power when ventilator is operating on
internal battery power.
Leak Comp
GUI-Patient
(Leak
Setup
Compensation)
Range: ON or OFF
ON = 3 – 8 L/min for Ped/Infant
patient selection
3 – 15 L/min for Adult patient selection
OFF = 3 L/min regardless of leaks/ no
leak
Non-Invasive Ventilation ON- Leak
Compensation is automatically
adjusted from 3-25 L/min.
Loops
Loops combinations:
OPR360U A0509
Flow/Volume, Volume/Pressure or
both on one screen
OPR360US H0711
GUI-Main
8-7
8 Specifications
Location and/or
Function
Range and Resolution or
Description
Low Baseline
Pressure
OPR360U A0509
Alarms-Non
Adjustable
When the monitored proximal
pressure </= low baseline pressure
criteria for more than 0.5 seconds for
two consecutive breaths.
Accuracy: ±1 cmH2O/mbar
Low Battery
Alarms-Non
Adjustable
Unsilenceable audible alarm sounds
when internal battery capacity has
dropped to 25% or less.
Low MVE
GUI-AlarmsAdjustable
5-1
Item
Range:
Ped/Infant: 0.01 to 9.99 L (resolution
0.01 L) 10.0 to 30.0 L (resolution 0.1L)
Adult: 1.00 to 9.99 L (resolution
0.01 L) 10.0 to 50.0 L (resolution
0.1 L)
Accuracy: ±10% or ±0.1 L, whichever
is greater
NOTE: When Non Invasive is
activated this alarm may be set to
OFF.
NOTE: Low MVE alarm is suspended
for 60 seconds once the breathing
circuit is reconnected following
activation of Suction Disconnect.
5-1
8-8
Low Paw
GUI-AlarmsAdjustable
Range:
Ped/Infant: 3 to 75 cmH2O/mbar
(resolution 1 cmH2O/mbar)
Adult: 3 to 95 cmH2O/mbar (resolution
1 cmH2O/mbar)
Accuracy: ±3% or ±2 cmH2O/mbar,
whichever is greater
Low Paw
Below PEEP
GUIInformational
Message
The current Low Paw alarm setting is
lower than the PEEP setting.
Mains
Control Panel
Lights when the ventilator is supplied
with AC power.
Manual
Inflation
Control Panel
Range: Up to 5 seconds
Delivers a manual inspiration while the
button is held down.
Terminates when the button is
released or when a High Pressure
OPR360U A0509
Alarm is violated, whichever comes
first.
MVE
GUI-Monitored
Data
Displayed range:
(cont. next page)
OPR360US H0711
8
Specifications
Location and/or
Function
Range and Resolution or
Description
Ped/Inf: 0.00 to 9.99 L (resolution
0.01 L)
Adult: 10.0 to 99.9 L (resolution 0.1 L)
Accuracy: ±10% or ±0.3 L, whichever
is greater
OPR360U A0509
MVE (cont.)
5-1
Item
NOTE: The display will not be
updated if the exhalation flow sensor
is disconnected.
MVI
NIF
Non-Invasive
GUI-Monitored
Data
Displayed range:
Ped/Inf: 0.00 to 9.99 L (resolution
0.01 L)
Adult: 10.0 to 99.9 L (resolution 0.1 L)
Accuracy: ±10% or ±0.3 L, whichever
is greater.
GUI-Technical
Generates NIF maneuver for
measuring airway pressure during
a maximum inspiratory effort. It
is available in all modes, with and
without Non Invasive Ventilation (NIV)
activated.
Control Panel
Range: ON (LED lights) or OFF
Available in all modes and breath
types. Leak Compensation is
automatically adjusted up to 25 L/min
when Non Invasive is ON.
No
Alarms-Non
Communications Adjustable
Numeric
5-1
OPR360US H0711
GUI-Main
No communications failure is a failure
of the SBC to send communication
to the Main Board or loss of monitor
processor.
Unsilenceable audible alarm.
Note: Ventilator continues to ventilate
at current control setting.
The Numeric screen displays all
monitored parameters on a single
screen, including Advance data
functions (except Volume Target).
Numeric table includes: Ppeak, Pplat,
Pmean, PEEP, Total PEEP, FIO2,
I:E, Peak Insp Flow, Peak Exp Flow,
WOBim, Cdyn effective, Cstat, RI, RE,
OPR360U A0509
Time Const., RR tot, RR spont,
RSBI,
t Insp, MVE spont, VTI, VTE, VTE %
Variance, MVI, MVE, Slope/Rise, Exp.
Threshold, Pause, Open Exh, Flow
Wave
8-9
8 Specifications
Location and/or
Function
Range and Resolution or
Description
Control Panel
When pressed delivers 100% oxygen
for 3 minutes. Pressing button again
turns off 100% oxygen delivery.
Indicator lights when O2 3 min is in
effect.
O2 Sensor
GUI-Sensors
Can perform an oxygen sensor
calibration by delivering 100% oxygen
to the system. O2 Sensor calibration is
always performed when the O2 3 min
button is pressed. Can disable O2 sensor.
O2 Sensor
Disconnected
GUIInformational
Message
Notification message that the O2
sensor has been disconnected.
O2 Sensor
Error
Alarms-Non
Adjustable
Alarm message is displayed and
audible alarm sounds if the oxygen
sensor fails.
GUI-Advanced
Data Set
Range: ON or OFF
Activates management of a partially
open exhalation valve. Coverts
Pressure Control mandatory breath
type to Biphasic Pressure Release
mandatory breath type (enables BPRV).
GUI-Technical
Generates P0.1 measurement for
assessing the patient’s respiratory
drive. It is available in all modes
and breath types but not available
when Non Invasive Ventilation (NIV) is
activated.
OPR360U A0509
O2 3 Min
Open
Exhalation
Valve
P0.1
Patient
Category
GUI-Patient
Setup
Patient
Trigger
Indicator
GUI-Monitored
Data
Pause
(Inspiratory)
GUI-Advanced
Data Set
5-1
8-10
5-1
Item
Range: Ped/Infant (pediatric/infant)
Adult (An icon located on the top left
corner of the GUI indicates category
selected.)
NOTE: Settable ranges for ventilator
parameters and alarms will vary
depending on the patient category
selected.
The area behind the patient category
icon at the top left side of the GUI
lights green to indicate that a patient
trigger has been activated.
OPR360U A0509
Range: Off, 0.1 – 2.0 seconds
(resolution 0.1 second)
Sets the duration of Pause at the
end of inspiration for volume control
mandatory breaths.
OPR360US H0711
8
Specifications
Item
Location and/or
Function
PEEP/CPAP
(Baseline
Pressure-Set)
Control Panel
Range:
Ped/Infant: 0 to 30 cmH2O/mbar
(resolution 1 cmH2O/mbar)
Adult: 0 to 45 cmH2O /mbar
(resolution 1 cmH2O/mbar)
Accuracy: ±10% or ±1 cmH2O/mbar,
whichever is greater.
Baseline
PressureMonitored
GUI-Monitored
Data
Displayed range: 0 to 99.9 cmH2O/
mbar (resolution 0.1 cmH2O/mbar)
Accuracy: ±3% or ±2 cmH2O/mbar,
whichever is greater.
GUI-Monitored
Data
Displayed range: 0 to 99.9 cmH2O/
mbar
Resolution: 0.1 cmH2O/mbar
Accuracy: Larger of ± 3% or 2
cmH2O/mbar
Maneuver–based with time stamp (for
up to 24 hours)
Total PEEP equals the sum of set
PEEP + AutoPEEP. Total PEEP is
updated immediately following an Exp
Hold.
Pmean
GUI-Monitored
Data
Displayed range: 0 to 140 cmH2O/
mbar (resolution 0.1 cmH2O/mbar)
Accuracy: ±3% or ±2 cmH2O/mbar,
whichever is greater
The average pressure in the patient
breathing circuit for the past 30
seconds
Power
Shutdown
Alarms-Non
Adjustable
When ventilator is powered off an
audible alarm sounds. Silence by
pressing Alarm Silence button.
GUI-Monitored
Data
Displayed range: 0 to 140 cmH2O/
mbar (resolution 0.1 cmH2O/mbar)
Accuracy: ±3% or ±2 cmH2O/mbar,
whichever is greater
Updated following each positive
pressure inflation
GUI-Monitored
Data
Displayed range: 0 to 140 cmH2O/
mbar (resolution 0.1 cmH2O/mbar)
Accuracy: ±3% or ±2 cmH2O/mbar,
whichever is greater
OPR360U A0509
NOTE: Displays time stamped
numeric value (for up to 24 hours)
following a valid inspiratory hold
maneuver or following Pause that
results in a stable pressure level.
OPR360U A0509
Ppeak
Pplat
OPR360US H0711
5-1
total PEEP
5-1
Range and Resolution or
Description
8-11
8 Specifications
Pressure Bar
Graph
Location and/or
Function
Control Panel
Range and Resolution or
Description
Displayed range: –10 to 120 cmH2O/
mbar
OPR360U A0509
Pressure Limit Control Panel
Range:
Ped/Infant: 0 to 70 cmH2O/mbar
(resolution 1 cmH2O/mbar)
Adult: 0 to 80 cmH2O/mbar (resolution
1 cmH2O/mbar)
Accuracy: ±10% or ±1 cmH2O/mbar,
whichever is greater
GUIPressure Limit
Informational
Below PEEP
Message
The current Pressure Limit setting is
lower than the PEEP/CPAP setting.
Pressure
Support
Control Panel
Range:
Ped/Infant: 0 to 50 cmH2O/mbar
(resolution 1 cmH2O/mbar) above
PEEP/CPAP setting
Adult: 0 to 60 cmH2O/mbar (resolution
1 cmH2O/mbar) above PEEP/CPAP
setting
Accuracy: ±10% or +1 cmH2O/mbar,
whichever is greater
NOTE: Out of Range alarm occurs if
PEEP + PS > 60 cmH2O/mbar.
Pressure
Support +
PEEP > 60
GUIInformational
Message
Indicates that the operator is
attempting to set a Pressure Support
or PEEP level that is greater than the
sum of the two settings.
Pressure
Units
GUI-Technical/
Regional
Select cmH2O (centimeters/water
pressure) or mbar (millibars).
RE
(cmH2O/mbar/ GUI-Monitored
L/s) (Expiratory Data
resistance)
5-1
Regional
8-12
GUI-Technical
5-1
Item
Displayed range:
0 to 999.9 cmH2O/mbar/L/s
Accuracy: ±1 cmH2O/mbar /L/s
Resolution: 0.1 cmH2O/mbar/L/s
RE = exhalation time constant/ Cstat.
Maneuver–based with time stamp (for
up to 24 hours)
The exhalation time constant is the
slope of volume/flow loop during
exhalation. Cstat must be valid to
calculate RE. Calculated for timetriggered breaths only.
OPR360U A0509
• Altitude Range: 0 to 4,000 meters (0
to 13,124 feet)
OPR360US H0711
8
Specifications
Location and/or
Function
OPR360U A0509
Resp Rate
(Respiratory
Rate)
RI
(cmH2O/mbar/
L/s)
(Inspiratory
resistance)
Control Panel
Range and Resolution or
Description
Range:
Ped/Infant: 1 to 120 b/min (resolution
1 b/min)
Adult: 1 to 80 b/min (resolution 1 b/
min)
Accuracy: ±1 b/min or ±10% of breath
period, whichever is less
Displayed range: 0 to 999.9 cmH2O/
mbar/L/s
Accuracy: ±1 cmH2O/mbar/L/s
GUI-Monitored
Data
Maneuver–based with time stamp (for
up to 24 hours)
RI = (Ppeak – Pplat)/ end inspiratory
flow. Calculated for volume control
breaths only. Ppeak and Pplat must
be valid to calculate RI. RI is updated
only once immediately following
update of Pplat (Insp Hold) or Pause.
RR spont
(b/min)
(Spontaneous
respiratory
rate)
GUI-Monitored
Data
Displayed range: 0 to 999 b/min
Accuracy: Larger of ± 3% or ± 2 b/min.
RR tot
(b/min)
(Total
respiratory
rate)
GUI-Monitored
Data
Displayed range: 0 to 999 b/min
Accuracy: ± 3% or ± 2 b/min.,
whichever is greater.
RSBI
(b/min/L)
(Rapid Shallow
Breathing
Index)
Displayed range: 0 to 9999 b/min/L
Accuracy: ± 1 b/min/L
GUI-Monitored
Data
Spontaneous respiratory rate/exhaled
tidal volume ratio. (RSBI =
RRspont2 / MVEspont). RR spont and
MVE (spont) must be valid to calculate
RSBI.
Screen Files
GUI-Technical
Contains list of the last 200 saved
screen images (.bmp files). Files are
assigned an 8-digit file name that
includes a letter for file type (W for
Wave, L for loop, etc), the OPR360U
last 4A0509
digits
of the serial number, and a 3 digit
sequential number.
Setting/Alarm
Limit out of
Range
Alarms- Non
Adjustable
Alarm or setting parameter out
of range for the selected patient
category.
5-1
OPR360US H0711
5-1
Item
8-13
8 Specifications
OPR360U A0509
Sigh
Slope/Rise
Suction
Disconnect
Sustained
High Baseline
Pressure
Location and/or
Function
GUI-Patient
Setup
Range: ON or OFF
In Volume Control A/CMV or SIMV
delivers 1 sigh breath every 100
breaths at tidal volume x 1.5.
During a sigh breath flow remains
at set value and inspiratory time is
lengthened.
GUI-Advanced
Data Set
Range: 1-19
Resolution: 1, where 1 is the slowest
pressurization and 19 is the fastest.
Slope/Rise sets the pressurization
gain for Pressure Control, Pressure
Support, Volume Targeted Pressure
Control, BPRV and Volume Targeted
Pressure Support breaths.
Alarm Feature
Holding down the Alarm Silence
button for one second or longer (until
the ventilator sounds a short beep)
enables the Suction Disconnect
Function.
Alarms- Non
Adjustable
Monitored circuit pressure Pbase has
been > 8 cmH2O/mbar above set
PEEP/CPAP for over 6 seconds for
Ped/Infant or 10 seconds for Adult
patients. Machine pressure is also > 8
cmH2O /mbar above set PEEP/CPAP.
Accuracy: ±1 cmH2O /mbar
WARNING! Ventilation and triggering
are suspended and the exhalation
valve and emergency intake valve
open to vent pressure.
Control Panel
t Insp
(inspiratory
time)
GUI Monitored
Data
5-1
Tidal Volume * Control Panel
8-14
Range and Resolution or
Description
5-1
Item
Range:
Ped/Infant: 0.10 to 3.00 seconds
(resolution 0.01 seconds)
Adult: 0.10 to 5.00 seconds (resolution
0.01 seconds)
Accuracy: ±0.05 seconds
Displayed range: 0 to 9.99 seconds
(resolution 0.01 seconds)
Accuracy: ±0.05 second
Updated following each spontaneous
OPR360U A0509
or mandatory breath.
Range:
Ped/Infant: 20 to 1000 mL (resolution
2 mL)
(cont. next page)
OPR360US H0711
8
Specifications
Location and/or
Function
OPR360U A0509
Tidal Volume *
Control Panel
(cont.)
Range and Resolution or
Description
Adult: 100 to 995 mL (resolution 5
mL), 1.00 to 3.00 L (resolution 0.01 L)
Accuracy: ±10% or ± 2 mL, whichever
is greater
5-1
Item
* Gas delivery is Body Temperature
Pressure Saturation compensated:
Body temperature 37 ºC, steam
saturated gas, and ambient pressure.
Time
Constant
GUI Monitored
Data
Displayed range: 0 to 9.99
Accuracy: +/- 0.01 s
Represents the exhalation Time
Constant: slope of flow-volume
loop during exhalation. Reliable
measurements require adequate time
for complete exhalation. Displayed as
time in seconds.
Trends
GUI-Main
Accuracy: Larger of the individual
parameter accuracy, or 2% of the
selected full scale.
P (pressure trigger sensitivity):
Range: 0.0 to -5.0 cmH2O/mbar
(resolution 0.1 cmH2O/mbar)
Accuracy: ±10%.
Trigger
[Press Trig
button above
the display to
select Flow or
P (pressure)]
Control Panel
Flow (trigger sensitivity)
Range:
Ped/Infant: 0.1 to 2.0 L/min (resolution
0.1 L/min)
Adult: 0.6 to 2.0 L/ min (resolution 0.1
L/min)
Accuracy: ±10% or ±0.1 L/min,
whichever is greater
NOTE: Automatically compensated
for bias flow/leak compensation.
Ventilation
Suspended
Informational
Message
Volume Target
GUI-Advanced
Data Set
5-1
OPR360US H0711
Displayed when the Suction
Disconnect feature has been activated
and the patient is disconnected
from the ventilator (See Suction
Disconnect).
OPR360U A0509
Range: ON or OFF
When enabled, turns on Volume
Target Pressure Control mandatory
(cont. next page)
8-15
8 Specifications
Location and/or
Function
Range and Resolution or
Description
breath type for all mandatory breaths
and Volume Target Pressure Support
for all spontaneous breaths.
OPR360U A0509
Volume Target GUI-Advanced
(cont.)
Data Set
5-1
Item
Minimum pressure control/support
is PEEP + 5 cmH2O/mbar, maximum
pressure control/support is Pressure
Limit setting.
When this feature is ON, Open Exh
(BPRV) is not active.
Volume Target Alarms-Non
Not Met
Adjustable
Volume Units
Range:
mL or mL/kg or mL/lb
VTE (mL)
GUI-Monitored
(expiratory tidal
Data
volume)
Displayed range: 0 to 3000 mL
(resolution 1 mL)
Accuracy: For set tidal volume
> 0.10 L , ±10% or ±0.02 L, whichever
is greater.
For set tidal volume < 0.10 L, ±20%
or +/- 0.002L, whichever is greater.
VTI (mL)
(Inspiratory
tidal volume)
GUI-Monitored
Data
Displayed range: 0 to 3000 mL
(resolution 1 mL)
Accuracy: For set tidal volume > 0.10
L , ±10% or ±0.02 L, whichever is
greater.
For set tidal volume < 0.10 L, ±20%
or +/- 0.002L, whichever is greater.
GUI-Monitored
Data
Displayed Range: 0 to 100%
(resolution: 1%)
Accuracy: +/- 10%
Percent difference between inspiratory
and expiratory tidal volumes.
Waveforms
GUI-Main
Waveform combinations:
Pressure / Time, Flow / Time, Volume
/ Time or combination of two can be
displayed on one screen
Weight Units
GUI-Patient
Setup And
Quick Setup
Range: lb or kg
WOBimp
(J/min)
GUI-Monitored
Data
Displayed range: 0 to 99.99 J/min
VTE % Var
5-1
GUI-Patient
Setup
In Volume Target Pressure Control
breath type the set tidal volume
cannot be delivered within the set
Pressure Limit/Inspiratory Time.
8-16
OPR360U A0509
OPR360US H0711
8
Specifications
Physical Specifications
Table 8-3
Description
5-1
OPR360U A0509
Power
Specifications
AC input range: 100 to 240 VAC, 250 VA maximum,
50/60 Hz (±10%), 2A for 125 VAC, 1A for 250 VAC
Internal battery: Fully charged battery can support
approximately one (1) hour of complete ventilator
function at the following standard settings: Adult, VC/
SIMV, VT 500, FiO2 .30, Insp Time 1.0 s, Resp Rate 15,
PS 0, PEEP +5,
Pause Off, Sigh Off, Square Wave.
The ventilator recharges the internal battery whenever AC
power is connected (whether the power switch is ON or
OFF).
Minimum recharge time:
From Low Battery Alarm to Full = 5 hours
From Empty to Full = 14 - 16 hours
Power Cord Requirements:
In the USA, power cord must comply with UL2601.
For 125 VAC, 15 A: 2-pole, 3-wire, 18 AWG, groundingtype, 5-15P hospital-grade plug cap, < 10 ft (3 m) long,
CSA and UL-approved or for 250 VAC, 15 A: 2-pole,
3-wire, 18 AWG, grounding-type, 6-15P, hospital-grade
plug cap, < 10 ft (3 m) long, CSA and UL-approved
5-1
Compliance
Complies with IEC 60601-1 with amendments 1 & 2,
C22.2 No 601.1-M90
and UL Std No 2601-1
Type B Applied Parts
Rated battery voltage: 12 VDC
Class I electrical-safety equipment
Mode of operation: continuous operation (as per Clause
5.6)
IPX0 rating (degree of protection against ingress of water)
Expiratory
Channel
Resistance
Pressure drop less than 1.7 cmH2O/mbar @ 50 L/min
Adult
less than 1.7 cmH2O/mbar @ 20 L/min Infant
NOTE: Testing was performed according to ASTM
F1100-90
Dimensions
Height: 14 in (35.56 cm)
Width: 12 in (30.48 cm)
Depth: 14 in (35.56 cm)
Weight: 40 lbs. (18.14 kg)
Display
6.4 in active matrix color LCD
Touch screen transparent plastic-covered glass.
Pressure-sensitive surface can electronically decode
touch position.
OPR360US H0711
OPR360U A0509
8-17
8 Specifications
Description
OPR360U A0509
Air and O2
supply
Inlet pressure: 30 to 90 psig, 50 psig nominal
Remote
Alarm/
Nurse Call
Range: Normally Open (refers to the electrical continuity
of the circuit)
For attachment to a nurse call or remote alarm system.
250 mA @ 100 VDC: Allowable current at maximum
voltage between the relay contact < .2 ohms: Maximum
initial contact resistance
NOTE: Always verify that the remote alarm function
is operational following initial connection to the nurse
call or remote alarm system and at regular intervals
thereafter.
NOTE: Always use shielded cables for connection
between the remote alarm and the nurse call or remote
alarm system.
RS232C
9-pin D-shell, 38.4k baud. For use with central
monitoring systems.
VGA
Output for external display monitor
USB
Output for connecting a data storage device
External
Alarm Silence
Input for optional Newport external alarm silence cable
External
Battery
3-pin DIN input for external power, 10 VDC to +14 VDC
Patient circuit
connections
Inspiratory and expiratory ports: 22-mm OD for
connection to a patient breathing circuit / filters.
5-1
8-18
5-1
Operating:
Temperature: 5 to 40 ºC
Relative humidity: 10 to 95% Rh non-condensing
Altitude: 0 to 13,124 feet (0 to 4000 meters)
Pressure: 21 to 31 in. Hg (700 to 1060 hPa)
Environmental Storage:
Requirements Ambient temperature: -20 to 60º C (–68 to 140 ºF)
Relative humidity: < 95% Rh non-condensing
Altitude: 0 to 18,000 feet (0 to 5500 meters)
Pressure: 15 to 31 in. Hg (500 to 1050 hPa)
NOTE: Gas temperatures of > 40 ºC may adversely
affect the performance of the e360.
OPR360U A0509
OPR360US H0711
Event History Screen
Event History
OPR360US H0711
Index
A/CMV- See Modes
AC Power Loss/Battery Backup
Alarm, 5-7
AC Power- See Power
Accept Button, 2-3, F-4 item 10
Adjustable Alarms, 5-3
Adjustment Knob, 2-3, F-4 item 10
Advanced Data Set, 4-10, F-4
Air Connection, 3-5
Air Supply Loss Alarm, 5-7
Alarms
& Message Display Bar, 5-1
Adjustable,5-3
Alarm History, Downloading,
4-17
Alarm History, Saving, 4-16
History, 5-3, 8-4
in Non-Invasive, 7-11
Indicators, Visual, 5-1
Lamp, 5-1
Loundness,8-1
Non-Adjustable, 5-6
Settings Screen, 5-3
Tones, 5-5, 8-1
Violation and Remedy Guide, 5-7
Alarm Reset, 5-6
Alarm Screen Button, F-4
Alarm Silence, 5-5, 8-1
Altitude, 4-7
Apnea Alarm, 5-7, 8-1
Assembly
Accessories, 3-1
Cart, 3-2
External Display Monitor, 3-3
Expiratory Filter Heater, 3-4
Automatic Leak Compensation- See
Leak Comp
Auto-Scale- See Waves and Loops
OPR360U A0509
B 5-1
Back Up Ventilation Alarm, 5-8, 8-1
Basic Data Set,4-15
Bias Flow, 7-9
Both Air/O2 Supply Loss Alarm,
5-8
BPRV-Biphasic Pressure Release
Ventilation
Description, 7-3
Setting, 4-10
OPR360US H0711
Open Exhalation Valve, 8-10
Breath Type
Description, 7-1, 7-4, 8-2
Display, 2-7
Selection, 2-3
Breathing Circuit, Installation, 3-6
C C Internal System Alarm, 5-9
Cautions, General, 1-8
Cdyn Effective- See Compliance
Check Flow Sensor Board Alarm, 5-8
Check Vent Fan Alarm, 5-9
Circuit Check, 4-2, F-5
Circuit Disconnect Alarm, 5-9
Circuit Type Selection, 4-6, 8-2
Cleaning, 6-9
Communication Protocol, 4-7, 8-3
Communications Failure Alarm, See No Communication Alarm
Compliance
Circuit Check, 7-11
Effective Dynamic-Cdyn, 8-2
Static-Cstat, 8-3
Compl Comp (Compliance
Compensation)
Description, 7-10
Setting, 4-6
Specification, 8-3
Contact Information, ii
Control µP Failed Alarm, 5-10
Control CPU Failed Alarm, 5-10
Control Panel Layout, 2-1, F-4, F-12
Control RAM Failed Alarm, 5-10
Control Task Failed Alarm, 5-10
Cstat (Static Compliance)- See
Compliance
D Data Read Failure Alarm, 5-10
Data Sets, 4-18
Date and Time
Display, 2-7
Setting, 4-7
Device Alert, 5-2, 5-11, 8-4
Device Description, 1-1OPR360U A0509
Dimensions, 8-18
Disassembly and Reassembly
Procedures, 6-2
Disconnect Threshold Alarm, 8-4
Display Brightness, 8-4, F-10
5-1
A I-1
Index
E
EEPROM Read Error Alarm, 5-11
Event History
Downloading, 4-17
Files, 4-7, 8-4
Saving, 4-17
Specifications, 8-4
Screen, 4-16, F-10
Exhalation Flow Sensor
Calibration,4-3
Cleaning, 6-11
Removal, 6-3
Exhalation Valve
Cleaning, 6-11
Removal, 6-5
Exp Flow (peak)- See Flow
Expiratory Hold Maneuver, 4-10, F-7
Expiratory Minute Volume- See MVE
Expiratory Resistance- See RE
Expiratory Tidal Volume- See VTE
Expiratory Threshold
Description,7-9
Setting, 4-10
Specifications, 8-5
Extended Functions Screen, 2-6, F-4
External Alarm Silence Cable Port, F-2, Item 3
External Battery
ConnectorF-2
Indicator2-7
F
Fan Filter
Cleaning, 6-11
Removal, 6-2
Filters
Use of, 6-1
Warnings, 1-6
FIO2
Setting, 2-4
Specifications, 8-5
FIO2 High Alarm, 5-11
FIO2 Low Alarm, 5-12
5-1FlexCycle - see Expiratory Threshold
Flow
Setting, 2-4
Specifications, 8-5
Flow Sensor - See Exhalation Flow
Sensor
OPR360U A0509
I-2
Flow Sensor Error Alarm, 5-13
Flow Trigger, See Trigger
Flow Waveform, 4-10, 8-5
Freeze- See Waves and Loops
Fuses, Removal, 6-8
G
Gas Supply Alarm, 8-6
Graphical User Interface (GUI), 2-1
GUI Navigation Map, 2-1, F-3
GUI Screens, 2-5
GUI Status Bar, 2-6
H
High Baseline Pressure Alarm, 5-13,
8-6
High MVE Alarm (Expiratory Minute
Volume), 5-13, 8-6
High Paw Alarm, 5-13, 8-6
High RR tot Alarm, 5-14, 8-6
Hour Meter, 2-7
I
I:E Ratio, 8-6
I:E Ratio Inverse Violation Message,
5-14
Ideal Body Weight, 4-5, 8-7
Imposed Work of Breathing - See
WOBimp
Inspiratory Flow (peak)- See Flow
Inspiratory Hold Maneuver, 4-10,
8-7, F-7
Inspiratory Manifold, Removal, 6-7
Inspiratory Pause- See Pause, 4-10,
8-5
Inspiratory Resistance- See RI
Inspiratory Time- See t insp
Inspiratory Time Too Long Alarm, 5-14
Inspiratory Time Too Short Alarm, 5-15
Intended Use Information, 1-2
Internal Battery
About, 2-7
Charge Level, 2-7
Charging, 2-7
Indicators, 2-7, 8-7
OPR360U A0509
5-1
Download, 4-21
Dual RAM Failed Alarm, 5-11
L
Leak Comp (Leak Compensation)
Description, 7-10
Non-Invasive, 7-11
Setting, 4-6
OPR360US H0711
Index
OPR360U A0509
N
5-1
Negative Inspiratory Force (NIF), 4-10
No Communication Alarm, 5-18
Non Adjustable Alarms, 5-6
Non Invasive
Description, 7-11
Setting, 2-3
Specifications, 8-9
Numeric Screen, 4-17, 8-9
O
OPR360US H0711
O2 (3min), 2-5, 8-9, F-4
O2 Sensor
Calibration, 4-4
Disable, 4-4
Removal, 6-8
Replacement, 6-13
Specification, 8-9
O2 Sensor Disconnect Alarm, 5-19
O2 Sensor Error Alarm, 5-19
O2 Supply Loss Alarm, 5-19
Open Exhalation Valve- See BPRV
Operating Temperature, 8-19
Out of Range Message, 5-19
Oxygen Connection, 3-5
P
P0.1 Measurement, 4-10
Patient Breathing Circuit, 3-5
Patient Category, 4-5, 8-10
Patient Selection- See Patient
Category
Patient Setup, 4-5
Patient Trigger, See Trigger
Patient Weight, See Ideal Weight
Pause (Inspiratory), 4-10, 8-10
Peak Expiratory Flow- See Flow
Peak Inspiratory Flow- See Flow
Peak Pressure (Ppeak)- See
Pressure
PEEP/CPAP
total PEEP, 8-10
Setting, 2-4
Specifications, 8-10
Physical Specifications, 8-18
Plateu Pressure, See Pressure
Pmean- See Pressure
Power
Connections, 3-5
Conditions, 4-1
Indicators, F-4
Shutdown Alarm, 5-20
Specifications, 8-18
Switch Location, F-2
Power Cord Requirements, 8-18
Power Failure Alarm, 5-19
Power Supply Warnings,
1-7A0509
OPR360U
Ppeak- See Pressure
Pplat- See Pressure
Preparing for Patient Ventilation, 4-1
5-1
Specifications, 8-7
Loops- See Waves and Loops
Low Baseline Pressure Alarm, 5-15,
8-8
Low Battery Alarm, 5-15, 8-8
Low MVE Alarm (Expiratory Minute
Volume), 5-16, 8-8
Low Paw Alarm, 5-16, 8-8
Low Paw Below PEEP Message,
5-17, 8-8
Lower Front Panel Layout, 2-1
M M Internal System Alarm, 5-17
Main Screen, 2-6, F-4
Mains, 8-8, F-4 item 13
Maintenance Frequency Summary,
6-12
Mandatory Breath Types, 7-1
Manual Inflation Button, 2-4, 8-8,
F-4 item 11
Mean Airway Pressure (Pmean)See Pressure
Mechanics Data Set, 4-15
Modes
and Breath Types Available, 2-3
Descriptions, 7-6
A/CMV, 7-7
Selecting, 2-3
SIMV, 7-7
SPONT, 7-8
Monitor µP Failed Alarm, 5-17
Monitor CPU Failure Alarm, 5-17
Monitor RAM Failed Alarm, 5-17
Monitor ROM Failed Alarm, 5-18
Monitor Task Failed Alarm, 5-18
MVE (Expiratory Minute Volume), 8-8
MVI (Inspiratory Minute Volume),
8-9
Pressure
I-3
Index
Alarms, 3-10
Minute Volume Alarm, 3-11
Setup and Inspection, 3-8
Shut Down Alarm, 3-12
Trigger / Pressure Support, 3-11
Volume/Flow/Rate Accuracy Test, 3-11
Safety Check Record, 3-13
Save Feature, 4-19
Scale- See Waves and Loops
Screen Files, 4-7, 8-13
Sensors- See Exhalation Flow or O2
Sensor
Setup and Calibration Menu, 2-6,
4-2, F-4
Shutdown Alarm, 5-20
Sigh, 4-5, 8-13
SIMV- See Modes
Slope/Rise
Description, 7-9
Setting, 4-10
Specifications, 8-14
SPONT- See Modes
Spontaneous Breath Management
7-4
Spontaneous Respiratory Rate- See
Respiratory Rate
Static Compliance (Cstat)- See
Compliance
Sterilizing, 6-9
Storage Temperature, 8-19
Storing the Ventilator, 6-14
Suction Disconnect Feature, 5-6
Support Arm Installation, 3-2
Sustained High Baseline Pressure
Alarm, 5-20
Symbols Control Panel, F-12
S t Insp (Inspiratory Time)
Monitoring, 4-13
Setting, 2-4
Specifications, 8-14
Technical Setup Screen, 4-7
Tidal Volume
Expiratory, 4-15, 8-16OPR360U A0509
Inspiratory, 4-15, 8-16
Setting, 2-4
Specifications, 8-14
Time Constant, 8-15
Trends Screen, 4-17
OPR360U A0509
Safety Check Procedure
AC Power Loss /Battery Back Up,3-10
Alarm Silence, 3-10
Apnea Alarm, 3-11
5-1 Back Up Ventilation Alarm, 3-11
Circuit Check, 3-9
Circuit Disconnect Alarm, 3-10
Emergency Intake Valve, 3-8
Gas Supply Alarms, 3-9
High/Low Airway Pressure I-4
5-1
Mean- Pmean, 8-11
Peak- Ppeak, 8-11
PEEP, 8-10
Plateu- Pplat, 8-11
Pressure Bar Graph, 8-11, F-4 item 7
Pressure Control Breath Type, 7-3
Pressure Limit
In VTPC, 7-4
In VTPS, 7-5
Setting, 2-4
Specifications, 8-11
Pressure Limit Below PEEP
Message, 5-20, 8-11
Pressure Support
Description, 7-4
Specifications, 8-12
Pressure Support + PEEP > 60
Message, 5-20, 8-12
Pressure Trigger- See Trigger
R
Rapid Shallow Breathing Index
(RSBI), 8-13
RE- Expiratory Resistance, 8-12
Rear Panel Layout, 2-2, F-14
Reassembly Procedures, 6-2
Regional Settings, 4-7, 8-12
Remote Alarm, F-2, 8-19
Repackaging the Ventilator, 6-14
Reset Button, Alarm, 5-6
Respiratory Rate- Resp Rate
Monitoring, 4-15
RR spont, 4-17, 8-13
RR tot, 4-15, 8-13
Specifications, 8-12
Responsibility for Patient Safety,
1-10
RI- Inspiratory Resistance, 8-13
T
OPR360US H0711
Index
5-1
Trigger
and Leaks, 7-8
and Non-Invasive, 7-11
Indicator, 2-7
Selecting Flow or Pressure, 2-4
Specifications, 8-15
V
Ventilation Controls, 2-4
Ventilation Controls Guide, 4-8
Ventilation Standby Condition, 4-1
Ventilation Suspended Message, 5-21, 8-15
Volume Control Breath Type, 7-2
Volume Target, 8-15
Volume Target Not Met Alarm, 5-21
Volume Target Pressure Control
(VTPC)
Description,7-4
Settings, 4-10
Volume Target Pressure Support
(VTPS)
Description, 7-5
Settings, 4-12
Volume Units, 4-5
VTE (Expiratory Tidal Volume), 8-16
VTE % Variance, 4-14, 8-17
VTI , 8-16
W
Warranty, 1-9
Warnings
General, 1-5
Filter, 1-6
Power Supply, 1-7
Gas, 1-8
Auxilliary Equipment, 1-8
Waves and Loops
Descriptions, 4-14
Adjusting Scales, 4-14
Auto Scale, 4-14
Cursors, 4-14
Freeze, 4-14, 8-6
Saving, 4-15
Downloading, 4-17
Weaning Data Set, 4-15, A-6
Weight Units, 4-5, 8-17
WOBimp, 8-17
OPR360U A0509
5-1
OPR360US H0711
OPR360U A0509
I-5
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