Newport e360 Ventilator with Accessories Operators Manual Rev B Jan 2019

This document contains proprietary information that is protected by copyright. All Rights Reserved. Reproduction, adaptation, or translation without prior written permission is prohibited, except as allowed under the copyright laws. The information contained in this manual is the sole property of Covidien and may not be duplicated without permission. This manual may be revised or replaced by Covidien at any time and without notice. While the information set forth herein is believed to be accurate, it is not a substitute for the exercise of professional judgment. The ventilator should be operated and serviced only by trained professionals. Covidien’s sole responsibility with respect to the ventilator and software, and its use, is as stated in the limited warranty provided. Nothing in this document shall limit or restrict in any way Covidien’s right to revise or otherwise change or modify the equipment (including its software) described herein, without notice. In the absence of an express, written agreement to the contrary, Covidien has no obligation to furnish any such revisions, changes, or modifications to the owner or user of the equipment (including its software) described herein. COVIDIEN, COVIDIEN with logo, and Covidien logo and Positive Results for Life are U.S. and internationally registered trademarks of Covidien AG. ™* brands are trademarks of their respective owners. Other brands are trademarks of a Covidien company. This manual © 2014, 2015, 2018 Covidien.

Table of Contents 1

Introduction

1.1 1.2 1.3 1.4 1.4.1 1.4.2 1.4.3 1.4.4 1.5 1.6 1.6.1 1.6.2 1.7 1.8 1.8.1 1.8.2 1.9 1.9.1 1.9.2 1.9.3 1.9.4 1.9.5 1.9.6 1.9.7 1.9.8 1.9.9 1.9.10 1.9.11 1.9.12 1.10 1.11 1.12 1.13 1.14 1.15 1.16 1.17 2 2.1

Device Description... 1-1 Models... 1-2 Intended Use Information... 1-3 About This Manual... 1-3 Chapter Summary... 1-3 Foldout Drawings... 1-4 Glossary... 1-4 Typing Conventions... 1-5 Versions and Configurations... 1-5 Service Guidelines... 1-6 Regular Service... 1-6 Complete Service Records... 1-6 Disclaimers... 1-6 Symbols and Descriptions... 1-7 Symbols on Equipment... 1-7 Symbols on Packaging and Labeling... 1-8 Warnings... 1-9 General Warnings...1-10 Warnings Regarding Fire Hazards...1-12 Warnings Regarding Environment of Use...1-13 Warnings Before Using Equipment...1-14 Warnings Regarding Electrical Power...1-15 Warnings Regarding Ventilator Settings...1-16 Warnings Regarding Hoses, Tubing, and Accessories...1-17 Warnings Regarding Gas Sources...1-18 Warnings Regarding Infection Control...1-18 Warnings Regarding Ventilator Maintenance...1-19 Filter Warnings...1-19 Auxiliary Equipment Warning...1-21 Cautions... 1-21 Notes... 1-22 Responsibility for Patient Safety... 1-22 Limitation of Liability... 1-23 Electromagnetic Compatibility... 1-23 Revision History... 1-23 Warranty Information... 1-24 Contact Information... 1-24 Ventilator Overview Ventilator System Overview

... 2-1

i

2.2 2.3 2.3.1 2.4 2.5 2.6 2.6.1 2.6.2 2.7 2.8 2.9 2.10 2.11 2.12 2.13 2.14 2.15 2.16 2.16.1 2.16.2 2.16.3 2.16.4 2.17 2.17.1 2.17.2 2.17.3 2.17.4 2.17.5 2.17.6 2.18 2.19 2.20 3

Unpacking, Assembly, and Safety Check

3.1 3.1.1 3.2 3.2.1 3.2.2 3.2.3 3.3 3.3.1 3.3.2 3.3.3

ii

Control Panel Layout and Labeling... 2-1 Graphical User Interface (GUI) and Controls... 2-1 Navigation Map for GUI Menus... 2-2 Lower Front Panel Layout... 2-2 Rear Panel Layout... 2-2 Navigating the Control Panel... 2-3 Using Touch - Turn - Accept... 2-3 Selecting Mandatory Breath Type and Mode... 2-3 Non-invasive Ventilation (NIV) Function... 2-4 Patient Triggering Methods... 2-4 Basic Ventilation Controls... 2-4 Flow or Inspiratory Time in Volume Control... 2-5 Manual Inflation Button... 2-5 O2 (3 min) Button... 2-5 Audio Paused Button... 2-5 Suction Disconnect Function... 2-5 Alarm Reset... 2-5 Graphical User Interface (GUI) Screens... 2-6 Alarms Screen... 2-6 Main Screen... 2-6 Extended Functions Screen... 2-6 Setup & Calibration Screen... 2-6 Graphical User Interface (GUI) Miscellaneous Indicators... 2-7 Patient and Breath Type/Mode Selection... 2-7 Patient Trigger Indicator... 2-7 Int. Battery Charge Level... 2-7 Ext. Battery Indicator... 2-7 Date/Time... 2-8 Hour Meter... 2-8 Internal Battery... 2-8 External Battery... 2-9 Battery Disposal... 2-9

Unpack the Ventilator and Accessories... 3-1 List of Package Contents... 3-1 Assembly... 3-2 Exhalation Valve Compartment... 3-5 Connect Air, Oxygen and AC Power... 3-6 Install the Breathing Circuit System... 3-7 Safety Check Procedure... 3-9 Setup and Inspection... 3-9 Emergency Intake Valve... 3-9 Circuit Check...3-10

3.3.4 3.3.5 3.3.6 3.3.7 3.3.8 3.3.9 3.3.10 4

Setting Up for Patient Use

4.1 4.1.1 4.2 4.3 4.3.1 4.3.2 4.3.3 4.3.4 4.3.5 4.4 4.5 4.6 4.7 4.7.1 4.7.2 4.8 4.8.1 4.8.2 4.9 4.9.1 4.9.2 4.9.3 4.9.4 4.10 4.11 4.12 4.13 4.14 4.14.1 4.14.2 4.14.3 4.14.4 4.14.5 4.14.6 4.15

Gas Supply Alarms...3-10 AC Power Loss/Battery Backup Alarm...3-11 High/Low Airway Pressure Alarms / Circuit Disconnect Alarm/ Audio Paused...3-11 Minute Volume / Back Up Ventilation / Apnea Alarms...3-12 Trigger/Pressure Support...3-13 Volume/Flow/Rate Accuracy Test...3-13 Shut Down Alarm...3-13

Power Conditions... 4-1 Shut Down Alarm... 4-1 Overview: Preparing For Patient Ventilation... 4-1 Setup & Calibration Menu... 4-3 Circuit Check... 4-3 Oxygen and Flow Sensors... 4-4 Patient Setup... 4-6 Quick Setup... 4-8 Technical...4-10 Ventilation Controls Guide... 4-11 Ventilation Settings in Advanced Data Set... 4-13 Inspiratory and Expiratory Hold Maneuvers... 4-14 P0.1 Measurement... 4-14 To Perform a P0.1 Measurement...4-15 Explanation of P0.1 Measurement Function Conditions...4-16 Negative Inspiratory Force (NIF) Maneuver... 4-16 To Perform a NIF Maneuver...4-17 Explanation of NIF Maneuver Function Conditions...4-18 Waves and Loops Displays... 4-18 Adjusting Scale...4-19 Auto-scale...4-19 Using the Freeze Function...4-19 Using the Cursor in Freeze...4-20 Event History Screen... 4-20 Numeric Screen... 4-20 Trends Screen... 4-21 Data Sets... 4-22 Save Feature... 4-23 Waves, Loops, Trends, Numeric and Extended Functions Screens...4-24 Alarm Setting Screen...4-24 Alarm History Screen...4-24 Event History Screen...4-24 P0.1 Screen...4-24 NIF Screen...4-25 Download Feature... 4-25

iii

4.16

Communication Ports

5

Alarms

5.1 5.2 5.2.1 5.2.2 5.2.3 5.3 5.3.1 5.3.2 5.3.3 5.3.4 5.4 5.4.1 5.4.2 5.4.3 5.4.4 5.5 6

6.2.1 6.2.2 6.3 6.3.1 6.3.2 6.3.3 6.3.4 6.3.5 6.4 6.5 6.5.1 6.5.2

7 7.1

iv

Introduction... 5-1 Visual Alarm Displays... 5-2 The 360˚ Alarm Lamp... 5-2 Alarm and Message Display... 5-2 Device Alert LED... 5-3 GUI Alarms Screen Environment... 5-3 Alarm Settings Screen... 5-3 Alarm History... 5-5 Alarm Loudness... 5-6 Exiting Alarm Screens... 5-6 Front Panel Alarm Interface Environment... 5-7 Audio Paused Button... 5-7 Suction Disconnect Feature... 5-7 Alarm Reset Button... 5-7 Non-Adjustable Alarms... 5-8 Alarm Violation and Remedy Guide... 5-9 Cleaning and Maintenance

6.1 6.2

6.6 6.7 6.8 6.9

... 4-27

Introduction... 6-1 Use of Filters... 6-1 Inspiratory (To Patient) Port... 6-1 Expiratory (From Patient) Port... 6-2 Disassembly and Reassembly Procedures... 6-3 Rear Panel Fan Filter... 6-3 Exhalation Manifold... 6-3 Inspiratory Manifold... 6-9 Fuses...6-10 O2 (Oxygen) Sensor...6-11 Cleaning... 6-12 Sterilizing... 6-12 Autoclave Sterilization...6-13 EtO (Ethylene Oxide) Sterilization...6-13 Guide to Cleaning and Sterilizing... 6-14 Guide to Preventive Maintenance... 6-15 Storing the Ventilator... 6-17 Repackaging the Ventilator... 6-17 Explanation of Modes, Breath Types and Special Functions Introduction

... 7-1

7.2 7.2.1 7.2.2 7.2.3 7.3 7.3.1 7.3.2 7.3.3 7.3.4 7.4 7.4.1 7.4.2 7.5 7.5.1 7.5.2 7.5.3 7.6 7.6.1 7.6.2 7.6.3 7.6.4 7.6.5 7.7 7.7.1 7.7.2 8

Specifications

8.1 8.2 8.3 8.4

Alarms, Controls, Monitored Data, Setup and Calibration... 8-1 Quick Setup Table... 8-15 Physical Specifications... 8-17 Manufacturer’s Declaration... 8-19

A

T Model / T+ Model Features

A.1 A.2 A.3 A.3.1 A.3.2 A.4 A.5 A.6 A.7

Settings Functions... 7-1 Timing Limitations to Ventilation Controls... 7-1 Control Retention... 7-1 Control Range... 7-2 Mandatory Breath Types... 7-2 Volume Control... 7-2 Pressure Control... 7-3 Biphasic Pressure Release Ventilation (Open Exhalation Valve)... 7-4 Volume Target (Volume Target Pressure Control - VTPC)... 7-4 Spontaneous Breath Management in SIMV and SPONT Modes... 7-4 Pressure Support... 7-5 Volume Target Pressure Support (VTPS)... 7-7 Ventilation Modes... 7-8 A/CMV... 7-8 SIMV... 7-9 SPONT (Spontaneous)... 7-9 Advanced Features & Special Functions... 7-10 Bias Flow...7-10 Slope/Rise...7-10 Expiratory Threshold and FlexCycle (Automatic Expiratory Threshold Management) . .7-11 Leak Compensation (Leak Comp)...7-11 Compliance Compensation (Compl Comp)...7-11 Non-invasive Ventilation (NIV)... 7-13 Leak Compensation in NIV...7-13 Alarm Settings in NIV...7-13

Introduction... A-1 External Touch Screen Capability... A-1 PV Maneuver Function... A-2 How To Perform a PV Maneuver...A-2 Explanation of PV Maneuver...A-3 Three Waveforms Displayed on One Screen... A-4 Real-Time I:E Ratio Pop-up Window... A-5 Expanded Pressure Trigger Range... A-5 Connecting the External Touch Screen Monitor... A-6

v

B

Safety Check Record Form

C

Foldout Drawings Glossary Index

vi

List of Figures Figure 1-1. Figure 2-1. Figure 2-2. Figure 3-1. Figure 3-2. Figure 3-3. Figure 3-4. Figure 3-5. Figure 3-6. Figure 3-7. Figure 3-8. Figure 3-9. Figure 4-1. Figure 4-2. Figure 4-3. Figure 4-4. Figure 4-5. Figure 4-6. Figure 4-7. Figure 4-8. Figure 4-9. Figure 4-10. Figure 4-11. Figure 5-1. Figure 5-2. Figure 5-3. Figure 6-1. Figure 6-2. Figure 6-3. Figure 6-4. Figure 6-5. Figure 6-6. Figure 6-7. Figure 6-8. Figure 6-9. Figure 6-10. Figure 6-11. Figure 7-1. Figure 7-2. Figure 7-3. Figure 7-4. Figure 7-5. Figure A-1.

Newport e360 Ventilator...1-2 Lower Front Panel Layout...2-2 GUI Status Bar...2-7 Mounting Accessories to Cart...3-2 External Monitor...3-3 Mounting Expiratory Filter Heater...3-4 Exhalation Valve Compartment...3-5 Fitting Flow Sensor Cable...3-5 Air, O2 and AC Power Connections...3-6 Heated Wire Breathing Circuit with Humidifier...3-7 Non-Heated Breathing Circuit with Humidifier...3-8 Non-Heated Breathing Circuit with HME...3-8 Sensors Screen...4-4 Basic Data Set Bar (indicating O2 sensor & FiO2 alarms disabled)...4-6 Advanced Data Set Options... 4-13 Main Screen (location of P.01 button shown)... 4-16 Main Screen (location of NIF button shown)... 4-17 Numeric Screen... 4-20 Data Sets... 4-22 Waveform Save and Start Buttons... 4-24 Screen and Event History Files List Screens (for download)... 4-25 Port Locations (e360S, e360P, e360E)... 4-27 Port Locations (e360T, e360T+)... 4-28 Alarms Screen Environment...5-2 Alarm History Log...5-5 Alarm Loudness...5-6 Fan Filter...6-3 Exhalation Valve and Flow Sensor...6-4 Remove Flow Sensor...6-5 Connect Cable to Sensor...6-6 Remove Exhalation Valve...6-7 Exhalation Valve Assembly...6-8 Align Exhalation Valve Cap and Body During Reassembly...6-9 Remove Panel Section...6-9 Inspiratory Manifold Block... 6-10 Remove Fuses... 6-11 Remove Panel Section... 6-11 Square Waveform in VCV...7-3 Descending Ramp Flow Waveform in VCV...7-3 Pressure Overshoot...7-6 A/CMV...7-8 SIMV...7-9 Technical Screen (showing location of PV Maneuver button)... A-2

vii

Figure A-2. Figure A-3. Figure A-4. Figure A-5. Figure C-1. Figure C-2. Figure C-3. Figure C-4. Figure C-5. Figure C-6. Figure C-7. Figure C-8. Figure C-9. Figure C-10. Figure C-11. Figure C-12.

viii

Loops Screen (showing graphical results of PV Maneuver)... A-3 Waves Screen (displaying Pressure, Volume and Flow waveforms)... A-4 I:E Ratio Pop-up Window... A-5 Newport e360 Ventilator Rear Panel (external touch screen cables attached)... A-6 Newport e360 Ventilator with Accessories... C-1 Newport e360 Ventilator Rear Panel... C-1 GUI Navigation Map... C-1 Control Panel - English Version... C-2 Circuit Check Screen... C-2 Main Screen... C-3 Extended Functions Screen... C-3 Alarms Screen... C-3 Quick Setup Screen (not available on S model)... C-3 Technical Screen... C-3 Patient Setup Screen... C-3 Control Panel - Symbols Version... C-4

List of Tables Table 1-1. Newport e360 Ventilator Model Configurations...1-5 Table 1-2. Newport e360 Ventilator Control Panel Labeling Configurations...1-6 Table 1-3. Symbols on Ventilator...1-7 Table 1-4. Symbols on Batteries...1-8 Table 1-5. Symbols on Shipping Carton / Labeling...1-8 Table 4-1. Ventilation Controls Guide... 4-11 Table 4-2. Ventilation Controls Guide (additional controls)... 4-12 Table 4-3. Trends Screens... 4-21 Table 4-4. Data Set Screen Contents... 4-22 Table 5-1. Alarm Violation and Remedy Guide...5-9 Table 5-2. Low Baseline Pressure Alarm Thresholds... 5-18 Table 6-1. Cleaning and Sterilizing... 6-14 Table 6-2. Preventive Maintenance... 6-15 Table 7-1. Control Selections for Mandatory Breaths...7-2 Table 8-1. Alarms, Controls, Monitored Data, Setup & Calibration...8-1 Table 8-2. Quick Setup... 8-15 Table 8-3. Physical Specifications... 8-17 Table 8-4. Electromagnetic Emissions... 8-20 Table 8-5. Electromagnetic Immunity... 8-20 Table 8-6. List of Compliant Cables... 8-22 Table C-1. Newport e360 Ventilator Optional Accessories... C-4 Table Glossary-1. Glossary of Ventilation Terms... Glossary-1 Table Glossary-2. Units of Measure... Glossary-4 Table Glossary-3. Technical Abbreviations... Glossary-4

ix

Page Left Intentionally Blank

x

1 Introduction

1.1

Device Description The Newport™ e360 Ventilator is a high-performance, microprocessor-controlled ventilator that is easy to use and maintain. It 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 Newport e360 ventilator has remote alarm (nurse call) and external audio pause cable connections, an RS232 interface to connect to central monitoring systems, a VGA port to connect to an external monitor, and a USB port for uploading software and downloading saved files. When the ventilator 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 tests for 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 Newport e360 ventilator 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. 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, baseline) and pulmonary mechanics. During exhalation, the ventilator 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.

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. Figure 1-1. Newport e360 Ventilator

1.2

Models This manual describes features and operation of the following Newport e360 ventilator models: e360S, e360P, e360E, e360T, and e360T+.



1-2

Note: Not all models are available in all areas. Consult with Covidien or with your local representative for details on availability of Newport e360 Ventilator models.

Operator's Manual

Intended Use Information

1.3

Intended Use Information The Newport e360 Ventilator System is intended to provide invasive or non-invasive ventilatory support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency. The Newport 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 Newport e360 Ventilator System is for use in hospitals, healthcare facilities, or during intra-hospital transport. For specific details about the intended use environment, reference Physical Specifications, page 8-17.*

1.4

About This Manual

1.4.1 Chapter Summary

Introduction This chapter contains information about the safe use of the Newport e360 Ventilator System, information about this manual, general warnings and cautions. Ventilator Overview This is the road map and directions for getting where you need to go. This chapter summarizes elements of the ventilator system, controls, and functions. Unpacking, Assembly and Safety Check This is the “putting it together/setting it up” chapter. 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 near the end of this manual for documenting the results of the safety check.

*.

Operator's Manual

A critical care ventilator intended for use in transport within a professional health care facility is not considered an emergency and transport ventilator.

1-3

Introduction

Setting Up for Patient Use This is the “how to use” chapter. It will guide you through setting up the ventilator for patient use and managing commonly used features during ventilation. Alarms This contains information related to the alarm systems and alarm troubleshooting. Cleaning and Maintenance Make sure to follow the guidelines in this chapter for cleaning, reprocessing, keeping the ventilator system in working order, storing, and packaging for shipment. Explanation of Modes, Breath Types and Special Functions This is the “how does it work” chapter of the manual, to give you a general description of available breath types, modes and special functions. Specifications This chapter is where you will find ranges, physical dimensions, and information about settings, controls, alarms, and displays. T Model / T+ Model Features This appendix contains information on additional functions available on the Newport e360T and e360T+ models. Safety Check Record Form Make copies of this form and use it to record results of periodic safety checks of the ventilator system. 1.4.2 Foldout Drawings

Foldout pages containing frequently referenced diagrams are placed in Appendix C of this manual. These foldouts are designed for easy reference while reading the manual. 1.4.3 Glossary

The glossary defines key terms found throughout the manual.

1-4

Operator's Manual

Versions and Configurations

1.4.4 Typing Conventions

Controls, buttons, and alarms are shown in this manual as italicized text, written as they appear on the ventilator (for example, MODE for ventilation mode). Glossary terms are denoted (on their first use in the text) in bold and italic (for example, FiO2).

   1.5

WARNING: A Warning describes a condition that can cause personal injury. Caution: A Caution describes a condition that can cause damage to equipment. Note: A Note emphasizes information that is important or adds convenience.

Versions and Configurations This manual applies primarily to three configurations of the Newport e360 Ventilator System: e360S, e360P and e360E. Table 1-1. provides details about each configuration. Table 1-1. Newport e360 Ventilator Model Configurations Distinguishing feature

e360S

e360P

e360E

Automatic Slope Rise

not available

Yes

Yes

Flex Cycle (Automatic Expiratory Threshold)

not available

Yes

Yes

Volume Target Pressure Control

not available

Yes

Yes

Open Exhalation Valve (for Biphasic Pressure Release Ventilation)

not available

Yes

Yes

Yes

not available

Yes

Expanded Tidal Volume and Resp. Rate Ranges

(For information about the e360T and e360T+ models, reference Appendix A.)

Operator's Manual

1-5

Introduction

Table 1-2. Newport e360 Ventilator Control Panel Labeling Configurations

1.6

Abbreviation

Labeling on control panel

WW

English

ES

Spanish

PT

Portuguese

JP

Japanese

CN

Chinese

SY

Symbols

RU

Russian

Service Guidelines

1.6.1 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. 1.6.2 Complete Service Records

All service performed on the Newport e360 Ventilator System must be recorded in a service log in accordance with hospital procedures and local and national regulations. 1.7

Disclaimers Covidien has no responsibility for the safe operation of the Newport e360 Ventilator System if the intended use, intended user, and intended use environment requirements specified in this document are not followed. Covidien has no responsibility for the safe operation of the Newport 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. Covidien disclaims all liability for the consequences of product alterations or modifications, as well as for the consequences that might result from the combination of

1-6

Operator's Manual

Symbols and Descriptions

this ventilator with other products, whether supplied by Covidien or by other manufacturers, if such a combination is not endorsed by Covidien. 1.8

Symbols and Descriptions

1.8.1 Symbols on Equipment

The following tables define symbols shown on the rear of the ventilator and on the ventilator’s internal and external batteries, respectively. Table 1-3. Symbols on Ventilator Symbol

Description Manufacturer.

Authorized representative in the European Community.

US federal law restricts this device to sale by or on the order of a physician.

The ventilator contains components manufactured with phthalates.

Follow instructions for use (symbol appears in blue on ventilator).

Not safe in any magnetic resonance (MR) environment.

Canadian and U.S. certification mark.

CE mark with TUV Notified Body Number.

Equipotentiality.

Alternating current. Fuse. Type B applied part.

Operator's Manual

1-7

Introduction

Table 1-3. Symbols on Ventilator (Continued) Symbol

Description Protection against fluid ingress: Drip-proof.

Table 1-4. Symbols on Batteries Symbol

Description WEEE (Waste from Electronical and Electronic Equipment) classification.

1.8.2 Symbols on Packaging and Labeling

The following table defines symbols shown on the ventilator shipping cartons and labeling. Table 1-5. Symbols on Shipping Carton / Labeling Symbol

Description US federal law restricts this device to sale by or on the order of a physician.

The ventilator contains components manufactured with phthalates.

Follow instructions for use (symbol appears in blue on ventilator).

Not safe in any magnetic resonance (MR) environment.

Atmospheric pressure limitation. For upper and lower limits, reference Physical Specifications, page 8-17. Humidity limitation. For upper and lower limits, reference Physical Specifications, page 8-17. Temperature limit. For upper and lower limits, reference Physical Specifications, p. 8-17.

1-8

Operator's Manual