HT70 Operators Manual Rev C

© 2014-2018 Covidien. All rights reserved. COVIDIEN, COVIDIEN with logo, and Covidien logo are U.S. and international trademarks of Covidien AG. ™* Third party brands are trademarks of their respective owners. All other brands are trademarks of a Covidien company. The information in this manual is the sole property of Covidien and may not be duplicated without permission.

Table of Contents 1

Introduction

1.1 1.2 1.2.1 1.2.2 1.2.3 1.3 1.4 1.5 1.5.1 1.5.2 1.5.3 1.6 1.7 1.8 2

Overview... 1-1 Brief Device Description... 1-1 Sophisticated Clinical Capabilities... 1-2 Exceptional Mobility... 1-2 Travel Certified... 1-3 Intended Use... 1-3 Ventilator Configurations... 1-4 Warnings, Cautions, and Notes... 1-4 General Warnings... 1-4 General Cautions... 1-8 General Notes... 1-8 Revision History... 1-9 Warranty Information... 1-9 Contact Information... 1-9 Overview of Controls, Screens, and Connectors

2.1 2.2 2.3 2.4 2.5 2.6 2.7

Front Panel Overview... 2-1 Touch Screen Overview (Hospital Domain)... 2-1 Internal Dual Battery System Overview... 2-1 Rear Panel Overview... 2-3 Right Side Overview... 2-4 Left Side Overview... 2-5 Bottom Panel Label... 2-6

3

Setup and Pre-Use Preparations

3.1 3.2 3.3 3.4 3.4.1 3.4.2 3.5 3.6 3.6.1 3.6.2 3.6.3 3.7 3.7.1 3.7.2

Operator’s Manual

Unpacking the Ventilator... 3-1 Assembling the Ventilator... 3-2 Connecting to AC Power... 3-2 Using the Power Switch... 3-4 Turning on the Power... 3-4 Turning Off the Power... 3-5 Making Parameter Changes... 3-5 Attaching a Patient Circuit... 3-6 With a Third-Party Humidifier... 3-6 With an HME (Artificial Nose)...3-11 Using the On-Airway Flow Sensor...3-13 Connecting Optional Accessories... 3-14 Air/Oxygen Entrainment Mixer...3-14 Low Flow Oxygen Reservoir...3-15

iii

3.7.3 3.7.4 4

Navigating the Screens

4.1 4.1.1 4.2 4.3 4.4 4.4.1 4.4.2 4.4.3 4.5 4.5.1 4.5.2 4.5.3 4.6 4.7 4.8 4.8.1 4.8.2 4.8.3 4.8.4 4.8.5 4.9 4.10 4.10.1 4.10.2 4.11 4.11.1 4.11.2 4.11.3 5

5.1.1 5.1.2 5.1.3 5.1.4 5.1.5

iv

Touch Screen (Graphical User Interface) Layout... 4-1 Primary Screen Navigation... 4-1 Primary Screen Buttons and Displays... 4-2 Ventilator Settings Adjustment... 4-3 Startup Screen Navigation (Standby Condition Only)... 4-4 Circuit Check Button... 4-5 Activate Preset Button... 4-6 Start Ventilation Button... 4-8 Alarms Screen Navigation... 4-8 Settable Alarms... 4-9 Alarm Loudness Level... 4-9 Alarm Quickset...4-10 Main Screen Navigation... 4-10 More Screen Navigation... 4-12 More Screen Details... 4-13 Events Screen...4-13 Trends Screen Navigation...4-14 Waves Screen...4-15 Oxygen Cylinder Data Screen...4-16 Calibrate O2 Mon Screen...4-17 Utility Screen... 4-17 Utility Screen Details... 4-19 Time/Altitude Screen...4-19 Custom Settings Screen...4-20 Domain Navigation... 4-22 Hospital Domain...4-23 Transport Domain...4-23 Basic Domain...4-24 Operating the Ventilator

5.1

5.2 5.3

DC Auto Lighter Power Adapter...3-18 Aequitron Remote Alarm Cable...3-18

Quick Check Procedure... 5-1 Equipment Needed... 5-1 Pre-Test Inspection... 5-1 Setup... 5-2 Standard Test Settings... 5-2 Quick Check Procedure... 5-2 Patient Set-Up Procedure... 5-5 Troubleshooting Guide... 5-7

Operator’s Manual

6

Ventilator Alarms

6.1 6.1.1 6.2 6.2.1 6.2.2 6.3 6.3.1 6.3.2 6.3.3 6.3.4 6.3.5 6.3.6 6.3.7 6.3.8 6.3.9 6.3.10 6.3.11 6.4 6.5 6.5.1 6.5.2 6.5.3 6.5.4 6.5.5 6.5.6 6.5.7 6.5.8 6.5.9 6.5.10 6.5.11 6.5.12 6.5.13 6.6 6.6.1 6.6.2 6.6.3 6.6.4 6.6.5 6.6.6 6.6.7 6.6.8 6.6.9 6.6.10

Operator’s Manual

Setting Alarms... 6-1 Alarm Quickset... 6-2 Alarm Indicators... 6-2 Audio Paused/Reset Button... 6-3 Audio Paused LED... 6-3 User-Adjustable Alarms... 6-3 Low Pressure Alarm... 6-4 High Pressure Alarm... 6-4 Low Inspiratory Minute Volume Alarm... 6-4 Low Expiratory Minute Volume Alarm... 6-4 High Inspiratory Minute Volume Alarm... 6-5 High Expiratory Minute Volume Alarm... 6-5 High Respiratory Rate Alarm... 6-5 High O2 Alarm... 6-5 Low O2 Alarm... 6-5 High Tidal Volume Alarm... 6-5 Apnea Alarm... 6-6 Backup Ventilation... 6-6 Automatic Alarms... 6-7 High Baseline Pressure Alarm... 6-7 Low Baseline Pressure Alarm... 6-7 Occlusion Alarm... 6-8 Sustained Occlusion Alarm... 6-8 Check Circuit or Prox Line Alarm... 6-8 Flow Sensor Disconnect/Failure Alarms... 6-8 Pressure Control Setting Not Reached Alarm... 6-8 No External Power Alarm... 6-8 Device Alert Alarm-System Error... 6-9 Motor Fault Alarm... 6-9 Shut Down Alert Alarm... 6-9 Internal Temperature Alarm... 6-9 O2 Cylinder Low/Empty Alarms... 6-9 Battery Alarms... 6-10 Power Pac Battery Pack Low Alarm...6-10 Integrated Power Pac Failure Alarm...6-10 Switching to Backup Battery Alarm...6-10 Running on Backup Battery Alarm...6-10 Backup Battery Low Alarm...6-10 Backup Battery Shutdown Imminent Alarm...6-10 Backup Battery Failure Alarm...6-11 Backup Battery Low Charge Alarm...6-11 Power Pac Battery Pack Temperature Alarm...6-11 Backup Battery Temperature Alarm...6-11

v

7

Battery Operation

7.1 7.1.1 7.1.2 7.2 7.3 7.4 7.5 7.6 7.7 7.8 7.8.1 7.8.2 7.8.3 7.8.4 7.8.5 8

Cleaning and Maintenance

8.1 8.1.1 8.2 8.3 8.3.1 8.3.2 8.4 8.5 8.6 8.7 8.7.1 8.7.2 8.7.3 8.7.4 8.7.5 8.8 8.9 8.10 9 9.1 9.2 9.3 9.4

vi

Internal Dual Battery System... 7-1 Power Pac Battery Pack... 7-1 Backup Battery... 7-2 Conditions that Affect Battery Use Time... 7-3 Check Battery Charge Level/Battery Time Estimator... 7-3 Best Use Tips... 7-4 Battery System Maintenance... 7-4 Power Pac Battery Pack Removal... 7-5 Battery Alarms Overview... 7-5 Power Accessories... 7-6 Power Pac Battery Pack (BAT3271A)... 7-6 AC Power Supply (SP-PWR3204P)... 7-6 Country-Specific Power Cord... 7-7 External Battery System (BAT3300A)... 7-7 DC Auto Lighter Power Adapter (SP-ADP3203P)... 7-7

Cleaning and Disinfecting... 8-1 Definitions... 8-1 Ventilator... 8-2 Accessories... 8-2 Low Flow Oxygen Reservoir... 8-2 Air/Oxygen Entrainment Mixer... 8-2 Reusable Breathing Circuits and Exhalation Valves... 8-3 Air Intake Filter... 8-4 Proximal Inline Filter... 8-4 Maintenance Guidelines... 8-5 Routine Maintenance... 8-5 6-Month Maintenance... 8-6 12-Month Maintenance... 8-6 24-Month Maintenance... 8-6 15 000-Hour Maintenance (or Every 4 Years)... 8-6 General Warnings... 8-7 Factory Maintenance or Repair... 8-7 Repacking/Return Information... 8-8 Specifications Front Panel Buttons-Symbols Version... 9-1 Miscellaneous Reference Symbols... 9-2 Control Data Selections... 9-3 Monitor Data Selections... 9-4

Operator’s Manual

9.5 9.6 9.7 9.8 9.9 9.10 9.11 9.11.1 9.11.2 9.11.3 9.11.4 9.11.5 10

Front Panel Membrane Buttons and Indicators... 9-5 Alarms... 9-5 Hardware Requirements... 9-7 Environment... 9-8 Size and Weight... 9-9 Factory Default Parameters... 9-9 Miscellaneous Specifications... 9-11 Patient Circuit...9-11 Ventilator Breathing System (VBS) Resistances...9-11 Pneumatic Requirements (Optional Equipment)...9-11 Manufacturer’s Declaration...9-12 Performance...9-16 Explanation of Modes and Controls

10.1 10.2 10.3 10.4 10.5 10.6 10.7 10.8 10.8.1 10.8.2 10.8.3

Assist/Control Mandatory Ventilation (A/CMV) Mode... 10-1 Synchronized Intermittent Mandatory Ventilation (SIMV) Mode... 10-1 Spontaneous Ventilation (SPONT) Mode... 10-2 Noninvasive Ventilation (NIV)... 10-2 Pressure Support (PS)... 10-2 Pressure Control (PC)... 10-3 Volume Control (VC)... 10-3 Backup Ventilation... 10-3 Backup Ventilation in A/CMV and SIMV Modes...10-4 Backup Ventilation in Spont Mode...10-4 Cancellation of Backup Ventilation...10-4

A

Quick Check Procedure Check-Off

B

Foldout Drawings

Operator’s Manual

vii

Page Left Intentionally Blank

viii

Operator’s Manual

List of Figures Figure 2-1. Figure 2-2. Figure 2-3. Figure 2-4. Figure 2-5. 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 3-10. Figure 3-11. Figure 3-12. Figure 3-13. Figure 3-14. Figure 3-15. Figure 3-16. 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 4-12. Figure 4-13. Figure 4-14. Figure 4-15. Figure 4-16. Figure 4-17. Figure 4-18. Figure 4-19. Figure 4-20. Figure 4-21. Figure 6-1.

Operator’s Manual

Internal Dual Battery System... 2-2 Newport™ HT70 Ventilator Rear Panel... 2-3 Newport™ HT70 Ventilator (Right Side)... 2-4 Newport™ HT70 Ventilator (Left Side)... 2-5 Newport™ HT70 Ventilator Bottom Panel Labeling... 2-6 Newport™ HT70 Ventilator and Power Supply... 3-3 Pinch-Release Power Plug... 3-3 Power Switch... 3-4 Startup Screen... 3-4 Shutdown Screen... 3-5 Patient Circuit Components (Third-Party Humidifier)... 3-7 Patient Circuit Connection to Humidifier... 3-8 Patient Circuit Connection to Patient Wye (Setup with Humidifier)... 3-9 Patient Circuit with Humidifier (Completed Setup)... 3-10 Patient Circuit Components (HME)... 3-11 Patient Circuit Connection to Exhalation Valve (Setup with HME)... 3-12 Patient Circuit with HME (Completed Setup)... 3-13 Air/Oxygen Entrainment Mixer... 3-14 Low Flow Oxygen Reservoir... 3-15 Oxygen Supply Flow Versus Desired Percent of Oxygen (For Use With PEEP)... 3-16 Oxygen Supply Flow Versus Desired Percent of Oxygen (For Use Without PEEP)... 3-17 Primary Screen Buttons and Displays... 4-2 Startup Screen (Standby condition)... 4-5 Circuit Check Screens... 4-5 Activate Presets... 4-7 Alarms Screen... 4-9 Main Screen... 4-10 More Screen Buttons... 4-12 Events Screen... 4-13 Trends Screen... 4-14 Waves Screen... 4-15 Oxygen Cylinder Data Screen... 4-16 Calibrate O2 Mon Screen... 4-17 Utility Screen... 4-18 Time/Altitude Screen... 4-19 Custom Settings Screen... 4-20 Custom Presets... 4-21 BUV Settings Screen... 4-22 Hospital Domain Screen... 4-23 Transport Domain Screen... 4-24 Basic Domain Screen (Time Display)... 4-24 Basic Domain Screen (Settings Display)... 4-25 Alarm Quickset... 6-2

ix

Figure 6-2. Figure 7-1. Figure 7-2. Figure 8-1. Figure B-1. Figure B-2. Figure B-3.

x

Backup Ventilation... 6-6 Power Pac... 7-2 Power Pac Battery Pack Removal... 7-5 Air/Oxygen Entrainment Mixer... 8-3 English Version-Front Panel Overview... B-1 Symbol Version-Front Panel Overview... B-3 HT70PM Model Touch Screen (Hospital Domain)... B-5

Operator’s Manual

List of Tables Table 1-1. Table 3-1. Table 3-2. Table 3-3. Table 3-4. Table 5-1. Table 5-2. Table 6-1. Table 6-2. Table 9-1. Table 9-2. Table 9-3. Table 9-4. Table 9-5. Table 9-6. Table 9-7. Table 9-8. Table 9-9. Table 9-10. Table 9-11. Table 9-12. Table 9-13. Table 9-14. Table 9-15. Table 9-16. Table 9-17. Table 9-18. Table 9-19. Table 9-20. Table 9-21.

Operator’s Manual

HT70 Ventilator Configurations... 1-4 Newport™ HT70PM Ventilator Parts... 3-1 Optional Accessories... 3-1 Pneumatic Requirements... 3-15 Pneumatic Requirements... 3-17 Standard Test Settings... 5-2 Troubleshooting... 5-7 User-Adjustable Alarms... 6-3 Automatic Alarms... 6-7 Front Panel Buttons-Symbols Version... 9-1 Miscellaneous Reference Symbols... 9-2 Control Data Selections... 9-3 Monitor Data Selections... 9-4 Front Panel Membrane Buttons and Indicators... 9-5 Alarms... 9-5 User-Adjustable Alarms... 9-6 Automatic Alarms... 9-6 Hardware Requirements... 9-7 Environment... 9-8 Size and Weight... 9-9 Factory Default Parameters (Patient Settings)... 9-9 Default Presets (Control Settings)... 9-9 Default Presets (Alarm Settings)... 9-10 VBS Resistances... 9-11 Pneumatic Requirements... 9-11 Electromagnetic Emissions... 9-12 Electromagnetic Immunity... 9-13 Electromagnetic Immunity-Conducted and Radiated RF... 9-14 Recommended Separation Distances... 9-15 Performance Parameter Specifications and Tolerances... 9-16

xi

Page Left Intentionally Blank

xii

Operator’s Manual

1 Introduction

1.1

Overview Thank you for using the Newport™ HT70 family of ventilators. With the Newport™ HT70 ventilator, you not only get a great ventilator, you get the support of Covidien. We have dedicated our efforts to providing ventilators that are easy to use, clinically versatile, and costeffective. We know that ventilatory support is critical in emergency situations. But for many of our customers, it is also a part of their daily lifestyle. The Newport™ HT70 ventilators offer home care users the expanded mobility that allows them to experience more freedom in their lives than many have known before. This manual was designed to be comprehensive and still very user-friendly. For the best performance from the ventilator, please take the time to review this manual completely.

1.2

Brief Device Description The Newport™ HT70 family of ventilators are state-of-the-art ventilators that combine ruggedness, ease of use, and clinical proficiency with exceptional mobility to provide ventilatory support for infant, pediatric, and adult patients in emergency care, transport, subacute care, and home care applications. They are also ideal for emergency preparedness applications. The compact, lightweight ventilator is built for hard work with a durable polymer exterior and robust overall design that stands up to harsh environments. This ventilator defines ease of use with all essential controls at your fingertips using a simple membrane button and touch screen combination. There are no complicated menus or difficult sequences to follow to make necessary adjustments for common operations. A three-tiered management domain system makes it very easy for caregivers to manage all controls while providing quick access to the more essential elements in transport situations and significantly enhanced safety and simplicity in the homecare environment.

1-1

Introduction

1.2.1 Sophisticated Clinical Capabilities

In addition to its durability and ease of use, the Newport™ HT70 ventilator offers the complete array of clinical capabilities needed for managing patients. The twin micro-piston pump’s ability to deliver a variable flow enables the ventilator to provide a full range of operating modes and breath types with servo-controlled, leak-compensated PEEP. Leak compensation helps to improve triggering and avoid auto-triggering when a leak is present. The ventilator may be used with an endotracheal tube, tracheal tube, face mask, nasal mask or prongs, or mouthpiece. There are two models for the HT70 series of ventilators: •

HT70M: HT70, with oxygen sensor; includes built-in oxygen monitor with alarms

•

HT70PM: HT70 Plus, adds on-airway flow sensor option with graphics, flow trigger, and exhaled volumes

The HT70M model provides monitoring of inspiratory tidal volume (every breath), inspiratory minute volume, total respiratory rate, peak pressure, mean pressure, and baseline (PEEP) pressure. Real-time patient circuit pressure is shown at all times on the airway pressure gauge on the face panel. A comprehensive alarm system is built-in to alert the user to violations of user-set or ventilator safety limits. A built-in oxygen sensor allows monitoring of O2 with high and low O2 alarms. The HT70PM model adds an on-airway flow sensor with on-screen graphics, exhaled tidal and minute volume monitoring/alarms, and flow trigger. (This manual describes the HT70PM model.) Gas delivery to the patient may be enriched with oxygen (21%–100%) using either the optional air oxygen entrainment (50 psi) mixer or optional low flow oxygen reservoir. 1.2.2 Exceptional Mobility

The ventilator’s unique design provides maximum mobility and safety for short- or long-distance transport of critically ill patients and also for patients who are going about their normal activities of daily life. This exceptional mobility is derived from two sources: patented, power-conserving dualmicro-piston technology that eliminates the need for an external compressed gas source, and the internal dual battery system, which allows virtually continuous use from battery power through hotswappable technology. The ventilator’s micro-pistons use a fraction of the power that is consumed by turbines and blowers. This enables longer battery use time. Our patented system also uses considerably less supplemental oxygen than turbine or blower systems, again improving mobility for transport or homecare use. The superior technology of our micro-piston system over the turbine and blower systems allow the ventilator to ventilate safely over a wide range of environmental conditions and altitudes. The ventilator’s twin micro-piston internal pump is made of mechanically moving components. As with any other gas delivery system made of moving components, it may emit a minor level of

1-2

Operator's Manual

Intended Use

noise during operation. This is not a malfunction and does not affect the performance of the ventilator. The internal dual battery system consists of two independent but coordinated lithium ion batteries: the Power Pac battery, located on the back of the ventilator and the backup battery inside the ventilator. The internal dual battery system can provide up to 10 hours of operation at standard settings when new and fully charged. This system assures continued support during transport, daily activities or power outages. The detachable Power Pac is “hot-swappable.” That is, if more battery time is needed, a depleted Power Pac can easily be removed from the back of the ventilator and replaced with a recharged Power Pac without interrupting ventilation. No tools are needed. The secondary backup battery maintains operation without interruption when the Power Pac is swapped out and also provides a minimum of 30 minutes of full operation when all other power sources are depleted. The Power Pac weighs 2 pounds and is charged anytime the ventilator is connected to an external power source (AC or DC). It can also be charged separately. The ventilator may be operated from a variety of AC (100–240 V AC @ 50/60 Hz) or DC (11-16 V DC) external power sources or from the internal dual battery system. The optional DC auto lighter power adapter accessory enables connection to an automobile-type DC outlet. Any time the ventilator is connected to external power, both batteries in the internal dual battery system are charging, whether or not the ventilator is in use. 1.2.3 Travel Certified

The Newport™ HT70 ventilator has been tested for and meets requirements for use in helicopter and fixed wing transport and for use on commercial airlines. Before traveling, be sure to speak with your airline representative about their particular concerns and clear all of your equipment with them well before your departure. The labeling that the FAA requires is located on the bottom of the ventilator. 1.3

Intended Use Newport™ HT70 family of ventilators is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or noninvasive interfaces. Specifically, the Newport™ HT70 family of ventilators is applicable for infant, pediatric, and adult patients greater than or equal to 5 kg (11 lbs) in hospital, sub-acute, emergency department, and home care environments as well as for transport and emergency response applications.



Note: Federal law (U.S.) restricts sale by or on the order of a physician.

Operator's Manual

1-3

Introduction

1.4

Ventilator Configurations Covidien offers two configurations for the HT70 family of ventilators (see Table 1-1. ). In addition, the front control panel labeling is available in various languages and regional power cords (for example, North American, European, etc.) can be specified. See your Covidien representative for details. Table 1-1. HT70 Ventilator Configurations Part number

1.5

Description

Distinguishing features

HT70PM

HT70 Plus

Full featured with flow sensor, graphics, and built-in oxygen monitor with alarms

HT70M

HT70, with oxygen sensor

Includes built-in oxygen monitor with alarms

Warnings, Cautions, and Notes Please review all warnings and cautions outlined in this manual before operating the ventilator. Use of the product requires full understanding and strict observation of all chapters of these instructions. The equipment is only to be used for the purposes specified under Intended Use and in conjunction with appropriate patient observation and monitoring. Observe all warnings and cautions that appear in this manual and on equipment labels.

  

WARNING: A warning describes a condition that can cause injury. Caution: A caution describes a condition that can cause damage to equipment. Note: A note emphasizes information that is important or convenient.

1.5.1 General Warnings



1-4

WARNING: The design of the Newport™ HT70 ventilator, the operating and service manuals, and the labeling on the ventilator take into consideration that the purchase and use of the equipment is restricted to trained professionals, and that certain inherent characteristics of the ventilator are known to the operator. Instructions, warnings, and caution statements are therefore limited to the specifics of the Newport™ HT70 ventilator.

Operator's Manual

Warnings, Cautions, and Notes

        

WARNING: This manual excludes references to various hazards that are obvious to medical professionals and operators of this equipment, including consequences of product misuse and potential adverse effects in patients with abnormal conditions. WARNING: Transport of patients with the Newport™ HT70 ventilator requires that medical staff have a good working knowledge of the ventilator and methods for problem resolution. Proper emergency backup equipment must be immediately available during transport. WARNING: Product modification or misuse can be dangerous. 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 this ventilator with other products, whether supplied by Covidien or by other manufacturers, unless such a combination has been specifically endorsed by Covidien. WARNING: There is a risk of explosion if used in the presence of flammable anesthetics. WARNING: A patient connected to a ventilator requires the constant attention of trained caregivers to the patient’s condition. WARNING: The ventilator offers a variety of breath delivery options. Throughout the patient's treatment, the clinician should carefully select the ventilation mode and settings to use for that patient, based on clinical judgment, the condition and needs of the patient, and the benefits. As the patient's condition changes over time, periodically assess the chosen modes and settings to determine whether or not those are best for the patient's current needs. WARNING: Ventilator alarms are a critical element in the safety net of patient care. It is extremely important for patient safety that caregivers immediately identify and correct alarm violations. WARNING: Do not pause, disable, or decrease the volume of the ventilator’s audible alarm if patient safety could be compromised. WARNING: Always have an alternate power source and means of ventilation available when the ventilator is in use in case of a mechanical or system problem.

Operator's Manual

1-5

Introduction

         1-6

WARNING: If a fault is detected in the ventilator and its life support functions are in doubt, immediately discontinue use; use an alternative method of ventilation until the fault has been corrected. Contact your service provider immediately. WARNING: Do not block the emergency gas intake (on the bottom panel) or the fresh gas intake port (on the right side panel). WARNING: Always use appropriate monitors to ensure sufficient oxygenation and ventilation (such as a pulse oximeter and/or a capnograph) when the Newport™ HT70 ventilator is in use on a patient. WARNING: The optional air/oxygen entrainment mixer and low flow oxygen reservoir are designed to operate with medical-grade oxygen. WARNING: Ensure that the oxygen source is not empty before and during the use of the optional air/oxygen entrainment mixer or low flow oxygen reservoir. WARNING: To avoid putting stress on the internal pump and compromising gas delivery to the patient, ensure that the air/oxygen entrainment mixer is not connected to the gas intake port on the ventilator when performing a circuit check. Ensure that the oxygen supply is enabled any time the optional air/oxygen entrainment mixer is secured in place while ventilating. WARNING: Calibrated oxygen monitoring at clinically appropriate levels is required for patient safety when supplemental oxygen is in use. WARNING: Always plug the Newport™ HT70 ventilator into an external power supply source whenever it is available, even when the ventilator is not in use, to keep the internal dual battery system fully charged and to ensure best battery performance. Check battery capacity on the front panel before detaching from external power. WARNING: When installing a replacement Power Pac during battery operation, always ensure that the charge level LED on the replacement pack is green, indicating 90% or higher charge level.

Operator's Manual

Warnings, Cautions, and Notes

         

WARNING: Always ensure that the green external power LED lights when the ventilator is connected to an external AC or DC power source. WARNING: To maintain grounding integrity when using AC power, only connect to properly grounded receptacles. WARNING: Use only the Covidien-supplied AC power supply (p/n SP-PWR3204P) with the Newport™ HT70 ventilator and Power Pac (p/n BAT3271A). WARNING: Always disconnect the external power supply prior to servicing. WARNING: After servicing the Newport™ HT70 ventilator, it must pass the operational verification procedure (OVP) before it is returned to patient use. See the service manual. WARNING: Do not use electrically conductive breathing circuits. Always use clean and dry breathing circuits. WARNING: Always use a clean, dry filter in the following locations: a standard bacteria filter on the gas output, a prox line (bacteria) filter on the proximal pressure tubing port, and an intake (bacteria) filter behind the filter cover. WARNING: Adding attachments or other components or sub-assemblies to the ventilator breathing circuit system can increase the patient’s work of breathing and/or add resistance to patient exhalation. WARNING: Always ensure that the audible alarm loudness level is set at a volume that can be heard by the caregiver. Do not use the ventilator in an environment where audible alarms cannot be heard by the caregivers. WARNING: The functioning of this machine may be adversely affected by the operation of other medical equipment (such as high frequency surgical (diathermy) equipment, defibrillators, or short-wave therapy equipment in the vicinity.

Operator's Manual

1-7

Introduction

 

WARNING: To avoid the risk of ventilator malfunction, operate the ventilator in an environment that meets specifications. Reference Environment on page 9-8. WARNING: This device has undergone EMC testing and found to be in conformance with EN 60601-1-2. These requirements are designed to provide reasonable protection against harmful interference in a typical medical installation, as well as in homecare environments. The equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with these instructions, may cause 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 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: • Reorient or relocate the receiving device. •

Increase the separation between the equipment.

•

Connect the equipment to an outlet on a circuit different from that to which the device(s) is (are) connected.

•

Consult the manufacturer or Covidien-trained service personnel for help.

1.5.2 General Cautions

  

Caution: Do not place liquids on or near the ventilator. Caution: Damage can occur if the Newport™ HT70 ventilator is exposed to extreme temperatures. Do not store the ventilator in areas where it may be exposed to temperatures below -40°C (-40°F) or above 65°C (149°F). Caution: To avoid the risk of electric shock, the ventilator should not be opened by anyone other than an approved service provider.

1.5.3 General Notes

 1-8

Note: The Newport™ HT70 ventilator has been designed to accommodate connectivity with nurse call/monitoring systems. Because it is not possible to anticipate every configuration of hardware and software associated with

Operator's Manual