HT70 Plus Model Service Manual SERHT70-2 Rev A Sept 2012

Manual Revision History HT70 Plus Service Manual SERHT70-2 Description

Rev A September 2012

New release, for software P05.12 and above

OPR360U A0509

5-1

SERHT70-2 A0912

OPR360U A0509

5-1

Revisions Date

Contact Information Contact Information Telephone: +1.714.427.5811 1.800.451.3111 (US only)

5-1

OPR360U A0509

Fax: +1.714.427.0489 Departments: Customer Service (Ext. 282) Technical Services (Ext. 500) available 24/7 Clinical Support (Ext. 123) available 24/7 Operational Hours: Days: Monday through Friday Hours: 8:00 am to 5:00 pm (PST) Emergency After-hours: 24-Hour Clinical and Technical Support Email: Customer Service: [email protected] Clinical Education and Support: [email protected] Technical Education and Support: [email protected] Internet: www.ventilators.com Shipping Address: Newport Medical Instruments Attn: Receiving Department 1620 Sunflower Avenue Costa Mesa, CA 92626, USA EC REP Authorized European Representative Emergo Europe Molenstraat 15 2513 BH, The Hague The Netherlands

5-1

SERHT70-2 A0912

OPR360U A0509

Table of Contents 1 Introduction

OPR360U A0509

2 Specifications Front Panel Buttons - Symbols Version... 2-1 Miscellaneous Reference Symbols... 2-2 Controls / Monitors... 2-2 Monitor Data Selections... 2-3 Front Panel Membrane Buttons and Indicators... 2-4 Alarms ... 2-4 User Adjustable... 2-5 Automatic... 2-5 Hardware Requirements... 2-7 Environment... 2-8 Size and Weight... 2-8 Factory Default Parameters... 2-9 Miscellaneous ... 2-9 (optional) Air / Oxygen Entrainment Mixer... 2-9 (optional) Low Flow Oxygen Reservoir... 2-9 Regulatory and Agency Standards...2-10

3 Theory of Operation Device Description... 3-1 Functional Subsystems Overview... 3-2 Pneumatics System... 3-2 Electronics System... 3-3 Ventilation Functions Overview... 3-7 Modes of Ventilation... 3-7 Breath Types... 3-10

4 Cleaning and Maintenance 5-1

Cleaning and Disinfecting... 4-1 Ventilator ... 4-1 OPR360U A0509 Accessories... 4-2 Low Flow Oxygen Reservoir... 4-2 Air/Oxygen Entrainment Mixer... 4-2 Reusable Breathing Circuits... 4-3

SERHT70-2 A0912

5-1

Brief Device Description... 1-1 Intended Use... 1-3 Ventilator Configurations... 1-4 Warnings, Cautions, Notes... 1-4

Table of Contents 5-1

Air Intake Filter... 4-3 Proximal Inline Filter... 4-4 Maintenance Guidelines... 4-4 Routine Maintenance... 4-4 6 Month Maintenance... 4-5 12 Month Maintenance... 4-5 24 Month Maintenance... 4-5 15,000 Hour Maintenance... 4-6 General Warnings... 4-6 Warranty ... 4-7 Factory Maintenance or Repair... 4-8 Repacking/Return Information... 4-8 OPR360U A0509

5 Service and Repair General Information... 5-1 Tools Required... 5-1 Removal and Replacement of the Rear Panel Assembly... 5-2 Rear Panel Assembly... 5-2 Single Board Computer (SBC) Assembly... 5-4 Main Control Board (MCB) Assembly... 5-5 Power Switch Assembly...5-6 Removal and Replacement of Top Case Assembly... 5-7 Inlet Air Filter... 5-7 Fan Filter and Guard... 5-8 Top Case Assembly... 5-9 Fan Assembly...5-11 Backup Battery...5-11 Display Board... 5-12 Chassis Assembly... 5-13 Buzzer Assembly...5-14 LCD/Touch Screen Display Assembly...5-14 Handle Assembly... 5-15 Membrane Switch Assemblies... 5-16 Removal and Replacement of the Base Assembly...5-17 Speaker Assembly...5-17 Solenoid Valve Group Assembly... 5-18 On/Off Valve... 5-20 Safety Valve... 5-20 Pump Assembly... 5-20 Manifold Assembly... 5-22

5-1

OPR360U A0509

SERHT70-2 A0912

Table of Contents 6 Performance Verification

OPR360U A0509

5-1

7 Troubleshooting

OPR360U A0509

Table 7.1 Troubleshooting Guide...7-1

SERHT70-2 A0912

5-1

General Information... 6-1 Test Equipment... 6-1 Quick Check... 6-1 Introduction... 6-1 Pre-test Inspection... 6-2 Setup and Circuit Check... 6-2 Standard Test Settings...6-4 Quick Check Procedure...6-5 Calibration Procedures... 6-8 Introduction... 6-8 Equipment Setup... 6-8 Pressure Transducer Calibration...6-8 Motor Speed Calibration...6-11 Pump Leak Calibration...6-11 FiO2 Sensor Calibration... 6-12 LCD Calibration... 6-13 Flow Sensor Board PCB3212A Calibration... 6-13 Operational Verification Procedure (OVP)... 6-13 Electrical Safety Test (EST)... 6-13 Equipment Setup... 6-13 Front Panel Test... 6-14 AC Power Loss and Shutdown Buzzer Alarm Test... 6-14 Circuit Check... 6-14 LED/Solenoid Check... 6-15 Pressure Relief Valve Test... 6-16 Pressure Verification Test... 6-16 System Leak Test...6-17 Flow Measurement...6-17 Emergency Intake Valve Test... 6-18 Patient Effort Indicator Test... 6-18 Pressure Control and PEEP Test... 6-19 FiO2 Verification Test... 6-19 Volume Control Test... 6-20 Manual Inflation Test... 6-21 Pressure Alarm Test... 6-21 Integrated Battery System Check... 6-22 OVP Test Record... 6-24

Table of Contents 8 Diagrams and Assembly Part Lists

OPR360U A0509

5-1

5-1

Diagram 8.1 - Pneumatics System... 8-1 Diagram 8.2 - Electronics System... 8-2 Diagram 8.3 - HT70 Plus Exploded View... 8-3 Diagram 8.4 - Base Assembly... 8-4 Diagram 8.5 - Case Assembly (1 of 7)... 8-5 Diagram 8.5 - Case Assembly (2 of 7)...8-6 Diagram 8.5 - Case Assembly (3 of 7)... 8-7 Diagram 8.5 - Case Assembly (4 of 7)... 8-8 Diagram 8.5 - Case Assembly (5 of 7)... 8-9 Diagram 8.5 - Case Assembly (6 of 7)... 8-10 Diagram 8.5 - Case Assembly (7 of 7) ...8-11

OPR360U A0509

SERHT70-2 A0912

Introduction

Introduction Section 1:

OPR360U A0509

Brief Device Description... 1-1 Intended Use... 1-3 Ventilator Configurations...1-4 Warnings, Cautions, Notes...1-4

5-1

OPR360U A0509

5-1

Introduction Section 1:

1

Introduction Brief Device Description

5-1

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, critical care, subacute care and home care applications. It is also ideal for emergency preparedness applications. OPR360U A0509

The compact, lightweight HT70 ventilator is built for hard work with a durable polymer exterior and robust overall design that stands up to harsh environments. The HT70 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 in order to make necessary adjustments for common operations. A three-tiered management domain system makes it very easy for critical 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. Sophisticated Clinical Capabilities In addition to its durability and ease of use, the HT70 ventilator offers the complete array of clinical capabilities needed for managing critical patients. The twin micro-piston pump’s ability to deliver a variable flow enables the HT70 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 HT70 may be used with an endotracheal tube, tracheal tube, face mask, nasal mask or prongs, or mouthpiece. There are 3 models for the HT70 series of ventilators:

5-1

HT70S HT70 HT70PM

HT70 Basic for use when Pressure Support is not needed. HT70 Classic, adds Pressure Support and related parameters and Trends screen HT70 Plus, adds on-airway flow sensor option with graphics, flow trigger and exhaled volumes OPR360U A0509

The HT70 Basic and Classic models provide 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 displayed at all times SERHT70-2 A0912

1-1

1 Introduction 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. An optional built-in oxygen sensor allows monitoring of O2 with high and low O2 alarms.

5-1

OPR360U A0509

The HT70 Plus model adds an on-airway flow sensor with onscreen graphics, exhaled tidal and minute volume monitoring/alarms, and flow trigger. This manual describes the HT70 Plus model and will denote features that are not available on the HT70 and HT70S models. Gas delivery to the patient may be enriched with oxygen (0.21-1.00) using either the optional Air Oxygen Entrainment (50 psi) Mixer or optional Low Flow Oxygen Reservoir. 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: Newport’s patented, power conserving dual-micro-piston technology which eliminates the need for an external compressed gas source, and the Internal Dual Battery System which allows virtually continuous use from battery power through hot-swappable technology. The HT70’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 HT70 to ventilate safely over a wide range of environmental conditions and altitudes. The HT70’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 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. of A0509 5-1The Internal Dual Battery System can provide up to 10 hoursOPR360U operation at standard settings when new and fully charged. This system assures continued support during transport, daily activities or power outages.

1-2

SERHT70-2 A0912

1

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 HT70 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 two pounds and is charged anytime the ventilator is connected to an external power source (AC or DC). It can also be charged separately.

5-1

Introduction OPR360U A0509

The HT70 may be operated from a variety of AC (100-240 VAC @ 50 / 60 Hz) or DC (12-24 VDC) 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. Travel Certified The HT70 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 to be on the ventilator is located on the bottom of the HT70.

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.

5-1

NOTE: Federal law (US) restricts sale by or on the order of a physician.

SERHT70-2 A0912

OPR360U A0509

1-3

1 Introduction Ventilator Configurations

5-1

Newport Medical offers five configurations for the 3 models in the HT70 family of ventilators. See Table 1. In addition, the front control panel labeling is available in various languages and regional power cords, i.e. North American, European, etc., can be specified. See your Newport Medical Representative for details. OPR360U A0509

Table 1 Part Number

Description

Distinguishing Features

HT70 Plus

Full featured with Flow sensor, graphics and built-in oxygen monitor with alarms. Compatible with optional plug and play pulse oximeter

HT70

HT70, w/o Oxygen Sensor

Classic features No built-in oxygen monitor

HT70M

HT70, with Oxygen Sensor

Classic features Includes built-in oxygen monitor with alarms

HT70S

HT70, Basic w/o Oxygen Sensor

Classic features except: • No Pressure Support or Pressure Support parameters • No Trends • No built-in oxygen monitor

HT70SM

Classic features except: • No Pressure Support or Pressure HT70, Basic with Support parameters Oxygen Sensor • No Trends Includes built-in oxygen monitor with alarms

HT70PM

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 sections of these instructions. The equipment is only to be used for the purposes specified under Intended Use and in conjunction OPR360U A0509 5-1with 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.

1-4

SERHT70-2 A0912

1

Introduction Caution: A caution describes a condition that can cause damage to equipment. NOTE: A note emphasizes information that is important or convenient.

5-1

OPR360U A0509

General Notes The Newport HT70 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 nurse call/monitoring system, it is the user’s responsibility to confirm proper functionality of the system when used in conjunction with the HT70. Verification of alarms, alerts and patient data transmissions is required. If the system performance is not as expected, contact Newport Medical Technical Support for assistance troubleshooting the set-up. Do not use the HT70 ventilator with a nurse call/monitoring system until the functionality of the ventilator/ system combination has been confirmed. General Cautions Do not place liquids on or near the ventilator. Damage can occur if the HT70 is exposed to extreme temperatures. Do not store the HT70 in areas where it may be exposed to temperatures below -40° C (-40° F) or above 65° C (149° F). To avoid the risk of electric shock, the ventilator should not be opened by anyone other than an approved service provider. General Warnings The design of the 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 HT70.

5-1

This manual excludes references to various hazards which are obvious to medical professionals and operators of this equipment including consequences of product misuse, and potentialOPR360U adverse A0509 effects in patients with abnormal conditions. Transport of patients with the HT70 requires that medical staff have a good working knowledge of the ventilator’s use and

SERHT70-2 A0912

1-5

1 Introduction problem resolution. Proper emergency backup equipment must be immediately available during transport.

5-1

Product modification or misuse can be dangerous. Newport Medical Instruments, Inc. disclaims all liability for the consequences of product alterations or modifications, as well as for the consequences which might result from the combination of this ventilator with other products, whether supplied by Newport or by other manufacturers, unless such a combination has been specifically endorsed by Newport Medical. There is a risk of explosion if used in the presence of flammable anesthetics. OPR360U A0509

A patient connected to a ventilator requires the constant attention of trained caregivers to the patient’s condition. 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. Always have an alternate power source and means of ventilation available when the ventilator is in use so that they are easy to access in case of a mechanical or system problem. 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. Do not block the Emergency Gas Intake (on the bottom panel) or the Fresh Gas Intake Port (on the right side panel). Always use appropriate monitors to ensure sufficient oxygenation and ventilation (such as a pulse oximeter and/or a capnograph) when the HT70 Ventilator is in use on a patient. The optional Air/Oxygen Entrainment Mixer and Low Flow Oxygen Reservoir are designed to operate with medical grade oxygen. 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.

5-1

OPR360U A0509

When the optional Air/Oxygen Entrainment Mixer is secured in place, ensure that the oxygen supply is enabled prior to powering the HT70 on to avoid putting stress on the internal pump and compromising gas delivery to the patient.

1-6

SERHT70-2 A0912

1

Introduction

5-1

Calibrated oxygen monitoring at clinically appropriate levels is required for patient safety when supplemental oxygen is in use. The optional built-in oxygen sensor on the HT70 allows High and Low O2 alarms to be enabled which can be used to assure proper oxygen delivery. OPR360U A0509

Always plug the HT70 into an external power supply source whenever it is available, even when HT70 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. 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. Always ensure that the green External Power LED lights after connecting the ventilator to an external AC or DC power source. To maintain grounding integrity when using AC power, only connect to properly grounded receptacles. Use only the Newport supplied AC Power Supply (p/n PWR3204P) with the HT70 ventilator and HT70 Power Pac (p/n BAT3271A). Always disconnect the external power supply prior to servicing. After servicing the HT70, it must pass the Operational Verification Procedure (OVP) before it is returned to patient use. See section 6 of the HT70 Service Manual. Do not use electrically conductive breathing circuits. Always use clean and dry breathing circuits. 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 and an intake (bacteria) filter behind the filter cover.

5-1

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. OPR360U A0509 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.

SERHT70-2 A0912

1-7

1 Introduction 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. OPR360U A0509

• • • •

5-1

This device has undergone EMC testing and found to be in conformance with IEC 60601-1-2:2001 and meets the requirement of CISPR11:2004 (Class B), IEC 61000-3-2:2006, and IEC 610003-3:1955 + A1:2001 + A2:2005. 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 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; 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 devices(s) is connected. Consult the manufacturer or field service technician for help.

Copyright Information © Copyright 2012 Newport Medical Instruments, Inc. All rights reserved. Newport HT70 Ventilator is manufactured in accordance with Newport Medical Instrument, Inc. proprietary information and is protected under U.S. Patent # 7,654,802.

5-1

1-8

OPR360U A0509

SERHT70-2 A0912

Specifications Section 2:

Specifications

OPR360U A0509

Front Panel Buttons - Symbols Version... 2-1 Miscellaneous Reference Symbols... 2-2 Controls / Monitors... 2-2 Monitor Data Selections... 2-3 Front Panel Membrane Buttons and Indicators... 2-4 Alarms... 2-4 User Adjustable Alarms... 2-5 Automatic Alarms... 2-5 Hardware Requirements... 2-7 Environment... 2-8 Size and Weight... 2-8 Factory Default Parameters... 2-9 Miscellaneous ... 2-9 (optional) Air / Oxygen Entrainment Mixer... 2-9 (optional) Low Flow Oxygen Reservoir... 2-9 Regulatory and Agency Standards... 2-10

5-1

OPR360U A0509

5-1

Specifications Section 2:

Specifications

2

Front Panel Buttons - Symbols Version Accept

5-1

Cancel

OPR360U A0509

Alarm Silence Reset / LED Breath Delivery Indicator Brightness Device Alert LED External Power LED Manual Inflation

Up/Down Arrow

5-1

SERHT70-2 A0912

OPR360U A0509

2-1