LTV2 2200/2150 Series Service Manual Ver C April 2022

LTV2™ 2200/2150 Series Ventilators Service Manual

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ii This document is protected by United States and international copyright laws. This document may not be copied, reproduced, translated, stored in a retrieval system, transmitted in any form, or reduced to any electronic medium or machine-readable form, in whole or in part, without the written permission of Vyaire Medical, Inc. Information in this document is subject to change without notice. This document is only for informational purposes and does not replace nor supplement the terms and conditions of the License Agreement. Trademarks are the property of their respective owners. © 2022 Vyaire. Vyaire, the Vyaire logo, and LTV2 are trademarks or registered trademarks of Vyaire Medical, Inc., or one of its affiliates. Manufactured By Vyaire Medical, Inc. 26125 North Riverwoods Blvd. Mettawa, IL 60045 U.S.A. 1-833-327-3284 www.vyaire.com

Authorized Representative in the European Community Emergo Europe Prinsessegracht 20 2514 AP The Hague The Netherlands

Australian Sponsor Vyaire Medical Pty Ltd Suite 5.03, Building C Foundation Park 7-11 Talavera Road Macquarie Park, NSW, 2113 Australia

Technical and clinical support 1-800-231-2466 [email protected] After hours service: 1-800-231-2466 from within the United States Customer care helpline 24 hours, seven days a week 1-800-231-2466 from within the United States Product, accessories, and parts ordering 1-833-327-3284 [email protected]

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User/owner responsibility This manual is intended for use only by service personnel who have been trained and authorized by Vyaire Medical to service the LTV2™ 2150 model ventilator and the LTV2 2200 model ventilator. Vyaire Medical does not condone or approve of service activity on its products by untrained and unauthorized personnel. Vyaire Medical is not responsible for any unauthorized repairs or any repairs made by unauthorized procedures or unauthorized modifications to the product. Use of an incorrect part or failure to exercise due care in the installation, removal, servicing, calibration or testing of parts and equipment may result in damage or malfunction of the equipment. This may also result in damage to property and injury, including death. The purchaser and installer of these parts shall bear full responsibility and liability for the above. All maintenance performed within the applicable warranty period must be authorized in advance by a Vyaire Medical technical support representative to retain the warranty status of the subject unit.

Warranty Vyaire Medical warrants that the LTV2 2200/2150 ventilator will be free from defects in material and workmanship for one (1) year from the date of shipment, or 8,800 hours as measured on the usage meter, whichever occurs first, with the following limitation: the internal battery is warranted for 90 days from date of shipment. Vyaire Medical will, at its option, either repair, replace, or issue credit for products that prove to be defective during the warranty period. For warranty service or repair, the product must be returned to Vyaire Medical or a service facility designated by Vyaire Medical, shipping prepaid by the Buyer. LIMITATION OF WARRANTY Ordinary maintenance, as specified in the LTV2 2200/2150 ventilator operator’s and service manuals, is not covered under the foregoing warranty. The foregoing warranty does not apply to defects or damage to the unit resulting from the following conditions: •

improper use or misuse

•

improper or inadequate maintenance

•

unauthorized modifications or repairs

•

use of the unit with unauthorized accessories such as an external battery or AC adapter

•

use or storage outside the specified environment

NO IMPLIED WARRANTIES This warranty is exclusive. There are no other warranties expressed or implied. LIMITATION OF LIABILITY Vyaire Medical shall not be liable for loss of profits, loss of use, consequential damages, or any other claim based on breach of warranty. Vyaire Medical liability for damages of any kind shall be limited to the purchase price of the defective unit.

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Contents User/owner responsibility ... iii Warranty ... iii Notices ... vii Symbols ... x Introduction ... 1-1 Maintenance schedule ... 2-1 Cleaning the ventilator ... 3-1 Replacing the fan filter ... 3-1 Replacing the air inlet filter ... 3-2 Replacing the O2 inlet filter (LTV2 2200 only) ... 3-3 Operating theory ... 4-1 Pneumatics ... 4-1 Electronics ... 4-3 Troubleshooting ... 5-1 Displays and buttons ... 5-2 Ventilator performance ... 5-5 Power and battery operation ... 5-11 Alarms ... 5-14 General checkout test failures ... 5-20 Component removal and replacement ... 6-1 Training and authorization... 6-1 Service record ... 6-1 Hand strap ... 6-1 Air inlet filter ... 6-2 O2 blender cap (LTV2 2200 only)... 6-3 O2 inlet filter (LTV2 2200 only) ... 6-4 Fan filter ... 6-5 Protective boots ... 6-6 LTV2 2200/2150 protective boot screw reference chart ... 6-6 Sense line bumper ... 6-9 Back weldment ... 6-10 Internal battery ... 6-14 Battery chamber assembly... 6-16 Single cell battery ... 6-18 Motor board ... 6-19 Internal flexible tubing ... 6-20 Tubing overview diagram ... 6-20 Tubing table ... 6-21 Solenoid manifold tube routing table... 6-22 Solenoid mount tube routing table ... 6-23 Tubing removal/replacement instructions ... 6-24 Flow valve ... 6-38 Accumulator ... 6-43 Solenoid mount ... 6-44 Analog board ... 6-48 Turbine manifold, O2 blender, and O2 block assemblies ... 6-54 External power connector ... 6-58

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v Power board ... 6-59 Side bracket (speaker, communications PCBA and cooling fan) ... 6-60 Rotary switch ... 6-63 Main board ... 6-65 Membrane circuit, overlay, and bezel ... 6-68 Front weldment ... 6-69 Software upgrades ... 7-1 Calibration and testing ... 8-1 Testing... 9-1 General checkout... 9-1 Performance checkout ... 9-6 Specifications... A-1 Modes and breath types ... A-1 Variable controls ... A-1 Button controls ... A-3 Mechanical controls ... A-3 Alarms... A-3 Variable alarms ... A-3 Fixed alarms ... A-4 Alarm delay ... A-5 Alarm sound level ... A-6 Circuit Limb Occlusion alarm ... A-6 Circuit Disconnect alarm (disconnected or occluded circuit limbs) ... A-6 Circuit Disconnect alarm (disconnected or occluded sense lines) ... A-7 High PEEP alarm ... A-7 High Pressure alarm ... A-7 Monitors ... A-8 Measurement uncertainty ... A-8 Smoothing and filtering techniques ... A-9 Displays ... A-9 Usage meter ... A-9 Packaging and materials ... A-9 Storage and operating conditions ... A-9 Storage ... A-9 Operating ... A-9 Orientation ... A-9 Oxygen inlet ... A-10 Shock and vibration ... A-10 Spillage ... A-10 External surface temperature ... A-10 Shipping requirements ... A-10 Sound levels (with no alarms active) ... A-10 Communications ... A-10 Power ... A-11 External power ... A-11 Internal and removable battery ... A-11 Desktop removable battery charger ... A-11 Battery durations... A-12 Breathing circuit and filters ... A-12 Inlet air filtration ... A-12 Recommended breathing system filter requirements ... A-12 Breathing circuit conformance ... A-13

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vi Internal compliance of ventilator ... A-13 DOT requirements... A-13 Equipment classification... A-13 Ventilator service life ... A-13 EMC and RF environments ... A-14 AIM Standard 7351731 Rev 2.00 23FEB2017 RFID Immunity Test Levels ... A-14 RTCA/DO160G: 2010 EMC Tests ... A-14 Reference information ... B-1 LTV2-specific tooling ... B-1 Display illumination chart ... B-2 Control test chart ... B-2 Bench top flow analyzer settings ... B-3 Parts list... B-3 Event trace ... C-1 Event codes ... C-3 Event codes by code number ... C-3 Event codes by event name ... C-6 Event trace data definitions ... C-9 Glossary ... D-1 Index ... E-1

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Notices

Documentation updates Product features are subject to change without notice.

Safety information Review the following safety information before servicing the ventilator. WARNING Unsafe Operation – Servicing LTV2 2150 and 2200 model ventilators without a complete and thorough understanding of their attributes may result in unsafe operating conditions. It is important that this manual be read and understood in its entirety before servicing the ventilator. Any questions regarding installing, operating, or maintaining LTV2 2150 and 2200 model ventilators should be directed to Vyaire Medical or a service technician certified by Vyaire Medical. See “Getting assistance” on page 1-1 for contact information.

Document conventions For clarity, the following written conventions are used throughout this manual: Bold Text Abbreviations

Words that appear in bold text typically represent text as it appears on the ventilator itself, or as it is displayed on the ventilator user interface. Bold is also occasionally used as emphasis. See the Glossary for abbreviations and acronyms used in this document.

Warnings, cautions, and notes Be sure to read the Warning and Caution statements that appear throughout this document. These statements are defined in the following examples. In addition to the warnings and cautions, Note statements are provided where appropriate. WARNING Warnings identify conditions or practices that could result in serious adverse reactions or potential safety hazards. CAUTION Cautions identify conditions or practices that could result in damage to the ventilator or other equipment. NOTE Notes provide additional information to clarify an explanation or instruction.

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viii General Warnings and Cautions which apply any time the ventilator is in use are listed here, while specific Warnings and Cautions appear throughout the manual where pertinent. WARNING Exposure to Potentially Contaminated Medical Equipment – To avoid exposure to infectious materials on contaminated medical equipment, we recommend: • Service personnel should assume all medical equipment received for servicing may have been contaminated with infectious materials. • Ventilator external surfaces, exhalation valves, diaphragms and patient circuits should be cleaned/disinfected before handling or servicing. • Service personnel should adhere to their institutional guidelines, policies, and procedures when handling potentially contaminated medical equipment. Ventilator Service and Repair – To avoid ventilator malfunction and possible operator or patient injury, all servicing or repair of LTV2 2150 and 2200 model ventilators must be performed by a service technician certified by Vyaire Medical. Startup – The ventilator does not deliver gas to the patient during startup and while any initial query is active. Ventilator Check and Maintenance Modes – The LTV2 2150 and 2200 model ventilators do not deliver gas during the ventilator check mode (VENT CHECK) or ventilator maintenance mode (VENT MTNCE) and should not be used to ventilate a patent during these tests. Before performing these tests disconnect the patient from the ventilator and provide ventilation using an alternative method. Use of Unauthorized Components or Parts – Serious harm to the patient may result from the use of unauthorized components or parts. Only items expressly approved by Vyaire Medical may be used in conjunction with LTV2 2150 and 2200 model ventilators. Use of Unapproved Accessories, Transducers, or Cables – The use of accessories, transducers, or cables other than those specified, with the exception of those sold by Vyaire Medical as replacement parts for internal components, may result in increased electromagnetic emissions or decreased electromagnetic immunity of the LTV2 2150 and 2200 ventilators. This could affect the safe and effective operation of the ventilator or other adjacent equipment, resulting in possible patient harm. Risk of Electrical Shock – To avoid the risk of an electrical shock: Use only batteries, adapters, cables, or external power supplies recommended by Vyaire Medical. • Do not use batteries, adapters, cables, or external power supplies with visible signs of damage. Fan Inlet and Exhaust Ports – The cooling fan inlet and exhaust ports must be kept clean and unobstructed. Failure to do so could result in a dangerous build-up of oxygen and/or damage to the ventilator due to overheating. Diminished Audible Alarms – To avoid diminished sound levels of audible alarms and possible consequent harm to patients, do not allow the ventilator’s alarm speaker ports to become covered or obstructed in any way by stickers, labels, or other equipment/devices applied, set, or mounted on or over them. Risk of Fire – Leaks at the oxygen inlet connections can cause dangerous O2 levels in the vicinity of the O2 fitting. To avoid the risk of fire, inspect oxygen fittings before and after connecting highpressure oxygen (to avoid unsealed connections) and take measures to properly ventilate the area. Operating the ventilator in the presence of flammable gases could cause a fire or explosion. Do not operate the ventilator when explosive gases are present under any circumstances. The presence of flammable anesthetic gases presents a danger to patient and operator. •

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CAUTION Operating Environment – To avoid the risk of equipment malfunction, do not operate the ventilator outside of a +5 to +40°C temperature range, or a 15 to 95% relative, noncondensing humidity range. Cleaning and Sterilization – To avoid irreparable damage to the ventilator, do not attempt to sterilize it. Do not spray liquids directly on or into any part of the ventilator. Do not allow liquids to drip onto or pool on the ventilator. Do not immerse the ventilator in liquids. Wet or Damp Filters – Do not install any wet or damp filters into the ventilator. This could damage the ventilator. High Pressure Air Nozzle – Only a low-pressure air nozzle with flow less than 10 liters-per-minute should be used around the ventilator. High pressure can damage the ventilator, in particular the sense line ports (differential pressure ports). Risk of Equipment Damage – To avoid the risk of equipment damage and consequent malfunction, do not allow the ventilator to be dropped or subjected to excessive impact or vibration. Storage Temperature – Storing the ventilator at temperatures outside of its specified storage temperature range can damage the ventilator and its batteries. Opening the Ventilator – Always turn the ventilator off and remove the external power before removing the ventilator housings or attempting to service the ventilator. Anti-static Precautions – Always wear a grounded anti-static wrist strap when handling the ventilator with the housings removed. Electrostatic discharge can damage the internal electronics. Electronic and Mechanical Parts – LTV2 2150 and 2200 model ventilators contain delicate electronic and mechanical parts that must be handled properly to avoid damage. Observe and follow all instructions in this manual carefully. Software Version – Never install a version of software lower than that originally or currently installed in the ventilator. Erroneous operation may result from the use of incompatible software. Verification of Operation – After opening the ventilator and performing any maintenance, verify proper operation of the ventilator by performing the tests and procedures as specified in “Chapter 9 Testing.”

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Symbols The symbols described below may be referenced on the device or in accompanying documentation. Symbol Meaning General warning Caution Manufacturer. Indicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC. Date of Manufacture. Indicates the date when the medical device was manufactured. Authorized representative in the European Community. Indicates the authorized representative in the European Community. Quantity. Indicates the amount of a labeled part number inside the given package. Serial Number. Labels the equipment serial number. Catalogue Number. Labels the equipment part number. Part number. Labels the equipment part number. Ingress Protection Rating. To label the device as protected from dripping water. Do not use if package is damaged. Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner. To indicate the fuse boxes, for example, and their location. To identify an output terminal when it is necessary to distinguish between inputs and outputs. To identify any terminal which is intended for connection to an external protective conductor for protection against electric shock in case of a fault or the terminal of a protective earth (ground) electrode. To mark a type BF equipment. To indicate on the rating plate that the equipment is suitable for direct current only; to identify relevant terminals. To indicate on the rating plate that the equipment is suitable for alternating current only; to identify relevant terminals. To identify equipment meeting safety requirements specified for Class II equipment. To identify Waste Electrical and Electronic Equipment (WEEE) that is not to be disposed of as unsorted municipal waste and is to be collected separately.

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Meaning Alarm audio silenced

Alarm reset Follow instructions for use Consult instructions for use CE Mark. To label the equipment as certified for sale in the European Economic Area. Restriction of Hazardous Substances (RoHS) Indicates the product is RoHS compliant. Nurse Call Do not block port. Air Inlet Humidity Limitation Indicates the range of humidity to which the medical device can be safely exposed. Temperature Limit Indicates the temperature limits to which the medical device can be safely exposed. Not User Serviceable Indicates that there are no user serviceable parts inside the device. To label a solid green LED as when a battery in the port is fully charged. To label a flashing green LED as when a battery in the port is still charging. To label a solid red LED as when a fault is detected in the battery charger. To label a flashing red LED as when a fault is detected in a battery in the port. Labels the equipment as a medical device.

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Introduction This manual describes how to perform routine maintenance, troubleshooting, and repairs on the LTV2 2150 and 2200 model ventilators. It is designed for use by service personnel who have been trained and authorized by Vyaire Medical. Do not perform any of the procedures in this manual unless you are trained and authorized for service on LTV2 2150 and 2200 ventilators. This manual contains what you need to know to: • Perform preventative maintenance. • Calibrate the ventilator. • Perform routine troubleshooting. • Remove and replace major components of the ventilator. See the LTV2 2200/2150 Ventilator Operator's Manual for information on setting up and operating the ventilator. Getting assistance: If a problem occurs while maintaining the LTV2 2150 or 2200 ventilator, or if you require additional information, contact Vyaire Medical: Technical and clinical support 1-800-231-2466 [email protected] After hours service: 1-800-231-2466 from within the United States Customer care helpline 24 hours, seven days a week 1-800-231-2466 from within the United States Product, accessories, and parts ordering 1-833-327-3284 [email protected]

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Chapter 1: Introduction

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Maintenance schedule The LTV2 2200/2150 ventilator is designed to operate for extended periods of time with minimal routine maintenance. The following table describes recommended periodic maintenance. Table 2-1.

Recommended maintenance schedule

Hours of Service Before initial use

While in storage, every six months Daily Annually

Biyearly*

Every 30,000 hours or six years, whichever comes first*

Maintenance Required • Charge the internal battery by plugging the ventilator into an AC power source for five hours to ensure a full charge. • Set up the ventilator / accessories according to the Operator’s Manual. • Check the ventilator for proper operation according to the Operator’s Manual. • Charge the internal battery by plugging the ventilator into an AC power source for five hours. • Check the air inlet filter; replace it if necessary. • Check the fan filter; or replace it if necessary. • Replace the air inlet filter. • Replace the O2 inlet filter (LTV2 2200 only). • Replace the fan filter. • Check the battery health or error log for all four batteries. • Calibrate the transducers. • Replace the air inlet filter. • Replace the O2 inlet filter (LTV2 2200 only). • Replace the fan filter. • Check the battery health or error log for all four batteries. • Calibrate the transducers. • Replace the components according to the biyearly PM. • Replace the following components • Silicone tubing • Rotary switch assembly • Accumulator • Fan assembly • Thermo conductive pad • Solenoid mount assembly • Main board assembly • Coin battery (real time clock battery) • Sounder alarm • Main internal battery

*Must be performed by Vyaire Medical authorized service personnel only.

Warning Qualified technicians – Only service technicians who have been trained and certified by Vyaire Medical to service the LTV2 2200 and 2150 ventilator are qualified to perform maintenance and service actions on the LTV2 2200 and 2150 model ventilators. Do not attempt to service the ventilator unless you have been properly trained to do so, personal injury could result. Refer all servicing and repair to Vyaire Medical or an authorized service center.

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Chapter 2: Maintenance schedule

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Cleaning the ventilator All external surfaces should be cleaned and disinfected before initial use, before and after each patient use, and as required. To clean the ventilator: Follow the cleaning and disinfecting instructions found in the LTV2 Operator’s Manual.

Replacing the fan filter 1.

Remove the fan filter by squeezing the foam filter gently with your fingers and pulling it out.

2.

Examine the filter for holes, tears, or lodged particles. Discard and replace it with a new filter if necessary. Reinstall the filter.

3.

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Chapter 3: Cleaning the ventilator

Replacing the air inlet filter 1.

Remove the inlet filter by squeezing the outer edges gently with your fingers and pulling it out.

2.

Examine the filter for holes, tears, or lodged particles. Discard and replace it with a new filter if necessary. Reinstall the filter.

3.

WARNING Air Inlet Filter. To prevent foreign material from being drawn into the ventilator resulting in patient injury and damage to the ventilator, ensure that the foam air inlet filter is clean and in place while the ventilator is in operation.

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Replacing the O2 inlet filter (LTV2 2200 only) The O2 inlet filter should be replaced when it becomes soiled. Failure to do this can affect ventilator performance. CAUTION Oxygen Supply Contamination – The accuracy of the oxygen delivery capabilities of LTV2 2200 ventilator can be compromised by foreign debris contamination in the oxygen supply system. To reduce the risk of airborne contaminants entering the ventilator, ensure that any oxygen supply connected to the ventilator is clean and properly filtered, and that the O2 inlet port cap is securely installed on the O2 inlet port whenever the ventilator is not connected to an external oxygen supply. To replace the O2 inlet filter: 1. If a high pressure O2 source is being used, disconnect the high pressure O2 hose from the oxygen block on the left side of the ventilator. 2. If a low pressure O2 source is being used, disconnect the O2 line from the barbed oxygen adapter. Unscrew and remove the barbed adapter from the oxygen block on the left side of the ventilator.

1 2 3.

Using a pick, gently remove the rubber O-ring from inside the O2 inlet port. Be careful not to damage the O-ring while removing it. Tip the ventilator to allow the O2 inlet filter to slide out.

1 2 4. 5. 6.

High Pressure O2 Connection Low Flow O2 Connection

O2 Inlet Filter O-ring

Inspect the filter for damage. If the filter is not intact or shows signs of damage, replace it with a new O2 inlet filter (P/N 19845-001) and O-ring (P/N 10609), available from Vyaire Medical. Replace the filter by sliding it back into the O2 inlet port. Replace the O-ring, making sure it is completely tucked under the retaining lip on the inside of the O2 inlet port. Reconnect the O2 line.

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