Operators Manual
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Vyaire Medical, Inc. Title: LTV2 2200/2150 Operator’s Manual Part no.: 34086-001
Cover Sheet
Ver.: A
Print the attached pages according to the printing instructions.
Do not print this page. Printing Instructions Document File #’s: 34086-001-A_LTV2_2200-2150_OpMnl.pdf - This file contains the LTV2 2200/2150 Ventilator Operator's Manual, with embedded high-resolution graphics. Print high resolution, black, double sided, book style, 8½” X 11”, white, 20 lb (or equiv) paper. 34086-001-A_CoverPage.pdf - This file contains the cover page with embedded high-resolution color graphics. Print the binder cover with high-resolution color, on 9 ±¼” X 11”, white, 100# gloss text #2 grade (or equiv) paper, laminated. Binding: Plastic Spiral “O”, black, 1” (± 1/4”) (inside diameter of the spiral), or equivalent. Paper: Cover pages (front / back), 9 ±¼” X 11” white, 100# gloss text #2 grade or equivalent paper. Laminate inside and outside front cover page and outside back cover page (back cover inside and inside pocket optional at buyer’s discretion). Text - 8½” X 11 “, White, 20 lb (or equivalent) paper. Ink: Color copied or 4CP (at buyer’s discretion) from MS Word, Adobe Acrobat, InDesign, or source file supplied. Pages: Page size and pagination according to the source file supplied with the order. Text - 8½” X 11, Cover Pages - 9 ±¼” X 11”, portrait orientation, double sided, book style. Artwork: Graphics files embedded high-resolution digital format (.jpg, .tiff, etc). Fulfillment: Contents - Collate cover and text. Proofs Required: Printer to provide two proof copies to Vyaire Medical for review and approval before printing production order quantities. One copy to be retained by Vyaire Medical documentation management as a control copy. Second copy to be returned to the vendor as the vendor control copy. Shrinkwrap each copy and package according to the purchase order instructions. Provide a certificate of conformance with each shipment. All files and/or materials supplied are Vyaire Medical confidential information, remain its sole and exclusive property and may not be used, disclosed, copied, or reproduced without the prior written permission of Vyaire Medical. •
Packaging: Note:
Versions Ver. A
Chg. Order
Description
102858
Initial Release
LTV2™ 2200/2150 Ventilators Operator’s Manual FDA has authorized the emergency use of the device.
34086-001 Version A
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. © 2020 Vyaire. Vyaire, the Vyaire logo, and LTV are trademarks or registered trademarks of Vyaire Medical, Inc., or one of its affiliates.
Manufacturer Vyaire Medical, Inc. 26125 North Riverwoods Blvd. Mettawa, IL 60045 USA vyaire.com Customer and Clinical Support Product, Accessories, and Parts Ordering 1-833-327-3284 [email protected]
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Warranty Vyaire Medical warrants that the LTV2™ 2200/2150 ventilator is free from defects in material and workmanship for a period of two years from the date of shipment, or 17,600 hours as measured on the usage meter, whichever comes 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: •
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 Introduction ... 1-1 Operator’s Safety Information... 1-2 Warnings ... 1-3 Cautions ... 1-9 Symbols ... 1-11 Ventilator Overview ... 2-1 Indications for Use ... 2-2 Intended Use ... 2-2 Contraindications ... 2-2 Essential Performance Requirements per ISO 80601-2-12:2011 ... 2-2 Power/Supplies Required ... 2-3 Information/Assistance ... 2-3 Breath Types ... 3-1 Volume Control Breaths ... 3-1 Sigh Breaths ... 3-2 Pressure Control Breaths ... 3-2 Pressure Support Breaths ... 3-4 Spontaneous Breaths ... 3-5 Ventilation Modes ... 4-1 Volume and Pressure Ventilation ... 4-1 Control Mode ... 4-1 Assist/Control Mode... 4-2 SIMV Mode ... 4-2 CPAP Mode ... 4-3 NPPV Mode ... 4-4 Apnea Backup ... 4-5 Using the Controls and Indicators ... 5-1 Ventilator Controls ... 5-1 Setting a Control ... 5-2 Variable Settings... 5-3 Buttons ... 5-3 Scroll Knob ... 5-3 Extended Features ... 5-3 Bright, Dim, and Blank Control Displays... 5-4
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v Flashing Controls ... 5-4 Dashes ... 5-4 Control Limiting ... 5-5 Control Locking ... 5-5 Control Retention ... 5-6 Control Panel ... 6-1 Menu/Select ... 6-1 Monitored Data ... 6-1 Extended Features ... 6-1 Battery Check ... 6-1 Scroll Knob ... 6-1 Variable Controls... 6-2 Extended Features ... 6-2 Power/Standby ... 6-2 Breath Rate... 6-3 Inspiratory Time ... 6-4 Tidal Volume ... 6-4 The Effect of Circuit Compliance on Delivered Tidal Volume ... 6-5 The Effect of Altitude or Barometric Pressure on Delivered Tidal Volume ... 6-5 Pressure Control ... 6-7 Pressure Support ... 6-8 Pressure Support in NPPV Mode ... 6-8 PEEP Control... 6-9 PEEP Control in NPPV Mode ... 6-9 FiO2 (Flush) (LTV2™ 2200 only) ... 6-10 Sensitivity ... 6-11 Flow Trigger ... 6-11 Pressure Trigger ... 6-11 Volume/Pressure Mode ... 6-12 Assist/Control – SIMV/CPAP – NPPV ... 6-12 Inspiratory / Expiratory Hold ... 6-13 Inspiratory Hold ... 6-13 Expiratory Hold ... 6-15 Manual Breath ... 6-17 Low Pressure O2 Source (LTV2 2200 only) ... 6-18 Control Lock... 6-21 Alarm Silence... 6-21
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vi Silencing Alarms ... 6-21 Preemptive Silence Period ... 6-21 Alarm Reset ... 6-22 High Pressure Limit ... 6-22 Low Peak Pressure... 6-22 Low Minute Volume ... 6-22 Displays and Indicators ... 7-1 Airway Pressure... 7-2 Display Window ... 7-2 Indicators ... 7-2 Patient Effort ... 7-2 Alarm Status ... 7-2 Power Source ... 7-3 Monitored Data ... 8-1 Automatic or Manual Data Display Scrolling ... 8-1 Monitored Data ... 8-1 PIP xxx cmH2O... 8-2 MAP xx cmH2O ... 8-2 PEEP xx cmH2O... 8-2 RATE xxx bpm ... 8-2 Vte xxx ml ... 8-2 VE xx.x L ... 8-2 I:E xx:xx ... 8-2 I:Ecalc xx:xx ... 8-3 Vcalc xxx Lpm ... 8-3 SBT xxx MIN ... 8-3 xxx f/Vt xx f ... 8-3 Informational Messages ... 8-3 SIGH ON ... 8-3 PRES TRIG ON ... 8-3 BIAS FLO OFF ... 8-3 O2 CONSRV ON ... 8-3 HI PEEP OFF ... 8-4 LO PEEP OFF ... 8-4 HI RATE OFF ... 8-4 LPP PS OFF ... 8-4
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vii LO PP OFF... 8-4 HMV OFF ... 8-4 LMV OFF ... 8-4 SBT HI f OFF ... 8-4 SBT LO f OFF ... 8-4 HI f/Vt OFF ... 8-4 LO f/Vt OFF ... 8-4 Ventilator Alarms ... 9-1 Low Priority (Advisory) Alarm ... 9-1 Medium Priority (Caution) Alarm ... 9-1 High Priority (Warning) Alarm ... 9-2 Multiple Alarm Priorities ... 9-3 Alarms ... 9-4 APNEA, APNEA xx bpm ... 9-4 Apnea Interval ... 9-5 Check Circuit (CHK CIRCUIT) ... 9-5 DEFAULTS... 9-6 DEFAULTS SET ... 9-8 External Power Lost (EXT PWR LOST)... 9-8 External Power Low (EXT PWR LOW) ... 9-9 High Minute Volume (HI MIN VOL) ... 9-9 High Respiratory Rate (HI RESP RATE) ... 9-10 High Oxygen Inlet Pressure (HI O2 PRES) (LTV2™ 2200 only) ... 9-11 High PEEP (HI PEEP)... 9-11 High Inspiratory Pressure (HI PRESSURE)... 9-12 Hardware Fault (HW FAULT) ... 9-14 Ventilator Inoperable (INOP) ... 9-15 Internal Battery Empty (IntBat EMPTY) ... 9-15 Internal Battery Fault (IntBat FAULT) ... 9-16 Internal Battery Low (IntBat LOW) ... 9-17 Internal Battery Temperature Critical (IntBat TEMP) ... 9-18 Internal Battery Temperature High (IntBatTempHi) ... 9-18 Internal Battery Temperature Low (IntBatTempLo) ... 9-18 Low Minute Volume (LOW MIN VOL) ... 9-19 Low O2 Source Pressure (LOW O2 PRES) (LTV2™ 2200 only) ... 9-20 LOW PEEP ... 9-21 Low Peak Inspiratory Pressure (LO PRESSURE) ... 9-21
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viii No Calibration Data (NO CAL DATA) ... 9-23 Removable Battery Empty (RemBat EMPTY) ... 9-23 Removable Battery Fault (RemBat FAULT)... 9-24 Removable Battery Low (RemBat LOW) ... 9-25 Removable Battery Temperature Critical (RemBat Temp) ... 9-25 Removable Battery Temperature High (RemBatTempHi) ... 9-26 Removable Battery Temperature Low (RemBatTempLo) ... 9-26 Remove Patient from Circuit (REMOVE PTNT)... 9-27 RESET / RESET 1 ... 9-27 Spontaneous Breathing Trial Ended (SBT OFF) ... 9-28 Low Respiratory Rate during SBT (LO SBT RATE) ... 9-28 High Respiratory Rate during SBT (HI SBT RATE) ... 9-29 Low f/Vt During SBT (LO SBT f/Vt) ... 9-29 High f/Vt During SBT (HI SBT f/Vt) ... 9-30 Transducer Fault (XDCR FAULT) ... 9-30 LOCKED... 9-31 WARMUP WAIT ... 9-31 Extended Features... 10-1 Navigating the Extended Features Menus ... 10-2 Alarm Operations ... 10-2 Alarm Volume ... 10-3 Apnea Interval ... 10-3 High Minute Volume ... 10-3 High Pressure Alarm Delay ... 10-3 Low Peak Pressure Alarm... 10-3 HI RESP RATE ... 10-4 High PEEP ... 10-4 Low PEEP ... 10-4 Nurse Call... 10-4 Exit ... 10-5 Vent Operations ... 10-5 Variable Rise Time ... 10-6 Variable Flow Termination ... 10-7 Variable Time Termination ... 10-8 Pressure Control Flow Termination ... 10-8 Leak Compensation ... 10-10 O2 Conserve (LTV2™ 2200 only) ... 10-11
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ix O2 Flush (LTV2™ 2200 only) ... 10-12 Control Unlock ... 10-12 Language Selection ... 10-13 Software Version ... 10-13 Usage Meter ... 10-13 Communications Setting ... 10-13 Set Date ... 10-13 Set Time ... 10-14 Date Format ... 10-15 PIP LED... 10-15 Model Number / Serial Number ... 10-15 Valve Home Position ... 10-16 Set Defaults ... 10-16 O2 Cylinder Duration (LTV2™ 2200 only) ... 10-17 Sigh ... 10-19 Bias Flow ... 10-19 Queries ... 10-20 Selecting the Preset Patient Size ... 10-21 LTV2™ 2200/2150 Presets Table ... 10-22 Turning Patient Query on or off ... 10-23 Leak Test Query ... 10-23 SBT Operations ... 10-24 Exit ... 10-26 SBT Alarms... 10-27 BATTERY OPS... 10-27 Exit ... 10-28 Transducer Autozero ... 10-28 Airway Pressure Transducer Autozero ... 10-29 Bi-directional Flow Transducer Differential Autozero ... 10-29 Exhalation Flow Transducer Differential Autozero–Wide ... 10-29 Exhalation Flow Transducer Differential Autozero–Narrow ... 10-30 Real Time Transducers ... 10-31 Ventilator Checkout Tests ... 11-1 VENT CHECK... 11-1 Alarm Test ... 11-4 Backup Alarm Test ... 11-5 Display Test ... 11-6
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x Control Test ... 11-8 Leak Test ... 11-10 Vent Inop Alarm Test ... 11-11 Exit ... 11-12 Operating Procedure ... 12-1 Turning the Ventilator On ... 12-1 Before Connecting the Ventilator to a Patient ... 12-3 Procedure for Control Mode Set Up ... 12-4 Procedure for Assist/Control Mode Set Up ... 12-6 Procedure for SIMV Mode Set Up ... 12-8 Procedure for CPAP Mode Set Up ... 12-10 Procedure for NPPV Mode Set Up ... 12-10 To Turn the Ventilator Off ... 12-12 Cleaning and Disinfecting the Ventilator and Accessories... 13-1 Cleaning the Ventilator and Accessories ... 13-2 Disinfecting the Ventilator and Accessories ... 13-2 Cleaning or Replacing the Fan Filter ... 13-4 Cleaning or Replacing the Air Inlet Filter ... 13-5 Cleaning or Replacing the O2 Inlet Filter (LTV2™ 2200 only) ... 13-6 Power and Battery Operation ... 14-1 Internal and Removable Battery Use... 14-2 Charging Priority ... 14-2 Charging the removable battery ... 14-3 Checking the battery charge level ... 14-3 Exchanging the Removable Battery in an LTV2 Series Ventilator ... 14-4 Battery Calibration/Relearn ... 14-5 Desktop Battery Charger ... 14-5 Using the AC Adapter ... 14-7 Using an External Battery ... 14-8 Caring for the Internal and Removable Batteries ... 14-10 Battery Replacement... 14-10 Battery Disposal ... 14-10 Cleaning ... 14-10 Troubleshooting ... 15-1 Displays and Buttons ... 15-2 Ventilator Performance ... 15-5
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xi Power and Battery Operation ... 15-10 Alarms ... 15-14 Checkout Test Failures ... 15-20 Test Lung Operations ... 15-21 Ventilator 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-5 Alarm Delay ... A-6 Alarm Sound Level ... A-6 Circuit Limb Occlusion Alarm ... A-6 Circuit Disconnect Alarm (Disconnected or occluded circuit limbs) ... A-7 Circuit Disconnect Alarm (Disconnected or occluded sense lines)... A-7 High PEEP Alarm ... A-8 High Pressure Alarm ... A-8 Monitors ... A-9 Measurement Uncertainty ... A-9 Smoothing and Filtering Techniques ... A-10 Displays ... A-10 Usage Meter ... A-10 Packaging and Materials ... A-10 Storage and Operating Conditions ... A-10 Storage ... A-10 Operating... A-10 Orientation ... A-10 Oxygen Inlet ... A-11 Shock and Vibration ... A-11 Spillage... A-11 External Surface Temperature ... A-11 Shipping Requirements ... A-11 Sound Levels (with no alarms active) ... A-11 Communications ... A-11 Power ... A-12
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xii External Power ... A-12 Internal and Removable Battery ... A-12 Desktop Removable Battery Charger ... A-12 Battery Durations ... A-13 Breathing Circuit and Filters ... A-13 Inlet Air Filtration ... A-13 Recommended Breathing System Filter Requirements ... A-13 Breathing Circuit Conformance ... A-14 Internal Compliance of Ventilator ... A-14 DOT Requirements ... A-14 Equipment Classification ... A-14 Ventilator Service Life ... A-14 EMC and RF Environments ... A-15 RTCA/DO160G: 2010 EMC Tests ... A-15 Set Up / Maintenance ... B-1 Recommended Maintenance Schedule... B-1 Service Assistance ... B-2 Installation and Checkout... C-1 Installation and Setup ... C-1 Unpacking the Ventilator – Instructions ... C-1 Patient Breathing Circuit – Connection Instructions ... C-1 Ventilator without Humidifier ... C-3 Ventilator with Humidifier and Water Trap ... C-5 Oxygen Lines – Connection Instructions ... C-6 Nurse Call System – Connection Instructions ... C-8 Communications Port ... C-9 Using the Remote Alarm/Nurse Call Cable ... C-9 Ventilator Open-source XML Protocol (VOXP) Port ... C-10 Checking the Ventilator for Proper Operation ... C-11 Ventilator Proper Operation Worksheet... C-13 Technical Description ... D-1 Overview ... D-1 Event Trace ... E-1 Event Codes ... E-3 Event Codes by Code Number ... E-3 Event Codes by Event Name ... E-5
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xiii Event Trace Data Definitions ... E-7 Glossary... F-1 Approved Accessory Listing ... G-1 Gas and Electrical Accessories ... G-1 Stands and Carrying Devices ... G-1 Other Stands and Carrying Accessories ... G-1 Electrical Power Accessories ... G-2 Breathing Circuits and Other Consumables ... G-2 Index ... H-1
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Intentionally left blank.
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Introduction This Operator’s Manual contains detailed information and instructions which when adhered to ensure the safe and effective set up, use and simple maintenance of the LTV2 2200 ventilator / LTV2 2150 ventilator. This manual is designed for use by respiratory therapists, nurses or other qualified and trained personnel under the direction of a physician and in accordance with applicable laws and regulations. It contains the following: •
Ventilator Overview
•
Installation and Checkout
•
Using the Controls and Indicators
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Monitored Data
•
Ventilator Alarms
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Extended Features
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Ventilator Checkout tests
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Operating Procedure
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Troubleshooting
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Cleaning and Disinfecting
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Set Up / Maintenance
•
Power and Battery Operation
Service tests, calibration, and major maintenance operations are described in the LTV2 2200/2150 Ventilator Service Manual.
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Operator’s Safety Information Read and ensure that you understand the following information about Warning, Caution and Note statements before operating the ventilator. 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.
Bold Text:
Words that appear in bold text typically represent text as it appears on the ventilator itself, or as it appears on the ventilator user interface. Bold is also occasionally used as emphasis. Abbreviations: “LTV2 2200/2150” ventilator, “LTV2,” and “the ventilator” are used interchangeably throughout this document.
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Warnings •
Untrained Personnel. To prevent patient injury, only properly trained personnel should operate the ventilator. The LTV2 2200/2150 ventilator is a restricted medical device designed for use by respiratory therapists, nurses, or other properly trained and qualified personnel under the direction of a physician and in accordance with applicable state laws and regulations. •
Before operating the LTV2, read the following Warning and Caution statements.
•
Please retain this document for reference.
•
Reading this document is not a substitute for proper training.
•
We recommend that personnel responsible for using the LTV2 ventilator undergo yearly competency training.
•
Patient Monitoring. To prevent patient serious injury or death, patients who are dependent on a ventilator must be constantly monitored by qualified personnel and appropriate monitors (such as pulse oximetry). Such personnel must be prepared to address equipment malfunctions and circumstances where equipment becomes inoperative.
•
Use of Masks. Masks used with the LTV2 2200/2150 must be non-vented (no holes or leak vents). With a vented mask, the patient's exhaled air escapes through holes or vents in the mask, elbow or swivel connector. With a non-vented mask, the patient's exhaled air escapes through the ventilator exhalation valve. Using a vented mask depletes the oxygen supply faster, and also may lead to patient-ventilator dyssynchrony. Excessive leakage can also occur if the mask is not properly sealed to the patient’s face. Leaks around the mask may cause the exhaled tidal volume measured by the ventilator to be different than what is actually exhaled from the patient. An end-tidal CO2 monitor (complying with ISO 80601-2-55) with alarms should be used during non-invasive ventilation.
•
Leak Testing the Patient Breathing Circuit. The patient circuit must be leak tested in the VENT CHECK mode before connection to the patient. In addition, the Ventilator Checkout mode should be used to check for correct operation of the ventilator alarm, displays and controls. Harm to the patient or ineffective ventilation may result from failure to leak test the patient breathing circuit before connection to a patient. When using a heated humidifier, include it in the circuit when performing leak testing. Leak test the patient circuit with all accessories connected before connection to the patient. Failing to do this can result in ineffective ventilation and possible harm to the patient. Refer to Leak Test on page 11-10 for detailed instructions.
•
Adjustable and Critical Alarms. To prevent patient injury, all adjustable alarms and all critical alarms must be set appropriately and checked to ensure proper operation. Setting an alarm to extreme values can render it useless for protecting the patient.
•
Alarms Function Verification. To prevent patient injury, all alarms must be verified as functioning properly before use. If any alarm malfunctions, immediately contact a certified Vyaire Medical service technician or Vyaire Medical.
•
Audible Alarm Volume. The LTV2 has an adjustable alarm volume. The volume of the alarm must be set to an appropriate level so it can be identified by caregivers to help ensure a quick response to prevent patient injury.
•
Alternative Ventilation. To reduce the risk of death or serious injury, an alternative means of ventilating the patient (such as a manual resuscitation device or backup ventilator) must be available at all times, and all ventilator operators and caregivers must be fully familiar with emergency ventilation procedures.
•
Fire or Explosion. Under no circumstances is the ventilator to be operated when explosive gases are present. The presence of nitrous oxide or flammable anesthetics presents a danger to the patient and operator. Operation of the LTV2 2200/2150 ventilator in the presence of flammable gases or any other flammable atmosphere could cause a fire or explosion.
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•
Patient Breathing Circuit Disconnection. Inadvertent disconnection of the patient from the patient breathing circuit can lead to patient harm.
•
Patient Breathing Circuit and Cable Positioning. Carefully drape or position the breathing circuit and any cables so as to not allow the patient or bystanders to become strangled or entangled leading to injury.
•
Critical Alarms. Failure to appropriately set the critical alarms such as the Low Minute Volume alarm and the Low Pressure alarm may cause non-detection (no alarm) for a disconnection of the lower sense line or the exhalation valve drive line.
•
Sustained High Pressure Alarm. During a sustained High Pressure alarm condition (HI PRESSURE), the ventilator’s turbine is stopped and gas is not delivered to the patient. Disconnect the patient from the ventilator and ventilate the patient using an alternative method to reduce the risk of patient harm. For additional information concerning the HI PRESSURE alarm, see page 9-12.
•
IntBat EMPTY Alarm. An IntBat EMPTY alarm indicates the internal battery is almost depleted. Connect the ventilator to an external power source or insert a charged, removable battery immediately to reduce the chance of cessation of ventilation.
•
Depleted battery and shutdown. If the LTV2 2200/2150 ventilator operates on its removable and/or internal batteries to the point that they are completely depleted, the ventilator shuts down and ventilation stops.
•
Battery Relearn. If battery run times are different than what is expected, the battery status should be checked to determine if the relearn process should be completed. This will help ensure a more accurate measurement and display of battery charge level and reduces the chance of interruption of ventilation.
•
Battery Run Time. When the battery reaches the IntBat LOW level, the ventilator will only run for approximately ten minutes before generating an internal battery empty alarm (IntBat EMPTY). The approximate times shown here are based on tests using the nominal settings, a new battery and a full charge cycle as specified in “Appendix A:–Ventilator Specifications.” Actual run time may be more or less depending on ventilator settings, patient demand, and battery age or condition. It is highly recommended that an alternate power source is connected BEFORE the ventilator reaches the IntBat EMPTY alarm condition to ensure continuous, uninterrupted patient ventilation. If the LTV2 2200/2150 ventilator is operated on its removable and/or internal batteries to the point that they are completely depleted, the ventilator will shut down.
•
Battery Fault Condition. In the event of a battery fault condition such as the Internal Battery Fault (IntBat Fault) and the Removable Battery Fault (RemBatFault), change the power source and contact a certified Vyaire Medical service technician.
•
INOP Alarm. If an INOP alarm occurs during ventilator operation, ventilation will be interrupted. Manually ventilate the patient using an alternative method disconnect the ventilator, and immediately contact a certified Vyaire Medical service technician or Vyaire Medical.
•
NO CAL Condition. Operation of the LTV2 2200/2150 ventilator under a NO CAL condition may result in inaccurate pressure and volume measurements and delivery leading to incorrect ventilation. If this condition occurs, disconnect the patient from the ventilator, provide an alternative method of ventilation, and immediately contact a certified Vyaire Medical service technician or Vyaire Medical.
•
XDCR FAULT Alarm. Continued operation of the LTV2 2200/2150 ventilator with an activated XDCR FAULT alarm may result in inaccurate flow and volume measurements and delivery. If this condition occurs, disconnect the patient from the ventilator and provide an alternative method of ventilation to reduce the risk of patient harm. Contact a certified Vyaire Medical service technician or Vyaire Medical immediately.
•
Personal Injury and Electric Shock. Operation of the LTV2 2200/2150 ventilator if any of its panels have been removed may result in electrical shock to the patient or operator. All servicing must be performed by a certified Vyaire Medical service technician.
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•
Audible Alarms. Failure to immediately identify and correct audible alarm situations may result in serious patient injury.
•
Equipment Malfunction or Failure. The LTV2 2200/2150 ventilator has alarms to notify operators of certain conditions and to cease operating upon detecting a possibly dangerous condition leading to serious patient injury. An alternative method of ventilation must be available and users are fully familiar with emergency ventilation procedures.
•
Improperly Functioning Ventilator. Operation of a ventilator that does not appear to be working properly may be hazardous to the patient or user. If the ventilator is damaged, fails Ventilator Checkout tests or malfunctions in any way, discontinue its use and immediately, provide an alternate means of ventilatory support and contact a certified Vyaire Medical service technician or Vyaire Medical.
•
Ventilator Checkout Tests. Be aware that gas is not delivered to the patient during these tests. To prevent patient injury, disconnect the patient from the ventilator and ventilate the patient using an alternative method before running the ventilator checkout tests.
•
Ventilator Checkout and Maintenance Modes. The LTV2 2200/2150 ventilator does not deliver gas during the Ventilator Checkout mode (VENT CHECK) or Ventilator Maintenance mode (VENT MTNCE). To prevent patient injury, do not attempt to ventilate a patient while the ventilator is in one of these modes.
•
Inspired Oxygen (FiO2) Concentration. If the patient has a variable respiratory rate, his/her minute ventilation will fluctuate. The LTV2 2200/2150 does not have integrated oxygen monitoring equipment. An oxygen monitor (complying with ISO 80601-2-55) with high and low oxygen delivery alarms must be used to monitor and help ensure delivered oxygen concentration and reduce the risk of patient injury.
•
End-Tidal CO2 Monitoring. The LTV2 2200/2150 does not have integral end-tidal CO2 monitoring equipment. To reduce the chance of harm, we recommend that an end-tidal CO2 monitor (complying with ISO 80601-2-55) with alarms be used. Follow instructions for use that accompany the CO2 monitoring equipment for proper use and sensor placement.
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