MR Conditional LTV 1200 Operators Manual Rev F March 2013

Document Revision History Document Revision Level

Revision Date

Rev. A, ECO 6557

05/14/10

Rev. B, ECO 6713

10/7/10

Rev. C, ECO 7022

5/8/12

Rev. D, ECO 80489

10/1/12

Rev. E, ECO 81024

February 2013

Rev. F, ECO 81227

March 2013

CareFusion 22745 Savi Ranch Parkway Yorba Linda, CA 92887 U.S.A.

CareFusion Germany 234 GmbH Leibnizstrasse 7 97204 Hoechberg Germany

Customer Care:

+49 931 4972-0 tel +49 931 4972-423 fax

800.754.1914 toll free 763.398.8500 763.398.8403 fax [email protected]

Any product malfunctioning issues that fall under Medical Device Directives Essential Requirements should be directed to CareFusion Germany 234 GmbH. [email protected] carefusion.com

LTV® 1200 and LTV® 1150 are trademarks belonging to Carefusion Corporation. Copyright © 2010–2013 CareFusion Corporation or one of its subsidiaries. All rights reserved.

Operator’s Manual P/N 19802-001 Rev. F

LTV® 1200 / 1150 Ventilators

Page i

Warranty CareFusion warrants that the LTV® 1200 / 1150 ventilator is free from defects in material and workmanship for a period of one (1) year from the date of shipment, or 8,800 hours as measured on the usage meter, whichever comes first, with the following limitations: 1) The internal battery is warranted for ninety (90) days from date of shipment. CareFusion 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 CareFusion or a service facility designated by CareFusion, shipping prepaid by the Buyer. LIMITATION OF WARRANTY Ordinary maintenance, as specified in the LTV® 1200 / 1150 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, e.g. 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 CareFusion shall not be liable for loss of profits, loss of use, consequential damages, or any other claim based on breach of warranty. CareFusion liability for damages of any kind shall be limited to the purchase price of the defective unit.

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LTV® 1200 / 1150 Ventilators

Operator’s Manual P/N 19802-001 Rev. F

Notices The LTV® 1200 or 1150 ventilator complies with limitations as specified in IEC 601-1-2 for Medical Electrical Equipment. It does however, use and radiate radio frequency energy. The function of this machine may be adversely affected by the operation of other nearby equipment, such as high frequency surgical diathermy equipment, short-wave therapy equipment, defibrillators, or MRI equipment (except the MR Conditional LTV® 1200). The LTV® 1200 and 1150 ventilator may emit and receive electromagnetic interference. Avoidance of this exposure is recommended whenever possible. The MR Conditional LTV® 1200 System is comprised of only (i.e., no unauthorized accessories): an MR Conditional LTV® 1200 ventilator (P/N 18888-2XX), LTV® 1200 MR Safe 15ft Patient Circuit (P/N 19189-001), MR Conditional Floor Stand (P/N 14982-001), and an LTV® AC adapter (P/N 18053001). The MR Conditional LTV® 1200 System is suitable for use in both 1.5 and 3.0 Tesla (not to exceed 3.0 Tesla static magnetic field) shielded magnetic scanners (see Chapter 16 – MR Conditional System for more information). To ensure that your use of the LTV® 1200 MR Conditional System results in images that are free of an unacceptable artifact, the LTV® 1200 MR Conditional System should be tested prior to initial clinical use (utilizing a suitable phantom) in each intended use MR environment utilizing the ventilator power source (AC Adaptor or SprintPack Lithium-ion Power System) that will be selected for use.

European Regulatory Requirements per 93/42/EEC Medical Device Directives CareFusion European Representative for vigilance reporting within the European Community is:

CareFusion Germany 234 GmbH Leibnizstrasse 7 97204 Hoechberg, Germany Main Office: 49.931.4972.0 Fax: 49.931.4972.423 Email: [email protected] Any product malfunctioning issues that fall under Medical Device Directives Essential Requirements should be directed to CareFusion Germany 234 GmbH.

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LTV® 1200 / 1150 Ventilators

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Notice To Operators Unsafe Operation - Operating the LTV® 1200 / 1150 ventilator without a complete and thorough understanding of its attributes is unsafe and may cause harm to the patient. It is important that this manual be read and understood in its entirety before operating the ventilator. Warnings and Cautions Section - Read the section on Warnings and Cautions carefully before operating the LTV® 1200 / 1150 ventilator. Use and Maintenance - Any questions regarding installing, operating, or maintaining the LTV® 1200 /1150 ventilator, should be directed to a certified CareFusion service technician or CareFusion.

Avis important Fonctionnement dangereux - L'opération d'un ventilateur de la LTV® 1200 / 1150 sans une excellente compréhension de ses attributs est dangereuse et risque de blesser le patient. Il est très important de lire et de comprendre entièrement ce manuel avant de faire fonctionner le ventilateur. Section Avertissements et Attention - Lire attentivement la section Avertissements et Attention avant de procéder à l'opération des ventilateurs de la LTV® 1200 / 1150. Utilisation et entretien - En cas de questions concernant l'installation, l'opération ou l'entretien des ventilateurs de la série LTV®, veuillez vous adresser à un technicien de service certifié de CareFusion ou directement à CareFusion.

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LTV® 1200 / 1150 Ventilators

Operator’s Manual P/N 19802-001 Rev. F

Contents Warranty ... ii Notices ...iii

Chapter 1 - Introduction ... 1-1 Operator’s Safety Information ... 1-2 Warnings ... 1-3 Cautions ... 1-10

Chapter 2 - Ventilator Overview ... 2-1 Indications for Use ... 2-2 Power/Supplies Required ... 2-3 Information/Assistance ... 2-4

Chapter 3 - Breath Types ... 3-1 Breath Types ... 3-1 Volume Control Breaths ... 3-2 Pressure Control Breaths ... 3-3 Pressure Support Breaths ... 3-5 Spontaneous Breaths ... 3-6

Chapter 4 - Ventilation Modes... 4-1 Control Mode ... 4-1 Assist/Control Mode... 4-1 SIMV Mode ... 4-2 CPAP Mode ... 4-3 NPPV Mode ... 4-4 Apnea Backup ... 4-5 Volume Pressure Ventilation ... 4-6 Bias Flow ... 4-6

Chapter 5 - Using the Controls and Indicators ... 5-1 Ventilator Controls ... 5-1 Ventilator Controls (continued) ... 5-2 Setting a Control ... 5-3 Variable Controls ... 5-3 Buttons ... 5-4 Set Value Knob ... 5-4 Extended Features ... 5-4 Bright, Dim and Blank Control Displays... 5-5 Flashing Controls ... 5-6 Dashes ... 5-6 Control Limiting ... 5-6 Control Locking ... 5-7 Control Retention ... 5-7

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LTV® 1200 / 1150 Ventilators

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Chapter 6 - Controls ... 6-1 Assist/Control - SIMV/CPAP - NPPV ... 6-1 Breath Rate ... 6-2 Control Lock ... 6-3 High Pressure Limit ... 6-4 Inspiratory / Expiratory Hold ... 6-5 Inspiratory Hold ... 6-6 Expiratory Hold ... 6-8 Inspiratory Time... 6-10 Low Minute Volume ... 6-11 Low Pressure ... 6-12 Low Pressure O2 Source ... 6-13 Manual Breath ... 6-17 O2 % (O2 Flush) (LTV® 1200 only) ... 6-18 On/Standby ... 6-20 PEEP Control ... 6-22 PEEP Control in NPPV Mode ... 6-22 Pressure Control ... 6-23 Pressure Support ... 6-24 Pressure Support in NPPV Mode ... 6-24 Select ... 6-25 Sensitivity ... 6-26 Set Value Knob ... 6-27 Silence Reset ... 6-28 Tidal Volume ... 6-29 Volume Pressure Mode ... 6-31

Chapter 7 - Displays and Indicators ... 7-1 Airway Pressure ... 7-1 Display Window ... 7-1 Indicators ... 7-1 Battery Level ... 7-2 Charge Status ... 7-4 External Power ... 7-5 NPPV ... 7-6 Patient Effort... 7-6 Vent Inop ... 7-6

Chapter 8 - Monitored Data ... 8-1 Automatic or Manual Data Display Scrolling ... 8-2 PIP xxx cmH2O... 8-3 MAP xx cmH2O ... 8-3 PEEP xx cmH2O... 8-3 f xxx bpm... 8-3 Vte xxx ml ... 8-3 VE xx.x L ... 8-3 Page vi

LTV® 1200 / 1150 Ventilators

Operator’s Manual P/N 19802-001 Rev. F

I:E xx:xx ... 8-3 I:Ecalc xx:xx ... 8-4 Vcalc xxx Lpm ... 8-4 SBT xxx min ... 8-4 xxx f/Vt xx f ... 8-4

Chapter 9 - Ventilator Alarms... 9-1 Alarms ... 9-2 APNEA, APNEA xx bpm ... 9-2 BAT EMPTY ... 9-3 BAT LOW ... 9-5 DEFAULTS ... 9-7 DEFAULTS SET... 9-9 DISC/SENSE ... 9-10 HIGH f... 9-11 HIGH O2 PRES (LTV® 1200 only) ... 9-12 HIGH PEEP ... 9-13 HIGH PRES ... 9-14 HW FAULT ... 9-16 INOP ... 9-17 LOW MIN VOL ... 9-18 LOW O2 PRES (LTV® 1200 only) ... 9-19 LOW PEEP ... 9-20 LOW PRES ... 9-21 NO CAL DATA, NO CAL Monitor Display ... 9-22 POWER LOST ... 9-23 POWER LOW ... 9-24 REMOVE PTNT ... 9-25 RESET / RESET 1 ... 9-26 SBT < f ... 9-27 SBT > f ... 9-28 SBT < f/Vt ... 9-29 SBT > f/Vt ... 9-30 SBT OFF ... 9-31 XDCR FAULT ... 9-32 Alarm Status Messages ... 9-33 f PEEP OFF ... 9-33 HI f/Vt OFF ... 9-33 HI PEEP OFF ... 9-33 H&L PEEP OFF... 9-34 HIGH f OFF ... 9-34 LMV LPPS OFF... 9-34 LMV OFF ... 9-35 LO PEEP OFF ... 9-35 LOCKED ... 9-35 LO f/Vt OFF ... 9-36 Operator’s Manual P/N 19802-001 Rev. F

LTV® 1200 / 1150 Ventilators

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LPPS OFF... 9-36 SBT f OFF ... 9-36 SBT f/Vt OFF ... 9-37 SBT HI f OFF ... 9-37 SBT LO f OFF ... 9-37 SBT TIME ... 9-38 WARMUP xx ... 9-38

Chapter 10 - Extended Features... 10-1 Navigating the Extended Features Menus ... 10-2 Alarm Operations ... 10-3 Alarm Volume ... 10-3 Apnea Interval ... 10-4 High Pressure Alarm Delay ... 10-4 Low Peak Pressure Alarm ... 10-4 High f ... 10-5 High PEEP ... 10-5 Low PEEP ... 10-5 Patient Assist ... 10-6 Exit ... 10-6 Vent Operations ... 10-7 Variable Rise Time... 10-8 Variable Flow Termination ... 10-9 Variable Time Termination ... 10-10 Pressure Control Flow Termination ... 10-11 Leak Compensation ... 10-12 O2 Conserve ... 10-13 O2 Flush (LTV® 1200 only)... 10-14 Control Unlock ... 10-15 Language Selection ... 10-15 Software Version... 10-16 Usage Meter ... 10-16 Communications Setting ... 10-16 Set Date ... 10-17 Set Time... 10-18 Date Format ... 10-18 PIP LED ... 10-19 Model Number / Serial Number ... 10-19 Valve Home Position ... 10-20 Set Defaults ... 10-20 O2 Cylinder Duration (LTV® 1200 only) ... 10-21 Queries ... 10-23 Turning Presets Query on or off ... 10-23 LTV® 1200 / 1150 Presets Table ... 10-24 Turning Leak Test Query on or off ... 10-25 SBT (Spontaneous Breathing Trial) Operations ... 10-26 Page viii

LTV® 1200 / 1150 Ventilators

Operator’s Manual P/N 19802-001 Rev. F

SBT Quick Start Feature... 10-29 SBT Alarms ... 10-29 Transducer Autozero ... 10-30 Airway Pressure Transducer Autozero ... 10-30 Bi-directional Flow Transducer Differential Autozero ... 10-31 Exhalation Flow Transducer Differential Autozero - Narrow ... 10-31 Exhalation Flow Transducer Differential Autozero - Wide ... 10-32 Real Time Transducers ... 10-33

Chapter 11 - Ventilator Checkout Tests ... 11-1 Alarm Test ... 11-3 Display Test ... 11-4 Control Test ... 11-6 Leak Test ... 11-8 Vent Inop Alarm Test ... 11-10 Exit ... 11-12

Chapter 12 - Operating Procedure... 12-1 To Turn the Ventilator On ... 12-1 Before Connecting the Ventilator to a Patient ... 12-3 Procedure for Control Mode Set Up ... 12-5 Procedure for Assist/Control Mode Set Up... 12-6 Procedure for SIMV Mode Set Up ... 12-7 Procedure for CPAP Mode Set Up ... 12-8 Procedure for NPPV Mode Set Up ... 12-9 To Turn the Ventilator Off ... 12-10 LTV® Ventilator Settings Checklist ... 12-11

Chapter 13 - Cleaning, Disinfecting and Sterilizing ... 13-1 Cleaning the Ventilator ... 13-1 Cleaning or replacing the Fan Filter ... 13-2 Cleaning or replacing the Inlet Filter ... 13-3 Cleaning or Replacing the O2 Inlet Filter (LTV® 1200 only) ... 13-4 Cleaning the Exhalation Valve and Reusable Patient Circuit ... 13-6

Chapter 14 - Power and Battery Operation ... 14-1 Using the AC Adapter ... 14-2 Using an External Battery (Not for use with the LTV® 1200 MR Conditional System) ... 14-3 Using the Automobile Cigarette Lighter Adapter (Not for use with the LTV® 1200 MR Conditional System) ... 14-6 Replacing the Automobile Adapter Fuse... 14-10 The Universal Power Supply (UPS) (Not for use with the LTV® 1200 MR Conditional System) 14-10 The SprintPack Li-Ion Power System ... 14-11 Caring for the Internal Battery ... 14-12 Battery Replacement ... 14-12 Battery Disposal ... 14-12

Operator’s Manual P/N 19802-001 Rev. F

LTV® 1200 / 1150 Ventilators

Page ix

Chapter 15 - Troubleshooting ... 15-1 Displays and Buttons ... 15-2 Ventilator Performance ... 15-6 Power and Battery Operation ... 15-15 Alarms ... 15-17 Checkout Test Failures ... 15-24 Test Lung Operations ... 15-26

Chapter 16 - MR Conditional System... 16-1 MR Conditional System Components ... 16-1 MR Conditional System – Conditions for Operation ... 16-2

Appendix A - Ventilator Specifications ... A-1 Appendix B - Set Up / Maintenance ... B-1 Recommended Maintenance Schedule ... B-1 Service Assistance ... B-2

Appendix C - Installation and Checkout... C-1 Installation and Setup ...C-1 Unpacking the Ventilator – Instructions ... C-1 Protective Boots ... C-2 Protective Boot Removal ... C-3 Protective Boot Installation ... C-6 Patient Breathing Circuit – Connection Instructions ... C-10 Oxygen Lines – Connection Instructions ... C-12 Patient Assist Call System – Connection Instructions ... C-14 Communications Port ... C-15 LTM™ Graphics Monitor (Not for use with the LTV® 1200 MR Conditional System) ... C-15 Using the Remote Alarm Cable ... C-16 Checking the Ventilator for Proper Operation ...C-18 Ventilator Proper Operation Worksheet ... C-20

Appendix D - Principles of Operation ... D-1 Overview ...D-1

Appendix E - Event Trace ... E-1 Event Codes ... E-3 Event Codes by Code # ... E-3 Event Codes by Event Name... E-6

Appendix F - Glossary ... F-1 Appendix G - Index... G-1

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LTV® 1200 / 1150 Ventilators

Operator’s Manual P/N 19802-001 Rev. F

Chapter 1 - 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 LTV® 1200 / 1150 ventilator. This manual is designed for use by Respiratory Therapists or other qualified and trained personnel under the direction of a physician and in accordance with applicable state laws and regulations. It contains the following: 

Ventilator Overview



Installation and Checkout



Using the Controls and Indicators



Monitored Data



Ventilator Alarms



Extended Features



Ventilator Checkout tests



Operating Procedure



Troubleshooting



Cleaning, Disinfecting and Sterilizing



Set Up / Maintenance



Power and Battery Operation

Service tests, calibration, and major maintenance operations are described in the LTV® 1200, 1150, and 1100 Ventilator Service Manual (P/N 18603-001).

NOTE Pressure Support and Pressure Control breaths on the LTV® 1200 / 1150 are compensated for PEEP. Delivered pressure is controlled by the Pressure Support or Pressure Control setting and is affected by the PEEP setting. For example, a Pressure Support setting of 20cmH2O and a PEEP setting of 10cmH2O results in a Peak Inspiratory Pressure (PIP) of 30cmH2O.

REMARQUE La pression de support et le contrôle de la pression des respirations sur le LTV® 1200 / 1150 sont compensés pour la pression expiratoire positive (PEP). La pression administrée est contrôlée par le réglage de la pression de support ou par le réglage du contrôle de la pression et elle dépend du réglage PEP. Par exemple, un réglage de la pression de support de 20 cmH2O et un réglage PEP de 10 cmH2O donnent une pression inspiratoire maximale (PImax) de 30 cmH2O.

Operator’s Manual P/N 19802-001 Rev. F

LTV® 1200 / 1150 Ventilators

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Operator’s Safety Information All Operators are to read and understand the following information about Warning, Caution and Note statements before operating the LTV® 1200 / 1150 ventilator.

WARNING “WARNING” statements alert the reader to potentially hazardous situations which, if not avoided, could result in death or serious injury.

AVERTISSEMENT Les énoncés « AVERTISSEMENT » informent le lecteur de situations dangereuses qui, si elles ne sont pas évitées, peuvent entraîner la mort ou des blessures graves.

CAUTION “CAUTION” statements alert the reader to potentially hazardous situations which, if not avoided, could result in equipment damage.

ATTENTION

Les énoncés « ATTENTION » informent le lecteur de situations dangereuses qui, si elles ne sont pas évitées, peuvent causer des dommages à l’équipement.

NOTE “NOTE” statements contain additional information to assist in the proper operation of the LTV® 1200 / 1150 ventilator.

REMARQUE

Les énoncés « REMARQUE » contiennent des informations supplémentaires pour aider à l'opération adéquate des ventilateurs de la LTV® 1200 / 1150.

Bold Text:

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. Abbreviations: LTV® 1200 / 1150 ventilator and the ventilator are used interchangeably throughout this document. The MR Conditional LTV® 1200 ventilator operates the same as an LTV® 1200 ventilator, except where noted throughout this manual.

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LTV® 1200 / 1150 Ventilators

Operator’s Manual P/N 19802-001 Rev. F

Warnings

WARNING Untrained Personnel – Only properly trained personnel should operate the ventilator. The LTV® 1200 / 1150 ventilator is a restricted medical device designed for use by Respiratory Therapists or other properly trained and qualified personnel under the direction of a physician and in accordance with applicable state laws and regulations. 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. Adjustable and Critical Alarms – For safety purposes, all adjustable alarms and all critical alarms must be checked to insure proper operation. Alarms Function Verification - All alarms must be verified as functioning properly on a daily basis. If any alarm malfunctions, immediately contact a certified CareFusion service technician or CareFusion. Patient Monitoring - Patients who are dependent on a ventilator should be constantly monitored by qualified personnel. Such personnel should be prepared to address equipment malfunctions and circumstances where equipment becomes inoperative. An alternative method of ventilation should be available for all patients dependent on the ventilator, and qualified personnel should be fully familiar with emergency ventilation procedures. Alternative Ventilation - It is recommended that an alternative means of ventilating the patient be available at all times and that all ventilator operators be fully familiar with emergency ventilation procedures. Fire or Explosion - Operation of the LTV® 1200 / 1150 ventilator in the presence of flammable gases could cause a 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. Patient Breathing Circuit Disconnection - Inadvertent disconnection of the patient from the patient breathing circuit can be dangerous. Critical Alarms - Failure to 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. Exhalation Valve Diaphragm – Patient ventilation may be ineffective or dangerous if the exhalation valve diaphragm is damaged or worn out. The exhalation valve diaphragm must be inspected on a daily basis and replaced whenever necessary. Sustained HIGH PRES Alarm - During a sustained High Pressure alarm condition (HIGH PRES), 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. See Chapter 15 - Troubleshooting, Alarms for additional information concerning the HIGH PRES alarm. BAT EMPTY Alarm - A BAT EMPTY alarm indicates the internal battery is almost depleted. Connect the ventilator to an external power source immediately.

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LTV® 1200 / 1150 Ventilators

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WARNING Battery run time - When the battery reaches the BAT LOW level, the ventilator will only run for approximately 10 minutes before generating a battery empty alarm (BAT EMPTY). The approximate time shown is based on tests using the nominal settings, a new battery and a full 8 hour 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 PRIOR to the ventilator reaching the BAT EMPTY alarm condition to ensure continuous, uninterrupted patient ventilation INOP Alarm - If an INOP alarm occurs during operation, ventilate the patient using an alternative method, disconnect the ventilator, and immediately contact a certified CareFusion service technician or CareFusion. NO CAL Condition - Operation of the LTV® 1200 / 1150 ventilator under a NO CAL condition may result in inaccurate pressure and volume measurements. Should this condition occur, disconnect the patient from the ventilator, provide an alternative method of ventilation and immediately contact a certified CareFusion service technician or CareFusion. XDCR FAULT Alarm - Continued operation of the LTV® 1200 / 1150 ventilator with an activated XDCR FAULT alarm may result in inaccurate flow and volume measurements. Should this condition occur, disconnect the patient from the ventilator, provide an alternative method of ventilation and immediately contact a certified CareFusion service technician or CareFusion. Personal Injury and Electric Shock - Operation of the LTV® 1200 / 1150 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 CareFusion service technician. Audible Alarms - Failure to immediately identify and correct audible alarm situations may result in serious patient injury. Equipment Malfunction or Failure - The LTV® 1200 / 1150 ventilator has alarms to notify operators of certain conditions and to cease operating upon detecting possible danger. In the event of equipment failure, all ventilator operators should have an alternative method of ventilation available and be fully familiar with emergency ventilation procedures. Improperly Functioning Ventilator - Operation of a ventilator that does not appear to be working properly may be hazardous. If the ventilator is damaged, fails Ventilator Checkout tests or malfunctions in any way, discontinue its use and immediately contact a certified CareFusion service technician or CareFusion. Ventilator Checkout Tests – Be aware that gas is not delivered to the patient during these tests. 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 LTV® 1200 / 1150 ventilator does not deliver gas during the Ventilator Checkout mode (VENT CHECK) or Ventilator Maintenance mode (VENT MTNCE) and should not be used to ventilate a patient during these tests. Inspired Oxygen (FIO2) Concentration – If the patient has a variable respiratory rate, his/her minute ventilation will fluctuate. If exact concentrations of inspired oxygen (FIO2) are required to be delivered to the patient, it is recommended that an accurate oxygen analyzer with alarms be used. O2 Cylinder Duration Information (LTV® 1200 only) - The accuracy of the displayed useable amount of oxygen remaining in an external O2 cylinder (O2 DUR hh:mm) is dependant on the precision of the pressure gauge used on the O2 cylinder and the accuracy of the information provided by the operator in the O2 CYL DUR menu settings. The calculated/displayed useable amount of oxygen information is to be used for reference purposes only.

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LTV® 1200 / 1150 Ventilators

Operator’s Manual P/N 19802-001 Rev. F

WARNING Ventilation Variables and O2 Consumption - Variations in the patient’s minute ventilation, I:E ratio and/or ventilator setting changes or equipment status (i.e. circuit leaks) affect the consumption rate of oxygen. When warranted by a patients condition, it is recommended that a back-up cylinder or alternative source of oxygen be available at all times. Before Using Automobile Cigarette Lighter or Power Outlets - Before using Automobile Cigarette Lighter or Power Outlets as a power source for the LTV® 1200 / 1150, assure that the ventilator’s internal battery is in good condition and fully charged. Poor cigarette lighter or power outlet connections, electrical system defects (battery, charging system, etc.), or use of vehicle accessories (air conditioner, high current lights, high power audio equipment, etc.) could result in less than the required voltage being delivered to the ventilator, generate a POWER LOST alarm and switch the ventilator’s power source to the internal battery. Unauthorized Parts or Accessories – Serious harm to the patient may result from the use of unauthorized parts or accessories. Only items expressly approved by CareFusion may be used in conjunction with the LTV® 1200 / 1150 ventilators. Unapproved Adapters – Only CareFusion Accessories should be used to connect the ventilator to Patient Assist Call Systems. These accessories incorporate safety features to reduce the risk of shock. Do not attempt to modify these accessories in any way. Patient Assist Call Connector – Do not apply more than 25V rms or 32VDC to the Patient Assist Call connector. Ventilator Service and Repair - All servicing or repair of the LTV® 1200 / 1150 ventilator must be performed only by a service technician certified by CareFusion. Patient Circuits – CareFusion Patient Circuits, Exhalation Valve Assemblies and Water Traps are shipped clean, not sterile. Ultra Violet Light Sensitivity – The material used in the tubing of the Reusable Patient Circuits is not UV stable. Avoid exposure of the tubing to UV light. Mounting Screws - Refer to the information contained in CareFusion Replacement Screws Kit, P/N 11149, to determine the appropriate accessories mounting screws or accessories replacement screws location, type and length to use when removing or exchanging external accessories on an LTV® ventilator. Mounting Screw Use – Internal damage to the ventilator may result if the wrong length mounting screws are used when installing or removing external accessories. Patient Circuit Accessories - The use of accessories such as Speaking Valves, Heat-Moisture Exchangers and Filters create additional patient circuit resistance and in the event of a disconnection, may impede the generation of a Low Pressure alarm. Ensure that the Low Pressure alarm settings accommodate these types of accessories when used in combination with patient circuits. Low Minute Volume Control Settings - The Low Min. Vol. control should be set to its highest clinically appropriate value. If there is a clinical need to set the Low Minute Volume alarm to lower values or off (“- - -“), perform a clinical assessment to determine if an alternative monitor (i.e. a Pulse Oximeter with an audible alarm, or a Cardio Respiratory Monitor) should be used. The MR Conditional LTV® 1200 System is specified as - An LTV® 1200 Ventilator (P/N 188882XX), LTV® 1200 MR Safe 15ft Patient Circuit (P/N 19189-001), MR Conditional Floor Stand (P/N 14982-001), and a LTV® AC adapter (P/N 18053-001). Adding not approved parts or accessories may cause patient and/or operator harm.

Operator’s Manual P/N 19802-001 Rev. F

LTV® 1200 / 1150 Ventilators

Page 1-5

Cautions

CAUTION Ventilator Sterilization – To avoid irreparable damage to the LTV® 1200 / 1150 ventilator, do not attempt to sterilize it. Cleaning Agents – To avoid damaging the ventilator’s plastic components and front panel, do not use cleaning agents containing ammonium chloride, other chloride compounds, more than 2% glutaraldehyde, phenols, or abrasive cleaners. Ventilator Immersion - Do not immerse the ventilator in liquids. Reusable Patient Circuit Components - To avoid degradation of the reusable patient circuit components, do not exceed the following constraints:  50 cleaning cycles or 1 year (whichever comes first) Steam Autoclave:  Pressure: 20 PSIG  Temperature: 275°F (135°C)  Time: 6 minutes Liquid Sterilizing Agent: Do not use any of the following solutions to clean, disinfect, or sterilize the patient circuit: 

Ketone



Chlorinated solutions



Phenol (>5%)



Chlorinated hydrocarbons



Inorganic acids



Aromatic hydrocarbons



Formaldehyde



Hypochlorite



Liquid agents containing more than 2% glutaraldehyde

Pasteurization:  A 30-minute warm water detergent and a 30-minute 165°F (74°C) hot water cycle.  Drying in a sterile drier for more than 1 hour or 140°F (59°C). Gas (ETO):  Temperature: 131°F (55°C) Differential Pressure Ports - A low pressure air nozzle with flow less than 10 liters per minute should be used for cleaning the differential pressure ports. Exhalation Valve Cleaning - Do not pour or spray liquid cleaners into the exhalation valve. Patient Wye Installation – After cleaning, install the patient wye in the patient circuit so the proximal sense lines are oriented up while operating.

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LTV® 1200 / 1150 Ventilators

Operator’s Manual P/N 19802-001 Rev. F

CAUTION Care of the Exhalation Valve - The exhalation valve is a delicate assembly and may be damaged if;  Care is not exercised when handling or cleaning it.  Cleaning instruments or foreign bodies are inserted into it.  High-pressure gas nozzles are used to dry it. Front Panel Cleaning – Do not pour or spray liquid cleaners onto the front panel. Care of Bacterial Filters – If bacterial filters are used in conjunction with the LTV® 1200 / 1150 ventilator, comply with all procedures as specified by the filter manufacturer. Wet or Damp Filters - Do not install a wet or damp filter into the LTV® 1200 / 1150 ventilator. This could damage the ventilator. Oxygen Supply Contamination - The accuracy of the oxygen delivery capabilities of LTV® 1200 / 1150 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, properly filtered1 and that the ventilator’s O2 Inlet Port Cap is securely installed on the O2 Inlet Port whenever the ventilator is not connected to an external oxygen supply. Proximal Sense Lines - Do not remove the proximal sense lines from the patient wye. Automobile Cigarette Lighter and Power Outlets – Automobile cigarette lighter and power outlets are normally wired for a positive center contact and ground sleeve contact. Connecting the ventilator to an improperly wired outlet will cause the adapter fuse to blow and may damage the adapter or the ventilator. Automobile Cigarette Lighter Outlet Power Rating - Running a ventilator from an improperly rated automobile cigarette lighter outlet (less than 20 amperes) may cause a fuse in the automobile to blow, causing the ventilator and possibly other accessories in the automobile to stop operating. Automobile Cigarette Lighter Adapter - Do not operate the ventilator from the Automobile Cigarette Lighter Adapter while starting the vehicle or when jump starting the automobile battery. Doing so may cause damage to the ventilator. Automobile Cigarette Lighter Adapter Tip - Use care when disconnecting the Automobile Cigarette Lighter Adapter after use, its tip may be hot. Automobile Cigarette Lighter Outlet – Depending on the condition of the automobile battery, whether the automobile is turned off, being started or running, automobile cigarette lighter outlets can provide varying levels of voltage (in some, the outlet only operates when the vehicle is running). Verify which power source the ventilator is using by checking the External Power LED on the ventilator. Remote Alarm - Always verify that the remote alarm properly reports the LTV® 1200 / 1150 ventilator alarms before use. Remote Alarm - Always follow the remote alarm manufacturer’s usage and maintenance requirements to guarantee proper function of the device.

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In addition to the existing internal O2 Inlet filter, P/N 19845-001, an External, In-Line Oxygen Filter (P/N 14470) is available from CareFusion.

Operator’s Manual P/N 19802-001 Rev. F

LTV® 1200 / 1150 Ventilators

Page 1-11

CAUTION External Battery Pack - The External Battery Pack should only be connected to the LTV® 1200 / 1150 ventilator using the CareFusion External Battery Cable (PN 10802). This cable is pre-wired and properly terminated to ensure safe connection of the External Battery Pack to the ventilator. Electrical Grounding – In the event of a loss of electrical protective ground, touching the ventilator could result in electrical shock. To ensure grounding and avoid this danger, use only the unmodified power cord originally supplied with the LTV® 1200 / 1150 ventilator, maintained in good condition and connected to a properly wired and grounded electrical power outlet. Do not cover the ventilator – To avoid damage to the ventilator, do not cover while operating or position relative to other objects such that the operation or performance of the ventilator may be adversely affected. Ensure that sufficient space exists around the ventilator while in use to allow free circulation of gases. Electrostatic Discharge – The use of electrically conductive hoses and tubing is not recommended. The use of such materials may result in damage to the ventilator from electrostatic discharge. External DC Power Source or External Battery - When connecting the LTV® 1200 / 1150 ventilator to an external DC power source or external battery, use only the approved method and connectors specified in Chapter 14 - Power and Battery Operation. AC Power Source - When connecting the ventilator to an AC power source, use only the approved LTV® AC Power Adapter. AC Power Earth Ground Validity – If the validity of the AC power earth ground connection is in doubt, use the internal battery, an external battery, or an external DC power source to operate the LTV® 1200 / 1150 ventilator. Fuse Fire Hazard – Replacement of existing fuses with fuses with different voltage or electrical current ratings may cause a fire. Storage Temperature - Storing the LTV® 1200 / 1150 ventilator at temperatures above 60°C (140°F) for long periods can damage the internal battery and cause expected battery duration to degrade. Patient Assist Call Connector – Do not apply more than 25V rms or 32VDC to the Patient Assist Call connector. Ventilator Checkout Tests - LTV® 1200 / 1150 ventilator Checkout tests must be performed before initial use of the ventilator. Rerun the tests whenever a question about the ventilator’s operation arises. Release Button - To avoid damaging the ventilator or the power connector, push the release button on the connector before removing it from the ventilator power port or the power port pigtail connector.

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LTV® 1200 / 1150 Ventilators

Operator’s Manual P/N 19802-001 Rev. F

Symbols Symbol

Compliance3

Title

Application

ISO 3864 (Prev. IEC 348) Symbol No.B.3.1

Caution (refer to accompanying documents)

Used to direct the user to the instruction manual where it is necessary to follow certain specified instructions where safety is involved.

IEC 417 Symbol No. 417-IEC-5016

Fuse

To indicate the fuse boxes, for example, and their location.

IEC 417 Symbol No. 417-IEC-5035

Output

To identify an output terminal when it is necessary to distinguish between inputs and outputs.

IEC 417 Symbol No. 417-IEC-5019

Protective earth (ground)

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.

IEC 417 Symbol No. 417-IEC-5333

Type BF equipment.

To mark a type BF equipment complying with IEC Publication 601.

IEC 417 Symbol No. 417-IEC-5031

Direct Current

To indicate on the rating plate that the equipment is suitable for direct current only; to identify relevant terminals.

IEC 417 Symbol No. 417-IEC-5032

Alternating current

To indicate on the rating plate that the equipment is suitable for alternating current only; to identify relevant terminals.

IEC 417 Symbol No. 417-IEC-5172

Class II equipment

To identify equipment meeting safety requirements specified for Class II equipment.

Sound; audio

Used to identify controls or terminals related to audio signals.

Directive 2002/96/EC

Waste Container

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.

ASTM F2503-05

MR Conditional

To identify equipment that has been demonstrated to pose no known hazards in a specified MR environment with specified conditions of use.

IEC 60417 Symbol No. 5182

3

Reference IEC Medical Electrical Equipment, 2nd. Edition 1988

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LTV® 1200 / 1150 Ventilators

Operator’s Manual P/N 19802-001 Rev. F