LTV 1000, 950, and 900 Series Operators Manual Rev E March 2013

Document Revision History Document Revision Level

Revision Date

Rev A, ECO 6591

5/26/10

Rev B, ECO 6713

10/7/10

Rev C, ECO 7022

5/8/12

Rev. D, ECO 81024

February 2013

Rev. E, 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® 1000, LTV® 950, LTV® 900, and LTV® are trademarks belonging to CareFusion Corporation. Copyright © 2010–2013 CareFusion Corporation or one of its subsidiaries. All rights reserved.

Operator’s Manual p/n 19795-001 Rev. E

LTV® Series ventilator

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Warranty CareFusion warrants that the LTV® Series 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) Patient circuit components, including hoses, exhalation manifold, and other associated parts are warranted for sixty (60) days from date of shipment. 2) 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® Series ventilator Operator’s and Service Manuals, is not covered under the foregoing warranty. The foregoing warranty does not apply to defects resulting from: 1) Improper or inadequate maintenance of the unit; 2) Improper use or misuse of the unit; 3) Unauthorized modifications or repairs to the unit; 4) Use of the unit with unauthorized accessories, e.g. external battery or AC adapter. 5) Operation of the unit 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’s liability for damages of any kind shall be limited to the purchase price of the defective unit.

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Operator’s Manual p/n 19795-001 Rev. E

Notices The LTV® Series 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. The LTV Series ventilator may emit and receive electromagnetic interference. Avoidance of this exposure is recommended whenever possible. Federal law restricts this device to sale by or on the order of a physician.

European Regulatory Requirements per 93/42/EEC Medical Device Directives CareFusion’s 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.

Operator’s Manual p/n 19795-001 Rev. E

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Notice To Operators Unsafe Operation - Operating the LTV® Series 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® Series ventilator. Use and Maintenance - Any questions regarding installing, operating, or maintaining the LTV® Series ventilator, should be directed to a certified CareFusion service technician or CareFusion.

Avis important Fonctionnement dangereux - L'opération d'un ventilateur de la série LTV® 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 série LTV®. 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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Operator’s Manual p/n 19795-001 Rev. E

Contents Warranty ... ii Notices ...iii

Chapter 1 - Introduction ... 1-1 Operator’s Safety Information ... 1-2 Warnings ... 1-3 Cautions ... 1-12 Symbols ... 1-18

Chapter 2 - Ventilator Overview ... 2-1 Intended Use ... 2-1 Power/Supplies Required ... 2-2 Information/Assistance ... 2-3

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 Apnea Backup ... 4-4 NPPV ... 4-5 Volume / Pressure Ventilation ... 4-6 Bias Flow ... 4-6

Chapter 5 - Using the Controls and Indicators ... 5-1 Ventilator Controls ... 5-1 Setting a Control ... 5-2 Variable Controls ... 5-2 Buttons ... 5-3 Set Value Knob ... 5-3 Extended Features ... 5-3 Mechanical Controls ... 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 Operator’s Manual p/n 19795-001 Rev. E

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Control Retention ... 5-7

Chapter 6 - Controls ... 6-1 Assist/Control / SIMV/CPAP Modes... 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 (LTV® 1000 Only) ... 6-13 Manual Breath ... 6-17 O2 % (O2 Flush) (LTV® 1000 Only) ... 6-18 On / Standby ... 6-20 PEEP Valve ... 6-21 Pressure Control (LTV® 1000 & 950 Only)... 6-23 Pressure Support ... 6-25 Select ... 6-27 Sensitivity ... 6-28 Set Value Knob ... 6-29 Silence / Reset ... 6-30 Tidal Volume ... 6-31 Volume / Pressure Mode (LTV® 1000 & 950 Only) ... 6-33

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 ... 8-4

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Operator’s Manual p/n 19795-001 Rev. E

VE xx.x L ... 8-4 I:E xx:xx ... 8-4 I:Ecalc xx:xx ... 8-4 Vcalc xxx Lpm... 8-4

Chapter 9 - Ventilator Alarms... 9-1 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® 1000 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® 1000 Only) ... 9-19 LOW PRES ... 9-20 NO CAL DATA, NO CAL Monitor Display ... 9-21 POWER LOST ... 9-22 POWER LOW ... 9-23 REMOVE PTNT ... 9-24 RESET / RESET 1 ... 9-25 XDCR FAULT ... 9-26 Alarm Status Messages ... 9-27 f PEEP OFF ... 9-27 HI PEEP OFF ... 9-27 HIGH f OFF ... 9-28 LMV LPPS OFF... 9-28 LMV OFF ... 9-28 LOCKED ... 9-29 LPPS OFF ... 9-29 WARMUP xx ... 9-30

Chapter 10 - Extended Features ... 10-1 Navigating the Extended Features Menus ... 10-2 Alarm Operations ... 10-3

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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 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 NPPV Mode ... 10-13 O2 Flush (LTV® 1000 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® 1000 Only) ... 10-21 Exit ... 10-22 Transducer Autozero ... 10-23 Airway Pressure Transducer Autozero ... 10-23 Bi-directional Flow Transducer Differential Autozero ... 10-24 Exhalation Flow Transducer Differential Autozero - Narrow ... 10-25 Exhalation Flow Transducer Differential Autozero - Wide ... 10-26 Real Time Transducers ... 10-27

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

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Chapter 12 - Operating Procedure ... 12-1 To Turn the Ventilator On ... 12-1 Before Connecting the Ventilator to a Patient ... 12-2 Procedure for Control Mode Set Up ... 12-4 Procedure for Assist / Control Mode Set Up... 12-5 Procedure for SIMV Mode Set Up ... 12-6 Procedure for CPAP Mode Set Up ... 12-7 Procedure for NPPV Mode Set Up ... 12-8 To Turn the Ventilator Off ... 12-9 LTV® Ventilator Settings Checklist... 12-10

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... 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 ... 14-3 Using the Automobile Cigarette Lighter Adapter ... 14-6 Replacing the Automobile Adapter Fuse... 14-10 The Universal Power Supply (UPS) ... 14-10 The SprintPack Li-Ion Power System ... 14-10 Caring for the Internal Battery ... 14-11 Battery Disposal ... 14-11

Chapter 15 - Troubleshooting ... 15-1 Displays and Buttons ... 15-2 Ventilator Performance ... 15-5 Power and Battery Operation ... 15-14 Alarms ... 15-16 Checkout Test Failures ... 15-23 Test Lung Operations ... 15-25

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

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Unpacking the Ventilator – Instructions ... C-1 Protective Boots ... C-2 Protective Boot Removal ... C-3 Protective Boot Installation ... C-6 Oxygen Lines – Connection Instructions ... C-12 Patient Assist Call System – Connection Instructions ... C-14 Communications Port ... C-15 LTM™ Graphics Monitor ... 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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Operator’s Manual p/n 19795-001 Rev. E

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® 1000, 950, and 900 Ventilators. It 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® Series ventilator Service Manual (P/N 10665).

Operator’s Manual p/n 19795-001 Rev. E

LTV® Series ventilator

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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® Series 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® Series ventilator.

REMARQUE

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

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LTV® Series ventilator

Operator’s Manual p/n 19795-001 Rev. E

Warnings

WARNING Untrained Personnel – Only properly trained personnel should operate the ventilator. The LTV® Series 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® Series 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.

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WARNING BAT EMPTY Alarm - A BAT EMPTY alarm indicates the internal battery is almost depleted. Connect the ventilator to an external power source immediately. 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® Series 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® Series 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® Series 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. NPPV Mode – NPPV1 is not a life support mode and is not suitable for patients that require life support ventilation. NPPV Mode should only be used for supplemental ventilation of non-life support patients. NPPV Mode - When operating in NPPV1 mode, many of the standard alarms are disabled. This may result in reduced ventilation accuracy should a problem occur. Carefully read Chapter 4 - Ventilation Modes, NPPV, before selecting this mode of operation. Accuracy of PEEP setting - Variations in the patient’s breathing pattern and/or leaks in the patient circuit (including leaks around the tracheostomy tube cuff) can affect PEEP. PSI recommends that the clinician set the PEEP to the prescribed level on a test lung while observing the PEEP value in the LTV display window. The clinician should also periodically monitor the PEEP value in the LTV display window. Using an inaccurate PEEP setting due to a patient leak can result in less than prescribed PEEP or undesirable increases in patient circuit pressure when the patient circuit leak changes. Audible Alarms - Failure to immediately identify and correct audible alarm situations may result in serious patient injury.

1

NPPV, Non-Invasive Positive Pressure Ventilation

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WARNING Equipment Malfunction or Failure - The LTV® Series 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® Series 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 - 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. 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® ventilator, 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® Series 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.

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WARNING Ventilator Service and Repair - All servicing or repair of the LTV® Series ventilator must be performed only by a service technician certified by CareFusion Disabled Oxygen Inlet Pressure Alarms - When the oxygen blending option is not installed, the Oxygen Inlet Pressure Alarms are disabled. 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 “Re-usable” Patient Circuits is not UV stable. Avoid exposure of the tubing to UV light. PEEP Valve Rotation – Attempting to adjust the PEEP valve counterclockwise past zero (0) may damage the PEEP valve assembly or cause circuit leaks.Accessories 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® Series 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. Specific Boot Replacement Screw Location - One leg of the upper protective boot has an additional screw hole (furthest from the end of the leg); On earlier version ventilators (screw was located in the upper hole in the leg of the boot) the use of a 3/16” mounting screw is required. On current version ventilators (screw was located in the lower hole in the leg of the boot) the use of a 1/4” mounting screw is required. Specific Boot Installation Screw Location - One leg of the upper protective boot has an additional screw hole (furthest from the end of the leg); On earlier version ventilators, the screw hole will align with the upper hole in the boot and requires the use of the 1/4” mounting screw. On current version ventilators, the screw hole will align with the lower hole in the boot and requires the use of the 3/8” mounting screw. 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 Minute Volume 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 Oxymeter with an audible alarm, or a Cardio Respiratory Monitor) should be used.

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Cautions

CAUTION Ventilator Sterilization – To avoid irreparable damage to the LTV® Series 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. 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.

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CAUTION Care of Bacterial Filters – If bacterial filters are used in conjunction with the LTV® Series 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® Series ventilators. This could damage the ventilator. Oxygen Supply Contamination - The accuracy of the oxygen delivery capabilities of LTV® ventilators 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 filtered2 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® Series ventilator alarms before use. Remote Alarm - Always follow the remote alarm manufacturer’s usage and maintenance requirements to guarantee proper function of the device. External Battery Pack - The External Battery Pack should only be connected to the LTV® Series 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® Series 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.

2

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.

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LTV® Series ventilator

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CAUTION 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® Series 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® Series 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® Series 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® Series 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® Series ventilator

Operator’s Manual p/n 19795-001 Rev. E