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Thoratec TLC-II Instructions For Use Manual

Portable vad driver and system
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Thoratec
VAD Driver and System
®
TLC-II
INSTRUCTIONS FOR USE
105800.E 03/2013
®
Portable
Caution: Federal
(USA) law restricts
this device to sale
by or on the order
of a physician.

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  • Page 1 ® Thoratec ® TLC-II Portable VAD Driver and System INSTRUCTIONS FOR USE 105800.E 03/2013 Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
  • Page 3 TLC-II apply to both driver models. " " Sections specific to the newer, enhanced model are referred to as TLC-II while the Plus first generation, older model is referred to as TLC-II Original. These two models can be identified by the following physical characteristics: TLC-II Original - "IVAD/PVAD"...
  • Page 4 4. Post-cardiotomy recovery patients who are unable to be weaned from cardiopulmonary bypass. The TLC-II portable pneumatic driver is intended for use both inside and outside the hospital, or for transportation of VAD patients via ground ambulance, fixed-wing aircraft, or helicopter.
  • Page 5 For patients using the TLC-II or receiving biventricular support on the Dual Drive Console driver, an additional TLC-II or Drive Console must be available as a back-up to be used in the event of a failure of the primary driver.
  • Page 6 Personnel should be trained how to hand pump a VAD in the event of a drive console or TLC-II failure. If for any reason there is a driver failure, blood flow can be maintained to the patient and stasis prevented in the blood pump by disconnecting the VAD airline tube from the driver and connecting it to the hand pump for the short period of time necessary to connect the back-up drive console.

  • Page 7: Table Of Contents

    ADVERSE EVENTS .....................54 SYSTEM OPERATION.........................57 THORATEC TLC-II PORTABLE DRIVER QUICK REFERENCE GUIDE ....57 SETTING UP THE TLC-II FOR A PATIENT FOR THE FIRST TIME USING THE HEARTTOUCH COMPUTER ................60 SETTING UP THE TLC-II WITHOUT THE HEARTTOUCH COMPUTER ....70 SWITCHING A PATIENT FROM A DUAL DRIVE CONSOLE TO A TLC-II ....71 USING THE TLC-II DRIVER WITH THE TLC-II AC ADAPTER ........74...
  • Page 8 Thoratec TLC-II Portable VAD Driver and System Instructions for Use TABLE OF CONTENTS (continued) UNPACKING AND SYSTEM ASSEMBLY..................115 DOCKING STATION ....................115 CHARGER AND BATTERIES ..................115 DRIVER ........................116 SYSTEM CHECK-OUT ....................116 APPENDIX A TLC-II TRAINING CHECKLIST FOR STAFF ................117 TLC-II TRAINING CHECKLIST FOR PATIENT/CAREGIVER ..........118 HAND PUMP TRAINING .......................119...
  • Page 9 TLC-II Control Panel Display During Initialization ............62 Figure 4.6 TLC-II Control Panel ....................63 Figure 4.7 TLC-II Driver Top Interface Showing Port Occluder and Set Up Plug ......63 Figure 4.8a HeartTouch Computer "VAD Settings Screen" for the TLC II Original ......65 Figure 4.8b HeartTouch Computer "VAD Settings Screen"...
  • Page 10 Thoratec TLC-II Portable VAD Driver and System Instructions for Use TABLE OF CONTENTS - FIGURES AND TABLES (continued) Figure 4.17 Battery Test Button and Battery Lights ................75 Figure 4.18 TLC-II Driver Accessory Pocket with Accessories ............76 Figure 4.19 TLC-II Driver Battery Removal ..................76 Figure 4.20...

  • Page 11: General Information

    PA= pulmonary artery, RA = right atrium, Apex = left ventricular apex. NOTE: Unless otherwise stated, all references to "TLC-II" apply to both driver models. Sections specific to the newer, enhanced model are referred to as TLC-II , while the original model is referred to as TLC-II Original.

  • Page 12: Figure 1.2 Thoratec Ivad

    Thoratec TLC-II Portable VAD Driver and System Instructions for Use Figure 1.2 Thoratec IVAD: Biventricular IVAD with left ventricular and right atrial cannulation (left), biventricular IVAD with left ventricular and right ventricular cannulation (middle), and left IVAD with left ventricular cannulation (right).

  • Page 13: Vad Blood Pump

    Using light reflection, the optic sensor sends a "full" signal via the signal processor lead to the DDC or TLC-II. When the IVAD is empty, a green indicator light illuminates on the signal processor. The percutaneous line, composed of wire reinforced Thoralon wrapped in velour, contains the optic sensor and pneumatic leads.

  • Page 14: Tlc-Ii Driver Principles Of Operation

    15003, for more detailed descriptions of the various cannulae configurations. Dual Drive Console The Thoratec VADs can be controlled with either the TLC-II or the Thoratec Dual Drive Console. These drive systems are designed to be interchangeable and both provide univentricular or biventricular pneumatic control of the pumps.
  • Page 15 VAD after recovery of the natural ventricle. Both the TLC-II and the Dual Drive Console automatically use this mode (which is called "Asynchronous" on the Dual Drive Console) if another mode is not chosen.

  • Page 16: Cautions

    Use, document number 15003. Do not connect items or equipment that have not been specified as part of the System. TAMPER EVIDENT SEAL. Do not open the back panel of the TLC-II Driver. If the driver needs service, contact Thoratec Customer Service.
  • Page 17 Two emergency hand pumps are available REMOVE KEY DURING OPERATION. The key should be removed from the key switch when the TLC-II is in operation and placed in the pocket of the carrying case. It cannot be removed when the unit is switched off.

  • Page 18: Contraindications

    13. Do not discard batteries. Return batteries to Thoratec for disposal. Used batteries are hazardous waste. CONTRAINDICATIONS Never attempt to use the TLC-II as an intra-aortic balloon pump or for any use other than that specifically indicated in the operating instructions. For the TLC-II Original Only Do not use on PVAD or IVAD patients requiring >160 mmHg drive pressure and...
  • Page 19 Thoratec TLC-II Portable VAD Driver and System Instructions for Use 1.6.1.1 Declaration Concerning General Safety Standards Type Degree of Protection Mode of Operation Continuous 100% EtO for blood pump and all Method of Sterilization sterile accessories Type of protection against electrical...
  • Page 20 1.6.1.2 Declaration and Guidance Concerning Electromagnetic Emissions The TLC-II and PVAD/IVAD System are intended for use in the electromagnetic environment specified below. The customer or the user of either device should ensure that it is used in such an environment.
  • Page 21 Thoratec TLC-II Portable VAD Driver and System Instructions for Use Declaration and Guidance Concerning Electromagnetic Immunity for all Thoratec PVAD and IVAD Equipment Electromagnetic IEC 60601-1-2 Immunity Test Compliance Level Environment Test Level Guidance Floors should be wood, concrete, Electrostatic discharge TLC-II on a Docking Station or ceramic tile.
  • Page 22 Immunity for Life-Sustaining Thoratec PVAD and IVAD Equipment, including VAD, Driver, and Batteries The TLC-II and PVAD/IVAD System are intended for use in the electromagnetic environment specified below. The customer or the user of either device should ensure that they are used in such an electromagnetic environment.
  • Page 23 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the TLC-II is used exceeds the applicable RF compliance level above, TLC-II should be observed to verify normal operation. If abnormal...
  • Page 24 Thoratec TLC-II Portable VAD Driver and System Instructions for Use The TLC-II and PVAD/IVAD System have been tested and found to comply with the limits for medical devices to the IEC 60601-1-2:2001 Medical electrical equipment — Part 1-2: General requirements for safety — Collateral standard: Electromagnetic compatibility.

  • Page 25: Tlc-Ii Ac Adapter

    Thoratec TLC-II Portable VAD Driver and System Instructions for Use 1.6.3 Environmental Conditions Operating Temperature (Driver, AC Adapter, HeartTouch Tablet, Docking Station): 10° to 40°C (50° to 104°F) Operating Temperature (Charger, Car Power Adapter): 10° to 35°C (50° to 95°F) Transportation/Storage Temperature: -20°...
  • Page 26 Thoratec TLC-II Portable VAD Driver and System Instructions for Use Docking Station: Input Voltage: 100-240 VAC, 50/60 Hz Voltage is key selectable to 100, 120, 220, and 240 VAC. Output Voltages: Computer power output 12 & 5 VDC. Two power outputs for drivers, 15 VDC each.
  • Page 27 Thoratec TLC-II Portable VAD Driver and System Instructions for Use 1.6.7 Input/Output Characteristics Connection Color Code Characteristics LVAD Electrical Lead (5ft) LVAD Full Signal (PVAD Only) LVAD Pneumatic Lead (5ft) Pneumatic Drive for LVAD RVAD Electrical Lead (5ft) Blue RVAD Full Signal (PVAD...

  • Page 28: List Of Symbols

    Thoratec TLC-II Portable VAD Driver and System Instructions for Use LIST OF SYMBOLS Off (power: disconnect from the mains) On (power: connect to the mains) Alternating Current Type CF Equipment Attention, consult ACCOMPANYING MANUAL External Power (Direct Current) Protective Earth (ground)

  • Page 29: Description

    Each rechargeable battery will provide at least 55 NOTE: Unless otherwise stated, all references to "TLC-II" apply to both driver models. Sections specific to the newer, enhanced model are referred to as TLC-II , while the original model is referred to as TLC-II Original.
  • Page 30 Thoratec TLC-II Portable VAD Driver and System Instructions for Use (BiVAD) to 80 (LVAD or RVAD) minutes of power to the TLC-II. The TLC-II Driver discharges 1 battery at a time before automatically switching to the other battery. To reduce driver weight, the battery charger is a separate component, located on the Docking Station.

  • Page 31: Figure 2.2 Tlc-Ii Driver Top Interface And Control Panel

    Thoratec TLC-II Portable VAD Driver and System Instructions for Use 2.1.3 Interfaces At the top of the TLC-II Driver are the system interfaces, the control panel, and the two rechargeable batteries (Figure 2.2). Above the control panel are the color-coded pneumatic and electrical lead connections providing interfaces with the VADs, external power, and the external HeartTouch computer.

  • Page 32: Figure 2.3 Tlc-Ii Driver Control Panel

    2.1.4 Control Panel On the top of the TLC-II Driver (Figure 2.3) is the control panel (a), which provides information about TLC-II function. On the sides of the control panel are 2 yellow change battery lights (b), 1 for battery A (on the left side) and battery B (on the right side), each of which illuminates when the rechargeable battery needs to be replaced with a fully charged battery.
  • Page 33 Investigate and correct the cause of any alarm condition. Initialize: Simultaneously holding down the MODE (e), SCROLL (g) and SILENCE (j) keys for 5 seconds will initialize settings in the TLC-II to the following default values: BiVAD mode...
  • Page 34 Thoratec TLC-II Portable VAD Driver and System Instructions for Use 2.1.5 Power The TLC-II is designed to operate with at least 2 power sources: either two batteries, or one battery and external power. It will operate with one power source, but after the number of power sources is reduced to one, a warning sounds every 30 seconds until a second power source is connected.

  • Page 35: Tlc-Ii Battery

    The TLC-II AC Adapter can be connected to the TLC-II Driver and to an electrical outlet to preserve battery life. External power is preferentially used by the TLC-II when it is available. The power adapter provides 15 VDC input to the TLC-II and operates over a wide range of input voltages (100-250 VAC, 50/60 Hz).

  • Page 36: Figure 2.6 Tlc-Ii Driver Emergency Battery Access

    10 minutes of battery power remain, an alarm will sound indicating that the battery needs to be replaced with a fully charged battery. This battery is located in the bottom left corner of the TLC-II, accessed after removing the TLC-II from its carrying case (Figure 2.6).

  • Page 37: Computer Interface

    Thoratec TLC-II Portable VAD Driver and System Instructions for Use 2.1.6 Carrying Case The TLC-II is designed to be used at all times in its nylon carrying case, which allows the TLC-II Driver to be carried either by hand, with the shoulder strap, or by placing it on the mobility cart.

  • Page 38: Tlc-Ii Docking Station

    AC power is connected through an isolation transformer to the battery charger and up to three internal DC power supplies: one 15 VDC power supply for each of the TLC-II Drivers, and a separate power supply for the HeartTouch computer.

  • Page 39: Docking Station Main Power Receptacle And On-Off Switch (Lower Rear Panel)

    (lower rear panel) The top drawer of the Docking Station contains two bays for holding 2 TLC-II Drivers in their carrying cases. The front bay is for the driver in use, and the back bay provides room for a backup driver.

  • Page 40: Figure 2.10 Connection Between Docking Station And Tlc-Ii Driver

    Thoratec TLC-II Portable VAD Driver and System Instructions for Use Docking Station Connectors: External Power (yellow) Computer (green) TLC-II Driver Connectors: External Power (yellow) and Computer (green) TLC-II Docking Station Docking Station Drawer Figure 2.10 Connection between Docking Station and TLC-II Driver 2.2.1.2...

  • Page 41: Battery Charger

    2.2.2 HeartTouch Tablet The HeartTouch Tablet (Figure 2.11) provides similar functionality as the TLC-II Docking Station but in a smaller form factor that is portable and allows wireless communication with the TLC-II when used with Wireless Adapter. The HeartTouch Tablet is intended for clinicians’ use only and should never accompany a patient out of the hospital when he or she is discharged.

  • Page 42: Hearttouch Computer

    Since the TLC-II Driver has its own internal microcontroller that controls all TLC-II functions, once it is in ambulatory use in a stable patient, the TLC-II does not need to be connected to the HeartTouch computer.

  • Page 43: Figure 2.13 Hearttouch Tablet

    The TLC-II connects to the computer by connecting the green color- coded cable from the green connector on the TLC-II Driver to the green connector on the Docking Station drawer. All user interfaces to the HeartTouch computer are accessed via a touchscreen.

  • Page 44: Figure 2.14 Tlc-Ii Wireless Adapter

    Main Screen The Main screen (Figure 2.15) displays the most basic information in the TLC-II: VAD rate and flow for each VAD in use, status of all power sources, and alarm information. If no information is received from the TLC-II Driver, or if the TLC-II is not connected to the HeartTouch computer, then a message is displayed: NO RESPONSE FROM THE TLC-II.

  • Page 45: Main Screen

    Thoratec TLC-II Portable VAD Driver and System Instructions for Use Figure 2.15 Main Screen Rate shows the current rate of the LVAD and/or the RVAD in beats per minute (bpm). Flow shows the current flow in liters per minute (L/min). If no full signal is received, then no flow information is displayed.

  • Page 46: Plots Screen

    Thoratec TLC-II Portable VAD Driver and System Instructions for Use Station to avoid potential hard drive failure. Follow the directions for shutting off the Docking Station computer found in Section 2.2.1.2 to ensure proper system shut down. 2.4.2.2 Plots Screen When the Plots screen (Figure 2.16) is selected, information...
  • Page 47 List Screen The List screen (Figure 2.17) displays lists of monitored information from the TLC-II in the top half of the screen. The monitoring information from the main screen is displayed in the bottom half of the screen. The top shaded row of information shows the most current status of the TLC-II.

  • Page 48: List Screen

    General screen. Up to 660 event records can be stored in the TLC-II. When the HeartTouch computer is connected to the TLC-II, event record information is transferred to the HeartTouch computer and stored on the hard disk.

  • Page 49: Plus

    TLC-II Original and TLC-II , respectively. The HeartTouch Plus computer is capable of detecting the TLC-II model that is being used and displaying the appropriate screen. Figure 2.18a HeartTouch Computer "VAD Settings Screen" for TLC-II Original Figure 2.18b HeartTouch Computer "VAD Settings Screen" for TLC-II...
  • Page 50 TLC-II. All changes also require user confirmation of the requested change. Once the change is made to a control parameter, it is stored in the TLC-II memory and is used. When the TLC-II is turned off, these most recent parameters are used the next time the TLC-II is turned on.
  • Page 51 If the Fixed Rate mode is selected for a patient with biventricular support, then both LVAD and RVAD operate in Fixed rate mode. The allowed range for the fixed rate mode is 30 to 100 bpm for the TLC-II Original and 30 to 125 bpm for the TLC-II Plus...
  • Page 52 Thoratec TLC-II Portable VAD Driver and System Instructions for Use The actual LVAD and RVAD mode ("FIXD" or "AUTO") are presented on the top and bottom rows of the message display on the TLC-II. 2.4.2.4.3 Accumulator Pressure TLC-II Original Valid range (LVAD):...
  • Page 53 Fixed rate timing mode. The default values are 80 bpm for the LVAD and 70 bpm for the RVAD. The allowed range is 30 to 100 bpm for the TLC-II Original and 30 to 125 bpm for the TLC-II...

  • Page 54: General Screen

    Thoratec TLC-II Portable VAD Driver and System Instructions for Use 2.4.2.5 General Screen Options available from this screen (Figure 2.19) are the following: Figure 2.19 General Screen 2.4.2.5.1 Change Patient Information When this option is selected, an alpha-numeric keyboard is shown to allow entry of patient ID number, name, or initials if desired.
  • Page 55 The current time onthe HeartTouch computer is displayed on the bottom status row. The Set Time option is used to change the time and date on the TLC-II Driver to equal the time and date on the HeartTouch computer. 2.4.2.5.7...

  • Page 56: Table 2.1A Stored Parameters In The Event Log Files (Tlc-Ii Original)

    Thoratec TLC-II Portable VAD Driver and System Instructions for Use Table 2.1a Stored Parameters in the Event Log Files (TLC-II Original) Item Parameter Item Parameter Low LVAD Pressure CURRENT TLC-II INFORMATION Log Time Low LVAD Vacuum Serial Number LVAD Occlusion...

  • Page 57: Plus

    Thoratec TLC-II Portable VAD Driver and System Instructions for Use Table 2.1b Stored Parameters in the Event Log Files (TLC-II Plus Item Parameter Item Parameter Low LVAD Vacuum CURRENT TLC-II INFORMATION Log Time LVAD Occlusion Serial Number Low LVAD Rate...

  • Page 58: Technical Screen

    Thoratec TLC-II Portable VAD Driver and System Instructions for Use 2.4.2.5.9 Set Date/Time Choose this option to set the date and time on the HeartTouch computer. The current date and time are displayed on bottom status row. 2.4.2.5.10 Language The current language used on the HeartTouch computer is shown here.
  • Page 59 Thoratec TLC-II Portable VAD Driver and System Instructions for Use 2.4.2.6.2 Compressor Temperature and Usage The temperature of the air compressor is continuously monitored by the TLC-II and is displayed here when the TLC-II is connected to the HeartTouch computer. A high temperature alarm occurs on the TLC-II if the temperature exceeds 60°C.

  • Page 60: Figure 2.21 Technical Screen - Wireless Connectivity

    Thoratec TLC-II Portable VAD Driver and System Instructions for Use • Connect/Disconnect button – the Connect button is pressed to complete a wireless connection with a selected driver. The Disconnect button is pressed to disconnect from a driver. • Notification status – A Bluetooth symbol (blue) is displayed in the lower left corner when an active connection is established with a selected driver.

  • Page 61: Mobility Cart

    Heart Touch Tablet. MOBILITY CART In addition to being able to carry the TLC-II by hand or by using the shoulder strap, the TLC-II can be used with the TLC-II mobility cart (Figure 2.22). This cart has 2 wheels, a telescoping handle and can be folded up for convenient storage.
  • Page 62 Thoratec TLC-II Portable VAD Driver and System Instructions for Use...

  • Page 63: Clinical Study

    NOTE: Unless otherwise stated, all references to "TLC-II" apply to both driver models. Sections specific to the newer, enhanced model are referred to as TLC-II , while the original model is referred to as TLC-II Original.

  • Page 64: Effectiveness: Vad Flow Index And Patient Outcomes

    The In-Hospital study included 31 patients that were enrolled at 10 investigational centers in the United States between February 5, 1999, and June 4, 2001. The baseline demographics for these patients were similar to the TLC-II Home Discharge patient cohort.

  • Page 65: Table 3.1 All Cause Adverse Events

    Thoratec TLC-II Portable VAD Driver and System Instructions for Use Patient 12-101 discharged 3 days before data freeze and is not included in this analysis (no adverse events reported). Table 3.1 All Cause Adverse Events Death and Adverse Event Rates During VAD Support (In-hospital vs.

  • Page 66: Table 3.2 All Cause Adverse Events Per 90 Patient Days

    Thoratec TLC-II Portable VAD Driver and System Instructions for Use Home Discharge (n=25 TLC-II In Hospital (n=31) Risk Ratio Event Events / 90 pt days Events / 90 pt days (95% Confidence Limits) Total days in study 2843 (7.8 yrs) 2361.0 (6.5 yrs)

  • Page 67: System Operation

    2. Connect to External Power if available. 3. Turn on key switch and remove key. NOTE: Unless otherwise stated, all references to "TLC-II" apply to both driver models. Sections specific to the newer, enhanced model are referred to as TLC-II , while the original model is referred to as TLC-II Original.
  • Page 68 RVAD port). Failure to do so will depressurize the system. 5. For RVAD-only support: Remove the occluder or set up plug on the backup TLC-II from the blue RVAD pneumatic connector. Disconnect the blue RVAD pneumatic lead from the Console/TLC-II Extension Set and connect it immediately to the blue TLC-II RVAD pneumatic connector on the backup unit.
  • Page 69 Thoratec TLC-II Portable VAD Driver and System Instructions for Use ALARM MESSAGE ACTION REQUIRED CHANGE BATTERY A or B Replace Battery A or B with a fully charged battery. <<<A (>>>B) CHANGE BATTERY A or B Immediately replace the battery next to the <...

  • Page 70: Setting Up The Tlc-Ii For A Patient For The First Time Using The Hearttouch Computer

    Thoratec TLC-II Portable VAD Driver and System Instructions for Use Setting up the TLC-II for a Patient for the First Time Using the HeartTouch Computer A. Connections and Power 4.2.1 Insert one fully-charged battery into each battery slot on the TLC-II driver (i.e.

  • Page 71: Figure 4.2 Docking Station Power Switch

    TLC- II to the green Docking Station connector (Figure 4.3). Continue to Section 4.2.4. External Power (yellow) Docking Station Connectors Computer (green) TLC-II Driver TLC-II Driver Connectors Docking Station Drawer (top view) Figure 4.3 TLC-II Driver and Docking Station Connectors (see also Figure 2.10)

  • Page 72: Figure 4.4 Hearttouch Tablet Power Button

    Adapter. Figure 4.4 HeartTouch Tablet Power Button 4.2.4 Turn on the TLC-II with the key switch. Note that the emergency backup system turns on for about 3 seconds and the control panel on the TLC-II Driver briefly displays "INITIALIZING" and the software version number (X.XX) and date (Figure 4.5).

  • Page 73: Figure 4.6 Tlc-Ii Control Panel

    Thoratec TLC-II Portable VAD Driver and System Instructions for Use 4.2.6 The main TLC-II system now takes control and displays the timing mode, beat rate and flow for LVAD (top row) and/or RVAD (bottom row) (Figure 4.6). When no VAD is connected, or when there is no full signal present, "- - -"...
  • Page 74 Note: eliminate pressure and vacuum alarms during the set-up procedure. 4.2.10 Verify that the TLC-II is receiving power through the external power input, and the external power indicator lamp is illuminated. If the External Power indicator light is not illuminated then the TLC-II is using the rechargeable batteries.

  • Page 75: Figure 4.8A Hearttouch Computer "Vad Settings Screen" For The Tlc Ii Original

    Tab, and press the Language button on the Touchscreen. Select a different language and confirm. 4.2.18 Touch the VAD Settings Tab and examine the existing settings for the TLC-II (Figures 4.8a and 4.8b). The Heart Touch computer will recognize the TLC-II model that is being used and will display the appropriate VAD Settings screen.

  • Page 76: Plus

    Plus Figure 4.8b HeartTouch Computer "VAD Settings Screen" for the TLC-II 4.2.19 To initialize all settings in the TLC-II to their default values, and to clear the patient name and ID, press Initialize Parameters and confirm Yes. This is the recommended start up for a new patient.

  • Page 77: Figure 4.9 Hearttouch Computer "Vad Configuration Dialog Box

    TLC-II should be approximately equal to the actual pumping rate being used on the Dual Drive Console. 4.2.23 To change the TLC-II rate, touch Beat Rate, and a dialog box appears with arrows allowing the rate to be increased (up arrow) or decreased (down arrow).

  • Page 78: Figure 4.11 Hearttouch Computer "Confirmation Dialog Box

    Auto rate mode while waiting for a full signal from the VAD. If no full signal is detected at this rate, the TLC-II switches to the Fixed rate mode. Typically Low Rate is kept at the default value of 50.

  • Page 79: Figure 4.12 Hearttouch Computer "Patient Information Screen

    4.2.37 Note that the TLC-II Driver is now programmed with the chosen settings. These settings are stored in memory even if the TLC-II is turned off. In addition, the same settings are used the next time the TLC-II is turned on.

  • Page 80: Setting Up The Tlc-Ii Without The Hearttouch Computer

    Thoratec TLC-II Portable VAD Driver and System Instructions for Use 4.2.38 To switch a patient from the Dual Drive Console to the TLC-II, skip to Section 4.4. WARNING: Always use the EXIT button before turning off the HeartTouch computer to avoid problems with the Windows operating system.

  • Page 81: Switching A Patient From A Dual Drive Console To A Tlc-Ii

    (color-coded red for the LVAD and blue for the RVAD). This extension set allows a 1.5 m (5 ft.) pneumatic and electrical lead to be used on the TLC-II and a 2 m (7 ft.) extension (for a total of 3.5 m) when using the Dual Drive Console (Figure 4.13).
  • Page 82 Thoratec TLC-II Portable VAD Driver and System Instructions for Use 4.4.3 For LVAD support: a. Remove the occluder or set-up plug on the TLC-II from the red LVAD pneumatic connector. b. Disconnect the red LVAD pneumatic lead from the end of the Console/ TLC-II Extension Set and connect it immediately to the red TLC-II LVAD pneumatic connector.

  • Page 83: Tlc-Ii Driver Vacuum Regulator (Lower Side Of Driver)

    4.4.8 Press the mode button to select the automatic rate mode for automatic control of VAD rate based on VAD filling. Verify that the words AUTO appear on the main TLC-II display for each VAD. Each time the mode button is pressed, the mode switches between Auto and Fixed rate modes of pumping (Figure 4.15).

  • Page 84: Using The Tlc-Ii Driver With The Tlc-Ii Ac Adapter

    Using Battery Power and Preparing for Ambulatory Use 4.6.1 The TLC-II is designed to operate from at least two power sources: either two batteries, or one battery and external power. The driver operates with one power source but an alarm sounds until the second power source is installed.

  • Page 85: Figure 4.17 Battery Test Button And Battery Lights

    5 green lights indicates the approximate capacity remaining (see Section 2.1.5.1). Depending on conditions, each battery when fully charged can run the TLC-II for at least 55 (BiVAD) to 80 (LVAD or RVAD) minutes (Figure 4.17).

  • Page 86: Figure 4.18 Tlc-Ii Driver Accessory Pocket With Accessories

    If the TLC-II is connected to the HeartTouch computer, a similar message is displayed on the touchscreen monitor. 4.6.6 To remove a depleted battery from the TLC-II, slide the retaining clip (as shown on diagram) and remove the battery. Slide a fresh battery into the slot, pushing all the way down until it snaps into place (Figure 4.19).

  • Page 87: Car Power Adapter

    The Car Power Adapter provides extra mobility to the patient by adding another source of power to the TLC-II Driver. The Car Power Adapter uses the power from an automobile's cigarette lighter socket and converts it to a voltage that is appropriate to power the TLC-II Driver.

  • Page 88: Car Power Adapter Connections

    Thoratec TLC-II Portable VAD Driver and System Instructions for Use Verify that the external power indicator lamp on the TLC-II is illuminated. If it is not illuminated. the TLC-II is still drawing power from Note: the batteries. A short beep indicates that external power has been connected.

  • Page 89: Figure 4.22 Tlc-Ii Driver In Carrying Case With Accessory Pocket

    Thoratec TLC-II Portable VAD Driver and System Instructions for Use 4.7.3 Trouble Shooting No Output (TLC-II External Power Indicator is not ON). Check the following in the order listed: Symptom Action Make sure car engine in ON. No voltage from Make sure cigarelle lighter plug is completely inserted into car cigarette lighter socket.

  • Page 90: Recharging Batteries

    (10° - 35°C, 50° - 95°F). If the light is steady, the battery should be inserted into a TLC-II Driver that is not on a patient to determine the battery voltage level. If the unloaded battery voltage, as shown on the technical screen, is above 20 V then the battery is acceptable for use.

  • Page 91: Using The Tlc-Ii Carrying Case And Mobility Cart

    Thoratec TLC-II Portable VAD Driver and System Instructions for Use Using the TLC-II Carrying Case and Mobility Cart 4.9.1 The TLC-II is designed to be used at all times in the nylon carrying case. The mobility cart provided is a convenient cart with wheels allowing movement of the TLC-II in its carrying case.

  • Page 92: Hearttouch Tablet And Accessories

    The HeartTouch Tablet and its accessories are intended for clinicians’ use Note: only and should never accompany a patient out of the hospital when he or she is dis- charged. The HeartTouch Tablet and its accessories are only to be used with the TLC-II and TLC-II Drivers. Plus Several features and functions have been intentionally disabled on the HeartTouch Tablet for simplicity of operation.
  • Page 93 Thoratec TLC-II Portable VAD Driver and System Instructions for Use 4.10.1 HeartTouch Tablet Warnings • Replace the HeartTouch Tablet lithium-ion battery only with Thoratec approved batteries. • Danger of explosion if battery is incorrectly replaced. • Dispose of used lithium-ion batteries according to the manufacturer's instructions or local laws.
  • Page 94 Thoratec TLC-II Portable VAD Driver and System Instructions for Use 12. Never open the equipment. For safety reasons, the equipment should be opened only by qualified service personnel. 13. If one of the following situations arises, contact Thoratec’s Technical Services: a.

  • Page 95: Figure 4.27 Press With Thumb Positioned Here

    Thoratec TLC-II Portable VAD Driver and System Instructions for Use 4.10.3.2 Installing a Battery The battery is designed specifically for use with the HeartTouch Tablet. It fits precisely into the back of the tablet and delivers the exact voltage required to power the unit. Under normal conditions, a fully charged battery will power the tablet for up to 5.0 hours.

  • Page 96: Figure 4.28 Ac Power Connection And Mini-Usb Behind Access Panel

    Thoratec TLC-II Portable VAD Driver and System Instructions for Use Follow these procedures in order: 1. From the AC Adapter, plug the DC power output connector to the DC power input of the HeartTouch Tablet (Figure 4.28). Figure 4.28 AC Power Connection and mini-USB Behind Access Panel 2.

  • Page 97: Figure 4.30 Hearttouch Tablet Cradle (Rear View)

    Thoratec TLC-II Portable VAD Driver and System Instructions for Use 4.10.3.4 Connecting the AC Adapter to the Cradle Be sure to always handle the power cords by holding the plug ends only. 1. From the AC Adapter, plug the DC power output connector to the DC power input of the Cradle (Figure 4.30).

  • Page 98: Figure 4.32 Stylus

    Wireless Adapter. Verify that the low battery LED is OFF and the Power LED on the Wireless Adapter is ON. 4. Turn ON the TLC-II if it is not currently operating. 5. Setup is complete. Use your finger or the provided stylus (Figure 4.32) to interact with the software’s menu selections.

  • Page 99: Figure 4.33 Mini Usb Adapter Cable

    Thoratec TLC-II Portable VAD Driver and System Instructions for Use 4.10.3.7 Downloading files using the USB connector Files on the tablet’s hard drive should be periodically reviewed and archived. When archiving or when specific log files or waveform data is required, a USB stick can be used to download files from the HeartTouch Tablet.
  • Page 100 Thoratec TLC-II Portable VAD Driver and System Instructions for Use 4.10.3.8 Charging the Battery The lithium-ion battery will charge in the tablet if the tablet is connected to AC power. This can take place when the tablet is connected directly to the AC adapter (Figure 4.28), or when it is placed in the cradle (Figure 4.34).
  • Page 101 Thoratec TLC-II Portable VAD Driver and System Instructions for Use 4.10.3.10 Storing the Computer WARNING: Do NOT store your Computer with the screen side down; otherwise damage to the display may occur. Store the computer in the Off state with a fully charged battery pack installed.

  • Page 102: Tlc-Ii Wireless Adapter

    4.11 TLC-II Wireless Adapter The TLC-II Wireless Adapter (Figure 4.35) is required to allow the HeartTouch Tablet to communicate with the TLC-II in order to control, monitor and download information. The Wireless Adapter communicates wirelessly with the tablet by using the Bluetooth communication protocol.

  • Page 103: Figure 4.37 Connecting To The Tlc-Ii

    Thoratec TLC-II Portable VAD Driver and System Instructions for Use If storage of the Wireless Adapter is expected to be greater than 3 months, then remove batteries from the adapter. Before use of the Wireless Adapter: Turn ON the adapter and verify that the low battery is OFF.

  • Page 104: Figure 4.38 Placement Of The Tlc-Ii Wireless Adapter

    Thoratec TLC-II Portable VAD Driver and System Instructions for Use Once connected, place the Wireless Adapter on top of the driver but avoid concealing the LCD screen and any alarm indicator. One example of proper placement of the Wireless Adapter is shown in Figure 4.38. If the center desires to secure by other means: •...

  • Page 105: Alarms And Troubleshooting

    Normal Alarm (red) Figure 5.1 TLC-II Control Panel Urgent and Normal Alarm Lights NOTE: Unless otherwise stated, all references to "TLC-II" apply to both driver models. Sections specific to the newer, enhanced model are referred to as TLC-II , while the original model is referred to as TLC-II Original.
  • Page 106 Thoratec TLC-II Portable VAD Driver and System Instructions for Use One or more of the following messages are displayed in 5.1.1.1 the TLC-II control panel (and on the HeartTouch computer), indicating an alarm from the LVAD (L) or RVAD (R): "HI L PRESSURE"...
  • Page 107 5.1.2 Full Signal Alarms If no full signal is detected by the TLC-II from the LVAD (L) or RVAD (R) for a period of approximately 8 seconds, an audible alarm sounds and the red alarm light illuminates. These alarms occur in the Auto or the Fixed rate modes.

  • Page 108: Example Of Display Showing

    R: F I X D 60 - - - Figure 5.2 Example of Display Showing "---" for Invalid Flow Measurement If the TLC-II is running in the Auto rate mode when a full signal 5.1.2.3 is lost, the TLC-II pumping rate slows down to the low rate value in an attempt to locate a full signal.

  • Page 109: Figure 5.3 Tlc-Ii Control Panel Change Battery Lights

    Thoratec TLC-II Portable VAD Driver and System Instructions for Use 5.1.3 Battery Alarms The status of all batteries (Battery A, Battery B, and the 5.1.3.1 emergency battery) are continuously monitored by the TLC-II. Additionally, the status of any battery, whether or not it is installed in the driver, can be determined by pressing the battery test button on the front of each battery.
  • Page 110 Thoratec TLC-II Portable VAD Driver and System Instructions for Use If there is only one power source available (in addition to the 5.1.3.5 emergency battery), an audible alarm turns on at 30 second intervals. The audible alarm changes to a continuous alarm when there 5.1.3.6...
  • Page 111 Thoratec TLC-II Portable VAD Driver and System Instructions for Use 5.1.4 Temperature Alarms An audible alarm, and the red alarm light turns on if the 5.1.4.1 temperature of the air compressor is greater than, or less than, a fixed threshold value. The main cause of this alarm is a dirty air in take filter.
  • Page 112 A message is displayed indicating the type of error: 5.1.6.3 "ALARM 18-22" In addition, a second message is also displayed: "REPLACE" WARNING: Do not use a TLC-II Driver if any of the internal alarms are on. Replace this TLC-II with a backup driver as soon as possible.

  • Page 113: Alarm Thresholds And Indicators

    5.3.1 VAD Filling Complete VAD filling is indicated by the green full light on the TLC-II control panel. For the PVAD, complete filling can also be confirmed by visual inspection of the VAD as a backup method. VAD filling is dependent on adequate preload.
  • Page 114 Thoratec TLC-II Portable VAD Driver and System Instructions for Use Possible Reasons for Inadequate VAD Filling: 5.3.1.1 • Hypovolemia • Bleeding • Right ventricular failure with isolated LVAD support • Cardiac tamponade • Inadequate pharmacologic support • VAD cannula position •...

  • Page 115: Table 5.1A Description Of Alarms (Tlc-Ii Original)

    Thoratec TLC-II Portable VAD Driver and System Instructions for Use Table 5.1a Description of Alarms (TLC-II Original) Condition Alarm On Alarm Clear Audible Interval Messages HI L PRESSURE High L Pressure ≥ 300 mmHg ≤ 280 mmHg Continuous REPLACE Low L Pressure ≤180 mmHg...

  • Page 116: Plus

    Thoratec TLC-II Portable VAD Driver and System Instructions for Use Low compressor <= 0 degrees > 2 degrees Celsius 1 second LO TEMPERATURE WAIT temperature Celsius TLC-II Service Exceeded Factory or maintenance 10 seconds SERVICE INTERVAL recommended reset REPLACE Interval hours...
  • Page 117 Thoratec TLC-II Portable VAD Driver and System Instructions for Use Low emergency Replace EMERGENCY BATT battery voltage; Acceptable emergency emergency Continuous approximately 10 battery voltage REPLACE battery minutes remaining. HI TEMPERATURE High compressor > = 60 degrees < 58 degrees...

  • Page 118: Troubleshooting The Wireless Connection Between Tlc-Ii Driver And Heart Touch Tablet

    Thoratec TLC-II Portable VAD Driver and System Instructions for Use With the IVAD, complete ejection is assessed by the green light on the signal processor lead or by an "empty" flag on the plot screen (Figure 5.4). EMPTY FLAG Spike at end of pressure (emptying)
  • Page 119 Thoratec TLC-II Portable VAD Driver and System Instructions for Use • More than 8 Wireless Adapters are ON at one time - Turn OFF adapters • HeartTouch Tablet too far from the Wireless Adapter - Move the HeartTouch Tablet and/or Driver closer to each other (within 30 ft with no obstructions) •...

  • Page 120: Backup Procedures

    Thoratec as Part Number 14787-2589-000 Hand Pump (one needed per VAD). If for any reason there is a TLC-II Driver failure, blood flow can be maintained to the patient and stasis prevented in the blood pump by disconnecting the VAD pneumatic lead from the TLC-II and connecting it to the hand pump.

  • Page 121: System Maintenance

    Thoratec TLC-II Portable VAD Driver and System Instructions for Use SYSTEM MAINTENANCE There is minimal routine maintenance required of the TLC-II, which consists mainly of changing emergency batteries, inspecting filters, and cleaning. The TLC-II also requires planned maintenance at regularly scheduled service intervals. This consists of refurbishment of the compressor and pneumatics.
  • Page 122 Thoratec TLC-II Portable VAD Driver and System Instructions for Use Loosen the 3 screws on the bottom of the TLC-II Driver and 6.1.1.5 open the emergency battery compartment (Figure 6.1). 6.1.1.5.1 Loosen the depleted emergency battery and install a fully charged battery (the connection pins should be inserted into the driver with the status panel showing).

  • Page 123: Servicing

    "SERVICE INTERVAL" "REPLACE" To display the driver cumulative usage time, press the scroll button once 6.2.2 on the TLC-II control panel, and the driver serial number and usage hours are displayed: "S/N XXX" "USAGE XXXX HR"...
  • Page 124 Thoratec TLC-II Portable VAD Driver and System Instructions for Use...

  • Page 125: Unpacking And System Assembly

    Thoratec TLC-II Portable VAD Driver and System Instructions for Use UNPACKING AND SYSTEM ASSEMBLY Docking Station Remove Docking Station from shipping crate and remove protective 7.1.1 plastic cover. Remove upper back panel from Docking Station. 7.1.2 Remove computer from shipping container and remove protective packing.

  • Page 126: Driver

    To check-out the TLC-II Driver and system, follow all steps in Section 4.1, 7.4.1 which are the steps used when setting up the TLC-II for a patient for the first time. Simulate different patient settings and verify that the TLC-II responds 7.4.2...

  • Page 127: Tlc-Ii Training Checklist For Staff

    AC adapter to the TLC-II Driver and electrical outlet. Able to appropriately connect the TLC-II Driver to the mobility cart. Able to hear audible alarms, and identify alarm messages on the TLC-II Driver. Understands the meaning of alarms and demonstrates appropriate responses to alarm conditions.

  • Page 128: Tlc-Ii Training Checklist For Patient/Caregiver

    AC adapter to the TLC-II Driver and electrical outlet. Able to appropriately connect the TLC-II Driver to the mobility cart. Able to hear audible alarms, and identify alarm messages on the TLC-II Driver. Understands the meaning of alarms and demonstrates appropriate responses to alarm conditions.

  • Page 129: Hand Pump Training

    EQUIPMENT: Two (2) Hand Pumps with Quick Connects SETUP: Connect TLC-II Driver to VAD. Set driver to fixed rate of 60 bpm with a 300 msec eject time. Adjust pressures to attain arterial pressures of 90-110 mmHg and atrial pressures of 10-20 mmHg.

  • Page 130: Training Checklist For Tlc-Ii Home Discharge Patients/Caregiver

    VAD and the possible consequences. Understands the care of the VAD pneumatic and electrical leads and cannulae. Able to successfully change the electrical lead between TLC-II Driver and VAD. Able to successfully change the pneumatic lead between TLC-II Driver and VAD.
  • Page 131 6035 Stoneridge Drive Pleasanton, CA 94588. Tel: 925-847-8600 Toll Free: 800-528-2577 Fax: 925-847-8574. www.thoratec.com. © 2013 Thoratec Corporation. Thoratec, the Thoratec logo, Thoralon, TLC-II and HeartTouch are registered trademarks, and IVAD and PVAD are trademarks of Thoratec Corporation. Printed in the USA. References on file.

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