Thoratec TLC-II User manual

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.

i
SPECIAL NOTICE
The instructions contained within this document (105800) cover the use of the Original
TLC-II®Portable VAD Driver System (C/N REF 20010-0000-132) and the TLC-IIPlus
System (C/N REF 100621), an enhanced version of the device.
For users of the HeartTouch®Tablet, please reference the Advantech Declaration of
Conformity & Safety for additional safety information.
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-IIPlus while the
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" sticker located on the battery slot adjacent to the key switch
- Driver control panel - White text on black background (see Figure A)
- Product label on front of unit lists the catalog reference number as 20010-0000-132
TLC-IIPlus
- "RVAD Reg" sticker located on the battery slot adjacent to the key switch
- Driver control panel - black text on grey background (see Figure B)
- Product label on front of unit that lists the catalog reference number as 100621
Figure A Driver Control Panel of TLC-II Original
Figure B Driver Control Panel of TLC-IIPlus

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Thoratec TLC-II Portable VAD Driver and System Instructions for Use
INDICATIONS FOR USE
The Thoratec Paracorporeal Ventricular Assist Device (PVADTM) and the Implanted
Ventricular Assist Device (IVADTM) are indicated for:
Bridge-to-transplant patients who meet all of the following criteria:
1. Candidate for cardiac transplantation.
2. Imminent risk of dying before donor heart procurement.
3. Dependence on, or incomplete response to, continued vasopressor support.
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.
CONTRAINDICATIONS
• Uncontrolled hemorrhage.
• Central nervous system damage resulting in fixed and dilated pupils.
• Contraindications to cardiac transplantation contraindicate use of the device for
bridge to transplant.
WARNINGS
Patient Population - General
VAD patients with prosthetic aortic valves may have increased risk of thromboembolism
due to blood flow shunted away from the valve.
Patients with greater than 1.5+ aortic insufficiency should either not be considered
a candidate for VAD support, or should be considered only after repair or replacement
of the aortic valve.
Significant right-to-left shunting can occur in patients with a patent foramen ovale.
Patency of the foramen ovale should be considered and corrected if necessary, prior
to insertion of VADs.
Cannulae may be difficult to insert in patients with small hearts, in patients with congenital
abnormalities, or in patients with previous cardiac reconstructive surgery. There are no
detailed data available at this time regarding this issue.
Patient Population - Bridge to Transplant
Patients with hepatic and/or renal dysfunction may require 2 to 3 weeks of VAD support
for major organ function to recover.

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Thoratec TLC-II Portable VAD Driver and System Instructions for Use
Patients with elevated levels in the panel of reactive antibodies (PRA) may require
extensive duration of VAD support in order to locate a donor heart. Patients should be
excluded if the expectation of finding a donor heart is not reasonable.
Patient Population - Postcardiotomy Recovery
There are no additional warnings other than those already listed for the general patient
population specific to the use of the device pending postcardiotomy myocardial recovery.
Procedural Techniques - All Indications for Use
The VAD is provided sterile; caution must be taken in opening the package. Do NOT
resterilize. Do NOT use if package is damaged. Store at 20 - 30°C.
Do NOT disassemble the VAD. Collet nuts and collets must be removed to attach
cannulae to the VAD, and this can be performed by hand. Disassembly or attempts
to loosen the cap ring, valve housing nuts, or any other component of the VAD may
affect VAD function.
Do NOT use polar organic solvents, such as ketones, chlorinated hydrocarbons, and
aromatic hydrocarbons, anywhere near the VAD. Such use has caused stress-cracking
of the polysulfone and other damage to the VAD housing. These solvents include, but are
not limited to, acetone, methyl ethyl ketone (MEK), methylene chloride, chloroform,
trichloroethane, and benzene and its derivatives.
Do NOT use povidone-iodine (e.g., betadine) ointments, or other polyethylene glycol-
based ointments in contact with the cannula for prophylactic care of the transdermal
skin site. Such use over several months has caused cannula degradation at the end
of the wire reinforced region. Povidone-iodine solution (not containing polyethylene
glycol) is recommended.
PRECAUTIONS
Training of Personnel
Surgical, nursing, and perfusion staff responsible for the VAD program at each hospital
should complete the Thoratec VAD Training program.
Required System Backup
Each Dual Drive Console contains two independent drive modules, and therefore
contains adequate built-in back-up capability for univentricular support. 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.

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Thoratec TLC-II Portable VAD Driver and System Instructions for Use
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. Squeeze the hand pump about once per second to
empty and fill the blood pump. Alternatively place hand pump on floor and use your foot.
Connect the back-up drive console or TLC-II as soon as possible. This procedure is for
emergency use only.
Steps to Minimize the Risk of Thrombosis
At low beat rates there is an increased risk of thrombus formation in the VAD. Therefore
it is recommended that the device be operated at rates above 40 bpm and with complete
filling and ejection of the VAD blood pump in the VOLUME mode (Auto Rate mode on
TLC-II). Pneumatic drive ejection pressures of at least 100 mmHg above the patient's
systolic blood pressure are recommended for complete ejection. Complete VAD
emptying can be verified by using a flashlight (see Section 12.7 of the Thoratec
Ventricular Assist Device Instructions for Use, document number 15003 for details).
During weaning of the patient from the VAD, and or during other conditions that result in
low flow or beat rates below 40 bpm, continuous infusion of heparin for anticoagulation to
achieve a partial thromboplastin time of 1.5 times control is recommended. See Section
13.4 of the Thoratec Ventricular Assist Device Instructions for Use, document number
15003, for anticoagulation regimen.
Interaction with Magnetic Resonance Imaging
This device contains ferro-magnetic metal components. Do NOT perform MRI imaging
procedures on patients with the Thoratec VAD.

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Thoratec TLC-II Portable VAD Driver and System Instructions for Use
TABLE OF CONTENTS
1 GENERAL INFORMATION.............................................................................................................1
1.1 INTRODUCTION ............................................................................................................1
1.2 OVERVIEW OF THE THORATEC VAD SYSTEM .........................................................1
1.3 TLC-II DRIVER PRINCIPLES OF OPERATION ............................................................4
1.4 CAUTIONS .....................................................................................................................6
1.5 CONTRAINDICATIONS .................................................................................................8
1.6 TLC-II SYSTEM SPECIFICATIONS ...............................................................................8
1.7 LIST OF SYMBOLS ......................................................................................................18
2 DESCRIPTION ..............................................................................................................................19
2.1 TLC-II PORTABLE VAD DRIVER ................................................................................19
2.2 COMPUTER INTERFACE ............................................................................................27
2.3 BATTERY CHARGER ..................................................................................................31
2.4 HEARTTOUCH COMPUTER .......................................................................................32
2.5 MOBILITY CART ..........................................................................................................51
2.6 CAR POWER ADAPTER .............................................................................................51
3 CLINICAL STUDY.........................................................................................................................53
3.1 STUDY OVERVIEW .....................................................................................................53
3.2 PATIENT POPULATION ..............................................................................................53
3.3 EFFECTIVENESS: VAD FLOW INDEX AND PATIENT OUTCOMES .........................54
3.4 ADVERSE EVENTS .....................................................................................................54
4 SYSTEM OPERATION.................................................................................................................57
4.1 THORATEC TLC-II PORTABLE DRIVER QUICK REFERENCE GUIDE ....................57
4.2 SETTING UP THE TLC-II FOR A PATIENT FOR THE FIRST TIME USING
THE HEARTTOUCH COMPUTER ...............................................................................60
4.3 SETTING UP THE TLC-II WITHOUT THE HEARTTOUCH COMPUTER ...................70
4.4 SWITCHING A PATIENT FROM A DUAL DRIVE CONSOLE TO A TLC-II .................71
4.5 USING THE TLC-II DRIVER WITH THE TLC-II AC ADAPTER ...................................74
4.6 USING BATTERY POWER AND PREPARING FOR AMBULATORY USE .................74
4.7 CAR POWER ADAPTER .............................................................................................77
4.8 RECHARGING BATTERIES ........................................................................................80
4.9 USING THE TLC-II CARRYING CASE AND MOBILITY CART ...................................81
4.10 HEARTTOUCH TABLET AND ACCESSORIES ..........................................................82
4.11 TLC-II WIRELESS ADAPTER ......................................................................................92
5 ALARMS AND TROUBLESHOOTING .........................................................................................95
5.1 ALARMS .......................................................................................................................95
5.2 ALARM THRESHOLDS AND INDICATORS ..............................................................103
5.3 TROUBLESHOOTING FOR VAD FILLING AND EMPTYING ....................................103
5.4 TROUBLESHOOTING THE WIRELESS CONNECTION BETWEEN
TLC-II DRIVER AND HEART TOUCH TABLET .........................................................108
5.5 BACKUP PROCEDURES ..........................................................................................110
6 SYSTEM MAINTENANCE...........................................................................................................111
6.1 ROUTINE MAINTENANCE ........................................................................................111
6.2 SERVICING ................................................................................................................113

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Thoratec TLC-II Portable VAD Driver and System Instructions for Use
TABLE OF CONTENTS (continued)
7 UNPACKING AND SYSTEM ASSEMBLY..................................................................................115
7.1 DOCKING STATION ..................................................................................................115
7.2 CHARGER AND BATTERIES ....................................................................................115
7.3 DRIVER ......................................................................................................................116
7.4 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
TRAINING CHECKLIST FOR TLC-II HOME DISCHARGE PATIENTS/CAREGIVER ..........120
OTHER SUGGESTED REFERENCES
a. Thoratec Ventricular Assist Device Instructions for Use (Document No. 15003)
b. Thoratec Implantable Assist Device (IVAD) Instructions for Use (Document No. 50012-0006-008)
c. Thoratec Clinical Operation and Patient Management (Document No. 101757)
d. Thoratec Ventricular Assist Device Dual Drive Console (Videotape No. 14805)
e. Thoratec Ventricular Assist Device Implantation Surgical Implant Procedure
(CD-ROM No. C063-0401)
f. Thoratec Dual Drive Console Instructions for Use (Document 14025)

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Thoratec TLC-II Portable VAD Driver and System Instructions for Use
TABLE OF CONTENTS - FIGURES AND TABLES
Figure A Driver Control Panel of TLC-II Original ...........................................................................i
Figure B Driver Control Panel of TLC-IIPlus .....................................................................................i
Figure 1.1 Thoratec PVAD and two cannulation approaches for biventricular support ..................1
Figure 1.2 Thoratec IVAD ...............................................................................................................2
Figure 1.3 VAD Blood Pump ...........................................................................................................3
Figure 2.1 TLC-II Driver and VADs ...............................................................................................19
Figure 2.2 TLC-II Driver Top Interface and Control Panel ............................................................21
Figure 2.3 TLC-II Driver Control Panel .........................................................................................22
Figure 2.4 TLC-II Battery ..............................................................................................................25
Figure 2.5 TLC-II AC Adapter .......................................................................................................25
Figure 2.6 TLC-II Driver Emergency Battery Access ....................................................................26
Figure 2.7 TLC-II Driver in Carrying Case with Accessory Pocket ...............................................27
Figure 2.8 TLC-II Docking Station ................................................................................................28
Figure 2.9 Docking Station Main Power Receptacle and On-Off Switch (lower rear panel) .........29
Figure 2.10 Connection between Docking Station and TLC-II Driver .............................................30
Figure 2.11 HeartTouch Tablet .......................................................................................................31
Figure 2.12 TLC-II System Battery Charger ...................................................................................32
Figure 2.13 HeartTouch Tablet .......................................................................................................33
Figure 2.14 TLC-II Wireless Adapter ..............................................................................................34
Figure 2.15 Main Screen ................................................................................................................35
Figure 2.16 Plots Screen ................................................................................................................36
Figure 2.17 List Screen ...................................................................................................................38
Figure 2.18a HeartTouch Computer "VAD Settings Screen" for TLC-II Original ..............................39
Figure 2.18b HeartTouch Computer "VAD Settings Screen" for TLC-IIPlus ........................................39
Figure 2.19 General Screen ...........................................................................................................44
Table 2.1a Stored Parameters in the Event Log Files (TLC-II Original) .........................................46
Table 2.1b Stored Parameters in the Event Log Files (TLC-IIPlus) ...................................................47
Figure 2.20 Technical Screen .........................................................................................................48
Figure 2.21 Technical Screen - wireless connectivity .....................................................................50
Figure 2.22 TLC-II Mobility Cart and Driver ....................................................................................51
Figure 3.1 Enrollment and Follow Up of Home Discharge Patients ..............................................53
Table 3.1 All Cause Adverse Events ............................................................................................55
Figure 3.2 Death and Adverse Event Rates During VAD Support ................................................55
Table 3.2 All Cause Adverse Events per 90 Patient Days............................................................56
Figure 4.1 TLC-II Driver, Battery, and Battery Test Button ...........................................................60
Figure 4.2 Docking Station Power Switch .....................................................................................61
Figure 4.3 TLC-II Driver and Docking Station Connectors (see also Figure 2.10) .......................61
Figure 4.4 HeartTouch Tablet Power Button ................................................................................62
Figure 4.5 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" for the TLC-IIPlus ..................................66
Figure 4.9 HeartTouch Computer "VAD Configuration Dialog Box" .............................................67
Figure 4.10 HeartTouch Computer "Beat Rate Dialog Box" ...........................................................67
Figure 4.11 HeartTouch Computer "Confirmation Dialog Box" .......................................................68
Figure 4.12 HeartTouch Computer "Patient Information Screen" ...................................................69
Figure 4.13 Dual Drive Console/TLC-II Extension Set ....................................................................71
Figure 4.14 TLC-II Driver Vacuum Regulator (lower side of driver) ................................................73
Figure 4.15 Mode Button on TLC-II Control Panel ..........................................................................73
Figure 4.16 AC Adapter ..................................................................................................................74

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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 Car Power Adapter ......................................................................................................77
Figure 4.21 Car Power Adapter Connections .................................................................................78
Figure 4.22 TLC-II Driver in Carrying Case with Accessory Pocket ...............................................79
Figure 4.23 TLC-II System Battery Charger and Indicator Lights ...................................................80
Figure 4.24 TLC-II Driver with Shoulder strap ................................................................................81
Figure 4.25 Mobility Cart with TLC-II Driver ....................................................................................81
Figure 4.26 HeartTouch Tablet with Stylus Pen .............................................................................82
Figure 4.27 Press with Thumb Positioned Here .............................................................................85
Figure 4.28 AC Power Connection and mini-USB Behind Access Panel .......................................86
Figure 4.29 HeartTouch Tablet AC Adapter/Cord ...........................................................................86
Figure 4.30 HeartTouch Tablet Cradle (rear view) .........................................................................87
Figure 4.31 Recharging Battery in the HeartTouch Tablet Cradle ..................................................87
Figure 4.32 Stylus ...........................................................................................................................88
Figure 4.33 Mini USB Adapter Cable ..............................................................................................89
Figure 4.34 USB Stick Plugged Directly into the Cradle .................................................................89
Figure 4.35 TLC-II Wireless Adapter ..............................................................................................92
Figure 4.36 Installing LR6 (AA) Batteries on Wireless Adapter Cable ............................................92
Figure 4.37 Connecting to the TLC-II .............................................................................................93
Figure 4.38 Placement of the TLC-II Wireless Adapter ..................................................................94
Figure 5.1 TLC-II Control Panel Urgent and Normal Alarm Lights ................................................95
Figure 5.2 Example of Display Showing "---" for Invalid Flow Measurement ...............................98
Figure 5.3 TLC-II Control Panel Change Battery Lights ..............................................................99
Table 5.1a Description of Alarms (TLC-II Original).......................................................................105
Table 5.1b Description of Alarms (TLC-IIPlus ) .................................................................................106
Figure 5.4 Empty Flag on Plot Screen ........................................................................................108
Figure 6.1 TLC-II Driver Emergency Battery Access ..................................................................111

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Thoratec TLC-II Portable VAD Driver and System Instructions for Use
INSTRUCTIONS FOR USE
1. GENERAL INFORMATION
1.1 INTRODUCTION
The Thoratec TLC-II Portable VAD Driver (TLC-II Driver) is a lightweight, portable,
pneumatic VAD driver, powered by batteries or from external power. The TLC-II
Driver is designed for use with the Thoratec Ventricular Assist Device (VAD) and
Thoratec Implantable Ventricular Assist Device (IVAD). The Thoratec VAD is
a paracorporeal pump and is referred to as the "PVAD" throughout this manual.
The TLC-II Driver provides portable pneumatic driver power for ambulatory PVAD
and IVAD patients and is completely interchangeable with the Thoratec Dual Drive
Console (DDC). It is, therefore, possible to switch patients from the console driver
to the portable driver and back depending on patient need. The system is designed
to supply isolated LVAD support, RVAD support, or biventricular support (both LVAD
and RVAD).
The TLC-II System consists of the TLC-II Driver, batteries, a portable AC adapter,
a mobility cart, and a computer interface (i.e., Docking Station or HeartTouch
Tablet). The Docking Station serves as a "home base" for the TLC-II Driver and
accessories, including the battery charger and the system computer, and is
intended for in-hospital use only. Use of each of these components is completely
described in this document. Section 1 provides an overview of the Thoratec VAD
System. A complete description of the TLC-II System is presented in Section 2,
followed by Clinical Study Information in Section 3, System Operation in
Section 4, Alarm Troubleshooting in Section 5, and Maintenance in Section 6.
1.2 OVERVIEW OF THE THORATEC VAD SYSTEM
The Thoratec TLC-II Portable VAD Driver is designed for use only with the Thoratec
PVAD and IVAD. The Thoratec VAD Systems can be used for partial circulatory
assistance or for total support of the right and/or left ventricles. The VADs are placed
in a paracorporeal position on the anterior abdominal wall and connected to the heart
and circulatory systems with cannulae crossing the chest wall.
Figure 1.1 Thoratec PVAD and two
cannulation approaches for biventricular
support.
Ao = aorta, LA = left atrial appendage,
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-IIPLUS, while the original model is referred to as TLC-II Original.

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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).
For left heart support, cannulation can be achieved from either the left atrium or
left ventricle with return to the aorta. For right heart support, atrial cannulation is
used with return to the pulmonary artery. The VAD blood pumps are operated and
controlled pneumatically by either the Thoratec Dual Drive Console or by the
Thoratec TLC-II Portable VAD Driver. Both Drivers deliver alternating pulses of
pressure and vacuum to empty and fill the VAD pumping chambers.
The Thoratec Systems consists of the following major components:
• Thoratec VAD blood pump: Either a PVAD (Paracorporeal Ventricular Assist
Device) or IVAD (Implantable Ventricular Assist Device)
• Selection of inflow and outflow cannulae
• Dual Drive Console or TLC-II Portable VAD Driver
Each component is briefly described in the following sections.
VAD Blood Pump
The central part of the system is the blood pump, which can be used for left
ventricular (LVAD), right ventricular (RVAD), or biventricular (BiVAD) assistance.
The pump has a rigid case that contains a blood-pumping sac composed of
Thoralon®, a proprietary polyurethane multipolymer. Silicon oil lubricates the
outside of the blood sac. Inside the VAD, two mechanical tilting disc valves maintain
unidirectional flow. The blood pump has an effective stroke volume of 65cc; and,
depending on various conditions, can generate flows up to 7.1 l/min at a rate of
110 beats per minute (bpm).

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Thoratec TLC-II Portable VAD Driver and System Instructions for Use
Figure 1.3 VAD Blood Pump
PVAD Pump
The PVAD (Figure 1.1) has a rigid plastic housing through which small bubbles in
the silicon oil lubricant can be observed during pumping. A small magnetic switch
(called the Hall effect switch) is mounted on the upper case. This switch is triggered
when the PVAD is full of blood, sending a "full" signal via the electrical lead to the
Dual Drive Console (DDC) or TLC-II. The Hall effect switch is attached to an
electrical lead and is bundled with the pneumatic lead on the PVAD. The two leads
are separated at a connector approximately 2" from the blood pump. The pneumatic
and electrical leads are available in a 5-foot length for use with the TLC-II Driver.
These leads can be combined with a 7-foot extension to achieve a 12-foot total
length for use on a DDC.
Note: Alternatively, 12-foot leads can be used for centers that only use the DDC.
IVAD Pump
The IVAD (Figure 1.2) has a titanium alloy case with an optic sensor located on
the upper housing. 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. The leads are separated at the Y connector. The 5-foot pneumatic
lead attaches directly to the TLC-II Driver or, using the 7-foot extension lead, to
the DDC. The signal processor lead connects directly to the TLC-II. If a DDC is
used, the 5 foot electrical lead connects to the signal processor lead as well as the
DDC adaptor lead.
FULLSWITCH
MONOSTRUT VALVE
SWITCH DIAPHRAGM
ACTUATING DIAPHRAGM
6.0 cm
VAD CASE
BLOOD SAC
12.5 cm
VALVE HOUSING
PNEUMATIC DRIVE LINE
FULL SWITCH CONNECTOR
TUBING

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Thoratec TLC-II Portable VAD Driver and System Instructions for Use
Cannulae
Blood is brought from the patient to the VAD blood pump by either a ventricular
apex cannula or an atrial cannula. For bridge to cardiac transplantation, it is usually
preferable to cannulate the patient's left ventricular apex.
Blood is pumped from the VAD to the patient through arterial cannulae which are
Thoralon polyurethane tubes with a smooth, blood-contacting surface attached to
a low porosity woven polyester graft The end of the Thoralon tube is reinforced
with wire to prevent deformation of the cannula where it passes through the
patient's ribs and skin. The reinforced portion of each cannula is covered with
polyester velour to encourage tissue ingrowth.
See Appendix A of the Thoratec Ventricular Assist Device Instructions for Use,
document number 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.
More detailed information on the Dual Drive Console is contained in Thoratec
Dual Drive Console Instructions for Use, document number 14025.
1.3 TLC-II DRIVER PRINCIPLES OF OPERATION
Both the Thoratec PVAD and IVAD Systems can provide pulsatile blood flow at
normal circulatory pressures in acute cardiac failure patients. In clinical practice,
a 65 ml stroke volume is possible at any rate from 30 to 110 bpm (depending on the
cannulae used and the size of the patient), which means an output ranging from
1.9 to 7.1 l/min.
They are designed to support the circulation of blood in the pulmonary and/
or systemic circulation when the natural heart, with the help of conventional
therapy, is unable to maintain normal flows and pressures in those vascular beds.
To accomplish this support, blood is shunted from the natural ventricle by way of
a cannula in the left ventricle, or the right or left atrium, to a VAD blood pump. Once
the VAD is full of blood, compressed air is pulsed to start ejection. The air moves
a diaphragm that squeezes the blood out of the blood sac, through the arterial
cannula, and into either the pulmonary artery or the ascending thoracic aorta.
After a time sufficient to eject the blood from the pump, the air chamber is either
vented to atmosphere or to a vacuum source, which allows air to escape from
the air chamber and blood to fill the blood chamber.

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Thoratec TLC-II Portable VAD Driver and System Instructions for Use
The TLC-II has two timing modes: Fixed and Auto:
Fixed: In this mode, the operator chooses a rate and the driver maintains that
pumping rate until the operator changes it. This mode is often used for start-up in the
operating room, or to wean the patient from the 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.
Auto: This mode is used in most clinical cases because of the automatic changes in
flow output that occur in response to changes in physiological conditions. The instant
the blood pump is filled with blood, the PVAD Hall Effect switch or IVAD optical
sensor signals the driver to begin ejection. The rate varies with changes in preload to
the pump. If the preload (or venous return) increases, the pump fills faster and thus
ejection begins sooner, which increases the rate. In the same way, the rate
decreases as preload decreases.
VAD output is determined by the VAD rate times the stroke volume; for example,
60 bpm times 65 ml equals 3.9 l/min. The maximum flow is achieved when the blood
pump fills and empties completely, with no time lost between phases of the cycle.
Implantation and removal of the Thoratec VAD involves standard surgical
procedures, which are described in the Thoratec Ventricular Assist Device
Instructions for Use, document number 15003.

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Thoratec TLC-II Portable VAD Driver and System Instructions for Use
1.4 CAUTIONS
USE OF THORATEC-APPROVED COMPONENTS ONLY. The Thoratec TLC-II
Driver and the Thoratec VAD have been developed, tested, and approved as a
System. Use of the TLC-II is authorized only in conjunction with related equipment
described in this document and in the Thoratec Ventricular Assist Device Directions
for 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.
INVESTIGATE THE CAUSE OF ALARMS. Turning off or clearing an audible
alarm has no effect on the condition causing the alarm. Investigate and correct
the cause of any alarm.
USE OF BACK-UP DRIVER. A TLC-II Driver or Dual Drive Console must be
available as a back-up to be used in the event of a failure of the primary driver.
CELLULAR PHONES. Do not use satellite phones, cell phones with power
outputs greater than 1 watt, or other radio transmitters (walkie-talkies) within
12 feet (3.6 meters) of the TLC-II Driver. Such devices may interfere with the
driver operation.
Cellular phones with power outputs of 1 watt or less can be used at a distance
of 2 feet or greater from the TLC-II. Check your cell phone's instruction manual
to determine its power rating.
MAINTENANCE OF ELECTRICAL SAFETY. The TLC-II System is designed
to meet AAMI/NFPA electrical safety requirements. Avoid potentially dangerous
electrical shock hazard by always connecting the power cord to an approved,
3-wire AC power receptacle. Never attempt to remove or defeat the electrical
ground or EMI shielding. The following table lists locations and sizes of the
fuses and circuit breakers used in the TLC-II Driver.
Fuse or Circuit
Breaker Location Thoratec TLC-II Driver
Size Fuse Type Location
AC Adapter 3½ Amps, 2 Pole 5 x20 mm
IEC 127
Time Lag
Internal (on PC board)
Docking Station 5 Amps for 120VAC
2.5 Amps for 230VAC
5 x20 mm
IEC 127
Time Lag
At power entry module
Battery Charger 4 Amps 5 x20 mm
IEC 127
Time Lag
At power entry module

7
Thoratec TLC-II Portable VAD Driver and System Instructions for Use
If any of these safety features are activated for any reason, determine the cause of
the problem before resetting the breaker or replacing the fuse.
REDUCTION OF EXPLOSION HAZARD. Do NOT operate the TLC-II in the
presence of flammable anesthetics or other flammable gases.
MAINTENANCE OF PATIENT SAFETY. Verify that all VAD pneumatic and electrical
connections are in place, secure, and connected to the driver in use before
attempting to operate the system.
ENVIRONMENT. Keep the TLC-II dry. Protect from showers, baths, rain, and liquid
spillage. Do NOT operate the TLC-II Driver below an ambient pressure of 525 mmHg
(700 mBar) or above an altitude of 10,000 feet in an unpressurized cabin.
PATIENT AMBULATION CHECKLIST. Before undertaking any excursions away
from the primary care area, ensure that:
• The system operation checklist has been followed
• The patient and/or caregiver are trained in emergency procedures
• Optimal settings have been selected using the system computer
• There are no alarms in operation
• Both batteries on the TLC-II are fully charged
• Additional fully charged spare batteries are available
• A functional TLC-II AC adapter is available
• 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.
TLC-II DRIVER STORAGE. The TLC-II Driver should always be connected to an
active AC outlet at any time when the patient is not ambulating in order to conserve
battery power. Batteries need to be recharged in the Battery Charger which is a
separate component from the TLC-II Driver.
TLC-II DRIVER CLEANING. Exercise extreme care in cleaning the TLC-II Driver. Do
NOT soak any item during cleaning or disinfection. Do NOT allow water or solvent to
come in direct contact with electrical connectors. See Section 6 for more information.
BATTERIES
1. Store batteries in a cool, dry place—in particular, avoid storing batteries at high
temperature.
2. Batteries should not be left in vehicles, direct sunlight, or other places where the
temperature may rise above 60°C (140°F).
3. Store and install batteries only within the specified range: -20° to 60°C
(-4° to 140°F).
4. Charge batteries within the specified temperature range: 10° to 35°C
(50° to 95°F).
5. Do not let batteries get wet.
6. Do not drop batteries or subject them to shock.

8
Thoratec TLC-II Portable VAD Driver and System Instructions for Use
7. Batteries should not be disassembled or modified.
8. Do not allow necklaces, chains, or other metallic items to come into contact
with the terminals.
9. Never use TLC-II batteries as a power supply for anything other than the
TLC-II Driver.
10. Never charge a TLC-II battery using anything other than the TLC-II charger.
11. Do not leave batteries in charger for longer than 14 days. Remove batteries
from driver for storage.
12. Do not incinerate batteries. Explosion or rupture of battery may occur.
13. Do not discard batteries. Return batteries to Thoratec for disposal. Used
batteries are hazardous waste.
1.5 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
>350 msec of ejection time for complete RVAD ejection when using the Dual Drive
Console. Note: This is NOT a limitation for the TLC-IIPlus.
1.6 TLC-II SYSTEM SPECIFICATIONS
1.6.1 Safety Standards
The TLC-II Portable VAD Driver, as part of the Thoratec VAD and
IVAD System, has been thoroughly tested and classified by Underwriters
Laboratories (UL) to fire, casualty, and electric shock hazard requirements
of UL 60601-1 and that all parts of the system are suitable for use within
the patient environment. In addition, both devices meet the following
European EN safety standards: EN 60601-1: 1987, Amendment 1:1993,
and Amendment 2:1995. These standards require making the following
declarations and stating the type and degree of protection for listed hazards.
See the following pages for more specific safety and testing classification
information.
The essential functions of the TLC-II system include:
a. Maintain programmed clinical settings in the driver (following Clinician
setup and programming).
b. Ensure proper alarm function and monitoring.
c. Provide uninterupped pneumatic support to maintain the programmed
VAD pump rate.
d. Sustain VAD flow to the patient.
During the electromagnetic compatibility (EMC) assessment, all of these
essential functions were properly performed without interruption.

9
Thoratec TLC-II Portable VAD Driver and System Instructions for Use
1.6.1.1 Declaration Concerning General Safety Standards
Medical Electrical Equipment
with respect to shock, fire,
mechanical and other specified
hazards only in accordance
with UL 60601-1 and CAN/CSA
C22.2 No. 601-1 7D72
T ype Degree of Protection
Mode of Operation Continuous
Method of Sterilization 100% EtO for blood pump and all
sterile accessories
Type of protection against electrical
shock Class I (grounded) and internally powered
Degree of protection against electric
shock Type CF (Cardio Floating)
Degree of safety of application in the
presence of a flammable anesthetic
mixture with air or with oxygen or
nitrous oxide
Equipment not suitable for use in the
presence of a flammable anesthetic
mixture with air or with oxygen or
nitrous oxide
Degree of protection against harmful
ingress of water
Docking Station with External AC Adapter
and Battery configurations: IPX1

10
Thoratec TLC-II Portable VAD Driver and System Instructions for Use
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.
1.6.1.3 Declaration and Guidance Concerning Electromagnetic
Immunity for all Thoratec PVAD and IVAD Equipment
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. See following table.
Emissions Test Compliance Electromagnetic
Environment
Guidance
RF emissions
CISPR 11
EN 55011
Group 1
The TLC-II and PVAD/IVAD System
use RF energy only for its internal
function. Therefore, its RF emissions
are very low and are not likely to cause
any interference in nearby electronic
equipment.
RF emissions
CISPR 11
Group 1
Class A
The TLC-II Driver and PVAD/IVAD
System connected in the Docking
Station configuration is suitable for
use in the hospital environment only.
RF emissions
CISPR 11
Group 1
Class B
The TLC-II and PVAD/IVAD System
when operating with batteries in a
stand-alone configuration or with AC
adapter configuration, are suitable for
use in all establishments, including
domestic establishments and those
directly connected to the public low-
voltage power supply network that
supplies buildings used for domestic
purposes.
Harmonic emissions
IEC 61000-3-2 Class A
Voltage fluctuations/ flicker
emissions
IEC 61000-3-3
Complies
Radiated emissions,
magnetic field
MILSTD-461E
RE101
(Army level)
The TLC-II and PVAD/IVAD System
generate magnetic fields due to the
presences of RF energy created by its
internal function only. Therefore, its
magnetic field emissions are very
low and are not likely to cause any
interference in nearby electronic
equipment.