TLC-II Portable VAD Driver and System Instructions for Use Aug 2008

Thoratec® TLC-II® Portable VAD Driver and System Instructions for Use

INDICATIONS FOR USE The Thoratec Ventricular Assist Device (VAD) is 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.

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.

Thoratec® TLC-II® Portable VAD Driver and System Instructions for Use

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 glycolbased 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.

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.

Thoratec® TLC-II® Portable VAD Driver and System Instructions for Use

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 TLCII). 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 D e v i c e Instructions for Use, document number 15003 for details). During weaning 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.

.

Thoratec® TLC-II® Portable VAD Driver and System Instructions for Use

TABLE OF CONTENTS

1.

2.

3.

4.

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

1.7

LIST OF SYMBOLS ...1

6

DESCRIPTION...1

6

SYSTEM

SPECIFICATIONS...8

2.1

TLC-II PORTABLE DRIVER ...1

6

2.2

DOCKING STATION... ...2

5

2.3

BATTERY CHARGER ...2

8

2.4

HEARTTOUCH™ COMPUTER... ...2

9

2.5

MOBILITY CART... ...4

2

2.6

MOBILE COMPUTER... ...4

2

2.7

CAR POWER ADAPTER... ...4

2

CLINICAL STUDY ...4

3

3.1

STUDY OVERVIEW ...4

3

3.2

PATIENT POPULATION... ...4

3

3.3

EFFECTIVENESS (VAD FLOW INDEX & PATIENT OUTCOMES) ...4

4

3.4

ADVERSE EVENTS... ...4

4

SYSTEM OPERATION ...47 4.1

THORATEC TLC-II PORTABLE DRIVER QUICK REFERENCE GUIDES ...47

4.2

SETTING UP THE TLC-II FOR A PATIENT FOR THE FIRST TIME, USING THE HEARTTOUCH COMPUTER.. ...49

5.

6.

4.3

SETTING UP THE TLC-II WITHOUT THE HEARTTOUCH COMPUTER.. ...5

6

4.4

SWITCHING A PATIENT FROM A DUAL DRIVE CONSOLE TO A TLC-II ...5

7

4.5

USING THE TLC-II DRIVER WITH THE TLC-II AC ADAPTER ...6

0

4.6

USING BATTERY POWER AND PREPARING FOR AMBULATORY USE...6

0

4.7

MOBILE COMPUTER & ACCESSORIES ...63

4.8

CAR POWER ADAPTER ...71

4.9

RECHARGING BATTERIES... ...74

4.10 USING THE TLC-II CARRYING CASE AND MOBILITY CART ...7

5

ALARMS AND TROUBLESHOOTING ...7

6

5.1

ALARMS ...7

6

5.2

ALARM THRESHOLDS AND INDICATORS ...8

3

5.3

TROUBLESHOOTING FOR VAD FILLING AND EMPTYING ...8

3

5.4

BACK-UP PROCEDURE. ...8

6

SYSTEM MAINTENANCE... ...8

7

6.1

ROUTINE MAINTENANCE...8

7

6.2

SERVICING ...8

9

Thoratec® TLC-II® Portable VAD Driver and System Instructions for Use

TABLE OF CONTENTS

7

UNPACKING AND SYSTEM ASSEMBLY ...9 0 7.1

DOCKING STATION ...9 0

7.2

CHARGER AND BATTERIES...9 0

7.3

DRIVER... ...9 1

7.4

SYSTEM CHECK-OUT... ...9 1

APPENDIX A - TLC-II TRAINING CHECKLISTS ...9 2

OTHER SUGGESTED REFERENCES a.

Thoratec Ventricular Assist Device Instructions for Use (Document No. 15003)

b.

Thoratec Ventricular Assist Device Console Operation with Illustrations

c.

Thoratec Patient Management Manual (Document No. 14910)

(Document No. 14909)

d.

Thoratec Ventricular Assist Device Dual Drive Console (Videotape No. 14805)

e.

Thoratec Ventricular Assist Device Implantation Procedure (Videotape No. 14804)

f.

Thoratec Dual Drive Console Instructions for Use (Document 14025)

Thoratec® TLC-II® Portable VAD Driver and System Instructions for Use

TABLE OF CONTENTS - FIGURES

Figure 1.1

Cannulation Approaches for the Thoratec VAD ...1

Figure 1.2

Thoratec IVAD ...2

Figure 1.3

VAD Blood Pump...3

Figure 2.1

TLC-II Driver and VADs ...1 7

Figure 2.2

TLC-II Driver Top Interface and Control Panel ...1 9

Figure 2.3

TLC-II Driver Control Panel ...2 0

Figure 2.4

TLC-II Battery ...2 2

Figure 2.5

TLC-II AC Adapter ...2 3

Figure 2.6

TLC-II Driver Emergency Battery Access...2 4

Figure 2.7

TLC-II Driver in Carrying Case with Accessory Pocket...2 4

Figure 2.8

TLC-II Docking Station ...2 5

Figure 2.9

Docking Station Main Power Receptacle and On-Off Switch...2 6

Figure 2.10

Connection between Docking Station and TLC-II Driver...2 7

Figure 2.11

TLC-II System Battery Charger ...2 8

Figure 2.12

HeartTouch Computer "Main Screen" ...3 0

Figure 2.13

HeartTouch Computer "Plots Screen” ...3 1

Figure 2.14

HeartTouch Computer "List Screen"... ...3 2

Figure 2.15

HeartTouch Computer "VAD Settings Screen" ...3 4

Figure 2.16

HeartTouch Computer "General Settings Screen" ...3 8

Figure 2.17

HeartTouch Computer "Technical Screen" ...4 1

Figure 2.18

TLC-II Mobility Cart and Driver...4 2

Figure 3.1

Enrollment & Follow Up of Home Discharge Patients...43

Table 3.1

All Cause Adverse Events...45

Figure 3.2

Death & Adverse Event Rates During VAD Support...45

Table 3.2

All

Figure 4.1

Docking Station Power Switch... ...4 9

Cause Adverse

Events

per

90

Patient

Days...46

Figure 4.2

TLC-II Driver and Docking Station Connectors ...4 9

Figure 4.3

TLC-II Driver, Battery, and Battery Test Button ...5 0

Figure 4.4

TLC-II Driver Top Interface Showing Port Occluder and Set-up Plug ...5 1

Figure 4.5

TLC-II Control Panel Display During Initialization ...5 1

Figure 4.6

TLC-II Control Panel...5 2

Figure 4.7

HeartTouch Computer "VAD Settings Screen" ...5 3

Figure 4.8

HeartTouch Computer "VAD Configuration Dialog Box" ...5 3

Figure 4.9

HeartTouch Computer "Beat Rate Dialog Box" ...5 4

Figure 4.10

HeartTouch Computer "Confirmation Dialog Box"...5 4

Figure 4.11

HeartTouch Computer "Patient Information Screen" ...5 5

Figure 4.12

Dual Drive Console/TLC-II Extension Set ...5 7

Figure 4.13

TLC-II Driver Vacuum Regulator ...5 9

Figure 4.14

Mode Button on TLC-II Control Panel ...5 9

Figure 4.15

AC Adapter ...6 0

Figure 4.16

Battery Test Button and Battery Status Lights... ...6 1

Figure 4.17

TLC-II Driver Accessory Pocket with Accessories... ...6 2

Figure 4.18

TLC-II Driver Battery Removal ...6 2

Figure 4.19

Mobile Computer ...6 3

Figure 4.20

Mobile Computer Setup...6 4

Figure 4.21

Status Indicators ...6 5

Figure 4.22

Hotpad ...6 7

Thoratec® TLC-II® Portable VAD Driver and System Instructions for Use

TABLE OF CONTENTS - FIGURES Figure 4.23

Car Power Adapter...71

Figure 4.24

Car Power Adapter Connections...72

Figure 4.25

TLC-II Driver In Carrying Case with Accessory Pocket...73

Figure 4.26

Battery Charger and Indicator Lights...74

Figure 4.27

TLC-II Driver with Shoulder Strap...75

Figure 4.28

Mobility Cart with TLC-II Driver...75

Figure 5.1

TLC-II Control Panel Urgent and Normal Alarm Lights...76

Figure 5.2

Example of Display Showing "- - -" for Invalid Flow Measurement...78

Figure 5.3

TLC-II Control Panel Change Battery Lights...80

Figure 5.4

Empty Flag on Plot Screen...85

Figure 6.1

TLC-II Driver Emergency Battery Access...87

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 docking station. The docking station is the "home base" for the TLC-II and accessories, including the battery charger and the system computer. 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 three cannulation approaches for univentricular left heart support (Panel A), and biventricular support (Panels B and C). Ao = aorta, LA = left atrial appendage, PA= pulmonary artery, RA = right atrium, Apex = left ventricular apex, IAG = cannula inserted via the interatrial groove and directed towards LA roof. Note that the VADs in Panel C are turned over and are on the sides of the chest that are opposite those of Panel B. (Modified from Farrar DJ et al, New England Journal of Medicine 1988; 318: 333-340. Copyright 1988, Massachusetts Medical Society.)

1

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 VADblood pump: Either a PVAD (Paracorporeal Ventricular Assist

•

Selection of inflow and outflow cannulae

•

Dual Drive Console or TLC-II Portable VAD Driver

Device) or IVAD (Implantable Ventricular Assist Device)

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 multi-polymer. 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).

2

Thoratec® TLC-II® Portable VAD Driver and System Instructions for Use

SWITCH DIAPHRAGM

ACTUATING DIAPHRAGM

FULLSWITCH

PNEUMATIC DRIVE LINE

6.0cm

TUBING

VALVE HOUSING VAD CASE

FULL SWITCH CONNECTOR

MONOSTRUT VALVE

BLOOD SAC

12.5cm

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 come in two lengths (5-foot and 7-foot extensions) and are attached to the DDC or the TLC-II Driver.

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

3

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.

4

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.

5

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.

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

Thoratec TLC-II Driver

Breaker Location

Size

AC Adapter

3½ Amps, 2 Pole

Fuse Type

Location

5 x 20 mm

Internal (on PC board)

IEC 127 Time Lag Docking Station

5 Amps for 120VAC

5 x 20 mm

2.5 Amps for 230VAC

IEC 127

At power entry module

Time Lag Battery Charger

4 Amps

5 x 20 mm IEC 127 Time Lag

6

At power entry module

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 shower, 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 keyswitch 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 anytime 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 dis-infection. DO NOT allow water or solvent to come in direct contact with electrical connectors. See Section 5 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 discharge 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.

7.

Batteries should not be disassembled or modified.

8.

Do not allow necklaces, chains, or other metallic items to come into contact

7

Thoratec® TLC-II® Portable VAD Driver and System Instructions for Use

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. Do not use on VAD or IVAD patients requiring >160 mmHg drive pressure and >350 msec of ejection time for complete RVAD ejection when using the Dual Drive Console.

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 2601-1. In addition, both devices meets 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.

8

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%

Method of Sterilization

EtO

for

blood

pump

and

all

sterile accessories

Type of protection against electrical

Class

shock

powered

Degree of protection against electric shock

I

(grounded)

and

internally

Type CF (Cardio Floating)

Degree of safety of application in

Equipment not suitable for use in

the presence of a flammable anes-

the presence of a flammable anes-

thetic mixture with air or with oxy-

thetic mixture with air or with oxy-

gen or nitrous oxide

gen or nitrous oxide

Degree of protection against harmful ingress of water

Docking Station with External AC Adapter and Battery configurations: IPX1

Medical Electrical Equipment with respect to shock, fire, mechanical and other specified hazards only in accordance with UL 2601-1 and CAN/CSA C22.2 No. 601-1 7D72

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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 VAD/IVAD System are intended for use in the electromagnetic environment specified below. The customer or the user of either device should assure that it is used in such an environment.

Emissions Test

Compliance

Electromagnetic Environment Guidance The TLC-II and VAD/IVAD System use RF energy only for its internal func-

RF emissions CISPR 11

Group 1

EN 55011

tion. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions

Class B

CISPR 11

suitable for use in all establishments,

Harmonic emissions IEC

Class A

61000-3-2

including domestic establishments and those directly connected to the public low-voltage power supply net-

Voltage fluctuations/ flicker emissions IEC

The TLC-II and VAD/IVAD System are

Complies

61000-3-3

work that supplies buildings used for domestic purposes.

The TLC-II and VAD/IVAD System generate magnetic fields due to the presences of RF energy created by its

Radiated emissions, magnetic field

RE101

internal function. Therefore, its magnetic field emissions are very low and

MILSTD-461E

are not likely to cause any interference in nearby electronic equipment.

1.6.1.3

Declaration and Guidance Concerning Electromagnetic Immunitry for all Thoratec PVAD and IVAD Equipment The TLC-II and VAD/IVAD System are intended for use in the electromagnetic environment specified below. The customer or the user of either device should assure that it is used in such an environment. See following table.

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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 Immunity Test

IEC 60601-1-2 Test

IEC

61000-4-2

Guidance Floors should be wood, con-

min. ±6 kV contact

min. ±8 kV air

TLC-II on a Docking Station

crete, or ceramic tile. If floors

[±6] kV contact

are covered with synthetic

[±8] kV air

material, the relative humidity should be at least 30 %.

TLC-II with AC power or bat-

Electrostatic discharge (ESD)

min. ±6 kV contact

tery power [±8] kV contact

IEC

61000-4-2

min. ±8 kV air

Electrical fast tran-

± 2 kV for power supply

sient/burst

lines

IEC

61000-4-4

Environment

Level

Electrostatic discharge (ESD)

Compliance Level

± 1 kV for input/output lines

[±15] kV air

± 2 kV for power supply lines

Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Mains power quality should be that of a typical commer-

± 1 kV for input/output lines

cial or hospital environment.

Mains power quality should

Surge

± 1 kV differential mode

± 1 kV differential mode

IEC

± 2 kV common mode

± 2 kV common mode

be that of a typical commer61000-4-5

cial or hospital environment.

<5 % U T

<5% U T

(>95 % dip in U ) T

(>95 % dip in U ) T

for 0.5 cycle

for 0.5 cycle

40 % U T

40 % U T

(60 % dip in U ) T

(60 % dip in U ) T

for 5 cycles

for 5 cycles

70 % U T

70 % U T

(30 % dip in U ) T

(30 % dip in U ) T

minutes for uni-VAD support.

for 25 cycles

for 25 cycles

Note: U is the AC mains T

<5 % U T

<5 % U T

(>95 % dip in U ) T

(>95 % dip in U ) T

for 5 s

for 5 s

Mains power quality should be that of a typical commer-

Voltage dips, short interruptions and voltage variations on power supply input lines

IEC

61000-4-11

cial or hospital environment. The TLC-II contains 2 batteries (1 primary and 1 backup), which will provide uninterruptible power for a minumum of 55 minutes for BiVAD and 80

voltage prior to application of the test level.

If disturbance occurs, it may be necessary to position the device further from sources of power frquency magnetic fields or install magnetic

Power frequency (50/60 Hz) magnetic field IEC

3 A/m

3 A/m

shielding. The power frequency magnetic field should be

61000-4-8

measured in the intended installation location to

assure that it is sufficiently low.

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Thoratec® TLC-II® Portable VAD Driver and System Instructions for Use

1.6.1.4

Declaration and Guidance Concerning Electromagnetic Immunity for Life-Sustaining Thoratec PVAD and IVAD Equipment, including VAD, Driver, and Batteries The TLC-II and VAD/IVAD System are intended for use in the electromagnetic environment specified below. The customer or the user of either device should assure that they are used in such an electromagnetic environment.

Immunity

IEC 60601

Compliance

Electromagnetic Environment

Test

Test Level

Level

Guidance Portable and mobile RF communications equipment should be used no closer to any part of the Thoratec PVAD or IVAD systems than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended Separation Distances

Conducted RF IEC 61000-4-6

Min. 3 Vrms

3.5

150 kHz to 80 MHz out-

d = [ −− ] /P

[3] Vrms

a side ISM bands

3

Min. 10 Vrms

12

150 kHz to 80 MHz in

d = [ −− ] /P

[10] Vrms

a ISM bands

10

12 d = [ −− ] /P

Radiated RF IEC 61000-4-3

10 80 MHz to 800 MHz

23 Min. 10 V/m

d = [ −− ] /P

[10] V/m

80 MHz to 2.5 GHz

10 800 MHz to 2.5 GHz

Field strengths from fixed RF transmitters, as determined by an electromagc netic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment that is marked with the IEC symbol for non-ionizing radiation. NOTE 1

At 80 MHz and 800 MHz, the higher frequency range applies

NOTE 2

These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption

and reflection from structures, objects, and people.

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