Dear Valued Customer,€¦ · Novadaq Technologies 300 Myles Standish Blvd., Suite 103 Taunton, MA 02780 The CO 2 Heart Laser 2 Operator's Manual 020-50000-000 Rev A

Getinge

45 Barbour Pond Drive

Wayne, NJ 07470 USA

www.getinge.com

Page 1 of 2

Dear Valued Customer,

Over the past five (5) years, Maquet/Getinge has been the exclusive US distributor of the

NOVADAQ Transmyocardial Revascularization CO2 Laser and associated disposable TMR

kits (TMR). NOVADAQ was recently acquired by Stryker and Stryker has recently notified

Maquet that we will no longer be the distributor of this product effective December 31, 2017.

Furthermore, Stryker has notified Maquet that they intend to discontinue manufacturing and

servicing this product at the end of this year. As a direct result, effective December 31, 2017,

Maquet/Getinge will no longer be able to distribute this product.

As Stryker has already taken steps to terminate the manufacturing of the procedural kits,

remaining inventory is limited. You may continue to purchase these kits from Maquet/Getinge

until the inventory is depleted, or until 12/31/2017 whichever occurs first. Any product

experience concerns or complaints related to the product after December 31st should also be

communicated to Stryker directly.

If you require service on your equipment prior to 12/31/2017, or if you have an existing

service contract extending beyond the discontinuation date of 12/31/2017 please contact

David Hartung at Stryker directly at 508-880-4700 or via email at [email protected].

Accounts with existing service contracts extending beyond the 12/31/17 discontinuation date

will be granted a prorated credit by Stryker.

We apologize for any inconvenience this notification may cause you and ask that you contact

Ryan Yearsley, Sr. Director of Integration at Stryker (on cell: 208-830-0320 or via email at

[email protected]) for additional questions related to the product or its

discontinuation.

Maquet/Getinge remains committed to helping you deliver optimal support for your patients

with our other product lines and we thank you for your continued support.

Sincerely,

Chris Schulte

Vice President of Operations, Americas

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opto esse. Commoveo modo haero facilisi facilisis. Persto causa transverbero eum ille illum luptatum vel pecus. Conventio pneum wisi usitas

quidem tincidunt a abico causa transverbero eum ille illum luptatum vevicis virtus vulputate duis esca fatua tincidunt. In vereor epulae dolor.

Volutpat venio gilvus dolus

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1234 Street Address

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Phone: +12 1234 567 890

Email: [email protected]

www.getinge.com

Page 2 of 2

Novadaq Technologies 300 Myles Standish Blvd., Suite 103

Taunton, MA 02780

The CO2 Heart Laser 2

Operator's Manual 020-50000-000 Rev A

Page ii Novadaq Technologies

020-50000-000 Rev. A CO2 Heart Laser 2 Operator’s Manual

US Federal law restricts this device to sale by or on the order of a physician or a licensed

practitioner.

The use of controls or adjustments or

performance of procedures other than those specified herein may result in hazardous

radiation exposure.

The CO2 Heart Laser 2 is to be used only by fully

trained, qualified physicians and operators.

2014 by Novadaq Technologies

Specifications Subject to Change without Notice

Novadaq Technologies Page iii

CO2 Heart Laser 2 Operator’s Manual 020-50000-000 Rev. A

TABLE OF CONTENTS

SECTION 1: INTRODUCTION ............................................................................................................ 1

1.1 TRANSMYOCARDIAL REVASCULARIZATION (TMR) ............................................. 1

1.2 SYSTEM DESCRIPTION .......................................................................................... 1

1.3 SYSTEM SPECIFICATIONS ..................................................................................... 3

SECTION 2: SAFETY ............................................................................................................................. 5

2.1 INTRODUCTION .................................................................................................... 5

2.2 OPTICAL HAZARDS .............................................................................................. 6

2.3 ELECTRICAL AND MECHANICAL HAZARDS .......................................................... 6

2.4 FIRE HAZARDS ..................................................................................................... 7

2.5 PROFESSIONAL INFORMATION .............................................................................. 8

2.6 LABELS .............................................................................................................. 10

2.6.1 Label Locations ............................................................................................. 10

2.6.2 Label Descriptions ........................................................................................ 11

SECTION 3: INSTALLATION ............................................................................................................ 15

3.1 CUSTOMER’S RESPONSIBILITIES ........................................................................ 15

3.2 UPON DELIVERY OF YOUR SYSTEM ................................................................... 15

3.3 FACILITIES REQUIREMENTS ............................................................................... 15

3.3.1 Electrical Requirements ................................................................................ 15

3.3.2 Environmental Requirements........................................................................ 16

3.4 RELOCATION ...................................................................................................... 16

SECTION 4: CONTROLS AND INDICATORS ................................................................................ 17

4.1 KEYSWITCH OPERATION .................................................................................... 17

4.2 THE TOUCHSCREEN CONTROLS ......................................................................... 17

4.3 DISPLAYED INFORMATION: ................................................................................ 30

4.4 OPERATIONAL CONNECTORS ............................................................................. 31

4.5 THE CALIBRATION PORT .................................................................................... 32

SECTION 5: OPERATION .................................................................................................................. 33

5.1 INITIAL SURGICAL SETUP ................................................................................... 33

5.2 VERIFYING LASER ENERGY ............................................................................... 34

5.3 PERFORMING THE SURGERY ............................................................................... 35

5.3.1 Disposable TMR Kit ..................................................................................... 35

5.3.2 ECG Leads .................................................................................................... 35

5.3.3 Connection of the Handpiece Lens Cell ....................................................... 37

5.3.4 Disposable Handpiece ................................................................................... 38

5.4 TROUBLESHOOTING BASIC PROBLEMS ............................................................... 39

5.5 ERROR MESSAGES ............................................................................................. 41

SECTION 6: TMR KIT INSTRUCTIONS.......................................................................................... 45

SECTION 7: MAINTENANCE ............................................................................................................ 47

Page iv Novadaq Technologies


7.1 GENERAL INFORMATION .................................................................................... 47

7.1.1 Cleaning the Touchscreen Display ............................................................... 47

7.1.2 Cleaning the Handpiece Lens Cell ................................................................ 47

7.1.3 Purge Tubing ................................................................................................. 48

7.1.4 Cleaning the Laser Console .......................................................................... 48

7.2 PREVENTATIVE MAINTENANCE SCHEDULE ........................................................ 48

7.3 ENERGY METER CALIBRATION .......................................................................... 48

7.4 ECG MONITOR CHECK ...................................................................................... 49

APPENDIX A: ENERGY METER CALIBRATION ....................................................................... 51

APPENDIX B: WARRANTY INFORMATION .............................................................................. 53

APPENDIX C: BIBLIOGRAPHY ..................................................................................................... 55

APPENDIX D: SERVICE AND SALES OFFICE LOCATIONS ................................................... 59

APPENDIX E: PHYSICIAN’S INFORMATION FOR USE .......................................................... 61

Novadaq Technologies Page v


Table Of Figures FIGURE 2.1 SYSTEM LABEL LOCATIONS 10

FIGURE 4.1 WARM UP STANDBY SCREEN 18

FIGURE 4.2 START LASER STANDBY SCREEN 19

FIGURE 4.3A MAIN OPERATING SCREEN – NOT READY 21

FIGURE 4.3B MAIN OPERATING SCREEN 22

FIGURE 4.4 PULSE WIDTH SCREEN 23

FIGURE 4.5 DELAY SCREEN 24

FIGURE 4.6 MAIN OPERATING SCREEN W/PILOT BEAM OPTIONS 24

FIGURE 4.7 OPTIONS SCREEN 25

FIGURE 4.8 CONNECT CAL PORT SCREEN 26

FIGURE 4.9 ARM LASER SCREEN 26

FIGURE 4.10 PRESS FOOTSWITCH SCREEN 27

FIGURE 4.11 ENERGY SCREEN 27

FIGURE 4.12 ZERO SHOTS SCREEN 28

FIGURE 4.13A LASER ARMED SCREEN 29

FIGURE 4.13B NOT READY SCREEN 29

FIGURE 4.14 SHUT DOWN SCREEN 30

FIGURE 4.15 MAIN OPERATING SCREEN 30

FIGURE 4.16 CONNECTION PANEL 32

FIGURE 4.17 CALIBRATION (CAL) PORT 32

FIGURE 5.1 SUGGESTED ECG LEAD PLACEMENT 36

FIGURE 5.2 ACCEPTABLE ECG SIGNAL 37

FIGURE A.1 – ENERGY METER ADJUSTMENTS, SYSTEM INTERFACE PCB 52

TABLE E.5.1 30-DAY MORTALITY ODDS RATIOS 68

TABLE E.5.2 INCIDENCE OF MAJOR CARDIAC ADVERSE EVENTS 69

TABLE E.6.A.1 SUMMARY OF STUDY SAFETY FINDINGS 71

TABLE E.6.A.2. INCIDENCE OF MAJOR CARDIAC ADVERSE EVENTS 72

TABLE E.6.A.3 SUMMARY OF STUDY EFFECTIVENESS FINDINGS 73

TABLE E.6.B.1 SUMMARY OF STUDY SAFETY FINDINGS 75

Page vi Novadaq Technologies


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Novadaq Technologies Page 1


SSeeccttiioonn 11:: IInnttrroodduuccttiioonn

The CO2 Heart Laser 2 has been designed for ease of use. The Operator's Manual is an important part of the laser system and is intended to be read by all personnel who may be involved with either using or maintaining the system.

The CO2 Heart Laser 2 is intended for use only by trained, qualified and authorized physicians; medical aspects of laser surgery are not dealt with in this manual.

Caution!

It is essential that the section on safety be read and

understood before operating, maintaining or servicing

this system.

The CO2 Heart Laser 2 is covered by one or more of

the following and additional patents:

US #5,125,926 US #6,113,587

US #5,219,347 US #6,132,422

The introduction hereunder describes the application for which the CO2 Heart Laser 2 system is designed and delivers a brief description of the system’s major components along with their function.

11..11 TTrraannssmmyyooccaarrddiiaall RReevvaassccuullaarriizzaattiioonn ((TTMMRR))

The CO2 Heart Laser 2 is used to create channels in under-perfused myocardium. Through an open incision made on the chest of the patient, the CO2 Heart Laser 2 is used to create channels approximately 1 mm in diameter from the exterior of the heart muscle into the interior of the heart’s left ventricle. TMR using the CO2 Heart Laser 2 is performed on a beating heart.

11..22 SSyysstteemm DDeessccrriippttiioonn

The CO2 Heart Laser 2 uses a very powerful CO2 laser to produce the energy needed to create 1 mm channels in the heart. The laser operates at a wavelength of 10.6 microns. The gaseous laser medium is excited using a high output radio frequency (RF) power supply. This method of excitation allows for better energy stability, higher power densities and pulse frequencies than other excitation methods.

Page 2 Novadaq Technologies


A Pentium microprocessor based computer system monitors and directs all system functions while a LCD touchscreen allows the operator to control the laser by touching appropriate sections on the screen. Most operations of the system are controlled by the computer with user selection of the pulse width / energy, the pulse delay, and the mode of pilot beam operation.

The CO2 Heart Laser 2 is capable of delivering energy ranging from 8 to 80 joules by varying the pulse width of the laser pulse from 10 to 99 milliseconds. A footswitch is used to trigger the laser once the operator and surgeon are ready. The laser is used in conjunction with a specially modified ECG control module mounted within the system. A standard five lead system is used to attach electrodes to the patient. The ECG module provides a trigger pulse for the laser at the peak of the R-wave. This signal in turn produces a “marker pulse” which will mark where on the ECG signal the laser will fire. The ECG signal is displayed on the touchscreen monitor with the marker pulse overlaid on it. In this manner, the surgeon can see where the laser pulse occurs in relation to the ECG wave. The top of the R-wave is selected because at this moment the beating heart is at rest and electrically neutral, reducing the risk of inducing irregular heart rhythm. Pulse delay control allows the operator to move the marker pulse in relation to the ECG signal if a need exists to adjust where the laser will fire. Once the laser is armed and the footswitch is depressed the laser will fire on the next detected patient’s heart pulse. This ensures the laser will always fire at a preset point on the ECG signal.

The laser energy delivery system consists of a seven mirror articulated arm, a focusing lens and special disposable handpieces for use in contact with the heart. Purge flow is provided to keep the handpiece focus lens clear of debris after pulsing. The handpiece lens cell has 125 mm focal length. A red diode pilot laser is used to show where the invisible CO2 laser energy will travel.



11..33 SSyysstteemm SSppeecciiffiiccaattiioonnss

OUTPUT

Output .......................................... 8 to 80 Joules Peak Power to Tissue .................. 800 Watts Pulse Width .................................. 10 to 99 milliseconds,

adjustable in increments of 1 ms. Pulse Delay .................................. 1 to 999 milliseconds,

adjustable in increments of 1 ms. Wavelength .................................. 10.6 µm Beam Geometry ........................... TEM00 Beam Diameter ............................ approximately 7-10 mm at the distal end of the

articulated arm Laser Configuration ...................... CO2 Slab-Laser, RF-excited (Class IV) Pilot Beam .................................... 5-milliwatt laser diode operating at

635 nm (Class 3A). BEAM DELIVERY

Articulated Arm ............................. Seven (7) - mirror carbon-composite articulated arm with 15/16-12 female threads at the delivery end.

Handpieces .................................. 125 mm focal length straight handpiece 125 mm focal length right-angled handpiece

Beam Diameter (focused) ............ approximately 1 mm ELECTRICAL

Line Voltage (nominal) ................. 100–120/220–240 VAC ± 10% Current ......................................... 10/5 Amp line capacity Frequency .................................... 50/60 Hertz Phase ........................................... Single phase CABINET

Maximum Width ........................... 30 inches (76.2 cm) Maximum Length .......................... 45 inches (114.3 cm) Height to Top of Console.............. 41 inches (104.1 cm) Height with Arm Folded ................ 80 inches (203.2 cm) System Weight (approx.) ............. 600 lbs. (272 kg) ENVIRONMENT

Ambient Temperature .................. 55° - 85°F (13º -29ºC)

Storage Temperature ................... 40° - 110°F (4.5º - 43ºC) Relative Humidity ......................... 20% - 80%, Non-condensing System Heat Load ........................ 0.5 kW ( 1707 BTU/Hr) Max



OTHER

Type ............................................. CF (Delivery Arm)

Type ..................................................... (ECG leads) IPXO ............................................ Equipment provides no protection against the

harmful ingress of water. Compliance Listing

This System has been found to be compliant to the following standards for electrical medical equipment.

UL2601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety

CSA C22.2 No. 601.1-M90 Medical Electrical Equipment, Part 1: General Requirements for Safety

IEC60601-2-22 Medical Electrical Equipment, Part 2: Particular Requirements for the Safety of Diagnostic and Therapeutic Laser Equipment.

IEC60601-2-25 Medical Electrical Equipment, Part 2: Particular Requirements for the Safety of Electrocardiographs.

IEC6001-1-2/EN60601-1-2 Medical Electrical Equipment, Part 1: General Requirements for Safety, 2. Collateral Standard Electromagnetic Compatibility- Requirements and Tests.

IEC60601-1/EN60601-1 Medical Electrical Equipment, Part 1: General Requirements or Safety

Accessory Part Numbers

5-Lead Patient ECG Cable ..................... CA00098 ECG Trunk Cable ................................... CA00097 Laser Eyewear (OD 5 @ 10.6µm) .......... FL00007 Focusing Lens Cell ................................. SB00076 TMR Disposable Kit ............................... AC00012 Footswitch .............................................. EP00161

TMR Kit Components

The sterile TMR Kit (Novadaq Part # AC00012) consists of the following components:

• Straight Handpiece

• Right Handpiece

• Laser Arm Drape

• Heart Diagram

• Non-toxic marker

• Mirror Swabs

• Plastic Trays



SSeeccttiioonn 22:: SSaaffeettyy

22..11 IInnttrroodduuccttiioonn

The CO2 Heart Laser 2 is designed to be a safe system for both users and patients, with many built-in safety features. However, it is ultimately the operator's responsibility to maintain safe practices to ensure safety of the personnel and equipment.

To protect against unauthorized use of the CO2 Heart Laser 2, the On/Off key should be removed from the keyswitch when not in use.

It is essential that the section on safety be read and

understood before operating, maintaining and servicing this

system.

At all times during the installation or operation of the laser,

avoid possible exposure to laser radiation in excess of the

accessible limits listed in the U.S. Code of Federal

Regulations, Title 21, Section 1040.10, Tables I-IV. (Tables

available upon request).

The Standard Operating Procedures of your hospital

supersedes all operating procedures outlined in this manual.



22..22 OOppttiiccaall HHaazzaarrddss

Injury to the eyes or skin may result from exposure to either direct or scattered laser radiation. Laser energy emitted from this system is high enough to cause severe burns to the skin if directly exposed to the beam.

All personnel in the operating room must be protected from stray or scattered radiation by wearing appropriate eyewear to guard against ocular injury. However, protective eyewear is no guarantee that the eyes are protected against a directed CO

2 laser beam.

With sufficient intensity the laser beam may crack glass and burn, melt or even possibly ignite plastic. Special CO

2 safety glasses are available from various manufacturers. It

is recommended that all safety eyewear have, at a minimum, an optical density (OD) of 5 at a wavelength of 10.6 µm (10,600 nm). The patient's eyes should also be protected by covering them with wet gauze.

The wavelength of the carbon dioxide laser used for treatment falls into the far-infrared portion of the electromagnetic spectrum and is invisible to the human eye. This invisible beam is marked with the use of a red Pilot Beam. Never look directly into either the carbon dioxide laser beam path or the pilot beam. The red pilot beam, while not capable of burning tissue, is intense and may cause permanent ocular damage if stared at directly.

Shiny metallic surfaces will reflect the misfired laser beam. Care must be exercised when using surgical instruments with a shiny finish in conjunction with the laser.

22..33 EElleeccttrriiccaall aanndd MMeecchhaanniiccaall HHaazzaarrddss

Internal voltages necessary for the operation of the CO2 Heart Laser 2 are hazardous and potentially lethal to operating personnel when handled in either a careless or unknowledgeable manner. Consequently, the laser system should only be serviced by properly trained personnel, who have received training from Novadaq.

The CO2 Heart Laser 2 weighs approximately 600 pounds; the bulk of this system may cause damage or personal injury if not controlled during relocation.

The laser is designed to withstand shocks that are normally incurred during movement within typical medical center environments. Nevertheless, care should be taken to prevent tipping or colliding with other equipment, walls, doors, or other objects. Be aware that physical shock sustained during movement may change the alignment of optics contained within the system.

The articulated arm should always be in its secured position when the system is being moved. Insure that the counterbalance weight will clear doorways or obstacles before proceeding.



22..44 FFiirree HHaazzaarrddss

Combustible Materials Precaution

Combustible materials may be ignited by carbon dioxide laser radiation unless they are kept wet or moistened. The following precautions will greatly minimize the danger of fire:

1. Completely surround the surgical field with wet towels or gauze.

2. Exclude flammable materials from the surgical field.

3. Modify all other flammable materials to make them fire-retardant.

Oxygen enriched atmospheres increase the combustibility of materials exposed to carbon dioxide laser radiation.

Do not use plastic or rubber endotracheal tubes as they are highly flammable. Use fireproof endotracheal tubes or protect the endotracheal tube from laser energy.

Ablation of biological tissue may produce excessive smoke, making smoke removal equipment necessary.

Warning!

Do not operate this product in the presence of

flammable gases or anesthetics. Explosions or fire

may result.

Caution!

Laser plume may contain

viable tissue particulate.



22..55 PPrrooffeessssiioonnaall IInnffoorrmmaattiioonn

US Federal law restricts this device to sale by or on the

order of a physician

or a licensed practitioner.

This professional information complements the Operation and Maintenance manual. The user should become familiar with the contents of this section as well as with the operational control and handling details of the CO2 Heart Laser 2 as described in this manual, in order to take full advantage of its capabilities and to minimize potential risks.

In order to become a competent laser user, the surgeon should follow the Standard of Practice issued by the American Society for Laser Medicine and Surgery:



A. AMERICAN SOCIETY FOR LASER MEDICINE AND SURGERY - Standards of Practice for the Use of Lasers in Medicine and Surgery

The following statement is proposed:

Hospital privileges are, and must remain, the responsibility of the hospital governing board. Those requesting privileges to use lasers shall meet all the standards of the hospital with regard to board certification, board eligibility, special training, ethical character, good standing, judgment, indications for application, etc. In addition, the following laser training and experience is recommended:

1. The applicant should review pertinent literature and audiovisual aids, and should attend laser-training courses devoted to teaching of laser principles and safety. These courses should include basic laser physics, laser-tissue interactions, discussion of the clinical specialty field, and hands-on experience with lasers. Such course or courses should be a minimum of eight to ten hours.

2. The individual should spend time with an experienced operator in the specialty area involved. Such time may consist of several brief visits or a more prolonged stay, with a minimum of six to eight hours of observation and hands-on involvement. It is essential that the individual see and document actual clinical applications of the laser in an outpatient or hospital setting as appropriate to the procedures in which the training is conducted.

3. The applicant should do only those procedures that he/she is capable of doing by conventional means, and to initially do simple procedures.

4. The applicant should establish a means to work closely with clinical engineering personnel.

Note: The Standards and Practice Committee of the American Society for Laser Medicine and Surgery advises that these criteria are to be reevaluated every two years. Younger investigators are encouraged to obtain formal training in their residency.

B. INDICATIONS FOR USE

Transmyocardial revascularization with the CO2 Heart Laser 2 is indicated for the treatment in patients with stable angina (Canadian Cardiovascular Society Class III or IV) refractory to medical treatment and secondary to objectively demonstrated coronary artery atherosclerosis and with a region of the myocardium not amenable to direct coronary revascularization.

For specific professional information concerning this device, please contact Novadaq directly.



22..66 LLaabbeellss

The following shows the locations of the warning and information labels on the CO2

Heart Laser 2.

2.6.1 Label Locations

Left Side View

Front View

Rear View

Right Side View

Figure 2.1 System Label Locations



2.6.2 Label Descriptions

Image and Title Additional Information

Laser Beam Label

The Laser Beam label denotes potentially hazardous laser radiation exposure points

Attention Label

The Attention label denotes areas which require special attention or caution, consult this manual for details

Dangerous Voltage Label

The Dangerous Voltage label denotes areas in which dangerous and even lethal voltages may exist

Cal Port Label

The Cal Port label denotes the location of the system’s Calibration Port

Footswitch Label

The Footswitch label denotes the footswitch connector

Remote Arm Label

The Remote Arm label denotes the attachment point for the remote arm switch

Safety Ground Label

The Safety Ground label denotes the presence of a safety ground point.




Earth Ground Label

The Earth Ground label denotes the presence of an earth ground point

Remote Interlock Label

The Remote Interlock label denotes the attachment point for a remote interlock circuit or jumper plug

SERVICE

Service Switch Label

The Service Switch label denotes the switch used to change the operating mode of the system’s software. This switch is for service use only.

Circuit Breaker Label

The Circuit Breaker label denotes the location of the system’s main circuit breaker.

ECG Label

The ECG Label (Defibrillator-proof type CF Equipment) denotes the attachment point for the Patient ECG leads

Type CF Equipment Label

The Type CF Equipment label denotes the equipment type

STOP

Emergency Stop Label

The Emergency Stop label denotes the location of the system’s Emergency Stop Button




Flammable Anesthetics Label

The Flammable Anesthetics label cautions against the use of the system in the presence of flammable anesthetics

Keyswitch Label

Legend:

OFF (only for part of the equipment)

ON (only for part of the equipment)

This symbol denotes the system’s Keyswitch.

Laser Aperture

Laser Aperture Label

The Laser Aperture label, located at the end of the articulated arm denotes the beam exist point

Prescription Caution Label

The Prescription Caution label restricts the use of the system

PATENTS

This product is covered by one or more

of the following and additional patents:

US# 5,125,926 US# 6,113,587

US# 5,219,347 US# 6,132,422

Patent Label

The Patent label lists US Patents associated with the system; additional patents may apply

ETL Listed Label

The ETL Listed label identifies the ETL certification information




System ID Label

The System ID label provides model and serial number information. Note: the ‘~’ symbol denotes Alternating or AC Voltage1

NOVADAQ Logo

The Novadaq logo identifies the system as a Novadaq product1

VISIBLE AND INVISIBLE LASER RADIATION

AVOID EYE AND SKIN EXPOSURETO DIRECT OR SCATTERED RADIATION

1500 W CO2 MAX

CLASS IIIa AIMING BEAM

635 nm Diode 5 mW MAX

2.5"

DANGER

CLASS IV LASER PRODUCT

1500 Watt Danger Label

The 1500 Watt Danger label provides the laser radiation warnings required by CDRH

Made in USA Label

The Made in USA label identifies the system’s country of origin

1 Some of devices were manufactured by PLC Medical Systems, Inc and are labeled accordingly. The

device labels have since been updated with the labels listed in this document.



SSeeccttiioonn 33:: IInnssttaallllaattiioonn

33..11 CCuussttoommeerr’’ss RReessppoonnssiibbiilliittiieess

Before installation of the CO2 Heart Laser 2 can be completed, certain conditions must be met to provide a working environment for the system. The site of install must; have the proper electrical power service with receptacle for the system, meet environmental requirements of the equipment, have sufficient room to accommodate the system. Lasers shipped within the United States will contain a medical grade 110 V plug. Shipments outside the US will not have a plug. Internationally, electrical receptacles and their matching power plugs are not supplied by Novadaq due to variations in type and style of outlet used from site to site and country to country. It is the customer’s responsibility to provide a plug for the CO2 Heart Laser 2 that matches the power receptacle used at a particular site.

33..22 UUppoonn DDeelliivveerryy ooff YYoouurr SSyysstteemm

1. Inspect the exterior of the shipping crate for signs of damage or evidence of mishandling. Report any problems found to the delivery carrier and Novadaq immediately. Reports of damage must be made within seven days of delivery. Novadaq is not responsible for damage caused during shipment. Such cases must be rectified with the equipment carrier.

2. If it is necessary to store the system prior to install, care must be taken to keep the crate in an area which is heated and dry and one which can be secured.

3. Please do not open the shipping crate. The system should only be installed by a Novadaq designated representative.

33..33 FFaacciilliittiieess RReeqquuiirreemmeennttss

This section is intended to provide information necessary to prepare an area for the installation of a CO2 Heart Laser 2. This information also serves as a guide for institutions that may need to relocate a system for whatever reason. Please consult Novadaq service if any questions remain after reading this section.

3.3.1 Electrical Requirements

The CO2 Heart Laser 2 operates on 100-120/220-240 Volts AC, single phase, 50/60 Hertz. Novadaq’s recommendation is that a 10 ampere (or greater) circuit be installed for this system to compensate for potential line voltage fluctuations, instantaneous current draw and component tolerances.



3.3.2 Environmental Requirements

The CO2 Heart Laser 2 creates approximately 0.5 KW (1700 BTU’s per hour) of heat. This is a worst case scenario with the laser functioning normally and pulsing at full power with no pause between shots.

33..44 RReellooccaattiioonn

The CO2 Heart Laser 2 was designed to be easily moved short distances by a single operator. Nevertheless, care should be taken to prevent tipping or colliding with other equipment, walls, doors, or any other object. Additionally, the bulk of this system may cause damage or personal injury if not controlled during relocation. Be aware that physical shock sustained during movement may change the alignment of optics contained within the system.

The articulated arm should always be in its secured position when the system is being moved. Insure that the counterbalance weight will clear doorways or obstacles before proceeding.

To avoid damage to the arm or misalignment of the optics, Service must be contacted to prepare the system prior to relocation to another building or installation.



SSeeccttiioonn 44:: CCoonnttrroollss aanndd IInnddiiccaattoorrss

Caution!

Use of controls or adjustments, or performance of

procedures other than those specified therein may result in

hazardous radiation exposure.

44..11 KKeeyysswwiittcchh OOppeerraattiioonn

1. Turn on the CO2 Heart Laser 2 by inserting the key into the keyswitch and turn it clockwise 1/2 turn. The key will then spring back 1/4 turn counterclockwise. This is the ON position.

2. Allow the computer to boot up (approx. 1 minute). The Initial Operating screen will then appear.

44..22 TThhee TToouucchhssccrreeeenn CCoonnttrroollss

All CO2 Heart Laser 2 functions are controlled via an LCD touchscreen display. The display is capacitive in nature and designed to be used with finger touch only. Use of instruments, pens and other objects in conjunction with this screen may cause permanent damage to the surface of the screen and a subsequent need for maintenance to the system. Keep the touchscreen dry and free from all liquids as these could damage the touchscreen.

Outlined areas of the screen serve as buttons for the operation of the system. A description of screen controls is as follows:



The screen displayed in figure 4.1 shows the CO2 Heart Laser 2’s Warm Up Standby screen. The screen offers three controls, the Pilot Beam button which controls the aiming beam status, the Warm Up button used to prepare the system for use and the ECG lead selection button. The current time and date are also shown in this view along with the patients ECG signal (if connected).

Figure 4.1 Warm Up Standby Screen

1. The Warm Up button

The message Connect Cal Port is displayed below the Warm Up button. The Warm up function will not be initiated if this message is displayed.

After the Warm Up button is pressed, the button will change color and the audible/visible emission indicators are turned on. This condition will persist until the system is ready for use or up to two minutes after which the Start Laser Standby screen is displayed (Figure 4.2). The Warm Up function is only displayed when the laser has been turned off for more than six hours. If the laser is turned back on before the six hour time period, the first screen displayed is the Start Laser screen.



Warning!

If the Warm Up function lasts the full two minutes, the system may not be operational! Confirm by attempting to fire a test shot with the arm in the calibration port.

Notify Novadaq’s Service Department or your Novadaq authorized service representative if the system cannot

be made operational.

Figure 4.2 Start Laser Standby Screen

The screen displayed in Figure 4.2 shows the CO2 Heart Laser 2’s Start Laser Standby screen, seen after Warm Up. The screen also offers three controls, the Pilot Beam button which controls the aiming beam status and the Start Laser button used to prepare the system for testing and surgical use and the ECG Lead select button.



2. Pilot Beam:

Once the Pilot Beam button is selected a drop down menu appears:

Touch Off to shut the aiming beam off.

Touch On to keep the aiming beam on continuously.

Touch Arm to have the aiming beam flash when the CO2 laser is armed. When the system is disarmed the aiming beam will remain solid

Touch Flash to have the aiming beam continuously flash.

Once any button is touched and released, the aiming beam will immediately start to operate in the chosen mode and the original screen will return.

The current operating mode is displayed under the Pilot Beam button. The aiming laser is in the Off mode when the system is initially powered up.

3. ECG Lead:

Press the ECG Lead select button to select the lead which results in the best signal. When the lead locations are as shown in Figure 5.1, then the lead location selected are as follows.

LEAD SELECTED LEAD LOCATION LEAD COLOR

I LA-RA BLACK-WHITE

II LL-RA RED-WHITE

III LL-LA RED-BLACK

aVR RA-LA+LL WHITE-BLACK+RED

aVL LA-RA+LL BLACK-WHITE+RED

aVF LL-LA+RA RED-BLACK+WHITE



4. Start Laser:

Pressing the Start Laser button prepares the laser for use. The Main Operating screen will then appear.

Figure 4.3a Main Operating Screen – Not Ready

When the display changes to the Main Operating Screen, Not Ready will appear beneath the Arm Laser button (see Figure 4.3a). This indicates that the RF Power Supply is charging and the Arm Laser button is inactive. When the supply is charged, the Not Ready message will be replaced with the Laser Disarmed message. At this point the Arm Laser button will be active again.

The Not Ready message will also appear after each shot is fired. This is the time when the RF Power Supply is again recharging. After the RF Power Supply is charged (up to 4 seconds), the Not Ready message will again be replaced by the Laser Disarmed message. The laser is then ready to be armed for the next shot.

Warning!

If the “Not Ready” signal persists for more than 20

seconds, shutdown the system and restart.

If the problem persists, shutdown and notify Novadaq’s

Service Department or your Novadaq authorized

service representative.



The screen displayed in Figure 4.3b shows the CO2 Heart Laser 2’s Main Operating screen. This screen offers a variety of controls not seen on the standby display including Delay, Pulse-Width, Options, Arm Laser and Shut Down.

Figure 4.3b Main Operating Screen

The Delay button may be used in cases where it is desired to change the timing of the Laser firing in relation to the ECG pulse seen in the operating screen window.

The Pulse Width button is used to adjust the laser’s output power.

The Options button allows the operator of this system to choose several options including the laser’s test mode.

The Arm Laser button is used to ‘arm’ the laser, preparing it to fire. The Shut Down button is used to shut down the system after use.

The ECG Lead button is used to toggle the ECG lead currently viewed in the main message window.



4. 5. Pulse Width:

Touch this button if you wish to change the length of the laser pulse. It can be adjusted from 10 to 99 ms. Changing the pulse width adjusts the amount of laser energy to be delivered.

When the button is touched, a menu of 5 choices will appear:

A double UP arrow for a fast UP adjust

A single UP arrow to move 1 ms up at a time

A double DOWN arrow for a fast DOWN adjust

A single DOWN arrow to move 1 ms down at a time;

The Done button locks in the setting and returns the operator to the normal screen.

The Pulse Width Screen (Figure 4.4) shows the Pulse Width button options.

Figure 4.4 Pulse Width Screen

6. Delay: Touch this button if the time between the peak of the R-wave and the start of the laser firing need to be adjusted. It can be adjusted from 1 (normal condition) to 999 ms. When the Delay button is touched, the same five menu choices described for Pulse Width are given. The Delay Screen (Figure 4.5) shows the delay button options. Delay should only be used when the patient's medical condition is such that the signal depicting the laser pulse does not occur at the peak of the R-wave. Delay would then be used to move this signal to the peak of the R-wave.



Figure 4.5 Delay Screen

7. Pilot Beam: This button operates as described previously. The Main Operating Screen w/Pilot Beam Options (Figure 4.6) shows the Pilot Beam button options.

Figure 4.6 Main Operating Screen w/Pilot Beam Options



8. Options:

Touching this button will provide you with the option of performing the following functions shown in the menu (see the Options Screen, Figure 4.7).

Run - Returns the system to normal operating mode.

Test - When the test button is touched, the system is put into a calibration test routine. When in Test mode, the message Test is displayed under the Options button. The ECG window on the control panel will instruct the user to first connect the end of the articulated arm to the calibration port on the right side of the machine.

Figure 4.7 Options Screen



The instruction Connect Cal Port will appear (Connect Cal Port Screen, Figure 4.8).

Figure 4.8 Connect Cal Port Screen

Once the arm is connected, the message will change to Arm the Laser (see the Arm Laser Screen, Figure 4.9).

Figure 4.9 Arm Laser Screen



Once the laser is armed, the message will change to Press Foot Switch (see the Press Footswitch Screen, Figure 4.10).

Figure 4.10 Press Footswitch Screen

After the footswitch is depressed and the laser has fired, the measured energy will be displayed (see the Energy Screen, Figure 4.11).

Figure 4.11 Energy Screen

The energy displayed in the window should be within 15% of the set energy, which is displayed over the pulse width. The pulse width can be changed to check the energy at other settings. After the calibration tests are completed, the laser is returned to the Main Operating Screen by touching Options then Run.



9. Zero Shots:

Allows you to reset the Shots Fired display. Touch Zero Shots and a choice of Yes or No appears (see Zero Shots Screen, Figure 4.12).

Figure 4.12 Zero Shots Screen

10. Arm Laser/Disarm Laser:

This button allows the operator to enable the laser to fire with use of the footswitch or, once armed, allows the operator to disarm or inhibit the laser from firing. When the laser is armed, there is a 2 second delay before the footswitch will activate the firing sequence, the armed lights will illuminate and the audible alarm will sound. Also, when armed, Laser Armed will be displayed and flashing under what has become the Disarm Laser button (see the Laser Armed Screen, Figure 4.13a). The laser will only fire once per arming and must be rearmed for each subsequent laser pulse.



Figure 4.13a Laser Armed Screen

After the shot is fired, the laser will automatically disarm. The Not Ready message will then appear for up to 4 seconds (see Figure 4.13b). This is the time when the RF Power Supply is recharging. During this time, the Arm Laser button is inactive. When the RF Power Supply is ready, the Not Ready message is replaced by Laser Disarmed message. The laser is then ready for the next shot.

Figure 4.13b Not Ready Screen



11. Shut Down:

Touch this button to get a Yes or No menu (see the Shut Down Screen, Figure 4.14). Yes starts the shutdown process and returns the laser to the First Initial Screen (Figure 4.1). No returns the laser to the Main Operating Screen.

Figure 4.14 Shut Down Screen

44..33 DDiissppllaayyeedd IInnffoorrmmaattiioonn::

The following information is displayed when the laser is being operated (see the Main Operating Screen, Figure 4.15).

Figure 4.15 Main Operating Screen



Energy is displayed in joules. This is a calculated number.

Pulse Width is displayed and can be varied between 10 and 99 ms by touching the Pulse Width button, the up or down arrows, then Done.

Pulse Delay is displayed and can be varied between 1 and 999 ms by touching the Delay button, the up or down arrows, then Done.

The number of shots fired is counted and displayed. This is the actual number of shots fired by depressing the footswitch and does not include shots fired during calibration test. Shots Fired can be reset in the Options menu.

A representation of the ECG is displayed on the screen while a patient or simulator is attached to the ECG. Various messages will be displayed in this window when the system is in Test mode.

Elapsed Time will display the amount of time that has passed since the first laser shot was fired. The Elapsed Time display resets whenever the Shots Fired is reset to zero.

The day/month/year and time (24 hour format) are displayed on the screen.

System controls default to the following settings at power up: the Delay is 1 ms, the Pulse Width is 50 ms and the pilot beam will be off. Set the laser parameters to your desired needs by using the controls and displays described above.

After the system is set to the parameters desired, the surgeon may proceed at any time. The machine operator must press the Arm Laser button or use the Remote Arm switch to enable the footswitch for the surgeon. The system must be rearmed before each shot. If for some reason the laser is to be disarmed without firing, the Disarm Laser button must be touched or the Remote Arm switch must be pressed again.

44..44 OOppeerraattiioonnaall CCoonnnneeccttoorrss

Figure 4.16 shows the connector panel located on the left side of the system.

The ECG port is for the connection of patient leads to the system.

The Remote Arm connection port is for a remote switch used by service personnel to arm the system during servicing. The remote switch is not provided with the system.

The Remote Interlock connector is provided for use with door interlock switches. If desired the laser can be configured to disarm in the event that the room’s door opens.

The Footswitch connector is for the connection of the system’s footswitch which is used to trigger laser output.



Figure 4.16 Connection Panel

44..55 TThhee CCaalliibbrraattiioonn PPoorrtt

The Calibration Port (Cal Port) shown in Figure 4.17 and located on the right side of the laser is used to verify laser power output prior to surgery.

Figure 4.17 Calibration (Cal) Port



SSeeccttiioonn 55:: OOppeerraattiioonn

All operating room personnel should be wearing

protective eyewear when the laser is in use. Failure to

follow this warning may result in ocular injury. See the

Safety section of this manual for more details.

The CO2 Heart Laser 2 meets the EMI Radiation

requirements of IEC 60601-1-2. Do not operate with

any covers removed. Potential interference with other

equipment could result.

55..11 IInniittiiaall SSuurrggiiccaall SSeettuupp

1. Connect the power cord to a proper AC electrical outlet. Verify that the other end of the power cord is securely connected to the power inlet connector on the system.

2. Remove the footswitch and connect it to the receptacle marked with the footswitch symbol located on the left side of the system. Connect the remote arm cable to the receptacle marked remote. (See Figure 4.16 for clarity.)

3. Make sure the remote interlock connector is plugged into the receptacle marked interlock.

4. Check that the main circuit breaker (inside the front door) is turned on.

5. Turn on the laser by inserting the key into the keyswitch and turn it clockwise 1/2 turn (it will then spring back 1/4 turn counterclockwise). This is the ON position.

6. Allow the computer to boot up (approx. 1 minute).



7. The Initial Operating screen will then appear. Press the ‘Warm’ Up button after it appears. When the warm up period is finished the ‘Start Laser’ button will appear. Note: The warm up function serves to recondition the CO2 laser cavity after periods of inactivity. As such the warm up time varies and may be instantaneous or may take as long as 2 minutes.

8. Carefully unlock the articulated arm from its storage position. The counterweight at the rear of the arm can be adjusted by carefully rotating the counterweight adjustment knob. Adjust the weight to achieve adequate arm balance. The articulated arm, when balanced properly, should not move by itself if released.

9. Point the laser aperture towards a white, non-reflective surface, such as a piece of paper. Turn on the Pilot Beam. Verify that the Pilot Beam is not distorted and appears centered on the surrounding halo.

55..22 VVeerriiffyyiinngg LLaasseerr EEnneerrggyy

NOTE: Laser energy verification should be done prior to the patient being brought into the operating room to ensure a working system prior to anesthesia.

1. Connect the arm into the calibration port on the right side of the laser.

2. If the laser is in the standby state press the ‘Warm Up’ and ‘Start Laser’ buttons (as described in section 5.1) to enter the laser’s run mode.

3. From the laser’s Main Operating screen, select the OPTIONS menu. When the drop-down menu appears, select TEST.

4. Set the output energy for 40 joules (50 msec) using the Pulse Width button on the touch screen display.

5. Arm the laser and step on the footswitch. After the laser fires, the delivered energy will appear in the message box on the touchscreen. This energy should be within ± 15% of the selected energy. Re-fire the system twice more for a total of three test pulses. If the output energy fails to come into range, contact Novadaq Service.



55..33 PPeerrffoorrmmiinngg tthhee SSuurrggeerryy

5.3.1 Disposable TMR Kit

1. Open the sterile TMR kit, using the hospital's standard sterile operating procedures, and place the components on a sterile table. Refer to Section 1.3 – System Specifications for a list of the TMR Kit components.

2. Using your hospital’s currently accepted sterile product handling technique, place the handpieces in one of the trays. Fill the remaining tray approximately 3/4 full with sterile water. This water will be used by the scrub nurse to clean the right angled handpiece between laser shots.

5.3.2 ECG Leads

Caution!

To protect patient against the effect of cardiac defibrillator discharge and

against high-frequency burns, use only the approved ECG Cable

(Novadaq P/N CA00098)

Place the electrodes as indicated in Figure 5.1. Ensure that the ECG

Cable does not contact the defibrillator electrodes.

Utilizing your facility’s accepted technique, disinfect the entire patient ECG cable prior to connecting the leads to the patient. Attach the ECG leads.

Proper ECG lead placement is necessary for the operation of the CO2 Heart Laser 2. The strongest signal possible gives the best results when operating the system. Ensure that the best ECG pad contact possible is made. The locations suggested in Figure 5.1 have been found to be the best lead locations for use on TMR patients.

The CO2 Heart Laser 2’s console is not sterile and should not come into contact with

sterile equipment or packaging.



Use only approved Novadaq products and disposables. Failure to use Novadaq

tested products may lead to system malfunction or serious injury.

Figure 5.1 Suggested ECG Lead Placement

Black: Top of shoulder or slightly behind (not on bone) White: Top of shoulder or slightly behind (not on bone) Green: Top of leg, mid-pelvis, Lateral Aspect Red: Top of leg, mid-pelvis, Lateral Aspect Brown: Left lower thoracic region, Lateral Aspect, or proximal region



The lead location to lead selected chart is described in section 4.2 (Touchscreen Controls) item 3 (ECG leads). The default selected lead is lead II, however It may sometimes be necessary to toggle the selected lead on the system display by hitting the ECG Lead Select button. For optimal use, the lead selected should appear without artifact and have the greatest amplitude when compared to other lead signals. Strong signals will produce marking pulses for each heart beat seen on the display. An absence of the square marking pulses under the ECG waveform seen on the screen indicates a weak or undesirable signal. An acceptable ECG signal would be similar to the representation in Figure 5.2.

Figure 5.2 Acceptable ECG Signal

5.3.3 Connection of the Handpiece Lens Cell

1. Prior to attaching, inspect the handpiece lens cell for cleanliness by looking through the lens, remove any dust or debris in the assembly with alcohol. Refer to section 7.1.2 for more detailed instructions on cleaning the handpiece lens cell.

2. Attach the handpiece lens cell to the end of the arm and connect the purge hose to the connector on the lens cell. It is important that the purge hose be securely connected to the handpiece lens cell during the entire procedure.

3. Drape the arm with the sterile arm drape. This procedure requires that a circulating (non-sterile) nurse holds the arm steady and guide the arm into the open end of the drape while a scrub (sterile) nurse holds the drape. When the handpiece lens cell is adjacent to the elastic end of the drape, the scrub nurse can grab hold of the lens cell while the circulating nurse pulls the distal end of the drape up the rest of the laser arm until it reaches the vertical post of the arm.

The scrub nurse can then spread the elastic end of the drape over the end of the handpiece lens cell, exposing only the threads of the handpiece lens cell.



5.3.4 Disposable Handpiece

1. Attach the desired sterile handpiece onto the threads which protrude through the end of the sterile drape.

2. Readjust the arm counter-weight to accommodate the added weight of the handpiece and drape components. The arm should balance perfectly without any additional support. Rotate the draped laser arm so the handpiece hangs within the sterile field. This will prevent accidental contact with non-sterile surgical items and personnel.

3. Set the system parameters to achieve desired output for the patient to be treated.

4. Perform the surgery on the patient. Arming of the system for treatment is done by pressing the arm laser button prior to each pulse. Arming should only occur on instruction of the user, when he or she is ready. Once armed, two laser warning lights will illuminate on the system and an audible tone will sound to signify that the laser is ready to fire. The laser operator should disarm the laser if the surgeon removes the handpiece away from the heart.

5. Use a heart diagram included with the TMR kit to track treatment for hospital records.

6. Following the laser surgery, properly dispose of all the components of the TMR kit. These components must be disposed of and should not be re-sterilized by any means. Novadaq Technologies cannot insure their quality, cleanliness, or sterility beyond one use.

7. Transcribe the data from the heart diagram used in the surgery (2 are contained in the TMR kit) to the clean heart diagram for the patient's record.

8. Before storing the system, remove and store of the system’s keys. This will ensure only qualified personnel use and service the unit.



55..44 TTrroouubblleesshhoooottiinngg BBaassiicc PPrroobblleemmss

SYMPTOM CAUSE SOLUTION

Keyswitch is on but nothing turns on

Power cord not connected

Confirm that the power cord is plugged into the wall outlet

Confirm that the power cord is securely plugged into the power receptacle under the rear of the system

No power at wall outlet Check operation of outlet, reconnect to working outlet

Main circuit breaker is in “off” position

Check circuit breaker (inside front door), reset if necessary

Emergency off switch is stuck in a depressed position

Press the emergency off button in. The button should release after being depressed if it does not call Novadaq Service

Power cord cable came loose at laser end.

Unplug from wall and check connection of cord at laser end.

No ECG signal is displayed on the LCD display

Patient lead cable loose or disconnected from system or patient

Check lead cable connections

Laser is in ‘test’ or ‘match’ modes where ECG signal is not displayed

Return laser to normal ‘run’ mode.

Low energy output from articulated arm

Arm alignment is not correct

Check to ensure that the laser arm is not stressed or being held forcefully in a position that would shift its alignment. Correcting this type of situation should improve output power.

Look at pilot beam by shining it on a surface. If the beam does not appear round, bright and centered in a dim red halo. Laser alignment by a qualified service person may be necessary.



SYMPTOM CAUSE SOLUTION

Laser does not fire in normal operation

ECG signal not strong enough

Improve signal. Ensure that the red Marker trace is displayed below the ECG wave.

Change the selected lead to Lead II (System default selection).

Check cable connection to and from the ECG board.

One or Both “Ready” lights not working

Connection under Laser top panel left disconnected.

Reconnect

Bulb Filament Failure Replace Bulbs

No response from touchscreen

Loose connection at rear of LCD touchscreen

Check cables on rear of screen

Computer may have locked up.

Check for clock operation on screen to verify lockup.

Turn off laser and turn on again after 5 seconds to reset. Contact Novadaq Service if the problem persists.

Water or other foreign substance on touchscreen.

Clean touchscreen per section 7.1.1.

No Aiming beam Aiming beam needs to be selected on touchscreen

Select Pilot Beam button on touchscreen; turn aiming beam on.

Arm out of alignment Call Novadaq Service



55..55 EErrrroorr MMeessssaaggeess

All error messages are displayed above the Elapsed Time display. Up to three error messages may be displayed at one time.

The following table denotes a list of possible error messages with meanings and action to be taken.

Problem Cause/Troubleshooting

No Purge Gas: Air purge pressure is not being detected by the unit. Verify purge-tubing connections. This error can be cleared by pressing the IGNORE button. Contact Novadaq’s service department if the problem persists.

RF Supply Fault: The laser power supply has shut down. The laser will not fire. If an IGNORE button is displayed, push the button to attempt further system operation. Contact Novadaq’s service department.

RF VSWR Error: The power supply has failed to ignite the laser cavity, in its warm up or pre-fire attempt. Retry warming the laser. Contact Novadaq’s service department if the problem persists.

Remote Door Opened: The remote door connection indicates ‘open’. The connection on the side of the system marked ‘Door Interlock’ must either be bypassed with a jumper supplied or must be connected to an external switch. If the connection is not completed in some form, this error message will be displayed. If the IGNORE button is pressed the warning will reappear after each laser pulse as long as the fault condition persists. Contact Novadaq’s service department for details.

Shutter is open: The mechanical beam shutter within the system is open when it should be closed. The laser will not arm if the shutter is open. Try shutting down the system and restarting if the error does not clear. Contact Novadaq’s service department.




Shutter Closed Too Soon:

This message appears if the shutter closes before the completion of a laser pulse. Check footswitch and its connections. Contact Novadaq’s service department if the problem becomes persistent.

Shutter Did Not Open: The shutter did not open when the footswitch was depressed. Retry firing the system. If this error does not clear, the laser will not operate. Contact Novadaq’s service department if the problem persists.

Shutter Interlock: The shutter is defective or is not connected. The laser will not arm if the message is showing.

Raise Foot Pedal: The footswitch is depressed when starting the laser or while trying to arm the laser. If the footswitch is not depressed when the message is displayed, the footswitch may be defective. The laser cannot be armed with this error displayed. Contact Novadaq’s service department if the problem persists.

Footswitch Interlock: The footswitch is not connected or is defective. The laser will not arm if the message is showing. Contact Novadaq’s service department if the problem persists.

Calibrate System: This appears when the RF power delivered to the laser is out of tolerance. Verify proper laser energy output. Contact Novadaq’s service department.

Warning: Pulse Width XXX msec.:

This appears when the pulse width is less than 18% or is greater than 18% from the pulse width set by the operator. Most commonly seen if the footswitch is released before the end of a laser pulse. Contact Novadaq’s service department if the problem persists.

No Shot Fired: This message appears if the system does not sense a laser pulse when the system should have fired. Contact Novadaq’s service department if the problem persists.




RF Supply Overtemp This message indicates that the RF power supply’s temperature has risen too high. Turn off the laser and let cool for 30 minutes. If the problem still persists, call Novadaq’s service department.

ECG Lead(s) Off: The message appears if any of the selected leads is loose or off.



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SSeeccttiioonn 66:: TTMMRR KKiitt IInnssttrruuccttiioonnss





SSeeccttiioonn 77:: MMaaiinntteennaannccee

The electrical and laser radiation hazards present during servicing of

the CO2 Heart Laser 2 can be extremely dangerous if proper safety

precautions are not utilized. Only factory-trained technicians who are

familiar with proper safety precautions should service this laser.

77..11 GGeenneerraall IInnffoorrmmaattiioonn

The CO2 Heart Laser 2 has been designed to perform and operate with a minimum of maintenance. However, there are certain parts of the system which require routine attention.

A detailed preventative maintenance checklist is outlined in the CO2 Heart Laser 2’s Service Manual.

7.1.1 Cleaning the Touchscreen Display

The manufacturer recommends the of use glass cleaner for cleaning the touchscreen. To reduce the risk of damage to the touchscreen, perform the following steps:

1. Moisten a clean lint-free cloth or paper towel with glass cleaner. Do not apply glass cleaner directly to the touchscreen.

2. Use the moistened cloth or towel to gently clean the touchscreen.

3. Use a dry lint-free cloth or paper towel to remove any moisture remaining on the touchscreen.

7.1.2 Cleaning the Handpiece Lens Cell

The handpiece lens cell should be inspected after every use. If the handpiece lens cell becomes dirty from smoke or debris, it should be cleaned to prevent it from degrading the beam quality or destroying the focusing lens.

The lens can be cleaned by using lens cleaning paper or cotton swabs lightly wetted with alcohol to wipe particles away. Use care and do not rub with force since the optical coatings are soft and may scratch rendering them useless.



7.1.3 Purge Tubing

The purge tubing which runs down the side of the articulated arm supplies a positive flow of air which assists in keeping the focusing lens cell clean and free of debris. The purge tubing should be checked to make sure there is no debris or contaminates in the tubing. The tubing should be replaced if necessary.

Notify Novadaq’s Service department if your tubing needs replacement.

7.1.4 Cleaning the Laser Console

All external console surfaces may be cleaned using a soft cloth lightly dampened with water. Do not use abrasives or solvents, since they may damage the paint or the control panel. Do not use soaked sponges or very wet cloths for cleaning; water runoff could come into contact with electrical components. Do not use flammable or explosive cleaning agents in the presence of the laser.

77..22 PPrreevveennttaattiivvee MMaaiinntteennaannccee SScchheedduullee

Novadaq recommends that the CO2 Heart Laser 2 receive preventative maintenance checks every 6 months. Failure to do such preventative maintenance may lead to premature component failures, poor system performance and/or unwarranted system down time.

The intent of the preventive maintenance is to clean all optics, make any necessary adjustments to the optical alignments, check all electrical connections and to verify proper operation of components within the system.

Preventative maintenance as well as any maintenance on the CO2 Heart Laser 2 should only be performed by Novadaq service or other Novadaq trained representative.

77..33 EEnneerrggyy MMeetteerr CCaalliibbrraattiioonn

Federal regulations require that the calibration of the laser energy meter be checked periodically. It is recommended that this check be performed at least annually or any time that the user suspects the laser energy meter may be reading incorrectly.

Calibration must be performed using an external energy meter with an accuracy of ± 5% that is traceable to the National Institute of Standards and Testing (NIST) or its international equivalent.

Calibration should only be performed by Novadaq service representatives or other Novadaq trained personnel familiar with the CO2 Heart Laser 2. Appendix A contains the calibration procedure for the internal energy meter.



77..44 EECCGG MMoonniittoorr CChheecckk

Verify ECG Monitor System proper operation by connecting the ECG Input to a patient simulator. Set the simulator for a 1 mv amplitude and a heart rate of 60 BPM. Using the procedure outlined in Section 5, verify that the ECG wave and Marker Pulse wave are as indicated in Figure 5.2 when ECG Lead II is selected. Verify the proper operation of the remaining ECG lead selections by ensuring that a signal is present when selected.






AAppppeennddiixx AA:: EEnneerrggyy MMeetteerr CCaalliibbrraattiioonn

The electrical and laser radiation hazards present during servicing of

the CO2 Heart Laser 2 can be extremely dangerous if proper safety

precautions are not utilized. Only factory-trained technicians who are

familiar with proper safety precautions should service this laser.

Calibration should be performed only by Novadaq service representative or other Novadaq trained personnel familiar with the CO2 Heart Laser 2.

To calibrate the energy meter in the calibration port, an external energy meter (accurate to ± 5%) must be available and the following instructions must be followed.



1. Remove the front and left side skin and the metal EMI panel to expose the system interface board:

R60Gain Adjust

R79Offset Adjust

Figure A.1 – Energy Meter Adjustments, System Interface PCB

2. Turn the system on. Enter the service control mode and select ‘ECG Test Mode’ from the Options menu in the service control screen.

3. Bring the system into the RUN mode and set the laser pulse width to 50 ms. Fire the laser into an external energy meter and record the energy level.

4. Bring the system into the TEST mode and keep the laser pulse width at 50 ms. Connect the arm to the calibration port, fire the laser and record the energy displayed on the screen.

If the internal meter and external meter energy levels differ by more than 10%, the internal energy meter channel should be calibrated.

5. Use the gain pot R60 to increase or decrease the output reading on the display screen. Fire the laser and monitor the new reading on the screen.

6. Reset the system for a 10 ms pulse width and repeat steps 3 and 4. Use the offset pot R79 if a low end adjustment is necessary.

7. Repeat steps 3 through 6 until the reading on the screen matches the reading on the external energy meter.

8. Restore the EMI and skin panels and return the system to an operational state.



AAppppeennddiixx BB:: WWaarrrraannttyy IInnffoorrmmaattiioonn

1. Novadaq Technologies warrants all parts of laser devices and systems of its manufacture to be free from defects caused by faulty material and poor workmanship. Liability under warranty is limited to the obligation to repair, or the replacement without charge of, any part found to be defective under normal use and service within the time period below, provided:

a) Novadaq is promptly notified within the warranty period in writing upon discovery of such defects.

b) The original parts are returned to Novadaq Technologies on Novadaq Technologies prior authorization, transportation charges prepaid.

c) Novadaq Technologies's examination shall disclose to its satisfaction that such defects have not been caused by abuse after delivery.

d) Warranties shall not apply to items which have been repaired or altered by other than Novadaq Technologies or its Representatives.

2. The period of warranty for the CO2 Heart Laser 2 is :

twelve (12) months from the date of installation.

3. Novadaq Technologies makes no warranties except as herein set forth. The warranties stated herein are in lieu of all other warranties, express or implied, and of all other obligations of liabilities on the part of Novadaq Technologies, and Novadaq Technologies neither assumes nor authorizes any other person to assume for it any other liability. The purchaser expressly waives any right, claim or cause of action that might otherwise arise out of the purchase and use of Novadaq Technologies's products or service. Novadaq Technologies shall not be liable for special or consequential damages or any nature with respect to any merchandise or service sold, delivered or rendered.

4. All above warranties are contingent upon proper use of the Product. This warranty will not apply if:

a) Adjustment, repair or parts replacement is required because of accidental, unusual physical, electrical or electromagnetic stress, neglect, misuse, failure of electric power, air-conditioning, humidity control, transportation or causes other than ordinary use, or;

b) if the Products have been modified without Novadaq Technologies's prior written approval.

c) where Novadaq’s serial numbers or warranty date decals have been removed or altered.



d) where damage has occurred as the result of attaching accessories to the laser system other than those approved by Novadaq Technologies.

e) where damage has occurred as a result of not using an uninterrupted power supply (UPS) where specified by Novadaq Technologies.



AAppppeennddiixx CC:: BBiibblliiooggrraapphhyy

Additional information on transmyocardial revascularization (TMR)

1. Wearn JT, Mettier SR, Kllumpp TG, Zachiesche LJ. The Nature of Vascular Communications Between the Coronary Arteries and the Chambers of the Heart, American Heart Journal, Vol. 9 (1993): 143-164.

2. Beck CS, The Development of a New Blood Supply to the Heart by Operation, Annals of Surgery, Vol 102 (1935): 801-813.

3. Vineberg A., Clinical and Experimental Studies in the Treatment of Coronary Artery Insufficiency by Internal Mammary Artery Implant, Journal of the International College of Surgeons, Vol. 22 (1954): 503-518.

4. Massimo C., Boffi L., Myocardial Revascularization by a New Method of Carrying Blood Directly from the Left Ventricular Cavity into the Coronary Circulation, Journal of Thoracic Surgery, Vol. 31 (1957): 257-264.

5. Goldman A., Greenstone S. M., Preuss F.S., et al., Experimental Methods for Producing a Collateral Circulation to the Heart Directly from the Left Ventricle, Journal of Thoracic Surgery, Vol. 31 (1956): 364-374.

6. Sen P. K., Udwadia T. E., Kinare S. G., Parulkar G. B., Transmyocardial Acupuncture; A New Approach to Myocardial Revascularization, Journal of Thoracic and Cardiovascular Surgery, Vol. 50 (1965): 181-189.

7. Khazei A. H., Kime W. P., Papdopoulos C., Cowley R. A., Myocardial Canalization: A New Method of Myocardial Revascularization, Annals of Thoracic Surgery, Vol. 6 (1968): 163-171.

8. Walter P., Hundeshagen H., Borst H. G., Treatment of Acute Myocardial Infarction by Transmural Blood Supply from the Ventricular Cavity, European Surgical Research, Vol. 3 (1971): 130-138.

9. Pifarre R., Jasuja M. L., Lynch R. D., Neville W. E., Myocardial Revascularization by Transmyocardial Acupuncture: A Physiologic Impossibility, Journal of Thoracic and Cardiovascular Surgery, Vol. 58 (1969): 424-431.

10. Pifarre R., Intramyocardial Pressure during Systole and Diastole, Annals of Surgery, Vol. 168 (1969): 871-875.

11. Mirhoseini M., Cayton M. M., Revascularization of the Heart by Laser, Journal of Microsurgery, Vol.2 (1981): 253-260.

12. Mirhoseini M., Fisher J. C., Cayton M., Byocardial Revascularization by Laser: A Clinical Report, Lasers in Surgery and Medicine, Vol. 3 (1983): 241-245.



13. Mirhoseini M., Shelgikar S., Cayton M. M., New Concepts in Revascularization of the Myocardium, Annals of Thoracic Surgery, Vol. 5 (1988): 415-420.

14. Hardy R. I., Bove K. E., James F. W., Kaplan S., Goldman L., A Histologic Study of Laser Induced Transmyocardiial Channels, Lasers in Surgery and Medicine, Vol. 6 (1987): 563-573.

15. Okada M., Nakamura K., Laser Application in the Fields of Cardiovascular Surgery, Chapter in the book Nd:YAG Laser in Medicine and Surgery, Ogura Y, et al, Eds. Professional Postgraduate Services, K.K. Tokyo, Japan (1986): 319-323.

16. O'Connor W. N., et al., Ventriculocoronary Connections in Hypoplastic Left Hearts: An Autopsy Microscopic Study, Circulation, Vol. 66 (1982): 1078-1086.

17. Cottier C., Kiowski W., vonBertrab R., Pfisterer M., Burkart F., Multiple Coronary Arteriocameral Fistulas as a Cause of Myocardial Ischemia, American Heart Journal, Vol. 115 (1988): 181-184.

18. Renault G., Sinet M., Muffat-Joly M., Cornillault J., Pocidalo J., In Situ Monitoring of Myocardial Metabolism by Laser Fluorimetry: Relevance of a Test of Local Ischemia, Lasers in Surgery and Medicine, Vol. 5 (1985): 111-122.

19. Mirhoseini M., Muckerheide M., Caytin M. M., Transventricular Revascularization by Laser, Lasers in Surgery and Medicine, Vol. 2 (1982): 187-198.

20. Mirhoseini M., Cayton M. .M., Shelgikar S., Fisher J. C., Conical Report: Laser Myocardial Revascularization, Lasers in Surgery and Medicine, Vol. 6 (1986): 459-461.

21. Hardy R. I., James F. W., Millard R. W., Kaplan S., Regional Myocardial Blood Flow and Cardiac Mechanics in Dog Hearts with CO2 Laser-induced

Intramyocardial Revascularization, Basic Research in Cardiology, Vol. 85 (1990): 179-197.

22. Landreneau R., Nawarawong W., Laughlin H., Ripperger J., Brown O., McDaniel W., McKown D., Curtis J., Direct CO2 Laser "Revascularization" of the

Myocardium, Lasers in Surgery and Medicine, Vol. 11 (1991): 35-42.

23. Mirhoseini M., Shelgikar S., Cayton M., Clinical and Histological Evaluation of Laser Myocardial Revascularization, Journal of Clinical Laser Medicine & Surgery Vol. 6 (1990): 73-78.

24. Crew J. R., Transmyocardial Revascularization by CO2 Laser, Surgical

Technology International, Vol. 1 (1991): 236-238.



25. Mirhoseini M., Shelgikar S., Cayton M. M., Transmyocardial Laser Revascularization; A Review, Journal of Clinical Laser Medicine & Surgery, Vol. 39 (1991): 1-4.

26. Yano O. J., Beilefeld M. R., Jeevanandam V., Treat M. R., Marboe C. C., Spotnitz H. M., Smith C. R., Revention of Acute Regional Ischemia with Endocardial Laser Channels, The Annals of Thoracic Surgery, Vol. 56 (1993): 46-53.

27. Okadaq M., Shimizu K., Ikuta H., Horii H., Nakamura K., A New Mthod of Myocardial Revascularization by Laser, Thoracic Cardiovascular Surgeon, Vol. 39 (1991): 1-4.

28. Cooley D. A., Frazier O. H., Kadipasaoglu K., Pehlivanoglu S., Shannon R. L., Angelini P., Transmyocardial Laser Revascularization: Anatomic Evidence of Long Term Channel Patency, Texas Heart Institute Journal, Vol. 21 (1994): 220-224.

29. Raffa H., Transmyocardial Laser Revascularization; "The Mirhoseini Procedure," Saudi Heart Journal, Vol. 5, No. 1 (1994): 57-62.

30. Horvath K. A., Smith W. J., Laurence R. G., Schoen F. J., Appleyard R. F., Cohn L. H., Recovery and Viability of an Acute Myocardial Infarct after Transmyocardial Laser Revascularization, American College of Cardiology, Vol. 25 (1995): 258-263.

31. Horvath K. A., Mannting F., Cummings N., Sherman S. K., Cohn L. H., Transmyocardial Laser Revascularization Operative Techniques and Clinical Results at Two Years, Western Thoracic Surgical Association, June 24, 1995.

32. Frazier O. H., Cooley D. A., Kadipasaoglu K. A., Pehlivanoglu S., Lindenmeir M., Barasch E., Conger J. F., Wilansky S., Moore W. H., Gould K. L., Myocardial Revascularization with Laser: Preliminary Findings, Circulation Supplement II, Vol. 92, No. 9 (1995) 1158-1165.

33. Prasad V. S., Sankar N. M., Arumugam S. B., Singh R. K. K., Cherian K. M., Transmyocardial Laser Revascularization - A New Concept in the Treatment of Coronary Artery Disease, Indian Heart Journal, Vol. 47 (1995): 49-51.

34. Smith J. A., Sunning J. J., Parry A. J., Large S. R., Wallwork J., Transmyocardial Laser Revascularization, Journal of Surgeons, Vol. 60 (1995): 569-572.

35. Tsang J. C. C., Chiu R. C. J., The Phantom of "Myocardial Sinusoids": A Historical Reappraisal, Society of Thoracic Surgeons, Vol. 60 (1995): 1831-1835.

36. Whittaker P., Rakusan K., Kloner R. A., Transmural Channels Can Protect Ischemic Tissue, Circulation, Vol. 93, No. 1 (1996): 143-152.



37. Kohmoto T., Fisher P. E., Gu A., Zhu S. M., Yano O. J., Spotniz H. M., Smith C. R., Burkhoff D, Does Blood Flow Through Holmium: YAG Transmyocardial Laser Channels?, Annals of Thoracic Surgeons, Vol. 61 (1996): 861-868.

38. Cooley D. A., Frazier O. H., Kadipasaolglu K. A., Lindenmeir M. H., Pahlivanoglu S., Kolff J. W., Wilansky S., Moore W. H, Transmyocardial Laser Revascularization: Clinical Experience with Twelve-Month Follow-Up, Journal of Thoracic and Cardiovascular Surgery, Vol. 111, No. 4 (1996): 791-799.

39. Horvath K. A., Cohn L. H., Cooley D. A., Crew J. R., Frazier O. H., Griffith B. P., Kadipasaoglu K., Lansing A., Mannting F., March R., Mirhoseini M. R., Smith C, Transmyocardial Laser Revascularization: Results of a Multi-Center Trial Using TLR as Sole Therapy for End Stage Coronary Artery Disease, Presented at AATS Meeting, San Diego, CA., April 29, 1996.



AAppppeennddiixx DD:: SSeerrvviiccee aanndd SSaalleess OOffffiiccee LLooccaattiioonnss

For service and sales support, please contact.

Novadaq Technologies

300 Myles Standish Blvd., Suite 103 Taunton, MA 02780 Emergency Service 1-508-880-4700 Customer Service 1- 800-230-3352 Email: [email protected]






AAppppeennddiixx EE:: PPhhyyssiicciiaann’’ss IInnffoorrmmaattiioonn ffoorr UUssee

US Federal law restricts this device to sale by or on the

order of a physician (or properly licensed practitioner).

US Federal law further restricts the use of this device

to practitioners who have been trained in laser heart

surgery including laser system calibration and

operation.

Use of this device is restricted to patients who have

signed a consent form to ensure that the risks

associated with TMR have been fully explained and

understood.



EE..11 DDEEVVIICCEE DDEESSCCRRIIPPTTIIOONN

The CO2 Heart Laser 2 is a very powerful CO2 slab-laser operated in a pulsed-only mode, producing pulses of 10 to 99 milliseconds at 8 to 80 Joules. The energy is delivered directly to the heart through a seven mirror articulated arm terminated with a 125 millimeter focal length hand piece producing an approximately 1 mm diameter hole. The CO2 laser beam is combined with a pilot (visible) beam as it exits the laser tube to facilitate aiming.

The CO2 Heart Laser 2 is a pulsed, ECG synchronized 10.6 µm CO2 laser intended for use in transmyocardial revascularization. The laser is set to deliver a maximum power of 800 watts in pulses 10 to 99 ms long at energies of 8 to 80 joules. Laser energy is delivered to the tissue through an articulated arm delivered by a single use, sterile, handpiece.

The laser housing contains all systems components, including the laser head, power supply, and computer. All laser functions are controlled from the computer touchscreen. The computer interfaces directly with the internal ECG board to trigger laser actuation at the peak of the R-wave. Laser pulse and ECG signals are displayed on the touchscreen to allow the operator to see the timing of the laser pulse in relation to the R-wave. The sterile disposable TMR kit contains straight and right-angle handpieces to access different sections of the myocardium.



EE..22 IINNDDIICCAATTIIOONNSS FFOORR UUSSAAGGEE

Transmyocardial revascularization with the CO2 Heart Laser 2 is indicated for the treatment in patients with stable angina (Canadian Cardiovascular Society Class III or IV) refractory to medical treatment and secondary to objectively demonstrated coronary artery atherosclerosis and with a region of the myocardium not amenable to direct coronary revascularization.



EE..33 CCOONNTTRRAAIINNDDIICCAATTIIOONNSS

No contraindications known.



EE..44 WWAARRNNIINNGGSS aanndd PPRREECCAAUUTTIIOONNSS

UNSTABLE ANGINA WAS ASSOCIATED WITH 22% PERI-OPERATIVE MORTALITY COMPARED TO 1% IN PATIENTS WITH STABLE ANGINA.

In the randomized clinical study involving 151 TMR surgeries, patients were classified as stable or unstable angina (requiring IV anti-anginal medication) based on the two weeks preceding surgery. Peri-operative mortality (surgery + 30 days thereafter) was 1% (1/102) in the absence of unstable angina compared to 22% (11/49) when the patient suffered from unstable angina.

Right ventricular wall, septal ischemia - TMR with the CO2 Heart Laser 2 should not be used on patients with myocardial ischemia limited to the right ventricular wall and/or interventricular septum due to access limitations with TMR.

Laser pulse timing – The laser pulse needs to be timed at the peak of the R-wave. Do not operate the CO2 Heart Laser 2 without proper placement of ECG electrodes.

Explosions or fire hazard - Do not operate the CO2 Heart Laser 2 in the presence of flammable gases, anesthetics, cleaning agents, combustible materials, or other volatile substances. Explosions or fire can result.

• Combustible or flammable materials (for example surgical drapes, gowns or gauze) in the surgical field may be ignited by CO2 radiation unless they are kept wet or moistened.

• Surround the surgical field with wet towels or wet gauze.

• Modify all other flammable materials to make them fire-retardant (for example flame resistant surgical drapes and gowns).

• Minimize oxygen exposure as oxygen increases the combustibility of materials exposed to CO2 laser radiation.

• Do not use plastic or rubber endotracheal tubes as they are highly flammable. Use fireproof endotracheal tubes or protect the endotracheal tube from laser energy.

Laser radiation - The CO2 Heart Laser 2 is a Class IV laser product.

• Avoid exposure to laser radiation at all times during the installation and operation of the laser as direct or reflected radiation may damage skin or eyes.

• DO NOT LOOK DIRECTLY INTO THE CO2 LASER BEAM (not visible) or the pilot beam as either can cause permanent ocular damage.

• Protect the patient's eyes by covering them with wet gauze.

• All operating room personnel must wear protective eyewear with a minimum

optical density of 5 at a wavelength of 10.6 µm when the CO2 Heart Laser 2 is in use.

• Do not use shiny metallic surfaces within the operative field which may reflect the laser beam. Use instruments with a dull, anodized, or ebonized finish near the laser beam.



Physician Training

• The CO2 Heart Laser 2 should only be used by properly trained surgeons (see Section E.11.1.3 Operator Training).

Handling and Sterilization

• The TMR kit is for single use only. Do not re-sterilize or reuse.

• Inspect sealed sterile package before opening. If seal is broken, contents may not be sterile and may cause infection in the patient

• After use, handle and dispose of TMR kit as appropriate for a biohazard.

• Clean exterior panels of laser of bio-contaminants following surgery.

Precautions During TMR

• Transmural penetration by the CO2 laser should be confirmed by transesophageal echocardiography (see Section E.6 CLINICAL STUDIES)



EE..55 AADDVVEERRSSEE EEVVEENNTTSS

Observed Adverse Events

Since the beginning of the clinical studies in the U.S. in 1990, a total of 1,115 patients have been treated with The Heart Laser™ System. The randomized trial of TMR using The Heart Laser System versus medical management (MM) involved 192 patients who were followed for a total of 140 patient-years. Following the randomized study, 458 subjects were treated with the Heart Laser under a continuation protocol. After FDA approval to market the product was obtained in 1998, a Post Market Registry study ensued during which an additional 516 subjects were enrolled in a Post Market Registry study. The subjects who received TMR from the Post Market study (438) and the subjects from the IDE randomized study who underwent TMR (151) are included in the analyses going forward.

There were no intra-operative deaths in any of the TMR treated subjects in the above mentioned studies. There were 3 recorded deaths in the peri-operative period (0-30 days post procedure) in the IDE randomized trial (one each of cardiogenic shock, cardiac arrest, and myocardial infarction). Nine of the subjects who had been originally randomized to the MM group but who crossed over (XO) to the TMR group after failing medical management died (ventricular fibrillation (3), acute MI (1), CVA (2), cardiogenic shock (1), low cardiac output (1) and unknown cause (1).

There were 15 deaths in the peri-operative period in the post-market registry study that were coded as either related to or possibly related to TMR (arrhythmia, asystole, exacerbation of CAD, cardiac arrest, heart block, heart failure, hypotension/Bradycardia, low cardiac output, left ventricular failure, acute MI (2), pulmonary embolism (2), and respiratory arrest (2).

A logistic regression was performed to identify peri-operative risk factors for 30-day mortality following TMR. Candidate variables for this analysis came from known predictors of bypass mortality and from those identified from the TMR clinical trials. Table E.5.1 below includes all patients who underwent TMR in the IDE randomized trial and in the Post Market Registry Study. The statistically significant risk factors that emerged were: Age greater than 65, History of CHF, and Renal Disease.



Table E.5.1 30-day Mortality Odds Ratios

All Patients (TMR IDE & TMR Post Market Registry Subjects)

Data Point Odds Ratio

Confidence Interval

Age (>65 yrs vs. < 65 years) 3.189 1.666 6.104 History of CHF 2.356 1.285 4.321 Previous Myocardial Infarction 2.216 0.916 5.361 Renal Disease 2.195 1.058 4.552 Previous CABG Surgery 2.120 0.496 9.068 Hypertension (requiring treatment) 1.817 0.750 4.401 Weight (< 188lbs vs. > 188lbs) 1.673 0.916 3.056 Hypercholesterolemia 1.612 0.663 3.921 Diabetes (on oral or insulin therapy)

1.536 0.846 2.719

Cerebrovascular/Stroke 1.366 0.707 2.641 Height (< 68” vs. > 68”) 1.339 0.729 2.457 COPD 1.338 0.596 3.002 History of Arrhythmia 1.288 0.703 2.359 Female 1.272 0.659 2.455 Prior Heart Surgery 1.216 0.418 3.538 Peripheral Vascular Disease 1.185 0.692 2.232 BMI 0.964 0.905 1.026 Previous PTCA 0.950 0.520 1.737 Prior Vascular Surgery 0.924 0.417 2.049 Former Smoker 0.857 0.448 1.640 History of Cardiac Arrest 0.769 0.102 6.233 Current Smoker 0.540 0.126 2.319



Table E.5.2 shows the incidence of major cardiac adverse events occurring within 30 days of the TMR procedure (days 1-30). Events captured during the Post-Market Registry included those in hospital events coded as serious and either device and/or surgery related. Events captured during the Randomized IDE study included major adverse events judged (by independent DSMB) as probably or possibly related to TMR.

Table E.5.2 Incidence of Major Cardiac Adverse Events in the Peri-operative Period

All Subjects undergoing TMR in the Phase III Randomized Trial (n=151) and the Post

Market Registry (n=438)

Major Cardiac Adverse Event Days 0 – 30 post TMR

Post-Market

Registry

Randomized Study TMR

Randomized Study Cross-

Over n=438 n=91 n=60

Acute Myocardial Infarction 1.0% 6.6% 6.7% Arrhythmia: Atrial 1.8% 2.2% 5.0% Arrhythmia: Ventricular 1.6% 9.9% 11.7% Cardiogenic Shock/Low Output 3.2% 3.3% 6.7% Chest Pain 0% 1.1% 0% Congestive Heart Failure 1.6% 11.0% 5.0% Laser Hit – Mitral Regurgitation 0% 1.1% 1.7% Left Ventricular Bleeding 0.2% 1.1% 1.7% Mitral Valve Regurgitation 0.2% 0% 0% Pericardial Tamponade 0.2% 0% 1.7% Ruptured Left Ventricle 0% 0% 1.7% Unstable Angina 0% 1.1% 3.3%

Additional adverse events that were coded as serious, but not related to either device and/or surgery occurred in .2 – 4% of the patients enrolled in the Post Market Registry, and included Anemia, CNS deficit, edema, infection, GI bleed, pleural effusion, pulmonary complications acute renal failure, hyperkalemia, and renal complications.

Between 1 and 8% of subjects enrolled in the randomized study experienced additional adverse events which included anemia, cancer, cerebrovascular accident, edema, GI complications, hemothorax, hyperglycemia, hypotension, infection, pleural effusion, pulmonary complications, renal complications, and syncope.

Potential Adverse Events

Adverse events potentially associated with the use of TMR include (in alphabetical order):

• Acute Myocardial Infarction

• Accidental Laser Hit

• Arrhythmia

• Cardiogenic Shock/Low cardiac Output

• Congestive Heart Failure

• Death

• Left Ventricular Bleeding

• Mitral Valve Damage

• Pulmonary Complications

• Unstable Angina



EE..66 CCLLIINNIICCAALL SSTTUUDDIIEESS

E.6.a IDE Randomized Study TMR vs. Medical Management

IDE Study:: TMR using The Heart Laser™ System versus Medical Management for the treatment of patients with chronic stable angina not amenable to direct revascularization.

Objective: The objective was to compare TMR using The Heart Laser System to medical management for the treatment of patients who were not candidates for conventional CABG or PTCA revascularization procedures and had CCS Class III/IV angina refractory to medical treatment.

Methods: The clinical trial was a controlled, 1:1 randomized concurrent study between TMR therapy using The Heart Laser System and medical treatment alone. Patients were randomized to receive either TMR or continued medical therapy. Transesophageal echocardiography (TEE) was performed to assess regional wall abnormalities, mitral valve anatomy, and confirm transmural penetration by the CO2 laser.

The protocol included a cross-over clause which permitted patients randomized to the continued Medical Management group to receive the TMR treatment once medical therapy had failed. Medical management failure was defined as the occurrence of an unstable angina event requiring ICU hospitalization for at least 48 hours with IV anti-anginal medication.

Endpoints: The objective of the study was to compare TMR and Medical Management patient groups. The study endpoints were:

• Change in number of myocardial segments with stress-induced ischemia as measured by standardized nuclear imaging studies

• Change in angina class as measured by the Canadian Cardiovascular Society Angina classification system.

Additionally, quality of life, cardioactive medications usage, mortality, and morbidity were monitored throughout the study. All adverse events observed during the randomized study were reviewed and analyzed by the Data Safety Monitoring Board (DSMB), an independent panel of experienced physicians.

Compliance Patients were followed for 12 months with evaluations at 3, 6 and 12 months. The overall study compliance was 92%.

Population: Patient enrollment in the randomized clinical trial occurred at 12 investigational sites and involved a total of 192 patients randomized to the TMR group (91) or the medical management group (101). Six additional patients were enrolled and randomized to TMR. They are not included in this analysis because they either did not receive TMR treatment (5) or were considered a protocol deviation (1). The protocol deviation involved a patient on IV nitrates at the time of enrollment. This patient died peri-operatively.



Patient characteristics at baseline were similar between the clinical sites and between the randomized study groups. More than half (58%) of the patients were classified as high-risk patients2.

Demographics Medical History Cardiac Status Risk Factors

• Female 21% • AMI: 80% • Class 4 Angina: 66% • Hypertension: 64%

• Age: 61±10 years • Arrhythmia: 20% • Class 3 Angina: 34% • Diabetes: 45%

• CHF: 34% • Unstable Angina: 10% • High Cholesterol: 61%

• CVA-TIA: 16% • LVEF (%): 50±11 • Current Smoker: 8%

• Prior CABG: 92% • LVEF ≤ 45%: 33%

• Prior PTCA: 50%

• Cardiac Arrest 5%

• COPD 8%

• Renal Disease,10%

Treatment: The average TMR procedure resulted in the creation of 36±13 laser

channels with 30±8 channels successfully reaching the left ventricular cavity. On

average, The Heart Laser was set to deliver 41±17 Joules per pulse. The TMR procedure was associated with a median ICU length of stay of 2 days and a median hospital length of stay of 7 days.

Results:

Table E.6.a.1 Summary of Study Safety Findings

All patients in the Phase III Randomized Trial (N=192), Percent and 95% [confidence intervals]

Incidence [95% Confidence Interval]

TMR Treatment (N=91)

Med. Management (N=101)

Difference TMR – Med. Mgt.

Adverse Events Incidence at 12 Month Follow-Up (1)

Acute myocardial infarction 11% [4%,18%] 22% [8%,36%] -11% [-25%,3%]

Congestive heart failure 16% [8%,24%] 23% [7%,39%] -7% [-21%,7%]

Unstable Angina

14% [7%,21%] 75% [66%,84%] 61%*

[-72%,-50%]

Survival at Follow-Upa (Freedom from death)

1-Year Survival 85% [78%,92%] 79% [65%,94%] +6% [-8%,20%]

2-Year Survival 81% [72%,90%] --- --- --- ---

Event Free Survival at Follow-Upa (Freedom from death, Unstable angina, and Class 4 angina)

1-Year Survival

69% [60%,79%] 15% [8%,22%] +54% [42%,66%]

a Survival analyses conducted using Kaplan-Meier estimator

* Difference statistically significant (p≤0.05) by Chi-square.

2 Higgins T, Estaphanos: Stratification of morbidity and mortality by preoperative risk factor in coronary artery bypass patients. JAMA 1992; 267: 2344-8.



Randomized IDE Study:

Table E.6.a.2. Incidence of Major Cardiac Adverse Events

All patients in the Phase III Randomized Trial (N=192)

Cardiac Related Event TMR assigned (N=91) Crossovers (N=60) MM (N=101)

Day 1-30 Month 1-12a Day 1-30 Month 1-12

a Month 1-12

a

Acute myocardial infarction 6.6% 7.7% 6.7% 6.7% 11.9%

Arrhythmia: Atrial 2.2% 2.2% 5.0% 5.0% -

Arrhythmia: Ventricularb 9.9% 9.9% 11.7% 11.7% -

Cardiogenic Shock / Low Output 3.3% 3.3% 6.7% 6.7% -

Chest Pain 1.1% 1.1% - - 1.0%

Congestive heart failure 11.0% 11.0% 5.0% 5.0% 9.9%

Laser Hit – Mitral Regurgitation 1.1% 1.1% 1.7% 1.7% -

Left Ventricular Bleeding 1.1% 1.1% 1.7% 1.7% -

Mitral Valve Regurgitation - 1.1% - - -

Pericardial Tamponade - - 1.7% 1.7% -

Pericarditis - 1.1% - - -

Ruptured Left Ventricle - - 1.7% 1.7% -

Unstable Angina 1.1% 2.2% 3.3% 5.0% 69.3%

a Average duration of follow-up was 10.4 mos for the 91 TMR patients, 8.7 mos for the 60 crossover patients, and 7.2 mos for the

101 MM patients – Month 1-12 includes Day 1-30 period b One patient had 2 events – a peri-operative event and a long-term event



Table E.6.a.3 Summary of Study Effectiveness Findings

All patients in the Phase III Randomized Trial (N=192), Percent and [95% confidence intervals]

Incidence or Mean ± Std Dev [95% Confidence Interval]

TMR Treatment (N=91)

Medical Management (N=101)

Difference TMR – Med. Mgt.

Angina Pectoris – Success Rate at Follow-Upa

Baseline to 3 Month Change 67% (52/78) [55%,79%] 6% (4/64) [2%,16%] +61%* [49%,73%]

Baseline to 12 Month Change 72% (44/61) [60%,84%] 13% (3/23) [5%,27%] +59%* [41%,77%]

Quality of Life – Change in Seattle Angina Questionnaire Scores at Follow-Upb

Baseline to 3 Month Change +170% [138%,201%] +7% [-9%,23%] +163%* [128%,198%]

Baseline to 12 Month Change +143% [112%,174%] +39% [13%,65%] +104%* [50%,158%]

Left Heart SPECT -Change in Number of Ischemic Perfusion Defects at Follow-Up

Baseline to 3 Month Change

-1.5 ± 3.4 (N=50) +0.8 ± 3.0 (N=38) -2.3* [-3.7,-0.9]

Baseline to 12 Month Change -1.4 ± 3.4 (N=38) +1.3 ± 2.3 (N=13) -2.7* [-4.7,-0.7]

a Therapy success = Decrease of at least 2 CCS angina classes between baseline and follow-up

b Average of 5 standard Seattle Angina Questionnaire indices

* Difference statistically significant (p≤0.05) by t-test.

Based on the last available follow-up assessment, 66 percent (52/79) of the patients in the TMR group were considered angina successes. Of these 52 patients, the use of cardioactive medications (beta blockers, calcium channel blockers or nitrates) were decreased in 31 to 42 percent, or unchanged in 52 to 40 percent.

In the randomized clinical study involving 151 TMR surgeries, patients were classified as stable or unstable angina (requiring IV anti-anginal medication) based on the two weeks preceding surgery. Peri-operative mortality (surgery + 30 days thereafter) was 1% (1/102) in the absence of unstable angina compared to 22% (11/49) when the patient met the definition for unstable angina.



E.6.b Post Approval Required Registry Study: Registry/Study: Post Market Registry for Transmyocardial Revascularization (TMR) Using the Heart Laser™ CO2 System Post-Market Registry Objective: The objective of the registry was to continue to increase the knowledge associated with TMR, with an emphasis towards a better understanding of the risks associated with the treatment.

Design: The Registry was randomized 1:1, prospectively assigning patients into two concurrent groups based upon the timing of the TMR treatment: at the time of enrollment (immediate) or 30 days after enrollment (delayed). The study was designed

to enroll 600 patients at all hospitals that use The Heart Laser CO2 TMR System.

Endpoints: The registry sought to further define:

• The risk factors for peri-operative mortality/morbidity

• The effect of operator experience on safety results

• The medical condition treated

Follow-up: 94% of subjects eligible for long-term follow-up (30days – 12 months) were compliant, 6% were lost to follow-up.

Population: patients who met the approved labeling criteria and who had been cleared for surgery were eligible for participation in the Registry. In addition, subjects could not have an evidence of a major non-cardiac illness that could interfere with TMR treatment, had to have an ejection fraction of >20%, could not be pregnant, nursing or undergoing labor or delivery and could not be under the age of 18.

Enrollment: A total of 516 patients were enrolled in the study at 39 sites. There were 240 patients enrolled in the delayed group, 248 were enrolled in the immediate group, and 28 were proctored (training) subjects. Prior to TMR surgery, 6 subjects died and 45 were withdrawn from the registry. The following results are based on the 438 randomized subjects who underwent TMR surgery.



Baseline Characteristics: Analyses were done which showed that the two groups did not differ in the baseline characteristics, thus the have been combined in the table below.

Demographics Medical History Clinical Status Risk Factors

• Female 26%

• Age 64+10 yr

• BMI 30+5

• AMI: 75%

• Arrhythmia: 44%

• CHF: 31%

• CVA/TIA: 17%

• CABG: 92%

• PTCA: 62%

• Unstable Angina: 77%

• Cardiac Arrest: 3%

• PVD: 30%

• COPD: 14%

• Renal Disease: 13%

• Anemia 11%

• LVEF <35%: 12%

• Operative Valve Insufficiency o Mitral: 2% o Aortic: 1%

• Serum Creatinine o >1.9: 7% o >1.6<1.8: 8%

• HTN: 83%

• Diabetes: 47%

• High Cholesterol: 87%

• Current Smoker: 7%

• Former Smoker: 70%

Treatment: At the time of TMR Surgery, 2% of subjects had been treated for unstable angina within 2 weeks of surgery, 0.7% of subjects were hemodynamically unstable, and 0.5% had ischemic valvular dysfunction. An intraortic balloon pump was utilized in 12% of the cases, and of those cases, it was used prophylactically 19% of the time.

Results:

Table E.6.b.1 Summary of Study Safety Findings

TMR Registry (n=438)

Adverse Event Incidence ( 0 – 30 days) Arrhythmia 21 (5%)

Cardiovascular 37 (8%) Cerebrovascular 1 (0.2%)

Other, (anemia, infection, etc.) 12 (3%) Pulmonary 32 (7%)

Renal 6 (1%) Mortality

Peri-operative (0 – 30 days) 38 (8.7%) 1 Year (0- 12 months) 57 (13%)



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Specific Patient Populations

The safety and effectiveness of The Heart Laser System has not been established for the following specific populations:

• patients under the age of 18;

• patients who are pregnant or undergoing labor and delivery;

• nursing mothers;

• patients suffering from active hepatic disease, renal failure, cancer or major infection;

• patients with a left ventricular ejection fraction less than <20%;



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This device is restricted to use in patients who sign an informed consent to ensure that the risks associated with TMR have been fully explained to and understood by the patient.

Patients should be advised that any reduction of angina will occur gradually, that they will continue on their antianginal medications, and that the need for these medications will be re-evaluated at subsequent visits.

Patients should be advised of the risks of the procedure including the possibility of:

• recurrence of angina;

• progression of myocardial ischemia;

• worsening heart failure;

• cardiac arrhythmia;

• death.



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The CO2 Heart Laser 2 has been tested to and conforms with the requirements of the following domestic and international standards:

UL2601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety

CSA C22.2 No. 601.1-M90 Medical Electrical Equipment, Part 1: General Requirements for Safety

IEC60601-2-22 Medical Electrical Equipment, Part 2: Particular Requirements for the Safety of Diagnostic and Therapeutic Laser Equipment.

IEC60601-2-25 Medical Electrical Equipment, Part 2: Particular Requirements for the Safety of Electrocardiographs.

IEC6001-1-2/EN60601-1-2 Medical Electrical Equipment, Part 1: General Requirements for Safety, 2. Collateral Standard Electromagnetic Compatibility- Requirements and Tests.

IEC60601-1/EN60601-1 Medical Electrical Equipment, Part 1: General Requirements or Safety



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Packaging

The CO2 Heart Laser 2 system consists of the laser unit and the sterile, disposable, TMR kit.

The 600 lb. laser is initially installed in the Hospital by Novadaq personnel.

The single-use TMR kits are supplied sterile for every TMR case. Sterility may be compromised if the package is opened or damaged

E.10.1.1 Storage

The storage life of the TMR kit is two years from date of sterilization.

E.10.1.2 Accessories

The Disposable TMR Kit includes:

• Straight Handpiece

• Right Handpiece

• Laser Arm Drape

• Heart Diagram

• Non-toxic marker

• Mirror Swabs

• Plastic Trays



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Patient Informed Consent

In addition to the standard surgical consent, Novadaq Technologies requires an additional consent form to be signed by each patient to ensure that the risks associated with TMR have been fully explained to the patient.

Operator’s Manual

Operating instruction for the laser unit is contained in the CO2 Heart Laser 2 Operator's Manual which includes seven sections describing operator safety, a detailed device description, unpacking and installation procedures, system operation, accessories, and preventive maintenance. It also contains five appendices which describe the energy meter calibration procedure, the warranty, a bibliography of articles relevant to TMR, a list of sales/service contacts, and Physician’s information for use.

It is essential that the Operator’s Manual, especially those parts dealing with laser safety be read and understood before operating, maintaining and servicing this system. Failure to operate the CO2 Heart Laser 2 in accordance with the Operator’s Manual may result in serious injury.

Operator Training

Federal law restricts the use of this device to practitioners who have been trained in laser heart surgery including laser system calibration and operation. Operator training for use of the CO2 Heart Laser 2 must include training in the use of the laser system and sterile disposable kit as well as appropriate clinical training.

Laser Training

The American Society For Laser Medicine And Surgery offers the following Standards of Practice for the Use of Lasers in Medicine and Surgery:

Hospital privileges are, and must remain, the responsibility of the hospital governing board. Those requesting privileges to use lasers shall meet all the standards of the hospital with regard to board certification, board eligibility, special training, ethical character, good standing, judgment, indications for application, etc. In addition, the following laser training and experience is recommended:

• The individual should review the pertinent literature and audiovisual aids, and should attend laser training courses devoted to teaching of laser principles and safety. These courses should include basic laser physics, laser-tissue interactions, discussion of the clinical specialty field, and hands-on experience with lasers.



• The individual should have spent time with an experienced operator in the specialty area involved. It is essential that the individual see and document actual clinical applications of the laser in the outpatient or hospital setting as appropriate to the procedures in which the training is conducted.

• The individual should work closely with the biomedical engineering personnel.

Clinical Training:

Use of the CO2 Heart Laser 2 should only be undertaken by personnel trained in accordance with the Novadaq Clinical Education Program. The comprehensive training program includes:

• Peer to peer training for surgeons offered periodically at regional training centers and through scheduled educational programs. On-site in-service training provided by Novadaq clinical education personnel. Novadaq’s clinical educators and/or consultant physician proctors will be available for initial case proctoring.

• Continuing education programs including online and peer to peer symposia will be offered on a periodic basis. These programs will offer surgeon users the opportunity to continuously review and discuss the techniques in TMR. Clinical educators are available for follow-up on-site in-service training and ongoing communication with CO2 Heart Laser 2 users.

Further information about training can be obtained from Novadaq Customer Service at 1-800-230-3352 or [email protected].

Mechanism of Action

The mechanism(s) whereby TMR relieves angina is not known. In addition to possible contribution of placebo effect, current theories include:

• Increased perfusion of myocardium via the channels created;

• Increased collaterization via angiogenesis;

• Symptom reduction resulting from disruption of pain fiber function;

• Possible microinfarcts to the myocardium.

Documents

Dear Valued Customer,€¦ · Novadaq Technologies 300 Myles Standish Blvd., Suite 103 Taunton, MA 02780 The CO 2 Heart Laser 2 Operator's Manual 020-50000-000 Rev A