Spectranetics CVX-300, CVX-300-P Operator's Manual

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7030-0068-26 28Jul16

CVX-300®

CVX-300®-P

Excimer Laser System

Operator’s Manual

Version 26

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CVX-300® Excimer Laser System Version 26 Operator’s Manual

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The documentation contained herein is condential and proprietary. Thisdocumentation may not be copied, reproduced, disclosed, transferred, or reduced to any form, including electronic medium or machine-readable form. Thisdocumentation may not be transmitted or publicly performed by any means, electronic or otherwise, without the written consent of The SpectraneticsCorporation.

The documentation contains valuable trade secrets and proprietary information and is protected by federal copyright laws. Unauthorized use of the documentation can result in civil damages and criminal prosecution.

MANUFACTURED UNDER ONE OR MORE OF THE FOLLOWING PATENTS: USP 5263952, 5267993, 5315614, 5321783, 5470330, 5383199, 5412682, 5415653 AND OTHER PATENTS PENDING.

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CVX-300® Excimer Laser System Version 26 Operator’s Manual

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Preface

The CVX-300 is an excimer laser system approved for use in minimally invasive interventional procedures within the cardiovascular system, and for the removal of problematic pacemaker and debrillator cardiac leads. The CVX-300 produces pulsed excimer radiation which is delivered to the target site with proprietary ber optic catheter technology, or other approved instruments or accessories, to complete the system.

Notice

THE CVX-300 CONTAINS NO USER SERVICEABLE PARTS OR ASSEMBLIES.

SERVICE OF THE SPECTRANETICS CVX-300 LASER SYSTEM MUST BE PERFORMED ONLY BY A SPECTRANETICS CERTIFIED FIELD SERVICE ENGINEER IN ORDER TO AVOID RISKS TO INDIVIDUALS, CUSTOMERS AND/OR PATIENTS. SERVICE OF THE SPECTRANETICS CVX-300 REQUIRES SPECIAL TOOLS, EQUIPMENT AND/OR GASES, SOME OF WHICH MAY NOT BE COMMERCIALLY AVAILABLE, OR MAY ONLY BE AVAILABLE TO OR FROM THE SPECTRANETICS CORPORATION.

SPECTRANETICS ASSUMES NO RESPONSIBILITY OR LIABILITY FOR ANY SERVICE PROVIDED BY NON-CERTIFIED REPRESENTATIVES. SERVICE PERFORMED BY ANYONE OTHER THAN A SPECTRANETICS CERTIFIED FIELD SERVICE ENGINEER VOIDS ALL WARRANTIES (IF ANY) TO THE LASER SYSTEM AND/OR THE DISPOSABLE LASER CATHETER DELIVERYDEVICES.

SPECTRANETICS RESERVES THE RIGHT TO REFUSE TO SELL PRODUCTS OR SERVICES TO ANY CUSTOMER NOT IN COMPLIANCE WITH MANUFACTURERS RECOMMENDED SERVICE REQUIREMENTS.

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CVX-300® Excimer Laser System Version 26 Operator’s Manual

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Contents

Warranty ...................................................................................................................................................6

Warnings and Responsibility .................................................................................................................7

Specications .........................................................................................................................................10

Safety Precautions ................................................................................................................................11

Nominal Ocular Hazard Distance (NOHD) ..........................................................................................12

EMC Precautions ....................................................................................................................................13

Stowable Control Panel / Energy Detector ......................................................................................... 17

Stowable Energy Detector ...................................................................................................................18

CVX‑300‑P Components .......................................................................................................................19

1. Control Panel .......................................................................................................................................................................19

2. Energy Detector .................................................................................................................................................................19

3. Catheter Connector .........................................................................................................................................................19

4. Front Storage Compartment ....................................................................................................................................... 19

5. Footswitch (IPX8 rated) .................................................................................................................................................. 19

6. Emergency Button............................................................................................................................................................19

7. Footswitch Connector ....................................................................................................................................................19

8. Interlock Plug ...................................................................................................................................................................... 19

9. Potential Equalization (PE) ............................................................................................................................................19

10. Power Connector ............................................................................................................................................................19

11. Main Circuit Breaker ...................................................................................................................................................... 19

CVX‑300‑P Labeling ..............................................................................................................................20

CVX‑300 Labeling ..................................................................................................................................23

CVX‑300 Markings .................................................................................................................................25

Control Buttons .....................................................................................................................................27

Calibrate ..................................................................................................................................................................................... 27

Fluence .......................................................................................................................................................................................27

Pulses Delivered .....................................................................................................................................................................27

Rate .............................................................................................................................................................................................. 27

Read Energy ............................................................................................................................................................................. 27

Ready ........................................................................................................................................................................................... 27

Reset ............................................................................................................................................................................................ 28

Standby ...................................................................................................................................................................................... 28

Keyswitch ..................................................................................................................................................................................28

Treatment Time ....................................................................................................................................................................... 28

Reset and Pulses Delivered ...............................................................................................................................................28

Reset and Standby ................................................................................................................................................................ 28

Reset and Treatment Time ................................................................................................................................................. 28

Advisory, Indicator and Status Lights ................................................................................................. 29

Aim Fiber Energy and Millijoules .................................................................................................................................... 29

Calibrate Button .....................................................................................................................................................................29

Calibrate Light ......................................................................................................................................................................... 29

Cal OK .......................................................................................................................................................................................... 29

Fault ..............................................................................................................................................................................................30

Fiber .............................................................................................................................................................................................30

Fluence and mJ/mm2 ........................................................................................................................................................... 30

Footswitch .................................................................................................................................................................................30

Lasing .......................................................................................................................................................................................... 30

Min-Sec .......................................................................................................................................................................................30

Power Error ...............................................................................................................................................................................30

Pulses ........................................................................................................................................................................................... 30

Rate and Pulses/Second ..................................................................................................................................................... 30

Ready ........................................................................................................................................................................................... 30

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CVX-300® Excimer Laser System Version 26 Operator’s Manual

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Service .........................................................................................................................................................................................30

Standby ...................................................................................................................................................................................... 31

Testing ......................................................................................................................................................................................... 31

Warm-up .................................................................................................................................................................................... 31

Operational Modes ...............................................................................................................................32

Setup Mode .............................................................................................................................................................................. 32

Testing Mode ........................................................................................................................................................................... 33

Warm-up Mode ......................................................................................................................................................................34

Standby Mode .........................................................................................................................................................................35

Calibrate Mode .......................................................................................................................................................................36

Standby Mode (Returning from Calibrate Mode) ................................................................................................... 39

Standby Mode (Returning from Ready Mode) .........................................................................................................40

Ready Mode ............................................................................................................................................................................. 40

Power Down .............................................................................................................................................................................44

Fault Codes .............................................................................................................................................44

Maintenance ..........................................................................................................................................45

Verication of Calibration ....................................................................................................................47

Troubleshooting ....................................................................................................................................49

Glossary ..................................................................................................................................................53

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CVX-300® Excimer Laser System Version 26 Operator’s Manual

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Warranty

The Spectranetics Corporation (“Spectranetics”) warrants that the CVX-300® Excimer Laser (“Laser”) will meet the written specications for the period described in the agreement between Spectranetics and the entity acquiring the Laser (“Customer”). This warranty will become immediately void in the event that any of the following conditions are not met or cease to be true:

(i) The Laser must be installed by a Spectranetics Certied Field Service Engineer; (ii) The Laser must be operated and stored in accordance with the Operator’sManual; (iii) All required and recommended maintenance must be performed on time by

Spectranetics Certied Field Service Engineers using authorized parts, components, and gases;

(iv) The Laser must be kept in the proper operating environment and site requirements;

and

(v) The Laser must be operated by trained personnel according to approved clinical

guidelines using authorized disposable devices.

Spectranetics’ sole obligation under this warranty shall be to provide all parts and labor required to cause the Laser to operate in accordance with the specications during the warranty period.

Spectranetics will perform all warranty service and repairs during the normal business hours of 8:00 am to 5:00 pm at Customer’s facility, Monday through Friday, excluding holidays. Customer is responsible for assuring that the Laser is accessible to Certied Field Service Engineers at the scheduled time. Customer will pay Spectranetics at its standard billing rates for: Warranty repairs requested outside of normal business hours; waiting time if the Laser is not available for scheduled maintenance; service made necessary as a result of Customer’s failure to follow the requirements in the Operator’s Manual; or service that is required due to any damage to the Laser from outside causes.

This warranty extends only to the entity that acquires the Laser from Spectranetics and will not extend to any successor of that entity.

Spectranetics makes no other warranties, expressed or implied. Spectranetics specically

disclaims any implied warranty of merchantability or tness for a particular purpose.

In no event will Spectranetics be liable for any indirect, special, incidental, punitive, or consequential damages, including, but not limited to, loss of prots and/or loss of business, arising out of or resulting from use of the Laser or its failure to meet the terms of this warranty, even if Spectranetics has been advised of the possibility of such damages.

This limited warranty covers only the Laser. Information on Spectranetics’ warranty relating to disposable items used with the Laser can be found in the documentation relating to those products.

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CVX-300® Excimer Laser System Version 26 Operator’s Manual

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Warnings and Responsibility

IMPORTANT

Read the Operator’s Manual thoroughly before operating the Excimer Laser System CVX-300. Pay particular attention to the NOTES, CAUTIONS, and WARNINGS throughout this manual to ensure safe operating conditions at all times. Also refer to the Instructions for Use which accompanies Spectranetics ber optic catheters. Indications and contraindications are included in individual instructions for use for the CVX-300 disposables.

WARNING

The CVX-300 is a Class III medical device which contains a Class IV laser that produces an invisible beam of high-energy ultraviolet radiation. Improper use of the CVX-300 could result in serious personal injury. Observe all safety precautions for use of Class IV laser equipment.

WARNING

The CVX-300 contains high voltages which are potentially lethal. To avoid electrical shock, do not open the CVX-300 cabinet. Internal maintenance must be performed solely by a Spectranetics Certied Field Service Engineer.

WARNING

Laser system is not intended to be used during a debrillationevent.

DANGER

Possible explosion hazard if used in the presence of ammable anesthetics.

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WARNING

Skin exposure to excimer radiation should be avoided.

WARNING

Move the Excimer Laser System carefully, and avoid jarring or sudden impacts. Disconnect and store the footswitch before moving the laser system. Do not run over power cables with the system. Depress the brake bar to lock the wheels when the Excimer Laser System is positioned for use. Lift up on the brake bar to release wheels.

CAUTION

Use of buttons or adjustments or performance of procedures other than those specied herein may result in hazardous radiation exposure.

WARNING

Use only bers and catheters approved by Spectranetics in the CVX-300 system. The Spectranetics laser ber optic catheters are supplied sterile. Sterility is guaranteed only if the package is unopened and undamaged.

WARNING

Use care when handling the ber optic catheter to ensure the distal or proximal bers are not chipped or scratched.

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CVX-300® Excimer Laser System Version 26 Operator’s Manual

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WARNING

Bypassing the warm-up period if the system has been o for longer than 30 seconds may damage internal components and render the CVX-300 Excimer Laser System inoperable.

NOTICE

The CVX-300 is intended for use only by licensed physicians. All persons who operate and service this equipment must be properly trained.

CAUTION

The CVX-300 is designed for continuous operation with intermittent loading. In procedures which exceed 50,000 laser pulses, the CVX-300 must be allowed to idle in Standby Mode for a minimum of one (1) hour.

NOTICE

The CVX-300 contains a gas mixture that is 0.05% HCl, a respiratory irritant. To avoid injury, only a trained and certied Spectranetics Field Service Engineer should handle the laser gas.

CAUTION

Federal Law restricts this device to the sale or on the order of a physician.

RESPONSIBILITY

Spectranetics is not responsible for injury or damage resulting from improper use of the CVX-300 equipment. If there is any doubt concerning the use of the CVX-300 or the Operator’s Manual, contact Spectranetics immediately for assistance.

CUSTOMER understands that the Equipment is manufactured with substances that are considered hazardous to the environment and cannot be disposed of directly. In the unlikely event that CUSTOMER wishes to remove the Equipment from service, they may elect to return the system (at their expense) to SPECTRANETICS. Once the Equipment is received, Spectranetics will bear the cost of properly disposing of and/or recycling the raw components according to law.

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Specications

The excimer laser is a pulsed laser with the following nominal specications.

Active Medium XeCl Wavelength 308 nm Catheter Output Fluence* 30 - 80 mJ/mm

Repetition Rate Range* 25 - 80 Hz Pulse Width 125-200 ns, FWHM Weight 650 lbs / 295 kg Length 49 in / 125 cm Height 35 in / 89 cm - unit 7-9 in / 18-23 cm - control panel Width 25 in / 62 cm (All Dimensions Approximate) Power Requirements 200 – 230 V ~ - Single Phase 50/60Hz 16 Amp

Environmental Specications

- Operating temperature: 12°C to 30°C (54°F to 86°F)

- Storage temperature: 0°C to 60°C (32°F to 140°F)

- Operating humidity: 5 to 95% relative humidity, non-condensing

- Storage humidity: 5 to 95% relative humidity, non-condensing

System footswitch is IPX8 rated.

Accessories: power cord, footswitch, interlock plug, safety glasses, and Spectranetics approved ber optic catheters.

Environment: Avoid exposing the laser system to extreme temperatures (below 32°F or 0°C, above 140°F or 60°C).

* Dependent on ber optic catheter in use and the CVX‑300 software installed; see

the Instructions for Use documentation supplied with each ber optic catheter for specic information.

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Safety Precautions

1. The laser must be operated only by trained personnel.

2. Establish a controlled-access laser operating area to limit access to persons instructed in the safe operation of lasers.

3. Post “LASER IN OPERATION” warning signs at all entries to the laser operatingarea.

4. Persons in the laser operating area including doctors, nurses, observers and the patient must wear the appropriate protective eyewear and protective gloves. Protective eyewear of 5 or greater at a 308 nanometer (nm) wave-length must be worn when operating the laser system. The laser safety glasses must state the OD rating and wavelength on the lens or on the side shields. Spectranetics oers safety glasses that may be purchased by calling Customer Service. Sources of information about eye protection include: Rockwell Laser Institute (rli.com) and Ultra-Violet Products (uvex.com).

5. Never look directly into the laser beam.

6. Avoid uncontrolled reections of the laser beam.

7. Skin exposure to excimer laser radiation should be avoided.

8. Do not allow direct or reected laser radiation to go beyond the laser operatingarea.

9. When not in use, the laser system should be protected against unauthorized use by removing the key.

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Nominal Ocular Hazard Distance (NOHD)

The nominal ocular hazard distance (NOHD) is dened by the American National Standard (ANSI®) Z136.1 – 2007 as the distance along the axis of the unobstructed beam from a laser, ber end, or connector to the human eye beyond which the irradiance or radiant exposure is not expected to exceed the applicable maximum permissible exposure (MPE) limits.

All laser energy produced by the CVX-300 Excimer Laser System, when operated in accordance with this manual, is enclosed within the CVX-300, the Spectranetics Fiber Optic Device or within the body except during the calibration of the ber optic device (refer to the CVX-300 Excimer Laser System Operating Instructions and precautions in this manual).

During these short calibration periods, the energy output from the laser is not contained and the operator should be aware of the NOHD from the tip of the ber. A 2.5mm ber optic device emits the highest amount of energy during calibration.

The Fiber NOHD was calculated with the system in the Normal Operating Mode during Calibration utilizing the following values;

Exposure time 20 seconds Energy at tip of catheter 76.5mJ Fiber Tip Diameter 2.5mm Repetition Rate (calibration) 25 Hz Numerical Aperture of the ber optic 0.22 Wavelength 308nM Pulse Width 135nS Repetitively Pulsed Yes

Using the ANSI® Z136.1 standard, the ber NOHD can be calculated as 1.35meters (53.1 inches) from the distal tip of the 2.5mm Reference Catheter device duringcalibration.

Always wear the appropriate laser safety glasses when using this equipment and follow all safety precautions as outlined within this manual.

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CVX-300® Excimer Laser System Version 26 Operator’s Manual

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EMC Precautions

Special precautions are required regarding the Electromagnetic Compatibility (EMC) of the CVX-300. The CVX-300 needs to be installed and put into service according the EMC information provided in this manual.

Portable and Mobile Radio Frequency (RF) communications equipment can aect any medical electrical equipment including the CVX-300.

Only cables and accessories provided by Spectranetics may be used with the CVX-300. The use of any other cable or accessories may have an adverse eect on the Electromagnetic Compatibility of the CVX-300 such as increased emissions or decreased immunity.

The CVX-300 should not be used adjacent to or stacked with other equipment. Shoulduse adjacent to other equipment become necessary, the CVX-300 should be observed to verify normal operation in that conguration.

Table 201 (EN 60601‑1‑2)

Guidance and Manufacturer’s Declaration- Electromagnetic Emissions

The CVX‑300 is intended for use in the electromagnetic environment specied

below. The customer or the user of the CVX‑300 should assure that it is used in such an environment.

Emissions Test Compliance Electromagnetic environment -

guidance

RF emissions CISPR 11

Group 1

The CVX‑300 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Class A

The CVX‑300 is suitable for use in all establishments other than domestic and those directly connected to the public low‑voltage power supply network that supplies buildings used for domestic purposes.

Harmonic Emissions IEC 61000‑3‑2

Class A

Voltage Fluctuations/ icker emissions IEC 61000‑3‑3

Complies

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CVX-300® Excimer Laser System Version 26 Operator’s Manual

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Table 202 (EN 60601‑1‑2)

Guidance and Manufacturer’s Declaration- Electromagnetic Emissions

The CVX‑300 is intended for use in the electromagnetic environment specied

below. The customer or the user of the CVX‑300 should assure that it is used in such an environment.

Immunity Test IEC 60601

Test Level

Compliance

Level

Electromagnetic

environment- guidance

Electrostatic Discharge (ESD)

IEC 61000‑4‑2

± 6 kV contact

± 8 kV air

± 6 kV contact

± 8 kV air

Floors should be wood, concrete or ceramic tile.

If oors are covered with

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

Electrical Fast Transient/Burst

IEC 61000‑4‑4

± 2 kV for power supply lines

± 1 kV for input/output lines

± 2 kV for power supply lines

± 1 kV for input/output lines

Mains power quality should be that of a typical commercial or hospital environment.

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

IEC 61000‑4‑11

<5% Ut (>95% dip in Ut) for 0,5 cycle

40% Ut (60% dip in Ut) for 5 cycles

70% Ut (30% dip in Ut) for 25 cycles

<5% Ut (>95% dip in Ut) for 5 sec.

100% dip for 0.5 cycles

60% dip for 5 cycles

30% dip for 25 cycles

100% dip for 5 seconds

Mains power quality should be that of a typical commercial of hospital environment. If the user of the CVX‑300 requires continued operation during power mains interruptions, it is recommended that the CVX‑300 be powered from an uninterruptible power supply or a battery.

Power Frequency (50/60 Hz)

magnetic eld

IEC 61000‑4‑8

3 A/m 3 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

NOTE: Ut is the ac mains voltage prior to application of the test level.

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CVX-300® Excimer Laser System Version 26 Operator’s Manual

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Table 204 (EN 60601‑1‑2)

Guidance and manufacturer’s declaration – Electromagnetic Immunity

The CVX‑300 is intended for use in the electromagnetic environment specied

below. The customer or the user of the CVX‑300 should assure that it is used in such an environment.

Immunity Test IEC 60601

Test Level

Compliance

Level

Electromagnetic

environment- guidance

Conducted RF IEC 61000‑4‑6

Radiated RF

IEC 61000‑4‑3

3 V rms

150 kHz

to 80 MHz

3 V/m

80 MHz

to 2.5 GHz

3 V rms

3 V/m

Portable and mobile RF communications equipment should be used no closer to any part of the CVX‑300 including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

d = (3.5/3) √P d = (3.5/3) √P 80 MHz to 800 MHz d = (7/3) √P 800 MHz to 2.5 GHz

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from xed RF

transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range b.

Interference may occur in the vicinity of equipment marked with the following symbol.

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by

absorption and reection from structures, objects and people.

Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and

land mobile radios, amateur radios, AM and FM radio broadcast and TV broadcast cannot be predicted

theoretically with accuracy. To assess the electromagnetic environment due to xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld strength in the location in which the

CVX‑300 is used exceeds the applicable RF compliance level above, the CVX‑300 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the CVX‑300.

Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.

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Table 206 (EN 60601‑1‑2)

Recommended separation distances between portable and mobile RF

communications equipment and the CVX-300

The CVX‑300 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the CVX‑300 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the CVX‑300 as recommended below, according to the maximum output power of the communications equipment.

Rated maximum

output power of transmitter

Separation distance according to frequency

of transmitter

150 kHz

to 80 MHz

80 MHz

to 800 MHz

800 MHz

to 2,5 GHz

0,01 0.12 0.12 0.23

0,1 0.37 0.37 0.74

1 1.2 1.2 2.0

10 3.7 3.7 7.4

100 12 12 12

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic

propagation is affected by absorption and reection from structures, objects

and people.

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CVX-300® Excimer Laser System Version 26 Operator’s Manual

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Stowable Control Panel / Energy Detector

Some CVX-300 Excimer Laser Systems have a control panel and an energy detector that can be stowed when not in use. This section will describe how these features areused.

Stowable Control Panel

When the laser system is not in use, the control panel may be folded at.

To raise the control panel, lift up on the handle.

When the control panel is raised, it may be rotated 90° left or right for easy access.

NOTICE

The control panel may only be stowed when the panel is rotated to face the front of the unit.

Do not attempt to rotate the control panel beyond its stops.

When stowing the control panel, keep ngers and hands out of the way.

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Stowable Energy Detector

The Energy Detector is located to the left of the laser/catheter coupler. The Energy Detector is used to calibrate ber optic catheters prior to use, and must be pulled up into position to facilitate system calibration.

Return the Energy Detector to the storage position by pushing it back into the unit and closing the protective cover.

NOTICE

At no time should the energy detector or its mounting pole be used in an attempt to move the CVX-300.

As with all CVX-300 units, it is necessary to keep the area around the Catheter Connector, Energy Detector, and Control Panel clean, dry and free of contaminants.

Open

Protective

Cover

Extend the Energy

Detector to the

fully up position

Push Energy

Detector back into

the unit and close

the Protective Cover

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CVX‑300‑P Components

1. Control Panel

2. Energy Detector

3. Catheter Connector

4. Front Storage

Compartment

5. Footswitch (IPX8 rated)

6. Emergency Button

7. Footswitch Connector

8. Interlock Plug

9. Potential Equalization

(PE) (Optional PE cable provided based on destination country)

10. Power Connector

11. Main Circuit Breaker

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CVX‑300‑P Labeling

(Follow Instructions for Use)

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CVX-300® Excimer Laser System Version 26 Operator’s Manual

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(Laser Radiation)

(Robert A. Golobic Memorial Label – Spectranetics Founder)

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English / English

(Label on Remanufactured CVX‑300 Only)

(Non‑Ionizing Radiation)(Emergency Stop)

(WEEE)

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CVX‑300 Labeling

(WEEE)

(Robert A. Golobic Memorial Label – Spectranetics Founder)

(Operating Instructions)

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(Laser Radiation)

(Emergency Stop)

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CVX‑300 Markings

Outside:

Equipotentiality

Footswitch Connector

Main Circuit Breaker

Laser Radiation

Warning, Danger, Caution

Follow Operating Instructions

WEEE (Waste from Electrical and Electronic Equipment)

Type CF

Emergency Stop

FOOTSWITCH

MAINS (16A) (US/CANADA/EU)

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Follow Instructions for Use

Non-Ionizing Radiation

World Wide Web Address

UDI Label

Inside:

Protective Earth (ground)

Dangerous Voltage

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Control Buttons

Calibrate: Depressing the Calibrate button places the Excimer Laser System in Calibrate mode. The Calibrate button is illuminated.

Fluence: The Fluence button adjusts the output energy of the Excimer Laser System. The

uence value is increased or decreased by depressing the appropriate Fluence button. The current uence value is visible in the display window and the mJ/mm2 indicator light is illuminated. A brief press of either the increase or decrease Fluence button while in other operating modes shows the current uence value. Depressing either the increase or decrease Fluence buttons for one second or longer changes the uence value accordingly.

Pulses Delivered: Depressing the Pulses Delivered button enables the total number of pulses during a procedure to be visible in the display window.

Rate: The Rate button adjusts the pulse repetition rate of the Excimer Laser System. The rate is increased or decreased by depressing the appropriate Rate button. The repetition rate is visible in the display window and the Pulses/Second indicator light is illuminated. A brief press of either the increase or decrease Rate button while in other operating modes shows the current repetition rate. Depressing either the increase or decrease Rate button for one second or longer changes the repetition rate accordingly.

Read Energy: Depressing the Read Energy button enables the ber output energy read by the calibration detector to be visible in the display window. The Read Energy button will be illuminated.

Ready: Depressing the Ready button places the Excimer Laser System in Ready mode. If the Excimer Laser System has not been calibrated, the Ready button is notactive.

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Reset: The Reset button is used in combination with the Standby button, Pulses Delivered and Treatment Time buttons.

Standby: If the system is in either Ready or Calibrate mode, depressing the Standby buttons places the Excimer Laser System in Standby mode. The Standby button and the green status light are illuminated.

Keyswitch: The keyswitch is the power control for the Excimer Laser System.

In case of emergency, the Excimer Laser System can be powered down by depressing the Emergency Shuto located on the back panel. Caution should be taken not to activate the Emergency Button accidentally. To reactivate the system, rotate the Emergency Shuto clockwise until it ascends and turn the keyswitch to the OFF( ) position and then to the ON ( | ) position. Refer to the Reset and Standby and

Warning below to bypass the CVX-300 Excimer Laser warm-up.

Treatment Time: Depressing the Treatment Time button enables the total lasing time of

the procedure to be visible in the display window.

Reset and Pulses Delivered: The Reset and Pulses Delivered buttons are depressed simultaneously to reset the total pulses delivered during the procedure.

Reset and Standby: The Standby and Reset buttons are depressed simultaneously to bypass the ve minute warm-up phase if the Excimer Laser System parameters, uence and rate, are set. The CVX-300 must not be o for longer than 30 seconds in order to use this feature. See Warning below.

Reset and Treatment Time: The Reset and Treatment Time buttons are depressed simultaneously to reset the total lasing time of the procedure.

Warning

Bypassing the warm‑up period may damage components in the Excimer Laser System if the system has been o for longer than 30 seconds.

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Advisory, Indicator and Status Lights

Aim Fiber Energy and Millijoules: The Aim Fiber advisory light and the Energy and Millijoules indicator lights illuminate simultaneously indicating the system is in the Calibrate mode or Read Energy has been selected in the Ready mode. To begin calibration,

aim the ber tip at the calibration detector head and depress the footswitch. The system reads and displays the ber output energy after each laser pulse.

Calibrate Button: The Calibrate button illuminates indicating the Excimer Laser System is operating in Calibrate mode.

Calibrate Light: The Calibrate advisory light indicates the Excimer Laser System needs to be calibrated.

Cal OK: The Cal OK advisory light indicates the Excimer Laser System has successfully completed calibration.

YELLOW when Power Error lamp is ON

GREEN when in STANDBY mode

YELLOW when in READY mode

RED when LASING

Status lamps at top of control panel

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Fault: If the Fault advisory light illuminates with a fault code in the display window, it indicates a malfunction. Record the fault code and notify Spectranetics for service.

Fiber: The Fiber advisory light indicates the ber is not connected or properly inserted into the ber adapter.

Fluence and mJ/mm2: The Fluence and mJ/mm2 indicator lights illuminate simultaneously when the uence setting is visible in the display window.

Footswitch: The Footswitch advisory light indicates the footswitch is not connected, not operating properly or is depressed during the Warm‑up or Standby mode.

Lasing: The Lasing status light indicates the footswitch is being depressed and the Excimer Laser System is lasing. The red status light on the top of the control panel also illuminates when the system is lasing.

Min‑Sec: The Min‑Sec indicator light is illuminated when the warm-up time or treatment time is visible in the display window.

Power Error: The Power Error advisory light indicates the laser energy is out of range and the Safety Power Monitor has disabled the laser beam. An audible tone will be heard whenever the Power Error lamp is illuminated. During normal operation, this light may icker as the laser energy varies within the acceptable range. The CVX-300 will continue to lase as the unit is working to correct the condition. The shutter will remain closed while Power Error is illuminated, preventing energy delivery through the ber. Refer to the Troubleshooting section in this manual. If the Power Error and yellow advisory light on top of the control panel illuminate constantly, this indicates a problem with the Excimer Laser System. Call Spectranetics Customer Service for assistance.

Pulses: The Pulses indicator light illuminates when the Pulses Delivered button is depressed and the number of laser pulses delivered is visible in the display window.

Rate and Pulses/Second: The Rate and Pulses/Second indicator lights illuminate simultaneously when the laser pulse repetition rate is visible in the display window.

Ready: The Ready button illuminates indicating the Excimer Laser System is operating in Ready mode. The yellow status light on top of the control panel also illuminates when the system is in Ready mode.

Service: The Service advisory light indicates that the laser is near its maximum energy

output and requires service. The Excimer Laser System is still operational and safe. Call Spectranetics immediately to schedule service.

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Standby: The Standby button illuminates indicating the Excimer Laser System is operating in Standby mode. The green status light on top of the control panel also illuminates when the system is in Standby mode.

Testing: The Testing status light indicates the Excimer Laser System is checking the internal operation of the control circuitry.

Warm‑up: The Warm‑up status light indicates the Excimer Laser System is operating in Warm‑up mode.

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Operational Modes

Setup Mode

1. Remove the footswitch from the front storage compartment. Close the storage door prior to operating the laser. Connect the footswitch plug into the receptacle located on the rear panel.

2. Connect the end of the power cord into the receptacle located on the lower back panel of the CVX-300. Ensure power cord is fully seated into the power receptacle. Insert the other end of the power cord into a wall receptacle with the proper output voltage.

Note: Anytime an extension cord is used to power the CVX-300 on a temporary basis, it must be a minimum 12 AWG cord of type SJO, SJT, SJOOW or equivalent. The power cord should be routed to avoid all tripping hazards and damage from other equipment. Any temporary extension cord must be disconnected and removed immediately upon completion of the task for which it was installed.

3. Insert the key in the keyswitch on the control panel. Turn the keyswitch clockwise to activate the system.

4. When the system is activated, it enters Testing mode.

5. Clean the surface of the energy detector with an alcohol prep before and after each

use.

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Testing Mode

1. The system executes an internal test which takes approximately 30 seconds.

2. The rst part of self-test is a control panel lamp test in which all status buttons and

advisory lights, except standby, and green status light on top of the control panel are illuminated simultaneously for approximately 5-7 seconds. Six number eights (8) are visible in the display window. (Figure 1)

Figure 1

Lamp Test

3. At the end of the lamp test, Standby and Testing are illuminated (Figure 2). Thesoftware version number will displayed following the lamp test.

During the test cycle, it is normal to hear a “clicking” sound inside the unit as the safety shutter is tested. The Power Error lamp will also ash several times during this test.

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Figure 2

Self Test

4. If a malfunction is detected by the internal test, a fault code will be visible in the display window and the Excimer Laser System locks in a non-operational mode. The malfunction must be corrected by Spectranetics service personnel before the system can be restored to an operational mode. Refer to the Fault Codes section. The operator may turn the laser to the OFF (  ) position for 5 seconds and then to the ON ( | ) position to attempt restarting the system.

5. When the internal test is complete, the Excimer Laser System enters Warm‑up mode. A 5 minute countdown timer indicates warm-up time remaining.

Warm‑up Mode

1. When the system is in Warm‑up mode, the Warm‑up advisory light will be illuminated. The Standby button and green status light on the top of the control panel are also illuminated. (Figure 3)

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Figure 3

Warm-up

2. The Warm‑up mode continues for ve minutes. The display window shows the remaining time in the Warm‑up mode. The warm-up period allows various components inside the unit to reach normal operating temperatures.

3. The Excimer Laser System automatically checks for proper connection of both the footswitch and the ber optic catheter. If either component is improperly connected or not connected at all, the appropriate advisory light, Fiber or Footswitch, illuminates.

4. The recommended calibration settings will automatically appear in the display when the ber optic catheter is inserted. (Some devices may have dierent Calibration settings than are displayed – always verify these settings with the recommended settings in the device’s Instructions for Use documentation.) The remaining warm-up time is normally visible in the display window. Brieydepressing a Fluence or Rate increment or decrement button enables the uence value and pulse repetition rate to be visible on the display window. Four seconds after releasing the button, the display reverts to the warm-up timer. Abrief push of either button will not cause a change in the values, but will display the currentsetting.

5. When the ve minute warm-up period is complete, the system enters Standbymode.

Standby Mode

1. The Standby button and the green status light on the top of the control panel are illuminated.

2. Depressing a Fluence or Rate button causes the uence value or pulse repetition rate to change.

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If a ber optic catheter is not installed, the Fluence and Rate can only be set to their minimum values, 30mJ/mm2 and 25Hz respectively, and the Fiber light will remain illuminated. (Figure 4)

Figure 4

Standby

3. When the Excimer Laser System is in Standby mode for the rst time after being powered up or a ber optic catheter is changed, depressing the Calibrate button causes the system to enter Calibrate mode.

Calibrate Mode

1. Insert the coupler, on the proximal end of the ber optic catheter, into the center of the connector on the CVX-300.

2. The appropriate calibration values will be displayed for the device in use. (Figure5)

Note: Calibration settings may vary between devices. The recommended settings are located in the device’s Instruction for Use.

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Figure 5

Calibrate

3. Allow the CVX-300 time to complete the ve-minute warm-up period and enter the

Standby mode.

4. Clean the face of the energy detector with an alcohol prep before and after eachuse.

5. Depress the Calibrate button to enter Calibrate mode.

6. The yellow Ready status on the top of the control panel, Aim Fiber, Energy,

Millijoules, Calibrate, Calibrate button, and Ready button lights are illuminated. The display window shows 00.0 on the three rightmost digits. (Figure 6)

Figure 6

Calibrate –Read Energy

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7. Point the distal tip of the ber optic catheter directly at the center of the energy detector. Ensure that the catheter is no less than one inch (2.5 cm) and no more than two inches (5 cm) away from the front surface. The red visible beam must be in the center of the detector when calibrating.

Warning: System faults may occur during the procedure if the catheter is not perpendicular to and/or at the proper distance from the detector surface duringcalibration.

8. Depress and hold the footswitch down until lasing stops. The Lasing light and red lasing status light on the top of the control panel illuminates and the CVX-300 begins lasing.

Note: the Power Error lamp may icker momentarily during the Calibration cycle as the laser adjusts energy output (an audible tone will be heard when the PowerError lamp illuminates.)

9. During the calibration, the display window shows, in the three rightmost digits, the energy out of the ber optic catheter. As the CVX-300 calibrates, the energy out of the distal tip of the ber optic catheter increases or decreases until the energy corresponding to the uence setting for that ber optic catheter is reached. When the calibration is completed, the CVX-300 stops lasing, displays the nal calibration energy value for approximately ve seconds, then returns to the Standby mode, and the Cal

OK advisory light illuminates. When the calibration is complete, the nal calibration energy value is visible in the display window.

10. Compare the calibration energy reading displayed with the energy range for the ber optic catheter selected. (See catheter package for appropriate ranges.)

NOTE: If the calibration energy at the end of the calibration step was not read, or if an energy reading is desired at any other time during the operation of the CVX-300, check the energy out of the ber optic catheter by selecting the Ready mode, depress the Read Energy button, aim the distal tip of the ber optic catheter at the energy detector, and depress the footswitch. After reading the energy, depress the Standby button to return the CVX-300 to the Standby mode. (Figure 7)

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Figure 7

Standby

11. If the calibration energy value indicated in the display window does not compare properly with the energy range listed on the pouch, repeat the calibration of the ber optic catheter at its recommended uence setting. If the energy values do not compare after the second calibration, the ber optic catheter should not be used and a new ber optic catheter should be obtained.

12. If a problem occurs during the calibration process, the CVX-300 will return to the Standby mode and the fault light will be illuminated. A numeric code will also appear in the display. Refer to the Troubleshooting section of this manual.

13. If a second calibration attempt is unsuccessful, call Spectranetics Customer Service for assistance.

14. The CVX-300 returns to the Standby mode if calibration is not completed within one minute.

15. If the Fault advisory light illuminates and a numerical fault code is displayed, refer to the Troubleshooting section of this manual. Always record the fault code number and report it to Spectranetics Customer Service.

Standby Mode (Returning from Calibrate Mode)

The Standby mode is automatically entered a few seconds after the Cal OK lamp isilluminated.

1. Standby mode is entered from the Calibrate mode by depressing the Standby button. (Figure 8)

2. The Standby button and green status light on the top of the control panel areilluminated.

3. The uence value and pulse repetition rate appear in the display window.

4. The Cal OK advisory light remains illuminated.

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Figure 8

Standby

Standby Mode (Returning from Ready Mode)

1. Standby mode is entered from Ready mode by depressing the Standby button.

2. The Standby button and green status light on the top of the control panel

areilluminated.

3. The uence value and pulse repetition rate appear in the display window.

4. The Cal OK advisory light remains illuminated. (Figure 8)

Ready Mode

1. Ready mode is entered from Standby mode by depressing the Ready button. (Figure

2. The Ready button, Cal OK light and yellow status light on the top of the control panel are illuminated.

3. The uence value and pulse repetition rate may be changed by depressing a Fluence or Rate button. After a change to either value, it is not necessary tore‑calibrate.

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Figure 9

Ready

4. The Excimer Laser System is now ready to use in a procedure.

5. Depressing the footswitch causes the red Lasing light and red status light on the top of

the control panel to illuminate. (Figure 10)

6. The Excimer Laser System begins to lase at the specied pulse repetition rate. Releasing the footswitch stops lasing, the red Lasing light and red status light on the top of the control panel go out.

Figure 10

Lasing

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7. While the Excimer Laser System is lasing, the total treatment time is stored. To retrieve the treatment time, stop lasing and depress the Treatment Time button. The Min/Sec indicator light illuminates and the total treatment time is visible in the display window. (Figure 11)

8. To reset the treatment time counter, depress the Reset and Treatment Time buttons simultaneously.

9. While the Excimer Laser System is lasing, the number of pulses delivered during a procedure is accumulated. To retrieve the total number of pulses delivered, stop lasing and depress the Pulses Delivered button. The count is visible in the display window. (Figure 12)

10. To reset the pulses delivered counter, depress the Reset and Pulses Delivered buttons simultaneously.

Figure 11

Treatment Time

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Figure 12

Pulses Delivered

11. Pressing the Read Energy button causes the ber output energy to be visible in the display window. To read the energy coming from the ber, aim the ber at the calibration detector and depress the footswitch. (Figure 13)

Figure 13

Read Energy

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12. If the system has been in the Ready mode for ve minutes without lasing, it returns to Standby mode.

Power Down

1. Press the Standby button.

2. Turn the keyswitch to the OFF ( ) position.

3. Disconnect the power cord from the power source.

4. Disconnect and store the Footswitch in the front storage compartment.

5. Close the catheter connector door.

6. Clean detector face with alcohol prep.

7. When not in use, the laser system should be protected from unqualied use by

removing the key.

8. Cover the laser system.

Fault Codes

When a fault is detected by the system, a code number is displayed in the middle of the display window corresponding to the appropriate fault. Refer to the Troubleshooting Section of this manual. Always record the fault code number and report it to Spectranetics Customer Service.

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Maintenance

Clean the external surfaces of the Spectranetics CVX-300 Excimer Laser System with a soft cloth and a mild detergent after each use. Clean the face of the energy detector with an alcohol prep before and after each use. The system should be stored in a secure place, protected from freezing or extremely high temperatures, and draped with a protective cover when not in use. Never store the laser system in areas that may be below 32°F (0°C) or above 140°F (60°C). Relativehumidity must be between 5% and 95% non‑condensing. The same conditions should be observed when transporting the laser system. When moving the laser system, avoid traversing large bumps or extremely roughsurfaces. The Spectranetics CVX-300 system requires regular maintenance and calibration to ensure problem-free operation. Spectranetics recommends that preventive maintenance be performed on the unit every three to six months. Preventive Maintenance is required annually at a minimum. Internal maintenance must be solely performed by a Spectranetics Certied Field Service Engineer. Internally, the CVX-300 contains no user serviceable parts. Product safety tests in the form of current leakage and ground testing should be performed by a Biomedical Engineer according to generally recognized technical rules.

Only cables and power cords supplied by Spectranetics should be used on the CVX-300. Use of alternate parts may aect EMC compliance.

Prior to use, the operator should perform the following checks on the laser system:

1) Visually inspect the system for damage of the laser covers.

2) Visually inspect the power cord to insure connections on both ends are notdamaged.

3) Visually inspect the power cord jacket to insure the insulation is not damaged.

4) Visually inspect the ground connection to insure it is intact.

5) Clean the face of the energy detector with an alcohol prep.

6) Turn the CVX-300 on, warm it up, and calibrate the laser with a Reference Catheter.

If any of the above do not pass visual inspection or the Reference Catheter does not calibrate, contact Spectranetics prior to using the laser.

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CAUTION

Anytime an extension cord is used to power the CVX-300 on a temporary basis, it must be a minimum 12 AWG cord of type SJO, SJT, SJOOW or equivalent. The power cord should be routed to avoid all tripping hazards and damage from other equipment. Any temporary extension cord must be disconnected and removed immediately upon completion of the task for which it was installed.

WARNING

The CVX-300 contains a Class IV laser that produces an invisible beam. Potentially lethal high voltages are present inside the system. The gas mixture utilized inside the laser contains 0.05% HCl, a respiratory irritant.

WARNING

Failure to service the equipment properly may result in personal injury or death. Service should only be completed by a Spectranetics Certied Field Service Engineer.

In the event that the laser has exceeded its useful life, contact Spectranetics to return the laser or for information regarding disposal of the equipment. See InstructionsforUse for each single-use device for disposal of these CVX-300 accessories.

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Verication of Calibration

CVX‑300 Energy Detector Circuit

The energy monitor on the CVX-300 Excimer Laser System requires verication of calibration every six months to ensure that the laser radiation output is within specication. This procedure may be performed more frequently if desired. Alwayswearthe appropriate laser safety glasses when using this equipment and follow the safety precautions as outlined within this manual.

Safety glasses specic to the CVX-300 Excimer Laser System are available for purchase from Spectranetics by calling our Customer Service Department.

Equipment required

• Spectranetics Laser Safety Glasses

• CVX-300 Excimer Laser System

• A commercially available National Institute of Standards and Technology (NIST) calibrated Joule Meter and Energy Detector rated at 308nM, 120nS, 0-100 mJ, and directions for use

• Spectranetics Reference Catheter

This procedure requires that the CVX-300 Excimer Laser System is operational and functions properly and that the operator has been trained by Spectranetics on the proper use, safety and operation of the CVX-300. This procedure also requires that the operator has been trained on the use, safety and operation of the NIST calibrated Joule Meter.

Energy Monitor Verication Procedure

1. Connect the power cord to the rear panel of the laser system. Ensure power cord is fully seated into the power receptacle. Insert the other end of the power cord into the appropriate receptacle with the proper output voltage.

2. Insert the key in the switch located on the control panel and rotate it clockwise to turn the system ON ( | ). The system will energize and enter the self test mode.

3. Remove the Footswitch from the front storage compartment and connect it to the receptacle located on the rear panel of the system.

4. Allow the laser system to complete the warm-up period.

5. Insert the Reference Catheter’s proximal end into the CVX-300 connector.

Theappropriate calibration Fluence and Rate will automatically be displayed when the

2.5mm Reference Catheter is inserted into the connector.

6. Ensure that all personnel in the room are wearing the appropriate laser safetyglasses.

7. Aim the distal end of the Reference Catheter directly at the center and one to two

inches away from the front surface of the Energy Detector on the front of theCVX-300.

8. Depress the Calibrate button on the CVX-300 display panel.

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9. Depress and hold the Footswitch down until the laser stops and the “Cal OK’ light is illuminated.

10. Record the energy reading in mJ shown on the CVX-300 display panel.

11. Depress the Ready button on the CVX-300 display panel.

12. Aim the Reference Catheter directly at the center of the NIST Detector and JouleMeter.

13. Depress the Footswitch and record the energy.

14. Compare the recorded energy value in step 10 with the recorded energy value in step

13.

15. The dierence in the two recorded energy values should be less than 20% (CFR 21

1040.11 Section 1) when using the following equation

(energy value in step 10 – energy value in step 13 )

/ energy value in step 13

16. Notify the Spectranetics Customer Service Department immediately if the dierence in the recorded energy values are greater than or equal to 20%.

17. Press the Standby button, turn the key switch to the OFF ( ) position, remove the key and store it in a safe place, disconnect the Footswitch and store it in the front compartment, disconnect the power cord from the power source and the laser, close the catheter connector door, cover the laser system with the protective cover.

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Troubleshooting

The keyswitch will not turn ON ( | ) the CVX‑300.

• Ensure the CVX‑300 power cord is connected to the proper source.

• Ensure the main circuit breaker, located on the lower back panel, is in the ON ( | ) position.

• Ensure the interlock plug is inserted into the receptacle located on the lower back panel.

The buzzer sounds when CVX‑300 power cord is plugged in.

• Release the emergency button by turning it in a clockwise direction.

The CVX‑300 will not enter the Calibrate mode.

• Allow the CVX‑300 time to complete the warm‑up mode.

• Insert a ber optic catheter into the coupler.

• Plug in the footswitch.

• Set the uence and pulse repetition rate.

Alarm sounds when the ready button is depressed.

• Calibrate the system.

The CVX‑300 does not complete calibration.

• Depress and hold the footswitch down until lasing stops and the Cal OK indication is illuminated.

Keyswitch is ON ( | ) but the CVX‑300 will not come on after the emergency button has been reset.

• Turn the keyswitch to the OFF ( ) position and then to the ON ( | ) position to reset the system.

Fiber indicator is illuminated. • Ensure the ber optic catheter

handle is fully inserted into the coupler.

Service indicator is illuminated. • Call Spectranetics Customer

Service for assistance.

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Power error indicator is illuminated constantly.

• Call Spectranetics Customer Service for assistance.

A fault occurs during Warm‑up or Calibration, the fault indicator is illuminated and a fault code number is shown in the middle of the display window.

• Refer to the Fault Code Table at the end of this section.

The laser gives an odor of HCl gas (like bleach).

• Place the laser in a well‑ventilated, yet isolated room. Call Spectranetics Customer Service to schedule an emergency service visit.

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Troubleshooting: CVX-300 Fault Codes & Error Lamps

Fault Code

Problem Description

Try this…

No energy detected at detector head

Clean the ber optic catheter tip and re‑calibrate at the

recommended settings (45/25 for ELCA devices; 60/40 for SLS devices.) Ensure the device is pointed at the center of the energy detector, one to two inches away. If calibration is unsuccessful, attempt to calibrate with

the Reference Catheter. If successful, try a new ber

optic catheter.

If calibration of the Reference Catheter is unsuccessful, record the Fault code and call Spectranetics Customer Service.

Calibration did not occur within the unit’s pre‑set pulse limit

Beam attenuator at maximum opening

Fiber Power Monitor test error

Clean the Energy Detector Surface with an alcohol prep.

Clean the ber optic catheter tip and re‑calibrate at the

recommended settings (45/25 for ELCA devices; 60/40 for SLS devices.) Ensure the device is pointed at the center of the energy detector, one to two inches away.

If calibration is unsuccessful, attempt to

re‑calibrate the device at a lower uence

setting (40/25 for ELCA devices; 50/40 for SLS devices.) If calibration is successful, proceed. Report the incident to Spectranetics after the case is complete.

If calibration is unsuccessful, turn the system OFF ( ), then back ON ( | ). Attempt to calibrate with the

Reference Catheter. If successful, try a new ber

optic catheter. If calibration of the Reference Catheter is unsuccessful, record the Fault code and call Spectranetics Customer Service.

5 Fiber optic

catheter handle improperly inserted

Remove the ber optic catheter and reinsert. If the fault

is repeated, call Spectranetics Customer Service.

10‑50 System Error

detected

Record the Fault Code and call Spectranetics Customer Service.

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Error Lamp

Problem Description

Try this…

Power

Error

Lamp

Internal energy deviation detected

Remove the ber from the treatment area. Aim ber at

the center of the detector. Ensure the device is pointed at the center of the energy detector, one to two inches away. Depress the footswitch and continue to lase for up to 10 seconds.

If the Power Error indicator turns off and remains off,

reintroduce the ber device and continue. Report the

incident to Spectranetics after the case is complete. If the Power Error indicator remains illuminated, turn the

unit OFF ( ), then back ON ( | ). Bypass the warm‑up period by pressing the RESET and STANDBY buttons simultaneously (in order to bypass the warm‑up period,

the system must not be OFF ( ) for longer than 30 seconds.)

Attempt to calibrate with the Reference Catheter.

If successful, attempt to calibrate the ber optic catheter to

be used in the patient. Proceed if successful. Report the incident to Spectranetics after the case is complete.

If the Power Error lamp continues to illuminate, either steadily or intermittently, call Spectranetics Customer Service.

Service

Lamp

System has reached 95% of maximum energy output

System operation is typically not affected when this indicator is initially illuminated. Call Spectranetics

immediately to schedule service.

Test the system using the Reference Catheter. If the unit operates normally and calibration is completed successfully, continue with the desired

ber optic catheter.

If calibration is unsuccessful, record the Fault Code and call Spectranetics Customer Service.

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Glossary

Align

To adjust the components of a system for proper interrelationship.

Circuit breaker

An electromagnetic device which opens a circuit automatically when the current exceeds a pre-determined value.

Distal

Located away from the point of origin or attachment.

Energy

The capacity for doing work and overcoming resistance. Heat, light, and electricity are examples of energy. Energy is measured in joules.

Excimer

Contraction of EXCIted and diMER.

Excimer laser

A pulsed, gas laser which lases when two atoms form a temporary excited molecule.

Excimer radiation

Electromagnetic radiation emitted from the CVX‑300 which includes all reected radiation and any other form of energy resulting from the primary beam.

Excitation

The addition of energy to a particle or system of particles to produce an excited state.

FDA

The Food and Drug Administration.

Fiber optic

Transparent, glass or quartz bers used for conducting light.

Fluence

Fiber optic catheter output energy density usually expressed in millijoules/square millimeter.

Hydrogen Chloride (HCl)

A gaseous compound which is the source of the excimer laser chlorine atom.

Hertz

One cycle per second; a unit of frequency. Abbreviated Hz.

IPX8

The degree of protection rating given the footswitch which means it is enclosed such that it is usable under water.

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Joule

One Watt second; a unit of energy.

Laser

(An acronym) Light Amplication by Stimulated Emission of Radiation: a device which amplies light, then releases it in a coherent powerful beam.

Non‑Ionizing Radiation

Electromagnetic radiation that does not have sucient energy to remove electrons from the outer shells of atoms. Types of non-ionizing radiation are: ultraviolet (UV), visible light, infrared (IR), microwave, radio (and television), and extremely low frequency (ELF, sometimes referred to as EMF or ELF-EMF).

Neon (Ne)

A rare, inert gas occurring in the atmosphere. It is colorless, but glows reddish-orange in an electrical discharge.

Proximal

Nearest to the point of attachment or origin.

Pulsed laser

A laser which delivers energy in short bursts.

Repetition rate

The rate at which the laser delivers pulses, usually expressed as pulses per second.

Type CF

Classication indicating direct conductive contact with the heart.

Ultraviolet

Pertains to electromagnetic radiation at wavelengths shorter than visible light.

Watt

One joule per second; a unit of power.

Wavelength

The distance between corresponding points on two successive waves.

WEEE (Waste from Electrical & Electronic Equipment)

Directive that mandates the collection and treatment of electronic and electrical equipment at end-of-life.

Xenon (Xe)

A noble gas.

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www.spectranetics.com

Spectranetics Corporation

9965 Federal Drive, Colorado Springs, CO 80921, USA Tel: 1-800-231-0978 Fax: 719-447-2022

Spectranetics CVX-300, CVX-300-P Operator's Manual

Specifications and Main Features

Frequently Asked Questions

User Manual