Spectranetics CVX-300 User manual

7030-0068-26

28Jul16

CVX-300®

CVX-300®-P

Excimer Laser System

Operator’s Manual

Version 26

7030-0068-26

28Jul16

Customer Service, Canada/US (719) 633-8333 / (800) 231-0978

Customer Service, Europe +31 33 434 7050

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

English / English

Thedocumentationcontainedhereiniscondentialandproprietary.Thisdocumentation

may not be copied, reproduced, disclosed, transferred, or reduced to any form, including

electronicmediumormachine-readableform.Thisdocumentationmaynotbetransmitted

orpubliclyperformedbyanymeans,electronicorotherwise,withoutthewrittenconsentof

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.

7030-0068-26

28Jul16

Customer Service, Canada/US (719) 633-8333 / (800) 231-0978

Customer Service, Europe +31 33 434 7050

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

English / English

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 OFTHE SPECTRANETICS CVX-300 REQUIRES SPECIALTOOLS,

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)TOTHE 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.

7030-0068-26

28Jul16

Customer Service, Canada/US (719) 633-8333 / (800) 231-0978

Customer Service, Europe +31 33 434 7050

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

English / English

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

7030-0068-26

28Jul16

Customer Service, Canada/US (719) 633-8333 / (800) 231-0978

Customer Service, Europe +31 33 434 7050

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

English / English

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

7030-0068-26

28Jul16

Customer Service, Canada/US (719) 633-8333 / (800) 231-0978

Customer Service, Europe +31 33 434 7050

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

English / English

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.

7030-0068-26

28Jul16

Customer Service, Canada/US (719) 633-8333 / (800) 231-0978

Customer Service, Europe +31 33 434 7050

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

English / English

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 maintenancemust be performed solelyby aSpectranetics

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.

7030-0068-26

28Jul16

Customer Service, Canada/US (719) 633-8333 / (800) 231-0978

Customer Service, Europe +31 33 434 7050

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

English / English

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.

7030-0068-26

28Jul16

Customer Service, Canada/US (719) 633-8333 / (800) 231-0978

Customer Service, Europe +31 33 434 7050

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

English / English

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.

7030-0068-26

28Jul16

Customer Service, Canada/US (719) 633-8333 / (800) 231-0978

Customer Service, Europe +31 33 434 7050

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

English / English

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/mm2

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.

This manual suits for next models

Table of contents

Popular Measuring Instrument manuals by other brands

Suaoki

Suaoki D40 user manual

Elster

Elster BK-G1.6 operating instructions

Endress+Hauser

Endress+Hauser Deltabar FMD71 technical information

Duratool

Duratool D03128 manual

Vega

Vega VEGAPULS 65 Quick setup guide

Tonghui

Tonghui TH2618B Operation manual

Tenmars

Tenmars TM-801 user manual

MSR

MSR 145 user manual

TPS

TPS WP-82 manual

ELMETRON

ELMETRON CP-511 user manual

PCB Piezotronics

PCB Piezotronics 003C30 Installation and operating manual

Tenma

Tenma 72-10465 manual

Endress+Hauser

Endress+Hauser Proline Promag 50 Brief operating instructions

Siemens

Siemens SITRANS F Coriolis FCT030 Function manual

KLINGER

KLINGER CMF V Series instruction manual

EXFO

EXFO FTB-2 Notice

Keysight

Keysight M8290A Getting started guide

ADTEK

ADTEK MW-5 operating manual