Spectranetics CVX-300 User manual

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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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© 2016 THE SPECTRANETICS CORPORATION. ALL RIGHTS RESERVED.
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.

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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 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.

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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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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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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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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.

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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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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/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.

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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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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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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: Utis the ac mains voltage prior to application of the test level.

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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 Pis 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.
a 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.
b 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
W
Separation distance according to frequency
of transmitter
m
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
11.2 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 din meters (m) can be estimated using the equation applicable
to the frequency of the transmitter, where Pis 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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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

19
7030-0068-26
28Jul16
Customer Service, Canada/US [phone] / [phone]
Customer Service, Europe [phone]
CVX-300® Excimer Laser System Version 26 Operator’s Manual
English / English
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

20
7030-0068-26
28Jul16
Customer Service, Canada/US [phone] / [phone]
Customer Service, Europe [phone]
CVX-300® Excimer Laser System Version 26 Operator’s Manual
English / English
CVX‑300‑P Labeling
(Follow Instructions for Use)
1
2
3
4
5
6
21
23