Erchonia FX 635 Manual

Operation &

Maintenance

Manual

Read this entire booklet before using your FX 635 Laser

READ THIS FIRST

To ensure proper use, and to achieve your best results, it is important that you read and understand the

instructions, warnings, precautions and safety information in this booklet before using your FX 635 laser for the

first time.

This symbol appears next to information about possible safety risks.

Questions? Our Erchonia Customer Care representatives are available to help. Contact us at:

Erchonia Customer Care

Phone: 1-321-473-1251

Email: info@erchonia.com

Or visit erchonia.com

ATTENTION: By purchasing this Erchonia device, you, the licensed health care professional, acknowledge

that you are solely responsibly to ensure: (i) that your use of this device is within the scope of your professional

practice; and (ii) that you use the device in accordance with all applicable laws, rules, and regulations, including

without limitation, any regulations promulgated by any state medical or professional board applicable to your

practice.

We recommend you periodically contact Erchonia Corporation to determine if additional product information

updates are available.

TABLE OF CONTENTS

SECTION 1 GENERAL INFORMATION.......................................................................................................... 1

PRODUCT DESCRIPTION............................................................................................................................... 1

PACKAGE CONTENTS.................................................................................................................................... 1

SYMBOLS USED ON THE EQUIPMENT....................................................................................................... 2

SAFETY INFORMATION ................................................................................................................................ 3

NOTIFICATION OF ADVERSE EVENTS ...................................................................................................... 6

ERCHONIA LASER INDICATIONS FOR USE .............................................................................................. 6

TECHNICAL INFORMATION......................................................................................................................... 6

SERVICE AND REPAIR ................................................................................................................................... 6

SECTION 2 PRODUCT OVERVIEW................................................................................................................... 7

NOMENCLATURE ........................................................................................................................................... 7

SECTION 3 SETUP & OPERATION.................................................................................................................. 13

WHEEL LOCKS .............................................................................................................................................. 13

MAIN ARM & LASER HEAD ASSEMBLY OPERATION.......................................................................... 13

POWERING UP THE DEVICE....................................................................................................................... 17

PRESET PROTOCOLS.................................................................................................................................... 18

USER PROTOCOLS FOR OTHER PAIN INDICATIONS............................................................................ 20

QUICK PROGRAM FOR OTHER PAIN INDICATIONS............................................................................. 23

CREDIT & DEVICE INFORMATION SCREEN ........................................................................................... 26

HOW DO CREDITS WORK?.......................................................................................................................... 26

TO ADD CREDITS.......................................................................................................................................... 27

LABELS ........................................................................................................................................................... 28

SECTION 4 PROFESSIONAL USE INSTRUCTIONS...................................................................................... 31

APPLICATION/ADMINISTRATION............................................................................................................. 31

HEEL PROTOCOL .......................................................................................................................................... 31

LOW BACK PROTOCOL ............................................................................................................................... 32

NECK PROTOCOL.......................................................................................................................................... 33

SHOULDER PROTOCOL ............................................................................................................................... 33

ELBOW PROTOCOL ...................................................................................................................................... 34

WRIST/HAND PROTOCOL ........................................................................................................................... 34

KNEE PROTOCOL.......................................................................................................................................... 34

ANKLE/FOOT PROTOCOL ........................................................................................................................... 35

PRE-OP PROTOCOL....................................................................................................................................... 35

POST-OP PROTOCOL .................................................................................................................................... 35

USER PROTOCOLS ........................................................................................................................................ 36

QUICK PROGRAM PROTOCOL ................................................................................................................... 36

CLINICAL TRIAL SUMMARIES .................................................................................................................. 37

SECTION 5 MAINTENANCE & WARRANTY INFORMATION ................................................................... 41

MAINTENANCE AND CLEANING .............................................................................................................. 41

FUSE REPLACEMENT................................................................................................................................... 41

WARRANTY ................................................................................................................................................... 42

CONTACT US.................................................................................................................................................. 43

LASER HEAD ASSEMBLY REMOVAL & INSTALLATION FOR SERVICE .......................................... 44

GUIDANCE AND MANUFACTURER’S DECLARATION-ELECTROMAGNETIC EMISSIONS &

IMMUNITY...................................................................................................................................................... 46

TECHNICAL SPECIFICATIONS ................................................................................................................... 49

SECTION 1 GENERAL INFORMATION

This Erchonia ® FX 635, model: HPS Operator’s Guide is designed to take you through set-up and proper use of your

device. It will cover the Device Overview, Operation, Cautions, Warnings, Professional Use Instructions and

Maintenance and Warranty Information.

It is important that you read and understand all of the information contained in this operator’s guide before performing

any treatments with the Erchonia ® FX 635.If you have any questions, contact our Erchonia Customer Care

representatives.

PRODUCT DESCRIPTION

The Erchonia® FX-635 (Model#: HPS) is low level laser system that uses three semi-conductor diodes (visible red-light)

630nm to 650nm with a mean power output of 17.25mW per diode. The Erchonia® FX-635™ (Model#: HPS) is a

variable hertz device. The variable hertz feature of the Erchonia® FX-635™ (Model#: HPS) is a pulsed wave, defined as

containing a selected series of breaks, variances that are preprogrammed. The Erchonia® FX 635 (Model#: HPS) has

been classified by the FDA/EC as a Class II device and a Class 2 Laser.

The components of the device include a mobile base which plugs into the wall, using a hospital grade power cord,

equipped with a medical grade transformer. Four (4) antistatic wheels that enable ease for maneuverability. A touch

screen that functions as a display screen and input panel. The touch screen communicates with the PCB to initiate, stop or

pause the energy flow to the laser diodes. The laser diodes can only be on or off; there is no user interface that allows the

end user to alter the laser diode output. The device has an adjustable main arm that is attached to the mobile base with

the laser head assembly located at the end. The adjustable main arm is capable to collapse into the mobile base for storage

and transporting or extends to position the laser heads above the area of involvement. The laser head assembly that is

attached to the adjustable main arm that is manually raised and lowered utilizes internal mechanics that collects the light

emitted from each of the three (3) laser diodes and processes each through a proprietary patented lens which redirects the

beam with a line refractor. The refracted light is then bent into a spiraling circle pattern that is totally random and

independent of the other diodes. When the laser head assembly is positioned 3-4 inches from the patient’s skin each diode

delivers .51J per minute. This assembly can be rotated 120 degrees for proper positioning to patient for accurate

treatment. The laser head assembly includes arms and pivots that allow the three (3) laser output heads to be rotated,

tilted, and raised / lowered independently. The device contains software that is loaded into the PCB drivers. This data

includes the touch screen images (GUI) and the command prompts that activate the screen icons; work in conjunction

with the component platform to ensure the device operates as intended. The exterior materials consist of 6061 T6 AL,

Kydex 430 and Copolymer Acetal with powder coating and carbon fiber finish.

PACKAGE CONTENTS

Erchonia® FX 635 is shipped in one large packing box with two components:

•FX 635 device

•Accessories (small box)

-Safety glasses

-Keys

-Manual

-Power Cord

-Height Extension Block w/ Locking Knob

When you receive the shipment, carefully inspect the container for damage. If the shipping container or cushion material

is damaged, keep it until the contents have been checked for completeness and the device has been checked for proper

function. If the contents are incomplete or if there is mechanical damage, contact Erchonia Corporation at 1-321-473-

1251. If the shipping container is damaged, also notify the carrier.

SYMBOLS USED ON THE EQUIPMENT

Any or all of the following symbols may be used in this manual or on this equipment:

SYMBOL

DESCRIPTION

Temperature Limitation

Type B patient connection - applied parts that are generally not conductive and can be

immediately released from the patient.

Conformité Européenne - Complies with EMC 2004/108/EC and LVD 2006/95/EC

Power ON

Power OFF

Date of Manufacture

Manufacturer

Authorized representative in the European Community.

Refer to Operating Instructions.

Warning alerts you about a situation which, if not avoided, could result in death or serious

injury. It may also describe potential serious adverse reactions and safety hazards.

Caution is used for the statement of a hazard alert that warns you of a potentially hazardous

situation which, if not avoided, may result in minor or moderate injury to the user or patient

or damage to the equipment or other property. It may also be used to alert against unsafe

practices. This includes the special care necessary for the safe and effective use of the

device and the care necessary to avoid damage to a device that may occur as a result of use

or misuse.

Do not Push-No pushing in this direction

Pinch point-keep hands clear

Rx Only Prescription only (In the US, Federal law restricts this device to sale by or on the order of a

physician)

DO NOT stare into laser beam

SAFETY INFORMATION

Read the following important safety information before using the FX 635 laser.

WHEN NOT TO USE

Safety of non-thermal lasers for use over a pregnant uterus has not been established.

DO NOT use if the following conditions exist:

Inflammatory: seronegative spondylarthritides (e.g. ankylosing spondylitis); rheumatoid arthritis;

infection - epidural abscess or osteomyelitis

Neoplastic: bone tumors (primary or metastatic); and intradural spinal tumors

Metabolic: osteoporotic fractures; osteomalacia; ochronosis; and chondrocalcinosis.

Psychosomatic: Tension myositis syndrome

Current, active chronic pain disease: chronic fatigue syndrome, fibromyalgia, endometriosis,

inflammatory bowel disease, interstitial cystitis.

Cancer or treatment for cancer in the past 6 months, including tumors of the spinal cord

WARNINGS

You must follow these Instructions for Use when using the FX 635 laser. Not following these instructions

may result in serious injury.

DO NOT permit any foreign materials or liquids to enter the device. Take care to prevent any foreign

materials including, but not limited to, inflammables, water, and metallic objects from entering the device.

These may cause device damage, malfunction, electrical shock, fire, or personal injury. To achieve the

specified level of protection against spilled or splashed liquids, unplug the device from the power supply and

thoroughly dry all exposed surfaces of this device and allow to dry thoroughly prior to operation.

DO NOT disassemble, modify, or remodel the device or accessories. This may cause device damage,

malfunction, electrical shock, fire, or personal injury.

To avoid risk of electric shock, do not defeat the safety purpose of the grounding-type plug. A grounding-

type plug has two blades and a third grounding prong. The wide blade or third prong is provided for your

safety. If the provided plug does not fit into your outlet, consult an electrician.

DO NOT submerge any part of the device in water. This could damage the device, or cause an electric

shock that may lead to serious injury or death.

Use of controls or adjustments or performance of procedures other than those specified herein may result in

hazardous radiation exposure.

This equipment/system may cause radio interference or may disrupt the operation of nearby equipment. It

may be necessary to re-orient or relocate the ME equipment or shieled the location. The long-term effects of

prolonged use of non-thermal laser exposure are unknown.

WARNINGS (Continued)

Dispose of device in accordance with local and national regulations and codes. When spent and beyond

repair or functional use, the device can be sent back to the manufacture for disposal. This ensures the proper

separation and handling of all the internal parts and reduces any risk to the end user and the environment.

Risk of explosion if used in the presence of flammable anesthetics. Use of this device in an oxygen-enriched

environment may produce potential of fire hazard. This device is not suitable for use in the presence of a

flammable anesthetic mixture with air or with oxygen or nitrous oxide.

Avoid direct contact of the laser beam into the eyes. Laser protective eyewear should be worn by the patient

to block light energy from the eyes during treatment.

DO NOT use over sensitive skin areas or in the presence of poor circulation; Laser treatment should be

applied only to normal, intact, clean skin or treatment will not be effective.

Laser treatment should not be applied over open wounds or over swollen, infected, or inflamed areas or skin

eruptions, e.g., phlebitis, thrombophlebitis, varicose veins, etc. as conclusive tests have not been conducted.

Laser treatment should not be applied over, or in proximity to, cancerous lesions as conclusive tests have not

been conducted.

The safety and effectiveness of this device has not been demonstrated for patients with the following

conditions: apophyseal osteoarthritis; diffuse idiopathic skeletal hyperostosis; degenerative discs;

Scheuermann's kyphosis; s ("slipped disc"); thoracic or lumbar spinal stenosis; spondylolisthesis and other

congenital abnormalities; fractures; leg length difference; restricted hip motion; misaligned pelvis - pelvic

obliquity; anteversion or retroversion; and abnormal foot pronation.

CAUTIONS

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

This device should only be used under the supervision of a suitably qualified and licensed healthcare

professional.

Read, understand, and practice the precautionary and operating instructions. Know the limitations and

hazards associated with using any laser device. Observe the precautionary and operational decals placed on

the device. If you have difficulty operating the device after carefully reviewing this reference guide, contact

our Erchonia Customer Care representatives for assistance.

DO NOT position equipment so that in an emergency it is difficult to disconnect the power cord from the

electric supply.

DO NOT place/operate this device in close proximity (6 inches) to other devices that emit frequency. If this

device causes interference to other devices, which can be determined by turning the device off and on, you

are encouraged to try to correct the interference by one of the following measures:

•Reorient or relocate the receiving device.

•Increase the separation between the equipment.

•Connect the equipment into an outlet on a circuit different from that to which the other device(s) are

connected.

This device should be operated in temperatures between 59° to 85°F (15° to 29°C), and transported in

temperatures between -22° to 158°F (-30° to 70°C), with relative humidity less than 75%.

There are no user-serviceable parts inside the device except the fuses. If a malfunction occurs, discontinue

use immediately and contact Erchonia® Corporation for repair service.

Inspect electrical cord and associated connectors before each use. ONLY use the power cord supplied with

the device. Using a different power cord could damage the device.

Physicians should exercise caution if the patient has sensitive skin areas or in the presence of poor

circulation.

NOTIFICATION OF ADVERSE EVENTS

As a health care provider, you may have responsibilities under the Medical Device Reporting for User Facilities (FDA 21

CFR part 803), or the local government Vigilance reporting requirements to report, the occurrence of events that include

device-related death and serious injury or illness. If such an event is brought to your attention, to ensure compliance;

contact both the Agent identified on the label and the manufacturer, Erchonia Corporation. As part of our Quality

Assurance Program, Erchonia Corporation requests to be notified of device failures or malfunctions. This information is

required to ensure that Erchonia Corporation provides only the highest quality products.

ERCHONIA LASER INDICATIONS FOR USE

The Erchonia® FX-635™ is indicated for the adjunctive use in providing temporary relief of nociceptive musculoskeletal

pain.

TECHNICAL INFORMATION

Technical documentation required by the customer, in case of necessary reparations, will be provided by Erchonia in the

US and our EU agent, internationally. These documents will be supplied once the manufacturer makes the determination

that the requested documents do not constitute a disclosure of proprietary or patent protected information and are a part of

the filed and documented technical file.

SERVICE AND REPAIR

If a device requires service, contact the Erchonia Service and Repair Department at:

Telephone: 1-321-473-1251

When requesting service or repair, please provide the following information to the service representative:

•Device serial number (located on the back label)

•Description of the problem

•Name of the person to contact

RETURNING A DEVICE FOR SERVICE

•Before sending a device to the Erchonia Service and Repair Department for repair, obtain a service order (SO) number

from the service representative.

•Pack the device and charger in the original containers (if available) or equivalent packaging. Be sure the assigned

service order number appears on the package.

Return the Device to:

Erchonia Corporation

650 Atlantis Rd.

Melbourne, FL 32904 USA

Attention: Service and Repair Department (SO Number)

NOTE: For international customers, PRIOR to sending a unit in for repair you must obtain from the Erchonia Service

department an annually revised FDA Form 2877. The Radiation Control form (2877) will be sent to you partially

complete, containing regulatory information. To complete, fill in the unique information associated with your device and

the shipment thereof; such as serial number, port, etc. The completed form 2877 must accompany your shipment affixed

to the outside of the package. Failure to include the form in the shipment may result in customs delays and fines. Any

resulting fines are the responsibility of the customer.

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