zerona Z6 User manual


Non-Prescriptive/Non-invasive Fat Loss Laser
INSTALLATION AND PROPER USE REFERENCE GUIDE

Read this entire booklet before using your Zerona Z6 OTC 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 Zerona Z6 OTC 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: [phone]
Email: [email protected]
Or visit erchonia.com
Erchonia Europe Customer Care
Phone: [phone]
Email: [email protected]
Or visit erchonia.com
ATTENTION: This device is sold “Over the Counter” (OTC). In general, there is no prescription
required for the use of this device by any individual. Notwithstanding the foregoing, if you are a
licensed healthcare professional using this device, you are solely responsible for your use of this
device and for ensuring that this device is properly used in accordance with any professional or
other regulations that may apply to your use of this device. The device should always be used in
accordance with the instructions set forth in this manual.
We recommend you periodically contact Erchonia Corporation to determine if additional product
information updates are available.



TABLE OF CONTENTS
SECTION 1: GENERAL INFORMATION.................................................................................................................................1
HOW TO USE THIS REFERENCE GUIDE...........................................................................................................................1
WHAT IS THE ZERONA Z6 OTC LASER?..........................................................................................................................1
HOW DOES IT WORK?.......................................................................................................................................................1
PACKAGE CONTENTS........................................................................................................................................................2
SYMBOLS USED ON THE EQUIPMENT..............................................................................................................................3
SAFETY INFORMATION......................................................................................................................................................4
LABELS................................................................................................................................................................................7
RISKS AND BENEFITS.........................................................................................................................................................9
SECTION 2: ZERONA Z6 OTC OVERVIEW & ASSEMBLY...................................................................................................11
ZERONA Z6 OTC ASSEMBLY...........................................................................................................................................11
DIAGRAM OF MACHINE...................................................................................................................................................11
ASSEMBLY DIRECTIONS...................................................................................................................................................12
BACKUP BATTERIES........................................................................................................................................................15
SECTION 3: ZERONA Z6 OTC OPERATION........................................................................................................................16
BASICS AND ESSENTIALS................................................................................................................................................16
MOVING THE LASER ARM...............................................................................................................................................16
WHEEL LOCKS..................................................................................................................................................................16
ZERONA Z6 TOUCH SCREEN..........................................................................................................................................17
DEVICE INFORMATION SCREEN......................................................................................................................................19
PROTECTIVE EYEWEAR...................................................................................................................................................20
PROPER DIODE PLACEMENT..........................................................................................................................................21
ZERONA®-Z6 OTC TREATMENT PROTOCOL................................................................................................................24
ZERONA®-Z6 OTC CLIENT QUALIFICATION CHECKLIST.............................................................................................25
MEASUREMENT PROTOCOL............................................................................................................................................28
SECTION 4: MAINTENANCE & WARRANTY INFORMATION.............................................................................................29
TECHNICAL INFORMATION.............................................................................................................................................29
SERVICE AND REPAIR......................................................................................................................................................29
RETURNING A DEVICE FOR SERVICE.............................................................................................................................29
MAINTENANCE AND CLEANING......................................................................................................................................30
WARRANTY.......................................................................................................................................................................32
CONTACT US....................................................................................................................................................................33
TROUBLESHOOTING............................................................................................................................................................34



GUIDANCE AND MANUFACTURER’S DECLARATION-ELECTROMAGNETIC EMISSIONS & IMMUNITY..........................35
TECHNICAL SPECIFICATIONS.............................................................................................................................................38


GENERAL INFORMATION | 1
SECTION 1: GENERAL INFORMATION
HOW TO USE THIS REFERENCE GUIDE
This reference guide is designed to take you through set-up and proper use of your Zerona Z6 OTC
laser. It will cover Warnings and Precautions, Assembly, Proper Placement of Laser Diodes,
Treatment Protocol and Client Measurement Guidelines.
It is important that you read and understand all the information contained in this reference guide
before doing any treatments with the Zerona Z6 OTC laser. If you have any questions, contact our
Erchonia Customer Care representatives.
WHAT IS THE ZERONA Z6 OTC LASER?
The ZERONA Z6 OTC Laser is indicated for use as a non-invasive dermatological aesthetic treatment
for the reduction of body circumference.
The Zerona Z6 OTC laser delivers a new non-invasive fat loss procedure designed to slim the body
without surgery, pain or needles. The protocol allows clients to continue daily activity without
interruption.
Clinical data on safety and effectiveness has only been generated for waist, hips, thighs, upper
abdomen, and upper arms. Presently there does not exist clinical data on safety or effectiveness
for other parts of the body
HOW DOES IT WORK?
The Zerona Z6 OTC laser works by using a patented and clinically proven low-level laser
technology. Each laser diode of the device emits visible red light (about 635 nanometer
wavelength). The laser emulsifies the fat, (defined as leakage of the fat out of the cell) within the
adipose tissue which is then released into the interstitial space. The excess fat is then passed
through the body during its normal course of detoxification.


GENERAL INFORMATION | 2
PACKAGE CONTENTS
The Zerona Z6 OTC laser is shipped in one large freight box with three components:
 Z6 control base
 Z6 laser diode arm
 Accessories (small box)
- Safety glasses
- Tape measure
- Keys
- Manual
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.


GENERAL INFORMATION | 3
SYMBOLS USED ON THE EQUIPMENT
Any or all of the following symbols may be used in this reference guide or on the equipment:
Symbol Description

Temperature Limitation

Type B receipt connection - applied parts that are generally not conductive and
can be immediately released from the client.

Conformité Européenne - Complies with EMC 2004/108/EC and LVD 2006/95/EC.

Power ON/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.
Precaution 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 client 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.
No pushing.
Pinch point-keep hands clear

WEEE Symbol- Separate Collection Recommended


GENERAL INFORMATION | 4
SAFETY INFORMATION
Read the following important safety information before using the Zerona Z6 OTC laser.
WHEN NOT TO USE

Avoid using the laser over a pregnant uterus.
DO NOT treat the face, neck or breast.
WARNINGS

You must follow these Instructions for Use when using the Zerona Z6 OTC laser. Not
following these instructions may result in serious injury.

DO NOT place/operate this device near mirrors or other reflective materials or surfaces
as the laser light could be deflected off a mirror or reflective surface into someone’s
eyes, possibly causing eye damage.

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.
Avoid direct contact of the laser beam into the eyes. Laser protective eyewear should
be worn by the client to block light energy from the eyes during treatment.

Beware of electrocution. 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
in this booklet may result in hazardous radiation exposure.

The Zerona Z6 OTC laser is not intended for use by persons with reduced physical,
sensory or mental capabilities.



GENERAL INFORMATION | 5
WARNINGS (Continued)

Keep out of reach from children

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.
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.
Avoid using the laser on skin that is infected, burned or cut, as this could cause
discomfort or irritation. Wait until the infection, burn or cut has healed before using the
laser. If the client has a skin condition, lack of skin sensitivity or are undergoing
professional cosmetic treatments, please check with their doctor or clinician before
using the laser.”
Laser treatment should not be applied over, or in proximity to (near), cancerous lesions
(such as moles and other suspicious skin markings unless known not to be cancerous).
There have not been conclusive tests that show if low level laser exposures on or near
cancerous lesions do or do not create a serious adverse effect.


GENERAL INFORMATION | 6
PRECAUTIONS
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 use sharp objects such as a pencil point or ballpoint pen to operate the buttons
on the touch screen as damage may result.
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 for 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


GENERAL INFORMATION | 7
LABELS
The device is manufactured in accordance to the Good Manufacturing Practices set forth by the
FDA, ISO Standards (International) and CE (Conformité Européenne or European Conformity)
standards and testing results per Article 9. The device is a Class I Shock Protection and a Class II
Medical device. Each of these governing agencies requires specific labeling. All required labels are
affixed per the relevant codes. Each label is pictured and described in this section. Additionally,
the placement of each label on the device is communicated.
The following diagram shows the compliance labels and their placement.
The large black background label is this primary label and is compliant to FDA and ISO standards;
the image captures the FDA code regulated classifications and International criteria. One of the (2)
identified pinch points is labeled below.


GENERAL INFORMATION | 8
The following diagram shows the location of the device arm serial number, no pushing reminder
and each of the laser diodes (6) have a label affixed that show the direction of the laser beam
output.
The following diagram shows one of the (2) identified pinch points, the device base serial number
and electrical input label containing Volts, Amps and fuse specifications.


GENERAL INFORMATION | 9
RISKS AND BENEFITS
Through clinical studies, the Zerona® Z6 OTC Laser has been shown to reduce the circumference of
the waist, hips and thighs.
The risks and benefits of the Zerona® Z6 OTC laser are based on participant’s feedback and all
other clinical studies conducted using Erchonia low level lasers for circumference reduction.
RISKS
There have been no side effects as a result of use of the Erchonia ZERONA® Z6 OTC laser. There
have also been other research studies using Erchonia low level lasers. In these studies, no side
effects resulted from or reported by any participant from use of the device.
The only known or anticipated risk with the use of the laser device is that long-term exposure to
laser light could cause damage to eyesight. As a precaution, when you are giving the treatments
with the Zerona® Z6 OTC, ensure that the client wears the special darkened protective glasses to
block out the light.
Women who are pregnant or trying to get pregnant should not be treated.
The following conditions or medications may affect the client’s outcome or weaken fat
mobilization or metabolic pathways:
 Steroid medications (may cause weight or girth gain)
 Diabetes (may experience rapid weight or girth gain)
 Metabolic Disorders (may experience rapid weight or girth gain)
 Lymphatic Impairment (fat mobilization may be hindered)
– Previous abdominoplasty, C-section, liposuction (procedures that have created scar tissue
around the treatment site)
It is possible that the client will not get the circumference reduction that they desire.


GENERAL INFORMATION | 10
BENEFITS
In the past, Erchonia’s low level laser technology was only available in a doctor’s office for
circumference reduction of the waist, hips and thighs. Erchonia first received FDA market
clearance in 2010 as a prescription only device.
The application of Erchonia’s low level laser technology has been proven through clinical trials to
induce transitory pore formation, releasing collected fatty material, which is absorbed, degraded
by the lymphatic system and removed from the treated area, creating a slimming outcome based
upon the volume reduction of fat cells.
In 2008, Erchonia conducted a yearlong clinical trial study to determine the effectiveness of the
Erchonia Zerona for non-invasive circumference reduction of the waist, hips and thighs with 6
treatments over a 2-week time frame.
A double-blind, randomized, multi-site, and placebo-controlled study with 67 participants was
conducted in which patients on average, lost 3.50 inches/ 8.9 cm* from their waist, hips and
thighs. These results are dramatic compared to the placebo group, which only lost an average of
half an inch.
In 2014, 22 participants between the ages of 18 to 65 participated in a multi-site clinical study that
was conducted in the United States using the Zerona Z6 OTC device. Participants received six
treatments over a two-week period. Throughout the study, participants were measured at the end
of each week. The participants saw a combined circumference reduction of the waist, hips and
thighs averaging 3.7 inches at the end of 2 weeks.
To achieve the best results, you must carefully read and follow the instructions in this booklet.
*individual results may vary



ZERONA Z6 OTC OVERVIEW & ASSEMBLY | 11
SECTION 2: ZERONA Z6 OTC OVERVIEW & ASSEMBLY
ZERONA Z6 OTC ASSEMBLY
DIAGRAM OF MACHINE

Fig. 1
1. Laser Head Assembly
2. Laser Output Head
3. Power Safety Lockout Key
4. Laser Arm
5. Arm Lock
6. Touch Screen
7. Main Upright of Base
8. Power Inlet/Fuse Holder
9. Wheel Locks
10. Electrical Connector – See Fig. 2
11. Locking Knob
12. Electrical Power Cord


ZERONA Z6 OTC OVERVIEW & ASSEMBLY | 12
ASSEMBLY DIRECTIONS
4. Laser Arm
7. Main Upright of base
10. Connector & Cable
11. Locking Knob

 This may require two people.
 Remove the locking knob [11] from the main
upright of base.
 Once the locking knob is removed, hold the laser
head assembly and laser arm piece while you
attach the base [7] and the arm piece [4].
Fig. 2

 Gently feed the laser arm cable into the base device’s
upright shaft. 


 With the cables fed into the base device’s upright shaft,
insert the arm tube into the base. Make sure the tube is
aligned with the locking knob hole.











ZERONA Z6 OTC OVERVIEW & ASSEMBLY | 13
ASSEMBLY DIRECTIONS (CONTINUED)
 Once the arm is inserted, gently push it down into
the base until the two pieces are flush and the hole
opening for the locking knob is aligned.
INCORRECT
CORRECT

 With the holes aligned, thread the locking knob into
place. This will keep the main head assembly from
unwanted rotation during use.

 Access the laser arm cable by pulling the tab on the
upright base cover as shown.
 Reach in and pull out the laser arm cable for ease of
connecting.




ZERONA Z6 OTC OVERVIEW & ASSEMBLY | 14
ASSEMBLY DIRECTIONS (CONTINUED)
WARNING-SHOCK HAZARD
To avoid risk of electric shock, ensure that the electrical power cord is disconnected
from electric supply when connecting electrical connector.
 Insert the two halves of the electrical connection
[10] together by aligning the yellow markings
slightly pushing the outlet into the inlet as shown.

 Twist the ring on the connector clockwise until it
can no longer be tightened to make sure it is secure.
This is important so that the two halves do not
separate while within the device.
 Place the connector and cable inside the upright
base shaft and secure the cover.

 Now that the laser has been put together, insert the electrical power cord [12] into the power
inlet [8] located at touch screen side of the base device. See figure 1.
 Plug the electrical power cord [12] into any standard electrical outlet for your country/region.
The device includes a transformer which converts AC power to match the power output (i.e.
110V or 240V). Only a 3-plug prong adaptor is required. Once the adaptor is fixed to the plug
end, insert it into the wall socket. Disconnecting this cord while the machine is in operation
will stop the machine, so this can be used as a second or emergency turnoff.
WARNING-SHOCK HAZARD
To avoid risk of electric shock, make certain that the device is grounded by connecting
only to a grounded electrical socket (3-prong) conforming to the applicable national and
local electrical codes.


ZERONA Z6 OTC OVERVIEW & ASSEMBLY | 15
ASSEMBLY DIRECTIONS (CONTINUED)
PRECAUTION - DO NOT connect to an electrical outlet controlled by a wall switch or
dimmer. For continued safety and performance, use only the power cord supplied by
Erchonia. Do not position equipment so that in an emergency it is difficult to disconnect
the power cord from the electric supply.
 Now insert one of the two provided keys into the keyhole on the base device.

The main power switch is the Power Safety Lockout Key
switch on top of the touch screen. There is an external key
for the switch to turn the device ON or OFF. (“O” = OFF and
“|” = ON). In the OFF position, the device is locked, and the
external key can be removed. This is a code-regulated
feature to ensure no unauthorized use of the laser device.
The device will not operate in the OFF position. Turning the
key to the OFF position while using the device will
immediately power off the device.
NOTE: It is highly recommended that you separate the two
keys provided and store one of them in a safe place until
needed.
BACKUP BATTERIES
ATTENTION: The laser device has two internal back-up batteries that retain certain aspects of the
device’s software memory in the case of power failure or shipping the device. These batteries
receive a charge whenever the device is powered ON. It is important that the device is powered
ON when first received by the user for a minimum of 2 minutes, as well as bi-weekly for a minimum
of 2 minutes, to ensure proper charge of the batteries. Failure to do so may result in certain
aspects of the memory being lost, which will require you to ship the device to the manufacture.