Related Manuals for zerona Z6
Summary of Contents for zerona Z6
- Page 1 Non-Prescriptive/Non-invasive Fat Loss Laser INSTALLATION AND PROPER USE REFERENCE GUIDE Read this entire booklet before using your Zerona Z6 OTC Laser...
- Page 3 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.
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Page 4: Table Of Contents
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 ... - Page 5 GUIDANCE AND MANUFACTURER’S DECLARATION-ELECTROMAGNETIC EMISSIONS & IMMUNITY ...... 35 TECHNICAL SPECIFICATIONS ............................. 38 ...
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Page 6: Section 1: General Information
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. -
Page 7: Package Contents
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. -
Page 8: Symbols Used On The Equipment
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. -
Page 9: Safety Information
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... - Page 10 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.
- Page 11 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.
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Page 12: Labels
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. - Page 13 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.
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Page 14: Risks And Benefits
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. - Page 15 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.
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Page 16: Section 2: Zerona Z6 Otc Overview & Assembly
SECTION 2: ZERONA Z6 OTC OVERVIEW & ASSEMBLY ZERONA Z6 OTC ASSEMBLY DIAGRAM OF MACHINE 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. -
Page 17: Assembly Directions
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 | 12... - Page 18 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 | 13...
- Page 19 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 | 14...
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Page 20: Backup Batteries
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. ZERONA Z6 OTC OVERVIEW & ASSEMBLY | 15... -
Page 21: Section 3: Zerona Z6 Otc Operation
SECTION 3: ZERONA Z6 OTC OPERATION BASICS AND ESSENTIALS Now that you understand the basic features of the Zerona Z6 OTC laser, it is important to understand how to use them when administering treatments. MOVING THE LASER ARM The arm is moved up and down using the laser arm, not the laser output head or flexible arms. -
Page 22: Zerona Z6 Touch Screen
Touch anywhere on the “Press Here to Begin” bar which is found across the bottom of the screen. This will take you to the ZERONA Z6 Mode screen. PRECAUTION - 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. - Page 23 NOTE: The device is preprogrammed to treat for a total of 40 minutes. After the first 20 minutes of treatment, the device will pause, displaying the “Zerona Z6 Halfway Point” screen. This is to give the client time to change from the front to the back treatment position.
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Page 24: Device Information Screen
“EXIT ZERONA MODE” this will return you to the start Zerona Z6 Mode Screen screen. Located to the right of the “Exit Zerona Mode” icon is the “Time Remaining" display that shows the current treatment time remaining. The countdown display activates once the treatment is started. -
Page 25: Protective Eyewear
BASICS AND ESSENTIALS (CONTINUED) PROTECTIVE EYEWEAR The Zerona Z6 OTC is classified by the FDA/IEC as a Class 2 laser device. This represents a current standard for use to ensure the safety of the client. A Class 2 laser is determined to have a chronic viewing hazard. Pointing the laser beam directly into the eye and maintaining it there for an extended period could prove to be damaging. -
Page 26: Proper Diode Placement
The lateral (side) adjustable laser heads are positioned over the areas of greatest waist and thigh fat accumulation on either side of the body. Anterior (Front) Treatment Diode Placement Perpendicular Placement of Diode in Reference to the Treatment Area ZERONA Z6 OTC OPERATION | 21... - Page 27 6 inches (15 cm) separating adjacent Line-Generated Beams Use the palm of your hand to position the adjustable laser heads, shifting the flexible arms to the region of greatest fatty accumulation, as shown. ZERONA Z6 OTC OPERATION | 22...
- Page 28 After the second 20-minute posterior (back) treatment, the laser will automatically turn off and alert you with 3 audio beeps. Raise the laser arms from the client. The client can get dressed, leave the office, and resume their daily lives. ZERONA Z6 OTC OPERATION | 23...
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Page 29: Zerona®-Z6 Otc Treatment Protocol
ZERONA®-Z6 OTC TREATMENT PROTOCOL Now that you understand how to operate the Zerona Z6 OTC device and how to position the diodes properly, the following section describes the steps to follow each time you administer a treatment with the device to a client. You will need to administer six treatments with the Zerona Z6 OTC device to the client over two weeks. -
Page 30: Zerona®-Z6 Otc Client Qualification Checklist
ZERONA®-Z6 OTC CLIENT QUALIFICATION CHECKLIST You should always use the Zerona Z6 OTC Client Qualification Checklist to make sure the client is suitable for treatments before starting any treatments. A. CLIENT QUESTIONS: Ask the client all four questions below and check the answer as ‘Yes’ or ‘No’... - Page 31 Check the correct box below and follow the action BMI is 30 or less => the client qualifies for Zerona Z6 OTC treatment. ☐ BMI is more than 30 => the client does not qualify for Zerona Z6 OTC ☐ ZERONA Z6 OTC OPERATION | 26...
- Page 32 ZERONA Z6 OTC OPERATION | 27...
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Page 33: Measurement Protocol
You may also want to take before and after photos of your clients. These are both great ways to show your client their progress! ZERONA Z6 OTC OPERATION | 28... -
Page 34: Section 4: Maintenance & Warranty Information
SECTION 4: MAINTENANCE & WARRANTY INFORMATION 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. -
Page 35: Maintenance And Cleaning
MAINTENANCE AND CLEANING MAINTENANCE The Zerona Z6 OTC, if used per the instructions contained within this manual, will operate efficiently for years. To ensure proper care, it is advisable for you to perform the following: 1. Regular visual inspections to ensure there is no external damage other than normal wear and tear. - Page 36 LASER GLASSES CLEANING Use only mild soap STORAGE The Zerona Z6 OTC laser should be stored in a cool, dry place out of the reach of children. MAINTENANCE & WARRANTY INFORMATION | 31...
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Page 37: Warranty
WARRANTY LIMITED WARRANTY The Erchonia® laser device is warranted to be free from defects in material and workmanship for a period of TWO YEARS from the date of purchase. For your device to be processed through the Service and Repair Department efficiently, contact the department prior to submitting your product. -
Page 38: Contact Us
CONTACT US Questions? If for any reason you are dissatisfied with this product, warranty concerns or questions regarding proper operation, please contact our Erchonia Customer Care representative for assistance. Contact us at: Erchonia Customer Care Phone: +1-321-473-1251 Email: info@erchonia.com Or visit erchonia.com Copyright ©... -
Page 39: Troubleshooting
TROUBLESHOOTING Use the following information to help solve problems that may arise during use. If you still have questions, please call Erchonia Customer Care at 1-321-473-1251, and we will be happy to help. Problem Possible Cause How to Resolve POWER AC power cord not plugged into Device does not... - Page 40 Medical electrical equipment requires special precautions regarding EMC and must be installed and put into service according to EMC information provided in this document. Portable and mobile RF communications equipment can affect the medical electrical equipment. This declaration currently applies to the Zerona Z6 OTC device. GUIDANCE AND MANUFACTURER’S DECLARATION-ELECTROMAGNETIC EMISSIONS The device is intended for use in the electromagnetic environment specified below.
- Page 41 GUIDANCE AND MANUFACTURER’S DECLARATION-ELECTROMAGNETIC IMMUNITY The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that the device is used in such an environment. Immunity test IEC60601-1-2 test level Compliance level Electromagnetic environment-guidance Floors should be wood, concrete or...
- Page 42 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Zerona Z6 OTC device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation.
- Page 43 NL-5076 NP Haaren Powder coated metal frame The Netherlands Non-allergenic material finished with black carbon fiber Applied Part: Type B Trade name: Zerona® Z6-OTC Leakage Current 0.3 -0.5 µA (Micro Amps) Model Number: SHR Laser Classifications ...
- Page 44 Congratulations on completing the Zerona Z6 OTC Installation and Proper Use Reference Guide. You are now ready to provide great outcomes with the Zerona Z6 OTC. Non-Prescriptive/Non-invasive Fat Loss Laser It’s just that simple Learn more about Erchonia lasers erchonia.com | 1-321-473-1251-USA | +44 (0)1491 821135 Europe...