Related Manuals for Erchonia EMERALD SHL
Summary of Contents for Erchonia EMERALD SHL
- Page 1 Operation & Maintenance Manual Read this entire booklet before using your Erchonia® EMERALD Laser...
- Page 2 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 Erchonia EMERALD Laser for the first time.
-
Page 3: Table Of Contents
SECTION 5 PROFESSIONAL USE INSTRUCTIONS ......................... 30 APPLICATION/ADMINISTRATION ............................... 30 ERCHONIA® EMERALD PROTOCOL ............................30 ERCHONIA ® EMERALD PATIENT QUALIFICATION CHECKLIST ..................30 MEASUREMENT PROTOCOL ................................. 34 SECTION 6 MAINTENANCE & WARRANTY INFORMATION ....................... 34 MAINTENANCE AND CLEANING ..............................34 WARRANTY ...................................... -
Page 4: Section 1 General Information
(the Erchonia® SHL Laser and the Erchonia® Zerona 2.0). Presently there does not exist clinical data on safety or effectiveness for other parts of the body. -
Page 5: Package Contents
If the contents are incomplete or if there is mechanical damage, contact Erchonia Corporation. If the shipping container is damaged, also notify the carrier. -
Page 6: Symbols Used On The Equipment
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. -
Page 7: Safety Information
Are taking photo-sensitizing drugs, anti-coagulants, or aspirin WARNINGS You must follow these Instructions for Use when using the Erchonia® Emerald 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. - Page 8 Observe the precautionary and operational decals placed on the device. Failure to use and maintain the Erchonia laser and its accessories in accordance with the instructions outlined in this manual will void your warranty.
-
Page 9: Notification Of Adverse Events
As a health care provider, you may have responsibilities under the Medical Device Reporting for User Facilities for reporting to Erchonia ® Corporation, and possibly to the FDA, the occurrence of certain events. These events, described in 21 CFR Part 803, include device-related death and serious injury or illness. -
Page 10: Service And Repair
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. -
Page 11: Section 2 Product Overview
ISO and FDA standards the device and laser are classified as Class 2. Each of these governing agencies requires specific labeling. All required labels are affixed according to the relevant codes. Each label is pictured and described in this manual. Additionally, the placement of each label, on the Erchonia® device, is communicated. - Page 12 [1] ELECTRICAL POWER CORD The device contains a hospital grade flexible detachable power cord. Plug the power cord into the Power Inlet Module [2] prior to plugging the other end into a wall socket. Fig. 2 DO NOT position the equipment so that it is difficult to disconnect the power cord. WARNING-SHOCK HAZARD This device must only be connected to an electric supply main with protective earth.
- Page 13 Refer to “SECTION 4 ERCHONIA® EMERALD OPERATION – INSTRUCTIONS FOR USE” and “SECTION 5 PROFESSIONAL USE INSTRUCTIONS - ERCHONIA® EMERALD PROTOCOL” for proper set up of device prior to facilitating a treatment on the patient.
- Page 14 Main Arm Fig. 5 CAUTION: PINCH HAZARD Keep hands and fingers clear from areas indicated [5] LASER HEAD ASSEMBLY HANDLE The laser head assembly handle serves to position the Laser Head Assembly [6] for proper placement to the subject for treatment;...
- Page 15 Main Arm Section A Outside Laser Arms Handle Fig. 6 Fig. 7 CAUTION: PINCH HAZARD Keep hands and fingers clear from areas indicated [6] LASER HEAD ASSEMBLY The laser head assembly located on the end of the main arm accommodates the Outside Laser Arms [7] and the ten Laser Output Heads [8].
- Page 16 [7] OUTSIDE LASER ARMS There are two outside laser arms on the device, each arm houses two Laser Output Heads [8]. It is designed to adjust by intentional force from the end user. This allows the end user to angle these laser output heads in and out for proper positioning to patient for accurate treatment distance.
-
Page 17: Protective Eyewear
PROTECTIVE EYEWEAR The Erchonia® Emerald is classified by the FDA/IEC as a Class 2 laser device. This designation represents a current standard for use in order to ensure the safety of the patient. A Class 2 laser is determined to have a chronic viewing hazard. -
Page 18: Section 3 Assembly
SECTION 3 ASSEMBLY The Erchonia® Emerald is shipped in two pieces and requires assembly for the device to be operational. This assembly may require two people. PROVIDED PARTS FOR ASSEMBLY: (Qty: 1) Laser Head Assembly (Qty: 1) Device base Fig. 1 Fig. - Page 19 ASSEMBLY INSTRUCTIONS FOR THE ERCHONIA® EMERALD LASER Lock all four wheels. . Insert the Laser Head Assembly onto the Main Arm on the Device in fig. 15 base as shown , carefully feeding the cable from the Laser Head Assembly into the cable cutout in the Main Arm.
- Page 20 Plug both connectors from the Laser Head Assembly into both connectors from the Main Arm until both locking tabs on the connectors in fig. are locked in place as shown Both connectors IMPORTANT: Fig. 17 must be fully seated to engage the lock, you will hear a snap and they will not pull apart.
-
Page 21: Section 4 Erchonia® Emerald Operation
SECTION 4 ERCHONIA® EMERALD OPERATION Now that you understand the basic features of the Erchonia® EMERALD, it is important to understand how to use them when administering treatments. Below are the steps for setting the patient up for treatment. WHEEL LOCKS Fig. - Page 22 3) Turn the Main Arm from side to side for the optimal treatment area for patient. Fig. 22 Fig. 23 , unlock the lever locks and angle the Outside Laser Arms to the optimal angle for Grab the Outside Laser Arms treating patient, then tighten lever locks to hold position.
-
Page 23: Emerald Touch Screen
EMERALD TOUCH SCREEN The touch screen is both a display screen that provides information to the user and an input panel that allows the user to operate the device by touching the appropriate icon. Make sure the power cord is connected. ... - Page 24 HOME SCREEN Touch anywhere on screen. Screen will change to the “Menu Screen”. NOTE: When “Home” icon is touched on any screen it will change to the “Home Screen”. Image 3 MENU SCREEN The “Menu Screen” has 3 icons: “Emerald Treatment”, “Credits Remaining”, & “Home”. Touching any of these icons will change the screen to the applicable command.
-
Page 25: Instructions For Use
INSTRUCTIONS FOR USE STEP 1: Have your patient put on the safety glasses and lay on their back. Position the center laser diodes and adjustable laser arms, no greater than 6 inches / 15 cm away from the patient’s target treatment areas. - Page 26 START: Touch “Start” icon to begin the non-invasive procedure. Once you start the procedure you will observe the following: • Ten visible green laser diodes turn on rotating clockwise; • The time remaining window starts counting down; EMERALD TREATMENT SCREEN •...
-
Page 27: Credit & Device Information Screen
FRONT OF THE BODY The patient lies comfortably flat on their back on the table. Position the patient so that their stomach (abdomen), their hips and frontal aspect of both thighs, are facing upward. The six center diodes of the EMERALD Laser are positioned above the patient, centered along the body’s midline (the line which vertically divides the body into two equal halves). -
Page 28: Change Passcode
The device will power down after 5 failed passcode attempts. To power the device back on, turn the Power Switch off and then back on. NOTE: If you forget your passcode you will need to contact Erchonia corporation’s Service and Repair Department. 1-888-242-0571 (US only) -
Page 29: How Do Credits Work
Screen allow you to view the amount of remaining credits on the device at any time. To ensure that your device is operational at all times, contact Erchonia’s Sales Support before the Credits Remaining reaches 0. Once the credits remaining reaches 0, the device will no longer operate. -
Page 30: Labels Used On Device
LABELS USED ON DEVICE The device is manufactured in accordance to the Good Manufacturing Procedures set forth by the FDA, ISO Standards (International) and CE (Certified European) standards and testing results per Article 9, the device is a Class I Shock Protection and a Class II Medical device. - Page 31 The following diagram shows the location of the pinch point labels. The opposite side displays a duplicate pinch point label in the same location. When transporting the device (example: from one room to another) ensure that the main arm [5] position is fully down and the outside arms [7] are condensed in towards center of laser head assembly, hold device handle and take caution to ensure the device does not tip.
- Page 32 The following diagram shows the image and location for each of the Laser Caution Labels that indicate the direction of the laser beam output. It shows an image of the Arm Control Switch Label indicating the direction for switch to move the arm up or down.
-
Page 33: Section 5 Professional Use Instructions
2. The patient lies comfortably flat on their back on the table such that the front area of their body is facing upwards. 3. Position the center diodes of the Erchonia® Emerald at a distance of no more than 6 inches above the patient’s targeted area following the procedure described in the previous section of this manual. - Page 34 You should always use this Patient Qualification Checklist to make sure the patient is suitable for Erchonia® Emerald treatments before starting any treatments. A. PATIENT QUESTIONS: Ask the patient all four questions below and check the answer as ‘Yes’ or ‘No’...
- Page 35 Check the correct box below and follow the action ☐ BMI is 40 or below => the patient qualifies for Erchonia® Emerald treatment. ☐ BMI is 41 or above=> the patient does not qualify for Erchonia® Emerald treatment P a g e | 32...
- Page 36 P a g e | 33...
-
Page 37: Measurement Protocol
MAINTENANCE AND CLEANING MAINTENANCE The Erchonia® Emerald, if used according to the instructions contained within this manual will operate efficiently for years. To ensure proper care, it is advisable for the end user to perform: 1. Regular visual inspections to ensure there is no external damage other than normal wear and tear. Inspect all electrical cords for signs of excessive wear (cuts in insulation or fraying). - Page 38 ROUTINE USER MAINTENANCE Clean the external surfaces of the device Weekly, or as needed Clean the touch screen display Weekly, or as needed Clean laser optics Weekly, or as needed CLEANING THE EXTERNAL SURFACES OF THE DEVICE Use a cloth dampened with non-caustic cleaning solution, such as mild soap and water, isopropyl alcohol, or a “hospital- grade”...
-
Page 39: Warranty
WARRANTY LIMITED WARRANTY The Erchonia® Emerald device is warranted to be free from defect 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 40: 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 1-888-242-0571, and we will be happy to help. PROBLEM POSSIBLE CAUSE HOW TO RESOLVE AC power cord not plugged into Connect power cord. - 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 IEC60601-1-2 TEST ELECTROMAGNETIC COMPLIANCE LEVEL TEST LEVEL...
- Page 42 ª Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. 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 [EMERALD] is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation.
-
Page 43: Specifications
Melbourne, FL 32904 13485 – Medical Device Quality 14971 – Risk Management IEC 60601-1-2 EMC IEC 60601-1 Safety IEC 60825-1 Laser Safety CB Certified Trade name: Erchonia ® EMERALD Laser Specifications Model Number: SHL Device • Weight: 118.5lbs / 53.75 kg Classifications •... - Page 44 Learn more about Erchonia lasers erchonia.com | 1-888-242-0571 June 2022 OM-SHL2-C Rev 07...
Need help?
Do you have a question about the EMERALD SHL and is the answer not in the manual?
Questions and answers
C1 C2 error codes mean?