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Related Manuals for Neauvia PLASMA IQ
Summary of Contents for Neauvia PLASMA IQ
- Page 1 USER MANUAL Neauvia North America Customer Service: 1-866-836-3113.
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Page 2: Table Of Contents
User Manual TABLE OF CONTENTS 1. KIT CONTENTS ........................3 2. PRODUCT DESCRIPTION ....................4 3. PRODUCT SPECIFCATIONS ....................5 4. DESCRIPTION OF INCLUDED SYMBOLS ................ 6 5. INDICATIONS FOR USE ....................... 7 6. GUIDELINES FOR USE ......................7 7. WARNINGS FOR USE AND ADVERSE EVENTS .............. -
Page 3: Kit Contents
User Manual 1. KIT CONTENTS The basic set includes: • PLASMA IQ device • The docking station • ACM12US15 Charger • Starter Kit 10 electrodes • Manual on USB stick... -
Page 4: Product Description
Neauvia North America, 8480 Honeycutt Road, Raleigh NC 27615. WARNING: PLASMA IQ DEVICE CAN CAUSE HARM TO THE USER AND/OR PATIENT IF NOT USED AS INSTRUCTED, USED FOR OTHER PURPOSES, OR CONTRADICTORY TO THE INTENDED METHOD OF OPERATION DEFINED IN THIS USER MANUAL. -
Page 5: Product Specifcations
By. IEC 60601-1-2 Group 2, Class B Applied part type Active electrode applied part BF Protection class IP21 Mode of operation: Continuous mode of operation Technical specifications active electrodes for the device PLASMA IQ: Length: 30 mm Diameter: 0.6 mm Maximum output voltage: 1.4 kVAC... -
Page 6: Description Of Included Symbols
User Manual 4. DESCRIPTION OF INCLUDED SYMBOLS Handle with care. WARNING! Do not drop. Keep dry Read the manual FRAGILE Handle with care, keep dry Applied part type F KEEP DRY °F Temperature storage AC Power Unit and transport conditions 32°F Humidity storage and Electrical Safety Class II... -
Page 7: Indications For Use
User Manual 5. INDICATIONS FOR USE PLASMA IQ is used in the removal and destruction of skin lesions and coagulation of tissue. Target population: women and men aged 22 to 90. 6. GUIDELINES FOR USE PLASMA IQ device is intended for use during non-invasive surgery. The PLASMA IQ device is intended for use only in professional health care settings. -
Page 8: Device Safety Measures
HF generator. • PLASMA IQ is equipped with the ability to control power output aspects by buttons installed on the side of the ESU. For this reason, the electrode active mode can be changed during operation without additional steps to change device parameters. -
Page 9: Operating Conditions And Transport
The manufacturer is not responsible for the malfunction of the product if it is used in a manner inconsistent with this manual. For PLASMA IQ devices that are under warranty, Neauvia North America will arrange to supply our customer a means to ship the defective device to our service department for necessary repairs and will ensure that the customer is supplied a temporary device for use during the repair process in a timely manner. -
Page 10: Cleaning, Disinfection & Maintenance
13. CLEANING AND DISINFECTION • Plasma IQ device does not directly contact the patient. The Operator of the Plasma IQ device is advised to use proper protective equipment including gloves. The Plasma IQ device should be cleaned before and after each use. The active electrode is for single use only and must be discarded after the treatment. -
Page 11: Electromagnetic Compatability
The PLASMA IQ device has been classified by EN ISO 60601-1-2 as Group 2, Class B. The Plasma IQ has an essential performance which is that there shall be no change in operating mode or false alarm , the delivered power shall not be higher than +20% of the set power. -
Page 12: Operating Activities
User Manual 15. OPERATING ACTIVITIES The PLASMA IQ device does not have any user replaceable parts. It also has no user replaceable fuses. In case the device does not work, please follow the steps below: Connect the charger adapter to the wall outlet. -
Page 13: List Of Indicators
No emission - in this case the LED on the device will not light up despite pressing the switch on the device • Damaged battery - after placing the PLASMA IQ in the docking station, the LED on the device placed in the stand will not change its color to red •... -
Page 14: Description Of Working Modes
User Manual 17. DESCRIPTION OF WORKING MODES MAX. POWER IMPEDANCE RATED 54 k∧ FREQUENCY 40 kHz MODULATION FREQUENCY... -
Page 15: Output Power Graph
User Manual 17. DESCRIPTION OF WORKING MODES 17.1 Output power graph The following graphs shows dependency between device output power and load impedance. The maximum output voltage levels: • for High Power (the “H”) - 950 Vrms • for Low Power (the “L”) - 650 Vrms... -
Page 16: Working With The Device
Connect the power supply and check that the green LED is on the docking station • Take out the PLASMA IQ from the docking station, press the LOW button and check if the yellow LED turns on • Take out the PLASMA IQ from the docking station, press the HIGH button and check that the yellow LED lights up 18.2 Preparing the device and equipment for work... -
Page 17: Charging The Device
18. WORKING WITH THE DEVICE 18.3 Charging the device If the yellow LED does not turn on or a significant power drop is noticeable, it means that the PLASMA IQ needs to be recharged. Warning: Do not leave the device uncharged or use the device before it is completely charged, because it may damage or shorten the life of the battery inside the device. -
Page 18: Shutting Down The Device
User Manual 18. WORKING WITH THE DEVICE 18.4 Shutting down the device To stop working with the device and shut it down, release all buttons, remove active electrode and place device on docking station. Warning: To avoid personal and/or material damage, remove the electrode from the device after completing the procedure and when placing the device in the docking station. -
Page 19: Terms Of Warranty
User Manual 19. TERMS OF WARRANTY • The PLASMA IQ device is covered by a warranty lasting 12 months from the date of purchase on the fiscal document delivery (accompanying document confirming the date of purchase) and / or invoice. •... - Page 20 NORTH AMERICA Neauvia North America Customer Service: 1-866-836-3113. ©2019 Neauvia North America, 8480 Honeycutt Road, Raleigh NC 27615 neauvia.com PI.NAM.01.190001 REV:022020...