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Chapter 2: Electrical Safety Tests

LS 06311-002US Rev A

18

Figure 1-1. Connections for the Ground Resistance Test

Figure 2-2. The measurement of the Ground Resistance (Ref IEC 62353 Figure 1)

Figure 2-3. The measurement of the insulation resistance (Ref IEC 62353 Figure 3)

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Summary of Contents for Sonata System

Page 1: ...Sonata System Service Manual For Sonata System 2 1 and Sonata System 2 2 SONATA2 110 with software SW 002 Manual Catalog REF 011US LS 06311 002US Rev A January 2021...

Page 2: ...use of this device or concerning any safety or operating instructions described in this manual or for additional copies of this manual please contact your local Gynesonics Representative or the servic...

Page 3: ...m Overview 11 1 5 Standards 13 1 6 Reference Documents 14 1 7 Personnel Qualification and Service Documentation 14 1 8 Tools Recommended for Service 15 Chapter 2 Electrical Safety Tests 16 2 1 Visual...

Page 4: ...hical symbols for use on equipment Catalogue number Indicates the manufacturer s catalogue number so that the medical device can be identified ISO 15223 1 5 1 6 Medical devices Symbols to be used with...

Page 5: ...the electrical equipment that is not ME EQUIPMENT have been dversely affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the ME SYSTEM e electrical equipment that is not ME EQUIPMENT have been determi...

Page 6: ...ded by Enclosures Fuse To identify fuse boxes or their location Accompanied by the type and full rating of the fuse IEC TR 60878 5016 Graphical symbols for electrical equipment in medical practice IEC...

Page 7: ...0 W001 Graphical symbols Safety colours and safety signs Registered safety signs ISO 7000 2621 Graphical symbols for use on equipment TUV Mark Indicates that the product was tested and met the certifi...

Page 8: ...L TITLE EXPLANATORY TEXT STANDARD REFERENCE STANDARD TITLE Prescription Only Requires a prescription in the United States 21 CFR 801 15 c 1 i F Labeling Medical devices prominence of required label st...

Page 9: ...LUG Part integral with or intended to be attached to a POWER SUPPLY CORD of electrical equipment to be inserted into a mains socket outlet IEC 60601 1 3 50 MSO MULTIPLE SOCKET OUTLET One or more socke...

Page 10: ...earth contact creates a shock hazard for the operator or may compromise the reliability of the system and other equipment attached to the same circuit Interrupting the protective conductor inside or o...

Page 11: ...ore attempting to check power cord connections to system SYSTEM INPUTS AND OUTPUTS The Sonata System has input output I O ports that are only intended for particular functions with regards to external...

Page 12: ...ssociated with heavy menstrual bleeding 1 3 Room Requirements The Sonata System is intended for use in locations in which minimally invasive procedures are performed The Sonata System is suitable for...

Page 13: ...e Sonata Graphical Guidance Software GGS integrates ablation planning targeting and ablation of fibroids The SMART Guide displays a real time graphic overlay on the live ultrasound image for targeting...

Page 14: ...ns and Controls on the RF Generator CAUTIONS POWER CORDS AND EXTENSION CORDS Use only approved line cords provided by Gynesonics DO NOT use additional multiple portable socket outlet strips or extensi...

Page 15: ...ectrical equipment and medical electrical systems EN IEC 60601 2 2 Medical Electrical Equipment Particular requirements for the basic safety and essential performance of high frequency surgical equipm...

Page 16: ...ocumentation The procedures in this manual are intended to be performed by personnel who are trained in the maintenance of electrical equipment such as typically found in hospital biomedical engineeri...

Page 17: ...ore of the requirements in the standards outlined in Section 1 5 Examples of appropriate instruments include DALE 601 Electrical Safety Analyzer Fluke ESA620 615 614 612 Electrical Safety Analyzer The...

Page 18: ...esting Item Instructions and Test Conditions Standards Clause Acceptance Criteria Visual Inspection of Physical Integrity 2 1 IEC 62353 Clause 5 2 NFPA 99 2018 10 3 1 Any condition that appears to aff...

Page 19: ...sing and enclosure of the RF Generator and Tablet Cabling including power cords USB and Sync cables Look for defects such as cuts and wear User documentation or IFU The documentation is accessible and...

Page 20: ...LS 06311 002US Rev A 18 Figure 1 1 Connections for the Ground Resistance Test Figure 2 2 The measurement of the Ground Resistance Ref IEC 62353 Figure 1 Figure 2 3 The measurement of the insulation r...

Page 21: ...are also tested and meet acceptance criteria prior to testing touch current Personnel safety may be compromised if the grounding conductor is not intact and the leakage or touch current is high Measur...

Page 22: ...Chapter 2 Electrical Safety Tests LS 06311 002US Rev A 20 Figure 2 5 Touch Current Test Connections PE Post for Leakage Tests...

Page 23: ...e ACCY 014 Conditions of test include Power plug connected normally System powered on Ground switch CLOSED NC limit 100 A and separately with ground switch OPEN SFC limit 500 A Leakage current measure...

Page 24: ...ssue temperature of 105 C as measured by thermocouples in the Radiofrequency Ablation RFA Handpiece 3 Temperature variation variation between signal to signal when measuring the same reference medium...

Page 25: ...nimum and maximum of all 4 temperature channels read by the RF Generator are within 4 C Click the message column to sort data and scroll down to find Hand Piece Connected TC s Figure 2 7 If the maximu...

Page 26: ...r 3 Troubleshooting Sonata System provide comprehensive messages for the system and device errors Please refer the error code list in Chapter 7 of the Sonata System Instructions for Use Anytime an abn...

Page 27: ...ta System 2 1 or Sonata System 2 2 hardware upgrade should be performed by a Gynesonics service representative After the upgrade the system visual inspections and safety tests should be performed and...

Page 28: ...tic uterine fibroids including those associated with heavy menstrual bleeding To learn more visit www gynesonics com sonata system Gynesonics Sonata and the logo are trademarks and registered trademar...

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