Gynesonics Sonata System User manual

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

LS 06311-002US Rev A
Notice
Sonata® System 2.1 and Sonata System 2.2 Service Manual
© 2021 Gynesonics, Inc. All Rights Reserved
The Sonata System and accessories, including the associated hardware, software, and Intrauterine
Ultrasound Probe, is owned by Gynesonics®, Inc. and is protected by the United States copyright
laws and international treaty provisions. This manual may not be copied in whole or in part or
reproduced without the written permission of Gynesonics, Inc. Copying includes translation into
another language and transferring into other media. Permitted copies must carry the same
proprietary and copyright notices as were affixed to the original under the law. Please note that
while every effort has been made to ensure that the information in this document is accurate, the
instructions, photos, figures, illustrations, tables, specifications, and schematics contained herein are
subject to change without notice. If you have any questions regarding the appropriate 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 service
department of Gynesonics at:
Gynesonics, Inc.
600 Chesapeake Drive
Redwood City, CA 94063 USA
Telephone: [phone]
Fax: [phone]
www.gynesonics.com
[email protected]
Trademark and Patent Information
Gynesonics, Sonata, and the logo forms of the foregoing are trademarks and registered trademarks
of Gynesonics, Inc. All other trademarks are properties of their respective owners. Gynesonics
products are covered by US and foreign patents. See www.Gynesonics.com/patents.
About this Instruction Manual
This Manual covers the routine inspections and checks that may be performed of the Sonata System.
Refer to the Sonata System 2.1 or Sonata System 2.2 Instructions for Use with Technical Appendix for
detailed information regarding the Sonata System. Contact Gynesonics for additional copies of this
manual, any additional questions or support required for training and service, including installation,
and maintenance.
Manual originally issued in English.

Table of Contents
LS 06311-002US Rev A i
Table of Contents
Symbols Glossary ........................................................................................................... ii
Glossary of Terms, Acronyms, and Definitions ........................................................ vii
Chapter 1 Introduction................................................................................................ 10
1.1 Manufacturer.......................................................................................................................... 10
1.2 Device Intended Use .............................................................................................................. 10
1.3 Room Requirements............................................................................................................... 10
1.4 System 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 Inspections.................................................................................................................. 17
2.2 Insulation Resistance ............................................................................................................. 17
2.3 Earth Leakage and Touch Current ......................................................................................... 19
2.4 Patient Lead Leakage............................................................................................................. 21
2.5 Temperature Sensing Accuracy Check.................................................................................. 22
Chapter 3 Troubleshooting ......................................................................................... 24
Chapter 4 Field Replacement and Software Upgrade............................................. 25

Symbols Glossary
LS 06311-002US Rev A ii
Symbols Glossary
The following tables show the safety symbols that are used on the Sonata System and throughout
this manual.
SYMBOL
SYMBOL
TITLE
EXPLANATORY
TEXT
STANDARD
REFERENCE
STANDARD TITLE
Manufacturer
Indicates the medical
device manufacturer.
ISO 15223-1
#5.1.1
Medical devices —Symbols to
be used with medical device
labels, labeling, and
information to be supplied.
EN 980 #5.12
Symbols for use in the labeling
of medical devices.
ISO 7000 -
3082
Graphical symbols for use on
equipment.
Date of
Manufacture
Indicates the date
when the medical
device was
manufactured.
ISO 15223-1
#5.1.3
Medical devices –Symbols to
be used with medical device
labels, labeling, and
information to be supplied.
EN 980 #5.6
Symbols for use in the labeling
of medical devices.
ISO 7000-
2497
Graphical 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 medical device
labels, labeling, and
information to be supplied.
EN 980 #5.10
Symbols for use in the labeling
of medical devices.
ISO 7000-
2493
Graphical symbols for use on
equipment.
Serial number
Indicates the
manufacturer’s serial
number so that a
specific medical
device can be
identified.
ISO 15223-1
#5.1.7
Medical devices –Symbols to
be used with medical device
labels, labeling, and
information to be supplied.
EN 980 #5.5
Symbols for use in the labeling
of medical devices.
ISO 7000-
2498
Graphical symbols for use on
equipment.
Follow
instructions for
use
Refer to instruction
manual/booklet.
IEC 60601-1
Table D.2,
Symbol 10
Medical electrical equipment —
Part 1: General requirements
for basic safety and essential
performance.
ISO 7010-
M002
Graphical symbols –Safety
colours and safety signs –
Registered safety signs.

Symbols Glossary
LS 06311-002US Rev A iii
SYMBOL
SYMBOL
TITLE
EXPLANATORY
TEXT
STANDARD
REFERENCE
STANDARD TITLE
High Frequency
(HF) isolated
patient circuit
Indicates connection to
a high frequency (HF)
isolated patient circuit.
IEC 60601-2-2
#201.7.2.10
Medical electrical equipment –
Part 2-2: Particular
requirements for the basic
safety and essential
performance of high
frequency surgical equipment
and high frequency surgical
accessories.
Type BF
applied part
To identify a Type BF
applied part complying
with IEC 60601-1.
Type BF refers to
classification of the
nature of patient
contact and degree of
patient protection from
risk of electrical shock.
IEC 60601-1
Table D.1.
Symbol 20
Medical electrical equipment
—Part 1: General
requirements for basic safety
and essential performance.
Linear or
curved array
probe
To identify the control
or the indicator to
activate a linear array
or curved array probe
for the electronic
generation of a sound
field and to identify the
corresponding
connector.
TR 60878
#5710
Graphical Symbols for
electrical equipment in
medical practice.
Non-ionizing
electro-
magnetic
radiation
To indicate generally
elevated, potentially
hazardous, levels of
nonionizing radiation,
or to indicate
equipment or systems,
e.g., in the medical
electrical area that
include RF transmitters
or that intentionally
apply RF
electromagnetic
energy for diagnosis or
ablation.
IEC 60878
#5140
Graphical Symbols for
electrical equipment in
medical practice.
IEC 60417
#5140
Graphical Symbols for Use on
Equipment.
© 2007 Association for the Advancement of Medical Instrumentation ANSI/AAMI/IEC 60601-1-2:2007 7
b) both the EMISSIONS and IMMUNITY of the electrical equipment that is not ME EQUIPMENT have been
determined not to adversely affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the ME SYSTEM;
and
c) the EMISSIONS of the electrical equipment that is not ME EQUIPMENT have been determined not to
cause the EMISSIONS of the ME SYSTEM to exceed applicable limits.
Check compliance by inspection of the documents for this determination and other appropriate
documents or certificates or, if this determination is not performed, by inspection of the documents to
verify that the electrical equipment that is not ME EQUIPMENT has been tested inaccordance with this
collateral standard.
4.2 * SINGLE FAULT CONDITION for ME EQUIPMENT
For EMC testing, the SINGLE FAULT CONDITION requirements ofthe general standard do not apply.
5 Identification, marking and documents
5.1 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
5.1.1 * Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts that include RF
transmitters or that apply RF electromagnetic energy for diagnosis or treatment
MEEQUIPMENT and ME SYSTEMS that include RFtransmitters orthat intentionally apply RFelectromagnetic
energy for diagnosis or treatment shall be labeled with symbol IEC 60417-5140 (2003-04) for non-ionizing
radiation. The symbol graphic is shown below.
5.1.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts for which the connector
testing exemption specified in 6.2.2.2 c) is used
For ME EQUIPMENT and ME SYSTEMS for which the connector testing exemption specified in 6.2.2.2 c) is
used, symbol IEC 60417-5134 (2003-04) for ESD sensitivity shall be applied adjacent to each connector
for which the testing exemption is used. The symbol graphic isshown below.
5.1.3 Marking on the outside of ME EQUIPMENT and ME SYSTEMS that are specified for use only in
a shielded location
MEEQUIPMENT and ME SYSTEMS specified for use only ina shielded location shall belabeled with a
warning that they should be used only in the specified type of shielded location (see 5.2.2.3).
Check compliance with the requirements of 5.1 by inspection.
Copyrighted material licensed to Diane King on 08-Jun-2010 for licensee's use only. No further reproduction or networking is permitted. Distributed by Thomson Scientific, Inc., www.techstreet.com.

Symbols Glossary
LS 06311-002US Rev A iv
SYMBOL
SYMBOL
TITLE
EXPLANATORY
TEXT
STANDARD
REFERENCE
STANDARD TITLE
Dangerous
voltage
To indicate hazards
arising from dangerous
voltages.
IEC 60601-1
Table D.1
symbol 24
Medical electrical equipment
—Part 1: General
requirements for basic safety
and essential performance.
IEC 60417
#5036
Graphical Symbols for Use on
Equipment.
Equipotentiality
To identify the
terminals which, when
connected together,
bring the various parts
of equipment or of a
system to the same
potential, not
necessarily being the
earth (ground)
potential, e.g., for local
bonding.
IEC 60601-1
Table D.1
symbol 8
Medical electrical equipment
—Part 1: General
requirements for basic safety
and essential performance.
IEC 60417
#5021
Graphical Symbols for Use on
Equipment.
IPX7
Degree of
Ingress
Protection
Provided by
Enclosure
Protected against the
effects of temporary
immersion in water.
The handle and device
shaft and tip are IPX 7
rated.
IEC 60601-1
Table D.3,
Symbol 2
Medical electrical equipment
—Part 1: General
requirements for basic safety
and essential performance.
IEC 60529
section 6
Degrees of Protection
Provided 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 60417
#5016
Graphical symbols for use on
equipment.
“ON” (power)
To indicate connection
to the mains, at least
for mains switches or
their positions, and all
those cases where
safety is involved
IEC 60601-1
Table D.1
symbol 12
Medical electrical equipment
—Part 1: General
requirements for basic safety
and essential performance
IEC 60878
#5007
Graphical Symbols for
electrical equipment in
medical practice.
“OFF” (power)
To indicate
disconnection from the
mains, at least for
mains switches or their
positions, and all those
cases where safety is
involved.
IEC 60601-1
Table D.1
symbol 13
Medical electrical equipment
—Part 1: General
requirements for basic safety
and essential performance.
IEC 60878
#5008
Graphical Symbols for
electrical equipment in
medical practice.
Stand-by
To identify the switch
or switch position by
means of which part of
the equipment is
switched on in order to
bring it into the stand-
by condition.
IEC 60601-1
Table D.1
symbol 29
Medical electrical equipment
—Part 1: General
requirements for basic safety
and essential performance.
IEC TR 60878
#5009
Graphical Symbols for
electrical equipment in
medical practice.

Symbols Glossary
LS 06311-002US Rev A v
SYMBOL
SYMBOL
TITLE
EXPLANATORY
TEXT
STANDARD
REFERENCE
STANDARD TITLE
Caution
To indicate that
caution is necessary
when operating the
device or control
close to where the
symbol is placed, or
to indicate that the
current situation
needs operator
awareness or
operator action in
order to avoid
undesirable
consequences.
IEC 60601‐1
Table D.1
symbol 10
Medical electrical
equipment —Part 1:
General requirements for
basic safety and essential
performance.
ISO 7000‐
0434A
Graphical symbols for use
on equipment
General
warning sign
To signify a general
warning.
IEC 60601-1
Table D.2
symbol 2
Medical electrical equipment
—Part 1: General
requirements for basic safety
and essential performance.
ISO 7010
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 certification
requirements for
electrical, and/or
mechanical products.
N/A
N/A
Recycle:
electronic
equipment
DO NOT dispose of
electronic equipment in
normal trash.
Directive
2012/19/EU
Annex IX
Marking of Electrical and
Electronic Equipment in
accordance with Article 15 (2)
of Directive 2012/19/EU
Authorized
representative
in the European
Community
Indicates the
authorized
representative in the
European Community.
ISO 15223-1
#5.1.2
Medical devices –Symbols to
be used with medical device
labels, labeling, and
information to be supplied.
EN 980 #5.13
Symbols for use in the
labeling of medical devices.
Medical Device
Indicates that the
device is a Medical
Device
MedTech
Europe
Guidance May
2019
Use of Symbols to Indicate
Compliance with the MDR

Symbols Glossary
LS 06311-002US Rev A vi
SYMBOL
SYMBOL
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
statements.
21 CFR
801.109
Labeling-Prescription devices.

Glossary of Terms, Acronyms, and Definitions
LS 06311-002US Rev A vii
Glossary of Terms, Acronyms, and Definitions
TERM
DEFINITION
AP
APPLIED PART: part of ME EQUIPMENT that in NORMAL USE necessarily comes into physical
contact with the PATIENT for ME EQUIPMENT or an ME SYSTEM to perform its function. [IEC
60601-1 #3.8]
DUT
Device Under Test which may be either the ESU or the SMART Tablet
ESU (RFG)
Electrosurgical Unit: Sonata Radiofrequency Generator.
IA
Leakage current from the applied part. For the ESU (RFG) this consists of leakage from both
Handpiece signals and the Neutral electrode connections. For the SMART Tablet this consists of
leakage from the Sonata Intrauterine Ultrasound Probe.
IP
Patient leakage is the current which flows to ground (PE) from the applied parts via the patient.
IN or IT
Isolated neutral (terre) describes a wiring system where the neutral line connection N is not
directly referenced to earth. Electrical Safety tester displays IT at top of display when IT
configuration is detected.
L
Line connection which is typically measures 230 ± 20 VAC to PE in an earth referenced neutral
wiring system. (TN)
LN
Line connection to DUT with normal polarity-L to L and N to N. Leakage currents are measured
with both normal and reversed polarity.
MAP
Mains on APPLIED PART: A method of assessing patient leakage current under the single fault
condition where MAINS VOLTAGE is present on the APPLIED PART.
MAINS PLUG
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 socket-outlets intended to be connected to, or
integral with, flexible cables, cords or ME EQUIPMENT providing SUPPLY MAINS or equivalent
voltage. [IEC 60601-1 #3.67]
N
Neutral line connection which typically measures 0 V ± 15 VAC in an earth referenced neutral
wiring system. (TN)
NE (DE)
Neutral electrode (DE dispersive electrode) provides return path for HF energy from patient to
ESU (RFG)
NL
Line connection to DUT with reversed polarity. DUT N lead measures 230 ± 20 VAC to PE.
PE
PROTECTIVE EARTH. The PROTECTIVE EARTH CONDUCTOR is a conductor to be
connected between the PROTECTIVE EARTH TERMINAL and an external protective earthing
system. [IEC 60601-1 #3.93]
PET
PROTECTIVE EARTH TERMINAL: The PROTECTIVE EARTH TERMINAL is a terminal
connected to conductive parts of CLASS I equipment for safety purposes. This terminal is
intended to be connected to an external protective earthing system by a PROTECTIVE EARTH
CONDUCTOR. [SOURCE: IEC 60601-1:2005, 3.95]
TN
Terre neutral describes an earth referenced wiring system where the Neutral connection is
connected to earth.
RINS
The insulation resistance includes two resistance measurements. Resistance is measured
between shorted mains L and N connections and the PE at the test socket. Resistance is
separately measured between the shorted mains L and N connections to the applied part
connections.
RPE
Resistance between protective earth lead and the protective earth terminal in the ESU (RFG)

Glossary of Terms, Acronyms, and Definitions
LS 06311-002US Rev A viii
GENERAL WARNINGS AND CAUTIONS
REFER TO SONATA SYSTEM INSTRUCTIONS FOR USE FOR COMPLETE WARNINGS AND
CAUTIONS
COMPONENTS ARE NOT OPERATOR SERVICEABLE
Do not attempt to remove protective covers on any components of the Sonata System. Parts within the
protective covers of any component are not serviceable by the operator.
DO NOT REMOVE COVERS
DO NOT attempt to remove protective covers on any components of the Sonata System. None of the parts
within the protective covers of any component are operator serviceable. As outlined in Technical Manual
Chapter 1, operator serviceable parts may be accessed without removal of the protective covers. The
protective covers prevent access to potential electrical and mechanical hazards. Touching any components
behind access covers may create a pathway for current leakage, presenting an electrical shock hazard to
the operator or to the patient. If the system function is in question, call a Gynesonics representative for
service
USE GROUNDED CONNECTIONS
Use only grounded electrical connections. Connecting the Sonata System to a power source that is not
equipped with a protective 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 outside the device, or interrupting the protective earth terminal can, create a shock
hazard for the operator. To achieve the enhanced grounding reliability of the hospital-grade plug provided,
use an outlet marked “hospital only” or “hospital grade”, if available.
SALE AND USE
Federal law restricts this device to sale by or on the order of a physician.
POWER CORDS AND EXTENSION CORDS
Use only approved line cords provided by Gynesonics. DO NOT use additional multiple portable socket-
outlet strips or extension cords
SMART TABLET CANNOT BE USED AS COMPUTER.
The SMART Tablet resembles a tablet computer, but DO NOT attempt to use it as one. Actions to use it as
a tablet computer may damage the system and expose it to risks such as attacks by viruses. These actions
include installing or updating software, connecting the system to a network, or attempting to access the
native operating system
COMPONENT OPENINGS
DO NOT obstruct any openings on Sonata System components, such as cooling vents for the SMART Tablet
and for the RF Generator. Doing so may result in compromised product life or cause overheating of
equipment
BATTERY
DO NOT attempt to remove or use the battery inside the SMART Tablet.

Glossary of Terms, Acronyms, and Definitions
LS 06311-002US Rev A ix
GENERAL WARNINGS AND CAUTIONS
FLUID INGRESS
The SMART Tablet is not protected from fluid spills. The RF Generator is not protected against excess fluid
ingress. Always disconnect cables before cleaning. DO NOT spray cleaners directly into vents, sockets, or
other openings. Fluid ingress may cause device malfunction.
UNPLUG MAIN POWER TO CHECK CONNECTIONS
For optimum safety, unplug the main system power cord before 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 I/O. Patient ablation data records and images may be accessed by connecting a standard USB
drive to the SMART Tablet when the system is not being used for targeting or treatment. A video output
cable may be attached to the Tablet monitor port for a supplemental signal to an external monitor. Beyond
these two (2) ports, no other ports should be used externally for other functions. Attempting to attach any
other form of external I/O may result in a system malfunction or damage.

Chapter 1: Introduction
LS 06311-002US Rev A 10
Chapter 1 Introduction
1.1 Manufacturer
Gynesonics, Inc.
600 Chesapeake Drive
Redwood City, CA 94063 USA
Telephone: [phone]
Fax: [phone]
[email protected]
www.gynesonics.com
1.2 Device Intended Use
The Sonata®Transcervical Fibroid Ablation System 2.1 and 2.2 are intended for diagnostic
intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those
associated 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 use within the patient environment as defined by IEC
60601-1. Additional room requirements are defined in the Sonata System Instructions for Use.
•Power: AC 100-240V, 50/60 Hz, 15A max, grounded. Backup is recommended.
•Temperature: 10°C to 35°C for all equipment and components.
•External Monitors: The SMART Tablet may be connected to an external monitor through a
video cable and adapter. The output format is micro HDMI. An adapter from Micro HDMI to
HDMI is provided.

Chapter 1: Introduction
LS 06311-002US Rev A 11
1.4 System Overview
The Sonata System is comprised of durable medical equipment, software, and various single-use and
reusable instruments. A Radiofrequency Ablation (RFA) Handpiece attaches to an Intrauterine
Ultrasound (IUUS) Probe to provide sonography-guided RF ablation. Once connected, the assembly of
the RFA Handpiece and the IUUS Probe is referred to as the Treatment Device. The 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 and
deployment of radiofrequency ablation. The system enables a clinician to deliver radiofrequency
energy to fibroid tissue resulting in thermal fixation and coagulative necrosis of the tissue.
Electrical Overview:
Electrical input ratings (V~, Hz, VA): 100-240 VAC, 50-60 Hz, < 15 A
Electrical classification: Class I
Mode of operation: Suitable for continuous operation
Applied Part (patient lead): Type BF
Figure 1-1. System Block Diagram

Chapter 1: Introduction
LS 06311-002US Rev A 12
Figure 1-2. Connection ports on the SMART Tablet.
Figure 1-3. Connections 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 extension cords
Footswitch
Power
Switch
Volume
Control Knob
RF ON/OFF
Potential
Equalization
Conductor Terminal
Power Cord

Chapter 1: Introduction
LS 06311-002US Rev A 13
1.5 Standards
The Sonata System has been tested to the following standards:
•EN/IEC 60601-1, Medical Electrical Equipment: General Requirements for Safety and
Essential Performance.
•EN/IEC 60601-1-2, Medical Electrical Equipment: General requirements for basic safety and
essential performance –Collateral standard: Electromagnetic compatibility –requirements
and tests.
•EN/IEC 60601-1-6, Medical electrical equipment Part 1-6: General requirements for basic
safety and essential performance - Collateral standard: Usability
•EN/IEC 60601-1-8, Medical electrical equipment Part 1-8: General requirements for basic
safety and essential performance - Collateral standard: General requirements, tests and
guidance for alarm systems in medical electrical 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 equipment and high frequency surgical
accessories.
•EN/IEC 60601-2-37, Medical Electrical Equipment: Particular requirements for the basic
safety and essential performance of ultrasonic medical diagnostic and monitoring
equipment.
The Sonata System components are not anticipated to degrade in performance under normal use
within the expected use life of 5 years. As such, periodic maintenance inspections are not
mandatory. For provider facilities with Quality Assurance Programs that may require routine
inspections the following standards and guidance are recommended for service tests:
•NFPA® 99 Health Care Facilities Code
•NFPA 99 Health Care Facilities Code Handbook
•IEC 62353 Recurrent test and test after repair of medical electrical equipment
•ANSI/AAMI ES 60601-1; EN 60601-1

Chapter 1: Introduction
LS 06311-002US Rev A 14
1.6 Reference Documents
The Sonata System 2.1 and 2.2 Instructions for Use with Technical Appendix describe:
•Intended use, patient selection, and risks;
•Room requirements, system setup, and accessories;
•Sonata System description and procedure, including user control Interface and messages
•Troubleshooting
•Clinical trial results
•Technical information
Additional copies of the Sonata System Instructions for Use with Technical Appendix may be obtained from
Gynesonics.
Table 1 Sonata System 2.1 and 2.2 Instructions for Use (IFU) with Technical Appendix
Sonata System
Durable Equipment
Sonata System
Software
IFU Order #
SONATA2-110
SW-002
Sonata System 2.1: REF-005
Sonata System 2.2: REF-009
1.7 Personnel Qualification and Service Documentation
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 engineering
departments. Personnel should review and understand this manual thoroughly prior to performing
procedures described herein. Supplemental training is available from Gynesonics upon request. For
all other service, contact Gynesonics or an authorized distributor.
All service information and data should be recorded on the FRM 06311-004 Sonata System Service
Form: Basic Safety and Function Checks. An updated safety check label should be added to the
system cart with date and service signature.
CAUTION
Procedures in this manual are intended to be performed by personnel who are trained
in the maintenance of electrical equipment. Electrical testing may present shock risk to
the testing personnel and if performed improperly may lead to reduced safety or loss of
function.

Chapter 1: Introduction
LS 06311-002US Rev A 15
1.8 Tools Recommended for Service
Various measurement instruments for Medical Electronic (ME) Equipment devices may be used to
perform these tests. The instruments should conform to one or more 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 following connective tools are necessary for the testing and can be obtained from Gynesonics.
•ACCY-014 Patient Lead Grounding Cable
Used for measurement of Patient Lead leakage current
Figure 1-4. ACCY-014 Patient Lead Grounding Cable

Chapter 2: Electrical Safety Tests
LS 06311-002US Rev A 16
Chapter 2 Electrical Safety Tests
The electrical safety tests in this section are based on and conform to IEC 62353 and NFPA 99
1
. They
are intended for electrical safety evaluation of cord-connected, electrically operated, patient care
equipment. If additional information is needed, refer to IEC 62353 and NFPA 99 or the
corresponding Handbook.
The tests summarized in Table 2 should be performed at regular intervals. The suggested interval is
annual or consistent with user site policy.
All tests listed in Table 2 can be done with a Safety Analyzer listed in 1.8 or equivalent.
To connect to the Safety Analyzer, use ACCY-014 Patient Lead Grounding Cable.
To connect to the chassis for leakage tests, connect to the Potential Equalization post on the chassis.
Table 2 Routine Electrical Safety Tests
Testing 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 affect
proper operation or present an
otherwise unsafe condition should
be repaired or replaced.
Safety related markings and labels
should be legible and complete
Sonata System documentation is
available and reflects the current
configuration of the system
Ground Resistance
(PE to Ground)
§2.2
IEC 62353: Clause 5.3.2.2b
NFPA 99:2018
10.3.2
≤ 0.30 Ω (IEC 62353)
≤ 0.50 Ω(NFPA 99)
Insulation Resistance
(Mains to PE)
§2.2
IEC 62353: Clause 5.3.3
≥2 M Ω
Earth Leakage Current
(LN)
§2.3
IEC 60101-1 subclause 8.7.3
≤ 500 A
Earth Leakage Current
(NL)
§2.3
IEC 60101-1 subclause 8.7.3
≤ 500 A
Touch (Chassis) Current,
§2.3
IEC 62353: Clause 5.3.4.1
NFPA 99:201810.3.3, 10.3.5
≤ 500 μA
Patient Lead Leakage,
Ground switch CLOSED
§2.4
NFPA 99:2018
10.3.6
≤ 100 µA
Patient Lead Leakage,
§2.4
IEC 62353: Clause 5.3.4.3
≤ 500 µA
1
IEC 62353, ED 2.0:2014; NFPS®99 Health Care Facilities Code Eleventh Edition 2018, §10.3

Chapter 2: Electrical Safety Tests
LS 06311-002US Rev A 17
Ground switch
OPEN
NFPA 99:2018
10.3.6
Functional Test
§2.5
EN 62353 #5.4
The minimum and maximum of
all 4 temperature channel read
by the RF Generator are within
4°C.
CAUTION
Electric Shock Hazard. When the meter's ground switch is OPEN, don't touch the unit!
2.1 Visual Inspections
Visual inspections form a critical part of the general safety inspections during the functional life of
the product. Confirm the physical integrity of the power cord assembly and other Sonata System
components as listed in Table 3.
Table 3 Visual Inspection
SPECIFICATION
INSPECTION
System Safety Marking and Labeling
Labels are intact and legible
Physical integrity
Check for any obstructions on Cart wheels,
wheel locks, and handles.
Housing and Enclosure
No external damages or cracks on housing 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 up to date
Replace cords if the attachment plug blades are bent. DO NOT re-straighten and DO NOT attempt to
repair abnormal cables. If damage has occurred to the insulation, replace the cord or cable
immediately, as electric shock and/or equipment damage may result.
Any condition that appears to affect proper operation or present an otherwise unsafe condition
should be repaired or replaced. For replacement of cords, connectors, or accompanying
documentation, contact the Gynesonics Representative.
2.2 Insulation Resistance
Measure resistance between the chassis and the ground pin of the attachment plug as shown in
Figure 1-1 through 2-3. During test, the cord shall be flexed at its connection to the attachment plug
or connector, and at its connection to the strain relief on the chassis. Note that vigorous flexing is
not needed.

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)