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

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: +1-650-216-3860

Fax: +1-650-299-1566

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

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.

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

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.

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.