Esaote O-scan Series User manual

O-scan
User Manual
350004900 Rev. 07
Esaote S.p.A.
Genoa

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Edition
April 2020
Guarantee
The information in this document are the exclusive property of Esaote
S.p.A. and are reserved. Reproduction or distribution in any form is
strictly prohibited. All rights reserved.
Translations of this document are strictly prohibited without prior
authorization from Esaote S.p.A.
The information contained in this documentation is subject to change
without prior notice.
Trademarks
All names are property of the respective owners and are used exclusively
for identification purposes.
Manufacturer’s Address
Esaote S.p.A.
Via Enrico Melen, 77
16152 Genoa, Italy
Important Information
O-scan and O-scan eXP comply with the Medical Equipment Directive
93/42/EEC and are CE marked.

350004900 Rev. 07 3 / 10
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Offices
ESAOTE S.p.A.
Via Siffredi, 58
16153 Genova, Italia
Tel. [phone]
Fax [phone]
[email protected]
ESAOTE FRANCE SARL
ZA du Bel Air
10 rue de Temara CS 40343
78105 Saint Germain en Laye Cedex
France
Tel. [phone]
Fax [phone]
[e-mail]
ESAOTE BIOMEDICA DEUTSCHLAND GmbH
Max-Planck-Str 27a
50858 Köln
Germany
Tel. [phone]
Fax [phone]
[e-mail]
ESAOTE MOSKOW REPRESENTATIVE OFFICE
Representative Office:
18 Leningradsky prospekt,
Off. 5 and 6
Moscow - 125040 - Russia
Tel. [phone]
Fax [phone]
[e-mail]
ESAOTE ESPAÑA SA
Avenida San Sebastian s/n
08960 Sant Just Desvern
Barcelona - Spain
Tel. [phone]
Fax [phone]
[e-mail]
ESAOTE EUROPE B.V.
Philipsweg 1
6227 AJ Maastricht
The Netherlands
Tel. [phone]
Fax [phone]
[e-mail]

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PIE MEDICAL IMAGING B.V.
Becanuusstraat 13D01
6216 BX Maastricht - The Netherlands
Tel. [phone]
Fax [phone]
[email protected]l
ESAOTE BENELUX B.V.
Philipsweg 1 6227 AJ
Maastricht
The Netherlands
Tel. [phone]
Fax [phone]
[e-mail]
ESAOTE BENELUX N.V.
Diegemstraat 46
1930 Zaventem - Belgium
Tel. [phone]
Fax [phone]
[e-mail]
ESAOTE UK
400 Thames Valley Park Drive
Reading, Berkshire
RG6 1PT
Tel. [phone]
Fax [phone]
[email protected]
ESAOTE NORTH AMERICA
8000 Castleway Drive
P.O. Box 50858 - Indianapolis, Indiana 46250 U.S.A
Tel. [phone]
Fax [phone]
[e-mail]
ESAOTE LATINOAMERICA S.A.
San Martin 551 - Piso 8, Oficina 52
1004 Buenos Aires - Argentina
Tel. [phone]
Fax [phone]
[e-mail]
ESAOTE HEALTHCARE DO BRASIL
Rua Dr. Tomàs Carvalhal 711
CEP 04006-001 San Paulo - Brasil
Tel. [phone]
Fax [phone]
[email protected]

350004900 Rev. 07 5 / 10
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ESAOTE CHINA LTD
8/F, 135 Bonham Strand Trade Centre,
135 Bonham Strand, Sheung Wan,
Hong Kong - China
Tel. [phone]
Fax [phone]
[email protected]
SHENZEN ESAOTE MEDICAL TECHNOLOGY CO. LTD.
1st Floor, icoEsaote B2
Shenzhen Digital Technology Park
Xinnan 7 Lu, Gaoxin Kejiyuan
South Area, Nanshan Dist.,
518057 Shenzhen - People’s Republic of China
ESAOTE ASIA PACIFIC DIAGNOSTIC PRIVATE LIMITED
F - 1 Level 1, Global Arcade, Near Global Business Park,
M.G. Road, Gurgaon (Haryana) - 122002 INDIA
Tel. [phone]
Fax [phone]
[e-mail]
Australian Sponsor
Emergo Australia
Level 20, Tower II
Darling Park
201 Sussex Street
Sydney, NSW 2000
Australia

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VIGILANCE SYSTEM
The equipment is subject to a supervision system (post-sales
supervision), which ESAOTE S.p.A., all associates and authorized
distributors apply to products issued onto the market, in relation to real or
potential hazards that may arise for the patient or operator during normal
use of the equipment, to ensure optimal solutions in the most efficient and
prompt manner possible.
Therefore, in the event of malfunctions, defective performance of the
equipment, or inadequate instructions, which may constitute a hazard to
the patient or operator, the user must notify ESAOTE S.p.A., associate
company or authorized distributor in writing, providing the information as
specified in the form below. Equipment data are found on the relative
identification plate.
On receipt of the notification Esaote S.p.A. will immediately activate the
process of examination and resolve the non-conformity that has been
reported.
ACCIDENT REPORT FORM
TO: ESAOTE S.p.A.
Quality Assurance Service
Via Enrico Melen, 77
16152 Genoa, Italy
Email: [email protected]
[or associate company]
[or authorized distributor]
Name of equipment /ESAOTE system .................................................
Code (REF) ....................................................................................
Serial Number (S/N)........................................................................
Description of accident or potential accident........................................
....................................................................................................
Comments or suggestions ................................................................
....................................................................................................
Person / department to contact .........................................................
Address .........................................................................................
Telephone ................................ Fax .............................................
Date........................................
Signature.................................

350004900 Rev. 07 7 / 10
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350004900 Rev. 07 9 / 10
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PRODUCT TRACEABILITY
To guarantee product traceability according to specifications of the
standard EN ISO 13485, and the European directive on medical
equipment 93/42/EEC and subsequent amendments, original owners, in
the event of equipment transfer to third parties, are requested to notify
ESAOTE S.p.A., associate company or authorized distributor of the said
transfer by means of the following form, duly compiled, or written
notification with the same data as specified in the form. Equipment data
are found on the relative identification plate.
PRODUCT TRACEABILITY FORM
TO: ESAOTE S.p.A.
Quality Assurance Service
Via Enrico Melen, 77
16152 Genoa, Italy
[or associate company]
[or authorized distributor]
Name of equipment /ESAOTE system.................................................
Code (REF) ....................................................................................
Serial Number (S/N)........................................................................
Name and address of original owner ..................................................
....................................................................................................
Name and address of new owner.......................................................
....................................................................................................
Signature ................................

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INDEX
Chapter 1 - Essential prescribing information
Description of the system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
New Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
General Warning and Precautions . . . . . . . . . . . . . . . . . . . . . . . . .3
MR examinations of Infants and Pregnant Women . . . . . . . . . . . . . .4
Maintaining Device Efficiency . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
Chapter 2 - Manual Requirements
Safety Information: Conventions . . . . . . . . . . . . . . . . . . . . . . . . .1
Special Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
Chapter 3 - Instructions for Safe Use
Operator Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
Personnel Qualifications and Training . . . . . . . . . . . . . . . . . . .2
Minimum physical requirements . . . . . . . . . . . . . . . . . .2
Use Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
Controlled Access Area . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
Peripheral equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
Projectiles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
Artifacts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
Peripheral equipment compatibility test . . . . . . . . . . . . . . . . . . . . .7
Patient area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
Pre-screening of patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Monitoring the Patient during MR Examinations . . . . . . . . . . . . . . .12
Pre-screening of MR Personnel . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Emergency medical procedure . . . . . . . . . . . . . . . . . . . . . . . . . . .13

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Operating Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
Personnel and patient exposure to the acoustic noise . . . . . . . . . . .16
Excessive Noise . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
Special precautions against acoustic noise . . . . . . . . . . . . . . .16
Personnel and patient exposure to the static magnetic field . . . . . . .17
MR personnel and patient . . . . . . . . . . . . . . . . . . . . . . .17
MR personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
Fringe magnetic field . . . . . . . . . . . . . . . . . . . . . . . . . .18
Main Magnetic field and main magnetic field gradient . . .22
Personnel and patient exposure to the time-varying magnetic field . . 23
Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24
MR personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24
MR personnel and patient exposure to the RF magnetic field . . . . . .26
Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26
MR personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26
MR personnel and patient exposure to contac currents . . . . . . . . . .28
Precautions against localized cutaneous heating . . . . . . . . . . . . . . .28
Special Precautions for Patient Positioning . . . . . . . . . . . . . . . . . . .30
Precautions against Mechanical Hazards . . . . . . . . . . . . . . . . . . . .32
Precautions against Electric Shock . . . . . . . . . . . . . . . . . . . . . . . .33
Fire and Explosion Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . .35
Precautions when using the contrast agent in MR examinations . . . .36
Disinfecting and cleaning the system . . . . . . . . . . . . . . . . . . . . . . .37
Periodic maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39
Quality Assurance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Automatic Shimming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41
System life cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42
Lifetime . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42
Maintainability Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Disposal at the end of product lifetime . . . . . . . . . . . . . . . . . .42
Correct management and privacy of patient data . . . . . . . . . . . . . .44
Conformance to Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Equivalence between European and international standards . . . 46

350004900 Rev. 07 3 / 8
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Index
Chapter 4 - Installation
Structural Requirements of the Installation Area . . . . . . . . . . . . . . 1
Electromagnetic requirements in the installation environment . . . . . 2
Electromagnetic compatibility (EMC) . . . . . . . . . . . . . . . . . . . 2
Recommended distences between RF communication systems and
O-scan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Magnetic Disturbance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
RF Disturbances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Power Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Light Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Safety Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Thermal Stability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Environmental Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Temperature and humidity requirements . . . . . . . . . . . . . . . . 14
Other requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Site preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Patient Routine Monitoring Requirements . . . . . . . . . . . . . . . . . . . 17
Installation Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Controlled Access Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Warning labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Environmental Conditions for Transport and Storage . . . . . . . . . . . . 20
Special Storage and Transport Conditions . . . . . . . . . . . . . . . 20
Packaging Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Chapter 5 - Technical Description
System architecture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Operating console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Monitor specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
System electronics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Computer functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Magnetic unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Technical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

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Imaging system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Magnetic System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
Special purpose gradient system . . . . . . . . . . . . . . . . . . . . . . 14
Radiofrequency system . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
Patient positioning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
Installation area conditions . . . . . . . . . . . . . . . . . . . . . . . . .16
Power supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
Overall dimensions and weights . . . . . . . . . . . . . . . . . . . . . .17
Service equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
Chapter 6 - Patient seat and cinematic devices
Description of patient seat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
Patient Seat in the eXP and Premium configuration . . . . . . . . .3
Other supports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Device for cinematic examinations of the knee . . . . . . . . . . . . . . . .6
Procedure for standard use . . . . . . . . . . . . . . . . . . . . . . . . .7
Procedure to be followed before knee examinations . . . . . . . .8
Procedure to be followed after knee examinations . . . . . . . . . .9
Procedure for using the device for cinematic studies . . . . . . . .9
Procedure for using patient seat and devices for cinematic studies . .10
Hand/wrist positioner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Positioner Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Patient positioning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
Accessories cabinet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
Chapter 7 - Shielding and insulating parts
Description and use of shielding collars . . . . . . . . . . . . . . . . . . . . .2
Integrity check of shielding collars . . . . . . . . . . . . . . . . . . . . . . . .4
Description of the Shielding straps . . . . . . . . . . . . . . . . . . . . . . . .4
Insulating strap . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
Cleaning, replacement and disposal . . . . . . . . . . . . . . . . . . . . . . . 6

350004900 Rev. 07 5 / 8
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Index
Chapter 8 - Coils
Dual Phased Array Coils . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Description of DPA Knee Coil 1 . . . . . . . . . . . . . . . . . . . . . . . 2
Description of Hand/Wrist DPA Coil 2 . . . . . . . . . . . . . . . . . . 3
Description of Foot/Ankle DPA Coil 3 . . . . . . . . . . . . . . . . . . . 4
Precautions when using coils . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Phantoms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Chapter 9 - Soft cushion Set
Cushion List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Patient seat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Cushions holder for Knee Coil 1 . . . . . . . . . . . . . . . . . . . . . . 2
Lumbar support cushion . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
General Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
General use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Chapter 10 - Positioning Protocols
Size constraints of the O-scan system . . . . . . . . . . . . . . . . . . . . . . 1
Centering the Coil and the Anatomy to be Examined . . . . . . . . . . . . 6
Image Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Removing the Patient in an Emergency . . . . . . . . . . . . . . . . . . . . . 8
Chapter 11 - Knee Examinations
Usable coils . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Cushions and insulating straps . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Patient Positioning Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Cinematic Knee Examinations . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Examination of cruciate ligaments and the femor-rotula joint . . 7
Chapter 12 - Calf examinations
Usable coils . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

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Cushions and insulating straps . . . . . . . . . . . . . . . . . . . . . . . . . . .2
Patient Positioning Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
Chapter 13 - Foot - Ankle Region Examinations
Usable coils . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
Cushions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
Ankle Examinations: Patient Positioning Procedure . . . . . . . . . . . . . 3
Forefoot Examinations: Patient Positioning Procedure . . . . . . . . . . .7
Achilles' Tendon Examinations: Patient Positioning Procedure . . . . . .12
Chapter 14 - Hand-Wrist examinations
Usable coils . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
Cushions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
Hand Examinations: Patient Positioning Procedure . . . . . . . . . . . . . 2
Wrist Examinations: Patient Positioning Procedure . . . . . . . . . . . . .6
Chapter 15 - Elbow examinations
Usable coils . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
Cushions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
Patient Positioning Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
Chapter 16 - Forearm examinations
Usable coils . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
Cushions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
Patient Positioning Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
Chapter 17 - Turning the system on and off
Turning on the system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Turning off the PC or User Logoff . . . . . . . . . . . . . . . . . . . . . . . . .2
Emergency stop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
Chapter 18 - Control panel

350004900 Rev. 07 7 / 8
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Index
Control panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Real time positioning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Control panel orientation . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Standard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Inclined . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Turning the control panel on and off . . . . . . . . . . . . . . . . . . . 3
Appendix A - General Principles of Magnetic Resonance
Imaging
The nuclear spin system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
The role of RF pulse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Relaxation times . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
From signal to image . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

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