Samsung H60 User manual

Type
User manual
Samsung Medison provides the following warranty to the purchaser of this unit. This warranty is valid for
a period of one year from the date of installation and covers all problems caused by faulty workmanship
or faulty material. Samsung Medison will, as sole and exclusive remedy and at no charge, replace any such
defective unit returned to Samsung Medison within the designated warranty period.
The warranty does not cover damages and loss caused by outside factors including, but not limited to, re,
ood, storm, tidal wave, lightning, earthquake, theft, abnormal conditions of operation, and intentional
destruction of the equipment. Damage caused by equipment relocation is not covered.
The warranty is void in cases where the equipment has been damaged as a result of an accident, misuse,
abuse, dropping, or when attempts to modify or alter any part or assembly of the equipment have taken
place.
Parts with cosmetic defects or deterioration will not be replaced. Replacement of batteries, training
materials, and supplies are not covered.
Samsung Medison will not be responsible for incidental or consequential damages of any kind arising
from or connected with the use of the equipment.
Samsung Medison will not be responsible for any loss, damage, or injury resulting from a delay in services
rendered under the warranty
This limited warranty is in lieu of all other warranties expressed or implied, including warranties of
merchant ability or tness for any particular use. No representative or other person is authorized to
represent or assume for Samsung Medison any warranty liability beyond that set forth herein.
Defective equipment shipped from you to Samsung Medison must be packed in the replacement
cartons. Shipping and insurance costs are the responsibility of the customer. To return defective material
to Samsung Medison contact the Samsung Medison Customer Service Department.
Samsung Medison or a local distributor will make available, upon request, circuit diagrams, a component
parts list, descriptions, calibration instructions and other information which will assist your appropriately
quali ed technical personnel to repair those parts of the equipment which are designed by Samsung
Medison as repairable.
CAUTION: United State federal law restricts this device to sale by or on the order of physicians.
WARRANTY
MANUFACTURER : SAMSUNG MEDISON CO., LTD.
42, Teheran-ro 108-gil, Gangnam-gu, Seoul, Korea
Customer Service Department : SAMSUNG MEDISON CO., LTD.
TEL : 82-2-2194-1234 FAX : 82-2-2194-1071
Website: www.samsungmedison.com
EC Representative : SAMSUNG ELECTRONICS (UK) LT D.
Blackbushe Business Park, Saxony Way,
Yateley, Hampshire, GU46 6GG, UK
Diagnostic Ultrasound System
MI68-02334A
Operation Manual
Version 1.00.00
English
PROPRIETRAY INFORMATION AND SOFTWARE LICENSE
The Customer shall keep confidential all proprietary information furnished or disclosed to the Customer
by Samsung Medison, unless such information has become part of the public domain through no fault of
the Customer. The Customer shall not use such proprietary information, without the prior written consent
of Samsung Medison, for any purpose other than the maintenance, repair or operation of the goods.
Samsung Medison’s systems contain Samsung Medisons proprietary software in machine-readable
form. Samsung Medison retains all its rights, title and interest in the software except that purchase of this
product includes a license to use the machine-readable software contained in it. The Customer shall not
copy, trace, disassemble or modify the software. Transfer of this product by the Customer shall constitute
a transfer of this license that shall not be otherwise transferable. Upon cancellation or termination of this
contract or return of the goods for reasons other than repair or modification, the Customer shall return to
Samsung Medison all such proprietary information.
Safety Requirements
Classifications:
X
Type of protection against electrical shock: Class I
X
Degree of protection against electrical shock (Patient connection): Type BF equipment
X
Degree of protection against harmful ingress of water: Ordinary equipment
X
Degree of safety of application in the presence of a flammable anesthetic material with air or
with oxygen or nitrous oxide: Equipment not suitable for use in the presence of a flammable
anesthetic mixture with air or with oxygen or nitrous oxide.
X
Mode of operation: Continuous operation
Electromechanical safety standards met:
X Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential
Performance IEC 60601-1:2005
X Medical Electrical Equipment, Part 1-2: General Requirements for Basic Safety and Essential
Performance- Collateral Standard: Electromagnetic Compatibility - Requirements and Tests IEC
60601-1-2:2007
X Medical Electrical Equipment, Part 1-6: General Requirements for Basic Safety and Essential
Performance- Collateral Standard: Usability IEC 60601-1-6:2006
X Medical Electrical Equipment, Part 2-37: Particular Requirements for the Basic Safety and Essential
Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment IEC60601-2-37:2007
X Medical Electrical Equipment, Part 1: General Requirements for Safety IEC 60601-1:1988 with
A1:1991 and A2:1995
X Medical Electrical Equipment, Part 1: General Requirements for Safety - 1 Collateral Standard: Safety
Requirement for Medical Electrical Systems IEC 60601-1-1:2000
X Medical Electrical Equipment, Part 1: General Requirements for Safety - 2 Collateral Standard:
Electromagnetic Compatibility - Requirements and Test IEC 60601-1-2:2001, A1:2004
X Medical Electrical Equipment, Part 1: General Requirements for Safety - 4 Collateral Standard:
Programmable Electrical Medical Systems IEC 60601-1-4: 1996, A1:1999
X Medical Electrical Equipment, Part 2: Particular Requirements for Safety - 37 Ultrasonic Medical
Diagnostic and Monitoring Equipment IEC60601-2-37: 2001 with A1:2004, A2:2005
X Medical Devices - Application of Risk Management to Medical Devices ISO 14971:2007
X Medical Electrical Equipment, Part 1: General Requirements for Safety UL60601-1:2003
X Medical Electrical Equipment - Part 1: General Requirements for Safety CAN/CSA 22.2
No.601.1-M90:1990, with R2003, with R2005
X Biological Evaluation of Medical Devices ISO10993:2009
X Standard Means for the Reporting of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment
IEC61157:2007
Declarations
This is the CSA symbol for Canada and United States of America.
This is the manufacturer’s declaration of product compliance with applicable EEC
directive(s) and the European notified body.
This is the manufacturer’s declaration of product compliance with applicable EEC
directive(s).
This is the GMP symbol that shows that the product complies with the Korean Good
Manufacturing Practice quality regulation system.
Precautions For Use
Be sure to read this manual thoroughly to familiarize yourself with the operation of the product and the
relevant safety information before attempting to use the product.
Keep this manual near the product and refer to it when using the product.
‘Chapter 1. Safety‘ and ‘Chapter 4. Maintenance, in particular, contain important safety information and
must be thoroughly understood.
This manual does not include diagnosis results or opinions. Also, check the reference information for
the measured area of the body before using the applications measurement results in any diagnosis.
This product is an ultrasound diagnosis device and cannot be used with your PC. The manufacturer is
not responsible for any problems that may be caused by such attempts.
This product must only be used by persons who are trained and/or certified to operate clinical
diagnostic devices. Unqualified persons must not use this product.
The manufacturer is not responsible for any damage to this product caused by user carelessness and/or
neglect.
The contents and specifications described in this manual may be changed without notice.
Products that are not manufactured by Samsung Medison are indicated with the trademarks of their
respective owners.
The following terms are used to highlight safety precautions that the user must be aware of:
DANGER: Disregarding this instruction may result in death, serious injury, or other dangerous
situations.
WARNING: Follow these instructions to prevent a serious accident or damage to property.
CAUTION: Follow these instructions to prevent a minor accident or damage to property.
NOTE: The accompanying information covers an installation, operation, or maintenance
procedure that requires careful attention from the user, but has little chance of leading directly to
a dangerous situation.
If You Need Assistance
If you need any assistance with the equipment, or the service manual, please contact Samsung Medison
s
Customer Service Department or one of their worldwide customer service representatives immediately.
Revision History
The revision history of this manual is as follows.
VERSION DATE NOTE
v1.00.00-00 2012-04-02 Initial Release
Product Upgrade and Manual Update
Upgrades to this product can include upgrades to its hardware or software components. Revised versions
of this manual will be published to reflect any upgrades to the product.
Please make sure that your operation manual is appropriate for your product version. If not, please contact
Samsung Medison's Customer Service Department.
15
Table of Contents
Table of Contents – Volume 1
Chapter 1 Safety
Indication for Use ....................................................................................................................... 1-3
Safety Information ..................................................................................................................... 1-4
Safety Symbols .................................................................................................................................................................... 1-4
Labels ...................................................................................................................................................................................... 1-6
Electrical Safety .......................................................................................................................... 1-7
Prevention of Electric Shocks ........................................................................................................................................ 1-7
ESD ........................................................................................................................................................................................... 1-8
EMI ........................................................................................................................................................................................... 1-9
EMC ........................................................................................................................................................................................ 1-9
Mechanical Safety .................................................................................................................... 1-17
Moving the Equipment ..................................................................................................................................................1-17
Precautions for Use ..........................................................................................................................................................1-18
Biological Safety ......................................................................................................................1-20
The ALARA Principle .......................................................................................................................................................1-20
Protecting the Environment ..................................................................................................1-35
Waste Electrical and Electronic Equipment ..........................................................................................................1-35
Chapter 2 Introduction
Product Specifications .............................................................................................................. 2-3
Product Configuration .............................................................................................................. 2-5
The Monitor .......................................................................................................................................................................... 2-6
The Control Panel ............................................................................................................................................................... 2-8
The Console .......................................................................................................................................................................2-15
Peripheral Devices ...........................................................................................................................................................2-17
Probes ................................................................................................................................................................................... 2-20
Accessories .........................................................................................................................................................................2-21
Optional Functions ..........................................................................................................................................................2-22
16
Operation Manual
Chapter 3 Utilities
System Settings .......................................................................................................................... 3-3
General System Settings .................................................................................................................................................3-4
General ................................................................................................................................................................................... 3-4
Patient .................................................................................................................................................................................... 3-7
Screen Display Settings (Imaging)............................................................................................................................... 3-8
Display .................................................................................................................................................................................... 3-8
Measurement Settings ...................................................................................................................................................3-11
Report ...................................................................................................................................................................................3-25
Anatomy ..............................................................................................................................................................................3-25
Comments ..........................................................................................................................................................................3-26
Annotation .........................................................................................................................................................................3-27
Body Marker .......................................................................................................................................................................3-31
Application .........................................................................................................................................................................3-35
Peripheral Device Settings ...........................................................................................................................................3-37
User Defined Keys (Customize Keys) ........................................................................................................................3-39
Customize Touch Menu .................................................................................................................................................3-42
Device ...................................................................................................................................................................................3-43
Connectivity Settings ....................................................................................................................................................3-44
DICOM Settings ................................................................................................................................................................3-44
Network Settings ...........................................................................................................................................................3-55
Service ..................................................................................................................................................................................3-56
Help .......................................................................................................................................................................................3-56
Chapter 4 Maintenance and Storage
Operational Environment ........................................................................................................ 4-3
Product Maintenance................................................................................................................ 4-4
Cleaning and disinfecting ............................................................................................................................................... 4-4
Fuse Replacement .............................................................................................................................................................4-6
Cleaning Air Filters ............................................................................................................................................................. 4-7
Accuracy Checks ................................................................................................................................................................. 4-7
Information Maintenance ........................................................................................................ 4-8
User Settings Backup ........................................................................................................................................................ 4-8
Backing Up Patient Information ...................................................................................................................................4-8
Software................................................................................................................................................................................. 4-8
17
Table of Contents
Chapter 5 Probes
Probes .......................................................................................................................................... 5-3
Ultrasound Transmission Gel ......................................................................................................................................... 5-8
Sheaths................................................................................................................................................................................... 5-9
Probe Safety Precautions ..............................................................................................................................................5-10
Cleaning and Disinfecting the Probe .......................................................................................................................5-12
Biopsy .........................................................................................................................................5-20
Biopsy Kit Components .................................................................................................................................................5-20
Using the Biopsy Kit ........................................................................................................................................................5-21
Cleaning and Disinfecting the Biopsy Kit ...............................................................................................................5-23
Assembling the Biopsy Kit ............................................................................................................................................5-25
**Reference Manual
A Reference Manual (English) is supplied with this product.
Indication for Use .............................................1-3
Safety Information ..........................................1-4
Safety Symbols .........................................................................1-4
Labels ........................................................................................... 1-6
Electrical Safety ................................................1-7
Prevention of Electric Shocks ..............................................1-7
ESD ................................................................................................ 1-8
EMI .................................................................................................1-9
EMC ..............................................................................................1-9
Mechanical Safety ........................................ 1-17
Moving the Equipment .......................................................1-17
Precautions for Use ...............................................................1-18
Biological Safety ........................................... 1-20
The ALARA Principle .............................................................1-20
Protecting the Environment ........................ 1-35
Waste Electrical and Electronic Equipment ................1-35
Chapter 1
Safety
  • Page 1 1
  • Page 2 2
  • Page 3 3
  • Page 4 4
  • Page 5 5
  • Page 6 6
  • Page 7 7
  • Page 8 8
  • Page 9 9
  • Page 10 10
  • Page 11 11
  • Page 12 12
  • Page 13 13
  • Page 14 14
  • Page 15 15
  • Page 16 16
  • Page 17 17
  • Page 18 18
  • Page 19 19
  • Page 20 20
  • Page 21 21
  • Page 22 22
  • Page 23 23
  • Page 24 24
  • Page 25 25
  • Page 26 26
  • Page 27 27
  • Page 28 28
  • Page 29 29
  • Page 30 30
  • Page 31 31
  • Page 32 32
  • Page 33 33
  • Page 34 34
  • Page 35 35
  • Page 36 36
  • Page 37 37
  • Page 38 38
  • Page 39 39
  • Page 40 40
  • Page 41 41
  • Page 42 42
  • Page 43 43
  • Page 44 44
  • Page 45 45
  • Page 46 46
  • Page 47 47
  • Page 48 48
  • Page 49 49
  • Page 50 50
  • Page 51 51
  • Page 52 52
  • Page 53 53
  • Page 54 54
  • Page 55 55
  • Page 56 56
  • Page 57 57
  • Page 58 58
  • Page 59 59
  • Page 60 60
  • Page 61 61
  • Page 62 62
  • Page 63 63
  • Page 64 64
  • Page 65 65
  • Page 66 66
  • Page 67 67
  • Page 68 68
  • Page 69 69
  • Page 70 70
  • Page 71 71
  • Page 72 72
  • Page 73 73
  • Page 74 74
  • Page 75 75
  • Page 76 76
  • Page 77 77
  • Page 78 78
  • Page 79 79
  • Page 80 80
  • Page 81 81
  • Page 82 82
  • Page 83 83
  • Page 84 84
  • Page 85 85
  • Page 86 86
  • Page 87 87
  • Page 88 88
  • Page 89 89
  • Page 90 90
  • Page 91 91
  • Page 92 92
  • Page 93 93
  • Page 94 94
  • Page 95 95
  • Page 96 96
  • Page 97 97
  • Page 98 98
  • Page 99 99
  • Page 100 100
  • Page 101 101
  • Page 102 102
  • Page 103 103
  • Page 104 104
  • Page 105 105
  • Page 106 106
  • Page 107 107
  • Page 108 108
  • Page 109 109
  • Page 110 110
  • Page 111 111
  • Page 112 112
  • Page 113 113
  • Page 114 114
  • Page 115 115
  • Page 116 116
  • Page 117 117
  • Page 118 118
  • Page 119 119
  • Page 120 120
  • Page 121 121
  • Page 122 122
  • Page 123 123
  • Page 124 124
  • Page 125 125
  • Page 126 126
  • Page 127 127
  • Page 128 128
  • Page 129 129
  • Page 130 130
  • Page 131 131
  • Page 132 132
  • Page 133 133
  • Page 134 134
  • Page 135 135
  • Page 136 136
  • Page 137 137
  • Page 138 138
  • Page 139 139
  • Page 140 140
  • Page 141 141
  • Page 142 142
  • Page 143 143
  • Page 144 144
  • Page 145 145
  • Page 146 146
  • Page 147 147
  • Page 148 148
  • Page 149 149
  • Page 150 150
  • Page 151 151
  • Page 152 152
  • Page 153 153
  • Page 154 154
  • Page 155 155
  • Page 156 156
  • Page 157 157
  • Page 158 158
  • Page 159 159
  • Page 160 160
  • Page 161 161
  • Page 162 162
  • Page 163 163
  • Page 164 164
  • Page 165 165
  • Page 166 166
  • Page 167 167
  • Page 168 168
  • Page 169 169
  • Page 170 170
  • Page 171 171
  • Page 172 172
  • Page 173 173
  • Page 174 174
  • Page 175 175
  • Page 176 176
  • Page 177 177
  • Page 178 178

Samsung H60 User manual

Type
User manual

Ask a question and I''ll find the answer in the document

Finding information in a document is now easier with AI