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GE Vscan Extend User Manual
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Regulatory requirement
This product complie
s with regulatory requirement
s of the following European
Directive 93/42/EEC concerning med
ical devices.
This manual is a refer
ence for the Vscan Extend. It applies to
all versions of the 1.0
sof
tware
for the Vscan Ext
end ultrasound
system.
Manufacturer:
GE VINGMED UL
TRASOUND A/S
S
trandpromenaden 45
3191 Horten, Norway
T
el.: (+47) 3302 1
100 Fax: (+47) 3302 1350
1
3
Table of Contents
Default Chapter
6
Certifications
6
Class II Equipment
7
Classifications
7
Original Documentation
7
Type BF Applied Part
7
Country Specific Approval
8
Importer Information
8
Table of Contents
9
Chapter 1 - Introduction
14
Overview
14
Attention
14
General Description
14
Principles of Operation
15
Safety
15
Intended Use
15
Indications for Use (for All Countries Except USA, China and Japan)
16
Indications for Use (for USA, China and Japan)
17
Contraindication for Use (for USA, China and Japan)
17
Intended Users
18
Prescription Device
18
Operator Profile
18
Warnings
19
Important Safety Considerations
19
Contact Information
22
Contacting GE Ultrasound
22
Global Ultrasound Support Center Phone Numbers
23
Manufacturer
26
Chapter 2 - Safety
28
Introduction
28
Overview
28
Owner Responsibility
29
Overview
29
Notice against User Modification
30
Important Safety Considerations
31
Overview
31
Patient Safety
31
Diagnostic Information
32
General Precautionary Advice for the Use of Diagnostic Ultrasound in Combination with Ultrasound Contrast Agents
32
Mechanical Hazards
32
Electrical Hazard
33
Personnel and Equipment Safety
33
Explosion Hazard
33
Electrical Hazard
34
Electromagnetic Compatibility (EMC)
36
Electromagnetic Emissions
40
Electromagnetic Immunity
40
Separation Distances
44
Essential Performance
44
Acoustic Output
45
Environmental Protection
49
Maximum Probe Temperature
50
Device Labels and Symbols
51
Vscan Extend Labels (Example)
51
Explanation of the Pollution Control Label for China
55
Chapter 3 - Preparing Vscan Extend for Use
58
Package Contents
58
Vscan Extend Package Contents
58
Environmental Requirements
59
Environmental Requirements for the Device
59
System Description
60
System Overview
60
Accessories and Configurations
63
External Battery Charger Compartment (Option)
67
Display Screens
68
Vscan Extend Battery
71
Battery
71
Initial Use
78
First Time Use
78
Power On/Off
78
Vscan Extend Activation
80
Chapter 4 - Vscan Extend Settings
95
Scan Settings
95
Server Settings
97
Diagnostics
106
System Settings
107
Administrator Access
109
Storage Access
111
Wi-Fi
115
Configuring Wi-Fi
117
MDM Installation Procedures (Optional)
118
Certificate Authority
122
GE Marketplace
125
Chapter 5 - Using Vscan Extend
132
Scanning
132
General Scanning Recommendations
132
Black and White Imaging
147
Color Imaging
150
Auto Freeze
153
Autocycle
153
Use of Sterile Sheath
153
Measurements
154
Taking Measurements
154
Review and Recall of Stored Data
156
Backups Recommended
156
Reviewing and Recalling Images or Videos from an Exam List
156
Deletion of Data
158
Data Export
160
Backup
172
Restore
175
Using Vscan Extend Apps
177
Overview
177
Bladder Volume
177
Lung Protocol
184
Tricefy
192
Chapter 6 - Vscan Extend Maintenance
196
System Care and Maintenance
196
Overview
196
Inspection
197
Cleaning and Disinfection
198
Cleaning the Device
198
Method of Cleaning: Manual
200
Disinfecting the Device
201
Disinfecting the Probe
203
Rinsing and Lubricating Agents
205
Upgrade Software
206
Scanner Software
206
Troubleshooting
208
Vscan Extend Troubleshooting
208
System Warning Messages
210
Chapter 7 - Appendix
214
Specifications
214
Dimension and Weight
214
Phased Array Transducer for Deep Scanning
214
Linear Transducer for Shallow Scanning
214
Acoustic Output Reporting Tables
215
Definitions, Symbols and Abbreviations
215
Acoustic Output Reporting Tables for Track 3/EN/IEC 60601-2-37
218
Chapter 8 - Privacy and Security
228
Overview
228
Network Connectivity
232
Overview
232
System Interconnections
232
Network Requirements
234
Network Protocols
234
Information Protection
235
Overview
235
Network Security
235
System Protection
242
Vscan Extend - System Protection
242
Personal Information Collected by the Product
243
Information Collection and Use
243
Manual Information Collection
244
Information Disclosure
245
Retention and Destruction of Personal Information
245
Potential Hazardous Situations Resulting from Failures of the IT Network
247
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GE Vscan Extend Specifications
General
Brand
GE
Model
Vscan Extend
Category
Medical Equipment
Language
English
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