GE Vscan Extend - Regulatory requirement; European Directive Compliance

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Regulatory requirement

This product complies with regulatory requirements of the following European

Directive 93/42/EEC concerning medical devices.

This manual is a reference for the Vscan Extend. It applies to all versions of the 1.0

software for the Vscan Extend ultrasound system.

Manufacturer:

GE VINGMED ULTRASOUND A/S

Strandpromenaden 45

3191 Horten, Norway

Tel.: (+47) 3302 1100 Fax: (+47) 3302 1350

Main Page

Default Chapter6
- Certifications6
- Class II Equipment7
- Classifications7
- Original Documentation7
- Type BF Applied Part7
- Country Specific Approval8
- Importer Information8
- Table of Contents9
Chapter 1 - Introduction14
Overview14
- Attention14
- General Description14
- Principles of Operation15
- Safety15
- Intended Use15
- 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 Users18
- Prescription Device18
- Operator Profile18
Warnings19
- Important Safety Considerations19
Contact Information22
- Contacting GE Ultrasound22
- Global Ultrasound Support Center Phone Numbers23
- Manufacturer26
Chapter 2 - Safety28
Introduction28
- Overview28
Owner Responsibility29
- Overview29
- Notice against User Modification30
Important Safety Considerations31
- Overview31
- Patient Safety31
- Diagnostic Information32
- General Precautionary Advice for the Use of Diagnostic Ultrasound in Combination with Ultrasound Contrast Agents32
- Mechanical Hazards32
- Electrical Hazard33
- Personnel and Equipment Safety33
- Explosion Hazard33
- Electrical Hazard34
- Electromagnetic Compatibility (EMC)36
- Electromagnetic Emissions40
- Electromagnetic Immunity40
- Separation Distances44
- Essential Performance44
- Acoustic Output45
- Environmental Protection49
Maximum Probe Temperature50
Device Labels and Symbols51
- Vscan Extend Labels (Example)51
- Explanation of the Pollution Control Label for China55
Chapter 3 - Preparing Vscan Extend for Use58
Package Contents58
- Vscan Extend Package Contents58
Environmental Requirements59
- Environmental Requirements for the Device59
System Description60
- System Overview60
- Accessories and Configurations63
- External Battery Charger Compartment (Option)67
- Display Screens68
Vscan Extend Battery71
- Battery71
Initial Use78
- First Time Use78
- Power On/Off78
- Vscan Extend Activation80
Chapter 4 - Vscan Extend Settings95
- Scan Settings95
- Server Settings97
- Diagnostics106
- System Settings107
- Administrator Access109
- Storage Access111
- Wi-Fi115
- Configuring Wi-Fi117
- MDM Installation Procedures (Optional)118
- Certificate Authority122
- GE Marketplace125
Chapter 5 - Using Vscan Extend132
Scanning132
- General Scanning Recommendations132
- Black and White Imaging147
- Color Imaging150
- Auto Freeze153
- Autocycle153
- Use of Sterile Sheath153
Measurements154
- Taking Measurements154
Review and Recall of Stored Data156
- Backups Recommended156
- Reviewing and Recalling Images or Videos from an Exam List156
- Deletion of Data158
- Data Export160
- Backup172
- Restore175
Using Vscan Extend Apps177
- Overview177
- Bladder Volume177
- Lung Protocol184
- Tricefy192
Chapter 6 - Vscan Extend Maintenance196
System Care and Maintenance196
- Overview196
- Inspection197
Cleaning and Disinfection198
- Cleaning the Device198
- Method of Cleaning: Manual200
- Disinfecting the Device201
- Disinfecting the Probe203
- Rinsing and Lubricating Agents205
Upgrade Software206
- Scanner Software206
Troubleshooting208
- Vscan Extend Troubleshooting208
- System Warning Messages210
Chapter 7 - Appendix214
Specifications214
- Dimension and Weight214
- Phased Array Transducer for Deep Scanning214
- Linear Transducer for Shallow Scanning214
Acoustic Output Reporting Tables215
- Definitions, Symbols and Abbreviations215
- Acoustic Output Reporting Tables for Track 3/EN/IEC 60601-2-37218
Chapter 8 - Privacy and Security228
- Overview228
Network Connectivity232
- Overview232
- System Interconnections232
- Network Requirements234
- Network Protocols234
Information Protection235
- Overview235
- Network Security235
System Protection242
- Vscan Extend - System Protection242
Personal Information Collected by the Product243
- Information Collection and Use243
- Manual Information Collection244
- Information Disclosure245
- Retention and Destruction of Personal Information245
- Potential Hazardous Situations Resulting from Failures of the IT Network247

GE Vscan Extend - Regulatory requirement; European Directive Compliance

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