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GE Brivo OEC 715 User Manual
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iii
REGULATORY REQUIREMENTS
International Electrotechnical Commission (IEC), international
standards organization, when
applicable.
This product conforms with the Medica
l Device Directive, Council Directive 93/42/EEC: June
14
,
1993, as amended by 2007/47/EC following the provisi
ons of Annex II, when it bears the
following CE Mark of Conformity.
European Representative:
GE Medical Systems S.C.S.
Quality Assurance Manager
283 rue de la Minière
78530 BUC France
Tel: +33 1 30 70 40 40
2
4
Table of Contents
default chapter
4
Table of Contents
4
Chapter1. Introduction And Safety
9
Overview
10
Owner Responsibilities
10
System Compatibility
10
Operator Qualifications
10
Continued Compliance
10
Unauthorized Modifications
11
Manufacturer's Responsibilities
12
X-Ray Equipment Certification
12
After-Sale Operating and Safety Practices
12
Essential Performance
12
Communication Center Telephone Numbers
12
Safety Hazards
13
Safety Hazard Alerts
13
Explosion
13
Equipment Stability and Positioning
14
Motorized Mechanical Movement
14
Improperly Attached Equipment
14
Electrical Fire
15
Ground Fault
16
Improper Access
16
Radiation Exposure
16
General Protection
16
Source-To-Skin Distance
16
Dose to Patient
17
Ingress of Fluids
24
Cooling Efficiency
24
Burns
24
Electromagnetic Compatibility Statement
25
Equipment Malfunction
32
Mains Isolation
32
External Devices
32
Patient Environment
33
Within the United States
33
Outside the United States
33
Chapter2. System Overview
34
General Description
35
C-Arm Components
36
Workstation Components
38
Chapter3. Mechanical Positioning
40
Overview
41
Positioning
41
C-Arm Orbital Rotation
41
Lateral Rotation
42
Wig-Wag
43
Vertical Column Operation
44
Horizontal Cross-Arm
45
C-Arm Brakes
46
C-Arm Steering Handle
47
Workstation Monitor Adjustment
47
Workstation Brakes
48
Moving the C-Arm and Workstation
49
Overview
49
Moving the C-Arm
50
Moving the Workstation
51
Chapter4. Start Up and Operating Control
53
Overview
53
Start up
53
Power on
53
Standby or Power off
56
C-Arm Controls
57
C-Arm Control Panel
57
Footswitch and Handswitch
65
Emergency Switch
67
Workstation Controls
68
Workstation Membrane Keyboard
68
Touch Screen
74
Image Quality Control
74
Chapter5. Usual Operations
77
Exam Management
78
Create a New Exam
78
Scheduled Exams Feature
79
Resume a Performed Exam
81
Edit Patient Information
82
Imaging Mode
83
Normal Fluoro Imaging
85
High Level Fluoro Imaging
85
Digital Spot Imaging
86
Pulsed Fluoro Imaging
86
Low Dose Imaging
87
Imaging Mode List
87
Modes of Operation: Engaging and Disengaging
89
Image Review, Print and Archive
89
Review Images
89
Review Dose Information
93
Print, Export and Import
100
Retrieve a Performed Exam
105
Pediatric Use
105
General Instructions for Small or Pediatric Patients
105
General Dose Planning
106
Emergency Mode
107
Chapter7. Radiographic Film
139
Overview
140
Setup and Make a Film Exposure
140
Chapter8. System Setup
142
System Information
143
Date Time & Region
144
C-Arm System
145
Security
146
Maintenance
148
Chapter9. Maintenance
150
Overview
151
Performance Checks
152
Mechanical Performance Check
152
Electrical Performance Check
152
Emergency Switch Performance Check
153
Fluoro Mode Performance Check
153
Film Mode Performance Check
154
Cleaning and Disinfections
155
Cleaning
155
Disinfections
156
Storage
157
Temporary Storage (Less than 60 Days)
157
Long Term Storage or Shipment (60 Days or More)
157
Maintenance Schedule
158
User Routine Checks Items
158
Periodic Maintenance
159
Chapter10. Display Messages
160
Overview
161
Error Recovery Steps
161
Messages
161
Chapter11. Labels And Symbols
162
Overview
163
Labels and Locations
163
Labels
163
Locations of the Labels
176
Symbols
178
Chapter12. Technical Reference
179
Overview
180
System Specifications
180
Classification Type
180
Environmental Requirements
180
Power Requirements
181
Physical Specifications
182
Specification of Key Components
184
X-Ray Generator
184
X-Ray Source Assembly
186
Grid
189
Image Intensifier
189
Camera
189
Others
189
Tube Rating Chart
190
Filament Emission Characteristics
190
Single Load Ratings
191
Thermal Characteristic
192
Scatter Radiation
193
Room Interface (RIF)
199
Options
200
Thermal/ Film Printers
200
Laser Aimer
201
30Cm Skin Spacer
202
Film Cassette Holder
203
Video Distributor
203
Removable Filter
203
Removable Grid
203
Wi-Fi Internet Adapter
204
Material Safety Data Sheets
204
Material Recycling
204
Replacement Parts
205
System Block
206
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GE Brivo OEC 715 Specifications
General
Brand
GE
Model
Brivo OEC 715
Category
Medical Equipment
Language
English
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