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Arthrex DualWave User Manual
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Electromagnetic Emission
s
DualWave Arthroscopy
Pump
U
ser’
s Gu
ide
DFU
-0212 Rev. 1
Pa
ge
51
of
54
Immunity
test
IEC 60601
test
level
Compliance
level
Electro
magnetic en
viron
ment
-
guidance
b Over the frequency r
ange 150 kHz to
80 MHz, field strengths sho
uld be less
than 3 V/m
.
56
58
Table of Contents
Table of Contents
3
General Warnings and Safety Notices - Read this First
7
Important Safety Conventions
7
Symbols Definition
10
Shipping, Unpacking, and Warranty Information
12
Product Description
13
Product Description and Intended Use
13
Product Features
15
AR-6480 Console: Front View
15
Figure 1 Front Panel of Console
15
Table 1 Front Panel Elements
15
AR-6480 Console: Rear View
16
Figure 2 Rear Panel of Console
16
Table 2 Rear Panel Elements
16
AR-6480 Operator Display Messages and Iconography
17
Table 3 AR-6480 Operator Display Messages and Iconography
17
Foot Pedal Unit (AR-6483)
19
Figure 3 Foot Pedal Unit (AR-6483)
19
Table 4 Foot Pedal Elements (AR-6483)
19
Remote Control Unit (AR-6482)
20
Figure 4 Remote Control Unit (AR-6482)
20
Table 5 Remote Control Unit Elements (AR-6482)
20
Tubing
21
Tubing Configurations
21
Figure 5 One-Piece Tubing Configuration
21
Table 6 Elements of the One-Piece Tubing Configuration
21
Figure 6 Two-Piece Tubing Configuration
22
Table 7 Elements of the Two-Piece Tubing Configuration
22
Main Pump Tubing Set (AR-6410: Region A)
23
Figure 7 Outflow Tubing Configuration (AR-6430)
23
Table 8 Elements of the Outflow Tubing Configuration
23
Redeuce™ Pump Tubing Set (AR-6411: Region A)
24
Redeuce Patient Tubing Set (AR-6421: Region A)
24
Extension Tubing System (AR-6220: Region A)
24
One-Piece Tubing Set System (AR-6415/AR-6415CL: Region B)
24
Main Pump Tubing Set (AR-6420/AR-6420CL: Region B)
24
Patient Extension Tubing System (AR-6425: Region B)
25
Outflow Pump Tubing Set (AR-6430)
25
Outflow Tub Set with Redeuce Tubing System (AR-6435: Region A)
25
Adapter Tubing (AR-6215)
25
Table 9 Tubing Set Correlation and Comparisons
26
Technical Specifications
27
Console
27
Table 10 Control Unit (AR-6480) Specifications
27
Table 11 Ambient Conditions for Operation
27
Table 12 Ambient Conditions for Storage (in Shipping Packaging)
27
Foot Pedal
28
Remote Control
28
Safety, EMC, and Regulatory Requirements
28
Table 13 Foot Pedal Unit (AR-6483) Specifications
28
Table 14 Remote Control Unit (AR-6482) Specifications
28
Setup
29
How to Set up the Console
29
AC Power Safety Considerations
29
Replacing the Fuses
30
Electromagnetic Compatibility (EMC)
31
Basic Setup Procedure for the AR-6480
31
Shaver Detect
33
Shaver Detect, Synergy System Connection
33
Shaver Detect, Shaver Power Cable
33
Shaver Detect, Inflow Only
34
Shaver Detect, Inflow/Outflow
34
Adjusting the Shaver Detect
35
How to Set up the Synergy Heads-Up Display
36
How to Set up Pump Tubing
36
How to Set up the Two-Piece Tubing System
37
How to Set up the Outflow Tubing
37
How to Change the Language Setting
38
How to Test the Power Supply Voltages
38
Safe Setup and Performance
38
Abnormal Operation
38
Overpressure Sensing
38
Roller Housing
38
Tubing Sensor Coupler
39
Shutdown Procedure
39
Operation and Frequently Used Functions
40
Initial Pressure Settings
40
Table 15 Initial Pressure Settings
40
How to Operate the AR-6480 in INFLOW ONLY Mode
41
How to Operate the AR-6480 in INFLOW/OUTFLOW Mode
42
How to Operate the AR-6480 in LAVAGE Mode
42
How to Operate the AR-6480 in RINSE Mode
43
Alternative Suction Pathway (ASP) Mode
43
Cleaning and Disinfecting
44
Console (AR-6480)
44
Remote Control Unit (AR-6482)
44
Foot Pedal Control Unit (AR-6483)
45
Tubing
46
Sterilization
47
Transmissible Spongiform Encephalopathy Agents
47
Maintenance
48
Periodic Maintenance
48
Technical Support
49
How to Display the Software Version
49
Additional Technical Information
49
Troubleshooting
50
Table 16 Troubleshooting: Faults, Their Causes, and Solutions
50
Troubleshooting Interference with Other Devices
51
Repair Policy
52
End of Life, Environmental Directives
53
Electromagnetic Emissions
54
Table 17 Guidance and Manufacturer's Declaration - Electromagnetic Emissions
54
Table 18 System Cables
54
Table 19 Guidance and Manufacturer's Statement - Electromagnetic Immunity
55
Table 20 Guidance and Manufacturer's Statement - Electromagnetic Immunity (Cont'D)
56
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Arthrex DualWave Specifications
General
Brand
Arthrex
Model
DualWave
Category
Medical Equipment
Language
English
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