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CUSA Clarity
Integra CUSA Clarity User Manual
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Int
egr
a
®
CUSA
®
Clarit
y
Ultr
asonic S
ur
gical Aspir
ator S
ystem
Integr
a
®
CUSA
®
Clarit
y
Ultr
asonic S
ur
gical Aspirat
or S
ystem
Oper
ator
’
s Manual
Oper
ator’
s Manual
6090519
7 Revision F 05/
18 060655
3-2
Integra Lif
eSciences (Ir
eland) Limited
IDA Business &
T
echnology P
ark
Sragh
T
ullamor
e
Count
y Offaly
Ireland
USA & Canada: (800) 9
97-
486
8
Outside USA: (609) 9
36-5400
www
.integralif
e.com
Manufact
urer
2
Table of Contents
Default Chapter
4
Table of Contents
4
Preface
10
Intended Audience
10
Trademark Acknowledgments
10
Manufacturer
11
Patent Information
11
Overview of Manual
11
System Features
12
Intended Uses
12
Conventions Used in this Guide
12
SECTION 1 Patient and Operating Room Safety
14
Indications for Use
14
Intended Users
15
Safety Information
15
Warnings and Cautions
16
Patient and Operating Room Safety
16
Classification and Console Symbols
22
SECTION 2 Introduction to the System
24
Overview
24
CUSA ® Clarity System
25
Fragmentation
27
Irrigation
27
Aspiration (Suction)
28
Touchscreen Display
29
Handpiece
29
Handpiece Functions
29
Handpiece Configurations
30
Handpiece Tips
30
Tissue Select Feature
30
Sterilization of Handpieces and Accessories
34
SECTION 3 Console Components
36
Overview
36
Console Features
37
Console - Front Panel
39
Console - Rear Panel
40
SECTION 4 Touchscreen Display and Functions
42
Overview
42
Touchscreen Layout
42
Main Screen
43
Setup Tasks Screen
44
Settings Screen
44
Online Help
45
Alarm Indicators
45
Ultrasonic Control Scale Adjustments
46
Adjusting the Ultrasonic Control Scale Values
46
Footswitch and Aspiration Modes
47
Footswitch Mode
47
Aspiration Mode
48
SECTION 5 Handpiece Components
50
Overview
50
Components of Assembled Handpieces
51
Handpiece
51
Tip
52
Nosecone
52
Flue
53
Additional Handpiece Components
53
CUSA Quick Connect ™ Cartridge and Tubing Set (Sterile)
53
Aspiration Tubing
54
Irrigation Tubing
54
Cartridge
54
Torque Base (Sterilizable)
55
SECTION 6 Assembling the System Prior to Use
56
Overview
56
Assembling the Console and Cart
57
Attaching the Power Cord
58
SECTION 7 System Setup in the Sterile Field
60
Overview
60
Quick Reference: Setting up in the Sterile Field
61
Assembling the Handpiece in the Sterile Field
62
Attaching a Tip
62
Attaching the Nosecone and the Flue
64
Attaching the Tubing
66
SECTION 8 System Setup in the Non-Sterile Field
70
Overview
70
Quick Reference: Setting up in the Non-Sterile Field
70
Assembling the Handpiece
70
Console Setup (Non-Sterile)
71
Powering up the System
71
Attaching the Footswitch
72
Attaching the Handpiece
72
Connecting the Tubing Set
73
SECTION 9 Operating the System
80
Overview
80
Quick Reference: Operating the System
81
Priming the System
81
Start Prime
81
Stop Prime
82
Testing the Handpiece
83
Start Test
83
Detailed Test Results
84
System Ready for Use
84
SECTION 10 Changing Tips in the Sterile Field During a Surgical Procedure
86
Overview
86
Quick Reference: Changing Tips
86
Changing a Tip
87
Removing the Used Tip
87
Assembling the New Tip on the Handpiece
91
SECTION 11 Disassembling, Cleaning, and Sterilizing the System
96
Overview
96
Quick Reference: Disassembling the System
96
Quick Reference: Cleaning the System
97
Disassembling the System
97
Clarity Items to Keep and Discard after a Surgical Procedure
97
Disassembling the Handpiece
97
Disassembling the Console
102
Detaching the Contamination Guard
105
Powering down the System
105
Cleaning the System
106
Cleaning the Touchscreen
106
Cleaning the Console and Cart
106
Cleaning the Handpiece, EUT, and Torque Base
107
Cleaning the Footswitch
108
Sterilization Tray Cleaning
108
Sterilizing the System
109
Packaging the Handpiece and Components for Sterilization
109
Sterilization Parameters
111
Sterilization Tray Packaging
111
Sterilizing the Handpiece and Components with Steam
112
SECTION 12 Maintaining the System
114
Overview
114
Quick Reference
115
Handpiece Maintenance
115
Return and Replace the Handpiece
115
Storage of the System and Accessories
116
Console
116
Console with Cart
116
Handpiece
117
Footswitch
117
Disposal of the Equipment
117
Return Equipment for Service
117
Obtaining a Return Authorization Number
117
Returning the Console
118
Returning the Handpiece
118
Ordering Replacement Parts
118
Integra Service Centers
119
US Service Center
119
Europe, Middle East and Africa Service Center
119
Asia Pacific Service Center
119
SECTION 13 Troubleshooting the System
121
Extracting Log Files
121
Alarm Descriptions
121
Technical Messages
122
Amplitude Troubleshooting
122
Aspiration Troubleshooting
124
Irrigation Troubleshooting
124
SECTION 14 MR Safety Information
126
Overview
126
Use of the CUSA Clarity System in the MR Environment
127
SECTION a Technical Specifications
128
Console
128
Dimensions
128
Tip Specifications
129
Subsystems
130
Handpiece
130
Dimensions
130
Frequency
130
Electrical Requirements
131
Power Input and Fusing
131
Maximum Low Frequency Leakage
132
Duty Cycle
132
Electromagnetic Interference
132
Environment
132
Operating
132
Storage and Shipping
132
Voluntary Standards
133
Statutory and Regulatory Classification
133
Guidance and Manufacturer's Declarations
134
SECTION B Warranty
138
Warranty
138
Coverage
138
Exclusions
138
Service, Repairs and Replacement
139
Service and Repairs
139
Equipment Replacement
139
Notification
139
Repair Parts and Services
139
Consoles
139
Handpieces
139
Modifications to Covered Equipment
140
Quality Control
140
Limitations of Liability
140
Other manuals for Integra CUSA Clarity
Instructions For Use
84 pages
Cleaning Instruction Guide
12 pages
5
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Integra CUSA Clarity Specifications
General
Brand
Integra
Model
CUSA Clarity
Category
Medical Equipment
Language
English
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