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Carriazo-Pendular
SCHWIND Carriazo-Pendular - User Manual
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USER MANUAL
(Instruct
ion for Use)
TREAT
Original version
Valid for Software Version 2.9
0483
_
2
Table of Contents
Main Page
Default Chapter
2
Dear Customer
2
Table of Contents
3
List of Figures
6
1 General Information
7
System Identification Data
7
Symbols for Warnings, Precautionary Measures and Notes
8
Notes on the User Manual
8
Scope of Documentation
9
Declaration of Manufacturer According to the European MDD 93/42/EWG for Microkeratome Carriazo-Pendular
9
Liability of the Manufacturer
10
Warranty
11
Limited Warranty of Parts and Items
11
Limitation of Warranty and Liability - General
11
Exclusion of Warranty and Liability
11
Exclusive Warranties
12
License Agreement
12
Copyright
12
Trademarks
12
2 Safety
13
General Notes
13
Regulations for Medical Devices
13
Restrictions of Use and Safety Precautions
14
Data and Virus Protection
14
Manufacturer's Responsibility
14
Training of User's and Operating Personnel
15
Instruction and Training
15
Protective Measures of the Manufacturer
16
Conformity with Safety Standards
16
Electrical Safety, Mechanical Safety, Functional Safety
16
Electromagnetic Compatibility (EMC)
16
Operator's Responsibility
17
Patient and Personal Safety
17
Device Safety
18
Electrical Safety
18
Dangers Resulting from Device Operation
19
Protection from Unauthorized Use
19
In Case of Emergency
19
Labelling
20
Labelling Pendular Device
20
Labelling Disposable Blades - Packaging Option a
20
Figure 2-1: Position of Carriazo-Pendular Type Label Example - Rear Side of the Console
20
Figure 2-2: Example of Type Label Carriazo-Pendular Disposable Blades - Primary Packaging
20
Figure 2-3: Example of Type Label Carriazo-Pendular Disposable Blades - Secondary Packaging
21
Figure 2-4: Safety Notice Label for the Secondary Packaging
21
Labelling Disposable Blades - Packaging Option B
22
Figure 2-5: Example of Type Label of Carriazo-Pendular Disposable Blades - Primary Packaging
22
Figure 2-6: Example of Type Label of Carriazo-Pendular Disposable Blades - Secondary Packaging
22
Figure 2-7: Example of Tertiary Packaging (Folding Box) (Front and Side View)
23
Figure 2-8: Example of Type Label Carriazo-Pendular Disposable Blades - Equal to Secondary Packaging
23
Type Label of the Disposable Tubings
24
Figure 2-9: Example of Quarternary Transport Box for Carriazo-Pendular Disposable Blades
24
Figure 2-10: Example of Type Label of Carriazo-Pendular Disposable Tubings - Primary Packaging
25
Figure 2-11: Example of Type Label of Carriazo-Pendular Disposable Tubings - Secondary Packaging
26
Explanation of Graphic Symbols Used in the Labels
27
3 Introduction
30
Intended Use
30
Side-Effects
30
Contraindications for LASIK
31
4 Device / System Description
32
System Overview
32
Principle of Cutting
32
Product Features and Components
33
Cutting Head
33
Disposable Blades
34
Suction Ring
35
Drive Motor
36
Pendulum Axis
36
Tonometer
36
Console - Control Unit
36
Foot Pedal
38
Monitoring Software
39
List of Applied Parts
39
Intended Accessory
39
Disposable Tubing
39
Lid Speculum
40
Approved System Combinations
41
5 Installation
42
General Notes
42
System Requirements
43
Shipping
43
Scope of Delivery
43
Packing of the Shipping Units
43
Unpacking and Checking the Delivery
44
Transportation Damages
45
Room and Installation Requirements
45
Device Installation / Start-Up
45
Transportation to Another Location
46
6 Operation
47
General Notes
47
Device Operation
48
Assembling the Microkeratome, Vacuum Test
48
Connection of the Console
48
Switch ON/OFF the Console
48
Disconnection from the Electronic Circuit
49
Software Operation
50
Standard System Messages
50
User Menu
51
System Supervisor & Error Table
52
Vacuum Level and Atmospheric Pressure
54
Assembly of the New Disposable Blade
55
7 Treatment
56
8 Cleaning and Reprocessing
56
Cleaning and Reprocessing of Resterilisable Parts, Accessories and Components
56
Cleaning and Disinfection of Non-Sterile Parts, Accessories and Components
56
Safety Notes and Warnings
56
Manual Cleaning and Disinfection of the Console and Foot Switch
58
Manual Cleaning and Disinfection of the Motor and Motor Cable
58
9 Maintenance, Function Control and Storage
60
Technical Safety Check (TSC)
61
Maintenance of Batteries and Accumulators
61
Test Protocol of Technical Safety Check
62
Maintenance Intervals
62
Regular Technical Inspections
62
Changing Fuses
63
List of Parts
64
Storage
64
Lifetime
65
Disposal
65
10 Technical Data
66
Electronic Console
66
Suction Rings
66
Cutting Head
66
11 Reference to Standards
67
12 Emc Guidance and Manufacturer's Declaration
68
Electromagnetic Interference
68
Essential Performance
73
List of Replacable Cables and Components
74
13 Manufacturer
75
Technical Assistance / Application Support
75
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SCHWIND Carriazo-Pendular Specifications
General
Brand
SCHWIND
Model
Carriazo-Pendular
Category
Medical Equipment
Language
English
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General
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