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SYMBYX PDCare Parkinson's Device Manuals
Manuals and User Guides for SYMBYX PDCare Parkinson's Device. We have
2
SYMBYX PDCare Parkinson's Device manuals available for free PDF download: Instruction Manual, Quick Start Manual
SYMBYX PDCare Instruction Manual (43 pages)
904 nm Laser
Brand:
SYMBYX
| Category:
Medical Equipment
| Size: 17.63 MB
Table of Contents
Table of Contents
2
General Information
7
Product Description
7
Separate Power Supply Source (Mains Supply Transformer)
8
Essential Performance and Basic Safety
8
Temperature Range for Use
8
User Restrictions
8
General Caution and Warning Statements
8
Device Description and Use
8
Operation Description of Laser Treatment (General)
9
General Risks and Hazards with Class 1 Lasers (IEC60825-1:2014)
9
Device Overview
10
Primary Operating Functions
12
Replacement of Batteries
12
Treatment Controls
13
Overview Parameters of the Treatment Protocol for Medical Recording
13
Medical Recording
13
Device Application Specification
14
Description
14
Expected Life before Service Required
14
Medical Purpose/Intended Use
14
Patient
14
Operator
14
Application
14
Environment
14
Home Healthcare Environment
15
Frequency of Device Use
15
Treatment/Application Time Per Patient
16
Treatment Interval
16
Number of Treatments Per Patient/Sessions Per Patient
16
Treatment Session Interval
17
Contraindications
17
Side Effects
17
Patient Potential Reaction
17
Patient Population
18
Intended OPERATOR
19
Operator Responsibilities
19
Responsible Organization
20
Patient Position
20
Training
21
General Battery Safety Information
22
Battery Safety
22
Warnings and Precautions
22
Recycling of Batteries
23
Replacement of Batteries
24
Transport and Storage of the Device
25
Laser Safety
26
General Laser Safety Information
26
General Risks with Class 1 Lasers (See Chapter 2.2) IEC 60825-1
27
Maintenance and Control of Emitted Output Power
27
Protective Eyewear. Personal Protective Equipment (Optional Requirement)
28
General Electrical and Mechanical Safety
28
Cleaning/Disinfection Procedures
28
Visual Inspections
29
Information for Service Technicians
30
Description of Controls, Messages, and Indicators
31
Laser Emission Control
31
On/Off
31
Technical Specifications (General)
32
Technical Specifications
33
Pdcare Laser 904 Nm by SYMBYX
33
Definitions
34
Labels and Symbols
36
Labels on the Device
37
Symbols and Marking on Package Label
38
Limitation of Liability
38
Disposal and Recycling of the Device
38
Transport and Packaging of the Device
38
Distributor and Manufacturer Contact Information
39
Reporting Serious Incidents
39
Electromagnetic Compatibility (EMC)
39
Electromagnetic Emissions - Guidance and Declaration
40
Electromagnetic Immunity - Guidance and Declaration
41
Separation Distances - Portable and Mobile RF Communications
43
Applied Standards
43
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SYMBYX PDCare Quick Start Manual (2 pages)
Treatment
Brand:
SYMBYX
| Category:
Personal Care Products
| Size: 1.93 MB
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