SYMBYX PDCare - Labels on the Device

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14.1 Labels on the device

These are legible reproductions of the labels and hazard warnings affixed to the device.

Main Page

Table of Contents2
General Information7
Product Description7
Separate Power Supply Source (Mains Supply Transformer)8
Essential Performance and Basic Safety8
Temperature Range for Use8
User Restrictions8
General Caution and Warning Statements8
Device Description and Use8
Operation Description of Laser Treatment (General)9
General Risks and Hazards with Class 1 Lasers (IEC60825-1:2014)9
Device Overview10
Primary Operating Functions12
Replacement of Batteries12
Treatment Controls13
Overview Parameters of the Treatment Protocol for Medical Recording13
Medical Recording13
Device Application Specification14
Description14
Expected Life before Service Required14
Medical Purpose/Intended Use14
Patient14
Operator14
Application14
Environment14
Home Healthcare Environment15
Frequency of Device Use15
Treatment/Application Time Per Patient16
Treatment Interval16
Number of Treatments Per Patient/Sessions Per Patient16
Treatment Session Interval17
Contraindications17
Side Effects17
Patient Potential Reaction17
Patient Population18
Intended OPERATOR19
Operator Responsibilities19
Responsible Organization20
Patient Position20
Training21
General Battery Safety Information22
Battery Safety22
Warnings and Precautions22
Recycling of Batteries23
Replacement of Batteries24
Transport and Storage of the Device25
Laser Safety26
General Laser Safety Information26
General Risks with Class 1 Lasers (See Chapter 2.2) IEC 60825-127
Maintenance and Control of Emitted Output Power27
Protective Eyewear. Personal Protective Equipment (Optional Requirement)28
General Electrical and Mechanical Safety28
Cleaning/Disinfection Procedures28
Visual Inspections29
Information for Service Technicians30
Description of Controls, Messages, and Indicators31
Laser Emission Control31
On/Off31
Technical Specifications (General)32
Technical Specifications33
Pdcare Laser 904 Nm by SYMBYX33
Definitions34
Labels and Symbols36
Labels on the Device37
Symbols and Marking on Package Label38
Limitation of Liability38
Disposal and Recycling of the Device38
Transport and Packaging of the Device38
Distributor and Manufacturer Contact Information39
Reporting Serious Incidents39
Electromagnetic Compatibility (EMC)39
Electromagnetic Emissions - Guidance and Declaration40
Electromagnetic Immunity - Guidance and Declaration41
Separation Distances - Portable and Mobile RF Communications43
Applied Standards43

SYMBYX PDCare - Labels on the Device

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