SYMBYX PDCare User manual

INSTRUCTION MANUAL
PDCare 904 nm Laser by SYMBYX

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CONTENTS
1 General information............................................................................................................................7
1.1 Product description ................................................................................................................................. 7
1.2 Separate power supply source (mains supply transformer) ............................................................. 8
1.3 Essential performance and basic safety .............................................................................................. 8
1.4 Temperature range for use .................................................................................................................... 8
1.5 User restrictions ...................................................................................................................................... 8
1.6 General caution and warning statements ............................................................................................ 8
2 Device description and use ................................................................................................................8
2.1 Operation description of laser treatment (general) ............................................................................ 9
2.2 General risks and hazards with class 1 lasers (IEC60825-1:2014) ................................................. 9
2.3 Device overview .................................................................................................................................... 10
3 Primary operating functions .............................................................................................................12
3.1 Replacement of batteries ..................................................................................................................... 12
4 Treatment controls ...........................................................................................................................13
4.1 Overview parameters of the treatment protocol for medical recording ......................................... 13
5 Medical recording .............................................................................................................................13
6 Device application specification .......................................................................................................14

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6.1 Description ............................................................................................................................................. 14
6.1.1 Expected life before service required ......................................................................................... 14
6.2 Medical purpose/intended use ............................................................................................................ 14
6.3 Patient ..................................................................................................................................................... 14
6.4 Operator ................................................................................................................................................. 14
6.5 Application ............................................................................................................................................. 14
6.6 Environment ........................................................................................................................................... 14
6.6.1 Home healthcare environment .................................................................................................... 15
6.7 Frequency of device use ...................................................................................................................... 15
6.8 Treatment/application time per patient .............................................................................................. 16
6.9 Treatment interval ................................................................................................................................. 16
6.10 Number of treatments per patient/sessions per patient .............................................................. 16
6.11 Treatment session interval .............................................................................................................. 17
6.12 Contraindications .............................................................................................................................. 17
6.13 Side effects ........................................................................................................................................ 17
6.14 Patient potential reaction ................................................................................................................. 17
6.15 Patient population ............................................................................................................................. 18

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6.16 Intended OPERATOR ...................................................................................................................... 19
6.17 Operator responsibilities .................................................................................................................. 19
6.18 Responsible organization ................................................................................................................ 20
6.19 Patient position .................................................................................................................................. 20
6.20 Training ............................................................................................................................................... 21
7 General battery safety information ...................................................................................................22
7.1 Battery safety ......................................................................................................................................... 22
7.2 Warnings and precautions ................................................................................................................... 22
7.3 Recycling of batteries ........................................................................................................................... 23
7.4 Replacement of batteries ..................................................................................................................... 24
7.5 Transport and storage of the device .................................................................................................. 25
8 Laser safety......................................................................................................................................26
8.1 General laser safety information ......................................................................................................... 26
8.2 General risks with Class 1 Lasers (see Chapter 2.2) IEC 60825-1 ............................................... 27
8.3 Maintenance and control of emitted output power ........................................................................... 27
8.4 Protective eyewear. Personal protective equipment (optional requirement) ................................ 28
9 General electrical and mechanical safety ........................................................................................28

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9.1 Cleaning/disinfection procedures ....................................................................................................... 28
9.2 Visual inspections ................................................................................................................................. 29
9.3 Information for service technicians ..................................................................................................... 30
10 Description of controls, messages, and indicators...........................................................................31
10.1 Laser emission control ..................................................................................................................... 31
10.2 ON/OFF .............................................................................................................................................. 31
11 Technical specifications (general)....................................................................................................32
12 Technical specifications ...................................................................................................................33
12.1 PDCare Laser 904 nm by SYMBYX ............................................................................................... 33
13 Definitions ........................................................................................................................................34
14 Labels and symbols .........................................................................................................................36
14.1 Labels on the device ......................................................................................................................... 37
14.2 Symbols and marking on package label ........................................................................................ 38
15 Limitation of liability ..........................................................................................................................38
16 Disposal and recycling of the device................................................................................................38
17 Transport and packaging of the device ............................................................................................38
18 Distributor and manufacturer contact information ............................................................................39
18.1 Reporting serious incidents ............................................................................................................. 39