Table of contents
Instructions for use • OR1 SmartScreen • PQJ219_EN_V1.0_04-2021_IFU_CE-MDR 3
Table of contents
1 General information.......................................................................................................................................4
1.1 Read the instructions for use....................................................................................................................4
1.2 Read the instructions for use of combinable products.............................................................................4
1.3 Scope........................................................................................................................................................4
1.4 Description of warning messages.............................................................................................................4
2 Normal use....................................................................................................................................................5
2.1 Intended use .............................................................................................................................................5
2.2 Indications.................................................................................................................................................5
2.3 Contraindications......................................................................................................................................5
2.4 Target user populations ............................................................................................................................5
2.5 Patient groups...........................................................................................................................................5
3 Safety............................................................................................................................................................6
3.1 Serious incidents ......................................................................................................................................6
3.2 Damaged products ...................................................................................................................................6
3.3 Unsterile product ......................................................................................................................................6
3.4 Contaminated products ............................................................................................................................6
3.5 Risks from electric current........................................................................................................................6
3.6 Damage due to ingress of liquid in electrical components.......................................................................7
3.7 Electromagnetic interference....................................................................................................................7
3.8 Combination with other components .......................................................................................................7
4 Product description ......................................................................................................................................9
4.1 Product overview ......................................................................................................................................9
4.2 Possible combinations..............................................................................................................................9
4.3 Technical data.........................................................................................................................................10
4.4 Symbols employed .................................................................................................................................11
4.4.1 Symbols on the packaging .......................................................................................................... 11
4.4.2 Symbols on the type plate........................................................................................................... 12
4.5 Ambient conditions .................................................................................................................................12
5 Preparation..................................................................................................................................................13
5.1 Unpacking the product ...........................................................................................................................13
5.2 Inspecting the device..............................................................................................................................13
5.3 Setting up the product............................................................................................................................13
5.4 Connecting the product..........................................................................................................................13
5.5 Connecting the product to AIDA.............................................................................................................14
5.6 Putting the product into operation..........................................................................................................15
6 Maintenance, servicing, repairs, and disposal............................................................................................16
6.1 Maintaining the product..........................................................................................................................16
6.2 Maintenance ...........................................................................................................................................16
6.3 Repairing the product .............................................................................................................................16
6.4 Disposing of the product ........................................................................................................................16
7 Accessories and spare parts ......................................................................................................................17
7.1 Accessories.............................................................................................................................................17
8 Electromagnetic compatibility.....................................................................................................................18
8.1 General notes on the operating environment .........................................................................................18
8.2 Accessories and cables ..........................................................................................................................18
8.3 Table 1 – Compliance level for immunity tests .......................................................................................18
8.4 Table 2 – Test levels for proximity fields from HF wireless communications equipment .......................20
8.5 Table 3 – Test levels for radiated and conducted immunity tests ..........................................................20
8.6 Table 4 – Emission class and group .......................................................................................................22
9 Subsidiaries.................................................................................................................................................23
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