Table of contents
Instructions for use • E-BOX • OYD476_EN_V1.0_03-2021_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 Initial commissioning ................................................................................................................................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 population.....................................................................................................................................5
3 Safety ............................................................................................................................................................6
3.1 Serious incidents ......................................................................................................................................6
3.2 Unsterile product ......................................................................................................................................6
3.3 Damaged products ...................................................................................................................................6
4 Product description ......................................................................................................................................7
4.1 Product overview ......................................................................................................................................7
4.2 Possible combinations..............................................................................................................................7
4.3 Technical data...........................................................................................................................................8
4.4 Ambient conditions ...................................................................................................................................8
4.5 Symbols on the packaging ....................................................................................................................... 9
5 Preparation..................................................................................................................................................10
5.1 Unpacking the product ...........................................................................................................................10
5.2 Testing the product.................................................................................................................................10
5.3 Connecting the product ..........................................................................................................................10
6 Disassembly................................................................................................................................................12
6.1 Disassembling the product ..................................................................................................................... 12
7 Maintenance, servicing, repairs, and disposal............................................................................................13
7.1 Repairing the product .............................................................................................................................13
7.2 Safety inspection in accordance with IEC 62353 ................................................................................... 13
7.3 Disposing of the product ........................................................................................................................13
8 Electromagnetic compatibility.....................................................................................................................14
8.1 General notes on the operating environment .........................................................................................14
8.2 Table 1 – Compliance level for immunity tests ....................................................................................... 14
8.3 Table 2 – Test levels for proximity fields from HF wireless communications equipment ....................... 16
8.4 Table 3 – Test levels for radiated and conducted immunity tests .......................................................... 17
8.5 Table 4 – Emission class and group .......................................................................................................18
8.6 Table 5 – Recommended separation distances between portable and mobile HF communications
equipment and the product ....................................................................................................................18
9 Subsidiaries.................................................................................................................................................20
