KARL STORZ ENDOSKOPE

IMAGE1 S H3 Camera Heads Instructions for Use Ver 1.0 Jan 2021

Instructions for Use

28 Pages

Table of contents  Table of contents 1 General information... 4 1.1 Read the instructions for use ... 4 1.2 Scope... 4 1.3 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 Unsterile product ... 6 3.3 Dangers from electrical current... 6 3.4 High light intensity ... 6 3.5 Failure of devices ... 6 4 Product description ... 7 4.1 Product overview ... 7 4.2 Possible combinations... 9 4.3 Technical data... 9 4.4 Symbols employed ... 10 4.4.1 Symbols on the packaging ... 10 4.4.2 Symbols on the product ... 11 4.5 Ambient conditions ... 11 5 Preparation... 12 5.1 Unpacking the product ... 12 5.2 Testing the product... 12 5.3 Assembling the product... 12 5.4 Connecting the light cable ... 12 5.5 Connecting the TH106 microscope camera head ... 13 6 Application ... 15 6.1 Using the product ... 15 6.2 Camera head buttons ... 15 7 Maintenance, servicing, repairs, and disposal... 17 7.1 Repairs to the product ... 17 7.2 Disposing of the product ... 17 8 Accessories and spare parts ... 18 8.1 Accessories... 18 9 Electromagnetic compatibility... 19 9.1 General notes on the operating environment ... 19 9.2 Table 1 – Compliance level for immunity tests ... 19 9.3 Table 2 – Test levels for proximity fields from HF wireless communications equipment ... 20 9.4 Table 3 – Test levels for radiated and conducted immunity tests ... 21 9.5 Table 4 – Emission class and group ... 22 9.6 Table 5 – Recommended separation distances between portable and mobile HF communications devices and the product ... 23 10 Subsidiaries... 24  Instructions for use • IMAGE1 S™ H3 Camera Heads • NXA595_EN_V1.0_01-2021_IFU_CE-MDR  3
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