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| Title: | MEDICAL ELECTRICAL EQUIPMENT: BASIC SAFETY & ESSENTIAL PERFORMANCE | |
| Company: | C-RAD POSITIONING AB - Uppsala, SWEDEN | |
| Product Information: |
Positioning system Catalyst+ (generic product number: SP-003): Model Nos. Catalyst+ Scanner HY-004 and HY-005, Gating Box Varian EXGI HZ-009, Gating Box Varian EXGI TrueBeam HZ-022, Gating Box UBTI HZ-025, Gating box UGI HZ-026, Laser Control Box HZ-020 and Laser elevator column HD-010. Also tested to: IEC 60601-1-6.
Positioning System, part of Sentinel SP001 System, Model Nos. Laser Scanner LS200, Gating Control Box HZ-006 Philips BigBore, Gating Control Box HZ-008, Siemens Open Interface, Gating Control Box HZ-011 Toshiba Interface, Gating Control Box HZ019 GE Interface, Laser Control Box HZ-020 and Laser elevator column HD-010. Also tested to IEC 60601-1-6. | |
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| Evaluated to the following: | A representative sample of the listed devices have been tested, investigated and found to comply with the requirements of the Standard(s) Medical Electrical Equipment, Part 1: General Requirements for Basic Safety & Essential Performance (AAMI-ES60601-1) and are identified as CLASSIFIED with the ETL Listed Mark. | |
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